Drug information Sofuled Ledipasvir 90mg/Sofosbuvir 400mg to treat hepatitis C
- Brand Name: Sofuled.
- Active ingredients: Ledipasvir and Sofosbuvir.
- Strength: 90mg and 400mg.
- Form: Film-coated tablets.
- Packaging: Box of 28 tablets.
What is Sofuled ?
Sofuled medicine is a medicine that contains the active ingredients ledipasvir and sofosbuvir. Hepatitis C is a virus that infects the liver.
The active ingredients in the drug work together by blocking two different proteins that the virus needs to grow and reproduce on its own, allowing the infection to be permanently cleared from the body. Sometimes taken with another medicine, ribavirin.
How does Ledipasvir/Sofosbuvir work?
The active ingredient ledipasvir is an HCV inhibitor that targets the HCV NS5A protein, which is required for both RNA replication and assembly of HCV virions.
Active ingredient sofosbuvir is a pan genotype inhibitor of HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate.
What does Sofuled do?
It is used to treat chronic (long-term) hepatitis C virus infection in adults and children 3 years of age and older.
Who should not take the drug?
- Do not use in patients with hypersensitivity to Ledipasvir, Sofosbuvir or to any of the ingredients of Sofuled.
- Do not use in combination with Rosuvastatin or St. John’s wort.
- Concomitant use with potent enteric P-glycoprotein inducers.
Dosage and how to use Sofuled?
Dosage of the drug Sofuled
- Recommended dose in adults: 1 tablet/time/day. Your doctor will tell you how many weeks you should take it.
- The recommended dose in children 3 years of age and older is based on weight. Take the medicine as advised by your doctor.
How to use the drug?
- Sofuled must be taken on the advice of your doctor.
- Swallow the tablets whole with or without food. Do not chew, crush or split the tablet as it has a very bitter taste. Tell your doctor or pharmacist if you have problems swallowing tablets.
- If you are taking an antacid, take it at least 4 hours before or at least 4 hours after you take it.
- If you are taking a proton pump inhibitor, take a proton pump inhibitor at the same time as Sofuled; don’t use it first.
- If you get sick (vomit) after taking the medicine, it may affect the amount of Sofuled in your blood. This can make the medicine less effective.
- If you are sick (vomiting) less than 5 hours after taking it, take another dose.
- If you are sick (vomiting) more than 5 hours after taking Sofuled, you do not need to take another dose until your next scheduled dose.
If you use more Sofuled than necessary
- If you accidentally take more than the recommended dose, you should contact your doctor or the nearest emergency room immediately for advice.
- Keep the pill bottle with you so you can easily describe what you’ve taken.
If you forget to drink
It is important not to miss a dose of Sofuled. If you miss a dose, calculate how long it has been since you last took it;
- If you notice within 18 hours of your usual time of taking the medicine, you must take your dose as soon as possible. Then take your next dose at your usual time.
- If it’s been 18 hours or more after your usual time, wait and take your next dose at your usual time. Do not take a double dose (two doses close to each other).
Don’t stop taking Sofuled
Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment so that the medicine has the best chance of treating your hepatitis C virus infection.
If you have any other questions about using this medicine, ask your doctor or pharmacist.
Notes when using the drug
You should not use this medicine if you are allergic to ledipasvir or sofosbuvir.
If you take Sofuled with ribavirin: There may be other reasons why you shouldn’t take this combination treatment. Tell your doctor about all of your medical conditions.
Tell your doctor if you have ever:
- Hepatitis B
- Liver problems other than hepatitis (including liver transplant)
- Kidney disease (or if you are on dialysis)
- HIV or AIDS
- A heart rhythm problem for which you take a medicine called amiodarone (Cordarone, Pacerone)
- If you use blood thinners (warfarin, Coumadin, Jantoven) and you have a routine “INR” or prothrombin time test.
Both men and women using Sofuled with ribavirin should use at least 2 effective forms of birth control to prevent pregnancy. Ribavirin can cause birth defects or death in an unborn baby if the mother or father is using this medicine.
- If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and monthly during treatment.
- If you are a man, do not use ribavirin if your sexual partner is pregnant.
Continue to use 2 forms of birth control while using ribavirin and for at least 6 months after your last dose. Tell your doctor right away if pregnancy occurs while the mother or father is using ribavirin.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risks.
Sofuled is not allowed for anyone under 3 years of age.
Sofuled side effects
Call your doctor right away if you have new or worsening symptoms such as:
- Pain in the upper right abdomen
- Vomiting, loss of appetite
- Jaundice (yellowing of the skin or eyes), and feeling unwell.
If you take Sofuled and you also take a heart rhythm medicine called amiodarone: This combination of drugs can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:
- Very slow heart rate, chest pain, shortness of breath
- Confusion, memory problems
- Weakness, extreme fatigue, light-headed feeling (like you might pass out).
Common side effects may include:
- Feeling tired.
This is not a complete list of side effects and other possible side effects. Call your doctor for medical advice about side effects.
What other drugs may interact with Sofuled?
What other drugs will affect Sofuled?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. medicine may affect the way other medicines work, and other medicines may affect the way Sofuled works.
You should not take it if you also take other medicines that contain sofosbuvir (Sovaldi).
Especially tell your healthcare provider if you take any of the following medicines:
- Amiodarone (Cordarone)
- Antacids containing aluminum or magnesium hydroxide. If you take an antacid during treatment with Sofuled, take the antacid 4 hours before or 4 hours after you take it.
- Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
- Digoxin (Lanoxin)
- Efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla)
- Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild)
- Medicines for indigestion, heartburn, or stomach ulcers, such as nizatidine (Axid), famotidine (Pepcid AC), cimetidine (Tagamet), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), ), rabeprazole (Aciphex), or pantoprazole (Protonix)
- Oxcarbazepine (Trileptal, Oxtellar XR)
- Phenytoin (Dilantin, Phenytek)
- Phenobarbital (Luminal)
- Rifabutin (Mycobutin)
- Rifampin (Rifadin, Rifamate, Rifater, Rimactane)
- Rifapentine (Priftin)
- Rosuvastatin (Crestor) and atorvastatin
- Simeprevir ( Olysio )
- John’s wort (Hypericum perforatum) or products containing St. John’s Wort
- Tipranavir (Aptivus) is used in combination with ritonavir (Norvir)
- Tenofovir disoproxil fumarate (Viread, Truvada) is used in combination with atazanavir (Reyataz) and ritonavir (Norvir), darunavir (Prezista) and ritonavir (Norvir), or used in combination with lopinavir and ritonavir (Kaletra).
- Warfarin (International Normalized Ratio (INR) values may increase and decrease abnormally in people taking warfarin. Therefore, regular monitoring of INR values is recommended in patients taking warfarin)
This is not a complete list of Sofuled drug interactions. Ask your doctor or pharmacist for more information.
For pregnant and lactating women
- Tell your doctor if you are pregnant or plan to become pregnant.
- The FDA classifies drugs based on their safety for use during pregnancy. Five categories – A, B, C, D and X, are used to classify the possible risks to the unborn baby from taking the drug during pregnancy.
- The drug is classified as Class B. No studies have been well done in humans with this drug. In animal studies, pregnant animals were given Sofuled and the young did not show any medical problems related to this medicine.
- It is not known whether Ledipasvir and Sofosbuvir pass into breast milk. Because many drugs can pass into breast milk and because of the potential for serious adverse reactions in a nursing infant when using this medicine, a choice must be made to discontinue nursing or discontinue this medicine.
- Your doctor and you will decide if the benefits outweigh the risks of using Sofuled.
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Preservation of drugs
- Store Sofuled at room temperature below 30°C.
- Keep it in its original container.
- Do not use the medicine inside if the seal on the bottle cap is broken or missing.
The above article is for reference only and is not a substitute for medical diagnosis or treatment. Readers should only follow the instructions of the doctor who is treating you, Index-China disclaims responsibility if problems occur.
Reputable source ThuocLP Vietnamese: Drug Sofuled Ledipasvir 90mg/Sofosbuvir 400mg to treat hepatitis C
Assoc.Prof.Dr. Tran Ngoc Anh is currently Hanoi Medical University Hospital, Associate Professor, Department of Internal Medicine, Gastroenterology and Head of Department of General-Uematology of Hanoi Medical University. Consulting doctor at ThuocLP Pharmacy.
Professional qualifications, Academic degrees – Education:
Graduated from General Practitioner System, Hanoi Medical University
Graduated with a Master degree in Internal Medicine, Hanoi Medical University
Graduated from the training program specialized in Gastrointestinal, Henri Mondor Institute Center, University of Paris 6, French Republic 1996-1997; 1999
Graduated from the training program specialized in Gastrointestinal, North Royal Sydney Hospital, Australia; 2002
Graduated from a training program specialized in chronic liver diseases, Pizza, Italy 2009
Graduated with a PhD in Gastrointestinal, Hanoi Medical University
Associate Professor, Gastroenterology, Hanoi Medical University
Training and Scientific Research:
Published more than 200 articles in domestic and international specialized journals
Editor of many monographs and participates in compiling 2 textbooks.
Guide many students and graduate students of Hanoi Medical University
Manager of many grassroots research projects
Certificate of Good Clinical Practice (GCP: 2012, 2015), Ministry of Health
Specialized certificates: General gastrointestinal endoscopy, Interventional gastrointestinal endoscopy, General gastrointestinal ultrasound, Interventional gastrointestinal ultrasound (Bach Mai BV), Chronic liver disease.