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Sofomax Duo
ACI Limited
Generic: Ledipasvir + Sofosbuvir
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Sofomax Duo. Please consult your doctor.
SAFE IF PRESCRIBED
Sofomax Duo is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Sofomax Duo is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
UNSAFE
Sofomax Duo may cause side effects which could affect your ability to drive.
Sofomax Duo, when taken together with other medicines for the treatment of hepatitis c infection, may produce dizziness, blurred vision and this may affect your ability to drive.
CAUTION
Sofomax Duo should be used with caution in patients with severe kidney disease. Dose adjustment of Sofomax Duo may be needed. Please consult your doctor.
Limited information is available on use of Sofomax Duo in these patients. No dose adjustment is recommended in patients with mild to moderate kidney disease.
SAFE IF PRESCRIBED
Sofomax Duo is safe to use in patients with liver disease. No dose adjustment of Sofomax Duo is recommended.
Medicine Overview of Sofomax Duo 90mg+400mg Tablet
Introduction
Sofomax Duo is a combination of two antiviral medicines. This prescription medicine is used in the treatment of chronic hepatitis C virus (HCV) infection. It fights against the viruses to resolve the infection. Sofomax Duo should be taken in the prescribed dose and duration. It can be taken with or without food, but take it at the same time daily. It is advised not to consume more than the recommended dose. It is important to inform your doctor if you have any health conditions such as liver or kidney disease. It is harmful to consume alcohol along with this medicine,...
... Show moreUses of Sofomax Duo
- Chronic hepatitis C virus (HCV) infection
Side effects of Sofomax Duo
Common
- Tiredness
- Headache
How to use Sofomax Duo
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sofomax Duo may be taken with or without food, but it is better to take it at a fixed time.
How Sofomax Duo works
Sofomax Duo is a combination of two antiviral medicines: Ledipasvir and Sofosbuvir. They work by lowering the amount of hepatitis C virus in the body and removing the virus from the blood over a period of time.
Quick Tips
- Sofomax Duo is used for the treatment of chronic hepatitis C virus (HCV) infection.
- Take it with food, preferably at the same time everyday.
- You will usually need to take this medicine every day for either 12 or 24 weeks.
- Skipping doses increases the risk of treatment failure. Make sure that you take all your doses at the correct time.
- It may cause fatigue, dizziness, and blurred vision. Don't drive or do anything requiring concentration until you know how it affects you.
- Sofomax Duo may cause headaches. Drink plenty of water and take a suitable painkiller. Inform your doctor if it does not go away.
- Your doctor may monitor your liver function and the amount of hepatitis C virus in your body regularly.
- Do not stop taking this medicine without your doctor’s advice.
Brief Description
Indication
Chronic hepatitis C (CHC), genotype 1, 4 & 6 infection in adults.
Administration
Can be taken with or without food.
Adult Dose
Oral
Hepatitis C
Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection
Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken once daily.
Recommended treatment duration:
Treatment-naive with or without cirrhosis: 12 weeks
Treatment-experienced without cirrhosis: 12 weeks
Treatment-experienced with cirrhosis: 24 weeks
Hepatic impairment
Mild, moderate, or severe: No dosage adjustment required
Decompensated cirrhosis: Safety and efficacy not established
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild or moderate: No dosage adjustment required
Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given
Contraindication
Hypersensitivity.
Mode of Action
Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in chain termination.
Precaution
Bradycardia with Amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking Amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of Amiodarone with Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended.
Lactation: Unknown if distributed in human breast milk
Side Effect
>10%
Asthenia (31-36%),Fatigue (4-18%),Headache (13-29%),Cough (5-11%)
1-10%
Nausea (6-9%),Diarrhea (3-7%),Dizziness (1-5%),Dyspnea (3-9%),Insomnia (3-6%),Increased bilirubin >1.5 x ULN (3 x ULN (<1 to 3%),Myalgia (4-9%),Irritability (7-8%)
Frequency Not Defined
Asymptomatic creatine kinase elevation, Grades 3/4
Interaction
Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral.
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