VIRAMUNE- nevirapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEVIRAPINE (UNII: 99DK7FVK1H) (nevirapine - UNII:99DK7FVK1H)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive studies, one of which (BI 1046) is described below. Additional important information regarding the use of VIRAMUNE for the treatment of HIV-1 infection: - Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, VIRAMUNE 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 VIRAMUNE 200 mg daily dosing has been demonstrated to reduce the frequency of rash [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. - If rash persists beyond the 14-d

Product summary:

VIRAMUNE tablets, 200 mg, are white, oval, biconvex tablets, 9.3 mm x 19.1 mm. One side is embossed with "54 193", with a single bisect separating the "54" and "193". The opposite side has a single bisect. Dispense in tight container as defined in the USP/NF. VIRAMUNE oral suspension is a white to off-white preserved suspension containing 50 mg nevirapine (as nevirapine hemihydrate) in each 5 mL. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children. This product was Manufactured By: Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road P.O. Box 368 Ridgefield, CT 06877 And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

New Drug Application

Patient Information leaflet

VIRAMUNE - NEVIRAPINE TABLET
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
Tablets
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
Oral Suspension
Read this Medication Guide before you start taking VIRAMUNE and each
time you get a refill. There
may be new information. This information does not take the place of
talking to your doctor about your
medical condition or treatment.
What is the most important information I should know about VIRAMUNE?
VIRAMUNE can cause serious side effects. These include severe liver
and skin problems which can
cause death. The risk of these problems is greatest during the first
18 weeks of treatment, but these
problems can also happen at any time during treatment.
Severe liver problems: Anyone who takes VIRAMUNE may get severe liver
problems. In some cases,
these liver problems can lead to liver failure and the need for a
liver transplant, or death. You may get a
rash if you have liver problems. People with higher risk of these
problems include women or anyone with
higher CD4+ cell counts when they begin VIRAMUNE treatment. Women with
CD4+ cell counts higher
than 250 cells/mm3 at the start of treatment have the greatest risk
for liver damage.
If you are a woman with CD4+ cell >250 cells/mm3 or a man with CD4+
cell >400 cells/mm3, you and
your doctor will decide if VIRAMUNE is right for you.
People who have abnormal liver test results and people with hepatitis
B or C have a greater chance of
getting liver problems and further increases in liver test results
during treatment.
If you get any of the following symptoms of liver problems, stop
taking VIRAMUNE and call your
doctor right away:
•
fever
•
"flu-like" symptoms or you do not feel well
•
dark (tea colored) urine
•
tiredness
•
light-colored bowel movements (stools)
•
nausea (feeling sick to your stomach)
•
pain or tenderness on your right side below your ribs
•
loss of appetite
•
yellowing of your skin or whites of your eyes
Your doctor should see you and do blood te

Summary of Product characteristics

VIRAMUNE - NEVIRAPINE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIRAMUNE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIRAMUNE.
VIRAMUNE® (NEVIRAPINE) TABLETS 200 MG
VIRAMUNE® (NEVIRAPINE) ORAL SUSPENSION 50 MG/5 ML
INITIAL U.S. APPROVAL: 1996
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY AND SKIN
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL AND NON-FATAL HEPATOTOXICITY (5.1)
FATAL AND NON-FATAL SKIN REACTIONS (5.2)
DISCONTINUE IMMEDIATELY IF EXPERIENCING:
Signs or symptoms of hepatitis (5.1)
Increased transaminases combined with rash or other systemic symptoms
(5.1)
Severe skin or hypersensitivity reactions (5.2)
Any rash with systemic symptoms (5.2)
Monitoring during the first 18 weeks of therapy is essential. Extra
vigilance is warranted during the first 6 weeks of
therapy, which is the period of greatest risk of these events (5) .
RECENT MAJOR CHANGES
Warnings and Precautions
Drug Interactions (5.4) 1/2010
INDICATIONS AND USAGE
VIRAMUNE is an NNRTI indicated for combination antiretroviral
treatment of HIV-1 infection (1)
Important Considerations:
Initiation of treatment is not recommended in the following
populations unless the benefits outweigh the risks (1, 5.1)
adult females with CD4 cell counts >250 cells/mm
adult males with CD4 cell counts >400 cells/mm
The 14-day lead-in period must be strictly followed; it may reduce the
frequency of rash (2.4, 5.2)
DOSAGE AND ADMINISTRATION
Any patient experiencing rash during the 14-day lead-in period should
not increase dose until the rash has resolved.
The lead-in dosing regimen should not be continued beyond 28 days
(2.4)
If dosing interrupted for >7 days, restart 14-day lead-in dosing (2.4)
*Total daily dose should not exceed 400 mg for any patient.
ADULTS
(≥16 yrs)
PEDIATRIC*
(>15 days)
FIRST 14 DAYS
200 mg once daily
150 mg/m once daily
AFTER 14 DAYS
200 mg twice daily
150 mg/m t