Description of Dacihep - 12 weeks
Product Index: Trade name: Dacihep Active component: Daclatasvir Strength: 60mg Mfg: Zydus Heptiza Pack: 28 tablets in a container Category: Anti-viral Description of Dacihep 12 weeks Hepatitis C virus is a RNA virus, which causes severe life threatening conditions like; o Chronic hepatitis o Cirrhosis o Hepatocellular carcinoma Dacihep is an anti-viral medication, which is available in tablet form. Daclatasvir exhibits its action by prohibiting the non structural 5A protein region of hepatitis C virus Dacihep is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus. Dacihep is available in the strength of 60mg
Pharmacology of Dacihep - 12 weeks
Dacihep mechanism of action for 12 weeks therapy: Dacihep is a NS5A inhibitors, NS5A protein is required for viral multiplication This NS5A has capability to merge with HCV RNA. There are two specific functions in RNA multiplication which is based on phosphorylated state â€¢ Cis acting function of phosphorylated NS5A: interfering HCV replication complex â€¢ Trans acting function: regulate HCV assembly and infectious particle production Dacihep will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Dacihep involved in blockade of intercellular viral RNA synthesis and colony of virion Pharmacokinetic: 12 weeks Absorption: The peak plasma concentration of Dacihep occurs within 2 hours. The mean bioavailability of Dacihep is 67% The steady state level reached in 4 days after administration of single dose Distribution: The volume of distribution occurs at 47L. The human plasma protein bound with Dacihep with the range of 99% Metabolism: Dacihep a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of Dacihep in plasma is in unchanged nearly 97% Elimination: The route of elimination of metabolites; Bile: 88%; feces 53% (unchanged form) and 6.6% in unchanged form through urine The mean terminal half life period of Dacihep occurs from the range of almost 12 to 15 hours
Indication of Dacihep - 12 weeks
Generally Dacihep tablets are used in combination with sofosbuvir for the condition like chronic hepatitis C viral infection by combining with or without ribavirin.
Dacihep used for treated genotype I or III induced HCV infection.
The major limitation of use of Dacihep;
Loss of virological responses happens in the patients suffered with genotype III infection associated HCV treated with Dacihep & sofosbuvir for 12 weeks.
Dose & Dosage's of Dacihep - 12 weeks
Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Dacihep is 60mg as a single dose Recommended dosage regimens: Genotype I: Without cirrhosis: Dacihep + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Dacihep + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Dacihep + Sofosbuvir + ribavirin for 12 weeks Genotype III: Without cirrhosis: Dacihep with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Dacihep with Sofosbuvir + ribavirin for 12 weeks Dose adjustments: While concomitant with strong CYP3A inhibitors: 30mg of Dacihep once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Dacihep as single dose With strong CYP3A inducers: contraindicated Dacihep should be administered with or without food Missed dose: Dacihep is a prescription medicine; it should be used only under the guaindance of doctor Do not self medicate If patient fail to take the dose of Dacihep tablet, must consult with physician and take the missed dose within the time Otherwise the missed dose should be skipped and follow the regular dosing schedule Do not take overdose
Side Effects of Dacihep - 12 weeks
Some common side effects occurred in 12 weeks therapy; Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea Pharmacological effects: GIT: Abdominal pain, gastro esophageal reflux, vomiting, elevated lipase, flatulence Muscle: Myalgia, arthralgia, back pain Other: Fatigue, asthenia, influenza like symptoms, pyrexia, hot flush, loss of weight Nerve: Headache, migraine, somnolence Dermatological: Rashes, Pruritus, dry skin, alopecia, and Erythema multiforme Psychiatric: Insomnia, irritability, depression, anxiety Blood: Anemia, neutropenia, thrombocytopenia, esinophillia Respiratory: Cough, Nasopharyngitis, dyspnea, nasal congestion, upper respiratory infection Metabolic: Loss of appetite CVS: Bradycardia, heart block, cardiac arrhythmias Liver: Increased AST & ALT, Hyperbilirubinaemia, hepatitis B reactivation Genitourinary: Urinary tract infection Ocular: Dry eye
Contraindication of Dacihep - 12 weeks
Dacihep with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur Concurrent use of CYP3A inducers strong with Dacihep, contraindicated to the patients
Drug Interaction of Dacihep - 12 weeks
Concurrent use of Dacihep with some drugs likes; Dacihep is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Dacihep, may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Dacihep Strong CYP3A inhibitors: increase the effect of concentration of Dacihep HMG CoA reductase: increase the effect of concentration of these lipid lowering drugs Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Dacihep Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Dacihep
Precaution of Dacihep - 12 weeks
There is a risk of adverse effects due to concurrent use of Dacihep with some other drugs causes; Loss of therapeutic effect Symptomatic bradycardia while using with amiodarone Risk related to ribavirin during combination Hepatitis B reactivation Serious life threatening conditions
Usage & Safety profile of Dacihep - 12 weeks Pregnancy & Lactation
During combination: pregnancy categories with ribavirin-X; causes severe ill effects like fetal harm even to death During monotherapy: pregnancy category of Dacihep -B; it is safe while using alone but under supervision of medical practitioner advice Breast feeding is safe during monotherapy but in combination with ribavirin breast feeding is not recommended
Storage of Dacihep - 12 weeks
Dacihep tablets containers are stored at 25oC (77oF); excursion between 15oC and 30oC (59oF and 86oF) Keep away from heat, moisture and heat