LEDIHEP
Drug profile:
Ledihep tablets are an anti-viral agent.
Ledihep tablets which have procured by a patient only with the prescription
Ledihep tablets fixed-dose combination contains sofosbuvir and ledipasvir
Trade name: Ledihep
Active components: sofosbuvir & ledipasvir
Strength of the components: 400mg & 90mg respectively
Mfg: Zydus hepatica
Package: 28 tablets in a container
Category: Anti-cancer agent.
Ledihep Prescribing Information:
Ledihep is a very effective drug, involves in the treatment of chronic hepatitis C viral infection
Ledihep is a single dose medicine, used alone or in combination with other anti-viral medicines in a chronic condition.
Ledihep, used by the patients having a valid prescription
Ledihep Mechanism of Action
Ledihep has two eminent compounds like;
Sofosbuvir & ledipasvir
Ledihep tablet is directly acting anti-viral drug, exhibits its activity by inhibiting the viral replication.
Ledipasvir: exhibits its action by intercedes with NS5A activity which is important for viral multiply, secretion, and colony of HCV virions. Due to the effect of ledipasvir, NS5A inhibitor causes eradicate viral growth.
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 a chain terminator.
Absorption:
The absorption of Ledihep 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:
Ledihep should be administered with or without food; the human plasma protein bound of ledipasvir occurs as >99.8%; sofosbuvir 61 to 65%.
The metabolite of sofosbuvir GS-331007 has minimal plasma protein bounding capability.
Metabolism:
Ledihep 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:
Ledihep 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 ledihep:
Ledihep tablets should be taken as a once a day, with or without the meal
Ledihep is a prescription medicine; care should be taken to avoid the self-medication problems
Ledihep used either alone or with the combination.
Dosage Regimens:
In adults:
The recommended dose of Ledihep tablets in adults are;
One tablet 90mg/400mg to be taken as a single dose.
Patients acquired without cirrhosis or with compensated cirrhosis:
Ledihep should be taken as a single dose orally for 12 weeks
Therapy-experienced without cirrhosis:
Ledihep should be taken as once a day for 12 weeks.
Therapy-experienced with compensated cirrhosis:
Ledihep should be taken as a single dose for 24 weeks alone or in combination with ribavirin.
In decompensated cirrhosis:
Ledihep 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:
Ledihep 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:
Ledihep should be 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:
Duration of therapy:
Genotype IV, V or VI:
Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:
Ledihep followed for 12 weeks as a single dose.
Genotype I:
Therapy naïve with compensated cirrhosis or without cirrhosis:
Ledihep recommended for 12 weeks as a single dose.
Therapy-experienced without cirrhosis:
Ledihep has taken orally as a single dose for 12 weeks.
Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:
Ledihep took for 24 weeks as a single dose.
Ledihep 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 a single dose
Ledihep Called side effects:
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 occur
Common side effects;
Headache
Fatigue
Nausea
Diarrhea
Insomnia
Drug Interaction:
Ledihep concomitant with other drugs likes:
Ledihep 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 with Sofosbuvir and ledipasvir may causes increase the intestinal absorption of these substrates
Food -Drug Interactions:
Food-drug interaction in Ledihep tablets; food does not interfere with the activity of Ledihep
Herbal product like st. Johns wort combined with Ledihep may cause loss of effect of concentration of Ledihep.
Possible Contraindications:
Ledihep tablets are contraindicated;
Hypersensitivity reactions occur
Renal and hepatic impairment patients
While combining with ribavirin contraindicated in 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 was taken in hepatic and renal impairment patients.
The 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:
Ledihep with ribavirin pregnancy category: X
Ribavirin causes fetal death
Ledihep pregnancy category: B1
Ledihep is safe to use in case of monotherapy (used alone)
Breastfeeding is not recommended for the patients who are getting ribavirin.
Storage and Handling:
Ledihep tablets container should be stored at room temperature below 30oC
The container should be kept away from moisture, heat, and light.
Missed Dose:
Ledihep 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 Ledihep, 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 Ledihep 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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