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Nevir

PRODUCT DETAILS

Trade name : Nevir
Active ingredient : Nevirapine
Strength availability : 200mg
Manufactured by : Emcure
Classified as : Anti-retroviral drug
Package : 60 tablets

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Nevir is belongs to antiviral drugs classification which inhibits HIV from reproducing in body. Nevir is a prescription drug provide under the guidance of doctors.

INDICATION

In adults and pediatric patients 15 days and older Nevir is mainly indicated for the treatment of HIV, the virus which can cause AIDS. Nevir oral solution is used in adults and children as young as 15 days old. Nevir extended-release tablets is indicated in adults and childerns about age atleast 6yrs old.

DOSAGE

For adult recommended dose. In combination with other antiretroviral agents the recommended dose for Nevir is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, The 14-day lead-in period with Nevir 200 mg daily dosing should be strictly followed as the lead-in period has been observed to decrease the incidence of rash . If rash continue apart from the 14-day lead-in period, do not dose expand to 200 mg twice daily. The 200 mg once-daily dosing drugs should not be continued above 28 days, at which point, an alternative drugs should be desired. For combination administered antiretroviral therapy, The usual dosage and monitoring should be followed. For pediatrics The usual oral dose for pediatric patients 15 days and older : 150 mg/m 2 given once daily for period of 14 days followed by 150 mg/m 2 administered twice daily thereafter. The entire dose for daily should not exceed 400 mg for any patient.

PHARMACOLOGY

Nevir is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. Nevir interpolated directly to reverse transcriptase (RT) and prevents the RNA- dependent and DNA-dependent DNA polymerase action by making a division of the enzyme's catalytic site. The activities of Nevir have not refined with template or nucleoside triphosphates. HIV-2 RT and eukaryotic DNA polymerases such as human DNA polymerases α, ß, γ, or δ are not prohibit by nevirapine.

PHARMACOKINETIC

Absorption : For 50mg tablet Nevir Bioavailabilty in human is 93±9% and 91 ± 8% for oral solution and in rate is 89.7%. high plasma concentration is 2 ± 0.4 mcg/ml attained by 4 hours.
Distribution : human Albumin of Plasma protein binding is 60%
Metabolism : Nevir extensively biotransformed via cytochrome P450 and metabolished to several hydroxylated metabolites
Elimination : Total radioactive in urine is 80% was made up of gluvuronide conjugation. The drug eliminated via urine 81.8 ± 11.1% and feces in 10.1 ± 1.5% Half life is 45 hours

PRECAUTION

Hepatotoxicity and hepatic impairment : Serious life-threatening in patient, and in some cases fatal hepatotoxicity, involving fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with Nevir.
Skin reaction : Serious and life-threatening skin reactions, involves fatal cases, have been reported in patients taking Nevir. Drug interactions Concomitant use of Nevir with efavirenz is not recommended as this combination has been associated with an increase in adverse reactions and no improvement in efficacy. Resistance
Immune reconstituents : Immune reconstitution syndrome has been resulted in patients reacted with combination antiretroviral therapy, including Nevir. During the initial phase of combination antiretroviral treatment, patients whose immune system behave may grow an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, tuberculosis, cytomegalovirus or Pneumocystis jiroveci pneumonia), which may necessitate further evaluation and treatment.
Fat redistribution : Redistribution/aggregation of body fat involves central obesity, buffalo hump (dorsocervical fat enlargement), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy

DRUG INTERACTION

Drugs extensively metabolised by CYP3A or CYP2B6 while interacting with. Efavirenz, atazanavir/ritonavir, fosamprenavir w/o ritonavir. Ketoconazole, fluconazole, itraconazole, warfarin, rifampicin, methadone

CONTAINDICATION

Patients are contraindicated with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment For indicated as part of occupational and non-occupational post-exposure prophylaxis (PEP) drugs.

MISSED DOSE

If patient missed a dose, patient should be consult with physician and follow the instructions. Follow the regular dosing schedule. Missed dose of drug should be avoided.

SIDE EFFECTS

Nevir has some side effects :
Signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss; Chest pain (specifically when you breathe), dry cough, wheezing, feeling short of breath.
Cold sores, sores on your genital or anal area :
rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement; Trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
Common side effects may include :
Skin rash; or changes in the s location of body fat (specifically in your arms, legs, face, neck, breasts, and waist).

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