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Dalsiclear mechanism of action


Dalsiclear is a NS5A inhibitors, NS5A protein is required for viral multiplication This NS5A inhibitor has efficiency to incorporate with HCV RNA. There are two essential mechanism in RNA proliferation which is based on phosphorylated state Cis acting function of phosphorylated NS5A: interfering HCV replication complex Trans acting function: regulate HCV assembly and infectious particle production Dalsiclear will disrupt hyperphosphorylated NS5A protein and mediated with newly formed RNA viral Dalsiclear involved in blockade of intercellular viral RNA synthesis and colony of virion

Pharmacokinetic


Absorption

The peak plasma concentration of Dalsiclear occurs within 2 hours. The mean bioavailability of Dalsiclear is 67%

Distribution

The volume of distribution occurs at 47L. The human plasma protein bound with Dalsiclear with the range of 99%

Metabolism

Dalsiclear a CYP3A substrates, it is dominantly metabolized by CYP3A4 isoenzymes High portion of drug in plasma is in unchanged mode nearly 97%

Elimination

The route of elimination of metabolites; Elimination of drug via Bile: 88%; feces 53% (unchanged form) and 6.6% in unchanged form through urine The mean terminal half life period of Dalsiclear occurs from the range of almost 12 to 15 hours

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Brand : Dalsiclear
Ingredients : Daclatasvir
Strength : 60mg
Manufactured : Abbott
Package : 28 tablets

Dosage and administration of Dalsiclear

Before initiating the therapy; NS5A resistance testing in HCV genotype 1a infected patients with cirrhosis has been evaluated The usual dose of Dalsiclear is 60mg as a single dose Recommended dosage regimens:

Genotype I

Without cirrhosis: Dalsiclear + Sofosbuvir for 12 weeks Compensated cirrhosis (child Pugh A): Dalsiclear + Sofosbuvir for 12 weeks Decompensated cirrhosis (child Pugh B or C): Dalsiclear + Sofosbuvir + ribavirin for 12 weeks

Genotype III

Without cirrhosis: Dalsiclear with Sofosbuvir for 12 weeks Compensated or decompensated cirrhosis: Dalsiclear with Sofosbuvir + ribavirin for 12 weeks

Dose adjustments

While concomitant with strong CYP3A inhibitors: 30mg of Dalsiclear once a day Concomitant with moderate CYP3A inducers & nevirapine: 90mg of Dalsiclear as single dose With strong CYP3A inducers: contraindicated Dalsiclear should be administered with or without food

Side effects of Dalsiclear

While using the drug Some common side effects occurred as follows:: Chest pain, dizziness Irregular heart beat Unusual tiredness More common: Headache, nausea Pharmacological effects:

Other

Pyrexia , hot flush, loss of weight, Fatigue, asthenia, influenza like symptoms

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

GIT

Gastro esophageal reflux, vomiting, Abdominal pain, elevated lipase, flatulence

Muscle

Myalgia, arthralgia, back pain

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



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Drug interaction

Concurrent use of Dalsiclear with some drugs likes; Amiodarone: serious bradycardia occurs Aprepitant: increase the serum concentration of CYP3A4 substrates Strong inducers of CYP3A causes decreased therapeutic effect of Dalsiclear Dalsiclear is an inhibitor of P-glycoprotein transporter, organic anion transporting polypeptide and breast cancer resistance protein; taking Dalsiclear , may elevate exposure to these drugs, which prolong the therapeutic effect Proteases inhibitors: increase effect of concentration of Dalsiclear Efavirenz, etravirine & nevirapine: decrease the effect of concentration of Dalsiclear Strong CYP3A inhibitors: increase the effect of concentration of Dalsiclear Interaction with HMG CoA reductase will increase the effect of concentration of these lipid lowering drugs.

Precaution and warning

There is a risk of adverse effects due to concurrent use of Dalsiclear with some other drugs may causes; Loss of therapeutic effect Serious life threatening conditions Symptomatic bradycardia while using with amiodarone Risk related to ribavirin during combination Hepatitis B reactivation




abdominal pain
abdominal pain
concluded as death
concluded as death
dark urine
dark urine
fatigue
fatigue
flu like syndrome
flu like syndrome
loss of apetite
loss of apetite
loss of weight
loss of weight


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