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Heptos

PRODUCT DETAILS

Trade name : Heptos
Active ingredient : Ribavirin
Strength availability : 200mg
Manufactured by : Hetero healthcare
Package : 140 capsules
Category : Anti-metabolite Anti-viral medicine

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Heptos tablet is belongs to an anti-viral drugs used mostly to treat hepatitis C viral infection. Heptos consist of an active component like Ribavirin which is described as nucleoside anti-metabolite anti-viral medication. Heptos is a type of synthetic nucleoside analogue of ribofuranose with anti-hepatitis viral activity.

INDICATION

Heptos tablet is mainly indicated in chronic hepatitis C viral infection by Co administration with other anti-viral drugs like Sofosbuvir or interferon alfa 2b. Heptos is mostly indicated for the patients with the age of 3 years or older with compensated cirrhosis.

MECHANISM

The mechanism of Heptos tablets are; The pharmacology by which ribavirin commit to its antiviral efficacy in the clinic is not fully understood. Ribavirin approach direct antiviral activity in tissue culture against many RNA viruses. Ribavirin raises the mutation frequency in the genomes of various viruses and ribavirin triphosphate prohibits HCV polymerase in a biochemical reaction. Heptos undergoes major activities like; RNA synthesis inhibition Triggers viral genome alterations Viral multiplication inhibition.

For capsules

In adults On the basis of body weight of the infected patients the dosage of Heptos should be recommended The patients weighing of 75kg: The usual dose is 2 Heptos capsules of 200mg should be taken as morning dose; 3 tablets of Heptos 200mg should be administered as second dose orally For <75kg: The usual dose of Heptos is 3 capsules should be taken as a morning dose and 3 capsules of Heptos should be taken as a second dose in a same day as orally.
In pediatrics The daily usual dose of Heptos is 15mg/kg orally in divided doses. The recommended duration of therapy is 48 weeks for pediatric patients with genotype I. Virological response rate of patients should be evaluated after 24 weeks of therapy, Conclusion of therapy should be taken into consideration in the patients who are not achieved HCV RNA below the limit of assay. The duration of therapy in both genotype II & III is 24 weeks.
In Heptos capsules with intron a combination treatment; The usual dose of peginterferon is 1.5mcg/kg/weeks given as subcutaneous by combining with 800 to 1400mg of Heptos administered as orally. On basis of body weight; Heptos dosage taken into consideration <40kg: 800mg/day 40 to 50kg: 800mg/day 51 to 60kg: 800mg/day 61 to 65kg: 800mg/day 66 to 75kg: 800mg/day 76 to 80kg: 1000mg/day 81 to 85kg: 1200mg/day 86 to 105kg: 1200mg/day >105kg: 1400mg/day During the therapy, following conditions may take; Appropriate hematological test may take Liver function test & TSH Pregnancy-monthly investigate the child bearing potential ECG.

DOSAGE

Discontinuing the treatment with Heptos : In adults patient, who are not accomplish the lower HCV RNA in assay, after 12 weeks or 24 weeks of treatment must discontinue the Heptos capsules using therapy.
In Heptos tablets : For genotype I & IV: <75kg: 1000mg /day for 48 weeks ≥75kg: 1200mg/day for 48 weeks For genotype II & III: The recommended dose is 800mg should be taken orally per day for 24 weeks In pediatrics; 23 to 33kg: 400mg/day 34 to 46kg: 600mg/day 47 to 59kg: 800mg/day 60 to 74kg: 1000mg/day ≥75kg: 1200mg/day
In renal impaired patients : CrCl 30 to 50ml/min: The recommended doses are taken alternatively by 200mg & 400mg every other day Less than CrCl 30ml/min: 200mg daily For hemodialysis patients: 200mg daily
Administration : Heptos capsules are administered with food. Heptos capsules are not recommended in the patients with the creatinine clearance value of less than 50ml/min. Heptos capsules should not be opened, crushed or chewed.
Over dosage : In most of the cases only over dosage of Heptos should be takes place, in such cases severe risk factors like cardiac disorders, blood related problems may occur. There is no special antitoxin appropriate for the over dosage of Heptos, to avoid this adverse condition patient should not skip or do not take the missed dose without getting advice from the medical adviser. Hemodialysis is not essential in over dosage condition of Heptos.

PHARMACOKINETIC

Absorption : Very quickly and intensively absorption of Heptos occurs. The Cmax value of Heptos is reaches within 2 hours after drug intake And Heptos bioavailability is 64%. In single dose, the maximum plasma concentration of Heptos is reaches in 1.7 hours; whereas in multiple dose (twice daily) within 3 hours.
Distribution : Heptos is heavily distributed in plasma and it has high volume of distribution like 2825L. Heptos does not bound to human plasma protein.
Metabolism : Heptos go through metabolism by two processes; 1. Reversibly phosphorylation pathway in nucleated cells 2. Degradative pathway along with deribosylation & amide hydrolysis to get Triazole carboxylic acid metabolite.
Excretion : This metabolite is eliminated renal with the range of 61%; in feces 12%. Nearly 17% of uptake drug is an unchanged form. The terminal half life period of Heptos about 120 to 170 hours The clearance value of Heptos 26L/hr.

PRECAUTION

Some risk factor has to be considered : Heptos is not an monotherapy; it must be administrated with some other anti-viral medication. The main toxic factor of Heptos is hemolytic anemia; this may result in annoyance of cardiac disease like myocardial infarction. Heptos tablets or capsules while using this tablet in pregnancy period. may causes Teratogenecity and embryocidal defects.
Safety precautions provided for reducing this severity : Heptos capsules or tablets may affect birth defects; to avoid this risk condition stop this intake in pregnancy condition.
Anemia : Frequently monitor the blood counts of the suspected patients before & after starting the therapy. To avoid the life threatening conditions
Pancreatitis : Discontinue the Heptos therapy, In this condition
Ophthalmologic disorders : This may occurs due to combination of Heptos with alpha interferon, this may prevent by avoid this combination Frequent eye checkup takes place. Stop the treatment to avoid the aggravation of disorders
Dental & periodontal disorders : These adverse effects may occur due to the concomitant use of Heptos with interferon, this may damage the teeth & mucous membranes. Avoid this combination or discontinue the treatment.
Growth impact in pediatric patients : This combinational therapy will retard the growth of the pediatric patients, use with cautiously on weight basis manner

DRUG INTERACTION

Interaction with Didanosine causes toxicities due to elevation of exposure of Didanosine & its metabolite. Avoid this concomitant to reducing the adverse effects related to Didanosine. In this combination some fatal liver injury may occur. In HIV/HCV co infected patients who are getting combination of anti-retroviral therapy for HIV infection, interferon alfa & Heptos may have chance of getting hepatic decompensated cirrhosis effect. The combination of nucleoside analogues with Heptos may leads to severe condition like decompensated cirrhosis. To avoid this risk factor care should be taken while concomitating the nucleoside analogues with Heptos or discontinue the anti-retroviral therapy or anti-viral therapy. This is because of the reason like; the cell culture anti-viral activity of stavudine & zidovudine against HIV are antagonized by Heptos, this may causes loss of anti-retroviral activity . The metabolism of Heptos is not mediated by cytochrome P450 enzymes, pharmacokinetic properties alteration will not occurs while combining Heptos with drugs metabolized by CYP450 isoenzymes. Interaction of Heptos with azathioprine causes various risk factors like, serious Pancytopenia and elevates the exposure of azathioprine along with adverse effects. During this Co administration, aggregation of azathioprine metabolites may occur and causes myelotoxicities. To avoid this type of exposure, patient must be investigate by counting the blood cells, including platelets count frequently.

CONTRAINDICATION

Heptos is contraindicated to pregnancy condition, may cause fetal deficiencies. Concurrent use of Heptos with Didanosine is contraindicated.

MISSED DOSE

Heptos capsules are will give serious illness, if patient missed to take the dose of Heptos must be discuss with medical practitioner and follow the instructions. Or, the missed dose should be skipped and follow the regular dosing schedule.

SIDE EFFECTS

Headache, Fatigue, Rigors, Fever, Flu like syndrome, Asthenia, Chest pain, Dizziness, Nausea, Anorexia, Dyspepsia, Vomiting, Myalgia, Arthralgia, Musculoskeletal pain, Insomnia, Irritability, Depression, Emotional liability, Concentration impairment , Nervousness, Dyspnea, Sinusitis, Alopecia, Rash, Pruritus, Hematological values alteration, Diminishing hemoglobulin values, Hearing disorders, Vertigo, Diabetes, Pulmonary hypertension, Aplastic anemia.

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