Generic Retrovir

1. Denomination

Combivir

2. Active Substance

Lamivudine/Zidovudine

3. Indications for Use.

The treatment of HIV-infection in adults and children over 12 years of age with progressive immunodeficiency (cellularity of CD4+ less than 500/mcl).

4. Action

Lamivudine/Zidovudine inhibits the change of genetic material of healthy Т-cells with a human immunodeficiency virus. It does not give cells the possibility to produce a new virus and reduces the virus’s quantity in the body.

5. Posology and Administration

Lamivudine/Zidovudine should be taken twice a day, one tablet in the morning and one in the evening with meal or without meal.

6. Counterindications

There are counterindications: kidneys disease; liver disease, pancreatitis; reduced activity of bone tissue (low number of red blood cells (anemia) or low number of white blood cells).

7. Should Be Taken with Precautions, if…

In the treatment period it is necessary to control the blood picture. Caution is needed while Lamivudine/Zidovudine therapy of the patients with hepatomegalia, hepatitis, or the risk factors predisposing to liver injury, especially in administration of Lamivudine/Zidovudine to obesity women.
Patients should be informed that antiretroviral therapy, such as Lamivudine/Zidovudine therapy does not prevent a risk of HIV-transmission to other people when there are sex contacts or infected blood transfusion, that is why the patients should observe appropriate precaution measures.

8. Interface with Other Medications

Lamivudine/Zidovudine is used only in combination with definite drugs. Medical doctors when administrating Lamivudine/Zidovudine should be governed by information on the use of these drugs.

9. Overdosing

When overdosage takes place there is a probability of the enhancement of side effects.

10. Side Effects

Problems of bone marrow may be observed, such as decrease in production of red blood cells and/or white blood cells, likewise dysfunction of muscles, including the heart, vomit, unusual discomfort in the stomach; weakness and tiredness; shortness of breath; weakness in arms and legs; sallowness under eyes; pains in the upper part of the stomach. The use of  Lamivudine/Zidovudine may result in the growth of the fat level (of cholesterol and triglyceride) in blood, change of normal body proportions (lipodystrophy, including increase of fat deposits in abdominal zone, in breast, rear part of the neck, likewise in the face, arms and legs) and to diabetes.
It is necessary to visit your doctor immediately if you feel an unusual tiredness, if you observe skin pallor, pain in the throat, fever or tremor, which may be symptoms of bone marrow problems.
If you withdraw Lamivudine/Zidovudine therapy abruptly it may be harmful and result in hepatic “dilatation”.

11. Pregnancy and Lactation

It is not recommended to take Lamivudine/Zidovudine in the first 3 months of pregnancy, apart from the cases when an expected utility of the therapy for the mother does not exceed a probable risk for the fetus.
It is not known whether Lamivudine/Zidovudine is passed with the mother’s milk and in which effects on the baby it may result. For infection prevention of noninfected newborns HIV-positive mothers are not recommended to breastfeed.

12. Driving

It is not recommended to drive vehicles both in the period of Lamivudine/Zidovudine therapy and to the patient whose disease has reached a canalized development.

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