Adult Dosing
Contraception
- 0.35 mg PO qd, taken at the same time every day, with no interruption between pill packs
Pediatric Dosing
Contraception (Post-menarche)
- 0.35 mg PO qd, taken at the same time every day, with no interruption between pill packs
Note:
- Not indicated before menarche
[Outline]
See Supplemental Patient Information
- Cigarette smoking increases the risk of serious cardiovascular disease. Women taking progestin-only pills (POPs) should be advised not to smoke
- Therapy should be stopped immediately in the event of any serious disease
- Physicians should remain alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on contraceptives
- Pregnancy should be excluded before starting therapy
- If follicular development occurs, atresia of the follicle may be delayed and the follicle may grow beyond the size attained in a normal cycle. Although they are often asymptomatic, they may be associated with mild abdominal pain in a few cases. Surgery may be required rarely if they twist or rupture
- Irregular menstrual bleeding patterns are common in women using progestin-only contraceptives; non-pharmacologic causes, such as infection, malignancy or other abnormal conditions, should be ruled out. Consider the possibility of pregnancy if prolonged amenorrhea occurs
- Epidemiological studies have shown an increased relative risk of developing breast cancer at a younger age and apparently related to the duration of use, predominantly in women using combined hormonal contraceptives. Some studies have even suggested an increased risk of cervical intraepithelial neoplasia associated with oral contraceptive use. However, there is insufficient data to determine if progestin-only pills increase the risk in both these cases
- Benign hepatic adenomas are associated with combined oral contraceptive use, which when ruptured may cause intra-abdominal hemorrhage and death. Studies have shown an increased risk of hepatocellular carcinoma associated with combined oral contraceptive use. Data is insufficient to determine if progestin-only contraceptives increase this risk
- Sexually active women using oral contraceptives should have history and physical examinations performed annually
- Pre-diabetic and diabetic women should be carefully monitored, as women on POPs may experience slight deterioration in glucose tolerance with accompanying hyperinsulinemia. Lipid metabolism may be affected causing decreased levels of HDL, HDL2, and apolipoprotein A-I and A-II and elevated hepatic lipase. Total cholesterol, HDL3, LDL or VLDL levels are usually not affected
- Certain endocrine tests may be affected, including sex hormone-binding globulin (SHBG) concentrations and thyroid binding globulin concentrations that may be decreased
- Effectiveness of POPs is reduced by hepatic enzyme-inducing drugs such as anticonvulsants including phenytoin, carbamazepine, barbiturates; and the antituberculosis drug such as the rifampin
- New onset or worsening of migraine or development of severe headache with focal neurological symptoms, which is recurrent or persistent, may require discontinuation of POPs and determination of the cause
Cautions: Use cautiously in
- Breastfeeding within 6 weeks postpartum
Supplemental Patient Information
- Counsel the patients that this product does not provide protection against HIV infection or any other sexually transmitted diseases
- Explain the progestin-only contraceptive users the importance of taking the pills at the same time every day, including throughout all bleeding episodes
- Advise the users to use a back up method such as condoms and spermicides for the next 48 hours whenever a POP is taken 3 or more hours late
- Instruct them to inform their physicians if prolonged episodes of bleeding, amenorrhea or severe abdominal pain occur during use
- Emphasize the need of using a barrier method in addition to POPs if a woman is at risk of contracting or transmitting STDs/HIV
Pregnancy Category:X
Breastfeeding: Norethindrone is considered the hormonal contraceptive of choice during lactation. The available evidence indicates that norethindrone does not adversely affect the composition of milk or its supply and the growth and development of the infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 06 May 2011). According to the manufacturer’s data, small amounts of progestins are excreted into the breast milk of nursing mothers. However, no adverse effects have been observed on breastfeeding performance or on the health, growth, or development of the infant, except for isolated instances of decreased milk production.
US Trade Name(s)
- Camila
- Errin
- Jencycla
- Jolivette
- Nor-QD
- Nora-BE
- Micronor
- Heather
US Availability
norethindrone (generic)
Camila, Errin, Heather, Jencycla, Jolivette
Nor-QD, Micronor, Nora-BE
Canadian Trade Name(s)
Canadian Availability
Micronor
UK Trade Name(s)
- Micronor
- Noriday
- Primolut N
- Utovlan
UK Availability
norethisterone (generic)
Primolut N, Utovlan
Micronor, Noriday
Australian Trade Name(s)
- Locilan 28 Day
- Micronor
- Noriday 28 Day
- Primolut N
Australian Availability
Locilan 28 Day, Micronor, Noriday 28 Day
Primolut N
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Jolivette 0.35 MG TABS [Disp Pack] (WATSON LABS)
28 mg = $35.99
84 mg = $103.97 - Nora-BE 0.35 MG TABS [Disp Pack] (WATSON LABS)
28 mg = $34.99
84 mg = $97.97 - Camila 0.35 MG TABS [Disp Pack] (TEVA PHARMACEUTICALS USA)
28 mg = $34.99
84 mg = $99.97 - Nor-QD 0.35 MG TABS [Disp Pack] (WATSON LABS)
28 mg = $71.99
84 mg = $199.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.