AFIRMELLE- levonorgestrel and ethinyl estradiol kit

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

थमां उपलब्ध:

Aurobindo Pharma Limited

INN (इंटरनेशनल नाम):

LEVONORGESTREL

रचना:

LEVONORGESTREL 0.1 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Afirmelle is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10   Source: Trussell J. Contraceptive efficacy. In: Hatch

उत्पाद समीक्षा:

AfirmelleTM (Levonorgestrel and ethinyl estradiol tablets USP) 0.1 mg/0.02 mg is available in cartons of 3 pouches and 6 pouches, each containing 28 tablets: 21 active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “59” on other side of the tablet. 7 inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet. 1 Pouch of 28 tablets                                        NDC 65862-849-28 Carton of 3 Pouches                                         NDC 65862-849-88 Carton of 6 Pouches                                         NDC 65862-849-92              Store at 20º to 25°C (68° to 77º F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AFIRMELLE- LEVONORGESTREL AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
----------
AFIRMELLE
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP) 0.1 MG/0.02 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST
TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES
(STDS)
SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS
B, AND
SYPHILIS.
DESCRIPTION
Each active, white tablet (21) contains 0.1 mg of levonorgestrel USP,
d(-)-13β-ethyl-17α-
ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen,
and 0.02 mg of
ethinyl estradiol USP, 17α-ethinyl-1,3,5(10)-estratriene-3,
17β-diol. The inactive
ingredients present are croscarmellose sodium, lactose monohydrate,
magnesium
stearate, microcrystalline cellulose, and povidone.
Each inactive, green tablet (7) contains the following inactive
ingredients: croscarmellose
sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow
10), lactose
anhydrous, magnesium stearate, microcrystalline cellulose, and
povidone.
TM
CLINICAL PHARMACOLOGY
MODE OF ACTION
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
uterus) and the endometrium (which reduce the likelihood of
implantation).
PHARMACOKINETICS
_ABSORPTION_
No specific investigation of the absolute bioavailability of Afirmelle
in humans has been
conducted. However, literature indicates that levonorgestrel is
rapidly and completely
absorbed after oral administration (bioavailability about 100%) and is
not subject to first-
pass metabolism. Ethinyl estradiol is rapidly and almost completely
absorbed from the
gastrointestinal tract but, due to first-pass metabolism in gut mucosa
and liver, the
bioavailability of ethinyl estradiol is between 38% and 48%.
After a single dose of Afirmelle to 22 women under fasting conditions,
maximum serum
con