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|Estradiol/Drospirenone |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Estradiol/DrospirenonePronouncation: (ES-tra-dye-ole/droh-SYPE-re-none)Class: Estrogen and progestin combined Trade Names: Indications and UsageTreatment of moderate to severe vasomotor symptoms associated with menopause; treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. ContraindicationsKnown or suspected pregnancy; undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent (eg, within past year) arterial thromboembolic disease (eg, MI, stroke); renal insufficiency; liver dysfunction or disease; adrenal insufficiency; hypersensitivity to any component of the product. Dosage and AdministrationAdultsPO 1 tablet daily. Storage/StabilityStore at 59° to 86°F. Drug InteractionsCorticosteroidsMay result in an increase in the pharmacologic and toxicologic effects of corticosteroids. Drugs affecting electrolytes (eg, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, NSAIDs)Potential increase in serum potassium. Hydantoins (eg, phenytoin)Possible loss of seizure control. Inducers of CYP3A4 (eg, carbamazepine, modafinil, NNRT inhibitors [eg, nevirapine], phenobarbital, phenytoin, rifampin, St. John"s wort)Estrogen plasma concentrations may be reduced, decreasing the therapeutic effects and changing the uterine bleeding profile. Inhibitors of CYP3A4 (eg, clarithromycin, erythromycin, grapefruit juice, itraconazole, ketoconazole, ritonavir)Estrogen plasma concentrations may be elevated, increasing the risk of adverse reactions. Thyroid hormonesSerum-free thyroxine concentration may be decreased, increasing the need for thyroid hormone. TopiramateMay reduce estrogen concentration, decreasing the efficacy. Laboratory Test InteractionsDecreasedDecreased antithrombin III activity; decreased levels of anti-factor Xa and antithrombin III; decreased free hormone concentrations; impaired glucose tolerance; reduced LDL; reduced response to metyrapone test; T 3 resin uptake is decreased. IncreasedIncreased activated partial thromboplastin time, platelet aggregation time, and PT; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulation activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta thromboglobulin; increased levels of fibrinogen activity; increased plasminogen antigen and activity; increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone; increased corticosteroid binding globulin; increased sex hormone binding globulin; increased angiotensinogen/rennin substrate, alpha-1-antitrypsin, ceruloplasmin; increased TBG and levels of various other lipids and lipoproteins may be affected. Adverse ReactionsCardiovascularDeep and superficial venous thrombosis; increased BP; MI; pulmonary embolism; stroke; thrombophlebitis. CNSHeadache (10%); changes in libido; chorea; dementia; dizziness; exacerbation of epilepsy; irritability; mental depression; migraine; mood disturbances; nervousness. DermatologicChloasma or melasma; erythema multiforme; erythema nodosum; hemorrhagic eruption; hirsutism; loss of scalp hair; pruritus; rash. EENTIntolerance to contact lenses; retinal vascular thrombosis. GIAbdominal pain (11%); enlarged abdomen (7%); abdominal cramps; bloating; gallbladder disease; nausea; pancreatitis; vomiting. GenitourinaryBreast pain (19%); vaginal hemorrhage (9%); endometrial disorder (2%); leukorrhea (1%); abnormal withdrawal bleeding or flow; breakthrough bleeding; breast cancer; breast enlargement, pain, and tenderness; changes in amount of cervical secretion, cervical ectropion, or vaginal bleeding pattern; dysmenorrhea; endometrial cancer; endometrial hyperplasia; fibrocystic breast changes; galactorrhea; increased size of uterine leiomyomata; nipple discharge; ovarian cancer; spotting; vaginitis, including vaginal candidiasis. HepaticCholestatic jaundice; enlargement of hepatic hemangiomas. MetabolicPeripheral edema (2%). Metabolic-NutritionalHypocalcemia; increased triglycerides; increased weight; reduced carbohydrate tolerance. MusculoskeletalBack pain (7%); arthralgia; leg cramps. RespiratoryUpper respiratory tract infection (19%); sinusitis (5%). MiscellaneousPain in extremities (8%); decreased weight, flu syndrome (7%); accidental injury (6%); surgery (5%); aggravation of porphyria; anaphylactic/anaphylactoid reactions, including angioedema and urticaria; edema; exacerbation of asthma. Precautions
PregnancyCategory X. LactationSecreted in breast milk. ChildrenNot indicated for use in children. Hepatic FunctionDrospirenone Cl may be decreased, and estrogens may be poorly metabolized. Use with caution in patients with history of cholestatic jaundice associated with estrogen use or pregnancy. Special Risk PatientsUse with caution in patients with asthma, diabetes mellitus, epilepsy, hepatic hemangiomas, migraine, porphyria, and systemic lupus erythematosus. Elevated BPSustained increases in BP have been attributed to idiosyncratic reactions to estrogens. Endometrial cancerUse of unopposed estrogens in women with intact uteri has been associated with increased risk of endometrial cancer, which is related to the dose and duration of estrogen therapy. EndometriosisMay be exacerbated. Fluid retentionCarefully monitor patients with conditions that might be influenced by fluid retention (eg, cardiac or renal dysfunction) because estrogen and estrogen/progestin therapy may cause fluid retention. Gallbladder diseaseThe risk of gallbladder disease requiring surgery is increased 2- to 4-fold. HypercalcemiaEstrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. HyperkalemiaDo not use in patients with conditions that predispose them to hyperkalemia (eg, adrenal insufficiency, hepatic or renal function impairment). HypertriglyceridemiaIn patients with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations in plasma triglycerides, leading to pancreatitis and other complications. HypocalcemiaUse with caution in patients with severe hypocalcemia. HyponatremiaRisk may be increased by drospirenone. Ovarian cancerThe risk may be increased. Visual abnormalitiesRetinal vascular thrombosis may occur, leading to diplopia, loss of vision, migraine, or sudden onset of proptosis. OverdosageSymptomsAltered potassium and sodium plasma concentrations, nausea, withdrawal bleeding in women. Patient Information
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