VIRAMUNE- nevirapine suspension VIRAMUNE- nevirapine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Boehringer Ingelheim Pharmaceuticals Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 50 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIRAMUNE is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, VIRAMUNE is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with CD4+ cell counts greater than 250 cells/mm3 or - adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)] . VIRAMUNE is contraindicated: - in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions (5.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that mon

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. VIRAMUNE tablets are supplied in bottles of 60 (NDC 0597-0046-60). 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. VIRAMUNE suspension is supplied in plastic bottles with child-resistant closures containing 240 mL of suspension (NDC 0597-0047-24). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 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
Boehringer Ingelheim Pharmaceuticals Inc.
----------
This Medication Guide has been approved by
the U.S. Food and Drug Administration
Revised: June 2022
MEDICATION GUIDE
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
oral suspension
VIRAMUNE® (VIH-rah-mune)
(nevirapine)
tablets
VIRAMUNE XR®
(VIH-rah-mune)
(nevirapine)
extended-release tablets
What is the most important information I should know about VIRAMUNE?
VIRAMUNE can cause severe liver and skin problems that may lead to
death. These problems can happen at
any time during treatment, but your risk is higher during the first 18
weeks of treatment.
VIRAMUNE can cause serious side effects, including:
•
Severe liver problems. Some people taking VIRAMUNE may develop severe
liver problems that can
lead to liver failure and the need for a liver transplant, or death.
If you have liver problems, you may
get a rash.
•
Women have a higher risk of developing liver problems during treatment
with VIRAMUNE
than men.
•
People who have abnormal liver test results before starting VIRAMUNE
and people with
hepatitis B or C also have a greater risk of getting liver problems.
People who have higher CD4+ cell counts when they begin VIRAMUNE 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.
Stop taking VIRAMUNE and call your doctor right away if you have any
of the following
symptoms of liver problems with or without a skin rash:
•
dark (tea colored) urine
•
light-colored bowel movements (stools)
•
feeling sick to your stomach (nausea)
•
pain or tenderness on your right side
below your ribs
•
loss of appetite
•
yellowing of your skin or
whites of your eyes
•
fever
•
feel unwell or like you
have the flu
•
tiredness
•
Severe skin reactions and rash.. Some skin reactions and rashes may be
severe, life-threatening, and
in some people, may lead to death. Most severe skin reactions and
rashes happen in th

Summary of Product characteristics

VIRAMUNE- NEVIRAPINE SUSPENSION
VIRAMUNE- NEVIRAPINE TABLET
BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
----------
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, FOR ORAL USE
VIRAMUNE® (NEVIRAPINE) ORAL SUSPENSION, 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 HAVE BEEN REPORTED IN PATIENTS
TAKING VIRAMUNE.
DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE
ELEVATIONS COMBINED
WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART VIRAMUNE
AFTER
RECOVERY. (5.1)
FATAL AND NON-FATAL SKIN REACTIONS, INCLUDING STEVENS-JOHNSON
SYNDROME, TOXIC
EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS, HAVE BEEN
REPORTED.
DISCONTINUE IMMEDIATELY IF SEVERE SKIN REACTIONS, HYPERSENSITIVITY
REACTIONS, OR ANY
RASH WITH SYSTEMIC SYMPTOMS OCCUR. CHECK TRANSAMINASE LEVELS
IMMEDIATELY FOR ALL
PATIENTS WHO DEVELOP A RASH IN THE FIRST 18 WEEKS OF TREATMENT. DO NOT
RESTART
VIRAMUNE AFTER RECOVERY. (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. (5.1, 5.2)
INDICATIONS AND USAGE
VIRAMUNE is an NNRTI indicated in combination with other
antiretroviral agents for the treatment of
human immunodeficiency virus (HIV-1) infection in adults and pediatric
patients 15 days and older. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in
controlled and uncontrolled trials,
VIRAMUNE is not recommended to be initiated, unless the benefit
outweighs the risk, in:
adult females with CD4 cell counts greater than 250 cells/mm
adult males with CD4 cell counts greater than 400 cells/mm (1, 5.1)
DOSAGE AND ADMINISTRATION
The 14-day lead-i