Pregina

Pregina

clomifene

Manufacturer:

BIOFEMME, Inc

Distributor:

United Lab
Concise Prescribing Info
Contents
Clomifene citrate
Indications/Uses
Induction of ovulation in patients w/ persistent ovulatory dysfunction who desire pregnancy.
Dosage/Direction for Use
1st course: 50 mg once daily for 5 days. Start clomifene therapy about the 5th day of the menstrual cycle. 2nd course (if ovulation does not occur): 100 mg once daily (two 50-mg tab given as a single dose) for 5 days. This course may be started as early as 30 days after the previous. Increasing the dose or duration of therapy beyond 100 mg/day for 5 days should never be undertaken.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or history of liver dysfunction. Hormone-dependent tumors or abnormal uterine bleeding of undetermined origin. Uncontrolled thyroid or adrenal dysfunction. Pituitary or ovarian tumors. Ovarian cysts & preexisting endometriosis. Pregnancy.
Special Precautions
Ovarian hyperstimulation syndrome. Patients w/ PCOS should be started on the lowest recommended dose & shortest treatment duration for the 1st course of therapy. Possibility of ovarian cyst formation during therapy. Examine patients who complain of pain in the pelvic or abdominal area to rule out ovarian cyst formation. Blurring &/or other visual symptoms eg, spots or flashes (scintillating scotomata), diplopia, phosphenes, or photophobia may occur. Incidence of anovulatory disorders & the tendency to develop endometrial carcinoma increases w/ age. Ovarian cancer. Patients w/ uterine fibroids; hepatic impairment; pre-existing mental depression or thrombophlebitis. Hypertriglyceridemia (w/ or w/o pancreatitis). Visual symptoms may make activities eg, driving or operating machinery more hazardous than usual under conditions of variable lighting. Multiple pregnancy. Ectopic pregnancy. Lactation. Not intended for childn. Not intended for elderly.
Adverse Reactions
Ovarian enlargement or cyst formation & vasomotor symptoms eg, hot flushes. Hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma, fibrocystic disease, breast carcinoma, endometrial carcinoma, astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess, luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma, hydatidiform mole, choriocarcinoma, melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma, neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia; leukocytosis; thyroid disorder; hypertriglyceridemia (w/ or w/o pancreatitis), increased appetite, wt gain/loss; anxiety, depression, disorientation, nervous tension, insomnia, mood disturbances (including altered mood, mood swings & irritability), nervousness, psychotic reactions including paranoid psychosis; cerebral thrombosis, CVA, convulsions, dizziness, headache, lightheadedness, migraine headache, neurological impairment, paresthesia, seizures, speech disturbance, stroke, syncope/fainting, vertigo; visual symptoms (blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes), abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm; temporary or prolonged loss of vision, possibly reversible; reduced visual acuity; tinnitus; arrhythmia, chest pain, edema, palpitation, pulmonary embolism, shortness of breath, tachycardia; HTN, phlebitis, thrombophlebitis; abdominal-pelvic discomfort (distention, bloating, pain, or soreness), acute abdomen, constipation, diarrhea, nausea, pancreatitis, vomiting; ascites, hepatitis, infectious hepatitis, jaundice; increased levels of transaminases; acne, allergic reaction, dermatitis/allergic dermatitis, alopecia, angioneurotic edema, ecchymosis, erythema, erythema multiforme, erythema nodosum, hair loss/dry hair, hypertrichosis, pruritus, rash, urticaria; arthralgia, back pain, myalgia, myopathy; increased urinary frequency/vol; ectopic pregnancy, heterotopic pregnancy, multiple pregnancies, tubal pregnancy; abnormal uterine bleeding (intermenstrual spotting, menorrhagia), breast discomfort, breast soreness, breast tenderness, cyclic ovarian pain (Mittelschmerz), endometriosis, exacerbation of pre-existing endometriosis, ovarian cysts, ovarian hemorrhage, ovarian hyperstimulation syndrome, uterine hemorrhage, vag dryness; reduced endometrial thickness; congenital heart lesions, Down's syndrome, neural tube defects, club foot, congenital gut lesions, hypospadias, microcephaly, harelip & cleft palate, congenital hip, hemangioma, undescended testes, polydactyly, conjoined twins w/ teratomatous malformation, patent ductus arteriosus, amaurosis (blindness), arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, persistent lingual frenulum, & multiple somatic defects; fatigue, fever, weakness.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Presentation/Packing
Form
Pregina tab 50 mg
Packing/Price
10's
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