VOLNEA- desogestrel and ethinyl estradiol kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets 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 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE 2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year * Method (1) Typical Use †(2) Perfect Use ‡ (3) (4) Chance§ 85 85 Spermicides¶ 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal# 2 Post-Ovulation 1 Withdrawal 19 4 CapÞ Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Condomß Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Adapted from Hatcher et al., 1998, Ref#1. Volnea is contraindicated in females who are known to have or develop the following conditions:

Produkt oppsummering:

Volnea™ (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) contains 21 round white tablets, 2 round green tablets and 5 round yellow tablets in a blister card within a unit carton, as follows: Each white tablet (debossed with “ SZ ” on one side and “D1 ” on the other side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each yellow tablet (debossed with “SZ ” on one side and “L1 ” on the other side) contains 0.01 mg ethinyl estradiol. Each green tablet (debossed with “ SZ ” on one side and “J1 ” on the other side) contains inert ingredients. NDC 63629-2449-1, one box containing 3 individual unit cartons Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VOLNEA- DESOGESTREL AND ETHINYL ESTRADIOL
BRYANT RANCH PREPACK
----------
VOLNEA™
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND
ETHINYL ESTRADIOL TABLETS, USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Volnea™ (desogestrel and ethinyl estradiol tablets, USP and ethinyl
estradiol tablets,
USP) provides an oral contraceptive regimen of 21 white round 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 alpha-tocopherol,
colloidal silicon dioxide,
aquarius cool vanilla (contains hypromellose 2910, polyethylene glycol
and titanium
dioxide), corn starch, lactose monohydrate, povidone, and stearic
acid, followed by 2
inert green round tablets contain the following inactive ingredients:
aquarius cottage
green (contains FD&C blue no. 2 aluminum lake, hypromellose 2910,
polysorbate 80,
titanium dioxide, triacetin, and yellow iron oxide), colloidal silicon
dioxide, corn starch,
lactose monohydrate, magnesium stearate and povidone.
Volnea™ also contains 5 yellow round 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 lactose monohydrate, microcrystalline cellulose, magnesium
stearate, and
opadry yellow (contains lecithin, polyvinyl alcohol, talc, titanium
dioxide, xanthan gum,
and yellow iron oxide). The molecular weights for desogestrel and
ethinyl estradiol are
310.48 and 296.40 respectively. The structural formulas are as
follows:
USP dissolution test 2 is used.
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
en