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Use and Dosing

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Contraception

Note:

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Contraception (Postpubertal adolescents)

Note:


[Outline]

Indications

Contraindications

Black Box Warnings

Dosing Adjustment

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions

See Supplemental Patient Information

Cautions: Use cautiously in

Supplemental Patient Information

Pregnancy/Breast Feeding

Pregnancy Category:X

Breastfeeding: Combination oral contraceptives probably do not affect the composition of milk substantially in healthy, well-nourished mothers and do not adversely affect long-term infant growth and development, but can transiently affect growth negatively during the first month after introduction. Rarely, reversible breast enlargement has been reported with higher doses of estrogen. Ethinyl estradiol in doses of 30 mcg daily or greater can suppress lactation leading to earlier discontinuation of breastfeeding than nonhormonal or progestin-only contraception. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum. As per US expert opinion, the risks of combination contraceptive products usually outweigh the benefits before 4 weeks postpartum. Between 4 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks. After 6 months postpartum, combination contraceptives can be used, but progestin-only methods are preferred if breastfeeding will be continued. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 April 2011).Small amounts of oral contraceptive steroids are excreted in breastmilk of nursing mothers and a few adverse effects on the child have occurred, including jaundice and breast enlargement. Combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Manufacturer advises the nursing mother to avoid using combination oral contraceptives and to use other forms of contraception until she has completely weaned her child.

Adverse Reactions

Clinical Pharmacology

Ethinyl estradiol

Levonorgestrel

Brands and Availability

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US Trade Name(s)

US Availability

Enpresse, Levonest, Myzilra, Trivora (ethinyl estradiol/levonorgestrel)

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Canadian Trade Name(s)

Canadian Availability

Triquilar 21 (ethinyl estradiol/levonorgestrel)

Triquilar 28 (ethinyl estradiol/levonorgestrel)

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UK Trade Name(s)

UK Availability

Logynon, TriRegol (ethinyl estradiol/levonorgestrel)

Logynon ED (ethinyl estradiol/levonorgestrel)

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Australian Trade Name(s)

Australian Availability

Logynon ED, Trifeme, Triphasil, Triquilar ED


[Outline]

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Classification

Obstetrics/Gynecology

Contraceptives
Estrogen And Progestin Combination

Pill

Drug Name: Triphasil 21 Day Pack

Ingredient(s): Ethinyl Estradiol mixture with Levonorgestrel

Imprint: 643; W

Color(s): Yellow

Shape: Round

Size (mm): 5.00

Score: 1

Inactive Ingredient(s): cellulose / iron oxides / lactose / magnesium stearate / polacrilin potassium / polyethylene glycol / titanium dioxide / hydroxypropyl methylcellulose

Drug Label Author:
Wyeth-Ayest Company

DEA Schedule:
Non-Scheduled


Drug Name: Trivora 28 Day Pack

Ingredient(s): Ethinyl Estradiol mixture with Inert Ingredients and Levonorgestrel

Imprint: Watson;P1

Color(s): Orange

Shape: Round

Size (mm): 6.00

Score: 1

Inactive Ingredient(s): anhydrous lactose / fd&c yellow no. 6 / lactose monohydrate / magnesium stearate / cellulose, microcrystalline

Drug Label Author:
Watson Pharma, Inc.

DEA Schedule:
Non-Scheduled