Combivir

Brand: COMBIVIR

Generic: LAMIVUDINE/ZIDOVUDINEL

COMBIVIR belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

COMBIVIR is used in antiretroviral combination therapy for the treatment of HIV infection in patients weighing more than 14 kg. COMBIVIR reduces the amount  of HIV virus in your body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection. COMBIVIR has been shown to significantly reduce the risk of disease progression. Response to treatment with COMBIVIR varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

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PATIENT INFORMATION

  Combivir Patient Information (1.2 MiB, 49 hits)

MEDICATION GUIDE

  Combivir Prescribing Information (349.1 KiB, 26 hits)

SAFETY INFORMATION

►Do not take COMBIVIR and tell your doctor if:

• If you are hypersensitive (allergic) to lamivudine or zidovudine or any of the other ingredients of COMBIVIR tablets.
• If you have very low red blood cell count (severe anaemia) or very low white blood cell count (neutropenia).

► Take special care with COMBIVIR

Discuss the use of COMBIVIR with your doctor if you have kidney or liver disease to ensure the doses of the active substances in COMBIVIR are suitable for you.

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 decide to prescribe lamivudine or zidovudine as separate medicines instead of COMBIVIR.

►Anaemia (low red blood cell count) and neutropenia/leucopenia (low white blood cell count) may occur within 4-6 weeks due to treatment with zidovudine, one of the active substances in COMBIVIR. If severe, your physician may stop treatment with COMBIVIR. This has occurred more commonly in patients with advanced HIV disease and with higher doses of zidovudine than the dose in COMBIVIR. Regular blood tests will be arranged to check whether there is a problem with your white and red blood cell count. This adverse reaction is infrequent in patients with early HIV disease and blood tests may be performed less frequently. If you take ribavirin and zidovudine together it may cause or worsen anaemia. Please contact your doctor if you notice symptoms of anaemia (such as tiredness and shortness of breath). Your doctor will advise you whether you should stop taking COMBIVIR.

►The class of medicines to which COMBIVIR belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis. This rare, but serious side effect occurs more often in women, particularly if very overweight. 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.

►Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

►In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body  to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

►Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased  risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.

►If you have a chronic hepatitis B infection, you should not stop your treatment without instructions from your doctor, as you may have a recurrence of your hepatitis. This recurrence may be more severe if you have serious liver disease.

►You will need to take COMBIVIR every day. This medicine helps to control your condition and delay disease progression, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor. Do not stop taking your medicine without first talking to your doctor.

►Treatment with COMBIVIR has not been shown to reduce the risk of passing HIV infection on to others by unprotected sexual contact or by blood transfer (for example, blood transfusions or sharing needles). You should continue to use appropriate precautions to prevent this.

►Bone problems
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

►Pregnancy and breast-feeding
If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.

If you have taken COMBIVIR during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

If you are breast-feeding please inform your doctor before taking any medicines. COMBIVIR is not recommended if you are breast-feeding. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

POSSIBLE SIDE EFFECTS

Like all medicines, COMBIVIR can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by COMBIVIR, by other medicines you are taking at the same time or by the HIV disease. For this reason it is very important that you inform your doctor about any changes in your health.

►COMBINATION ANTIRETROVIRAL THERAPY

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include:

• loss of fat from legs
• arms and face
• increased fat in the abdomen (belly) and other internal organs
• breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’).

The cause and long-term health effects of these conditions are not known at this time.

Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

►VERY SERIOUS SIDE EFFECTS (may affect more than 1 user in 10):

• headache
• nausea

►COMMON SIDE EFFECTS (may affect 1 to 10 users in 100):

• vomiting
• stomach pain
• diarrhoea
• increase in certain liver enzymes
• joint pain
• muscle pain and other muscle disorders
• dizziness
• tiredness
• difficulty sleeping
• hair loss
• anaemia (low red blood cell count)
• neutropenia (low white blood cell count). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infection.

►UNCOMMON SIDE EFFECTS (may affect 1 to 10 users in 1,000):

• flatulence
• breathlessness
• rash (red, raised or itchy)
• fever
• general aches and pains
• reduction in platelets (blood cells important for blood clotting). If you have a low platelet count you may notice that you bruise more easily.

►RARE SIDE EFFECTS (may affect 1 to 10 users in 10,000):

• cough
• nasal symptoms
• patchy colour changes inside the mouth
• heartburn
• chest pain (possibly indicating a heart muscle disease called cardiomyopathy)
• breakdown of muscle tissue
• liver disorders such as enlarged liver
• fatty liver
• inflammation of the liver (hepatitis)
• inflammation of the pancreas, nail and skin
• colour changes
• sweating
• flu-like feeling
• drowsiness
• passing urine more frequently
• breast enlargement in male patients
• chest pain, chills, loss of appetite,
• taste changes
• tingling in the limbs
• seizures
• inability to concentrate
• depression and feeling anxious
• increase of lactic acid in the body known as lactic acidosis.

While many of the side effects that have been reported occur with both lamivudine and zidovudine when given as separate medicines, some are more likely to occur with one of the medicines only. Your doctor may decide that you need to stop taking COMBIVIR and take lamivudine and zidovudine separately. This will allow your doctor to vary the dose or stop one of the active substances if it is considered that this will help manage any side effects.

If any of the side effects gets serious, or if you notice any side effects not, please tell your doctor or pharmacist.

DRUG INTERACTION

It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself. These may affect the action of COMBIVIR, or COMBIVIR may affect their action.

►As one of the active substances in COMBIVIR may interact with the following, COMBIVIR should not be taken with:

• high doses of co-trimoxazole
• injections of ganciclovir or foscarnet
• aslamivudine

►COMBIVIR should also not be taken with stavudine, as zidovudine the other active substance in COMBIVIR may reduce the action of this medicinal product. Zidovudine, may also interact with the following medicines and may make any side effects worse:

• phenytoin
• probenecid
• rifampicin
• atovaquone
• valproic acid
• methadone
• dapsone
• pentamidine
• pyrimethamine
• co-trimoxazole
• fluconazole
• amphotericin
• flucytosine
• ganciclovir
• interferon
• clarithromycin
• vincristine
• vinblastine
• doxorubicin.