LOESTRIN / LOESTRIN FE Tablet (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Teva Women's Health, Inc.

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1. Description

LOESTRIN 21 and LOESTRIN Fe 28 are progestogen-estrogen combinations. LOESTRIN Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous ...

2. 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 ...

3. Indications and Usage

LOESTRIN 21 and LOESTRIN Fe 28 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 ...

4. Contraindications

Oral contraceptives should not be used in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic ...

5. Warnings

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite ...

6. Precautions

Patients should be couns eled that this product does not protect against HIV infection (AIDS) and others exually transmitted diseases. Physical Examination and Follow-Up It is good medical practice ...

6.2. Information for Patients

See patient labeling printed below.

6.4. Drug Interactions

Effects of Other Drugs on Oral Contraceptives (78) Rifampin Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence ...

6.5. Drug/Laboratory Test Interactions

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

See WARNINGS section.

6.7. Pregnancy

Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections.

6.9. Nursing Mothers

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In ...

6.10. Pediatric Use

Safety and efficacy of LOESTRIN have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years ...

7. Adverse Reactions

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis Arterial thromboembolism Pulmonary embolism ...

9. Overdosage

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. ...

10. Dosage and Administration

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days ...

11. How Supplied

LOESTRIN 1/20 (21 Tablets) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets USP) are packaged in cartons of five blister cards. Each card contains 21 light yellow, round, flat-faced, ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

14. References

Back DJ, Breckenridge AM, Crawford FE, Mclver M, Orme MLE, Rowe PH and Smith E: Kinetics of norethindrone in women II. Single-dose kinetics. Clin Pharmacol Ther 1978;24:448-453. Humpel M, Nieuwober B, ...