Rosiglitazone/Metformin

Pronunciation: ROE-si-GLI-ta-zone/met-FOR-min
Generic Name: Rosiglitazone/Metformin
Brand Name: Avandamet

Rosiglitazone/Metformin may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or who drink alcohol. Lab tests, including kidney function, may be performed while you take Rosiglitazone/Metformin.

Do not begin to take Rosiglitazone/Metformin if you are older than 80 years unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection or low blood oxygen levels, or you are dehydrated. Tell your doctor you take Rosiglitazone/Metformin before you have any surgery or lab procedures.

Contact your doctor right away if you notice symptoms such as muscle pain or tenderness; unusual drowsiness, dizziness, or lightheadedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.

Thiazolidinedione antidiabetics, such as rosiglitazone (one of the components of Rosiglitazone/Metformin), may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Rosiglitazone/Metformin should not be used to treat patients who have heart failure with symptoms, or moderate to severe heart failure. You will be monitored for signs of heart failure when you start Rosiglitazone/Metformin and if your dose increases. Contact your doctor at once if you develop symptoms of heart failure (eg, swelling of the hands, ankles, legs, or feet; shortness of breath; sudden, unexplained weight gain). Your doctor may need to stop your medicine or change your dose.

Rosiglitazone may also increase the risk of a heart attack. Seek immediate medical attention if you experience chest, jaw, or arm pain; numbness of an arm or leg; sudden, severe headache, dizziness, or vomiting; sudden vision changes; or fainting.

Rosiglitazone/Metformin is used for:

Treating type 2 diabetes in patients who are already taking rosiglitazone. It may also be used in certain patients who are unable to control their blood sugar on other diabetes medicines and, after talking with their doctor, have decided not to take pioglitazone or another medicine that contains pioglitazone. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Rosiglitazone/Metformin is a thiazolidinedione and biguanide antidiabetic combination. The biguanide works by decreasing the amount of sugar that the liver produces and the intestines absorb. The thiazolidinedione works by making your body more sensitive to the insulin that you naturally produce. This helps to lower blood sugar.

Do NOT use Rosiglitazone/Metformin if:

• you are allergic to any ingredient in Rosiglitazone/Metformin


• you have type 1 diabetes


• you have heart failure with symptoms, or moderate to severe heart failure


• you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or dehydration


• you have had a stroke or a recent heart attack, or you are in shock


• you are 80 years or older and have not had a kidney function test


• you will be having surgery or certain lab procedures


• you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone


• you are using insulin

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

Before using Rosiglitazone/Metformin:

Some medical conditions may interact with Rosiglitazone/Metformin. 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 heart problems (eg, heart failure, a heart attack), liver problems or abnormal liver function tests, diabetic ketoacidosis, a stroke, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, a certain type of diabetic eye disease (macular edema) or other eye or vision problems, or lactic acidosis


• if you have fluid retention or swelling problems (edema), vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B₁₂ levels, or anemia


• if you have an infection, a fever, a recent injury, or moderate to severe burns


• if you drink alcohol or have a history of alcohol abuse


• if you will be having surgery or certain lab procedures


• if you are taking a beta-blocker (eg, propranolol)


• if you take medicines for high blood pressure, high cholesterol, heart failure, or for prevention of heart disease or a stroke

Some MEDICINES MAY INTERACT with Rosiglitazone/Metformin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Insulin because the risk of certain heart problems (eg, a heart attack, heart failure) may be increased


• Other antidiabetics (eg, glipizide), calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, nicotinic acid, phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased


• Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin, or medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, tacrolimus) because they may increase the risk of Rosiglitazone/Metformin's side effects. Ask you doctor if you are unsure if any of your medicines might harm the kidney


• Gemfibrozil because it may increase the risk of Rosiglitazone/Metformin's side effects


• Rifamycins (eg, rifampin) because they may decrease Rosiglitazone/Metformin's effectiveness, resulting in high blood sugar


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Rosiglitazone/Metformin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosiglitazone/Metformin 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 Rosiglitazone/Metformin:

Use Rosiglitazone/Metformin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rosiglitazone/Metformin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rosiglitazone/Metformin refilled.


• Take Rosiglitazone/Metformin by mouth with meals.


• Taking Rosiglitazone/Metformin at the same time each day will help you remember to take it.


• Take Rosiglitazone/Metformin on a regular schedule to get the most benefit from it.


• Continue to take Rosiglitazone/Metformin even if you feel well. Do not miss any doses.


• If you miss a dose of Rosiglitazone/Metformin, 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 Rosiglitazone/Metformin.

Important safety information:

• Rosiglitazone/Metformin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rosiglitazone/Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Proper diet and exercise are important for best results with Rosiglitazone/Metformin. Follow the diet and exercise program given to you by your health care provider.


• It may take 2 weeks for Rosiglitazone/Metformin to start to lower your blood sugar. It may take up to 3 months to see the full effect of Rosiglitazone/Metformin. Do not take more than the recommended dose or stop taking Rosiglitazone/Metformin without checking with your doctor.


• Do not drink large amounts of alcohol while you take Rosiglitazone/Metformin. Talk to your doctor or health care provider before you drink alcohol while you take Rosiglitazone/Metformin.


• Tell your doctor or dentist that you take Rosiglitazone/Metformin before you receive any medical or dental care, emergency care, or surgery.


• Rosiglitazone/Metformin contains rosiglitazone. It may cause or worsen heart failure in some patients. It may also increase the risk of a heart attack. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.


• Be careful not to become dehydrated, especially during hot weather, while you are being active, or if you have vomiting or diarrhea. Dehydration may increase your risk of side effects from Rosiglitazone/Metformin.


• Rosiglitazone/Metformin may cause ovulation in women who have not reached menopause but do not ovulate. To avoid pregnancy, be sure to use an effective form of birth control while taking Rosiglitazone/Metformin.


• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels regularly as directed by your doctor. If they are often higher or lower than they should be and you take Rosiglitazone/Metformin exactly as prescribed, tell your doctor.


• Rosiglitazone/Metformin does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Rosiglitazone/Metformin along with certain other medicines for diabetes (eg, sulfonylureas, insulin). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• Rosiglitazone/Metformin may commonly cause upset stomach, indigestion, nausea, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.


• An increased incidence of bone fracture has been reported in women who take Rosiglitazone/Metformin. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain, especially in the hand, foot, or upper arm.


• Lab tests, including complete blood cell counts, fasting blood sugar, hemoglobin A_1c, eye exams, or kidney and liver function, may be performed while you use Rosiglitazone/Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Rosiglitazone/Metformin with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of heart failure or low blood sugar. Low blood sugar levels may also be more difficult to recognize in the elderly.


• Rosiglitazone/Metformin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Rosiglitazone/Metformin should not be used if you are pregnant. If you think you may be pregnant, contact your doctor. It is not known if Rosiglitazone/Metformin is found in breast milk. Do not breast-feed while taking Rosiglitazone/Metformin.

Possible side effects of Rosiglitazone/Metformin:

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:

Back or joint pain; cold-like symptoms; diarrhea; dizziness; headache; indigestion; nausea; stomach upset; tiredness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; chest, jaw, or arm pain or discomfort; dark urine; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; lightheadedness; muscle pain or weakness; numbness of an arm or leg; persistent loss of appetite; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; shortness of breath; slow or irregular heartbeat; sudden, severe headache or dizziness; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; symptoms of low blood sugar (eg, anxiety, increased sweating, dizziness or drowsiness, headache, chills, tremors, increased hunger); unusual bone pain (especially in the hand, foot, or upper arm); unusual stomach pain or discomfort; unusual tiredness or weakness; yellowing of the eyes or skin.

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.

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 dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Proper storage of Rosiglitazone/Metformin:

Store Rosiglitazone/Metformin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in bathroom. Keep Rosiglitazone/Metformin out of the reach of children and away from pets.

General information:

• If you have any questions about Rosiglitazone/Metformin, please talk with your doctor, pharmacist, or other health care provider.


• Rosiglitazone/Metformin 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.


• If using Rosiglitazone/Metformin for an extended period of time, obtain refills before your supply runs out.


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

This information is a summary only. It does not contain all information about Rosiglitazone/Metformin. 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 Rosiglitazone/Metformin resources

• Rosiglitazone/Metformin Dosage
• Rosiglitazone/Metformin Use in Pregnancy & Breastfeeding
• Rosiglitazone/Metformin Drug Interactions
• Rosiglitazone/Metformin Support Group
• 3 Reviews for Rosiglitazone/Metformin - Add your own review/rating

Compare Rosiglitazone/Metformin with other medications

• Diabetes, Type 2

Amiodarone PH&T

Amiodarone PH&T may be available in the countries listed below.

Ingredient matches for Amiodarone PH&T

Amiodarone

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodarone PH&T in the following countries:

• Italy

International Drug Name Search

Neo-Klar

Neo-Klar may be available in the countries listed below.

Ingredient matches for Neo-Klar

Clarithromycin

Clarithromycin is reported as an ingredient of Neo-Klar in the following countries:

• Myanmar

International Drug Name Search

Remeron SolTab Orally Disintegrating Tablets

Pronunciation: mir-TAZ-a-peen
Generic Name: Mirtazapine
Brand Name: Remeron SolTab

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Remeron SolTab Orally Disintegrating Tablets outweigh the risks.

Families and caregivers must closely watch patients who take Remeron SolTab Orally Disintegrating Tablets. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Remeron SolTab Orally Disintegrating Tablets are used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Remeron SolTab Orally Disintegrating Tablets are a tetracyclic antidepressant. Exactly how Remeron SolTab Orally Disintegrating Tablets improves depression symptoms is not known. It is thought to increase the activity of certain chemicals in the brain (norepinephrine, serotonin) that help improve mood.

Do NOT use Remeron SolTab Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Remeron SolTab Orally Disintegrating Tablets


• you are taking oxitriptan or tryptophan


• you are taking or have taken furazolidone, linezolid, methylene blue, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Remeron SolTab Orally Disintegrating Tablets:

Some medical conditions may interact with Remeron SolTab Orally Disintegrating Tablets. 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 liver problems, high cholesterol, kidney problems, heart problems, blood vessel problems, a low white blood cell count, or phenylketonuria (PKU)


• if you have a history of dizziness or fainting, seizures, heart attack, angina (chest pain), or stroke


• if you have low blood pressure, low blood volume, low blood sodium levels, or you are dehydrated


• if you have a history of mental or mood problems (eg, depression, bipolar disorder) or suicidal thoughts or behaviors


• if you take medicine to treat high blood pressure

Some MEDICINES MAY INTERACT with Remeron SolTab Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluvoxamine, furazolidone, linezolid, lithium, MAOIs (eg, phenelzine), methylene blue, oxitriptan, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin 5-HT₁ receptor agonists (eg, sumatriptan), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), St. John's word, tramadol, tryptophan, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of serotonin syndrome, including increased risk of restlessness, fever, excessive sweating, twitching, and seizures that can, rarely, be life-threatening


• Azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or nefazodone because they may increase the risk of Remeron SolTab Orally Disintegrating Tablets's side effects


• Carbamazepine, phenytoin, or rifampin because they may decrease Remeron SolTab Orally Disintegrating Tablets's effectiveness


• Warfarin because the risk of its side effects may be increased by Remeron SolTab Orally Disintegrating Tablets


• Clonidine because its effectiveness may be decreased by Remeron SolTab Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Remeron SolTab Orally Disintegrating Tablets 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 Remeron SolTab Orally Disintegrating Tablets:

Use Remeron SolTab Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Remeron SolTab Orally Disintegrating Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Remeron SolTab Orally Disintegrating Tablets refilled.


• Take Remeron SolTab Orally Disintegrating Tablets by mouth with or without food.


• Take Remeron SolTab Orally Disintegrating Tablets in the evening before bedtime unless your doctor tells you otherwise.


• Do not remove the blister from the outer pouch until you are ready to take Remeron SolTab Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Remeron SolTab Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.


• Improvement should be noticed within 1 to 4 weeks of taking Remeron SolTab Orally Disintegrating Tablets.


• Continue to take Remeron SolTab Orally Disintegrating Tablets even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Remeron SolTab Orally Disintegrating Tablets without checking with your doctor. Side effects may occur. They may include abnormal dreams, numbness or tingling, confusion, dizziness, fatigue, mental or mood changes (eg, agitation, anxiety), headache, nausea, sweating, tremor, or vomiting. If you need to stop taking Remeron SolTab Orally Disintegrating Tablets, your doctor will slowly lower your dose.


• If you miss a dose of Remeron SolTab Orally Disintegrating Tablets, 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 Remeron SolTab Orally Disintegrating Tablets.

Important safety information:

• Remeron SolTab Orally Disintegrating Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Remeron SolTab Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are taking Remeron SolTab Orally Disintegrating Tablets.


• Check with your doctor before you take medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Remeron SolTab Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Remeron SolTab Orally Disintegrating Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Children, teenagers, and young adults who take Remeron SolTab Orally Disintegrating Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Remeron SolTab Orally Disintegrating Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Remeron SolTab Orally Disintegrating Tablets. Your risk may be greater if you take Remeron SolTab Orally Disintegrating Tablets with certain other medicines (eg, antidepressants, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; irritability; fever; fast or irregular heartbeat; tremor; excessive sweating; rigid muscles; severe headache or dizziness; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Remeron SolTab Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Remeron SolTab Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, confusion, or low blood sodium levels.


• Remeron SolTab Orally Disintegrating Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Remeron SolTab Orally Disintegrating Tablets while you are pregnant. It is not known if Remeron SolTab Orally Disintegrating Tablets are found in breast milk. If you are or will be breast-feeding while you use Remeron SolTab Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Remeron SolTab Orally Disintegrating Tablets:

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:

Abnormal dreams; abnormal thinking; constipation; dizziness; drowsiness; dry mouth; flu symptoms; increased appetite; weakness; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth sores; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, trouble sleeping, restlessness, or inability to sit still; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; sluggishness; suicidal thoughts or actions; symptoms of infection (eg, fever, chills, sore throat); tremors; unusual or severe mental or mood changes; worsening of depression.

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: Remeron SolTab 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 agitation; disorientation; drowsiness or deep sleep; fast heartbeat; impaired memory; loss of consciousness; rigid muscles; sluggishness.

Proper storage of Remeron SolTab Orally Disintegrating Tablets:

Store Remeron SolTab Orally Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Remeron SolTab Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Remeron SolTab Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Remeron SolTab Orally Disintegrating Tablets are 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 Remeron SolTab Orally Disintegrating Tablets. 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 Remeron SolTab resources

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

Compare Remeron SolTab with other medications

• Anxiety
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• Hot Flashes
• Insomnia

Cefradin Pharbaco

Cefradin Pharbaco may be available in the countries listed below.

Ingredient matches for Cefradin Pharbaco

Cefradine

Cefradine is reported as an ingredient of Cefradin Pharbaco in the following countries:

• Vietnam

International Drug Name Search

Ikelan

Ikelan may be available in the countries listed below.

Ingredient matches for Ikelan

Buflomedil

Buflomedil hydrochloride (a derivative of Buflomedil) is reported as an ingredient of Ikelan in the following countries:

• China

International Drug Name Search

Benzonatate

Dosage Form: capsule
Benzonatate CAPSULES USP, 100 mg and 200 mg

Rx only

Benzonatate Description

Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7.

Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg Benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.

Benzonatate - Clinical Pharmacology

Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

Indications and Usage for Benzonatate

Benzonatate is indicated for the symptomatic relief of cough.

Contraindications

Hypersensitivity to Benzonatate or related compounds.

Warnings

Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Effects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep Benzonatate out of reach of children. Accidental ingestion of Benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

Precautions

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Information for patients:

Swallow Benzonatate Capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate capsules. Release of Benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep Benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of Benzonatate, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of Benzonatate at one time.

Usage in Pregnancy:

Pregnancy Category C.

Animal reproduction studies have not been conducted with Benzonatate. It is also not known whether Benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate should be given to a pregnant woman only if clearly needed.

Nursing mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when Benzonatate is administered to a nursing woman.

Carcinogenesis, mutagenesis, impairment of fertility:

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Benzonatate.

Pediatric Use:

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Adverse Reactions

Potential Adverse Reactions to Benzonatate may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Deliberate or accidental overdose has resulted in death, particularly in children.

Overdosage

Intentional and unintentional overdose may result in death, particularly in children.

The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms:

The signs and symptoms of overdose of Benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.

CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment:

In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

Benzonatate Dosage and Administration

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

How is Benzonatate Supplied

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with “PA46”, available in bottles of 100’s and 500’s.

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in bottles of 100’s.

The capsules should be protected from light, moisture and humidity, and stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].

Dispense in a tight, light-resistant container as defined in USP/NF.

Manufactured by:

BANNER PHARMACAPS INC.;

High Point, NC 27265

Distributed by:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Revised February 2011

PRINCIPAL DISPLAY PANEL

Benzonatate Capsules, USP 200 mg 100s Label Text

NDC 0555-1883-02

Benzonatate

Capsules, USP

200 mg

PROTECT FROM LIGHT

Rx only

100 Soft Gelatin Capsules

TEVA

Benzonatate  Benzonatate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-1883 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (Benzonatate) Benzonatate 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10   GELATIN   GLYCERIN   WATER

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 12mm Flavor Imprint Code PA83 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-1883-02 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA081297	11/14/2010

Labeler - Barr Laboratories Inc. (802716563)

Revised: 06/2011Barr Laboratories Inc.

More Benzonatate resources

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

• Benzonatate Professional Patient Advice (Wolters Kluwer)


• Benzonatate MedFacts Consumer Leaflet (Wolters Kluwer)


• Benzonatate Monograph (AHFS DI)


• benzonatate Advanced Consumer (Micromedex) - Includes Dosage Information


• benzonatate Concise Consumer Information (Cerner Multum)

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Mukoseptonex

Mukoseptonex may be available in the countries listed below.

Ingredient matches for Mukoseptonex

Carbaethopendecine Bromide

Carbaethopendecine Bromide is reported as an ingredient of Mukoseptonex in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Doxil

Generic Name: doxorubicin hydrochloride liposome (Intravenous route)

dox-oh-ROO-bi-sin hye-droe-KLOR-ide LYE-poh-some

Intravenous route(Solution)

Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin hydrochloride (HCl) approaches 550 mg/m(2). Cardiac toxicity may also occur at lower cumulative doses with mediastinal irradiation or concurrent cardiotoxic agents. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Administer at an initial rate of 1 mg/min to minimize the risk of infusion reactions. Severe myelosuppression may occur with therapy. Reduce dosage in patients with impaired hepatic function. Doxorubicin HCl liposome should not be substituted for doxorubicin HCl on a mg per mg basis .

Commonly used brand name(s)

In the U.S.

• Doxil

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

Uses For Doxil

Liposomal doxorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat patients with ovarian cancer, and Kaposi's Sarcoma in patients with human immunodeficiency virus (HIV). Liposomal doxorubicin is also used together with bortezomib to treat multiple myeloma in patients who have not yet received bortezomib in the past and have received at least one prior treatment .

Liposomal doxorubicin seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by liposomal doxorubicin, 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 liposomal doxorubicin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Liposomal doxorubicin 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, liposomal doxorubicin is used in certain patients with the following medical conditions:

• Cancer of the breast


• Multiple myeloma, in combination with vincristine and dexamethasone

Before Using Doxil

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

There is no specific information comparing the use of liposomal doxorubicin in children with use in any other age group. Safety and efficacy of liposomal doxorubicin in children have not been established. However, problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of the active ingredient, doxorubicin.

Geriatric

This medicine has been tested in a limited number of patients 60 years of age or older and has not been shown to cause different side effects in older people than it does in younger adults. However, problems are more likely to occur in the elderly, who are usually more sensitive to the effects of the active ingredient, doxorubicin. The elderly are also more likely to have blood problems.

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 receiving 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


• Cisplatin


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Trastuzumab


• Typhoid Vaccine


• Varicella Virus Vaccine


• 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.

• Paclitaxel

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.

• Heart disease—Risk of heart problems caused by liposomal doxorubicin may be increased.

• Infection—Liposomal doxorubicin can decrease your body's ability to fight infection.

• Liver disease—Effects of liposomal doxorubicin may be increased because of slower removal from the body.

Proper Use of Doxil

Liposomal doxorubicin 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 take them at the right times.

While you are receiving liposomal doxorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive it, even if you begin to feel ill. 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 Doxil

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

Check with your doctor immediately if you are having chest pain or discomfort, fast or irregular heartbeat, shortness of breath, swelling of the feet and lower legs, or troubled breathing. These could be symptoms of a serious heart problem .

Acute infusion-related reactions can occur during treatment with this medicine. Symptoms of this reaction include: flushing; shortness of breath; swelling of the face; headache; chills; chest pain; back pain; tightness in chest and throat; fever; itching skin; rash; bluish color of fingernails, lips, skin, palms, or nail beds; difficulty breathing; wheezing; fainting; lightheadedness; or fast, pounding, or irregular heartbeat or pulse .

This medicine may cause hand-foot syndrome. Check with your doctor right away if you experience tingling or burning, redness, swelling, blistering, or small sores on the palms of your hands or soles of your feet.

You should not receive this medicine if you are pregnant or breastfeeding. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away .

While you are being treated with liposomal doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Liposomal doxorubicin 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 poliovirus vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. 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 the mouth.

Liposomal doxorubicin 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.


• 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 can occur.

If liposomal doxorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

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.

Doxil 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 as soon as possible if any of the following side effects occur:

More common–in any treatment group

• Black, tarry stools


• blistering, peeling, redness, and/or swelling of palms of hands or bottoms of feet


• blood in urine or stools


• chills


• cough or hoarseness


• facial swelling


• fever


• headache


• loss of strength and energy


• low blood pressure


• lower back or side pain


• numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet


• painful or difficult urination


• pinpoint red spots on skin


• shortness of breath


• sore throat


• sores in mouth and on lips


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common–in any treatment group

• Skin rash or itching

Rare–in any treatment group

• Chest pain


• decreased urine output


• dilated neck veins


• extreme fatigue


• irregular breathing


• irregular heartbeat


• shortness of breath


• swelling of face, fingers, feet, or lower legs


• tightness in chest


• troubled breathing


• weight gain


• wheezing


• yellowing of the eyes and skin

Less common—for patients being treated for Kaposi's sarcoma

• Cough


• fever


• pain at place of injection


• troubled breathing


• wheezing

Rare—for patients being treated for Kaposi's sarcoma

• Blurred or loss of vision


• eye pain


• flushed, dry skin


• frequent urination


• fruit-like breath odor


• unusual thirst

Less common—for patients being treated for ovarian cancer

• Bloating or swelling of face, hands, lower legs, and/or feet


• chest pain


• cough or hoarseness


• decreased urination


• fever or chills


• lower back or side pain


• painful or difficult urination


• rapid weight gain

Rare—for patients being treated for ovarian cancer

• Cough


• difficulty swallowing


• hives


• pain at place of injection


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


• shortness of breath


• tightness in chest


• wheezing

Symptoms of overdose

• 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


• sores in mouth and on lips


• unusual bleeding or bruising

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–in any treatment group

• Diarrhea


• nausea


• vomiting

Less common–in any treatment group

• Back pain


• difficulty swallowing


• dizziness

More common—for patients being treated for Kaposi's sarcoma

• Creamy white, curd-like patches in mouth or throat


• pain when eating or swallowing

Less common—for patients being treated for Kaposi's sarcoma

• Constipation


• headache

More common—for patients being treated for ovarian cancer

• Abdominal or stomach pain


• changes in the lining of the mouth or nose


• constipation


• headache


• loss of appetite


• pain


• rash


• sore throat


• tingling, burning, or prickly sensations

Less common—for patients being treated for ovarian cancer

• Anxiety


• bad, unusual, or unpleasant (after)taste


• burning, dry, or itching eyes


• change in taste


• difficulty swallowing


• excessive tearing


• itching skin


• muscle aches


• redness, pain, swelling of eye, eyelid, or inner lining of eyelid


• trouble sleeping

Rare—for patients being treated for ovarian cancer

• Change in sense of smell


• chills


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


• cough


• fever


• general feeling of discomfort or illness


• increased white vaginal discharge


• joint pain


• nausea


• shakiness and unsteady walk


• shivering


• sore throat


• sweating


• thinking abnormal


• vomiting

Liposomal doxorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

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—for patients being treated for ovarian cancer

• Dry skin

Less common—for patients being treated for ovarian cancer

• Change in skin color

This medicine often causes a temporary and total loss of hair. After treatment with liposomal doxorubicin 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:

• Fast or irregular heartbeat


• shortness of breath


• swelling of feet and lower legs

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: Doxil side effects (in more detail)

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More Doxil resources

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

• Doxil Prescribing Information (FDA)


• Doxil Concise Consumer Information (Cerner Multum)


• Doxil MedFacts Consumer Leaflet (Wolters Kluwer)

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