Description of MyDekla - 12 weeks
Product Index: Trade name: Mydekla Active component: Daclatasvir Strength: 60mg Mfg: Mylan Pack: 28 tablets in a container Category: Anti-viral Description of Mydekla 12 weeks Hepatitis C virus is a RNA virus, which causes severe life threatening conditions like; Chronic hepatitis Cirrhosis Hepatocellular carcinoma Mydekla is an anti-viral medication, which is available in tablet form. Mydekla exhibits its action by prohibiting the non structural 5A protein region of hepatitis C virus Mydekla is not monotherapy medicine; it should be combined with other anti-viral drugs for treating chronic hepatitis C infection caused by virus Mydekla is available in the strength of 60mg
Pharmacology of MyDekla - 12 weeks
Mydekla mechanism of action for 12 weeks therapy: Mydekla 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 Ã¯Æ’Ëœ Cis acting function of phosphorylated NS5A: interfering HCV replication complex Ã¯Æ’Ëœ Trans acting function: regulate HCV assembly and infectious particle production Mydekla will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Mydekla involved in blockade of intercellular viral RNA synthesis and colony of virion Pharmacokinetic: Mydekla 12 weeks Absorption: The peak plasma concentration of Mydekla occurs within 2 hours. The mean bioavailability of Mydekla 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 Mydekla with the range of 99% Metabolism: Mydekla a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of Mydekla 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 Mydekla occurs from the range of almost 12 to 15 hours
Indication of MyDekla - 12 weeks
For the most part Mydekla tablets are utilized as a part of blend with sofosbuvir for the condition like endless hepatitis C viral contamination by joining with or without ribavirin.
Mydekla utilized for treated genotype I or III initiated HCV disease.
The significant confinement of utilization of Mydekla;
Loss of virological reactions occurs in the patients endured with genotype III contamination related HCV treated with Mydekla and sofosbuvir for 12 weeks.
Dose & Dosage's of MyDekla - 12 weeks
Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Mydekla is 60mg as a single dose Recommended dosage regimens: Genotype I: Patients suffered by without cirrhosis: Mydekla + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Mydekla + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Mydekla + Sofosbuvir + ribavirin for 12 weeks Genotype III: Patients without cirrhosis: Mydekla with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Mydekla with Sofosbuvir + ribavirin for 12 weeks Dose adjustments: While concomitant with strong CYP3A inhibitors: 30mg of Mydekla once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Mydekla as single dose With strong CYP3A inducers: contraindicated Mydekla should be administered with or without food. Missed dose: Mydekla 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 Mydekla 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 MyDekla - 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 MyDekla - 12 weeks
Mydekla with ribavirin contraindicated to pregnancy condition Hypersensitivity reaction occur Concurrent use of CYP3A inducers strong with Mydekla, contraindicated to the patients
Drug Interaction of MyDekla - 12 weeks
Concurrent use of Mydekla with some drugs likes; Mydekla is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Mydekla, may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Mydekla Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Mydekla Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Mydekla Strong CYP3A inhibitors: increase the effect of concentration of Mydekla HMG CoA reductase: increase the effect of concentration of these lipid lowering drugs
Precaution of MyDekla - 12 weeks
There is a risk of adverse effects due to concurrent use of Mydekla 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 MyDekla - 12 weeks Pregnancy & Lactation
During monotherapy: pregnancy category of Mydekla -B; it is safe while using alone but under supervision of medical practitioner advice During combination: pregnancy categories Mydekla 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 MyDekla - 12 weeks
Storage: Mydekla tablets containers are stored at 25oC (77oF); excursion between 15oC and 30oC (59oF and 86oF) Keep away from heat, moisture and heat