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Geslutin

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Indications:

Injection Amenorrhea and abnormal uterine bleeding caused by hormonal imbalance in the absence of organic pathology (eg, uterine cancer). Gel Progesterone supplementation or replacement as part of an assisted reproductive technology (ART) treatment for infertile women with progesterone deficiency. Capsules Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogen tablets. Capsules and Gel Use in secondary amenorrhea. Vaginal Insert Support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an ART treatment program for infertile women.

Contraindications:

Hypersensitivity to progestins or any other ingredients in these products; active or history of thrombophlebitis, thromboembolic disorders; active or recent history (within past year) of MI or stroke; peanut allergy (oral); cerebral hemorrhage (or history of); impaired liver function; breast or genital organ cancer; undiagnosed abnormal vaginal bleeding; missed abortion; etopic pregnancy; as a diagnostic test for pregnancy; pregnancy or suspected pregnancy (oral).

Adverse reactions:

Cardiovascular Angina pectoris, hypertension, palpitation, syncope (less than 5%); circulatory collapse, congenital heart disease, hypertension, hypotension, patent ductus arteriosus, syncope with or without hypotension, tachycardia, ventricular septal defect (postmarketing). CNS Somnolence (27%); dizziness (24%); headache (17%); nervousness (16%); depression (11%); decreased libido (10%); fatigue (9%); irritability (8%); emotional lability (6%); aggressive reactions, anxiety, asthenia, confusion, forgetfulness, hypertonia, impaired concentration, insomnia, migraine, personality disorder, speech disorder, tremor (less than 5%); abnormal gait, aggression, depersonalization, depressed consciousness, difficulty walking, disorientation, dysarthria, feeling abnormal, feeling drunk, loss of consciousness, paresthesia, sedation, seizures, stupor, suicidal ideation, transient ischemic attack (postmarketing). Dermatologic Acne, increased sweating, pruritus, rash, seborrhea, skin discoloration, skin disorder, urticaria, verruca, wound debridement (less than 5%); alopecia, hirsutism (postmarketing). EENT Abnormal vision, conjunctivitis, earache, nasal congestion, pharyngitis, rhinitis (less than 5%); blurred vision, diplopia, throat tightness, tinnitus, vertigo, visual disturbance (postmarketing). GI Constipation (27%); nausea (22%); abdominal pain (20%); diarrhea (8%); vomiting (5%); dry mouth, dyspepsia, eructation, flatulence, gastritis, gastroenteritis, hemorrhagic rectum, hernia hiatus, toothache (less than 5%); abdominal distention (4%); acute pancreatitis, dysphagia, swollen tongue (postmarketing). Genitourinary Breast enlargement (40%); perineal pain (17%); breast pain (16%); nocturia (13%); ovarian hyperstimulation syndrome, vaginal discharge (7%); dyspareunia (6%); genital pruritus, moniliasis (5%); uterine spasm (4%); vaginal bleeding (3%); cystitis, dysmenorrhea, dysuria, fungal vaginitis, leucorrhea, micturition frequency, premenstrual tension, uterine fibroid, UTI, vaginal dryness, vaginitis (less than 5%); amenorrhea, breakthrough bleeding, breast tenderness, change in menstrual flow, changes in cervical erosion and secretions, endometrial carcinoma, galactorrhea, intrauterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion, spotting (postmarketing). Hepatic Cholestasis, cholestatic hepatitis, hepatic enzymes increased, hepatic failure, hepatic necrosis, hepatitis, increased LFTs, jaundice (postmarketing). Hematologic-Lymphatic Anemia, lymphadenopathy, purpura (less than 5%). Hypersensitivity Allergic reaction, allergy (less than 5%); anaphylactic reactions, hypersensitivity (postmarketing). Lab Tests Increased ALT, AST, blood glucose, and gamma-glutamyl transferase (postmarketing). Local Post-oocyte retrieval pain (28%). Metabolic-Nutritional Edema, peripheral edema, thirst (less than 5%); decreased and increased weight (postmarketing). Musculoskeletal Musculoskeletal pain (12%); arthralgia, back pain (8%); arthritis, leg cramps, leg pain, muscle disorder, myalgia, skeletal pain (less than 5%); muscle cramp (postmarketing). Respiratory Cough (8%); upper respiratory tract infection (5%); asthma, bronchitis, dyspnea, hyperventilation, pneumonitis, sinusitis (less than 5%); choking (postmarketing). Miscellaneous Cramps (15%); viral infection (12%); pain (8%); bloating (7%); abnormal crying, abscess, accidental injury, benign cyst, chest pain, decreased appetite, fever, herpes simplex, hot flashes, infection, influenza-like symptoms, water retention, xerophthalmia (less than 5%); cleft lip, cleft palate, face edema (postmarketing).

Interactions:

CYP3A4 inhibitors (eg, ketoconazole) May inhibit progesterone metabolism, increasing plasma levels and the risk of adverse reactions. Rifamycins (eg, rifampin) Progesterone levels may be reduced, decreasing efficacy. Laboratory Test Interactions Altered metyrapone test; increased sulfobromophthalein retention and other hepatic function tests; increase in prothrombin factors VII, VIII, IX, and X; altered pregnanediol determination; increase in protein-bound iodine and butanol-extractable protein-bound iodine; decrease in T3 uptake.

Warnings:

Warnings Capsules: Progestins and estrogens should not be used for prevention of CV disease. The Women’s Health Initiative study reported increased risks of MI, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 yr of treatment with oral conjugated estrogens combined with medroxyprogesterone. In addition, increased risk of developing probable dementia was reported in postmenopausal women 65 yr of age and older during 4 yr of treatment with oral conjugated estrogens plus medroxyprogesterone. Although other doses of oral conjugated estrogens with medroxyprogesterone and other combinations and dosage forms of estrogens and progestins were not studied, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Pregnancy Category B (capsules). Lactation Excreted in breast milk. Children Safety and efficacy not established. Elderly Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy. Benzyl alcohol Injection may contain benzyl alcohol. Birth defects There is an increased risk of minor birth defects with use during first 4 mo of pregnancy. Cancer May increase risk of breast and/or ovarian cancer. CV Discontinue treatment if signs of MI, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis are suspected. Syncope and hypotension may occur. Depression Carefully observe patients with history of depression. Fluid retention Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal function impairment, epilepsy). Glucose tolerance Because decreased glucose tolerance has been reported, use with caution and carefully observe patients who have a history of diabetes. Immobilization Discontinue during prolonged immobilization. Ophthalmic effects Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Peanut oil Capsule contains peanut oil; do not use in patients allergic to peanuts. Surgery Discontinue estrogens with progestins at least 4 to 6 wk before surgery of the type associated with increased risk of thromboembolism. Vaginal bleeding With irregular vaginal bleeding, including breakthrough bleeding, consider nonfunctional causes and undertake adequate diagnostic measures.

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Samir Moussa M.D. ENT Specialist

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