VOLNEA- desogestrel and ethinyl estradiol kit

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

RPK Pharmaceuticals, Inc.

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 rate. 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 Yeara Method (1) Typical Useb (2) Perfect Usec (3) (4) Chanced 85 85 Spermicidese 26 6 40 Periodic abstinence 25

Produktu pārskats:

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. NDC 70700-122-85, Carton containing 3 blister cards. 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. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

VOLNEA- DESOGESTREL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
----------
VOLNEA
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND
ETHINYL ESTRADIOL TABLETS, USP)
RX ONLY
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including Volnea, are contraindicated in women who
are over 35
years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
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 fol