VIRAMUNE- nevirapine tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

VIRAMUNE XR tablets, 400 mg, are yellow, oval, biconvex tablets, debossed with "V04" on one side and the Boehringer Ingelheim logo on the other side. VIRAMUNE XR 400 mg tablets are supplied in bottles of 30 (NDC 54868-6370-0). Storage Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Authorization status:

New Drug Application

Patient Information leaflet

VIRAMUNE - NEVIRAPINE TABLET, EXTENDED RELEASE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
Tablets
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
Oral Suspension
VIRAMUNE XR® (VIH-rah-mune)
(nevirapine)
Extended-Release Tablets
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 that can
cause death. These problems can happen at any time during treatment,
but your risk is higher during
the first 18 weeks of treatment.
1.
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.
People who have a higher CD4+ cell count when they begin VIRAMUNE
treatment have a
higher risk of liver problems, especially:
•
Women with CD4+ counts higher than 250 cells/mm3. This group has the
highest
risk.
•
Men with CD4+ counts higher than 400 cells/mm3.
If you are a woman with CD4+ counts higher than 250 cells/mm3 or a man
with
CD4+ counts higher than 400 cells/mm3, you and your doctor will decide
whether
starting VIRAMUNE is right for you.
In general, women have a higher risk of liver problems compared to
men.
People who have abnormal liver test results before starting VIRAMUNE
treatment
and people with hepatitis B or C also have a greater chance of getting
liver problems.
You may get a rash if you have liver problems.
Stop taking VIRAMUNE and call your doctor right away if you have any
of the following
symptoms of liver problems:
•
dark (tea colored) urine
•
yellowing of your skin or whites of your eyes
•
light-colored bowel movements (stools)
•
fever
•
nausea (feeling sick to your stomach)
•
feel unwell or like you

Summary of Product characteristics

VIRAMUNE - NEVIRAPINE TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIRAMUNE XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR VIRAMUNE XR.
VIRAMUNE XR® (NEVIRAPINE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
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
Indications and Usage (1)
11/2012
Dosage and Administration
General Dosing Considerations (2.1)
11/2012
Pediatric Patients (2.3)
11/2012
Dosage Adjustment (2.5)
11/2012
Warnings and Precautions
Immune Reconstitution Syndrome (5.5)
11/2012
INDICATIONS AND USAGE
VIRAMUNE XR is an NNRTI indicated for combination antiretroviral
treatment of HIV-1 infection in adults and in
children 6 to less than 18 years of age. (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 greater than 250 cells/mm
adult males with CD4 cell counts greater than 400 cells/mm
The 14-day lead-in period with immediate-release VIRAMUNE (200 mg once
daily) must be strictly followed; it has
been demonstrated to reduce the frequency of rash. (2.5, 5.2)
DOSAGE AND ADMINISTRATION
The VIRAMUNE XR tablets must be swallowed whole and must not be
chewed, crushed, or divided (2.1)
Adult patients must initia