Sovir Plus

Sovir Plus Dosage/Direction for Use

sofosbuvir + ledipasvir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Full Prescribing Info
Dosage/Direction for Use
Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
Recommended adult and pediatric dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food.
HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables as follows, respectively.
If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications.
Recommended adult treatment regimen and duration: see Table 1.

Click on icon to see table/diagram/image

Recommended treatment duration for pediatric patients 12 years of age and older or weighing at least 35 kg. (See Table 2.)

Click on icon to see table/diagram/image

A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
Paediatric Population aged < 12 years: The safety and effectiveness of ZIFAM SOVIR PLUS in paediatric patients aged < 12 years have not been established. No data on paediatric patients aged < 12 years are available.
Missed dose: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken. If vomiting occurs more than 5 hours after dosing, no further dose is needed. If a dose 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 at the usual time. Patients should be instructed not to take a double dose.
Elderly: No dose adjustment is warranted for elderly patients.
Renal impairment: No dose adjustment of ZIFAM SOVIR PLUS is required for patients with mild or moderate renal impairment. The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR) < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Hepatic impairment: No dose adjustment of ZIFAM SOVIR PLUS is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C). Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis.
Method of administration: For oral use.
Patients should be instructed to swallow the tablet whole with or without food. Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
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