JENCYCLA Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Lupin Pharmaceuticals, Inc.

Λέξεις κλειδιά

68180-877

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BOXED WARNING SECTION

<b>Patients should be couns eled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.</b>

1. Description

<b>Jencycla Tablets:</b> Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C yellow No. 10, FD&C blue No. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate. ...

2. Clinical Pharmacology

Mode of Action Jencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering ...

3. Indications and Usage

Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, ...

4. Contraindications

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal ...

5. Warnings

Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke. Jencycla does not contain estrogen and, therefore, this ...

6. Precautions

Physical Examination and Follow up It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination ...

6.1. General

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

6.2. Information for Patients

See DETAILED PATIENT LABELING for detailed information. Counseling issues The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives: The necessity ...

6.4. Drug Interactions

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No ...

6.5. Drug/Laboratory Test Interactions

The following endocrine tests may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin (SHBG) concentrations may be decreased. Thyroxine concentrations may be decreased, due ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

See WARNINGS.

6.7. Pregnancy

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted ...

6.9. Nursing Mothers

In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have ...

6.10. Pediatric Use

Safety and efficacy of Jencycla tablets 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 ...

7. Adverse Reactions

Adverse reactions reported with the use of POPs include: Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding ...

9. Overdosage

There have been no reports of serious ill effects from overdosage, including ingestion by children.

10. Dosage and Administration

To achieve maximum contraceptive effectiveness, Jencycla must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill ...

11. How Supplied

Jencycla Tablets containing 0.35 mg of norethindrone, green colored, round, flat face, beveled edge tablets, debossed with O23 on one side and LU on the other side. Jencycla Tablets are available in a ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

14. References

1. McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994. 2. Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction ...