Sofocure 400mg Tablet (Sofosbuvir)
Prescription RequiredManufactured By
Emcure
Pack Of
28
Salt Composition
Sofosbuvir
Storage
Keep in cold place
ALL SUBSTITUTES
Resof 400mg Tablet
Sofokast 400mg Tablet
Overview
Sofocure 400mg Tablet (Sofosbuvir) contains Sofosbuvir 400mg per tablet. A component of combination treatment for hepatitis C; never use sofosbuvir alone as a complete HCV regimen. Sofosbuvir is converted within hepatocytes to an active uridine analogue triphosphate that is incorporated by HCV NS5B polymerase, terminating viral RNA synthesis.
Before treatment, assess HCV RNA, prior therapy, cirrhosis status, hepatitis B markers, other medicines and relevant liver and kidney tests. Cure is generally assessed by undetectable HCV RNA at least 12 weeks after completion (SVR12). Viral clearance does not remove the need for liver cancer surveillance in patients with cirrhosis. Do not describe 400mg sofosbuvir monotherapy as curative treatment.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | sofocure |
| Generic / Active Ingredient | Sofosbuvir |
| Strength | 400 |
| Dosage Form | Tablet |
| Manufacturer / Marketer | emcure |
| Pack Size | 28 |
| Prescription Required | Yes |
| Therapeutic Categories | Hepatitis Medicines |
| Uses | hepatitis |
Uses and Indications
A component of combination treatment for hepatitis C; never use sofosbuvir alone as a complete HCV regimen. Sofocure treatment selection is based on HCV genotype where relevant, cirrhosis stage, prior antiviral exposure, coinfections and potential drug interactions. Before treatment, assess HCV RNA, prior therapy, cirrhosis status, hepatitis B markers, other medicines and relevant liver and kidney tests. Cure is generally assessed by undetectable HCV RNA at least 12 weeks after completion (SVR12). Viral clearance does not remove the need for liver cancer surveillance in patients with cirrhosis.
How Sofocure 400mg Tablet Works
Sofocure 400mg Tablet is a direct acting antiviral tablet containing sofosbuvir which is used to treat chronic infections of HCV. The mechanism of action of Sofosbuvir is based on inhibition of the HCV NS5B RNA-dependent RNA polymerase, an enzyme involved in replication of genetic material of HCV. Inhibition of NS5B leads to prevention of multiplication of HCV in the body.
Sofosbuvir is converted within hepatocytes to an active uridine analogue triphosphate that is incorporated by HCV NS5B polymerase, terminating viral RNA synthesis. Sofocure 400mg tablet is normally prescribed in combination with other antiviral medicine according to HCV genotype and clinical picture.
Clinical Evidence for Sofocure 400mg Tablet
Sofosbuvir-containing combinations achieved high sustained virologic response rates in pivotal NEUTRINO, FISSION, POSITRON and FUSION studies; results depend on the companion treatment and population, not Sofocure alone. SVR12 is a standard efficacy endpoint in HCV studies; rates cannot be transferred to different genotypes, regimens or cirrhosis groups without qualification.
Side Effects of Sofocure 400mg Tablet
Fatigue and headache; adverse effects depend substantially on accompanying ribavirin or peginterferon. Side effects of sofocure tablet may change when additional medicines are included. Discuss persistent symptoms with the treating clinician. Sofocure 400 mg is an antiviral medicine that helps to cure certain chronic infections caused by HCV. Like other drugs, Sofocure 400 mg can also have certain side effects.
Common side effects of Sofocure 400 mg are:
- Headache
- Fatigue or weakness
- Nausea
- Trouble sleeping
- Diarrhea
- Irritability
In addition, side effects of Sofocure 400 mg can vary according to other antiviral drug used along with this medicine. If you suffer from any severe or unusual side effect, then see your doctor.
Critical Safety Warning
HBV reactivation during/after direct-acting antiviral therapy; serious symptomatic bradycardia when sofosbuvir-containing regimens are combined with amiodarone; combination-partner risks. Do not describe 400mg sofosbuvir monotherapy as curative treatment.
Sofocure 400mg Tablet Dosage and How To Take It
| Clinical situation | Dose |
|---|---|
| Full medicine identity | Sofocure 400mg Tablet (Sofosbuvir) |
| Per-unit composition | Sofosbuvir 400mg per tablet |
| Route | Oral |
| Dosing context | The usual adult component dose is 400mg orally once daily, with or without food, together with the selected companion antiviral(s). Regimen and duration depend on genotype, cirrhosis, prior treatment and companion agents. |
| Treatment duration | Set by specialist according to complete regimen and patient factors |
Sofocure 400mg Tablet Missed Dose
Follow the exact manufacturer instructions for this product and prescribed regimen. Do not double doses. Contact the treating team promptly if a dose is missed or a course is interrupted; the correct response varies between daily direct-acting antivirals and weekly peginterferon injection.
Safety Advice for Sofocure 400mg Tablet
| Category | Status | Guidance |
|---|---|---|
| HBV coinfection | Requires monitoring | Check HBV status and monitor for reactivation during/after HCV antiviral therapy where relevant. |
| Cirrhosis | Requires medical assessment | Stage liver disease before treatment; some protease-inhibitor regimens are unsafe in decompensated disease. |
| Pregnancy | Requires caution; strict precautions if used with ribavirin | Review complete regimen; ribavirin requires strict pregnancy precautions. |
| Other medicines | Requires medicine interaction review | Reconcile prescriptions, OTC medicines, supplements and herbal products. |
| Adherence | Complete the prescribed course and follow-up testing is required | Complete the prescribed course and attend post-treatment HCV RNA testing. |
Monitoring During Sofocure 400mg Tablet Treatment
HCV RNA after treatment, HBV markers/monitoring, liver function, interaction and adherence review. Confirm sofosbuvir treatment response with HCV RNA at least 12 weeks after the final dose. While on Sofocure 400 mg (sofosbuvir), the healthcare provider can monitor the levels of HCV RNA, as well as perform tests to assess the patient’s liver and kidney function, as well as drug interactions.
Sofocure 400mg Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Strength / concentration | Sofosbuvir 400mg per tablet |
| Form / route | Oral tablet |
| Mechanism | HCV NS5B nucleotide polymerase inhibitor |
| How administered | The usual adult component dose is 400mg orally once daily, with or without food, together with the selected companion antiviral(s). Regimen and duration depend on genotype, cirrhosis, prior treatment and companion agents. |
| Key caution | HBV reactivation during/after direct-acting antiviral therapy; serious symptomatic bradycardia when sofosbuvir-containing regimens are combined with amiodarone; combination-partner risks. |
| Presentation | Confirm exact brand pack |
Sofocure 400mg Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Amiodarone | Concomitant use with sofosbuvir-containing regimens may cause serious symptomatic bradycardia, particularly when used with certain other antiarrhythmic or cardiac medicines. | Avoid concomitant use when possible. If use is clinically necessary, follow the current prescribing information and ensure appropriate cardiac monitoring. |
| Rifampicin | May substantially reduce sofosbuvir exposure and potentially decrease antiviral effectiveness. | Avoid concomitant use with sofosbuvir according to the current product information. |
| Carbamazepine | May reduce sofosbuvir exposure and potentially compromise antiviral treatment effectiveness. | Avoid concomitant use and review alternative therapy with the treating healthcare professional. |
| Phenytoin | May reduce sofosbuvir exposure and potentially decrease antiviral effectiveness. | Avoid concomitant use and review the patient's treatment regimen with the healthcare professional. |
| St. John's wort (Hypericum perforatum) | May reduce sofosbuvir exposure and potentially compromise antiviral effectiveness. | Avoid concomitant use with sofosbuvir-containing treatment. |
| Other medicines, supplements and dietary products | Other products may interact with sofosbuvir or with other components of the patient's hepatitis C treatment regimen. | Review the full current prescribing information for all components before initiating or changing treatment, and perform a formal interaction check against the patient's complete medication list. |
FAQs About Sofocure 400mg Tablet
What is the exact medicine name?
Sofocure 400mg Tablet (Sofosbuvir)
What is the active ingredient and strength?
Sofosbuvir 400mg per tablet
What is it used for?
A component of combination treatment for hepatitis C; never use sofosbuvir alone as a complete HCV regimen.
How does Sofosbuvir work?
Sofosbuvir is converted within hepatocytes to an active uridine analogue triphosphate that is incorporated by HCV NS5B polymerase, terminating viral RNA synthesis.
How is Sofosbuvir taken or given?
The usual adult component dose is 400mg orally once daily, with or without food, together with the selected companion antiviral(s). Regimen and duration depend on genotype, cirrhosis, prior treatment and companion agents.
Can Sofosbuvir be used alone?
Do not describe 400mg sofosbuvir monotherapy as curative treatment.
What side effects may occur?
Fatigue and headache; adverse effects depend substantially on accompanying ribavirin or peginterferon.
What are the important warnings?
HBV reactivation during/after direct-acting antiviral therapy; serious symptomatic bradycardia when sofosbuvir-containing regimens are combined with amiodarone; combination-partner risks.
What should be monitored?
HCV RNA after treatment, HBV markers/monitoring, liver function, interaction and adherence review.
How is cure checked?
An HCV RNA test at least 12 weeks after completion is used to assess sustained virologic response.
Can I stop once I feel better?
No. Complete the specialist-prescribed course unless the treating team changes it.
Is the pack presentation confirmed?
Only the stated user-supplied composition is used; unprovided pack details require carton verification.
References
- Molecule/regimen prescribing information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80beab2c-396e-4a37-a4dc-40fdb62859cf.
- AASLD-IDSA HCV Guidance: https://www.hcvguidelines.org/.
- WHO hepatitis C guidance: https://www.who.int/health-topics/hepatitis.
- Medical information only. Individual treatment and dose selection require specialist assessment. https://pmc.ncbi.nlm.nih.gov/articles/PMC12999791/
- Int.J App Pharm. Sofosbuvir: Treatment of chronic hepatitis c and the main trends in patient protection. https://journals.innovareacademics.in/index.php/ijap/article/view/33502/20412
Marketer Details
Emcure
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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