CIPLA-ZIDOVUDINE (Capsules) are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in adults, children and mothers who are not breast-feeding and for the prophylaxis of maternal-foetal HIV transmission in HIV positive pregnant women of over 14 week gestation and their own newborn infants.
1. What CIPLA-ZIDOVUDINE is and what it is used for.
2. What you need to know before you take/use CIPLA-ZIDOVUDINE.
Tell your doctor if you have ever had any unusual or allergic reaction to zidovudine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. CIPLA-ZIDOVUDINE (Capsules) can cause serious side-effects in any patient. Therefore, it is especially important that you discuss with your child's doctor the good that this medicine may do as well as the risk of using it. Your child must be carefully followed, and frequently seen, by the doctor while he or she is taking zidovudine.
Do not take CIPLA-ZIDOVUDINE (Capsules): If you have known hypersensitivity to zidovudine or any other ingredients of the formulation.
Take special care with CIPLA-ZIDOVUDINE (Capsules)
The presence of other medical problems may affect the use of zidovudine. Make sure to tell your doctor if you have any other medical problems, especially:
- Anemia or other blood problems
- Liver disease
- Low amounts of folic acid of vitamin B12 in the blood
- At risk of liver disease
- Obesity
- Taking medicines called nucleosides for a long time
Taking CIPLA-ZIDOVUDINE (Capsules) with food and drink:
CIPLA-ZIDOVUDINE (Capsules) can be taken with or without food.
Pregnancy and breast-feeding:
If you may become pregnant or are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. The safety of CIPLA-ZIDOVUDINE (Capsules) has not been established in human pregnancy. Since zidovudine may pass into breast milk, breastfeeding by mothers taking CIPLA-ZIDOVUDINE (Capsules) are not recommended. Breast-feeding is usually not recommended in patients with HIV infection because of the risk of passing the HIV to the infant.
3. How to take/use CIPLA-ZIDOVUDINE.
Always take CIPLA-ZIDOVUDINE (Capsules) exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure of the dosage of CIPLA-ZIDOVUDINE (Capsules). The usual dose is:
Recommended dosage in adults:
CIPLA-ZIDOVUDINE (Capsules) in combination with other antiretroviral agents: 500 or 600 mg daily in two or three divided doses. More than 1000 mg daily in divided doses has been used. The effectiveness of dosages lower than 1000 mg daily in the treatment or prevention of HIV-associated neurological dysfunction is unknown.
Recommended dosage in children 3 months to 12 years of age:
CIPLA-ZIDOVUDINE in combination with other antiretroviral agents: 360 to 480 mg/m2 daily in three or four divided doses. For the treatment or prevention of HIV-associated neurological dysfunction, the effectiveness of dosages less than 720 mg/m2 daily, i.e. 180 mg/m2 every six hours, is unknown. The maximum dosage should not exceed 200 mg every six hours.
Recommended dosage in the prevention of mother-to-foetus transmission:
Pregnant women over 14 weeks of gestation: 500 mg orally per day, i.e. 100 mg five times per day, until the beginning of labour. During labour and delivery zidovudine should be administered intravenously at 2 mg/kg body mass over 1 hour, followed by a continuous intravenous infusion at 1 mg/kg per hour until the umbilical cord is clamped. The newborn infants: starting within 12 hours after birth until at 6 weeks of age: 2 mg/kg body mass orally every 6 hours. Infants unable to receive oral dosing should be given zidovudine intravenously at 1.5 mg/kg body mass, infused over 30 minutes every 6 hours.
4. Possible side effects.
CIPLA-ZIDOVUDINE (Capsules) can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. The adverse event profile appears to be similar for adults and children.
Side-effects:
Haematological system: The most serious adverse reactions include anaemia, usually occurring after six weeks of therapy but occasionally earlier and often requiring transfusions; neutropenia, usually occurring at any time after 4 weeks of therapy but sometimes earlier; and leucopenia, which is usually secondary to neutropenia. Thrombocytopenia and pancytopenia with marrow hypoplasia have also been reported. Anaemia, neutropenia, and leucopenia occur more frequently at higher dosages of 1 200 to 1 500 mg/day, and in patients with advanced HIV disease, especially where there is poor bone marrow reserve prior to treatment, and particularly in patients with low T4 (T-helper) cell counts (less than 100/mm3). Dosage reduction or cessation of therapy may become necessary.
The incidence of neutropenia was also increased in patients with pre-existing neutropenia or anaemia, those with low vitamin B12 levels and those taking paracetamol concomitantly. The following events have also been reported in patients treated with CIPLA-ZIDOVUDINE. The relationship between these events and the use of CIPLA-ZIDOVUDINE may be difficult to evaluate, particularly in medically complicated situations that characterize advanced HIV disease. A reduction in dose or suspension of CIPLA-ZIDOVUDINE therapy may be warranted in the management of these conditions.
Gastro-intestinal disorders:
Nausea, vomiting, pigmentation of the oral mucosa, abdominal pain, dyspepsia, anorexia, diarrhoea, flatulence.
Hepatobilliary disorders:
Liver disorders such as severe hepatomegaly with steatosis, raised blood levels of liver enzymes and bilirubin, pancreatitis.
Metabolic/Endocrine disorders:
Lactic acidosis in the absence of hypoxia (see Special Precautions).
Musculoskeletal system disorders:
Myalgia, myopathy, asthenia.
Psychiatry disorders:
Anxiety, depression.
Skin and appendages:
Nail and skin pigmentation, rash, urticaria, pruritus, sweating.
Respiratory system disorders:
Dyspnoea, cough, chest pain.
Central and peripheral nervous system disorders:
Headache, dizziness, insomnia, paraesthesia, somnolence, loss of mental acuity, convulsions.
Genitourinary system disorders:
Urinary frequency, gynaecomastia.
Special senses disorders:
Taste perversion.
Body as whole:
Fever, malaise, generalised pain, chills, influenza-like syndrome.
5. How to store CIPLA-ZIDOVUDINE.
Store below 25 °C, protected from light. Keep the blister strips in the carton until required for use. KEEP OUT OF REACH OF CHILDREN. Keep all medicines out of the reach and sight of children. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist.