Zifam Sovir Tablet

 

 

Composition:

Each film coated tablet contains:

Sofosbuvir 400 mg

Excipients: q. s

Colour: Iron oxide yellow, Titanium dioxide BP

 

Pharmacological action:

1. Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus.
2. It is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. It is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.

Therapeutic category: Antiviral drug

Therapeutic Indication:

1. Sofosbuvir is Hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
2. Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infections, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection

Posology and Method of Administration:

Route of administration: Oral

1. The recommended dose is one 400 mg tablet, taken orally, once daily with or without food
2. lt should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of Chronic Hepatitis C Infection (CHC) in adults.
3. In combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen.
4. It should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first.
5. A dose recommendation cannot be made for patients with severe renal impairment or end-stage renal disease

 

Contraindications:

1. When Sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies.
2. Sofosbuvir combination treatment with ribavirin or peginterferon alfa/ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin.

Warning & Precautions:

Pregnancy

When Sofosbuvir is used in combination with ribavirin or peginterferon alfa/ ribavirin, women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time.

Use with Potent P-gp Inducers

Drugs that are potent P-gp inducers in the intestine (eg., ritampin, St. John’s wort) may significantly decrease Sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of Sofosbuvir. 0610

Adverse effects:

1. The most common adverse events (≥ 20%) for Sofosbuvir + Ribavirin combination therapy were fatigue and headache.
2. The most common adverse events (≥ 20%) for Sofosbuvir + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.
3. Less common adverse reactions reported in clinical trials (<1%):

Hematologic effects: pancytopenia (particularly in subjects receiving concomitant pegylated interferon) Psychiatric disorders: severe depression particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide.

 

Drug Interactions:

1. Drugs that are potent P-gp inducers in the intestine (e.g., rifampin or St. John’s wort) may decrease Sofosbuvir plasma concentration leading to reduced therapeutic effect of Zifam Sovir and thus should not be used with Sofosbuvir:
2. Co administration of Sofosbuvir with drugs that inhibit P-gp and/or BCRP may increase Sofosbuvir plasma concentration without increasing GS-331007 plasma concentration; accordingly, Zifam Sovir may be co administered with P-gp and/or BCRP inhibitors.
3. The interaction between Sofosbuvir and the following drugs was evaluated in clinical trials and no dose adjustment is needed for either drug: cyclosporine, darunavir/ ritonavir, Efavirenz, emtricitabine, methadone, oral contraceptives, raltegravir, rilpivirine, Tacrolimus, or Tenofovir Disoproxil fumarate.
4. Co-administration of Sofosbuvir with Carbamazepine, Phenytoin, Phenobarbital or oxcarbazepine is expected to decrease the concentration of Sofosbuvir, leading to reduced therapeutic effect of Sofosbuvir.

Overdosage:

1. The highest documented dose of Sofosbuvir was a single supratherapeutic dose of Sofosbuvir 1200 mg administered to 59 healthy subjects. In that trial, there were no untoward effects observed at this dose level, and adverse events were similar in frequency and severity to those reported in the placebo and Sofosbuvir 400 mg treatment groups. The effects of higher doses are not known.
2. No specific antidote is available for overdose with Sofosbuvir. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. A 4-hour hemodialysis session removed 18% of the administered dose.

Pharmaceutical information:

Storage conditions:

Store in a cool and dry place below 30°C.

Protect from light and moisture.

Keep Medicine away from children.

Shelf Life: 24 months

Pack size: Bottle Pack of 28 Tablets

Myanmar – Reg. No.: R2702AA1429

Product of: Zifam Pinnacle Pty Ltd., Sydney, Australia.

Manufactured by: Fredun Pharmaceuticals Com

14, 15, 16, Zorabian Indi. Complex, Vevoor, Palghar- 401404, Maharashtra State, INDIA.