Tuesday, October 9, 2012

Lorabid


Generic Name: loracarbef (lor a KAR bef)

Brand Names: Lorabid, Lorabid Pulvules


What is Lorabid (loracarbef)?

Loracarbef is an antibiotic that fights bacteria in your body.


Loracarbef is used to treat many different types of infections caused by bacteria.


Loracarbef may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Lorabid (loracarbef)?


Do not take this medication if you are allergic to loracarbef, or to similar antibiotics, such as Ceftin, Cefzil, Duricef, Fortaz, Keflex, Omnicef, Spectracef, Suprax, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).


Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.


What should I discuss with my healthcare provider before taking Lorabid (loracarbef)?


Do not take this medication if you are allergic to loracarbef or to any cephalosporin antibiotic, such as:

  • cefadroxil (Duricef);




  • cefdinir (Omnicef);




  • cefditoren (Spectracef);




  • cefixime (Suprax);




  • cefprozil (Cefzil);




  • ceftazidime (Fortaz);




  • cefuroxime (Ceftin);




  • cephalexin (Keflex); and others.



Before taking loracarbef, tell your doctor if you have:



  • kidney disease;




  • a history of intestinal problems (especially colitis); or




  • are allergic to any drugs, especially penicillins.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take loracarbef.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loracarbef passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The liquid form of loracarbef may contain sucrose (sugar). Talk to your doctor before using this form of loracarbef if you have diabetes.


How should I take Lorabid (loracarbef)?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


Take this medicine with a full glass of water. Take loracarbef on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take loracarbef for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Loracarbef will not treat a viral infection such as the common cold or flu.

Contact your doctor if your infection does not improve or if your symptoms get worse.


Store this medication at room temperature away from moisture and heat.

Throw away any unused liquid medication that is older than 14 days.


What happens if I miss a dose?


Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.


What should I avoid while taking Lorabid (loracarbef)?


Avoid using antacids within 1 hour before or after taking loracarbef. Antacids can make it harder for your body to absorb loracarbef.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.


Lorabid (loracarbef) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;




  • seizure (convulsions);




  • fever, sore throat, and joint pain with a severe blistering, peeling, and red skin rash;




  • easy bruising or bleeding, unusual weakness; or




  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness.



Less serious side effects may include:



  • mild itching or skin rash;




  • mild nausea, vomiting, stomach pain, loss of appetite;




  • warmth, redness, or tingling under your skin;




  • headache;




  • dizziness, drowsiness; or




  • vaginal itching or discharge.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.


What other drugs will affect Lorabid (loracarbef)?


Before you take loracarbef, tell your doctor if you are also taking:



  • probenecid (Benemid); or




  • a diuretic (water pill) such as amiloride (Midamor, Moduretic), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), and others.



This list is not complete and there may be other drugs that can interact with loracarbef. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.



More Lorabid resources


  • Lorabid Side Effects (in more detail)
  • Lorabid Use in Pregnancy & Breastfeeding
  • Lorabid Drug Interactions
  • Lorabid Support Group
  • 1 Review for Lorabid - Add your own review/rating


  • Lorabid Prescribing Information (FDA)

  • Lorabid Monograph (AHFS DI)

  • Lorabid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lorabid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Lorabid with other medications


  • Bladder Infection
  • Bronchitis
  • Impetigo
  • Kidney Infections
  • Otitis Media
  • Pneumonia
  • Sinusitis
  • Skin Infection
  • Strep Throat
  • Tonsillitis/Pharyngitis
  • Upper Respiratory Tract Infection


Where can I get more information?


  • Your pharmacist can provide more information about loracarbef.

See also: Lorabid side effects (in more detail)


Monday, October 8, 2012

Tramacet


Generic Name: tramadol and acetaminophen (Oral route)


TRAM-a-dol hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen


Oral route(Tablet)

Ultracet(R) contains tramadol hydrochloride and acetaminophen; acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death and most cases of liver injury associated with doses exceeding 4000 mg/day and often involve more than one acetaminophen-containing product



Commonly used brand name(s)

In the U.S.


  • Ultracet

In Canada


  • Tramacet

Available Dosage Forms:


  • Tablet

Therapeutic Class: Analgesic Combination


Chemical Class: Tramadol


Uses For Tramacet


Tramadol and acetaminophen combination is used to relieve pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.


Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for the short-term relief of pain, physical dependence will probably not occur.


Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.


This medicine is available only with your doctor's prescription.


Before Using Tramacet


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of tramadol and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving tramadol and acetaminophen combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rasagiline

  • Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acetophenazine

  • Amitriptyline

  • Amoxapine

  • Bromperidol

  • Carbamazepine

  • Chlorpromazine

  • Chlorprothixene

  • Citalopram

  • Clobazam

  • Clomipramine

  • Clorgyline

  • Clovoxamine

  • Clozapine

  • Cyclobenzaprine

  • Desipramine

  • Desvenlafaxine

  • Dothiepin

  • Doxepin

  • Duloxetine

  • Escitalopram

  • Ethopropazine

  • Femoxetine

  • Fluoxetine

  • Flupenthixol

  • Fluphenazine

  • Fluvoxamine

  • Haloperidol

  • Imipramine

  • Isocarboxazid

  • Ketamine

  • Linezolid

  • Lofepramine

  • Loxapine

  • Melperone

  • Mesoridazine

  • Methotrimeprazine

  • Milnacipran

  • Mirtazapine

  • Moclobemide

  • Molindone

  • Nortriptyline

  • Olanzapine

  • Paroxetine

  • Penfluridol

  • Perphenazine

  • Phenelzine

  • Pimozide

  • Pipotiazine

  • Prochlorperazine

  • Promazine

  • Promethazine

  • Propiomazine

  • Protriptyline

  • Remoxipride

  • Risperidone

  • Sertraline

  • Sulpiride

  • Tapentadol

  • Thiethylperazine

  • Thioridazine

  • Thiothixene

  • Tranylcypromine

  • Trifluoperazine

  • Triflupromazine

  • Trimeprazine

  • Trimipramine

  • Venlafaxine

  • Vilazodone

  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Carbamazepine

  • Digoxin

  • Isoniazid

  • Phenytoin

  • Quinidine

  • Warfarin

  • Zidovudine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse, history of or

  • Central nervous system (CNS) depression (not awake and alert) or

  • Central nervous system (CNS) infection (e.g., meningitis) or

  • Depression, history of or

  • Drug abuse, history of or

  • Head injury or

  • Increased pressure in the head or

  • Mental illness, history of or

  • Metabolic disorders or

  • Respiratory depression (hypoventilation or slow breathing) or

  • Seizures or epilepsy, history of or

  • Stomach problems, severe—Use with caution. The chance of side effects may be increased.

  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Liver disease—Should not be used in patients with this condition.

Proper Use of tramadol and acetaminophen

This section provides information on the proper use of a number of products that contain tramadol and acetaminophen. It may not be specific to Tramacet. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.


This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For pain:
      • Adults—2 tablets every 4 to 6 hours as needed for up to 5 days.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Tramacet


It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.


Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines; medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; opioids; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.


Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions) and may cause a serious condition called serotonin syndrome.


This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.


This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.


This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.


Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.


Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.


Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing; irregular, fast or slow, or shallow breathing; nausea or vomiting; pain in the upper stomach; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, shortness of breath, or yellow eyes or skin.


Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.


Tramacet Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Burning, itching, and redness of the skin

  • chest pain

  • cough

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • hives

  • itching

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • seizures (convulsions)

  • shortness of breath

  • skin rash

  • tightness in the chest

  • unusual tiredness or weakness

  • vomiting

  • wheezing

Incidence not known
  • Blistering, peeling, or loosening of the skin

  • chills

  • diarrhea

  • difficulty with breathing

  • joint or muscle pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • noisy breathing

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Abdominal or stomach pain

  • black, tarry stools

  • chest pain or discomfort

  • dark urine

  • difficulty with sleeping

  • disorientation

  • drowsiness to profound coma

  • fever

  • headache

  • irregular, fast or slow, or shallow breathing

  • lethargy

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • mood or other mental changes

  • nausea

  • pale or blue lips, fingernails, or skin

  • seeing, hearing, or feeling things that are not there

  • unpleasant breath odor

  • vomiting of blood

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Acid or sour stomach

  • anxiety

  • belching

  • bloated or full feeling

  • constipation

  • dry mouth

  • excess air or gas in the stomach or intestines

  • false or unusual sense of well-being

  • feeling of warmth

  • heartburn

  • increase in bowel movements

  • increased sweating

  • indigestion

  • loose stools

  • loss of strength or energy

  • muscle pain or weakness

  • nervousness

  • numbness or tingling of the hands, legs, and feet

  • painful or difficult urination

  • redness of the face, neck, arms, and occasionally the upper chest

  • sleepiness or unusual drowsiness

  • sleeplessness

  • soft stools

  • stomach discomfort

  • trouble with sleeping

  • unable to sleep

  • weight loss

Rare
  • Abnormal thinking

  • blurred vision

  • change in vision

  • clumsiness, unsteadiness, trembling, or problems with muscle control or coordination

  • cold sweats

  • continuing ringing, buzzing, or unexplained noise in the ears

  • crying

  • decrease in the frequency or amount of urination

  • decreased awareness or responsiveness

  • decreased interest in sexual intercourse

  • depression

  • difficulty in passing urine (dribbling)

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • dysphoria

  • euphoria

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • feeling of constant movement of self or surroundings

  • feeling unusually cold

  • headache, severe or continuing

  • high or low blood pressure

  • increased muscle tone

  • involuntary muscle contractions

  • loss of memory

  • loss of sense of reality

  • loss of sexual ability, desire, drive, or performance

  • migraine headache

  • morbid dreaming

  • paranoia

  • pounding in the ears

  • problems with memory

  • quick to react or overreact emotionally

  • rapidly changing moods

  • sensation of spinning

  • severe stomach pain

  • shakiness and unsteady walk

  • shivering

  • swelling of the tongue

  • vomiting of blood or material that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



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More Tramacet resources


  • Tramacet Use in Pregnancy & Breastfeeding
  • Drug Images
  • Tramacet Drug Interactions
  • Tramacet Support Group
  • 25 Reviews for Tramacet - Add your own review/rating


Compare Tramacet with other medications


  • Pain
  • Rheumatoid Arthritis

felodipine



fe-LOE-di-peen


Commonly used brand name(s)

In the U.S.


  • Plendil

Available Dosage Forms:


  • Tablet, Extended Release

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Calcium Channel Blocker


Chemical Class: Dihydropyridine


Uses For felodipine


Felodipine is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Felodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. Felodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart, which reduces the workload.


felodipine is available only with your doctor's prescription.


Before Using felodipine


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For felodipine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to felodipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of felodipine in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of felodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving felodipine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking felodipine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using felodipine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Amiodarone

  • Atazanavir

  • Cyclosporine

  • Dantrolene

  • Droperidol

  • Mibefradil

Using felodipine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acebutolol

  • Alprenolol

  • Amprenavir

  • Atenolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bucindolol

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Dalfopristin

  • Dilevalol

  • Esmolol

  • Fluconazole

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Labetalol

  • Levobunolol

  • Magnesium

  • Mepindolol

  • Metipranolol

  • Metoprolol

  • Nadolol

  • Nebivolol

  • Nelfinavir

  • Oxcarbazepine

  • Oxprenolol

  • Penbutolol

  • Phenobarbital

  • Pindolol

  • Propranolol

  • Quinupristin

  • Rifapentine

  • Sotalol

  • St John's Wort

  • Talinolol

  • Tertatolol

  • Timolol

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using felodipine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use felodipine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Grapefruit Juice

Other Medical Problems


The presence of other medical problems may affect the use of felodipine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Heart failure—Use with caution. May make this condition worse.

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of felodipine


In addition to the use of felodipine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


Remember that felodipine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.


Swallow the extended-release tablet whole. Do not crush, break, or chew it.


You may take felodipine without food or with a light meal.


Dosing


The dose of felodipine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of felodipine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (extended-release tablets):
    • For high blood pressure:
      • Adults—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of felodipine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using felodipine


It is very important that your doctor check your progress at regular visits to make sure felodipine is working properly and to check for unwanted effects.


Low blood pressure (hypotension) may occur while taking felodipine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.


felodipine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet; tingling of the hands or feet; or unusual weight gain or weight loss.


Redness, swelling, or bleeding of the gums may occur while taking felodipine. Brushing and flossing your teeth carefully and regularly, and massaging your gums may help prevent this. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any redness, swelling, or bleeding of your gums.


felodipine Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Bloating or swelling of face, arms, hands, lower legs, or feet

  • rapid weight gain

  • tingling of hands or feet

  • unusual weight gain or loss

Less common
  • Body aches or pain

  • chills

  • cough

  • difficulty in breathing

  • ear congestion

  • fever

  • headache

  • loss of voice

  • nasal congestion

  • runny nose

  • sneezing

  • sore throat

  • unusual tiredness or weakness

Incidence not known
  • Blurred vision

  • chest pain, tightness, or heaviness

  • confusion

  • congestion

  • cough producing mucus

  • diarrhea

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • fast, slow, or irregular heartbeat

  • general feeling of discomfort or illness

  • hoarseness

  • joint pain

  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of appetite

  • muscle aches and pains

  • nausea

  • pain or discomfort in arms, jaw, back, or neck

  • pale skin

  • shivering

  • shortness of breath

  • sweating

  • swelling or puffiness of face

  • tender or swollen glands in neck

  • trouble in swallowing

  • trouble sleeping

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • voice changes

  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Feeling of warmth

  • redness of the face, neck, arms and occasionally, upper chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Acid or sour stomach

  • belching

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • constipation

  • heartburn

  • indigestion

  • lack or loss of strength

  • skin rash

  • stomach discomfort, upset, or pain

Rare
  • Bleeding gums

  • irritation in mouth

  • redness and swelling of gums

Incidence not known
  • Bloated or full feeling

  • bloody nose

  • burning while urinating

  • decreased interest in sexual intercourse

  • difficult or painful urination

  • difficulty in moving

  • discouragement

  • disturbed color perception

  • double vision

  • dry mouth

  • excess air or gas in stomach or intestines

  • feeling sad or empty

  • fear or nervousness

  • frequent strong or increased urge to urinate

  • halos around lights

  • hives or welts

  • inability to have or keep an erection

  • increased need to urinate

  • increased volume of pale or dilute urine

  • irritability

  • itching

  • loss in sexual ability, desire, drive, or performance

  • loss of interest or pleasure

  • muscle cramps or stiffness

  • night blindness

  • overbright appearance of lights

  • pain or tenderness around eyes and cheekbones

  • passing gas

  • passing urine more often

  • redness of skin

  • sleepiness or unusual drowsiness

  • sleeplessness

  • sores, welting, or blisters

  • swelling of the breasts or breast soreness in both females and males

  • swollen joints

  • tiredness

  • trouble concentrating

  • tunnel vision

  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: felodipine side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More felodipine resources


  • Felodipine Side Effects (in more detail)
  • Felodipine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Felodipine Drug Interactions
  • Felodipine Support Group
  • 3 Reviews for Felodipine - Add your own review/rating


  • Felodipine Prescribing Information (FDA)

  • Felodipine Professional Patient Advice (Wolters Kluwer)

  • Felodipine Monograph (AHFS DI)

  • Felodipine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Plendil Prescribing Information (FDA)

  • Plendil Consumer Overview



Compare felodipine with other medications


  • Angina Pectoris Prophylaxis
  • High Blood Pressure
  • Raynaud's Syndrome

Tuesday, October 2, 2012

Stemetil Injection





1. Name Of The Medicinal Product



Stemetil 12.5mg/ml Injection


2. Qualitative And Quantitative Composition



Each 1 ml of Stemetil injection contains 12.5 mg prochlorperazine mesilate.



Excipients:



Each 1 ml of Stemetil injection contains 1 mg of sodium sulphite, 0.75 mg of sodium metabisulphite and 6 mg of sodium chloride.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Colourless sterile solution.



4. Clinical Particulars



4.1 Therapeutic Indications



Stemetil is a potent phenothiazine neuroleptic.



Uses: The treatment of nausea and vomiting and in schizophrenia (particularly the chronic stage) and acute mania.



4.2 Posology And Method Of Administration



Adults



For deep intramuscular injection.










Indication




Dosage




Treatment of nausea and vomiting




12.5 mg by deep i.m. injection followed by oral medication 6 hours later if necessary.




Schizophrenia and other psychotic disorders




12.5 mg to 25 mg b.i.d. or t.d.s. by deep i.m. injection until oral treatment becomes possible.



Children



Intramuscular Stemetil should not be given to children.



Elderly



A lower dose is recommended (see section 4.4)



4.3 Contraindications



Known hypersensitivity to prochlorperazine or to any of the other ingredients. The use of Stemetil injection is contraindicated in children as it has been associated with dystonic reactions after the cumulative dose of 0.5 mg/kg.



4.4 Special Warnings And Precautions For Use



Stemetil should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma or agranulocytosis.



Close monitoring is required in patients with epilepsy or a history of seizures, as phenothiazines may lower the seizure threshold.



As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires immediate haematological investigation.



It is imperative that treatment be discontinued in the event of unexplained fever, as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity). Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brain disease are predisposing factors.



Acute withdrawal symptoms, including nausea, vomiting and insomnia, have very rarely been reported following the abrupt cessation of high doses of neuroleptics. Relapse may also occur, and the emergence of extrapyramidal reactions has been reported. Therefore, gradual withdrawal is advisable.



In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time.



Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and congenital or acquired (i.e. drug induced) QT prolongation. The risk-benefit should be fully assessed before Stemetil treatment is commenced. If the clinical situation permits, medical and laboratory evaluations (e.g. biochemical status and ECG) should be performed to rule out possible risk factors (e.g. cardiac disease; family history of QT prolongation; metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia; starvation; alcohol abuse; concomitant therapy with other drugs known to prolong the QT interval) before initiating treatment with Stemetil and during the initial phase of treatment, or as deemed necessary during the treatment (see sections 4.5 and 4.8).



Avoid concomitant treatment with other neuroleptics (see section 4.5).



In randomised clinical trials versus placebo performed in a population with elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Stemetil should be used with caution with stroke risk factors.



As with all antipsychotic drugs, Stemetil should not be used alone where depression is predominant. However, it may be combined with antidepressant therapy to treat those conditions in which depression and psychosis coexist.



Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight.



To prevent skin sensitisation in those frequently handling preparations of phenothiazines, the greatest care must be taken to avoid contact of the drug with the skin (see section 4.8).



Postural hypotension with tachycardia as well as local pain or nodule formation may occur after i.m. administration.



It should be used with caution in the elderly, particularly during very hot or very cold weather (risk of hyper-, hypothermia).



The elderly are particularly susceptible to postural hypotension.



Stemetil should be used cautiously in the elderly owing to their susceptibility to drugs acting on the central nervous system and a lower initial dosage is recommended. There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use. Care should also be taken not to confuse the adverse effects of Stemetil, e.g. orthostatic hypotension, with the effects due to the underlying disorder.



Increased Mortality in Elderly people with Dementia



Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.



Stemetil is not licensed for the treatment of dementia-related behavioural disturbances.



Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Stemetil and preventative measures undertaken.



Hyperglycaemia or intolerance to glucose had been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes, who are started on Stemetil, should get appropriate glycaemic monitoring during treatment (see section 4.8).



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Adrenaline must not be used in patients overdosed with Stemetil (see section 4.9).



The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. Respiratory depression may occur.



Anticholinergic agents may reduce the antipsychotic effect of neuroleptics and the mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs, possibly leading to constipation, heat stroke, etc.



Some drugs interfere with absorption of neuroleptic agents: antacids, anti-Parkinson drugs and lithium.



Where treatment for neuroleptic-induced extrapyramidal symptoms is required, anticholinergic antiparkinsonian agents should be used in preference to levodopa, since neuroleptics antagonise the antiparkinsonian action of dopaminergics.



High doses of neuroleptics reduce the response to hypoglycaemic agents, the dosage of which might have to be raised.



The hypotensive effect of most antihypertensive drugs especially alpha adrenoceptor blocking agents may be exaggerated by neuroleptics.



The action of some drugs may be opposed by phenothiazine neuroleptics; these include amfetamine, levodopa, clonidine, guanethidine, adrenaline.



Increases or decreases in the plasma concentrations of a number of drugs, e.g. propranolol, phenobarbital have been observed but were not of clinical significance.



Simultaneous administration of desferrioxamine and prochlorperazine has been observed to induce transient metabolic encephalopathy characterised by loss of consciousness for 48-72 hours.



There is an increased risk of arrhythmias when antipsychotics are used with concomitant QT prolonging drugs (including certain antiarrhythmics, antidepressants and other antipsychotics) and drugs causing electrolyte imbalance.



There is an increased risk of agranulocytosis when neuroleptics are used concurrently with drugs with myelosuppressive potential, such as carbamazepine or certain antibiotics and cytotoxics.



In patients treated concurrently with neuroleptics and lithium, there have been rare reports of neurotoxicity.



4.6 Pregnancy And Lactation



There is inadequate evidence of safety in pregnancy. There is evidence of harmful effects in animals. Stemetil should be avoided in pregnancy unless the physician considers it essential. Neuroleptics may occasionally prolong labour and at such time should be withheld until the cervix is dilated 3-4 cm. Possible adverse effects on the neonate include lethargy or paradoxical hyperexcitability, tremor and low apgar score.



Phenothiazines may be excreted in milk, therefore breast feeding should be suspended during treatment.



4.7 Effects On Ability To Drive And Use Machines



Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.



4.8 Undesirable Effects



Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders.



Adverse effects:



Blood and lymphatic system disorders: A mild leukopenia occurs in up to 30% of patients on prolonged high dosage. Agranulocytosis may occur rarely: it is not dose related (see section 4.4).



Endocrine: Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia, amenorrhoea, impotence.



Nervous system disorders: Acute dystonia or dyskinesias, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.



Akathisia characteristically occurs after large initial doses.



Parkinsonism is more common in adults and the elderly. It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism. Commonly just tremor.



Tardive dyskinesia: If this occurs it is usually, but not necessarily, after prolonged or high dosage. It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible.



Insomnia and agitation may occur.



Eye disorders: Ocular changes and the development of metallic greyish-mauve coloration of exposed skin have been noted in some individuals mainly females, who have received chlorpromazine continuously for long periods (four to eight years). This could possibly happen with Stemetil.



Cardiac disorders: ECG changes include QT prolongation (as with other neuroleptics), ST depression, U-Wave and T-Wave changes. Cardiac arrhythmias, including ventricular arrhythmias and atrial arrhythmias, a-v block, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.



There have been isolated reports of sudden death, with possible causes of cardiac origin (see section 4.4), as well as cases of unexplained sudden death, in patients receiving neuroleptic phenothiazines.



Vascular disorders: Hypotension, usually postural, commonly occurs. Elderly or volume depleted subjects are particularly susceptible; it is more likely to occur after intramuscular injection. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - Frequency unknown.



Gastrointestinal disorders: dry mouth may occur.



Respiratory, thoracic and mediastinal disorders: Respiratory depression is possible in susceptible patients. Nasal stuffiness may occur.



Hepato-biliary disorders: Jaundice, usually transient, occurs in a very small percentage of patients taking neuroleptics. A premonitory sign may be sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstruction of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinphilia indicates the allergic nature of this phenomenon. Treatment should be withheld on the development of jaundice (see section 4.4).



Skin and subcutaneous tissue disorders: Contact skin sensitisation may occur rarely in those frequently handling preparations of certain phenothiazines (see section 4.4). Skin rashes of various kinds may also be seen in patients treated with the drug. Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight.



General disorders and administration site conditions: Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic (see section 4.4).



Intolerance to glucose, hyperglycaemia (see section 4.4)



4.9 Overdose



Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.



If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.



Generalised vasodilatation may result in circulatory collapse; raising the patient's legs may suffice. In severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.



Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended. Avoid the use of adrenaline.



Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.



Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10 mg) or orphenadrine (20-40 mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.



Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Psycholeptics; Phenothiazines with piperazine structure, ATC code: N05AB04



Stemetil is a potent phenothiazine neuroleptic.



5.2 Pharmacokinetic Properties



There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium sulphite anhydrous (E221)



Sodium metabisulphite powder (E223)



Sodium chloride



Ethanolamine



Water for injections (non-sterilised)



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



5 years



6.4 Special Precautions For Storage



Keep ampoules in the outer carton, in order to protect from light. Discoloured solutions should not be used.



6.5 Nature And Contents Of Container



Stemetil injection is supplied in colourless glass ampoules in packs of 10 x 1ml.



6.6 Special Precautions For Disposal And Other Handling



No special requirements.



7. Marketing Authorisation Holder



Sanofi-aventis



One Onslow Street



Guildford



Surrey



GU1 4YS



UK



8. Marketing Authorisation Number(S)



PL 04425/0590



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of first authorisation: 28 February 1973



Date of latest renewal: 16 September 2002



10. Date Of Revision Of The Text



7th July 2011



LEGAL STATUS


POM




Lexapro



Generic Name: Escitalopram Oxalate
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: 1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-S-(+)-5-isobenzofurancarbonitrile oxalate
Molecular Formula: C20H21FN2O•C2H2O4
CAS Number: 219861-08-2


  • Suicidality


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 e f Escitalopram is not approved for use in pediatric patients.1 (See Pediatric Use under Cautions.)




  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.e f




  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.e f g




  • Appropriately monitor and closely observe all patients who are started on escitalopram therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 e f g (See Worsening of Depression and Suicidality Risk under Cautions.)




Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI) and S-enantiomer of citalopram.1


Uses for Lexapro


Major Depressive Disorder


Management of major depressive disorder.1


Efficacy in hospital settings not established.1 8


Generalized Anxiety Disorder


Management of generalized anxiety disorder.1


Lexapro Dosage and Administration


General



  • Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, and vice versa.1




  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 e f g (See Worsening of Depression and Suicidality Risk under Cautions.)




  • Sustained therapy may be required; monitor periodically for need for continued therapy.1




  • Avoid abrupt discontinuance of therapy.1 To avoid withdrawal reactions, taper dosage gradually.1 5 6 7 (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)




  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)



Administration


Oral Administration


Administer orally once daily (morning or evening) without regard to meals.1


Dosage


Available as escitalopram oxalate; dosage is expressed in terms of escitalopram.1


Escitalopram dosages of 10 mg daily appear to be comparable to racemic citalopram dosages of 40 mg daily.2


Adults


Major Depressive Disorder

Oral

Initially, 10 mg daily.1 May be increased to 20 mg daily after ≥1 week; no additional therapeutic benefit with higher dosages.1


Optimum duration not established; may require several months of therapy or longer.1 5


Generalized Anxiety Disorder

Oral

Initially, 10 mg daily.1 Dosage may be increased to 20 mg daily after ≥1 week.1


Not studied >8 weeks of therapy; periodically reevaluate need for therapy.1


Special Populations


Hepatic Impairment


10 mg daily.1


Renal Impairment


No dosage adjustment required in patients with mild to moderate renal impairment; not studied in patients with severe renal impairment (Clcr <20 mL/minute).1


Geriatric Patients


10 mg daily.1


Cautions for Lexapro


Contraindications



  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.1 (See MAO Inhibitors under Warnings and see Specific Drugs under Interactions.)




  • Concurrent pimozide therapy.1 (See Specific Drugs under Interactions.)




  • Known hypersensitivity to escitalopram, citalopram, or any ingredient in the formulation.1



Warnings/Precautions


Warnings


MAO Inhibitors

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 (See Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)


Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT1 receptor agonists [“triptans”] or drugs that impair serotonin metabolism (e.g., MAO inhibitors).1 18 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).1 18 (See Specific Drugs under Interactions.)


Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.1 e f g h However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.e f g


Appropriately monitor and closely observe patients receiving escitalopram for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.1 e f g (See Boxed Warning and also see Pediatric Use under Cautions.)


Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.f g Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 e f g If decision is made to discontinue therapy, taper escitalopram dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 f (See Withdrawal of Therapy under Cautions.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 f


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.1 f


Bipolar Disorder

May unmask bipolar disorder.1 f (See Activation of Mania or Hypomania under Cautions.) Escitalopram is not approved for use in treating bipolar depression.1


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 f


Fetal/Neonatal Morbidity and Mortality

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, reported in neonates exposed to escitalopram, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.1


Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial morbidity and mortality.1 25 27


Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.1 25 26


Sensitivity Reactions


Hypersensitivity Reactions

Possible anaphylaxis, allergic reactions, and angioedema.1


General Precautions


Withdrawal of Therapy

Possibly severe withdrawal reactions (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania); avoid abrupt discontinuance of therapy.1 Taper dosage gradually (e.g., over a period of several weeks).1 5 6 7


Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding; use with caution.1


Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.1 (See Interactions.)


SIADH or Hyponatremia

Possible SIADH secretion or hyponatremia requiring medical intervention and/or escitalopram discontinuance.1


Activation of Mania or Hypomania

Possible activation of mania and hypomania in major depressive disorder; use with caution in patients with a history of mania.1 (See Bipolar Disorder under Cautions.)


Seizures

Risk of seizures not systematically evaluated; use with caution in patients with a history of seizures.1


Cognitive/Physical Impairment

Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery).1


Concomitant Disease

Limited experience; use with caution in patients with altered metabolism or hemodynamics.1


Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT not studied.1


Specific Populations


Pregnancy

Category C.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.1 25 26


Lactation

Distributed into milk;23 24 possible serious adverse reactions (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 8 The manufacturer states that escitalopram was not demonstrated to be effective in a placebo-controlled trial in children and adolescents with major depressive disorder.1


FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 f However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.h No suicides occurred in these pediatric trials.1 f h


Carefully consider these findings when assessing potential benefits and risks of escitalopram in a child or adolescent for any clinical use.1 e f g h (See Worsening of Depression and Suicidality Risk under Cautions.)


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1


Titrate dosage carefully.1 (See Geriatric Patients under Dosage and Administration.)


In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.e f (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)


Hepatic Impairment

Systemic exposure to escitalopram may be increased.1 (See Elimination: Special Populations, under Pharmacokinetics.) Use with caution.1


Renal Impairment

Use with caution in patients with severe renal impairment (Clcr <20 mL/minute).1 (See Elimination: Special Populations, under Pharmacokinetics.)


Common Adverse Effects


Insomnia,1 nausea,1 increased sweating,1 sexual dysfunction (ejaculation disorder [primarily ejaculatory delay], decreased libido, anorgasmia),1 fatigue,1 and somnolence.1


Interactions for Lexapro


Extensively metabolized in the liver, principally by CYP2C19 and 3A4.1 Does not inhibit CYP1A2, 2C9, 2C19, 2E1, or 3A4 in vitro and exhibits only modest inhibition against CYP2D6.1


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP2C19 and 3A4: clinically important pharmacokinetic interaction unlikely since escitalopram is metabolized by multiple enzyme systems.1


Drugs Metabolized by Hepatic Microsomal Enzymes


Substrates of CYP2D6: potential pharmacokinetic (increased peak plasma concentrations and AUC of the substrate) interactions.1 Use with caution.1


Drugs Affecting Hemostasis


Potential pharmacologic interaction (increased risk of bleeding) with drugs that affect coagulation; use with caution.1 11


Drugs Associated with Serotonin Syndrome


Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.1 18 Avoid such use, or use with caution.1 18 (See Serotonin Syndrome under Cautions.)


Specific Drugs








































































Drug



Interaction



Comment



Alcohol



Does not potentiate the cognitive and motor effects of alcohol1



Concomitant use not recommended1



Antidepressants, tricyclics (TCAs) (e.g., desipramine, imipramine)



Possible increased plasma TCA concentrations with TCAs that are substrates of CYP2D61 c



Use with caution1



Carbamazepine



Possible increased escitalopram clearance1



Cimetidine



Increased racemic citalopram AUC and peak plasma concentrations1 7



Citalopram



Therapeutic duplication; escitalopram is the more active isomer of racemic citalopram1



Concomitant use not recommended1



CNS drugs



Potentially additive CNS effects1



Use with caution1



Digoxin



Pharmacokinetic interaction unlikely1



5-HT1 receptor agonists (“triptans”)



Potentially life-threatening serotonin syndrome1 18



Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 18



Isoniazid



Possible serotonin syndromed



Ketoconazole



Decreased peak plasma concentrations and AUC of ketoconazole1



Linezolid



Possible serotonin syndrome1 19 20 21 22



Use with caution1



Lithium



Enhanced serotonergic effects of escitalopram1


Pharmacokinetic interaction unlikely1



Use with caution1



MAO inhibitors



Possible serotonin syndrome or NMS1



Concomitant use contraindicated1


Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, or vice versa1



Metoprolol



Increased plasma metoprolol concentrations possibly resulting in decreased cardioselectivity1



NSAIAs (e.g., aspirin)



Increased risk of bleeding1



Use with caution1



Pimozide



Possible increased risk of QTc interval prolongation with racemic citalopram1


Pharmacokinetic interactions unlikely with racemic citalopram1



Concomitant use contraindicated1



Ritonavir



Pharmacokinetic interactions unlikely1



Sibutramine



Possible serotonin syndrome18



Use with caution18



Theophylline



No effects evident on theophylline pharmacokinetics1



Triazolam



Pharmacokinetic interactions unlikely1



Tryptophan and other serotonin precursors



Possible serotonin syndrome1



Concomitant use not recommended1



Warfarin



Possible increased PT and risk of bleeding1 11


Pharmacokinetic interactions unlikely with racemic citalopram1 11



Use with caution1


Lexapro Pharmacokinetics


Absorption


Bioavailability


Well absorbed following oral administration, with peak plasma concentration usually attained within 5 hours.1


Commercially available tablets and oral solution are bioequivalent.1


Onset


Antidepressant effect usually occurs within 1–4 weeks.1


Food


Food does not affect absorption.1


Special Populations


In geriatric patients, AUC is increased approximately 50%.1


Distribution


Extent


Crosses the placenta.1


Distributed into breast milk.23 24


Plasma Protein Binding


Approximately 56%.1


Elimination


Metabolism


Extensively metabolized in the liver to less pharmacologically active metabolites by multiple enzyme systems, including CYP3A4 and CYP2C19.1


Elimination Route


Eliminated principally in urine.1


Half-life


27–32 hours.1


Special Populations


In geriatric patients, half-life is increased by 50%.1


Hepatic impairment decreases racemic citalopram oral clearance by 37% and doubles its half-life.1


Mild to moderate renal impairment decreases racemic citalopram oral clearance by 17%.1 Pharmacokinetics not studied in patients with severe renal impairment (Clcr <20 mL/minute).1


Stability


Storage


Oral


Solution and Tablets

25°C; excursions permitted to 15–30°C.1


ActionsActions



  • S-enantiomer of citalopram,1 an SSRI that occurs as a 50:50 racemic mixture of the R- and S-enantiomers.1 4




  • At least 100-fold more potent as an inhibitor of serotonin (5-hydroxytryptamine [5-HT]) reuptake at presynaptic membranes and 5-HT neuronal firing rate than R-enantiomer and is twice as potent as racemic mixture.1 2 9 b




  • Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).1




  • Highly selective; minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake and little or no affinity for α- or β-adrenergic, dopamine D1–5, histamine H1–3, GABA-benzodiazepine, muscarinic M1–5, or 5-HT1–7 receptors or various ion channels (e.g., calcium, chloride, potassium, sodium channels).1



Advice to Patients



  • Risk of suicidality; importance of patients, families, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.1 e f g FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.1 e f g




  • Risk of psychomotor impairment; importance of exercising caution while operating hazardous machinery, including automobile driving, until they gain experience with the drug’s effects.1




  • Risks associated with concomitant use of escitalopram with alcohol or racemic citalopram.1




  • Importance of continuing escitalopram therapy even if a response is not evident within 1–4 weeks, unless directed otherwise.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., bipolar disorder) or personal or family history of suicidality or bipolar disorder.1 15




  • Importance of informing patients of risk of serotonin syndrome with concurrent use of escitalopram and 5-HT1 receptor agonists (“triptans”) or other serotonergic agents.1 18 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.1 18




  • Importance of informing patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.




























Escitalopram Oxalate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



5 mg (of escitalopram) per 5 mL



Lexapro (with parabens and propylene glycol)



Forest



Tablets, film-coated



5 mg (of escitalopram)



Lexapro



Forest



10 mg (of escitalopram)



Lexapro (scored)



Forest



20 mg (of escitalopram)



Lexapro (scored)



Forest


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Lexapro 10MG Tablets (FOREST): 30/$109.99 or 90/$289.97


Lexapro 20MG Tablets (FOREST): 30/$109.99 or 90/$309.97


Lexapro 5MG/5ML Solution (FOREST): 240/$169.99 or 720/$485.95


Lexapro 5MG Tablets (FOREST): 30/$99.99 or 90/$279.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Forest Pharmaceuticals, Inc. Lexapro (escitalopram oxalate) tablets/oral solution prescribing information. St. Louis, MO; 2006 Sep.



2. Burke WJ, Gergel I, Bose A. fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002; 63:331-6. [IDIS 479908] [PubMed 12000207]



3. Anon. Forest Lexapro approval includes label claim of greater potency than celexa. FDC Rep. Aug 19, 2002:3.



4. Forest Pharmaceuticals, Inc. Celexa (citalopram hydrobromide) prescribing information. (dated 2000 Dec). In: Physicians’ desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:1365-9.



5. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 150(Suppl 4):1-45.



6. The European Agency for the Evaluation of Medicinal Products (EMEA). Committee for proprietary medicinal products (CPMP) position paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions. London, UK; 2000 Apr 12. From EMEA web site.



7. Lazowick AL, Levin GM. Potential withdrawal syndrome associated with SSRI discontinuation. Ann Pharmacother. 1995; 29:1284-5.



8. Forest Pharmaceuticals, Inc., St. Louis, MO: Personal communication.



9. Anon. Escitalopram (Lexapro) for depression. Med Lett Drugs Ther. 2002; 44:83-4. [PubMed 12360121]



10. Reviewers’ comments (personal observations).



11. Priskorn M, Sidhu JS, Larsen F et al. Investigation of multiple dose citalopram on the pharmacokinetics and pharmacodynamics of racemic warfarin. Br J Clin Pharmacol. 1997; 44:199-202.



12. Anon. FDA issues public health advisory entitled: Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.



13. Anon. Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Public Health Advisory. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.



14. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.



15. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA web site.



16. Lepola UM, Loft H, Reines EH. Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2003; 18:211-7. [PubMed 12817155]



17. Food and Drug Administration (FDA). FDA Public Health Advisory regarding worsening depression and suicidality in patients being treated with antidepressant medications. From FDA website. 2003 Mar 22.



18. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website.



19. Clark DB, Andrus MR, Byrd DC. Drug interactions between linezolid and selective serotonin reuptake inhibitors: case report involving sertraline and review of the literature. Pharmacotherapy. 2006; 26:269-76. [PubMed 16466332]



20. Hachem RY, Hicks K, Huen A et al. Myelosuppression and serotonin syndrome associated with concurrent use of linezolid and selective seotonin reuptake inhibitors in bone marrow transplant recipients. CID. 2003; 37:e8-11.



21. Sola CL, Bostwick JM, Hart DA et al. Anticipating potential linezolid-SSRI interactions in the general hospital setting: an MAOI in disguise. Mayo Clin Proc. 2006; 81:330-4. [PubMed 16529136]



22. Taylor JJ, Wilson JW, Estes LL. Linezolid and serotonergic drug interactions: a retrospective survey. CID. 2006; 43:180-7.



23. Castberg I, Spigset O. Excretion of escitalopram in breast milk. J Clin Psychopharmacol. 2006; 26:536-8. [PubMed 16974204]



24. Rampono J, Hackett LP, Kristensen JH et al. Transfer of escitalopram and its metabolite demethylescitalopram into breastmilk. Br J Clin Pharmacol. 2006; 62:316-22. [PubMed 16934048]



25. Food and Drug Administration. Public health advisory: treatment challenges of depression in pregnancy. Rockville, MD; 2006 Jul 19. From the FDA website.



26. Cohen LS, Altshuler LL, Harlow BL et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006; 295:499-507. [PubMed 16449615]



27. Chambers CD, Hernandez-Diaz S, Van Marter LJ et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. New Engl J Med. 2006; 354:579-87. [PubMed 16467545]



b. Burke WJ, Gergel I, Bose A. A fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002; 63:331-6. [IDIS 479908] [PubMed 12000207]



c. Forest Pharmaceuticals, Inc. Celexa (citalopram hydrobromide) prescribing information. St. Louis, MO; 2002 Aug.



d. Evans ML, Kortas KJ. Potential interaction between isoniazid and selective serotonin-reuptake inhibitors. Am J Health Syst Pharm. 1995; 52:2135-6. [IDIS 354730] [PubMed 8535949]



e. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site.



f. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site.



g. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site.



h. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]



More Lexapro resources


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  • Lexapro Prescribing Information (FDA)

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