Ledifos 12 Weeks

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BRAND :  LEDIFOS PRICE :  725$ STRENGTH : SOFOSBUVIR 400MG & LEDIPASVIR 90MG ACTIVE :  LEDIFOS-SOFOSBUVIR-400MG-LEDIPASVIR-90MG-12WEEKS COMPANY NAME :  HETERO TABLETS... read more

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Drug profile

Ledifos tablets are anti-viral agent.

Ledifos tablets which has procure by a patients only with prescription

Ledifos tablets fixed dose combination, contains sofosbuvir and ledipasvir

 

Trade name: Ledifos

Active components: sofosbuvir & ledipasvir

Strength of the components: 400mg & 90mg respectively

Mfg: Hetero healthcare 

Package: 28 tablets in a container

Category: Anti-cancer agent

 

Ledifos Prescribing Information

Ledifos is a very effective drug, involves in the treatment of chronic hepatitis C viral infection

Ledifos is a single dose medicine, used alone or combination with other anti-viral medicines in chronic condition.

Ledifos, used by the patients having valid prescription

 

Ledifos Mechanism of Action

Ledifos has two eminent compounds like;

Sofosbuvir & ledipasvir

Ledifos 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 Ledifos occurs rapidly, the peak plasma concentration of sofosbuvir 0.8 to 1 hour, ledipasvir is 4 to 4.5 hours; and GS-331007 3.5 to 4 hours

 

Distribution

Ledifos 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

Ledifos 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

Ledifos 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 Ledifos tablets

Ledifos tablets should be taken as a once a day, with or without meal

Ledifos is used either alone or with combination

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

 

Dosage Regimens

In pediatric:

Used for HCV infection:

Duration of therapy:

Genotype IV, V or VI:

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Ledifos followed for 12 weeks as a single dose

Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Ledifos recommended for 12 weeks as single dose

Therapy experienced without cirrhosis:

Ledifos taken orally as a single dose for 12 weeks

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Ledifos taken for 24 weeks as a single dose

Ledifos 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


In adults:

The recommended dose of Ledifos tablets in adults are;

One tablet 90mg/400mg to be taken as a single dose

Patients acquired without cirrhosis or with compensated cirrhosis:

Ledifos should be taken as single dose orally for 12 weeks

Therapy experienced without cirrhosis:

Ledifos should be taken as once a day for 12 weeks

Therapy experienced with compensated cirrhosis:

Ledifos should be taken as single dose for 24 weeks alone or combination with ribavirin

In decompensated cirrhosis:

Ledifos 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:

Ledifos 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:

Ledifos 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


Ledifos 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

Ledifos concomitant with other drugs likes;

Ledifos With antacids: like proton pump inhibitors, H2 receptor antagonist causes reduce effect of concentration of ledipasvir

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

Ledifos With amiodarone: serious bradycardia occurs

Ledifos With digoxin: increase the effect of concentration of digoxin

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

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


Food -Drug Interactions

Food drug interaction in Ledifos tablets; food does not interfere with the activity of Ledifos

Herbal product like st. Johns wort combined with Ledifos may causes loss of effect of concentration of Ledifos


Possible Contraindications

Ledifos tablets are contraindicated;

Renal and hepatic impairment patients

While combining with ribavirin contraindicated to pregnancy conditions

Hypersensitivity reactions occur


Safety Measures

Exposed to adverse effects due to concomitant with ribavirin

Risk of reaction of HBV infection to HCV/HBV co infected patients

Possibility of symptomatic bradycardia occurs during combination with ribavirin

Risk of loss of therapeutic effect because of combination with P-gp inducers

Care taken in hepatic and renal impairment patients

 

 

Pregnancy and Lactation

Ledifos with ribavirin pregnancy category: X

Ribavirin causes fetal death

Ledifos pregnancy category: B1

Ledifos 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

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

Ledifos Container should be keep away from moisture, heat and light

 

Missed dose

If patient fail to take the dose Ledifos, must consult with medical practitioner and administered the missed dose as soon as possible within the time. Ledifos tablets are prescription use, before taking the tablet patient must advice by physician for avoiding self medication

Otherwise the missed dose should be skipped and maintain the regular dosing schedule

Do not take overdose

 

Over dosage

The maximum dose of Ledifos (Sofosbuvir and ledipasvir) was 1200mg and 120mg twice daily for 10days.

No special antidote is recommended for over dosage of ledipasvir and Sofosbuvir

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%

If over dosage of both drugs, patients should be examine for confirmation of toxicity

 

Other precaution: in case of over dosage, contact poison information centre as soon as possible

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