NEVIRAPINE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carlsbad Technology, Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nevirapine is indicated for combination antiretroviral treatment of HIV-1 infection in adults and in pediatrics patients 15 days and older [ see Clinical Studies ( 14.1), ( 14.2) ]. Additional important information regarding the use of nevirapine 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/mm 3 unless the benefit outweighs the risk [ see Boxed Warning and Warnings and Precautions ( 5.1) ]. - The 14-day lead-in period with nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [ see Dosage and Administration (

Product summary:

Nevirapine tablets, 200 mg, are white modified capsule shaped, biconvex tablets. One side is debossed with S on the left side of bisect and G on the right side of bisect and the other side with 1 on the left side of bisect 00 on the right side of bisect. Nevirapine tablets are supplied in bottle of 60 (NDC 61442-470-60). Dispense in tight container as defined in the USP/NF. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NEVIRAPINE- NEVIRAPINE TABLET, COATED
Carlsbad Technology, Inc.
----------
MEDICATION GUIDE
Nevirapine Tablets, USP
(ne vir' a peen)
Read this Medication Guide before you start taking nevirapine 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 nevirapine?
Nevirapine 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 nevirapine 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 nevirapine
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 nevirapine 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 nevirapine
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 nevirapine 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 have the flu
•
pain or tenderness on your right side below your ribs
•
tiredness
•
loss of appetite
Your doctor shou

Summary of Product characteristics

NEVIRAPINE- NEVIRAPINE TABLET, COATED
CARLSBAD TECHNOLOGY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEVIRAPINE TABLETS,
USP.
NEVIRAPINE TABLETS, USP 200 MG, 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).
INDICATIONS AND USAGE
Nevirapine is an NNRTI indicated for combination antiretroviral
treatment of HIV-1 infection in adults and in pediatric
patients 15 days and older. ( 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/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3
The 14-day lead-in period must be strictly followed; it has been
demonstrated to reduce the frequency of rash ( 2.4,
5.2)
DOSAGE AND ADMINISTRATION
If any patient experiences rash during the 14-day lead-in period, do
not increase dose until the rash has resolved. Do
not continue the lead-in dosing regimen beyond 28 days. ( 2.4)
If dosing is interrupted for greater than 7 days, restart 14-day
lead-in dosing. ( 2.4)
*T otal daily dose should not exceed 400 mg for any patient.
ADULTS
(≥16 yrs)
PEDIATRIC PATIENTS*
(≥15 days)
FIRST 14 DAYS
200 mg once daily
150 mg/m
once daily
A