AVIGAN Tablets Ref.[8719] Active ingredients: Favipiravir

Publisher: Manufactured and Marketed by: TOYAMA CHEMICAL CO., LTD. 2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo, 160-0023, Japan

4.1. Therapeutic indications

Novel or re-emerging influenza virus infections (limited to cases in which other anti-influenza virus agents are not effective or insufficiently effective).

Precautions:

  1. AVIGAN is a drug the use of which is considered only when there is an outbreak of novel or re-emerging influenza virus infections in which other anti-influenza virus agents are not effective or insufficiently effective, and the government decides to use the drug as a countermeasure against such influenza viruses. When administering the drug, obtain the latest information including government’s direction of countermeasures against such influenza viruses, and prescribe only to appropriate patients.
  2. AVIGAN is not effective against bacterial infections.
  3. AVIGAN has not been administered to children.

4.2. Posology and method of administration

The usual dosage of favipiravir for adults is 1600 mg orally twice daily for 1 day followed by 600 mg orally twice daily for 4 days. The total administration period should be 5 days.

Precautions: The administration should be started promptly after the onset of influenza-like symptoms.

Use in the Elderly

Since the elderly often have reduced physiological functions, AVIGAN should be administered with care to them by monitoring their general conditions.

Pediatric Use

AVIGAN has not been administered to children. (In a one month study with juvenile dogs [8 weeks old], death cases have been reported after day 20 with a dosage [60 mg/kg/day] which was lower than the lethal dosage for young dogs [7 to 8 months old]. In juvenile animals [6-day-old rats and 8-week-old dogs], abnormal gait, atrophy and vacuolation of skeletal muscular fiber, degeneration/necrosis/mineralization of papillary muscle have been reported.)

6.5. Nature and contents of container

AVIGAN Tablets 200mg: boxes of 100 tablets in press-through packages.

6.6. Special precautions for disposal and other handling

Precautions concerning Use

Precautions regarding dispensing

For drugs that are dispensed in a press-through package (PTP), patients should be instructed to remove the drug from the package prior to use. (It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.)

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