Sovihep 12 Weeks

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BRAND :   SOVIHEP PRICE : 599$ STRENGTH :400MG ACTIVE INGERIDENTS: SOVIHEP-SOFOSBUVIR-400MG COMPANY NAME : ZYDUS HEPTIZA TABLETS COUNT : 28 TABLETS read more

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Drug profile

Sovihep is comes under the pharmacological category of hepatitis C virus NS5B viral RNA polymerase inhibitor

Sovihep is a single dose therapy, absorbed very rapidly within 0.5 to 2 hours after administration.

In most of the patients, Sovihep is not combined with peg interferon because of adverse effects produced by peg interferon. Even though this concomitant is avoided, the curable rate is outstanding rate.

Sovihep tablets are prescription medicine, not used ordinarily it is used for the patients who are all having a valid prescription and under the guidance of medical practitioner

Trade name: Sovihep

Active ingredient: Sofosbuvir

Strength: 400MG

Mfg: Zydus hepatica

Package: 28 tablets in a container

Category: Anti-hepaciviral activity


Prescribing information of Sovihep

The prescribing information of Sovihep tablets for the patients affected with chronic hepatitis C infection;

Sovihep is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines

The effective of Sovihep is established in the genotype I, II III or IV infections, patients who are having HIV-1/HBV co infection.

Sovihep mainly prescribed for adolescent patients, and for pediatric patients with age of 12 years or weighing at least 35kg in genotype II or III induced hepatitis C infection


Mechanism of Sovihep

Sovihep containing sofosbuvir is a pan genotype, HCV NS5B RNA polymerase inhibitor.

This RNA polymerase enzyme is involved in viral production. Sovihep is a prodrug which converted into active pharmacological metabolite by undergoing intracellular metabolism.

The active metabolite is known as uridine triphosphate. This metabolite is get inserted into viral RNA by HCV viral RNA polymerase and exhibits anti-viral activity by chain termination process


Absorption

After an oral administration, the peak plasma time of Sovihep is reaches within 0.5 to 2 hours and its circulating metabolite GS-331007 has peak plasma time 2 to 4 hours


Distribution

The human plasma protein bound capacity with Sovihep is occur nearly at the range of 61 to 65%

The circulating metabolite has minimal protein bounding property.


Metabolism

Sovihep is highly metabolized in liver, whereas Sovihep is a substrate of P-gp & BCRP


Excretion

Sovihep is eliminated through urine by glomerular filteration

The terminal half life period of Sovihep is 0.51 hours and its metabolite has 27 hours


How to take the Tablet Sovihep

Generally Sovihep is administered with or without food.

Sovihep is taken as a single dose

Do not crush or chew the tablet, swallow the tablet as whole with some water


Dosage regimens

400mg of Sovihep (sofosbuvir)

The recommended dosage of Sovihep by combination with other medicines;

Patient acquired with genotype I, IV, V or VI chronic hepatitis C viral infection:

Sovihep is combined with ribavirin and peg interferon alfa should be taken as a single dose for 12 weeks

Sovihep and ribavirin should be taken in case of patients are undesirable to take peg interferon alfa for 24 weeks

Patients suffered with genotype II chronic hepatitis C:

Sovihep should be combined with ribavirin as a single dose for 12 weeks

Patients with genotype III hepatitis:

Sovihep combined with ribavirin and peg interferon alfa and it should be taken as a single dose for 12 weeks

Otherwise Sovihep with ribavirin should be taken as single dose for 24 weeks


In liver transplantation:

Sovihep should be concurrently used with ribavirin as a single dose until liver transmission.


In pediatric:

Sovihep tablet is recommended for the children at age 12 or weight of at least 35kg;

In without cirrhosis or with child Pugh A or compensated:

The recommended dosage is one tablet of Sovihep should be combined with weight based ribavirin as a single dose for 12 weeks

In decompensated cirrhosis:

The prescribed dosage of Sovihep is one tablet should be used with ribavirin for 24 weeks


Ribavirin dosage:

Ribavirin is recommended to take in two divided doses only with food

Initial dose 600mg slowly increased up to 100mg per day in weight less than 75kg

1200mg should be taken per day with the weight at least 75kg


In pediatric ribavirin dosage;

<47kg: 15mg/kg/day

47 to 49kg: 600mg/day

50 to 65kg: 800mg/day

66 to 80kg: 1000mg/day

>80kg: 1200mg/day

No dosage adjustment is followed in the therapy using Sovihep in case of renal and hepatic impairment.


Sovihep caused side effects

General side effects of Sovihep;

Fatigue

Headache

Insomnia

Pruritus

Nausea

Bradycardia

HBV reactivation

Depression

Asthenia

Diarrhea

Fever, chills

Neutropenia

Anemia

Loss of appetite

Rash

Myalgia

Irritability

Influenza like syndrome

Pancytopenia


Drug interactions

Sovihep is a substrate of P-gp & BCRP transporters. While using Sovihep with P-gp or BCRP strong inducers like rifampin or st Johns wort may causes decreasing the plasma concentration of sofosbuvir. Thus the results depletion of therapeutic effect of Sovihep

While combining with Sovihep with amiodarone, no effect of concentration occurs but symptomatic bradycardia occurs

Sovihep with vitamin K antagonist, fluctuate the effect of vitamin K antagonist

Sovihep with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes decreasing the effect of Sovihep

Sovihep with anti-mycobacterials causes depletion in effect of concentration of Sovihep

Sovihep co administration with P-gp or BCRP inhibitors, causes increasing the plasma concentration of Sovihep

Sovihep with analeptic drug like modafinil causes decreasing the effect of concentration of Sovihep.


Food drug interaction

Diet should be followed under the guidance of physician

Drug with herbal interaction occurs like; Sovihep with st Johns wort may cause depletion of therapeutic effect of Sovihep

No food drug interaction occurs while taking Sovihep, but caution should be taken during therapy

Possible contraindications

Sovihep tablet combined with ribavirin or peg interferon alfa, contraindicated to pregnancy condition

Hypersensitive reaction produce because of patients contraindicated to the component present in Sovihep tablet


Safety measures

Use with caution in decompensated condition; ribavirin should be combined with Sovihep. Ribavirin causes fetal abnormalities and death. In pregnancy condition ribavirin not recommended

Sovihep combined with P-gp or BCRP strong inducers leading to loss of therapeutic effect. Avoid this combination.

While concomitant amiodarone with Sovihep, patient must counsel about the exposure of this combination, on the other hand some alternative medicines should be prescribed to reduce the risk of symptomatic bradycardia

In HIV-1/HBV co infected patients, HBV reactivation occurs during or after the treatment, to avoid this problem patient must examine to calculate the level of HBV surface antigen & HBV core antibody before starting the treatment


Pregnancy and lactation

Sovihep comes under pregnancy category B1

Whereas Sovihep combined with ribavirin in chronic condition, ribavirin has pregnancy category X; which means causes fetal damage even to death

Ribavirin should not be recommended in pregnancy

Breast feeding should not be recommended


Storage and handling

The storage condition of Sovihep tablets;

Sovihep tablet container stored at room temperature below 30oC

Container should be kept in dry and cool place, free from moisture, heat & light

Keep out of reach from children

The shelf life of the tablet is around 5 years


Missed dose

Sovihep is a prescription medicine, if patient fail to take the dose of Sovihep must consult with physician and take the dose within the time

Otherwise the missed dose should be skipped and follow the regular dosing schedule

Medicine schedule: prescription medicine


Over dosage

The maximum dose of sofosbuvir is 1200mg, there is no distinct antidote is required for over dose of Sovihep.

If overdose occurs in the patients two possible way to overcome from this difficulty;

  1. Patients first confirmed from the toxicity and Patients should be periodically monitored for their symptoms & clinical status. To maintain safety measures properly
  2. Hemodialysis is another method which is involved in over dosage condition, predominantly eliminate the sofosbuvir circulating metabolite contents from the body with separating at the range of 54%
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