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| (nor-eth-IN-drone ASS-uh-TATE) |
| Aygestin |
| Tablets: 5 mg |
| Class: Progestin |
Actions Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation.
Indications Treatment of secondary amenorrhea; endometriosis; abnormal uterine bleeding caused by hormonal imbalance in the absence of organic pathology (eg, uterine cancer).
Contraindications Thrombophlebitis, thrombolic disorders, cerebral apoplexy, or a history of these conditions; markedly impaired liver function or liver disease; known or suspected carcinoma of the breast; undiagnosed vaginal bleeding; missed abortion; as a diagnostic test for pregnancy.
Secondary Amenorrhea, Abnormal Uterine Bleeding
ADULTS: PO 2.5 to 10 mg/day for 5 to 10 days during second half of the theoretical menstrual cycle.
Endometriosis
ADULTS: PO 5 mg/day initially for 2 wk, then increase in increments of 2.5 mg/day q 2 wk until 15 mg/day is achieved. Therapy may be continued at this level for 6 to 9 mo or until breakthrough bleeding demands temporary termination.
Rifampin: Elimination of norethindrone may be increased, decreasing the therapeutic effect.
Lab Test Interferences Pregnanediol determinations may be altered; thyroid and LFT results may be affected; increased amounts of coagulation factors; reduced response to metyrapone test.
CARDIOVASCULAR: Thrombophlebitis; cerebral thrombosis and embolism; hypertension; edema. CNS: Depression; changes in libido; changes in appetite; headache; nervousness; dizziness; fatigue. DERMATOLOGIC: Allergic rash; melasma; chloasma; hirsutism; alopecia; erythema multiforme; erythema nodosum; hemorrhagic eruption; itching. EENT: Neuro-ocular lesions (eg, retinal thrombosis, optic neuritis). GU: Breakthrough bleeding; spotting; amenorrhea; increased cervical erosion and secretion; cystitis. HEPATIC: Cholestatic jaundice. METABOLIC: Weight gain and loss. RESPIRATORY: Pulmonary embolism. OTHER: Premenstrual syndrome; backache.
Pregnancy: Category X. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Fluid retention: Use with careful observation when conditions that might be affected by fluid retention are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Mental depression: Carefully observe patients with history of depression. Ophthalmic effects: Discontinue therapy if there are any sudden changes in vision or onset of proptosis, diplopia, migraine, papilledema, or retinal vascular lesions.
| PATIENT CARE CONSIDERATIONS |
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