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BRAND : Daclahep
INGREDIENT : HepatitisC-Hetero-Daclatasvir-60mg-Daclahep
COUNT : 28 Tablets

Description of Daclahep

Generic: Daclatasvir Brand: Daclahep Strength of the content: 60mg Mfg: Hetero labs Primary use: for chronic hepatitis C viral infection (HCV) Description: Daclahep is classified as anti-viral drug called hepatitis C virus NS5A Daclahep is a prominent first non structural viral protein NS5A inhibitor. Daclahep is a phosphoprotein that acts as leading role in hepatitis C multiplication. Daclahep is used along with other antiviral medicines like Sofosbuvir The action produced by Daclatasvir, which inhibits the NS5A replication complex is not clearly known. But it is conclude that Daclatasvir prohibits viral RNA multiplication.

Pharmacology of Daclahep

NS5A is an unstructured viral polyprotein; it acts as replicating complex in viral RNA Daclahep (Daclatasvir) act as hepatitis C NS5A inhibitor. This NS5A has ability to bind to HCV RNA, undergone multiplication. Daclahep interfere with the activity of polyprotein and block the function of new HCV multiplication synthesis and virion assembly or secretion Daclahep worked by blocking the viral replication leads to chain termination. Pharmacokinetic: Absorption: The plasma peak concentration of Daclahep occurred within 2 hours. The absolute bioavailability of Daclahep is 67% Distribution: The human plasma protein bound with Daclahep in affected persons is nearly 99% The volume of distribution is 47L. Metabolism: Daclahep is a substrate of CYP3A enzymes which is required for its metabolism. The distribution of drug in plasma is in unchanged form Excretion: Among 88% of total dose of Daclahep is eliminated through bile and feces in 53% as an unchanged form; 6.6% in urine as unchanged form The terminal half life period of Daclahep is around 12 to 15 hours.

Indication of Daclahep

Daclahep is an anti-viral drug, useful for the treatment of chronic hepatitis C viral infection by inhibiting the replication of hepatitis C virus Daclahep is involved in the treatment of genotype III advanced hepatitis C virus in adults without cirrhosis Generally Daclahep tablets are not used alone, it may combined with other anti-viral medicines like Sofosbuvir, interferon and ribavirin

Dose & Dosage's of Daclahep

Daclahep is usually used in the condition like hepatitis C virus infection; Daclahep with Sofosbuvir in genotype I and III infection Genotype I: Without cirrhosis or with compensated cirrhosis (child Pugh A) 60mg of Daclahep with 400mg of Sofosbuvir taken as orally for 12 weeks as single dose In decompensated cirrhosis: Daclahep 60mg with 400mg of Sofosbuvir and ribavirin should be taken as orally for 12 weeks as single dose Genotype III: Without cirrhosis: 60mg Daclahep plus 400mg Sofosbuvir for 12 weeks taken as single dose orally In decompensated cirrhosis: Daclahep 60mg with 400mg of Sofosbuvir and ribavirin should be taken as orally for 12 weeks as single dose Ribavirin dosing: HCV genotype I or III with decompensated cirrhosis or post transplantation: 600mg initial dose taken as single use, increasing up to 1000mg/day if tolerated HCV genotype III with compensated cirrhosis: Based on weight <75kg: 1000mg/day ≥75kg: 1200mg/day It should be taken as twice daily with food In pediatric: <18 years the safety and efficacy of the tablet Daclahep has not been established Missed dose: If patients fail to take the dose of Daclahep tablets, consult the medical practitioner and follow the advice

Side Effects of Daclahep

Pulmonary disorders: Cough, Nasopharyngitis, dyspnea Exertional dyspnea, nasal congestion, upper respiratory tract infection GIT: Diarrhea, nausea, Upper abdominal pain, abdominal pain, constipation, flatulence, gastro esophageal reflux disease, dry mouth, vomiting, elevated lipase Musculoskeletal Myalgia, arthralgia, Back pain Digestive problems: Decreased appetite Cardiovascular Symptomatic bradycardia, heart block, cardiac arrhythmias Liver problems Increased ALT, increased AST, increased total bilirubin Hepatitis B reactivation Genitourinary Urinary tract infection CNS: Headache Dizziness, Migraine, Somnolence Skin problems; Erythema, Pruritus, rash, dry skin, alopecia and Erythema multiforme Mental disorder: Insomnia, irritability Depression, anxiety Blood related problems: Anemia, neutropenia Thrombocytopenia, decreased hemoglobin Eosinophilia Ocular Dry eye Other side effects; Signs of allergic reactions; hives Difficulty in breathing Swelling of peripheral organs In case of receiving Daclahep with amiodarone, this combination may lead to; Very slow heartbeats Chest pain Breathing difficulty

Contraindication of Daclahep

Concomitant with strong CYP3A inducers (carbamazepine, phenytoin, rifampin) cause some hypersensitivity reaction When used in combination with ribavirin, contraindicated to pregnancy condition Anaphylactic reaction occurs

Drug Interaction of Daclahep

While some concomitant drugs may cause interactions Amiodarone: concomitant with Daclahep causes bradycardia Aprepitant: increase the serum concentration of CYP3A4 substrates Some list of drugs; Asunaprevir, betrixaban, bilastine, buprenorphine CYP3A4 inducers (strong): decrease the serum concentration of Daclahep CYP3A4 inhibitors: decrease the metabolism of CYP3A4 substrates Warfarin: Daclahep increase the anti-coagulant activity

Precaution of Daclahep

While combining with amiodarone care should be taken because Daclahep causes increase the bradycardia effects of amiodarone Care should be taken while using Daclahep tablets in patients having conditions like: Cardiovascular disease patient Hepatic impairment Hepatitis B reactivation occurs after discontinuation Before going to start the treatment, if patient having the following conditions they must seek medical advice; Liver problems or liver transplant Heart problems Pregnant condition Breast feeding Trying to become pregnant

Usage & Safety profile of Daclahep Pregnancy & Lactation

While concomitant Daclahep with ribavirin in advanced stage; it is not recommended in pregnancy condition and breast feeding Ribavirin pregnancy category: X Ribavirin causes fetal death

Storage of Daclahep

Daclahep tablet container should be stored at 25oC (77oF); excursion permitted between 15oC and 30oC (59oF and 86oF)