Hepcvir L 12 Weeks

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BRAND :  HEPCVIR L PRICE :  750$ STRENGTH : 400 MG AND 90 MG ACTIVE :  HEPCVIR-L-SOFOSBUVIR-400MG-LEDIPASVIR-100MG-12WEEKS COMPANY NAME :  CIPLA TABLETS :  28 TABLETS read more

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Drug profile

Hepcvir L tablets are categorized as anti-viral agent. Hepcvir L is a cipla product which has acquire by a patients only with valid prescription

 

Trade name: Hepcvir L

Active components: sofosbuvir & ledipasvir

Strength of the components: 400mg & 90mg respectively

Mfg: Cipla

Package: 28 tablets in a container

Category: Anti-cancer agent

 

Hepcvir L Prescribing Information

Hepcvir L is a very efficient medicine, involved in the treatment of chronic hepatitis C viral infection

Hepcvir L, used by the patients having valid prescription

Hepcvir L is a single dose medicine, used alone or combination with other anti-viral medicines in chronic condition

 

Hepcvir L Mechanism of Action

Hepcvir L is directly acting anti-viral drug, exhibits its activity by inhibiting the viral replication

Hepcvir L has two prominent compounds like;

 

Sofosbuvir & ledipasvir

Sofosbuvir: Generally it is anti-hepaciviral associated with NS5B polymerase inhibitor. This polymerase enzyme is responsible for viral proliferation, by interfering with these enzymes causes stoppage of viral reproduction acts as chain terminator

Ledipasvir: exhibits its action by intercedes with NS5A activity which is important for viral multiply, secretion and colony of HCV virions. Due to effect of ledipasvir, NS5A inhibitor causes eradicate viral growth

 

Absorption

The absorption of Hepcvir L occurs rapidly, the peak plasma concentration of ledipasvir is 4 to 4.5 hours; sofosbuvir 0.8 to 1 hour and GS-331007 3.5 to 4 hours

 

Distribution

Hepcvir L should be administered with or without food; the human plasma protein bound of ledipasvir is occurs as >99.8%; sofosbuvir 61 to 65%.

The metabolite of sofosbuvir GS-331007 has minimal plasma protein bounding capability

 

Metabolism

Hepcvir L tablet contains ledipasvir which is not metabolized hepatically and is excreted through feces as an unchanged form. Sofosbuvir metabolized to pharmacologically active form GS-461203

 

Elimination

Excretion occurs through feces and urine

 

Sofosbuvir:

Urine: 80%, feces: 14%, exhaled air: 3.5%

 

Ledipasvir:

99% in feces & 1% in urine as an unchanged

 

When to take Hepcvir L tablet

Hepcvir L tablets should be taken as a once a day, with or without meal

Hepcvir L is a prescription medicine; care should be taken to avoid the self medication problems

Hepcvir L used either alone or with combination

 

Dosage Regimens  

In adults:

The recommended dose of Hepcvir L tablets in adults are;

One tablet 90mg/400mg to be taken as a single dose

Patients acquired without cirrhosis or with compensated cirrhosis:

Hepcvir L should be taken as single dose orally for 12 weeks

Therapy experienced without cirrhosis:

Hepcvir L taken as once a day for 12 weeks

 

Therapy experienced with compensated cirrhosis:

Hepcvir L should be taken as single dose for 24 weeks alone or combination with ribavirin

 

In decompensated cirrhosis:

Hepcvir L combined with weight based ribavirin followed for 12 weeks

Ribavirin dosage regimen:

<75kg: 1000mg per day

≥75kg: 1200mg per day

In Genotype I or IV:

Spontaneous therapy and therapy competent without cirrhosis or with compensated cirrhosis:

Hepcvir L with ribavirin for 12 weeks as a single dose

In genotype IV, V or VI:

Therapy experienced and therapy naïve without cirrhosis or with compensated cirrhosis:

Hepcvir L taken as single dose for 12 weeks

 

Dosage adjustment:

In renal and hepatic impairment patients, mild or moderate conditions, on dosage adjustments required

In decompensated condition, safety and efficacy has not been established

 

In pediatric:

Used for HCV infection:

Hepcvir L is majorly indicated in pediatric patients with the age of 12 or older or weight of 35kg

<12 years or <35kg: the safety and efficacy has not been established

≥12 years or ≥35kg: one tablet to be taken as single dose

Duration of therapy:

Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Hepcvir L for 12 weeks as single dose

Therapy experienced without cirrhosis:

Hepcvir L taken orally as a single dose for 12 weeks

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Hepcvir L for 24 weeks

Genotype IV, V or VI:

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Hepcvir L followed for 12 weeks as a single dose

 

Hepcvir L Called side effects

Serious bradycardia occurs

While combining with ribavirin, related problems occurs

Common side effects;

Headache

Fatigue

Nausea

Diarrhea

Insomnia

Adverse effects in cirrhosis condition;

Asthenia, headache, fatigue, Myalgia, dyspnea, dizziness and irritability

Elevation of bilirubin levels

Elevation of lipase level

Elevation of creatine kinase levels

In cardiac: bradycardia, cardiac arrest

Skin: angioedema and rashes

 

Drug Interaction

Hepcvir L concomitant with other drugs likes;

With antacids: like proton pump inhibitors, H2 receptor antagonist causes reduce effect of concentration of ledipasvir

With amiodarone: serious bradycardia occurs

With digoxin: increase the effect of concentration of digoxin

With anti-convulsants: reduce the effect of concentration of Sofosbuvir and ledipasvir

With anti-mycobacterials: reduce the effect of concentration of Sofosbuvir and ledipasvir

With HMG CoA reductase: increase the effect of concentration of these lipid mimic drugs

Ledipasvir: Drug transporter P-gp inhibitors and breast cancer resistance protein inhibitor, while concomitant with Sofosbuvir and ledipasvir may causes increase the intestinal absorption of these substrates

 

Food -Drug Interactions

Food drug interaction in Hepcvir L tablets; food does not interfere with the activity of Hepcvir L

Herbal product like st. Johns wort combined with Hepcvir L may causes loss of effect of concentration of Hepcvir L

 

Possible Contraindications

Hepcvir L tablets are contraindicated;

While combining with ribavirin contraindicated to pregnancy conditions

Hypersensitivity reactions occur

Renal and hepatic impairment patients

 

Safety Measures

Possibility of symptomatic bradycardia occurs during combination with ribavirin

Risk of loss of therapeutic effect because of combination with P-gp inducers

Exposed to adverse effects due to concomitant with ribavirin

Risk of reaction of HBV infection to HCV/HBV co infected patients

Care taken in hepatic and renal impairment patients

 

Pregnancy and Lactation

Hepcvir L pregnancy category: B1

Hepcvir L is safe to use in case of monotherapy (used alone)

Hepcvir L with ribavirin pregnancy category: X

Ribavirin causes fetal death

Breast feeding is not recommended for the patients who are getting ribavirin

 

Storage and Handling

Hepcvir tablet container should be stored at room temperature below 30oC

Container should be keep away from moisture, heat and light

 

Missed dose

Hepcvir L tablets are prescription use, before taking the tablet patient must advice by physician for avoiding self medication

If patient fail to take the dose Hepcvir L, must consult with medical practitioner and administered the missed dose as soon as possible within the time

Otherwise the missed dose should be skipped and maintain the regular dosing schedule

Do not take overdose

 

Hepcvir L Over dosage

The maximum dose of Hepcvir L Sofosbuvir and ledipasvir were 1200mg and 120mg twice daily for 10days.

No special antidote is recommended for over dosage of ledipasvir and Sofosbuvir

If over dosage of both drugs, patients should be examine for confirmation of toxicity

Hemodialysis is suitable for elimination of ledipasvir hence; ledipasvir is largely bound to plasma protein and also helps to expel the dominant circulating metabolite of Sofosbuvir GS-331007 with range of 53%

Other precaution: in case of over dosage, contact poison information centre as soon as possible

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