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Antifungals & Antivirals

Zidovudin STADA® 300 mg

 

Pack szie:

Box of 1 bottle of 60  tablets.


Composition:

Each film - coated tablet contains zidovudine 300 mg.


Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30°C

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Used in conjunction with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients.
  • Zidovudine is not a cure for HIV infection, and patients may continue to acquire illnesses associated with HIV infection. Therefore, the patients must be informed to seek medical care for any significant change in their health status, and be given continuous support and treatment.
  • Administered orally without regard to meals.
  • The recommended oral dosage of zidovudine for the treatment of HIV-1 infection in adults 18 years of age or older is 600 mg daily in divided doses (300 mg twice daily).
  • For pediatric patients with body weight 30 kg or more, the dosage regimen of zidovudine is 300 mg twice daily.
  • Dosage in renal and hepatic impairment:
    Because zidovudine is eliminated principally by renal excretion following metabolism in the liver, dosage of the drug should be reduced in patients with severe renal impairment (i.e., creatinine clearance less than 15 ml/minute).
    Data are insufficient to recommend dosage adjustment for patients with mild to moderate impaired hepatic function or liver cirrhosis; however, a reduction in dosage may be necessary in these patients and frequent monitoring for hematologic toxicities is advised.
     

Or as prescribed by physicians.

 

  • Known to be hypersensitive to zidovudine, or to any ingredient of the drug.
  • Patients with low neutrophil counts, less than 0.75 x 109/l, or low hemoglobin levels, less than 75 g/l.

     

  • The major toxicities of zidovudine are neutropenia or anemia. The incidence and severity are greater when the disease is advanced or initiated treatment late. In patients with severe HIV, the risk of blood toxicity is from 25 to 30%.

Most common:

  • Granulocytopenia.
  • Severe anemia.

Common:

  • Abdominal pain, dyspepsia, nausea, vomiting, insomnia, and headache. Myopathy and nail pigmentation sometimes occur when using for long time.
  • Megaloblastic anemia, granulocytopenia, leucopenia, neutropenia.
  • Nausea, vomiting, diarrhea, dyspepsia.
  • Severe headache, insomnia, malaise, vertigo, manic syndrome, convulsions, mental disorder, confusion, fever.
  • Cholestasis hepatitis, fatty degeneration.
  • Rash, nail pigmentation, alopecia, epidermal necrolysis.
  • Tremor, myalgia, arthralgia, polymyositis.
  • Neutropenia, leucopenia and anemia occur frequently when using at high dosage (1200 - 1500 mg/ 24 hours) and in the patients with a history of neutropenia or anemia, especially in the patient with bone marrow failure and lymphocyte CD4 counts less than 100/ mm3.

     

  • Zidovudine should be used with care in patients with anaemia or bone-marrow suppression. The incidence of neutropenia is greater in patients with low vitamin B12 concentrations. Dosage adjustments may be necessary and it has been recommended that it should not be used if the neutrophil count or haemoglobin value is abnormally low.
  • Care is also required in the elderly and in patients with reduced renal or hepatic function who may require reductions in dose. Patients with risk factors for liver disease should be monitored during treatment. Particular care may be necessary in obese patients and in women. Patients with hepatitis receiving interferon alfa and ribavirin may be at special risk. Zidovudine treatment should be stopped if there is symptomatic hyperlactataemia and metabolic or lactic acidosis, progressive hepatomegaly, or a rapid increase in aminotransferase concentrations. It should not be given to neonates with hyperbilirubinaemia requiring treatment other than phototherapy or with markedly increased aminotransferase concentrations.
  • Women who are in the first trimester of pregnancy may consider delaying initiation of antiretroviral therapy until after 10 – 12 weeks' gestation.
  • Zidovudine is distributed into human milk. Because of the potential for HIV transmission and the potential for serious adverse effects from zidovudine in nursing infants, women should be instructed not to breast-feed while they are receiving zidovudine.
  • No studies on the effects on the ability to drive and use machines have been performed.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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