Twinvir90 mg+400 mg

Twinvir 90 mg+400 mgLedipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1, 4 & 6 infection in adults.Theropeutic ClassHepatic viral infections (Hepatitis C)PharmacologyIt 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.Dosage & Administration of Twinvir 90 mg+400 mgRecommended 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.Dosage of Twinvir 90 mg+400 mgRecommended 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.Interaction of Twinvir 90 mg+400 mg 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 ContraindicationsThis combination is contraindicated in patients with Known hypersensitivity to Ledipasvir, Sofosbuvir or any other ingredient in the product.Side Effects of Twinvir 90 mg+400 mgThe most common adverse reactions with treatment with Ledipasvir and Sofosbuvir combination for 8, 12, or 24 weeks are fatigue and headache.Pregnancy & LactationPregnancy 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.Lactation: It is not known whether Ledipasvir and Sofosbuvir?and its metabolites are present in human breast milk.Precautions & WarningsBradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended. Use with other drugs containing sofosbuvir, is not recommendedOverdose Effects of Twinvir 90 mg+400 mgNo specific antidote is available for overdoseStorage ConditionsKeep out of the reach of children. Keep in a cool & dry place. Protect from light.Use In Special PopulationsPediatric 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.Drug ClassesHepatic viral infections (Hepatitis C)Mode Of ActionIt 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.PregnancyPregnancy 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.Lactation: It is not known whether Ledipasvir and Sofosbuvir?and its metabolites are present in human breast milk.Pediatric UsesPediatric 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.