LEVONORGESTREL tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Fáanlegur frá:

Lupin Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Levonorgestrel tablets, 0.75 mg are progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later. Levonorgestrel tablets, 0.75 mg are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel tablets, 0.75 mg are not indicated for routine use as a contraceptive. Levonorgestrel tablets, 0.75 mg are contraindicated for use in the case of known or suspected pregnancy. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of levonorgestrel tablets, 0.75 mg emergency contraception before menarche is not indicated. This product is not intended for use in postmenopausal women. No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets, 0.75 mg and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown. No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg. No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg. Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of levonorgestrel tablets, 0.75 mg.

Vörulýsing:

Levonorgestrel Tablets, 0.75 mg are white to off white round biconvex tablets, debossed with "LU" on one side and "S24" on the other side. Levonorgestrel Tablets, 0.75 mg are available in a wallet containing 2 tablets (NDC 68180-851-11). Each wallet is packed in a carton (NDC 68180-851-13). Store Levonorgestrel Tablets, 0.75 mg at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LEVONORGESTREL- LEVONORGESTREL TABLET
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL
TABLETS, 0.75 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVONORGESTREL TABLETS, 0.75 MG.
LEVONORGESTREL TABLETS, 0.75 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Levonorgestrel tablets, 0.75 mg are progestin-only emergency
contraceptive, indicated for prevention of
pregnancy following unprotected intercourse or a known or suspected
contraceptive failure. Levonorgestrel
tablets, 0.75 mg are available only by prescription for women younger
than age 17 years, and available
over the counter for women 17 years and older. Levonorgestrel tablets,
0.75 mg are not intended for
routine use as a contraceptive. (1)
DOSAGE AND ADMINISTRATION
The first tablet is taken orally as soon as possible within 72 hours
after unprotected intercourse. The
second tablet should be taken 12 hours after the first dose. Efficacy
is better if levonorgestrel tablet, 0.75
mg is taken as soon as possible after unprotected intercourse. (2)
DOSAGE FORMS AND STRENGTHS
A total of two 0.75 mg tablets taken 12 hours apart as a single course
of treatment. (3)
CONTRAINDICATIONS
Known or suspected pregnancy. (4)
WARNINGS AND PRECAUTIONS
Ectopic Pregnancy: Women who become pregnant or complain of lower
abdominal pain after taking
levonorgestrel tablets, 0.75 mg should be evaluated for ectopic
pregnancy. (5.1)
Levonorgestrel tablets, 0.75 mg are not effective in terminating an
existing pregnancy. (5.2)
Effect on menses: Levonorgestrel tablets, 0.75 mg may alter the next
expected menses. If menses is
delayed beyond 1 week, pregnancy should be considered. (5.3)
STI/HIV: Levonorgestrel tablets, 0.75 mg does not protect against
STI/HIV. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥10%) in the clinical trial
included menstrual changes (26%),
nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%),
d