Norethindrone Information
Norethindrone () Description
Each tablet contains 0.35 mg Norethindrone () USP. Inactive ingredients include colloidal silicon dioxide, corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, methylene chloride, isopropyl alcohol and talc.
Norethindrone () Indications And Usage
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
Norethindrone () Contraindications
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
Norethindrone () Warnings
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
Norethindrone () tablets do not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
Norethindrone () Precautions
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL, LDL, or VLDL.
Norethindrone () Adverse Reactions
Adverse reactions reported with the use of POPs include:
Norethindrone () Overdosage
There have been no reports of serious ill effects from overdosage, including ingestion by children.
Norethindrone () Dosage And Administration
To achieve maximum contraceptive effectiveness, Norethindrone () tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
Norethindrone () How Supplied
Norethindrone () tablets USP, 0.35 mg are available in 28-tablet dispensers as light yellow round, flat faced beveled edged, uncoated tablets with ‘305’ debossed on one side and ‘G’ on the other side.
Carton of 3 Dispensers each containing 28 tablets (NDC 68462-305-29).
Norethindrone ()
Norethindrone () References
McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.
Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3.
Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast feeding patterns. Am J Obstet Gynecol.; 186(6): 1250-1258.
Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51 (2004): 539-579.
Cooke ID, Back DJ, Shroff NE: Norethindrone () concentration in breast milk and infant and maternal plasma during ethynodiol diacetate administration. Contraception 1985; 31:611-21.
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August 2010
Norethindrone ()
