sofosbuvir tablets

Name: sofosbuvir tablets
Brand: DEVLIFE CORPORATION PRIVATE LIMITED
Price: 1.0 INR
Availability: InStock

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About sofosbuvir tablets

COMPOSITION:

Each film coated tablet contains:

Sofosbuvir.400 mg

Excipientsq.s.

Color: Titanium Dioxide BP & Yellow Oxide of Iron

INDICATIONS:

SOFODEV is indicated for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and older.

DOSAGE AND ADMINISTRATION:

Adults: The recommended dose is one 400 mg tablet, taken orally, once daily with food.

Paediatrics: The dose for paediatric patients aged 3 years and above is based on weight as follows:

Body Weight (kg) Dose

35 One 400 mg tablet once daily or

17 to < 35 Two 200 mg tablets once daily

One 200 mg tablet once daily

SIDE EFFECTS:

Very Common: Insomnia, headache, nausea, alopecia, fatigue, decreased appetite, irritability.

Common: Anaemia, depression, dyspnoea, constipation, abdominal discomfort, pruritus, pyrexia, myalgia, back pain, muscle spasms, arthralgia.

DRUG INTERACTIONS:

Co-administration of Sofosbuvir with P-gp inducers such as modafinil, oxcarbazepine and rifepentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect.

Co-administration of amiodarone with a sofosbuvir containing regimen may result in serious symptomatic bradycardia.

WARNINGS AND PRECAUTION:

Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.

Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating the treatment.

When sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment.

PREGNANCY AND LACTATION:

The safety of SOFODEV administered to women has not been established. Therefore, should not be given to pregnant women unless, the clinical benefits outweigh the possible risks. It is not known whether this drug is excreted in human milk. Caution should be exercised when SOFODEV is administered to a nursing woman.

OVERDOSAGE:

If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with SOFODEV consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite.

CONTRAINDICATIONS:

Hypersensitivity to the active substance or to any of the excipients.

Co-administration with medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort).

STORAGE:

Store in a cool, dry place at a temperature not exceeding 30C.

Protect from light and moisture.

Keep out of reach of children.

Keep the container tightly closed.

Do not use if seal over jar opening is broken or missing.

PRESENTATION:

28 Tablets in jar in printed carton with pack insert.

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