Adrucil

Generic Name: fluorouracil (Intravenous route, Injection route)

flure-oh-URE-a-sil

Intravenous route(Solution)

It is recommended that patients be hospitalized at least during the initial course of therapy with fluorouracil because of the possibility of severe toxic reactions .

Commonly used brand name(s)

In the U.S.

• Adrucil

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Adrucil

Fluorouracil belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the colon, rectum, breast, stomach, and pancreas. It may also be used to treat other kinds of cancer, as determined by your doctor.

Fluorouracil interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by fluorouracil, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with fluorouracil, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Fluorouracil is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fluorouracil is used in certain patients with the following medical conditions:

• Cancer of the outside layer of the adrenal gland


• Cancer of the anus


• Cancer of the bladder


• Cancer of the cervix


• Cancer of the endometrium


• Cancer of the ovaries


• Cancer of the esophagus


• Cancer of the head and neck


• Cancer of the penis


• Cancer of the liver


• Cancer of the prostate


• Cancer of the skin


• Cancer of the vulva


• Carcinoid tumors


• Hepatoblastoma (a certain type of liver cancer that occurs in children)


• Glaucoma, during and after certain surgery (trabeculectomy)

Before Using Adrucil

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

Although there is no specific information comparing use of fluorouracil in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of fluorouracil in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

• Rotavirus Vaccine, Live

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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Metronidazole


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Tamoxifen


• Tinidazole


• Typhoid Vaccine


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine

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.

• Leucovorin


• Levamisole


• Levoleucovorin


• Phenytoin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Infection—Fluorouracil can decrease your body's ability to fight infection

• Kidney disease or


• Liver disease—Effects of fluorouracil may be increased because of slower removal from the body

Proper Use of Adrucil

This medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.

Fluorouracil often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if your stomach is upset. Ask your health care professional for ways to lessen these effects.

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.

Precautions While Using Adrucil

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

While you are being treated with fluorouracil, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Fluorouracil may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Fluorouracil can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Adrucil 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

• Diarrhea


• heartburn


• sores in mouth and on lips

Less common

• Black, tarry stools


• cough or hoarseness, accompanied by fever or chills


• fever or chills


• lower back or side pain, accompanied by fever or chills


• nausea and vomiting (severe)


• painful or difficult urination, accompanied by fever or chills


• stomach cramps

Rare

• Blood in urine or stools


• pinpoint red spots on skin


• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Chest pain


• cough


• shortness of breath


• tingling of hands and feet, followed by pain, redness, and swelling


• trouble with balance

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:

More common

• Loss of appetite


• nausea and vomiting


• skin rash and itching


• weakness

Less common

• Dry or cracked skin

This medicine often causes a temporary loss of hair. After treatment with fluorouracil has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness, accompanied by fever or chills


• fever or chills


• lower back or side pain, accompanied by fever or chills


• painful or difficult urination, accompanied by fever or chills


• pinpoint red spots on skin


• unusual bleeding or bruising

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: Adrucil side effects (in more detail)

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More Adrucil resources

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

• Adrucil Prescribing Information (FDA)


• Adrucil MedFacts Consumer Leaflet (Wolters Kluwer)


• Adrucil injection Concise Consumer Information (Cerner Multum)


• Adrucil Monograph (AHFS DI)


• Fluorouracil Professional Patient Advice (Wolters Kluwer)

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Tavanic 250mg tablets

1. Name Of The Medicinal Product

Tavanic 250 mg film-coated tablet

2. Qualitative And Quantitative Composition

Each film-coated tablet of Tavanic contains 250 mg of levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate.

For excipients, see 6.1

3. Pharmaceutical Form

Film-coated tablet.

Score line pale yellowish-white to reddish-white film-coated tablets

4. Clinical Particulars

4.1 Therapeutic Indications

In adults with infections of mild or moderate severity, Tavanic tablets are indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms:

• Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)

• Acute bacterial exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)

• Community-acquired pneumonia

• Uncomplicated urinary tract infections

• Complicated urinary tract infections including pyelonephritis

• Chronic bacterial prostatitis.

• Skin and soft tissue infections.

Before prescribing Tavanic, consideration should be given to national and/or local guidance on the appropriate use of fluoroquinolones.

4.2 Posology And Method Of Administration

Tavanic tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.

Duration of treatment

The duration of treatment varies according to the course of the disease (see table below). As with antibiotic therapy in general, administration of Tavanic tablets should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

Method of administration

Tavanic tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dosage. The tablets may be taken during meals or between meals. Tavanic tablets should be taken at least two hours before or after iron salts, antacids and sucralfate administration since reduction of absorption can occur (see section 4.5).

Posology

The following dose recommendations can be given for Tavanic:

Dosage in patients with normal renal function (creatinine clearance > 50 ml/min)

Indication	Daily dose regimen (according to severity)	Duration of treatment
Acute sinusitis	500 mg once daily	10 - 14 days
Acute exacerbations of chronic bronchitis	250 to 500 mg once daily	7 - 10 days
Community-acquired pneumonia	500 mg once or twice daily	7 - 14 days
Uncomplicated urinary tract infections	250 mg once daily	3 days
Complicated urinary tract infections including pyelonephritis	250 mg once daily	7 - 10 days
Chronic bacterial prostatitis.	500 mg once daily	28 days
Skin and soft tissue infections	250 mg once daily or 500 mg once or twice daily	7 - 14 days

Special populations

Impaired renal function (creatinine clearance

	Dose regimen
	250 mg/24 h	500 mg/24 h	500 mg/12 h
Creatinine clearance	first dose: 250 mg	first dose: 500 mg	first dose: 500 mg
50-20 ml/min	then: 125 mg/24 h	then: 250 mg/24 h	then: 250 mg/12 h
19-10 ml/min	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/12 h
< 10 ml/min (including haemodialysis and CAPD) 1	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/24 h

¹ No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function

No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.

In the elderly

No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function. (See section 4.4 QT interval prolongation).

In children

Tavanic is contraindicated in children and growing adolescents (see section 4.3).

4.3 Contraindications

Tavanic tablets must not be used:

• in patients hypersensitive to levofloxacin or other quinolones or any of the excipients,

• in patients with epilepsy,

• in patients with history of tendon disorders related to fluoroquinolone administration,

• in children or growing adolescents,

• during pregnancy,

• in breast-feeding women.

4.4 Special Warnings And Precautions For Use

In the most severe cases of pneumococcal pneumonia Tavanic may not be the optimal therapy.

Nosocomial infections due to P. aeruginosa may require combination therapy.

Tendinitis and tendon rupture

Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendinitis and tendon rupture is increased in the elderly and in patients using corticosteroids. Close monitoring of these patients is therefore necessary if they are prescribed Tavanic. All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with Tavanic must be halted immediately, and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon.

Clostridium difficile-associated disease

Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Tavanic tablets, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudomembranous colitis. If pseudomembranous colitis is suspected, Tavanic tablets must be stopped immediately and patients should be treated with supportive measures ± specific therapy without delay (e.g. oral vancomycin). Products inhibiting the peristalsis are contraindicated in this clinical situation.

Patients predisposed to seizures

Tavanic tablets are contraindicated in patients with a history of epilepsy and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures, such as patients with pre-existing central nervous system lesions, concomitant treatment with fenbufen and similar non-steroidal anti-inflammatory drugs or with drugs which lower the cerebral seizure threshold, such as theophylline (see section 4.5). In case of convulsive seizures, treatment with levofloxacin should be discontinued.

Patients with G-6- phosphate dehydrogenase deficiency

Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution.

Patients with renal impairment

Since levofloxacin is excreted mainly by the kidneys, the dose of Tavanic should be adjusted in patients with renal impairment (see section 4.2).

Hypersensitivity reactions

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema up to anaphylactic shock), occasionally following the initial dose (see section 4.8). Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.

Hypoglycemia

As with all quinolones, hypoglycemia has been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with insulin. In these diabetic patients, careful monitoring of blood glucose is recommended. (See section 4.8).

Prevention of photosensitisation

Although photosensitisation is very rare with levofloxacin, it is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium), in order to prevent photosensitisation.

Patients treated with Vitamin K antagonists

Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with Tavanic in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these drugs are given concomittantly (see section 4.5).

Psychotic reactions

Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin (see section 4.8). In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.

QT interval prolongation

Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:

- congenital long QT syndrome

- concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides).

- uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)

- elderly

- cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

(See section 4.2 Elderly, section 4.5, section 4.8, section 4.9).

Peripheral neuropathy

Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.

Opiates

In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.

Hepatobiliary disorders

Cases of hepatic necrosis up to life threatening hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see section 4.8). Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Effect of other medicinal products on Tavanic

Iron salts, magnesium- or aluminium-containing antacids

Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids are administered concomitantly with Tavanic tablets. It is recommended that preparations containing divalent or trivalent cations such as iron salts, or magnesium- or aluminium-containing antacids should not be taken 2 hours before or after Tavanic tablet administration (see section 4.2). No interaction was found with calcium carbonate.

Sucralfate

The bioavailability of Tavanic tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and Tavanic, it is best to administer sucralfate 2 hours after the Tavanic tablet administration (see section 4.2).

Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs

No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. However a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other agents which lower the seizure threshold.

Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.

Probenecid and cimetidine

Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%). This is because both drugs are capable of blocking the renal tubular secretion of levofloxacin. However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.

Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients.

Other relevant information

Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.

Effect of Tavanic on other medicinal products

Ciclosporin

The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).

Drugs known to prolong QT interval

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides). (See section 4.4 QT interval prolongation).

Other forms of interactions

Meals

There is no clinically relevant interaction with food. Tavanic tablets may therefore be administered regardless of food intake.

4.6 Pregnancy And Lactation

Pregnancy

Reproductive studies in animals did not raise specific concern. However in the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Tavanic tablets must not be used in pregnant women. (see sections 4.3 and 5.3)

Lactation

In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Tavanic tablets must not be used in breast-feeding women. (see sections 4.3 and 5.3)

4.7 Effects On Ability To Drive And Use Machines

Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

4.8 Undesirable Effects

The information given below is based on data from clinical studies in more than 5000 patients and on extensive post marketing experience.

The adverse reactions are described according to the MedDRA system organ class below.

Frequencies are defined using the following convention: very common (1/10), common (1/100, <1/10), uncommon (1/1000, 1/10000,

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Infections and infestations

Uncommon : Fungal infection (and proliferation of other resistant microorganisms)

Blood and lymphatic system disorders

Uncommon : Leukopenia, eosinophilia

Rare : Thrombocytopenia, neutropenia

Very rare : Agranulocytosis

Not Known : Pancytopenia, haemolytic anaemia

Immune system disorders

Very rare : Anaphylactic shock (see section 4.4)

Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose

Not known : Hypersensitivity (see section 4.4)

Metabolism and nutrition disorders

Uncommon : Anorexia

Very rare : Hypoglycemia, particularly in diabetic patients (see section 4.4)

Psychiatric disorders

Uncommon : Insomnia, nervousness

Rare : Psychotic disorder, Depression, confusional state, agitation, anxiety

Very rare : Psychotic reactions with self-endangering behaviour including suicidal ideation or acts (see section 4.4), hallucination

Nervous system disorders

Uncommon : Dizziness, headache, somnolence

Rare : Convulsion, tremor, paraesthesia,

Very rare : sensory or sensorimotor peripheral neuropathy, dysgeusia including ageusia, parosmia including anosmia

Eye disorders

Very rare : Visual disturbance

Ear and Labyrinth disorders

Uncommon : Vertigo

Very rare : Hearing impaired

Not known : Tinnitus

Cardiac disorders

Rare : Tachycardia

Not Known : Electrocardiogram QT prolonged (see section 4.4 QT interval prolongation and section 4.9)

Vascular disorders

Rare : Hypotension

Respiratory, thoracic and mediastinal disorders

Rare : Bronchospasm, dyspnoea

Very rare : Pneumonitis allergic

Gastrointestinal disorders

Common : Diarrhoea, nausea

Uncommon : Vomiting, abdominal pain, dyspepsia, flatulence, constipation

Rare : Diarrhoea –haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis

Hepatobiliary disorders

Common : Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT)

Uncommon : Blood bilirubin increased

Very rare : Hepatitis

Not known: Jaundice and severe liver injury, including cases with acute liver failure, have been reported with levofloxacin, primarily in patients with severe underlying diseases (see section 4.4).

Skin and subcutaneous tissue disorders

Uncommon : Rash, pruritus

Rare : Urticaria

Very rare : Angioneurotic oedema, photosensitivity reaction

Not Known : Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hyperhidrosis

Mucocutaneous reactions may sometimes occur even after the first dose

Musculoskeletal and Connective tissue disorders

Rare : Tendon disorder (see section 4.4) including tendinitis (e.g. Achilles tendon), arthralgia, myalgia

Very rare : Tendon rupture (see section 4.4). This undesirable effect may occur within 48 hours of starting treatment and may be bilateral, muscular weakness which may be of special importance in patients with myasthenia gravis

Not Known : Rhabdomyolysis

Renal and urinary disorders

Uncommon : Blood creatinine increased

Very rare : Renal failure acute (e.g. due to nephritis interstitial)

General disorders and administration site conditions

Uncommon : Asthenia

Very rare : Pyrexia

Not known : Pain (including pain in back, chest, and extremities)

Other undesirable effects which have been associated with fluoroquinolone administration include:

• extrapyramidal symptoms and other disorders of muscular coordination,

• hypersensitivity vasculitis,

• attacks of porphyria in patients with porphyria.

4.9 Overdose

According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of Tavanic tablets are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as gastro-intestinal reactions such as nausea and mucosal erosions.

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones

ATC code: J01MA12

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug substance ofloxacin.

Mechanism of action

As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.

PK/PD relationship

The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).

Mechanism of resistance

The main mechanism of resistance is due to a gyr-A mutation. In vitro there is a cross-resistance between levofloxacin and other fluoroquinolones.

Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.

Breakpoints

The EUCAST recommended MIC breakpoints for levofloxacin, separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are presented in the below table for MIC testing (mg/L).

EUCAST clinical MIC breakpoints for levofloxacin (2006-06-20):

Pathogen	Susceptible	Resistant
Enterobacteriacae		>2 mg/L
Pseudomonas spp.		>2 mg/L
Acinetobacter spp.		>2 mg/L
Staphylococcus spp.		>2 mg/L
S.pneumoniae 1		>2 mg/L
Streptococcus A,B,C,G		>2 mg/L
H.influenzae M.catarrhalis 2		>1 mg/L
Non-species related breakpoints3		>2 mg/L
1 the S/I-breakpoint was increased from 1.0 to 2.0 to avoid dividing the wild type MIC distribution. The breakpoints relate to high dose therapy. 2 Strains with MIC values above the S/I breakpoint are very rare or not yet reported. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. 3 Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where susceptibility testing is not recommended or for which there is insufficient evidence that the species in question is a good target (Enterococcus, Neisseria, Gram negative anaerobes)

The CLSI (Clinical And Laboratory Standards Institute, formerly NCCLS) recommended MIC breakpoints for levofloxacin, separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are presented in the below table for MIC testing (µg/mL) or disc diffusion testing (zone diameter [mm] using a 5 µg levofloxacin disc).

CLSI recommended MIC and disc diffusion breakpoints for levofloxacin (M100-S17, 2007):

Pathogen	Susceptible	Resistant
Enterobacteriaceae
Non Enterobacteriaceae.
Acinetobacter spp.
Stenotrophomonas maltophilia
Staphylococcus spp.
Enterococcus spp.
H.influenzae M.catarrhalis 1
Streptococcus pneumoniae
beta-hemolytic Streptococcus
1 The absence or rare occurrence of resistant strains precludes defining any results categories other than « susceptible ». for strains yielding results suggestive of a « nonsuceptible » category, organism identification and antimicrobial susceptibility test results should be confirmed by a reference laboratory using CLSI reference dilution method.

Antibacterial spectrum

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable

Commonly susceptible species Aerobic Gram-positive bacteria Staphylococcus aureus* methicillin-susceptible Staphylococcus saprophyticus Streptococci, group C and G Streptococcus agalactiae Streptococcus pneumoniae * Streptococcus pyogenes * Aerobic Gram- negative bacteria Burkholderia cepacia$ Eikenella corrodens Haemophilus influenzae * Haemophilus para-influenzae * Klebsiella oxytoca Klebsiella pneumoniae * Moraxella catarrhalis * Pasteurella multocida Proteus vulgaris Providencia rettgeri Anaerobic bacteria Peptostreptococcus Other Chlamydophila pneumoniae* Chlamydophila psittaci Chlamydia trachomatis Legionella pneumophila* Mycoplasma pneumoniae* Mycoplasma hominis Ureaplasma urealyticum

Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Enterococcus faecalis* Staphylococcus aureus methicillin-resistant Staphylococcus coagulase spp Aerobic Gram- negative bacteria Acinetobacter baumannii * Citrobacter freundii * Enterobacter aerogenes Enterobacter agglomerans Enterobacter cloacae * Escherichia coli * Morganella morganii * Proteus mirabilis* Providencia stuartii Pseudomonas aeruginosa* Serratia marcescens* Anaerobic bacteria Bacteroides fragilis Bacteroides ovatus$ Bacteroides thetaiotamicron$ Bacteroides vulgatus$ Clostridium difficile$

* Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications.

$ natural intermediate susceptibility

Other information

Nosocomial infections due to P. aeruginosa may require combination therapy.

5.2 Pharmacokinetic Properties

Absorption

Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1h. The absolute bioavailability is approximately 100 %.

Food has little effect on the absorption of levofloxacin.

Distribution

Approximately 30 - 40 % of levofloxacin is bound to serum protein. 500 mg once daily multiple dosing with levofloxacin showed negligible accumulation. There is modest but predictable accumulation of levofloxacin after doses of 500 mg twice daily. Steady-state is achieved within 3 days.

Penetration into tissues and body fluids:

Penetration into Bronchial Mucosa, Epithelial Lining Fluid (ELF)

Maximum levofloxacin concentrations in bronchial mucosa and epithelial lining fluid after 500 mg p.o. were 8.3 μg/g and 10.8 μg/ml respectively. These were reached approximately one hour after administration.

Penetration into Lung Tissue

Maximum levofloxacin concentrations in lung tissue after 500 mg p.o. were approximately 11.3 μg/g and were reached between 4 and 6 hours after administration. The concentrations in the lungs consistently exceeded those in plasma.

Penetration into Blister Fluid

Maximum levofloxacin concentrations of about 4.0 and 6.7 μg/ml in the blister fluid were reached 2 - 4 hours after administration following 3 days dosing at 500 mg once or twice daily, respectively.

Penetration into Cerebro-Spinal Fluid

Levofloxacin has poor penetration into cerebro-spinal fluid.

Penetration into prostatic tissue

After administration of oral 500mg levofloxacin once a day for three days, the mean concentrations in prostatic tissue were 8.7 µg/g, 8.2 µg/g and 2.0 µg/g respectively after 2 hours, 6 hours and 24 hours; the mean prostate/plasma concentration ratio was 1.84.

Concentration in urine

The mean urine concentrations 8 -12 hours after a single oral dose of 150 mg, 300 mg or 500 mg levofloxacin were 44 mg/L, 91 mg/L and 200 mg/L, respectively.

Biotransformation

Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for < 5 % of the dose excreted in urine. Levofloxacin is stereochemically stable and does not undergo chiral inversion.

Elimination

Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t_½: 6 - 8 h). Excretion is primarily by the renal route (> 85 % of the administered dose).

There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangeable.

Linearity

Levofloxacin obeys linear pharmacokinetics over a range of 50 to 600 mg.

Subjects with renal insufficiency

The pharmacokinetics of levofloxacin are affected by renal impairment. With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below:

Clcr [ml/min]	< 20	20 - 40	50 - 80
ClR [ml/min]	13	26	57
t1/2 [h]	35	27	9

Elderly subjects

There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects, except those associated with differences in creatinine clearance.

Gender differences

Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics. There is no evi

Isoket Retard 20

1. Name Of The Medicinal Product

Isoket Retard 20 Tablets

2. Qualitative And Quantitative Composition

Each tablet contains isosorbide dinitrate 20 mg in a prolonged release formulation.

For excipients see 6.1.

3. Pharmaceutical Form

Prolonged release tablets.

White with break score, marked IR 20 on the upper side and with SCHWARZ PHARMA on the reverse side.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis and treatment of angina pectoris.

4.2 Posology And Method Of Administration

For oral administration.

Adults: One tablet to be taken twice daily without chewing and with a sufficient amount of fluid. The second dose should be given 6 to 8 hours after the first. For patients with higher nitrate requirements the dose may be increased to one tablet three times daily; the last dose should be taken around 6pm.

Elderly: Clinical experience has not necessitated alternative advice for use in elderly patients.

Children: The safety and efficacy of Isoket Retard has yet to be established.

4.3 Contraindications

This product should not be given to patients with a known sensitivity to nitrates (or any other ingredient in this product), very low blood pressure, acute myocardial infarction with low filling pressure, marked anaemia, head trauma, cerebral haemorrhage, acute circulatory failure, severe hypotension or hypovolaemia.

Phosphodiesterase inhibitors (e.g. Sildenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated.

4.4 Special Warnings And Precautions For Use

These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, severe liver disease or renal disease.

Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation.

This product may give rise to symptoms of postural hypotension and sycope in some patients.

These tablets should be used with particular caution and under medical supervison in the following:

Hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis, and diseases associated with raised intracranial pressure.

Treatment with these tablets must not be interrupted or stopped to take phosphodiestearase inhibitor products due to the increased risk of inducing an attack of angina pectoris.

If these tablets are not taken as indicated with the appropriate dosing interval (see section 4.2) tolerance to the medication could develop.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent intake of drugs with blood pressure lowering properties e.g. beta-blockers, calcium antagonists, vasodilators etc. and/or alcohol may potentiate the hypotensive effect of the tablets. Symptoms of circulatory collapse can arise in patients already taking ACE inhibitors.

The hypotensive effect of nitrates is potentiated by concurrent administration of phosphodiesterase inhibitors (e.g. sildenafil). This might also occur with neuroleptics and tricyclic antidepressants.

Reports suggest that when administered concomitantly, nitrates may increase the blood level of dihydroergotamine and its hypertensive effect.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy or lactation unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Headaches, tiredness and dizziness may occur. These may affect the ability to drive and operate machinery. Patients should not drive or operate machinery if their ability is impaired.

4.8 Undesirable Effects

A very common (> 10% of patients) adverse reaction to these tablets is headache. The incidence of headache diminishes gradually with time and continued use,

At start of therapy or when the dosage is increased, hypotension and/or light-headedness on standing are observed commonly (i.e. in 1-10% of patients.) These symptoms may be associated with dizziness, drowsiness, reflex tachycardia, and a feeling of weakness.

Infrequently (i.e. in less than 1% of patients), nausea, vomiting, flush and allergic skin reaction (e.g. rash), which may be sometimes severe may infrequently occur. In isolated cases exfoliative dermatitis may occur. Very rarely, Stevens-Johnson-Syndrome or angiodema may occur.

Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration. Uncommonly collapse may occur (sometimes accompanied by bradyarrhythmia and syncope). Uncommonly severe hypotension may lead to enhanced angina symptoms.

A few reports on heartburn most likely due to a nitrate-induced sphincter relaxation have been recorded.

During treatment with these tablets, a temporary hypoxaemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.

4.9 Overdose

Clinical Features:

• Fall of blood pressure

• During isosorbide mononitrate biotransformation nitrite ions are released, which may include methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It can not be excluded that an overdose of isosorbide dinitrate may cause this adverse reaction.

• In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.

Supportive measures:

• Stop intake of the drug

• General procedures in the event of nitrate-related hypotension:

- Patient should be kept horizontal with the head lowered and legs raised

- Supply oxygen

- Expand plasma volume

- For specific shock treatment admit patient to intensive care unit

Specific Procedures:

• Raising the blood pressure if the blood pressure is very low

• Treatment of methaeglobinaemia

- Reduction therapy of choice with vitamin C, methylene-blue, or toluidine-blue

- Administer oxygen (if necessary)

- Initiate artificial ventilation

- Hemodialysis (if necessary)

• Resuscitation measures:

In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: C01D A08 (Organic nitrates)

Isosorbide dinitrate causes a relaxation of vascular smooth muscle thereby inducing a vasodilation.

Both peripheral arteries and veins are relaxed by isosorbide dinitrate. The latter effect promotes venous pooling of blood and decreases venous return to the heart, thereby reducing ventricular end-diastolic pressure and volume (preload).

The action on arterial, and at higher dosages arteriolar vessels, reduce the systemic vascular resistance (afterload). This in turn reduces the cardiac work.

The effect on both preload and afterload lead subsequently to a reduced oxygen consumption of the heart.

Furthermore, isosorbide dinitrate causes redistribution of blood flow to the subendocardial regions of the heart when the coronary circulation is partially occluded by arteriosclerotic lesions. This last effect is likely to be due to a selective dilation of large coronary vessels. Nitrate-induced dilation of collateral arteries can improve the perfusion of poststenotic myocardium. Nitrates also dilate eccentric stenoses as they can counteract possible constricting factors acting on the residual arch of compliant smooth muscle at the site of the coronary narrowing. Furthermore, coronary spasms can be relaxed by nitrates.

Nitrates were shown to improve resting and exercise haemodynamics in patients suffering from congestive heart failure. In this beneficial effect several mechanisms including an improvement of valvular regurgitation (due to the lessening of ventricular dilation) and the reduction of myocardial oxygen demand are involved.

By decreasing the oxygen demand and increasing the oxygen supply, the area of myocardial damage is reduced. Therefore, isosorbide dinitrate may be useful in selected patients who suffered a myocardial infarction.

Effects on other organ systems include a relaxation of the bronchial muscle, the muscles of the gastrointestinal, the biliary and the urinary tract. Relaxation of the uterine smooth muscles is reported as well.

Mechanism of action:

Like all organic nitrates, isosorbide dinitrate acts as a donor of nitric oxide (NO). NO causes a relaxation of vascular smooth muscle via the stimulation of guanylyl cyclase and the subsequent increase of intracellular cyclic guanosine monophosphate (cGMP) concentration. A cGMP-dependent protein kinase is thus stimulated, with resultant alteration of the phosphorylation of various proteins in the smooth muscle cell. This eventually leads to the dephosphorylation of the light chain of myosin and the lowering of contractility

5.2 Pharmacokinetic Properties

After administration of one tablet of Isoket Retard 20 at least two peak concentrations of ISDN occurred in the plasma. The initial peak (mean 1.9 ng/ml, range 1.0 to 3.4 ng/ml) occurred during 0.5 to 2 hours and then the mean plasma concentrations declined to 1.3 ng/ml at 3 hours. The concentration then increased again to reach a major peak level (mean 6.2 ng/ml range 1.6 to 12.3 ng/ml) during 4 to 6 hours after dosing. Plasma concentrations of ISDN have been measured after administration of increasing doses in the range 20 to 100 mg as Isoket Retard 20 tablets. Means of peak concentrations of 4.2 ng/ml, 13.1 ng/ml, 20.7 ng/ml, 36.8 ng/ml and 34.9 ng/ml were measured after doses of 20mg, 40mg, 60mg, 80mg and 100mg respectively.

Gastrointestinal absorption is slower than absorption through the oral mucosa. The first pass effect is higher when given orally. Isosorbide dinitrate is metabolised to isosorbide 2-mononitrate with a half life of 2.01 h (±0.4 h) to 2.5 h and isosorbide 5-mononitrate with a half-life of 4.6 h (±0.8 h). Both metabolites are pharmocologically active.

The relative bioavailability of Isoket Retard in comparison to the non-sustained-release tablet amounts to more than 80% after oral use.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose monohydrate

Talc

Polyvinyl acetate

Magnesium stearate

Potato starch

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Cartons of blister strips of polypropylene (PP) and aluminium or of PP/PP

Pack sizes 50, 56, 60, 84 and 90 tablets.

Only the pack sizes marked in bold are currently marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0743

9. Date Of First Authorisation/Renewal Of The Authorisation

30 June 2008

10. Date Of Revision Of The Text

Haemophilus B Polysaccharide Conjugate Vaccine

Pronunciation: hem-OFF-fil-us pol-i-SAK-ka-ride
Generic Name: Haemophilus B Polysaccharide Conjugate Vaccine
Brand Name: Examples include ActHIB and PedvaxHIB

Haemophilus B Polysaccharide Conjugate Vaccine is used for:

Preventing infection caused by Haemophilus influenza type b bacteria and/or diphtheria, tetanus, and pertussis.

Haemophilus B Polysaccharide Conjugate Vaccine is a vaccine. It works by stimulating the body to produce antibodies against the organism that causes H. influenza infection.

Do NOT use Haemophilus B Polysaccharide Conjugate Vaccine if:

• you are allergic to any ingredient in Haemophilus B Polysaccharide Conjugate Vaccine


• you have an infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Haemophilus B Polysaccharide Conjugate Vaccine:

Some medical conditions may interact with Haemophilus B Polysaccharide Conjugate Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances, including latex


• if you have a bleeding disorder or a reduced blood platelet count (thrombocytopenia), a fever, or cancer, or you have had an allergic reaction to a vaccine in the past

Some MEDICINES MAY INTERACT with Haemophilus B Polysaccharide Conjugate Vaccine. However, no specific interactions with Haemophilus B Polysaccharide Conjugate Vaccine are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Haemophilus B Polysaccharide Conjugate Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Haemophilus B Polysaccharide Conjugate Vaccine:

Use Haemophilus B Polysaccharide Conjugate Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Haemophilus B Polysaccharide Conjugate Vaccine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any questions that you may have about Haemophilus B Polysaccharide Conjugate Vaccine.


• If you miss a dose of Haemophilus B Polysaccharide Conjugate Vaccine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Haemophilus B Polysaccharide Conjugate Vaccine.

Important safety information:

• Additional monitoring of your dose or condition may be needed if you are taking immunosuppressive therapy (eg, cyclophosphamide, methotrexate) or an anticoagulant (eg, warfarin).


• It is important that your child completes the vaccination series.


• If your child has a fever or an infection, your doctor may delay giving this vaccine.


• Make sure your health care provider has a complete record of your child's vaccinations and is aware of your child's current health status.


• Haemophilus B Polysaccharide Conjugate Vaccine may cause fever, irritability, and redness, tenderness, or a lump at the injection site. These symptoms should go away within 1 to 2 days.


• Haemophilus B Polysaccharide Conjugate Vaccine is not recommended for use in INFANTS younger than 2 months or CHILDREN older than 6 years of age. Safety and effectiveness in these age groups have not been confirmed.

Possible side effects of Haemophilus B Polysaccharide Conjugate Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fever; irritability; redness, tenderness, pain, swelling, or a lump at the injection site; sleepiness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Haemophilus B Polysaccharide Conjugate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Haemophilus B Polysaccharide Conjugate Vaccine:

Haemophilus B Polysaccharide Conjugate Vaccine is usually handled and stored by a health care provider. If you are using Haemophilus B Polysaccharide Conjugate Vaccine at home, store Haemophilus B Polysaccharide Conjugate Vaccine as directed by your pharmacist or health care provider. Keep Haemophilus B Polysaccharide Conjugate Vaccine out of the reach of children and away from pets.

General information:

• If you have any questions about Haemophilus B Polysaccharide Conjugate Vaccine, please talk with your doctor, pharmacist, or other health care provider.


• Haemophilus B Polysaccharide Conjugate Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Haemophilus B Polysaccharide Conjugate Vaccine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Haemophilus B Polysaccharide Conjugate Vaccine resources

• Haemophilus B Polysaccharide Conjugate Vaccine Side Effects (in more detail)
• Haemophilus B Polysaccharide Conjugate Vaccine Use in Pregnancy & Breastfeeding
• Haemophilus B Polysaccharide Conjugate Vaccine Drug Interactions
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• Haemophilus influenzae Prophylaxis

Alka-Seltzer Plus Cold/Sinus

Pronunciation: a-seet-a-MIN-oh-fen/soo-do-e-FED-rin
Generic Name: Acetaminophen/Pseudoephedrine
Brand Name: Examples include Alka-Seltzer Plus Cold/Sinus and Ornex

Alka-Seltzer Plus Cold/Sinus is used for:

Relieving symptoms such as pain and sinus congestion due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Alka-Seltzer Plus Cold/Sinus is an analgesic and decongestant combination. The analgesic works in the brain to help decrease pain. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Alka-Seltzer Plus Cold/Sinus if:

• you are allergic to any ingredient in Alka-Seltzer Plus Cold/Sinus


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alka-Seltzer Plus Cold/Sinus:

Some medical conditions may interact with Alka-Seltzer Plus Cold/Sinus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, an overactive thyroid, severe kidney problems, or liver problems (eg, hepatitis), or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Alka-Seltzer Plus Cold/Sinus. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Alka-Seltzer Plus Cold/Sinus may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Alka-Seltzer Plus Cold/Sinus


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Alka-Seltzer Plus Cold/Sinus

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alka-Seltzer Plus Cold/Sinus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alka-Seltzer Plus Cold/Sinus:

Use Alka-Seltzer Plus Cold/Sinus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alka-Seltzer Plus Cold/Sinus may be taken with or without food.


• If you miss a dose of Alka-Seltzer Plus Cold/Sinus, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alka-Seltzer Plus Cold/Sinus.

Important safety information:

• Alka-Seltzer Plus Cold/Sinus may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alka-Seltzer Plus Cold/Sinus. Using Alka-Seltzer Plus Cold/Sinus alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Alka-Seltzer Plus Cold/Sinus without checking with you doctor.


• Alka-Seltzer Plus Cold/Sinus contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Alka-Seltzer Plus Cold/Sinus for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Alka-Seltzer Plus Cold/Sinus may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Alka-Seltzer Plus Cold/Sinus. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Alka-Seltzer Plus Cold/Sinus may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Alka-Seltzer Plus Cold/Sinus or other pain relievers/fever reducers. Alcohol use combined with Alka-Seltzer Plus Cold/Sinus may increase your risk for liver damage.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Alka-Seltzer Plus Cold/Sinus.


• Use Alka-Seltzer Plus Cold/Sinus with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Alka-Seltzer Plus Cold/Sinus in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Alka-Seltzer Plus Cold/Sinus, discuss with your doctor the benefits and risks of using Alka-Seltzer Plus Cold/Sinus during pregnancy. Alka-Seltzer Plus Cold/Sinus is excreted in breast milk. If you are or will be breast-feeding while you are using Alka-Seltzer Plus Cold/Sinus, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alka-Seltzer Plus Cold/Sinus:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Alka-Seltzer Plus Cold/Sinus side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Alka-Seltzer Plus Cold/Sinus:

Store Alka-Seltzer Plus Cold/Sinus at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alka-Seltzer Plus Cold/Sinus out of the reach of children and away from pets.

General information:

• If you have any questions about Alka-Seltzer Plus Cold/Sinus, please talk with your doctor, pharmacist, or other health care provider.


• Alka-Seltzer Plus Cold/Sinus is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alka-Seltzer Plus Cold/Sinus. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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