Camila (Norethindrone) - Indications and Dosage

INDICATIONS AND USAGE:

1. Indications:

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

2. Efficacy:

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. The following table lists the pregnancy rates for users of all major methods of contraception.

Table 1 Comparison of reversible contraceptive methods: Percent of women experiencing a contraceptive failure (pregnancy) during the first year of use.

Adapted with permission. 1
	Percent of women experiencing a pregnancy within the first year of use
Method	Average Use	Perfect Use
No contraception	85	85
Spermicides	21	6
Periodic abstinence	20	1-9 2
Withdrawal	19	4
Cervical caps Given birth Never given birth	36 18	26 9
Diaphragms	18	6
Condoms Female Male	21 12	5 3
Pills Progestin-only Combined	3	0.5 0.1
IUDs Progesterone Copper T 380A	2 0.8	1.5 0.6
Injectables	0.3	0.3
Implant	0.09	0.09

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 PATIENT LABELING for detailed instructions.

HOW SUPPLIED:

Camila™ (norethindrone tablets, USP 0.35 mg) are packaged in cartons of six blister cards each containing 28 tablets. Each light pink, round, flat-faced, unscored tablet is debossed with stylized b on one side and 715 on the other side. (NDC 0555-0715-58)

Store at controlled room temperature 15°-30°C (59°-86°F) [See USP].