Combivir 150mg/300mg

Generic Name: Lamivudine/Zidovudine 150mg/300mg
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Best Value On Brand Combivir 150mg/300mg
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Best Value On Generic Lamivudine/Zidovudine 150mg/300mg
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Lamivudine/Zidovudine 150mg/300mg Prescription Required
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Lamivudine/Zidovudine from online pharmacy: India
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About Combivir

What Combivir is used for

The name of your medicine is COMBIVIR (lamivudine and zidovudine). COMBIVIR is a treatment that contains a combination of two active ingredients that are currently available as separate medicines: 3TC (lamivudine) and RETROVIR (AZT) (zidovudine). COMBIVIR can only be obtained with a prescription from your doctor. You should not be taking RETROVIR (AZT) (zidovudine) nor 3TC (lamivudine) while taking COMBIVIR.

What Combivir does

The Human Immunodeficiency Virus (HIV) is a retrovirus. Infection with HIV damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses.

COMBIVIR is an antiretroviral medication. COMBIVIR does not cure AIDS or kill the HIV virus, but helps to prevent further damage to the immune system by slowing down the production of new viruses.

When Combivir should not be used

Do not use COMBIVIR:

  • If you previously had an allergic reaction to COMBIVIR or to any of the ingredients in the product (see What the important nonmedicinal ingredients are:).

  • If you have a very low red blood cell count (anemia) or very low white blood cell count (neutropenia).

The coadministration of COMBIVIR with 3TC or RETROVIR (AZT) is not recommended.

What the medicinal ingredients for Combivir are

Each COMBIVIR tablet contains 150 mg of lamivudine and 300 mg of zidovudine.

What the important nonmedicinal ingredients for Combivir are

Each COMBIVIR tablet also contains the nonmedicinal ingredients colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.

What dosage forms Combivir comes in

Each COMBIVIR tablet contains 150 mg of lamivudine and 300 mg of zidovudine.


Warnings and Precautions

Serious Warnings and Precautions

  • lactic acidosis (high levels of acid in the blood) with severe hepatomegaly with steatosis (swollen and fatty liver). (See Warnings and Precautions and Side Effects.)

  • worsening of hepatitis B. (See Warnings and Precautions and Side Effects.)

  • pancreatitis (inflammation of the pancreas). (See Warnings and Precautions and Side Effects.)

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 infection.

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

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

    Your doctor will advise whether you should stop taking COMBIVIR.

If your answer is yes to any of these questions, tell your doctor or pharmacist as soon as possible, if you have not already done so.

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.

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.

Because your medicine helps to control your condition but does not cure it, you will need to take it every day. Do not stop taking your medicine without first talking to your doctor.

It is important that your doctor knows about all your symptoms even if you think they are not related to HIV infection. Your doctor may need to change the dose of your medicine.

Use of This Medicine During Pregnancy and Breastfeeding

If you are pregnant, or likely to become pregnant soon, or if you are breastfeeding, please inform your doctor before taking any drugs, including COMBIVIR.

Administration of COMBIVIR in the first 3 months of pregnancy is not recommended.

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

There have been very rare reports of disease that affect the nervous system such as delayed development and seizures.

These findings do not affect the current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies.

It is recommended that HIV infected women do not breastfeed their infants in order to avoid transmission of HIV. The active substances in COMBIVIR are found in human breast milk. Mothers taking COMBIVIR should not breastfeed their infants.

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.

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 Combivir

It is important that your doctor know about all your medicines so that you get the best possible treatment. 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 or zalcitabine.

It is important that you tell your doctor if you are taking any of the medicines below. Ask your doctor if you are not sure:

  • phenytoin, valproic acid, oxazepam, lorazepam

  • acetylsalicylic acid, codeine, morphine, methadone, rifampicin, indomethacin, ketoprofen, naproxen, cimetidine, clofibrate, isoprinosine, probenecid

  • pentamidine, pyrimethamine, co-trimoxazole, dapsone, atovaquone, amphotericin, flucytosine, interferon

  • vincristine, vinblastine, doxorubicin

  • clarithromycin


Proper Use of Combivir

Usual dose

Take your medicine as your doctor has advised you. The label on it will usually tell you the amount to take, and how frequently. If it does not, or you are not sure, ask your doctor or pharmacist.

Adults and Adolescents (at least 12 years old)

As a general guide, swallow one tablet twice a day. COMBIVIR can be taken with or without food.

If your doctor wishes to reduce your dose of COMBIVIR, for example if you have kidney problems, then your medicine may be changed to lamivudine and zidovudine taken as separate medicines, 3TC and RETROVIR (AZT).

If you are also taking clarithromycin, your doctor may advise you to take this medication at least 2 hours before or 2 hours after COMBIVIR, to avoid a drug interaction.

Overdose

Accidentally taking too much of your medicine is unlikely to cause any serious problems. However, you should immediately contact either your doctor, your hospital emergency department or the nearest poison control centre.

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. Then continue as before.


Side Effects for Combivir and What to Do About Them

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. 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.

Always tell your doctor or pharmacist about any undesirable effects, even those not mentioned in this leaflet.

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

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Common Serious allergic reaction and symptoms of sudden wheeziness and chest pain or tightening, swelling of eyelids, face or lips, skin rash or ‘hives’ anywhere on the body    
Rare Pancreatitis (inflammation of the pancreas and symptoms such as nausea, vomiting and severe stomach cramps)Lactic acidosis (high level of acid in the blood) and symptoms such as weight loss, fatigue, malaise, abdominal pain, shortness of breath, severe hepatomegaly (swollen liver), with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea.    
Uncommon Blood problems and symptoms such as anemia (lowered red blood cell count) resulting in fatigue, breathlessness), low white blood cell count making you prone to infections.    

This is not a complete list of side effects. For any unexpected effects while taking COMBIVIR, contact your doctor or pharmacist.


Technical Information