Resof L

Discount 5.00 USD
BRAND :  RESOF L PRICE :  275$ STRENGTH : 400MG & 90MG ACTIVE :  RESOF-L-SOFOSBUVIR-400MG-LEDIPASVIR-90MG COMPANY NAME :  DR.REDDY'S TABLETS :  28 TABLETS read more

275.00 USD
280.00
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Drug profile:

Resof L tablets are classified as an anti-viral agent. Resof L which has procure by a patients only with prescription

Trade name: Resof L

Active components: sofosbuvir & ledipasvir

Strength of the components: 400mg & 90mg respectively

Mfg: Dr. Reddy’s

Package: 28 tablets in a container

Category: Anti-cancer agent.


Resof L Prescribing Information:

Resof L is a single dose medicine, used alone or combination with other anti-viral medicines in chronic condition. Resof L is a very effective drug, involves in the treatment of chronic hepatitis C viral infection

Resof L, used by the patients having valid prescription

Resof L Mechanism of Action

Resof L is directly acting anti-viral drug, exhibits its activity by inhibiting the viral replication

Resof L has two eminent compounds like;

Sofosbuvir & ledipasvir

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

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.


Absorption:

The absorption of Resof L 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:

Resof L 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:

Resof L 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:

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 Resof L:

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

Resof L is a prescription medicine; care should be taken to avoid the self-medication problems

Resof L used either alone or with a combination.


Dosage Regimens

In adults:

The recommended dose of Resof L tablets in adults are;

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


Patients acquired without cirrhosis or with compensated cirrhosis:

Resof L should be taken as a single dose orally for 12 weeks.


Therapy-experienced without cirrhosis:

Resof L should be taken as once a day for 12 weeks.


Therapy-experienced with compensated cirrhosis:

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


In decompensated cirrhosis:

Resof L 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:

Resof L 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:

Resof L 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 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:

Resof L followed for 12 weeks as a single dose.


Genotype I:

Therapy naïve with compensated cirrhosis or without cirrhosis:

Resof L recommended for 12 weeks as a single dose.


Therapy-experienced without cirrhosis:

Resof L taken orally as a single dose for 12 weeks.


Therapy naïve and experienced without cirrhosis or with compensated cirrhosis:

Resof L taken for 24 weeks as a single dose.


Resof L 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.


Resof L 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:

Resof L concomitant with other drugs likes;

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

With amiodarone: serious bradycardia occurs

With digoxin: increase the effect of concentration of digoxin

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

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

With HMG CoA reductase: increase the effect of concentration of these lipid mimic drugs.


Food -Drug Interactions:

Food-drug interaction in Resof L tablets; food does not interfere with the activity of Resof L

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


Possible Contraindications:

Resof L 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 the 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:

Resof L with ribavirin pregnancy category: X

Ribavirin causes fetal death

Resof L pregnancy category: B1

Resof L is safe to use in case of monotherapy (used alone)

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


Storage and Handling:

Resof L tablets container should be stored at room temperature below 30oC

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


Missed Dose:

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

If patient fail to take the dose Resof L, 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.


Overdosage:

The maximum dose of Resof L (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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