Unifav 200mg

Tablet
Favipiravir
Unimed Unihealth MFG. Ltd

Other Strength:

Alternative:
- Viraflu tablet 200mg
- Piravir 200mg
- Akarvia 200mg
- Favinil™ 200mg
- Favilar 200mg
- Faviravir 200mg
- Favigan 200mg



Unifav
Presentation
Unifav 200 tablet: Each film coated tablet contains Favipiravir INN 200 mg.

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

Dosage and 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
1. Careful Administration (Favipiravir should be administered with care in the following patients.) Patients with gout or a history of gout, and patients with hyperuricaemia (Blood uric acid level may increase, and symptoms may be aggravated).

2. Important Precautions

A. No clinical study has been conducted to examine the efficacy and safety of Favipiravir with the approved dosage. The approved dosage was estimated based on the results of a placebo-controlled phase I/II clinical study in patients with influenza virus infection and the pharmacokinetic data from Japanese and overseas studies. Increase of plasma level of favipiravir has been reported in patients with liver function impairment in pharmacokinetic study conducted outside of Japan.

B. Although the causal relationship is unknown, psychoneurotic symptoms such as abnormal behavior after administration of anti-influenza virus agents including Favipiravir have been reported. For the treatment of children and minors, as a preventive approach in case of an accident due to abnormal behavior such as, patients/their family should be instructed that, after the start of treatment with anti-influenza virus agents, (i) abnormal behavior may be developed, and (ii) guardians and others should make an arrangement so that children/minors are not left alone for at least 2 days when they are treated at home. Since similar symptoms associated with influenza encephalopathy have been reported, the same instruction as above should be given.

C. Influenza virus infection may be complicated with bacterial infections or may be confused with influenza-like symptoms. In case of bacterial infection or suspected to be bacterial infection, appropriate measures should be taken, such as administration of anti-bacterial agents.

Drug Interactions
Favipiravir is not metabolized by cytochrome P-450 (CYP), 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
(Favipiravir should be administered with care when co-administered with the following drugs)

Adverse Reactions
Favipiravir has never been administered with the approved dosage. In Japanese clinical studies and the global phase III study (studies conducted with dose levels lower than the approved dosage), adverse reactions were observed in 100 of 501 subjects (19.96%) evaluated for the safety (including abnormal laboratory test values). Major adverse reactions included increase of blood uric acid level in 24 subjects (4.79%), diarrhoea in 24 subjects (4.79%), decrease of neutrophil count in 9 subjects (1.80%), increase of AST (GOT) in 9 subjects (1.80%), increase of ALT (GPT) in 8 subjects (1.60%).

(1) Clinically significant adverse reactions (similar drugs)

The following clinically significant adverse reactions have been reported with other anti-influenza virus agents. Patients should be carefully monitored, and if any abnormality is observed, the treatment should be discontinued and appropriate measures should be taken.

1. Shock, anaphylaxis
2. Pneumonia
3. Hepatitis fulminant, hepatic dysfunction, jaundice
4. Toxic epidermal necrolysis (TEN), oculomucocutaneous syndrome (Stevens-
Johnson syndrome)
5. Acute kidney injury
6. White blood cell count decreased, neutrophil count decreased, platelet count
decreased
7. Neurological and psychiatric symptoms (consciousness disturbed, abnormal
behavior, deliria, hallucination, delusion, convulsion, etc.)
8. Colitis haemorrhagic

(2) Other adverse reactions

If the following adverse reactions occur, appropriate measures should be taken according to the symptoms.

Note: Adverse reactions observed in Japanese clinical studies and the global phase III clinical study (studies conducted with dose levels lower than the approval dosage).

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

Use during Pregnancy, Delivery or Lactation
(1) Do not administer Favipiravir to women known or suspected to be pregnant.

(Early embryonic deaths [rats] and teratogenicity [monkeys, mice, rats and rabbits] have been observed in animal studies with exposure levels similar to or lower than the clinical exposure.)

(2) When administering Favipiravir to lactating women, instruct to stop lactating.
(The major metabolite of Favipiravir, a hydroxylated form, was found to be distributed in breast milk.)

Pediatric Use
Favipiravir 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.)

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.)

Other Precautions
In animal studies, histopathological changes of testis in rats (12 weeks old) and young dogs (7 to 8 months old), and abnormal findings of sperm in mice (11 weeks old) have been reported. Recovery or tendency of recovery has been observed in those studies after the administration was suspended.

Pharmaceutical precautions
Store below 30ºC temperature in a cool and dry place, protected from light.

Packaging quantities
Unifav 200 tablet: Each box contains 30 film coated tablets in Alu-Alu blister pack.

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