Actavir tablets (Favipiravir).

• Composition :
  Favipiravir 200/400/800 mg.
• Indications :
  For the treatment of adults in mild to moderate COVID-19 disease under restricted emergency use.
• Pharmacodynamics :
  Favipiravir selectively inhibits RNA polymerase involved in viral replication.
• Dosage and administration :
  The recommended dosage of favipiravir for adults is 1800 mg orally twice daily on 1st day followed by 800 mg orally twice daily, up to maximum of 14 days.
• Contraindications :
  Women known or suspected to be pregnant (Early embryonic deaths and teratogenicity have been observed in animal studies), lactating women, severe renal and hepatic impairment. Hypersensitivity to the active substances or to any of the excipients.
• Precautions and warnings :
  : When administering favipiravir to women of child-bearing potential, confirm a negative pregnancy test result before starting the treatment. Explain fully the risks and instruct thoroughly to use most effective contraceptive methods with her partner during and for 7 days after the end of the treatment. If pregnancy is suspected during the treatment, instruct to discontinue the treatment immediately and to consult a doctor. Favipiravir is distributed in sperm. When administering the drug to male patients, explain fully the risks and instruct thoroughly to use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of the treatment (men must wear a condom). In addition, instruct not to have sexual intercourse with pregnant women. Prior to the treatment, explain thoroughly the efficacy and risks (including the risk of exposure to fetus) to patients or their family members and written informed consent from each patient/ or his representative prior to administration of the drug shall be obtained by the prescriber. Caution in patients with history of abnormalities in metabolism of uric acid or having Gout. Psychoneurotic symptoms such as abnormal behaviour after administration of anti-influenza virus agents including favipiravir have been reported.
• Use in pregnancy, lactation & pediatrics :
  Contraindicated in pregnant and lactating women. No studies have been done in children.
• Drug interactions :
  Favipiravir mostly metabolized by aldehyde oxidase (AO), and partly metabolized by xanthine oxidase (XO). The drug inhibits AO and CYP2C8, but does not induce CYP. Precautions for co-administration of Pyrazinamide, repaglinide, famciclovir, sulindac.
• Adverse reactions :
  The major undesirable effects observed in clinical studies with favipiravir include: increase in blood uric acid level, diarrhoea, decrease in neutrophil count and increase in AST and ALT.
• Therapy Area :
  Anti-Virals