NEVIRAPINE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Amneal Pharmaceuticals LLC

Designació comuna internacional (DCI):

NEVIRAPINE

Composición:

NEVIRAPINE 200 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Nevirapine tablets, USP 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, USP for the treatment of HIV-1 infection: - Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP 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, USP 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 Precautions (5.2) ]. - If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought. Nevirapine, USP 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) ]. Nevirapine, USP is contraindicated for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions (5.1) ]. Teratogenic Effects, Pregnancy Category B. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits. The maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than those seen at the recommended daily human dose (based on AUC). In rats, decreased fetal body weights were observed due to administration of a maternally toxic dose (exposures approximately 50% higher than that seen at the recommended human clinical dose). There are no adequate and well-controlled trials of Nevirapine in pregnant women. The Antiretroviral Pregnancy Registry, which has been surveying pregnancy outcomes since January 1989, has not found an increased risk of birth defects following first trimester exposures to nevirapine. The prevalence of birth defects after any trimester exposure to nevirapine is comparable to the prevalence observed in the general population. Severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic Nevirapine therapy as part of combination treatment of HIV-1 infection. Regardless of pregnancy status, women with CD4+ cell counts greater than 250 cells/mm3 should not initiate Nevirapine unless the benefit outweighs the risk. It is unclear if pregnancy augments the risk observed in non-pregnant women [see Boxed Warning ]. Nevirapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women exposed to Nevirapine, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Nevirapine is excreted in breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Nevirapine. The safety, pharmacokinetic profile, and virologic and immunologic responses of Nevirapine have been evaluated in HIV-1 infected pediatric subjects age 3 months to 18 years [see Adverse Reactions (6.2) and Clinical Studies (14.2) ]. The safety and pharmacokinetic profile of Nevirapine has been evaluated in HIV-1 infected pediatric subjects age 15 days to less than 3 months [see Adverse Reactions (6.2) and Clinical Studies (14.2) ]. The most frequently reported adverse events related to Nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and Nevirapine [see Adverse Reactions (6.2) and Clinical Studies (14.2) ]. Clinical trials of Nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. In subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. Nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. No adjustment in nevirapine dosing is required in patients with CrCL greater than or equal to 20 mL/min. In patients undergoing chronic hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ]. Because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer Nevirapine to patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Contraindications (4.1), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3) ].

Resumen del producto:

Nevirapine Tablets, USP, 200 mg , are supplied as white to off-white oval shaped tablets engraved “N2” with a single bisect separating ‘N’ and ‘2’ on one side and plain on the other side. They are available as follows: Bottles of 60   NDC  65162-209-06 Storage Store below 30° C. Protect from light. Store in a safe place out of the reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Amneal Pharmaceuticals LLC
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MEDICATION GUIDE
Nevirapine Tablets
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 highest 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 should see you and do blood tests often to check your
liver fu

Fitxa tècnica

NEVIRAPINE- NEVIRAPINE TABLET
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NEVIRAPINE.
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 tablets, USP 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 interrupted for greater than 7 days, restart 14-day lead-in
dosing (2.4)
ADULTS
(≥16 yrs)
PE DIATRIC *
(>15 days)
FIRST 14
DAYS
200 mg once daily 150 mg/m once daily
AFTER 14
DAYS
200 mg twice daily150 mg/m twice daily
*Total daily dose should not exceed 400 mg for any patient.
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg (3)
CONTRAI