VIENVA- levonorgestrel and ethinyl estradiol kit

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:

Xiromed, LLC.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is 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 II 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, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method (1) Typical Use1 (2) Perfect Use2 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Cond

Product summary:

Vienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side. NDC 70700-118-85, Carton containing 3 blister cards. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature ]. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain PI-118-03 Rev. 02/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VIENVA - LEVONORGESTREL AND ETHINYL ESTRADIOL
XIROMED, LLC.
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VIENVA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP) 0.1 MG/0.02 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST
TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES
(STDS)
SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS
B, AND
SYPHILIS.
DESCRIPTION
Each active, white tablet (21) contains 0.1 mg of levonorgestrel,
d(-)-13β-ethyl-17α-
ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen,
and 0.02 mg of
ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol.
The inactive ingredients present in the active tablet are: corn
starch, crospovidone,
lactose monohydrate, magnesium stearate, povidone, and pregelatinized
starch.
The inactive ingredients present in the inert tablet are: corn starch,
crospovidone, FD&C
Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium
stearate, povidone.
CLINICAL PHARMACOLOGY
MODE OF ACTION
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).
®
PHARMACOKINETICS
ABSORPTION
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl
estradiol in humans has been conducted. However, literature indicates
that
levonorgestrel is rapidly and completely absorbed after oral
administration (bioavailability
about 100%) and is not subject to first-pass metabolism. Ethinyl
estradiol is rapidly and
almost completely absorbed from the gastrointestinal tract but, due to
first-pass
metabolism in gut mucosa and liver, the bioavailability of ethinyl
estradiol is between 38%
and 48%.
After a single dose of levonorgestrel and ethinyl estradiol to 22
women under fasting
conditions, maximum serum concentrations of levonorge