SHAROBEL- norethindrone kit

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Saatavilla:

Northstar Rx LLC

INN (Kansainvälinen yleisnimi):

NORETHINDRONE

Koostumus:

NORETHINDRONE 0.35 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.  5  4  3  0.4  24  12  20  9  21  18  5  2  41  43  0.8  0.2  0.6  0.2  78  80 Emergency Contraception: Emergency contraceptive pills or insertion of a copper intrauterine contraceptive after unprotected intercourse substantially reduces the risk of pregnancy.9 (See Chapter 6.) Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 (See Chapter 18.) Source: Truss

Tuoteyhteenveto:

SHAROBEL™ (0.35 mg Norethindrone Tablets, USP) is available in a compact card (NDC 16714-441-01) containing 28 green, biconvex, round tablets imprinted "V2" on one side. SHAROBEL™ is available in the following configurations: Carton of 1 NDC 16714-441-02 Carton of 3 NDC 16714-441-03 Carton of 6 NDC 16714-441-04 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep out of the reach of children. REFERENCE 1. McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994. 2. Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006;44(3):113-118. 3. Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3. 4. Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6): 1250-1258. 5. Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539-579. 6. Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611-21. 7. 2008 USPC Official:12/1/08-4/30/09, USP Monographs: Norethindrone Tablets (page 1 of 5).

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SHAROBEL- NORETHINDRONE
NORTHSTAR RX LLC
----------
SHAROBEL™
(NORETHINDRONE TABLETS, USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
SHAROBEL
Tablets.
Each tablet contains 0.35 mg norethindrone. Inactive ingredients
include FD&C Blue No.
1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, titanium dioxide,
polyvinyl alcohol,
talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya),
hypromellose, lactose
monohydrate, magnesium stearate, and pregelatinized starch.
Meets USP Dissolution Test 3.
CLINICAL PHARMACOLOGY
1. MODE OF ACTION
SHAROBEL
progestin-only oral contraceptives prevent conception by suppressing
ovulation in approximately half of users, thickening the cervical
mucus to inhibit sperm
penetration, lowering the midcycle LH and FSH peaks, slowing the
movement of the
ovum through the fallopian tubes, and altering the endometrium.
2. PHARMACOKINETICS
Serum progestin levels peak about two hours after oral administration,
followed by rapid
distribution and elimination. By 24 hours after drug ingestion, serum
levels are near
baseline, making efficacy dependent upon rigid adherence to the dosing
schedule. There
are large variations in serum levels among individual users.
Progestin-only administration
results in lower steady-state serum progestin levels and a shorter
elimination half-life
than concomitant administration with estrogens.
™
™
INDICATIONS AND USAGE
1. Indications
Progestin-only oral contraceptives are indicated for the prevention of
pregnancy.
2. Efficacy
If used perfectly, the first-year failure rate for progestin-only oral
contraceptives is
0.3%. However, the typical failure rate is estimated to be closer to
9%, due to late or
omitted pills. Table 1 lists the pregnancy rates for users of all
major methods of
contraception.
TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY
DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE
OF
CONTRACEPTION AND TH