TRI-SPRINTEC- norgestimate and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

MedVantx, Inc.

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.18 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reporte

Product summary:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) 0.18 mg/0.035 mg are gray, round, unscored tablets debossed with stylized b on one side and 985 on the other side; 0.215 mg/0.035 mg are light blue, round, unscored tablets debossed with stylized b on one side and 986 on the other side; 0.25 mg/0.035 mg are blue, round, unscored tablets debossed with stylized b on one side and 987 on the other side. Tri-Sprintec 28 (norgestimate and ethinyl estradiol tablets) are packaged in cartons of six blister cards. Each card contains 28 tablets as follows: Each gray tablet contains 0.18 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.25 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, and the 7 white placebo tablets contain inert ingredients (Placebo tablets are white, round, unscored tablets, debossed with stylized b on one side and 143 on the other side). (NDC 0555-9018-58). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRI-SPRINTEC- NORGESTIMATE AND ETHINYL ESTRADIOL
MEDVANTX, INC.
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TRI-SPRINTEC
(NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS - TRIPHASIC REGIMEN)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
RX ONLY
DESCRIPTION
T ri-Sprintec
Tablets are a combination oral contraceptive containing the
progestational compound
norgestimate and the estrogenic compound ethinyl estradiol.
Each gray tablet contains 0.18 mg of the progestational compound,
norgestimate (18, 19-Dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and
0.035 mg of the estrogenic
compound, ethinyl estradiol (19-nor-17α-pregna,
1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive
ingredients include anhydrous lactose, lactose monohydrate, lake blend
black LB 636 (ingredients
include aluminum sulfate solution, aluminum-chloride solution, FD&C
blue no. 2, FD&C red no. 40,
FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium
stearate, and pregelatinized
starch.
Each light blue tablet contains 0.215 mg of the progestational
compound norgestimate (18, 19-Dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol (19-nor-17α-pregna,
1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive
ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake,
(ingredients include aluminum
sulfate solution, aluminum-chloride solution, sodium bicarbonate and
sodium carbonate), lactose
monohydrate, magnesium stearate, and pregelatinized starch.
Each blue tablet contains 0.25 mg of the progestational compound
norgestimate (18, 19-Dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol (19-nor-17α-pregna,
1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive
ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake,
(ingredients include aluminum
sulfate solution, aluminum