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MyHep ALL

MyHep ALL Dosage/Direction for Use

sofosbuvir + velpatasvir

Manufacturer:

Mylan Healthcare

Distributor:

Antah Pharma
Full Prescribing Info
Dosage/Direction for Use
The recommended dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is one tablet, taken orally, once daily with or without food (see Pharmacology: Pharmacokinetics under Actions). (See Table 16.)

Click on icon to see table/diagram/image

Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is needed (see Pharmacology: Pharmacodynamics under Actions).
If a dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg at the usual time. Patients should be instructed not to take a double dose of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg.
Elderly: No dose adjustment is warranted for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is required for patients with mild or moderate renal impairment.
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis. Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg can be used in these patients with no dose adjustment when no other relevant treatment options are available (see Precautions, Adverse Reactions, Pharmacology: Pharmacokinetics and Pharmacodynamics under Actions).
Hepatic impairment: No dose adjustment of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see Pharmacology: Pharmacokinetics under Actions). Safety and efficacy of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Paediatric population: The safety and efficacy of Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg in children and adolescents aged less than 18 years have not yet been established. No data are available.
Method of administration: For oral use.
Patients should be instructed to swallow the tablet whole with or without food (see Pharmacology: Pharmacokinetics under Actions). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
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