Ledihep 12 Weeks

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BRAND :  LEDIHEP PRICE :  750$ STRENGTH : 400MG & 90MG ACTIVE :  LEDIHEP-SOFOSBUVIR-400MG-LEDIPASVIR-90MG-12WEEKS COMPANY NAME :  ZYDUS TABLETS :  28 TABLETS read more

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Drug profile

Ledihep tablets are anti-viral agent.

Ledihep tablets which has procure by a patients only with 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 combination with other anti-viral medicines in chronic condition.

Ledihep, used by the patients having valid prescription

 

Ledihep Mechanism of Action

Ledihep has two eminent compounds like;

Sofosbuvir & ledipasvir

Ledihep 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 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 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 is 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 meal

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

Ledihep used either alone or with 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 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 single dose for 24 weeks alone or 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 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:

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 single dose

Therapy experienced without cirrhosis:

Ledihep taken orally as a single dose for 12 weeks

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Ledihep taken 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 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 occurs

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

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

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

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

Ledihep With amiodarone: serious bradycardia occurs

Ledihep With digoxin: increase the effect of concentration of digoxin

 

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 causes 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 to pregnancy conditions

 

Safety Measures

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

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)

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

 

Storage and Handling

Ledihep tablets container should be stored at room temperature below 30oC

Container should be keep away from moisture, heat and light

 

Missed dose

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

If patient fail to take the dose Ledihep, 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

 

Over dosage

The maximum dose of Ledihep 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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