Empetus 100mg (Ritonavir)

DESCRIPTION

Empetus should used with valid doctor’s prescription. It used for treatment for the infection caused by HIV. Empetus is not a curable for HIV or prevention against AIDS.

The patient who had no treatment for HIV in past will undergo therapy by Empetus drug. It will target HIV infection from multiplying and decrease the destruction of immune system and delay the occurring HIV or AIDS disease.

INDICATION

Empetus is mainly used in adult by combination with antiretroviral drugs for the treatment of HIV infection.

MECHANISM OF ACTION

Empetus is a Competitive, particular and reversible HIV protease inhibitor which includes with the essential formation of proteins and enzymes. Empetus inhibits the virus infection and causes ineffective, premature and non-infectious virions development.

ADME PROPERTIES

ABSORPTION

Fast absorption from the GI tract, absorption increased with food, peak plasma concentration is approx 2-4hr.

DISTRIBUTION

Minimal amount distribution enters into CNS, volume of distribution about 0.16-0.66 L/kg. binding of plasma protein is approx 98%.

METABOLISM

Empetus is mainly metabolized in liver by CYP3A4 & lesser extent by CYP2D6 isoenzymes.

ELIMINATION

Empetus exceted by both unchanged and metabolite via faeces approx 86% and 3.5% as unchanged drug via urine approx 11%. The terminal elimination half life is 3-5hr.

DOSAGE MANAGEMENT

Empetus administration in adult, initially 300mg twice daily (bid) for 3 days. Gradually increased the dose to 100mg (bid) for 14days; Max dose of Empetus drug is 600mg In children, starting with 250mg/m2 twice daily, gradually increased by 50mg/m2 bid for 2-3 day intervals upto 350-400mg/m2bid. Max dose is 600mg bid. Empetus administrated through oral route with food, one tablet same time every day.

SIDE EFFECTS
GI effects: abdominal pain, nausea, vomiting, diarrhea, anorexia Common side effects: asthenia, taste disorder, headache, numbness or tingling around the mouth or extremities, anxiety, insomnia, fever, dizziness, malaise, hyperaesthesia, pharyngitis, rash, pruritus, sweating, vasodilatation, wt loss, Allergic reactions : urticaria, bronchospasm, angioedema, mild skin eruptions, immune reconstitution syndrome, lipodystrophy, osteonecrosis, Metabolic abnormalities: hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia. Reduced levels of Hb, K, free and total thyroxine; increased eosinophil, liver enzymes, amylase and uric acid; reduced or increased WBC and neutrophil counts. Major side effects: Pancreatitis, hepatic dysfunction, Stevens-Johnson syndrome. Rarely, anaphyla.

PRECAUTION

Before taking Empetus , inform your doctors about as follows: Patient with ischaemic heart disease, cardiomyopathy, pre-existing conduction abnormalities or structural heart disease, haemophilia A or B, porphyria, increased triglycerides. Renal and severe hepatic impairment without decompensation in Childern& Pregnancy. Monitoring Parameters Monitor cholesterol, triglycerides, CBC, LFTs, creatine phosphokinase, uric acid,viral load,CD4 count, serum amylase and lipase, glucose.

DRUG INTERACTION

In drug Empetus will Increased plasma conc of certain drugs highly metabolized by CYP3A . Empetus interaction with phenobarbital, carbamazepine, dexamethasone, phenytoin, rifabutin and rifampicn will decrease the plasma concentration. Increased plasma concentration of certain drugs highly metabolized by CYP3A. Empetus interaction with sildenafil leads to serum levels of sildenafil increase. Serious risk: Avoid contemporaneous admin of oral solution (contains alcohol) with disulfiram / metronidazole. Empetus with simvastatin or lovastatin increased risk of myopathy. Concurrent use Empetus with alfuzosin may lead to serious hypotension.

PREGNANCY

Category B: Animal studies have been developed adverse effect, but sufficient and well-tolerated studies in pregnant women which have failed to develop arisk to the fetus in all trimester in pregnancy

STORAGE

Empetus store at 20-25°C. Store at cool and dry place Keep Empetus tablet away from the children. Use Empetus drug before expiry date.