KALLIGA- desogestrel and ethinyl estradiol kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aurobindo Pharma Limited

INN (Mezinárodní Name):

DESOGESTREL

Složení:

DESOGESTREL 0.15 mg

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

KalligaTM tablets are 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with KalligaTM , 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§ Lactation Amenorrhea Method: LAM is

Přehled produktů:

KalligaTM (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg is available in  cartons of 3 pouches and 6 pouches, each containing 28 tablets: 21 active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “25” on other side. 7 inert tablets: Green, round, mottled, biconvex, beveled-edge tablets, debossed with “S” on one side and “7” on other side.                           1 Pouch of 28 tablets                                      NDC 65862- 887-28                           Carton of 3 Pouches                                       NDC 65862- 887-88                           Carton of 6 Pouches                                       NDC 65862- 887-92 STORAGE Store at 20º to 25°C (68° to 77º F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

KALLIGA- DESOGESTREL AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
----------
KALLIGA™
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP 0.15 MG/0.03 MG)
RX ONLY
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive use. This risk increases with age,
particularly in
women over 35 years of age, and with the number of cigarettes smoked.
For this
reason, combination oral contraceptives, including Kalliga
, should not be used by
women who are over 35 years of age and smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Kalliga
tablets provide an oral contraceptive regimen of 21 white to off-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) and 0.03 mg ethinyl estradiol USP
(19-nor-17 alpha-
pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients
include colloidal silicon
dioxide, lactose monohydrate, potato starch, povidone, stearic acid,
and vitamin E. Each
green tablet contains the following inactive ingredients: anhydrous
lactose,
croscarmellose sodium, FD&C Blue No.2 Aluminum Lake, ferric oxide
yellow, magnesium
stearate, microcrystalline cellulose, and povidone.
TM
TM
Kalliga meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Combined 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 changes in the endometrium which reduce the likelihood of
implantation.
Receptor binding studies, as well as studies in animals, have shown
that 3-keto-
desogestrel, the biologically active metabolite of desogestrel,
combines high
progestational activity with minimal intrinsic androgenicity.
The relevance of this
latter finding in hu