Sofovir 400mg Tablet (7'S)

Manufacturer: Hetero Drugs Ltd

Salt Composition : Sofosbuvir(400mg)


Sofovir 400mg Tablet contains the active component as Sofosbuvir. It is a direct-acting antiviral medication used to treat hepatitis C virus (HCV) infection. This medication is often combined with other antiviral drugs to form a regimen that can effectively eliminate HCV from the body. Sofovir 400mg Tablet has significantly shortened the duration of HCV treatment compared to older therapies. It is effective against multiple genotypes of the hepatitis C virus. This broad-spectrum activity makes it a versatile treatment option that can be used for a wide range of patients infected with different HCV genotypes. 


Patients have generally well-tolerated with this medication, with few serious side effects reported. Sofovir 400mg Tablet should not be used in individuals with known hypersensitivity or allergic reactions to it or its components. This medication is primarily eliminated through the kidneys. Therefore, individuals with severe renal impairment may require dosage adjustments. It is not approved for use in children under the age of 18.


Basic Information

Mechanism Of Action

Sofovir 400mg Tablet, a direct-acting antiviral medication, exerts a potent therapeutic effect in treating hepatitis C virus (HCV) infections. This medication disrupts the virus's ability to replicate and proliferate within the body by inhibiting the RNA polymerase enzyme necessary for HCV replication. When combined with other antiviral drugs, this targeted action leads to high cure rates, improved treatment outcomes, and shorter treatment durations.

Pharmacokinets

Pharmacokinetics. Sofosbuvir is only administered orally. The peak concentration after oral administration is 0.5–2 hours post-dose, regardless of initial dose. Peak plasma concentration of the main circulating metabolite GS-331077 occurs 2–4 hours post-dose.

Side Effects

Sofovir 400mg Tablet cause some side effects like all medications, although not everyone will experience them.

Serious:

Allergic reactions that affect skin and breathing

Hepatitis B infection reactivation

Bradycardia (slow heartbeat)

Common:

Fatigue

Headache

Nausea

Insomnia

Diarrhea

Itching

Decreased appetite

Rash or skin reactions

Contra Indications

Hypersensitivity.

Pregnancy or planning pregnancy, including men whose female partners are pregnant/planning to get pregnant.

CrCl less than 50 mL/min.

Pancreatitis.

Hemoglobinopathies (e.g., thalassemia major, sickle cell anemia)

Coadministration with diagnosing.

Pregnancy Related Information

The safety of Sofovir 400mg Tablet use during pregnancy has not been established. If you are pregnant or planning to become pregnant, discussing the potential risks and benefits with your healthcare professional is essential.


Product And Alcohol Interaction

It is generally advisable to avoid consuming alcohol while taking Sofovir 400mg Tablet. Alcohol can impair the body's immune system, making it less effective in fighting infections.


Breast Feeding Related Information

Limited data are available on the safety of Sofovir 400mg Tablet during breastfeeding, and it is important to discuss the potential risks and benefits with a healthcare professional.


Indications

Sofosbuvir is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.

Interactions

Drug-Drug Interaction: SOFOSBUVIR may interact with anticonvulsants (oxcarbazepine, carbamazepine, phenytoin, phenobarbital), wakefulness-promoting agents (modafinil), antibiotics (rifapentine, rifabutin, rifampin), anti-HIV drug (tipranavir) and medicine used to treat irregular heartbeats (amiodarone).

Drug-Food Interaction: Avoid taking SOFOSBUVIR with St. John’s wort (Hypericum perforatum) or a product containing St. John’s wort (herbal medicine used to treat depression).

Drug-Disease Interaction: If you have diabetes or liver problems other than hepatitis C (if you are awaiting liver transplantation), inform your doctor before taking SOFOSBUVIR.

Drug-Drug Interactions Checker List:

OXCARBAZEPINE

CARBAMAZEPINE

PHENYTOIN

PHENOBARBITAL

MODAFINIL

RIFABUTIN

RIFAMPICIN

TIPRANAVIR

AMIODARONE

Storage Requirements

Stored at controlled room temperature, between 20°C to 25°C (68°F to 77°F).

Keep away from moisture, heat, and light.

It should not be frozen.

Keep away from children and pets.

Expert Advice

Before starting treatment, inform your healthcare provider if you have a history of hepatitis B, your liver function, HBV DNA levels (an indicator of hepatitis B infection in the blood) will closely monitor during treatment. Be aware of the risk of serious bradycardia when Sofovir 400mg Tablet is combined with Amiodarone, and inform your healthcare provider if you are taking this medication. Any signs of allergic reactions, such as difficulty breathing or swelling, should be reported immediately. Pregnant and breastfeeding individuals should discuss the potential risks and benefits with their healthcare provider. Adhere to the prescribed treatment regimen and attend regular check-ups to monitor treatment response.

How To Use

Sofovir 400mg Tablet is typically prescribed with other antiviral medications for treating hepatitis C (HCV) infection. This medication is usually taken orally once a day, with or without food. It is recommended to complete the full course of treatment as prescribed, even if symptoms improve, to ensure the best chance of achieving a sustained virologic response (SVR) and curing the HCV infection.

FAQs

Q 1. Can Sofovir 400mg Tablet be used as a single therapy for hepatitis C?

No, Sofovir 400mg Tablet is not recommended as a monotherapy for hepatitis C. It is typically used in combination with other antiviral medications. The specific combination therapy will depend on factors such as the HCV genotype, previous treatment history, and the presence of liver cirrhosis.

Q 2. Can Sofovir 400mg Tablet prevent hepatitis C transmission?

Sofovir 400mg Tablet primarily treats individuals already infected with hepatitis C. While it can cure the infection and reduce the viral load, it does not provide direct protection against acquiring hepatitis C or prevent transmission to others. Prevention of hepatitis C transmission involves practicing safe behaviors such as using barrier methods during sexual activity, avoiding sharing needles or other drug paraphernalia, and taking precautions to prevent blood-to-blood contact.

Q 3. Can Sofovir 400mg Tablet be used in patients with liver cirrhosis?

Yes, Sofovir 400mg Tablet can be used in patients with liver cirrhosis. It has shown efficacy and safety in patients with compensated and decompensated liver cirrhosis. However, careful monitoring and individualized treatment plans may be required for patients with advanced liver disease.

Q 4. Can Sofovir 400mg Tablet cause weight gain?

Weight gain is not a commonly reported side effect of Sofovir 400mg Tablet. However, individual responses to medications can vary, and some patients may experience changes in weight during or after treatment.