Concise Prescribing Info
Infertility & pregnancy Provides luteal support in luteal phase defects in threatened/recurrent abortion, prevent preterm delivery. Luteal phase insufficiency Progesterone challenge test in secondary amenorrhea, dysfunctional uterine bleeding (DUB), menstrual irregularities due to dysovulation or anovulation, premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause. Postmenopausal women Prevents endometrial hyperplasia in postmenopausal women w/ intact uterus who are receiving estrogen as hormone replacement therapy.
Dosage/Direction for Use
Threatened/recurrent abortion w/ luteal phase defect 200-600 mg daily. Preterm delivery 400 mg every 6-8 hr depending on acute phase, then supporting dose of 600 mg/day divided into 3 doses until 36th wk of pregnancy. Progesterone challenge test in secondary amenorrhea 400 mg daily at bedtime for 10 days. Dysfunctional uterine bleeding, menstrual irregularities due to dysovulation or anovulation 200 mg once daily from 17th day of cycle for 10 days. Premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause 200 or 400 mg/day for 10 days (usually beginning from the 14th-17th day to complete 10 days). Prevention of endometrial hyperplasia in postmenopausal women w/ intact uterus who are receiving estrogen as hormone replacement therapy 200 mg at bedtime for 12 days sequentially per 28 day cycle. 
Should be taken on an empty stomach: Take at bedtime. In women who experience difficulty swallowing the cap, take w/ a glass of water while in standing position.
Hypersensitivity. Allergy to peanuts; active liver disease especially the obstructive type; history of known or suspected estrogen-dependent or progestin-dependent malignant neoplasia (eg, breast cancer or endometrial cancer); undiagnosed abnormal genital bleeding; active or history of arterial thromboembolic disease (eg, stroke, MI, CHD); classical migraine; cerebral hemorrhage; active or history of confirmed venous thromboembolism (eg, DVT or pulmonary embolism) or active thrombophlebitis; partial or complete loss of vision due to ophth vascular disease; missed or incomplete abortion; porphyria. Not intended for pregnancy test.
Special Precautions
Not to be used for the prevention of CV disease or dementia. Discontinue if stroke occur or be expected. Possible increased risk of CV morbidity in the 1st year of use. Monitor BP in women using HRT. Risk of developing VTE (ie, DVT or pulmonary embolism): Personal history or family history, severe obesity (BMI >30 kg/m2), age & smoking. Increased risk on prolonged immobilization, major trauma or major surgery. Discontinue in case VTE is suspected or develops after initiation of therapy. Patients w/ conditions that might be aggravated by fluid retention eg, HTN, cardiac disease, renal disease, epilepsy, migraine, asthma; history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity & breastfeeding mothers. Closely observe diabetic patients or w/ predisposition to diabetes. Patients w/ metabolic & malignant bone diseases associated w/ hypercalcemia & patients w/ renal insufficiency. Familial hyperlipidemias or porphyria. Women w/ existing or history of breast cancer; known risk factors of breast cancer eg, strong family history of breast cancer (1st degree relative), present a breast condition w/ an increased risk (abnormal mammograms &/or atypical hyperplasia at breast biopsy). May cause breakthrough bleeding & spotting bleeding during the 1st mth of treatment. Increased risk of ovarian cancer in long-term use (at least ≥5 yr) of estrogen + progestin & estrogen-only HRT. Discontinue if patient experiences visual disturbances, classical migraine, transient aphasia, paralysis, or loss of consciousness during therapy. Increased risk of probable dementia in women after 65 yr w/ combined conjugated estrogen & medroxyprogesterone acetate. Preexisting mental depression; discontinue if depression recurs to a serious degree during therapy. Withhold if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilledema, retinal vascular lesions, or migraine occurs. May affect ability to drive & use machinery. Hepatic & renal impairment. Pregnancy & lactation. Childn. Elderly >65 yr.
Adverse Reactions
Upper resp infection, viral infection; breast carcinoma; jaundice; anaphylaxis, angioedema, asthma, erythema multiforme, erythema nodosum, facial edema, hypersensitivity, urticaria; hirsutism, masculinization of female fetus, ovarian hyperstimulation syndrome; changes in appetite, changes in body wt, edema, fluid & Na retention; aggression, anxiety, confusion, depersonalization, disorientation, drowsiness, dysarthria/slurred speech, emotional lability, impaired conc, insomnia, mental depression, mood change, nervousness, somnolence, stupor, suicidal ideation, throat tightness; aggravation of migraine episodes, convulsion, depressed level of consciousness, difficulty walking/gait disturbance, dizziness. headache, loss of consciousness, neuritis, paresthesia, sedation, vertigo; blurred vision, contact lens intolerance, diplopia, neuro-ocular lesions (eg, retinal thrombosis, optic neuritis), steepening of the corneal curvature, visual disturbances; tinnitus; chest pain, coronary thrombosis, dyspnea, palpitation, tachycardia; circulatory collapse, hot flush, HTN, hypotension, syncope (w/ or w/o hypotension), thromboembolic disorders, thrombophlebitis, TIA, VTE; choking, cough, nasopharyngitis; abdominal discomfort, acute pancreatitis, constipation, diarrhea, dysphagia, GI disturbance, nausea, swollen tongue, vomiting; asymptomatic impaired liver function, cholestasis, cholestatic hepatitis, cholestatic jaundice, gallbladder disorder, hepatic failure, hepatic necrosis, hepatitis; acne, chloasma, eczema, hair loss, hemorrhagic eruption, pruritus, rash; arthralgia, back pain, muscle cramp, musculoskeletal pain; cystitis, dysuria, urinary problems, UTI; spontaneous abortion; altered menstrual cycle/irregular menstrual bleeding, breast discomfort, breast pain, breast tenderness, change in libido, changes in cervical erosion & amount of cervical secretion, dysmenorrhea, dyspareunia, endometrial carcinoma, endometrial hyperplasia, gynecomastia, heavier menses, hypospadia, menstrual disorder, metrorrhagia, ovarian cyst, perineal pain, premenstrual like syndrome, reactivation of endometriosis, shortening of the menstrual cycle or breakthrough bleeding, spotting, uterine hemorrhage, vag discharge, vag dryness, vag itching, vag mycosis; cleft lip, cleft palate, congenital heart disease; fatigue, feeling abnormal, feeling drunk, fetal death, fever, irritability, lethargy, malaise, night sweats, pain, peripheral swelling; altered coagulation tests & lipid profile, breast excisional biopsy, decreased glucose tolerance & wt, increased blood glucose level, BP, liver function tests & wt.
Drug Interactions
Enhanced metabolism & reduced activity w/ drugs inducing liver enzymes eg, carbamazepine, griseofulvin, barbiturates, hydantoins, meprobamates, phenylbutazone or rifampicin; ketoconazole. Decreased glucose tolerance & therefore dose adjustment in antidiabetics is required. Decreased action w/ bromocriptine. Increased plasma ciclosporin conc. Increased total estrone & equilin conc & decreased 17β estradiol conc. Reduced effect w/ St. John's wort. Increased sulfobromophthalein retention & other hepatic function tests, coagulation tests (increase in prothrombin factors VII, VIII, IX & X), pregnanediol determination, thyroid function (increases in PBI & butanol extractable protein bound iodine & decreases in T3 uptake values).
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Heragest soft-gel cap 200 mg
100's (P53.5/soft-gelatin cap, P5,350/box)
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