Hepcvir L

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BRAND :  HEPCVIR L PRICE :  275$ STRENGTH : 400 MG AND 90 MG ACTIVE :  HEPCVIR-L-SOFOSBUVIR-400MG-LEDIPASVIR-90MG COMPANY NAME :  CIPLA TABLETS :  50 TABLETS read more

275.00 usd
280.00
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Drug profile:

Hepcvir L tablets are categorized as anti-viral agent. Hepcvir L is a Cipla product which has acquired by a patient only with a 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 a valid prescription.

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

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

Hepcvir L used either alone or with the 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 a 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 a single dose for 24 weeks alone or in 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 a 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 have 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 have not been established.

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


Duration of therapy:

Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Hepcvir L for 12 weeks as a 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 the 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 cause loss of effect of concentration of Hepcvir L.


Possible Contraindications:

Hepcvir L tablets are contraindicated;

While combining with ribavirin contraindicated in pregnancy conditions.

Hypersensitivity reactions occur.

Renal and hepatic impairment patients.


Safety Measures:

A 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 the reaction of HBV infection to HCV/HBV co-infected patients.

Care was 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

Breastfeeding is not recommended for the patients who are getting ribavirin.


Storage and Handling:

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

The container should be kept away from moisture, heat, and light.


Missed Dose:

Hepcvir L tablets are prescription use, before taking the tablet patient must advise by a physician for avoiding self-medication.

If the patient fails to take the dose Hepcvir L, must consult with a 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 an overdose.


Hepcvir L Overdosage:

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

No special antidote is recommended for overdosage of ledipasvir and Sofosbuvir.

If overdosage of both drugs, patients should be examined 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 a range of 53%.

Other precaution: in case of overdosage, contact poison information center as soon as possible.


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