ALTAVERA- levonorgestrel and ethinyl estradiol

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:

Sandoz Inc

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral contraceptives are 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 1 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Par

Product summary:

AltaveraTM tablets (levonorgestrel and ethinyl estradiol, USP) are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are peach, round, film-coated, debossed with SZ on one side and L3 on the other side. The 7 inert tablets are white, round, film-coated, debossed with SZ on one side and J1on the other side. NDC 0781-5583-15, one carton containing 3 individual blister cartons STORAGE 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

ALTAVERA- LEVONORGESTREL AND ETHINYL ESTRADIOL
SANDOZ INC
----------
ALTAVERA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP) 0.15 MG/0.03 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
21 peach Altavera
tablets, each containing 0.15 mg of levonorgestrel, (d(-)-13
beta-ethyl-17-alpha-
ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic
progestogen, and 0.03 mg of ethinyl
estradiol, (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol), and
7 white inert tablets. The inactive
ingredients present in the active tablet are: lactose anhydrous, iron
oxide black, iron oxide red, iron
oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl
alcohol-part hydrolyzed, povidone,
talc, titanium dioxide. The inactive ingredients present in the
inert/placebo tablet are: lactose anhydrous,
magnesium stearate, polyethylene glycol, polyvinyl alcohol-part
hydrolyzed, povidone, talc, titanium
dioxide.
TM
TM
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 uterus) and the
endometrium (which reduce the likelihood
of implantation).
INDICATIONS AND USAGE
Oral contraceptives are 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 1 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 and the IUD, depends upon
the reliability with which they
are used. Correct and consistent use of methods can result in lower
failure rates.
TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY
DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
METHO