Sofomax Duo 90 mg+400 mg

Sofomax Duo 90 mg+400 mg | INDICATIONS AND USES

Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.

Sofomax Duo 90 mg+400 mg | PHARMACOLOGY

This is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. Following oral administration of this tablet, ledipasvir median peak concentrations were observed 4 to 4.5 hours post-dose.

Sofomax Duo 90 mg+400 mg | DOSAGE & ADMINISTRATION

Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food Recommended treatment duration:

Treatment-naive with or without cirrhosis: 12 weeks
Treatment-experienced without cirrhosis: 12 weeks
Treatment-experienced with cirrhosis: 24 weeks

A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease.

Sofomax Duo 90 mg+400 mg | DRUG INTERACTIONS

Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of Ledipasvir and Sofosbuvir combination with Amiodarone is not recommended
P-gp inducers (e.g., Rifampin, St. John’s wort): May alter concentrations of Ledipasvir and Sofosbuvir. Use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended

Sofomax Duo 90 mg+400 mg | SIDE EFFECTS

The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with this tablet for 8, 12, or 24 weeks are fatigue, headache, nausea, diarrhea and insomnia.

Sofomax Duo 90 mg+400 mg | USE DURING PREGNANCY AND LACTATION

Pregnancy Category B. There are no adequate and well-controlled studies with Ledipasvir and Sofosbuvir in pregnant women. Because animal reproduction studies are not always predictive of human response, this should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Ledipasvir and Sofosbuvir and its metabolites are present in human breast milk.

Sofomax Duo 90 mg+400 mg | PRECAUTIONS & WARNINGS

Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients takingamiodarone, particularly in patients also receiving beta-blockers or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with this tablet is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Use with other drugs containing sofosbuvir, is not recommended.

Sofomax Duo 90 mg+400 mg | USE IN SPECIAL POPULATIONS

Pediatric Use: Safety and effectiveness of Ledipasvir and Sofosbuvir have not been established in pediatric patients.Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment of Ledipasvir and Sofosbuvir is warranted in geriatric patients.

Sofomax Duo 90 mg+400 mg | THERAPEUTIC CLASS

Hepatic viral infections (Hepatitis C)

Sofomax Duo 90 mg+400 mg | STORAGE CONDITIONS

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.