Gemmily (Page 4 of 7)

7.2 Effects of Combined Oral Contraceptives on Other Drugs

COCs containing ethinyl estradiol may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.

7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Gemmily with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [s ee Warnings and Precautions (5.3)].

7.4 Interference with Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no use for contraception in pregnancy; therefore, Gemmily should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

8.2 Lactation

Risk Summary

Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see Dosage and Administration (2.2)]. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Gemmily and any potential adverse effects on the breast-fed child from Gemmily or from the underlying maternal condition.

8.3 Nursing Mothers

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

8.4 Pediatric Use

Safety and efficacy of Gemmily have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

8.5 Geriatric Use

Gemmily has not been studied in postmenopausal women and is not indicated in this population.

8.6 Renal Impairment

The pharmacokinetics of Gemmily has not been studied in subjects with renal impairment [see Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

The pharmacokinetics of Gemmily has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [ s ee Contraindications (4) and Warnings and Precautions (5.2)] .

8.8 Body Mass Index

The safety and efficacy of Gemmily in women with a body mass index (BMI) > 35 kg/m2 has not been evaluated [ s ee Clinical Studies (14)] .

10 OVERDOSAGE

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

11 DESCRIPTION

Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Gemmily provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below:

  • 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
  • 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate

Each pink active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol glycerin, FD&C Red #40, purified water, and titanium dioxide.

Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, lecithin, beeswax, gelatin, sorbitol, glycerin, FD&C Blue #1, FD&C Red #40, purified water, and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose.

The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is C20 H24 O2 and the structural formula is:

The following structural formula for The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-]. The empirical formula of ethinyl estradiol is C20H24O2.

The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate is C22 H28 O3 and the structural formula is:

The following structural formula for The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17a)-]. The empirical formula of norethindrone acetate is C22H28O3. The following structural formula for The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-]. The empirical formula of ethinyl estradiol is C20H24O2.The following structural formula for The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17a)-]. The empirical formula of norethindrone acetate is C22H28O3.

12 CLINICAL PHARMACOLOGY

Figure 2. Mean Plasma Norethindrone Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Norethindrone Acetate/Ethinyl Estradiol Tablets to Healthy Female Volunteers under Fasting Condition (n = 17)Figure 3. Mean Plasma Ethinyl Estradiol Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Norethindrone Acetate/Ethinyl Estradiol Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)

12.1 Mechanism of Action

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

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