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Basic Drug Info
Drug Name:Aygestin
Manufacturer:DURAMED PHARMACEUTICALS, INC.
Other Info:DURAMED PHARMACEUTICALS, INC.Subsidiary of Barr Pharmaceuticals, Inc.Pomona, New York 10970 Revised JULY 2007BR-424



Clinical Trials:


Indications and Usage

AYGESTIN® is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

AYGESTIN®  is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
SECONDARY AMENORRHEA --

Endometriosis, site unspecified -- A condition in which functional endometrial tissue is present outside the UTERUS. It is often confined to the PELVIS involving the OVARY, the ligaments, cul-de-sac, and the uterovesical peritoneum.

Uterine hemorrhage -- Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.

Endocrine System Diseases -- impairment of health or a condition of abnormal functioning of the system of glands that release their secretions (hormones) directly into the circulatory system.

Pathology processes -- structural and functional changes which cause or are caused by disease.

Fibroid Tumor -- A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues.

Uterine Fibroids -- A benign smooth muscle neoplasm arising from the body of the uterus. It is characterized by the presence of spindle cells with cigar-shaped nuclei, interlacing fascicles, and a whorled pattern.

Uterine Cancer -- Primary or metastatic malignant neoplasm involving the uterine corpus and/or the cervix. --2003

Contraindications

Known or suspected pregnancy.

There is no indication for AYGESTIN® in pregnancy.

(See PRECAUTIONS.)Undiagnosed vaginal bleedingKnown, suspected or history of cancer of the breastActive deep vein thrombosis, pulmonary embolism or history of these conditionsActive or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)Impaired liver function or liver disease As a diagnostic test for pregnancy Hypersensitivity to any of the drug components
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Primary malignant neoplasm --

Deep Vein Thrombosis -- A blood clot (thrombus) in a deep vein in the thigh or leg.

Deep vein thrombosis of lower limb --

Pulmonary Embolism -- Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Arteriopathic disease -- An impairment of the structure or function of the blood vessels which carry blood away from the heart.

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Liver diseases -- Pathological processes of the LIVER.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings
Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.