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ADME process

Absorption

AUC is highly variable in pediatric patients because increased clearance, problems with compliance and inconsistent food intake with dosing. The time to high plasma concentration is 2 to 4 hours.

Distribution

Volume of distribution is 2 to 7 L/kg

Metabolism

Mainly metabolized through Hepatic via CYP2C19 and 3A4

Excretion

The elimination of drug through feces 98% to 99% and as metabolite 78% and unchanged drug as 22% and through urine 1% to 2%.

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Brand : Nelvir
Ingredients : Nelfinavir
Strength : 250mg
Manufactured : Cipla
Package : 100 Tablets

DOSAGE AND ADMINISTRATION

The recommended dose for adult dose for HIV infections in patients is 1250 mg given orally twice a day or 750mg given orally 3 times a day The drug administer in combination with other antiretroviral agents for treatment of HIV-1 Infection. For Nonoccupational Exposure the dose US CDC prescribed as 1250mg two times a day orally or 750mg three times a day orally given for 28 days.

For pediatric dose age 2 to less than 13 years prescribed dose is 45 to 55 mg/kg given orally twice a day Or 25 to 35 mg/kg given orally three times a day Maximum dose is 2500mg/day. Age 13 years or older = 1250mg given orally twice times a day or 750mg taken orally three times a day. The children weighing 16 kg or more administer 250mg for twice-daily

SIDE EFFECTS

Side effects by Clinical trials experience- adult and adolescents (13 yrs and older) Digestive system: diarrhea, nausea, flatulence, epigastric pain Skin /appendages: rash Hemic/lymphatic system: anemia, leucopenia and thrombocytopenia Metabolic/nutritional: liver function test abnormalities amylase, SGOT, SGPT, hypoglycemia, dehydration Musculoskeletal system: arthralgia, arthritis, cramps,myalgia Respiratory: dyspnae, pharyngitis, rhinitis, and sinusitis. Special sense: acute iritis and eye disorder.

Postmarketing Expeience

Hypersensitivity reaction Qtc prolongation Jaundice Bilirubinemia, metabolic acidosis.



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Drug interaction

While interaction with antacids, Phenobarbital, carbamazepine, aminoglutethimide, phenytoin, rifampicin, nafcillin, nevirapine, omeprazole will reduce the levels of nevimune Interaction with antifungal agents, cimetidine, Efavirenz wills increases serum levels. Reduced plasma effects while concomitant use with hormonal contraceptives, methadone, theophylline derivatives

Contraindications

The combination of nelfinavir with CYP3A for clearance is contraindicated

Precautions

Risk of serious adverse reaction due to drug interaction Hepatic impairment: the drug should not be used Phenylketourics ; nelfinavir contains phenylalanine which is harmful to patients with phenylketouria. Diabetes mellitus/hyperglycemia Hemophilia: increased bleeding level with nelfinavir treatment Fat distribution Immune Reconstitution Syndrome


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