VIORELE- desogestrel and ethinyl estradiol and ethinyl estradiol kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Glenmark Pharmaceuticals Inc., USA

INN (Διεθνής Όνομα):

DESOGESTREL

Σύνθεση:

DESOGESTREL 0.15 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Oral contraceptives should not be used in women who currently have the following conditions:

Περίληψη προϊόντος:

VIORELE® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) contains 21 round white to off-white tablets, 2 round pale green to yellowish green tablets and 5 round light yellow to yellow tablets in a blister. Each white to off-white, biconvex, film-coated tablet (debossed with ‘C1’ on one side and ‘G’ on the other side) contains 0.15 mg desogestrel, USP and 0.02 mg ethinyl estradiol, USP. Each pale green to yellowish green, biconvex, film-coated tablet (debossed with ‘C3’ on one side and ‘G’ on the other side) contains inert ingredients. Each light yellow to yellow colored, biconvex, film-coated tablet (debossed with ‘C2’ on one side and ‘G’ on the other side) contains 0.01 mg ethinyl estradiol, USP. Boxes of 3 NDC 68462-318-29 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

VIORELE- DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
GLENMARK PHARMACEUTICALS INC., USA
----------
VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.02
MG
AND ETHINYL ESTRADIOL TABLETS, USP 0.01 MG)
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 VIORELE, are contraindicated in women who
are over
35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
VIORELE (desogestrel and ethinyl estradiol tablets, USP and ethinyl
estradiol tablets,
USP) provides an oral contraceptive regimen of 21 white to off-white,
round tablets each
containing 0.15 mg desogestrel, USP (13-ethyl-11-
methylene-18,19-dinor-17 alpha-
pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17
alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-diol), and inactive ingredients which include
vitamin E, potato
starch, povidone, isopropyl alcohol, colloidal silicon dioxide,
magnesium stearate,
lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2
inert pale green to
yellowish green, round tablets with following inactive ingredients:
lactose, starch,
magnesium stearate, hypromellose, titanium dioxide, macrogol, talc,
iron oxide yellow,
FD&C blue No. 2 indigo carmine aluminum lake. VIORELE also contains 5
light yellow to
yellow, round tablets containing 0.01 mg ethinyl estradiol, USP
(19-nor-17 alpha-pregna-
1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which
include vitamin E,
lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon
dioxide, magnesium
stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide
yellow. The molecular
weights for desogestrel, USP and ethinyl estradiol, USP are 310.48
g/mol and 296.40
g/mol respectively. The structural formulas are as follows:
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