HEPCINAT LP
Drug profile:
Hepcinat LP tablets are categorized as anti-viral agent. Hepcinat LP which has procure by a patients only with valid prescription
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| HEPCINAT LP |
Trade name: Hepcinat LPActive components: sofosbuvir & ledipasvirStrength of the components: 400mg & 90mg respectivelyMfg: NatcoPackage: 28 tablets in a containerCategory: Anti-cancer agent.
Hepcinat LP Prescribing Information:
Hepcinat LP is a very effective drug, involves in the treatment of chronic hepatitis C viral infection
Hepcinat LP is a single dose medicine, used alone or combination with other anti-viral medicines in chronic condition
Hepcinat LP, used by the patients having valid prescription.
Hepcinat LP Mechanism of Action:
Hepcinat LP is directly acting anti-viral drug, exhibits its activity by inhibiting the viral replication
Hepcinat LP has two eminent 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 Hepcinat LP 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:
Hepcinat LP 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:
Hepcinat LP 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 the Hepcinat LP:
Hepcinat LP tablets should be taken as a once a day, with or without a meal
Hepcinat LP is a prescription medicine; care should be taken to avoid the self-medication problems
Hepcinat LP used either alone or with a combination.
Dosage Regimens
In adults:
The recommended dose of Hepcinat LP tablets in adults are;
One tablet 90mg/400mg to be taken as a single dose.
Patients acquired without cirrhosis or with compensated cirrhosis:
Hepcinat LP should be taken as a single dose orally for 12 weeks.
Therapy-experienced without cirrhosis:
Hepcinat LP should be taken as once a day for 12 weeks.
Therapy-experienced with compensated cirrhosis:
Hepcinat LP should be taken as a single dose for 24 weeks alone or in combination with ribavirin.
In decompensated cirrhosis:
Hepcinat LP 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:
Hepcinat LP with ribavirin taken for 12 weeks as a single dose.
In genotype IV, V or VI:
Therapy-experienced and therapy naïve without cirrhosis or with compensated cirrhosis:
Hepcinat LP should be 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 have not been established.
In pediatric:
Used for HCV infection:
Hepcinat LP 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:
Hepcinat LP recommended for 12 weeks as a single dose.
Therapy-experienced without cirrhosis:
Hepcinat LP taken orally as a single dose for 12 weeks.
Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:
Hepcinat LP for 24 weeks.
Genotype IV, V or VI:
Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:
Hepcinat LP followed for 12 weeks as a single dose.
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
Serious bradycardia occurs
While combining with ribavirin, related problems occurs
Common side effects;
Headache
Fatigue
Nausea
Diarrhea
Insomnia.
Drug Interaction:
Hepcinat LP concomitant with other drugs likes;
With antacids: like proton pump inhibitors, H2 receptor antagonist causes reduce effect of concentration of ledipasvir
Ledipasvir: Drug transporter P-gp inhibitors and breast cancer resistance protein inhibitor, while concomitant withSofosbuvir and ledipasvir may causes increase the intestinal absorption of these substrates
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.
Food -Drug Interactions:
Food-drug interaction in Hepcinat LP tablets; food does not interfere with the activity of Hepcinat LP
Herbal product like st. Johns wort combined with Hepcinat LP may causes loss of effect of concentration of Hepcinat LP.
Possible Contraindications:
Hepcinat LP tablets are contraindicated;
Hypersensitivity reactions occur
Renal and hepatic impairment patients
While combining with ribavirin contraindicated to pregnancy conditions.
Safety Measures:
Exposed to adverse effects due to concomitant with ribavirin
Risk of the reaction of HBV infection to HCV/HBV co-infected patients
Care taken in hepatic and renal impairment patients
Possibility of symptomatic bradycardia occurs during combination with ribavirin
Risk of loss of therapeutic effect because of combination with P-gp inducers.
Pregnancy and Lactation:
Hepcinat LP with ribavirin pregnancy category: X
Ribavirin causes fetal death
Hepcinat LP pregnancy category: B1
Hepcinat LP is safe to use in case of monotherapy (used alone)
Breastfeeding is not recommended for the patients who are getting ribavirin.
Storage and Handling:
Hepcinat LP tablets container should be stored at room temperature below 30oC.
The container should be kept away from moisture, heat, and light.
Missed dose:
Hepcinat LP 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 Hepcinat LP, 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.
Overdosage:
The maximum dose of Hepcinat LP (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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