TRI-SPRINTEC- norgestimate and ethinyl estradiol kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Proficient Rx LP

INN (International Nazwa):

NORGESTIMATE

Skład:

NORGESTIMATE 0.18 mg

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, the IUD, and the Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower

Podsumowanie produktu:

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) 0.18 mg/0.035 mg are gray, round, flat-faced, beveled-edge, 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, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 986 on the other side; 0.25 mg/0.035 mg are blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 987 on the other side; placebo tablets are white, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) 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, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each blue tablet contains 0.25 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP, and the 7 white placebo tablets contain inert ingredients. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TRI-SPRINTEC- NORGESTIMATE AND ETHINYL ESTRADIOL
PROFICIENT RX LP
----------
TRI-SPRINTEC
(NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP)
9018
RX ONLY
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral
contraceptive use. This risk increases with age, particularly in women
over 35 years of age, and
with the number of cigarettes smoked. For this reason, combination
oral contraceptives, including
T ri-Sprintec
, should not be used by women who are over 35 years of age and smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
T ri-Sprintec
(norgestimate and ethinyl estradiol tablets USP) is a combination oral
contraceptive
containing the progestational compound norgestimate, USP and the
estrogenic compound ethinyl
estradiol, USP.
Each gray tablet contains 0.18 mg of the progestational compound,
norgestimate, USP (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, USP
(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 corn starch.
Each light blue tablet contains 0.215 mg of the progestational
compound norgestimate, USP (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, USP
(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, FD&C
blue no. 2, sodium bicarbonate
and sodi