DELYLA- levonorgestrel and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

OHM LABORATORIES INC.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DELYLA 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: Hatcher RA

Product summary:

DELYLA™ (levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg) are available as follows: NDC 51660-572-86 Blister Pack of 28 Tablets 21 active tablets: white, round biconvex, film-coated tablet debossed with “C4 ” on one side. 7 inert tablets: yellow, round biconvex, film-coated tablet debossed with “C2 ” on one side. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DELYLA- LEVONORGESTREL AND ETHINYL ESTRADIOL
OHM LABORATORIES INC.
----------
DELYLA™
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP)
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 lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polacrilin potassium
and Aqua Polish White 014.17 MS
which contains hydroxypropylcellulose, hydrogenated cottonseed oil,
hydroxypropylmethylcellulose,
talc, and titanium dioxide.
Each inactive, yellow tablet (7) contains the following inactive
ingredients: lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polacrilin potassium
and Aqua Polish Yellow 024.15
MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil,
hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow,
talc, and titanium dioxide.
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
levonorgestrel and ethinyl estradiol 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 almos