Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
nevirapine, Quantity: 200 mg
Sun Pharma ANZ Pty Ltd
Nevirapine
Tablet, uncoated
Excipient Ingredients: magnesium stearate; povidone; colloidal anhydrous silica; sodium starch glycollate type A; lactose monohydrate; microcrystalline cellulose
Oral
14, 60, 100
(S4) Prescription Only Medicine
Nevirapine in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and adolescents over the age of 16 years.,Resistant virus emerges rapidly when Nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.
Visual Identification: White to off-white, oval-shaped, uncoated tablets with a break line on both sides and debossed with 'RX921' on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-11-07
NEVIRAPINE RBX PI V9 Sep 2013 Page 1 of 33 PRODUCT INFORMATION NEVIRAPINE RBX Nevirapine 200 mg Tablets NAME OF THE MEDICINE Nevirapine Structural formula: Molecular Formula: C 15 H 14 N 4 O Chemical Name: 11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2’,3’- e][1,4]diazepin-6-one Molecular Weight: 266.3 CAS Number: 129618-40-2 DESCRIPTION Nevirapine is a non-nucleoside reverse transcriptase inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is a white to almost white powder with a pKa of 2.8. It is practically insoluble in water, sparingly soluble or slightly soluble in methylene chloride, and slightly soluble in methanol. NEVIRAPINE RBX immediate-release tablets contain 200 mg of nevirapine and the inactive ingredients lactose, microcrystalline cellulose, povidone, sodium starch glycollate type A, colloidal anhydrous silica and magnesium stearate. PHARMACOLOGY 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- NEVIRAPINE RBX PI V9 Sep 2013 Page 2 of 33 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. In clinical studies, nevirapine has been associated with an increase in HDL-cholesterol and an overall improvement in the total to HDL-cholesterol ratio. However, in the absence of specific studies with nevirapine on modifying the cardiovascular risk in HIV infected patients, the clinical impact of these findings is not known. The selection of antiretroviral drugs must be guided primarily by their antiviral efficacy. MICROBIOLOGY _IN VITRO _HIV SUSCEPTIBILITY The _in vitro _antiviral activity of nevirapine has been measured in a variety of cell lines includin Lue koko asiakirja