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Rx Item-Nevirapine ER 400Mg Tab 30 By Alvogen Pharma

NDC 00781-5893-31 UPC/GTIN No.3-07815-89331-6 Mfg.Part No.589331BRAND: NEVIRAPINE NDC: 47781-0317-30,47781031730 UPC: 3-47781-31730-0,347781317300 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Nevirapine ER 400Mg Tab 30 By Alvogen Pharma

$706.42$744.05

Item No.:RX47781-0317-30/A, Item No. RX423626, 423626, NDC No.: 47781-0317-30, 47781-317-30, 4778131730, 47781031730, 0317-30, 031730 UPC No. 3-47781-31730-0, 347781-317300, 347781317300, Rx Item-Nevirapine ER 400Mg Tab 30 By Alvogen Pharma Only Physician, Pharmacy Or Licensed Facility Can purchase this RX Item Brand/Generic: , Drug Category: Antiviral Agents Non-Nucleoside Reverse Transcriptase Inhibitors (Nnrtis) Drug Class: 8180816 Hiv Non Nucleoside Rev. Transcrip. Inhib.

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VIRAMUNE- nevirapine tablet, extended release
Boehringer Ingelheim Pharmaceuticals, Inc.
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS

HEPATOTOXICITY:

Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3 , including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated [see Contraindications (4.2)]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately [see Warnings and Precautions (5.1)].



SKIN REACTIONS:

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with immediate-release VIRAMUNE 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [see Warnings and Precautions (5.2)].

MONITORING:

Patients must be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart nevirapine following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.

1??INDICATIONS AND USAGE

VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age [see Clinical Studies (14.1, 14.2)].

Additional important information regarding the use of VIRAMUNE XR for the treatment of HIV-1 infection:

Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see Boxed Warning and Warnings and Precautions (5.1)].
The 14-day lead-in period with immediate-release VIRAMUNE dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see Dosage and Administration (2.5) and Warnings and Precautions (5.2)].
If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.
2??DOSAGE AND ADMINISTRATION

2.1??General Dosing Considerations
VIRAMUNE XR tablets must be swallowed whole and must not be chewed, crushed, or divided.
Children should be assessed for their ability to swallow tablets before prescribing VIRAMUNE XR tablets.
VIRAMUNE XR can be taken with or without food.
No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet.
DESCRIPTION

VIRAMUNE XR is the brand name for nevirapine extended-release tablets. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.

The chemical name of nevirapine is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C15 H14 N4 O.
VIRAMUNE XR Tablets are for oral administration. Each tablet contains 100 mg or 400 mg of nevirapine and the inactive ingredients lactose monohydrate, hypromellose, iron oxide, and magnesium stearate.

12??CLINICAL PHARMACOLOGY

12.1??Mechanism of Action
Nevirapine is an antiviral drug
Microbiology
Mechanism of Action
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates. HIV-2 RT and eukaryotic DNA polymerases (such as human DNA polymerases ?, ?, ?, or ?) are not inhibited by nevirapine.

NDC 00781-5893-31 UPC/GTIN No.3-07815-89331-6 Mfg.Part No.589331
RX ITEM-Nevirapine ER 400Mg Tab 30 By Al
NDC 00781-5893-31 UPC/GTIN No.3-07815-89331-6 Mfg.Part No.589331

BRAND: NEVIRAPINE NDC: 47781-0317-30,47781031730 UPC: 3-47781-31730-0,347781317300
Nevirapine ER 400Mg Tab 30 By Alvogen Ph
BRAND: NEVIRAPINE NDC: 47781-0317-30,47781031730 UPC: 3-47781-31730-0,347781317300

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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