CAMILA .35 mg/1
NORETHINDRONE · TABLET · Dr. Reddy's Labratories Inc.
CAMILA is a tablet containing norethindrone at .35 mg/1, taken oral. Manufactured by Dr. Reddy's Labratories Inc..
Key Facts
- Brand Name
- CAMILA
- Generic Name
- NORETHINDRONE
- NDC Code (Product)
75907-074- Manufacturer
- Dr. Reddy's Labratories Inc.
- Strength
- .35 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076177
- Drug Class
- Progestin [EPC]
- Marketing Start
- 05/06/2024
Recall History
Physicians Total Care, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Teva Pharmaceuticals USA, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Method (1) Typical Use Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. (2) Perfect Use Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregn…
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Camila 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.
Warnings
WARNINGS Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Camila does 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. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. Ectopic Pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users …
Contraindications
CONTRAINDICATIONS Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease
Drug Interactions
4. Drug Interactions Change in contraceptive effectiveness associated with coadministration of other products: a. Anti-infective Agents and Anticonvulsants Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin. b. Anti-HIV Protease Inhibitors Several of the anti-HIV protease inhibitors have been studied with coadministration of oral contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of OC products may be affected with the coadministration of anti-HIV protease inhibitors. Health care providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information. c. Herbal Products Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cyto…
Adverse Reactions
ADVERSE REACTIONS Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely. To report SUSPECTED ADVERSE EVENTS, contact Dr. Reddy’s Laboratories Inc, at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
Frequently Asked Questions
What is CAMILA used for?
CAMILA contains NORETHINDRONE. It is a tablet taken oral. Consult your doctor for specific uses.
Is CAMILA a controlled substance?
CAMILA is not classified as a controlled substance by the DEA.
What is the generic name for CAMILA?
The generic name for CAMILA is NORETHINDRONE. There are 12 other brand versions of NORETHINDRONE.
What is the NDC code for CAMILA .35 mg/1?
The NDC (National Drug Code) for CAMILA .35 mg/1 is 75907-074, listed by Dr. Reddy's Labratories Inc..
Other Norethindrone Brands
See all →- Microgestin 1/2075907-084
- Jinteli5 ug/10093-3122
- LO LOESTRIN FE50090-1456
- Norethindrone acetate5 mg/150742-267
- Emzahh.35 mg/159651-136
- Nylia 7/7/765862-897
- Aurovela Fe 1/2065862-940
- Hailey 1.5/30.03 mg/168462-504
- NORETHINDRONE.35 mg/10378-7292
- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0378-7303
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)