Drug Updates
New Drugs
New Indications
Patient Teaching
News Capsules
Drug Warnings
Herbal Spotlight
Quik Tools
Drug Info
Links
Drug Info Bookstore
Feedback
Registration
Disclaimer
|
|
 norethindrone, ethinyl estradiol, and ferrous fumarate |
| Femcon Fe |
Pharmaceutical
company:
Warner Chilcott
www.warnerchilcott.com |
Pharmacologic classification: progesterone, estrogen
Therapeutic classification: hormonal contraceptive
Pregnancy risk category: X
AVAILABLE FORMS
Tablets: 0.4 mg norethindrone with 35 mcg ethinyl estradiol (chewable), and 75 mg ferrous fumarate
INDICATIONS AND DOSAGES
Contraception--
Women: One white tablet P.O. daily beginning on the first day of menstrual cycle or the first Sunday after menstrual cycle begins for 21 consecutive days, followed by one brown tablet (ferrous fumarate) P.O. daily for 7 consecutive days. Tablets should be taken at the same time each day and may be swallowed whole or chewed. If chewed, follow with a full glass of liquid.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with thrombophlebitis, thromboembolic disorders; history of deep venous thrombosis or thromboembolic disorders; cerebrovascular disease or CAD (history or current); valvular heart disease with thrombogenic complications; uncontrolled hypertension; diabetes with vascular involvement; headaches with focal neurologic symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast or history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use; hepatic adenoma or carcinoma or active liver disease; known or suspected pregnancy; hypersensitivity to any component of the drug.
Use cautiously in patients with hyperlipidemias, history of depression, and conditions that could be aggravated by fluid retention.
INTERACTIONS
Drug-drug.
Acetaminophen: May decrease acetaminophen level and increase estradiol level.
Ampicillin, rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, tetracyclines: May decrease contraceptive effect and increase risk of pregnancy, breakthrough bleeding, or both. Tell patient to use an additional form of contraception while taking these medications.
Ascorbic acid, atorvastatin, itraconazole, ketoconazole: May increase estradiol level. Monitor patient for adverse effects.
Clofibric acid, morphine, salicylic acid: May increase clearance of these drugs. Monitor patient for effectiveness.
Cyclosporine, prednisolone, theophylline: May increase levels of these drugs. Monitor levels if appropriate and adjust dosage.
Protease inhibitors: May increase or decrease plasma levels of estrogen and progestin. Refer to specific protease inhibitor drug literature. May need to use a backup method of contraception.
Drug-herb.
St. John's wort: May reduce contraceptive effectiveness and increase the risk of breakthrough bleeding and pregnancy. Discourage use together.
ADVERSE REACTIONS
CNS: migraine headache, mood changes, depression, stroke, retinal thrombosis.
CV: thromboembolism, MI, hypertension, mesenteric thrombosis, edema.
EENT: ocular changes.
GI: abdominal pain, changes in appetite, cramping, bloating, nausea, vomiting, gallbladder disease, hepatic adenoma.
GU: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, temporary infertility after discontinuation of treatment, change in cervical ectropion and secretion, vaginitis.
Metabolic: weight changes.
Respiratory: pulmonary embolism.
Skin: chloasma, melasma, rash.
Other: breast changes, exacerbation of autoimmune disorders.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
|
