Sofomax 400mg

Tablet
Sofosbuvir
ACI Pharmaceuticals

Other Strength:

Alternative:
- Sofovir-C 400mg
- Hopetavir 400mg
- Suvirux 400mg
- Sovalvir 400mg



Sofomax
Description
Sofomax®is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. Sofomax®inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. Sofomax®is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4. It is also used in combination with the viral NS5a inhibitor Ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection.

Sofomax®is also used in HCV patients with an HIV co-infection.

Indications
Sofomax®is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.

Dosageand administration
The recommended dosage of Sofomax®is one 400 mg tablet taken orally once daily with or without food.

Administer Sofomax®in combination with Ribavirin or in combination with Pegylated interferon and Ribavirin for the treatment of HCV. The recommended treatment regimen and duration for Sofomax®combination therapy is below -

Patient PopulationTreatment RegimenDurationGenotype 1 or 4Sofomax®+ PEG interferon Alfa + Ribavirin12 weeksGenotype 2Sofomax®+ Ribavirin12 weeksGenotype 3Sofomax®+ Ribavirin24 weeks

Usein pediatric patients
Safety and effectiveness of Sofomax®in children less than 18 years of age have not been established.

Usein pregnancy
Pregnancy category of Sofosbuvir: B

Use ingeriatric
No dosage adjustment of Sofomax®is warranted in geriatric patients.

Use in renal impairment patients
No dosage adjustment of Sofomax®is required for patients with mild or moderate renal impairment. The safety and efficacy of Sofomax®have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD.

Use in hepatic impairment patients
No dosage adjustment of Sofomax®is required for patients with mild, moderate or severe hepatic impairment. Safety and efficacy of Sofomax®have not been established in patients with decompensated cirrhosis.

Side effects
The most common side effects ofSofomax®when used in combination with Ribavirin
include:
Tiredness
Headache

The most common side effects of Sofomax®when used in combination with PEG interferon Alfa and Ribavirin include:
Tiredness
Headache
Nausea
Difficulty sleeping
Low RBC count

Precautions
Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, and confusion or memory problems.

Contraindications
Sofosbuvir is contraindicated in patients having Amiodarone, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, Tipranavir and Ritonavir.

Drug interactions
Sofosbuvir has drug-drug interactions with Cyclosporine, Darunavir, Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate, Methadone, Rilpivirine, and Tacrolimus.

Pharmaceuticalprecautions
Sofomax®400 mg tablet: Store inacool (below 30° C) and dryplace.Protect fromlight. Keep away from the reach of children

Presentation
Sofomax®400mg tablet:Eachcoated tablet containsSofosbuvir INN 400mg.

Package quantities
Sofomax®400mg tablet: Cartonof7tabletsinblister pack.


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