NEVIRAPINE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

State of Florida DOH Central Pharmacy

INN (Jina la Kimataifa):

NEVIRAPINE

Tungo:

NEVIRAPINE 200 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Nevirapine tablets are 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 trials, one of which (BI 1046) is described below. Additional important information regarding the use of nevirapine tablets for the treatment of HIV-1 infection: - Based on serious and life threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets 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 nevirapine tablets 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see Dosage and Administration (2.4) and Warnings and

Bidhaa muhtasari:

Nevirapine Tablets, USP are available containing 200 mg of nevirapine, USP. The 200 mg tablets are white to off-white oval, scored tablets debossed with NE to the left of the score and 200 to the right of the score on one side of the tablet and M to the left of the score and blank to the right of the score on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

NEVIRAPINE - NEVIRAPINE TABLET
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
NEVIRAPINE TABLETS, USP
(ne vir′ a peen)
200 mg
Read this Medication Guide before you start taking nevirapine tablets
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
tablets?
Nevirapine tablets 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 highest during the
first 18 weeks of treatment.
1.
Severe liver problems: Anyone who takes nevirapine tablets 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 tablets 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 tablets 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

Tabia za bidhaa

NEVIRAPINE - NEVIRAPINE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR NEVIRAPINE TABLETS.
NEVIRAPINE TABLETS USP, 200 MG
INITIAL U.S. APPROVAL: 1996
WARNING: LIFE THREATENING (INCLUDING FATAL) HEPATOTOXICITY AND SKIN
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
FATAL AND NONFATAL HEPATOTOXICITY (5.1)
FATAL AND NONFATAL 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 tablets are 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 greater than 250 cells/mm
adult males with CD4 cell counts greater than 400 cells/mm
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)
*
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 twice daily
DOSAGE FORMS AND STRENGTHS
200 mg tablets (3)
CONTRAINDICATIONS
Patients with moderate or severe (Chi