Description of Natdac - 12 weeks
Product Index: Trade name: Natdac Active component: Daclatasvir Strength: 60mg Mfg: Natco pharma Pack: 28 tablets in a container Category: Anti-viral Description of Natdac 12 weeks Hepatitis C virus is a RNA virus, which causes severe life threatening conditions like; Chronic hepatitis Cirrhosis Hepatocellular carcinoma Natdac is an anti-viral medication, which is available in tablet form. Natdac exhibits its action by prohibiting the non structural 5A protein region of hepatitis C virus Natdac is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus Natdac is available in the strength of 60mg
Pharmacology of Natdac - 12 weeks
Natdac mechanism of action for 12 weeks therapy: Natdac 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 ïƒ˜ Cis acting function of phosphorylated NS5A: interfering HCV replication complex ïƒ˜ Trans acting function: regulate HCV assembly and infectious particle production Natdac will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Natdac involved in blockade of intercellular viral RNA synthesis and colony of virion Pharmacokinetic: Natdac 12 weeks Absorption: The peak plasma concentration of Natdac occurs within 2 hours. The mean bioavailability of Natdac 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 Natdac with the range of 99% Metabolism: Natdac a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of Natdac in plasma is in unchanged form 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 Natdac occurs from the range of almost 12 to 15 hours
Indication of Natdac - 12 weeks
Generally Natdac tablets are used as a piece of mix with sofosbuvir for the condition like unending hepatitis C viral pollution by joining with or without ribavirin.
Natdac used for treated genotype I or III started HCV ailment.
The huge control of usage of Natdac;
Loss of virological responses happens in the patients continued with genotype III defilement related HCV treated with Natdac and sofosbuvir for 12 weeks.
Dose & Dosage's of Natdac - 12 weeks
Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Natdac is 60mg as a single dose Recommended dosage regimens: Genotype I: Patients suffered by without cirrhosis: Natdac + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Natdac + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Natdac + Sofosbuvir + ribavirin for 12 weeks Genotype III: Patients without cirrhosis: Natdac with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Natdac with Sofosbuvir + ribavirin for 12 weeks Dose adjustments: While concomitant with strong CYP3A inhibitors: 30mg of Natdac once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Natdac as single dose With strong CYP3A inducers: contraindicated Natdac should be administered with or without food. Missed dose: Natdac 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 Natdac 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 Natdac - 12 weeks
Pharmacological effects: CVS: Bradycardia, heart block, cardiac arrhythmias Liver: Increased AST & ALT, Hyperbilirubinaemia, hepatitis B reactivation Genitourinary: Urinary tract infection Ocular: Dry eye 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 Some common side effects occurred in 12 weeks therapy; Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea
Contraindication of Natdac - 12 weeks
Natdac with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur Concurrent use of CYP3A inducers strong with Natdac, contraindicated to the patients
Drug Interaction of Natdac - 12 weeks
Concurrent use of Natdac with some drugs likes; Natdac is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Natdac, may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Natdac Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Natdac Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Natdac Strong CYP3A inhibitors: increase the effect of concentration of Natdac HMG CoA reductase: increase the effect of concentration of these lipid lowering drugs
Precaution of Natdac - 12 weeks
There is a risk of adverse effects due to concurrent use of Natdac with some other drugs causes; Symptomatic bradycardia while using with amiodarone Risk related to ribavirin during combination Hepatitis B reactivation Loss of therapeutic effect Serious life threatening conditions
Usage & Safety profile of Natdac - 12 weeks Pregnancy & Lactation
During monotherapy: pregnancy category of Natdac -B; it is safe while using alone but under supervision of medical practitioner advice During combination: pregnancy categories Natdac with ribavirin-X; causes severe ill effects like fetal harm even to death Breast feeding is safe during monotherapy but in combination with ribavirin breast feeding is not recommended
Storage of Natdac - 12 weeks
Natdac tablets containers are stored at 25oC (77oF); excursion between 15oC and 30oC (59oF and 86oF) Keep away from heat, moisture and heat