Combivir (Zidovudine/Lamivudine)

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Combivir 150mg/300mg

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Manufactured by: VIIV Healthcare ULC
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Combivir 150mg/300mg
Product of Canada
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Lamivudine/Zidovudine 150mg/300mg

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Lamivudine/Zidovudine 150mg/300mg
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Lamivudine/Zidovudine 150mg/300mg

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Manufactured by: Cipla Ltd
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Lamivudine/Zidovudine 150mg/300mg
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Combivir (Zidovudine/Lamivudine) Dosage and Side Effects

COMBIVIR is used in the treatment of the Human Immunodeficiency Virus (HIV) infection.

Proper Use of this medication

Take your medicine as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual dose:

For Adults and Adolescents weighing at least 30 kg:

One tablet by mouth twice a day at the same time each day.

COMBIVIR tablet can be taken with or without food.

If you have kidney or liver problems and your dose needs to be reduced your doctor may have you take 3TC (lamivudine) and RETROVIR (zidovudine) as separate medicines.

Missed dose:

If you forget to take your medicine, take it as soon as you remember. Then continue as before.

Do not double dose to make up for a forgotten dose.

Side Effects

Consult your doctor at your next visit if any of the following undesirable events occur:

Headaches, nausea, vomiting, diarrhea, fever, rash, fatigue, a general feeling of being unwell, or a numbness, tingling sensation or sensation of weakness in your limbs.

COMBIVIR may also cause a decrease in certain types of blood counts (including red blood cells, white blood cells and platelets) and an increase in certain liver enzymes.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk or internal organs. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.

Lactic acidosis is a rare but serious side effect.

Some people taking COMBIVIR, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.

Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs.

Lactic acidosis is more likely to develop in people who have liver disease, especially women.

Signs of lactic acidosis include:

  • deep, rapid, difficult breathing

  • drowsiness

  • numbness or weakness in the limbs

  • feeling sick (nausea), being sick (vomiting)

  • stomach pain.

During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you:

See your doctor as soon as possible.

Always tell your doctor or pharmacist about any undesirable effects.

If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.

Listed below are some side effects that have been noted:

Very common side effects

These may affect more than 1 in 10 people:

  • headache

  • feeling sick (nausea)

Common side effects

These may affect up to 1 in 10 people:

  • being sick (vomiting)

  • diarrhea

  • stomach pains

  • feeling dizzy

  • tiredness, lack of energy

  • fever (high temperature)

  • general feeling of being unwell

  • muscle pain and discomfort

  • joint pain

  • skin rash

  • hair loss

Common side effects that may show up in blood tests are:

  • a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)

  • an increase in the level of liver enzymes

  • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow

  • increased levels of lactic acid in the blood

Uncommon side effects

These may affect up to 1 in 100 people:

  • shortness of breath

  • wind/gas (flatulence)

  • itching

  • muscle weakness

Uncommon side effects that may show up in blood tests are:

  • a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia)

Rare side effects

These may affect up to 1 in 1000 people:

  • difficulty in sleeping (insomnia)

  • lactic acidosis

  • changes in body shape

  • liver disorders, such as an enlarged liver or fatty liver

  • inflammation of the pancreas (pancreatitis)

  • chest pain; disease of the heart muscle (cardiomyopathy)

  • fits (convulsions)

  • feeling depressed or anxious, not being able to concentrate, feeling drowsy

  • indigestion, taste disturbance

  • changes in the colour of your nails, your skin, or the skin inside your mouth

  • a flu-like feeling—chills and sweating

  • loss of appetite

  • breakdown of muscle tissue

  • passing urine more often

  • enlarged breasts in men

  • cough

  • sweating

  • itchy, bumpy rash (hives)

  • tingly feelings in the skin (pins and needles)

Rare side effects that may show up in blood tests are:

  • increase in an enzyme called amylase

  • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia)

Very rare side effects

These may affect up to 1 in 10 000 people:

  • Damage to nerves (peripheral neuropathy) which may include the following:

    • sensation of weakness in the limbs

    • numbness

Very rare side effects that may show up in blood tests are:

  • a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia)

Warnings and Precautions

BEFORE you use COMBIVIR talk to your doctor or pharmacist if:

  • You ever had to stop taking this or another medication for this illness because you were allergic to them or they caused problems.

  • You had, or do you have, any diseases of the kidney.

  • You had, or do you have, any diseases of the liver, particularly hepatitis B or C infection.

  • You had, or you have, very low red blood cell count (severe anemia), very low white blood cell count (neutropenia) or any type of blood disorder.

  • You are taking ribavirin as it could cause or worsen anemia (symptoms of tiredness, shortness of breath).

    Your doctor will advise whether you should stop taking COMBIVIR.

  • You are taking interferon.

Remember that treatment with COMBIVIR does not reduce the risk of passing the infection onto others. You will still be able to pass HIV by sexual contact or by blood transfusion and you should use appropriate precautions, for example:

  • Use a condom when you have oral or penetrative sex.

  • Don’t risk blood transfer—for example, don’t share needles.

While taking COMBIVIR or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. Therefore, you should keep in regular contact with the doctor who is treating your condition.

Your doctor will arrange regular blood tests to check for side effects. See Side Effects and What to Do About Them: for more details.

Use of This Medicine During Pregnancy and Breastfeeding:

If you are pregnant, or planning to become pregnant soon, you must inform your doctor before taking any medicine. The safe use of COMBIVIR in pregnancy has not been established. Your doctor will decide whether you should continue to be treated with COMBIVIR if you are pregnant. If you take COMBIVIR while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.

Babies and infants exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour show minor temporary increases in blood levels of lactate. The clinical importance of these temporary increases is unknown.

These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. There have been very rare reports of disease that affect the neonatal (babies) nervous system such as delayed development and seizures. The long term effects of COMBIVIR are not known.

It is recommended that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV from mother to child. The active substances in COMBIVIR are likely to be found in breast milk.

You are recommended not to breastfeed your baby while taking COMBIVIR.

REMEMBER: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Pancreatitis in Pediatric Patients:

In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, COMBIVIR should be used with caution. Treatment with COMBIVIR should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur (see Adverse Reactions).

Other Special Warnings:

The class of medicines to which COMBIVIR belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with COMBIVIR your doctor will monitor you closely for any signs that you may be developing lactic acidosis. See Side Effects and What to Do About Them: for additional information.

If you have hepatitis B infection, you should not stop COMBIVIR without instructions from your doctor, as you may have recurrence of your hepatitis. This may occur due to you suddenly stopping the active substance lamivudine in COMBIVIR.

Interactions with this medication

Tell your doctor about all your medicines, including vitamin supplements, herbal remedies or homeopathic remedies, including those you have bought yourself. COMBIVIR should not be taken with stavudine, emtricitabine, zalcitabine, ribavirin, lamivudine or zidovudine.

It is important that you tell your doctor if you are taking any of the medicines below:

  • phenytoin, valproic acid

  • oxazepam, lorazepam

  • codeine, morphine, methadone

  • acetylsalicylic acid, indomethacin, ketoprofen, naproxen

  • rifampicin, co-trimoxazole (trimethoprim and sulfamethoxazole), dapsone, pentamidine

  • ganciclovir, fluconazole, amphotericin, flucytosine

  • vincristine, vinblastine, doxorubicin

  • cimetidine

  • probenecid

  • clofibrate

  • atovaquone, pyrimethamine

  • interferon

  • isoprinosine

  • clarithromycin to be taken 2 hours before or 2 hours after taking COMBIVIR

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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