AZURETTE- desogestrel/ethinyl estradiol and ethinyl estradiol kit

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

थमां उपलब्ध:

RPK Pharmaceuticals, Inc.

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II 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 these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accid

उत्पाद समीक्षा:

AZURETTE® (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) contain 21 round dark blue tablets, 2 round white tablets and 5 round green tablets in a blister card (NDC 51862-890-01) within a plastic dispenser. Each dark blue tablet (debossed with "M3" on one side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each white tablet (debossed with "P" on one side and the "N " on the other side) contains inert ingredients.Each green tablet (debossed with "M4" on one side) contains 0.01 mg ethinyl estradiol. AZURETTE Tablets are available in the following configurations: Carton of 1 NDC 51862-890-02 Carton of 3 NDC 51862-890-03 Carton of 6 NDC 51862-890-06 Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Rx Only

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AZURETTE - DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
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AZURETTE
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND ETHINYL ESTRADIOL
TABLETS,
USP 0.15 MG/0.02 MG AND 0.01 MG)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Azurette (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl
Estradiol tablets,
USP) provide an oral contraceptive regimen of 21 dark blue tablets
each containing 0.15
mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17
alpha-pregn-4-en-20-yn-17-ol),
0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-diol), and
inactive ingredients which include: titanium dioxide, macrogol/PEG 400
NF,
hydroxypropyl-methylcellulose/hypromellose, FD&C Red #40, FD&C Yellow
#6, FD&C
Blue #1, vitamin E, lactose monohydrate, povidone, stearic acid and
pregelatinized
starch, followed by 2 white tablets with the following inactive
ingredients: titanium
dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene
glycol 8000,
lactose, magnesium stearate and pregelatinized corn starch. Azurette
also contains 5
green tablets containing 0.01 mg ethinyl estradiol (19-nor-17
alpha-pregna-1,3,5 (10)-
trien-20-yne-3,17-diol) and inactive ingredients which include:
polyvinyl alcohol, titanium
dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C
Blue No. 1, Iron
Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate
and
pregelatinized starch. The molecular weights for desogestrel and
ethinyl estradiol are
310.48 and 296.21 respectively. The structural formulas are as
follows:
®
The 21 dark blue tablets meet USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the
primary mechanism of this action is inhibition of ovulation, other
alterations include
changes in the cervical mucus (which increase the difficulty of sperm
entry into the