Myhep Lvir

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BRAND :  MYHEP LVIR PRICE :  299$ STRENGTH : 400MG & 90MG ACTIVE :  MYHEP-LVIR-SOFOSBUVIR-400MG-LEDIPASVIR-90MG COMPANY NAME :  MYLAN TABLETS :  28 TABLETS read more

299.00 usd
300.00
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Drug profile:

Myhep LVIR tablets come under the anti-viral group

Myhep LVIR tablets which have to procure by patients only with a prescription

Myhep LVIR tablets fixed-dose combination contains sofosbuvir and ledipasvir

Trade name: Myhep LVIR

Active components: sofosbuvir & ledipasvir

Strength of the components: 400mg & 90mg respectively

Mfg: Mylan 

Package: 28 tablets in a container

Category: Anti-cancer agent.

Myhep LVIR Prescribing Information:

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

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

Myhep LVIR, used by the patients having a valid prescription.

Myhep LVIR Mechanism of Action:

Myhep LVIR has two eminent compounds like;

Sofosbuvir & ledipasvir

Myhep LVIR 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 Myhep LVIR 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:

Myhep LVIR 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:

Myhep LVIR 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:

Myhep LVIR 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 Myhep LVIR tablets:

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

Myhep LVIR is used either alone or with a combination

Myhep LVIR 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:

Myhep LVIR followed for 12 weeks as a single dose.

Genotype I:                

Therapy naïve with compensated cirrhosis or without cirrhosis:

Myhep LVIR recommended for 12 weeks as a single dose.

Therapy-experienced without cirrhosis:

Myhep LVIR taken orally as a single dose for 12 weeks.

Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Myhep LVIR taken for 24 weeks as a single dose.

Myhep LVIR 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.

In adults:

The recommended dose of Myhep LVIR tablets in adults are;

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

Patients acquired without cirrhosis or with compensated cirrhosis:

Myhep LVIR should be taken as a single dose orally for 12 weeks.

Therapy-experienced without cirrhosis:

Myhep LVIR should be taken as once a day for 12 weeks.

Therapy-experienced with compensated cirrhosis:

Myhep LVIR should be taken as a single dose for 24 weeks alone or in combination with ribavirin.

In decompensated cirrhosis:

Myhep LVIR 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:

Myhep LVIR 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:

Myhep LVIR 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.

Myhep LVIR 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:

Myhep LVIR concomitant with other drugs likes:

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

Myhep LVIR with HMG CoA reductase: increase the effect of concentration of these lipid mimic drugs.

Myhep LVIR With amiodarone: serious bradycardia occurs.

Myhep LVIR With digoxin: increase the effect of concentration of digoxin.

Myhep LVIR 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.

Myhep LVIR With anti-mycobacterials: reduce the effect of concentration of Sofosbuvir and ledipasvir.


Food -Drug Interactions:

Food-drug interaction in Myhep LVIR tablets; food does not interfere with the activity of Myhep LVIR.

Herbal product like st. Johns wort combined with Myhep LVIR may cause loss of effect of concentration of Myhep LVIR.

Possible Contraindications:

Myhep LVIR 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 a 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 was taken in hepatic and renal impairment patients.

Pregnancy and Lactation:

Myhep LVIR with ribavirin pregnancy category: X

Ribavirin causes fetal death

Myhep LVIR pregnancy category: B1

Myhep LVIR is safe to use in case of monotherapy (used alone)

Breastfeeding is not recommended for the patients who are getting ribavirin.

Storage and Handling:

Myhep LVIR tablets container should be stored at room temperature below 30oC

Myhep LVIR Container should be kept away from moisture, heat, and light.

Missed Dose:

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

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

Do not take an overdose.

Overdosage:

The maximum dose of Myhep LVIR (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 a range of 53%

If overdosage of both drugs, patients should be examined for confirmation of toxicity

Other precaution: in case of overdosage, contact poison information center as soon as possible.

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