8, Akanbi-Onitiri Crescent, Off Eric Moore Road, Surulere, Lagos. Lagos.
Tel: 234-1-5875179, 5874082, 5877689; 90405798
Teva Pharmaceutical Ind. Ltd, Basel Street, Petah Tikva, Israel.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-2008): Bromocriptine (as mesylate) 2.5 mg.
Pack Size: 30.
Prolactin-dependent menstrual cycle disorders such as amenorrhoea, female infertility, premenstrual symptoms, hyper-prolactinaemia in men, prolactinomas, acromegaly, inhibition of lactation such as after abortion, benign breast disease; Parkinson's disease.
Hypersensitivity to bromocriptine or other ergot alkaloids, toxaemia of pregnancy, hypertension postpartum and in the puerperium.
Pregnancy; history of psychic or severe cardiovascular disorders, patients on drugs that can alter B.P. should be monitored; acromegalic patients with history or evidence of peptic ulceration.
Advice to Patients:
Take with food or milk; drowsiness commonly occurs upon initiation of therapy; limit use of alcohol; avoid exposure to cold; incidence of side effects is high with nausea the most common; hypotension occurs commonly with initiation of therapy, usually upon rising after prolonged sitting or lying; discontinue immediately if pregnant; may restore fertility; women desiring not to become pregnant should use mechanical contraceptive means.
Alcohol, erythromycin, CNS depressants.
Orthostatic hypotension, nasal congestion, nausea, vomiting, somnolence; very rarely constipation, dyspepsia, psychomotor agitation, cold-induced vasospasm; at high doses, psychic disturbances, fatigue, bladder trouble.
Dosage & Administration
By mouth, Menstrual Cycle disorder and female infertility, 1.25 mg 2 - 3 times daily; increased to 2.5 mg 2 - 3 times daily, if necessary.
Premenstrual symptoms, 1 - 2.5 mg daily starting on the 14th day of the cycle; increased in steps of 1.25 mg daily up to 2.5 mg twice daily until menstruation sets in.
Hyperprolactinaemia in men, 1.25 mg 2 - 3 times daily; increased gradually to 5 - 10 mg per day.
Prolactinomas, 1.25 mg 2-3 times daily; increased gradually as required to keep plasma prolactin adequately suppressed (occasionally up to 30 mg daily).
Acromegaly, 1.25 mg 2-3times daily; increased gradually to 10-20 mg daily depending on response and side effects.
Inhibition of lactation, 1.25 mg with food in the morning and evening on the 1st day; followed by 2.5 mg twice daily for 14 days. To prevent the onset of lactation, treatment should be instituted within a few hours of parturition or abortion, but not before vital signs have stabilized.
Puerperal breast engorgement, 2.5 mg as a single dose; may be repeated after 6 - 12 hours.
Incipient puerperal mastitis, as for inhibition of lactation plus an antibiotic.
Benign breast disease, 1.25 mg 2 - 3 times daily; increased gradually to 5 - 7.5 mg per day.
Parkinsons disease, 1.25 mg daily, preferably in the evening, for the first week; increased gradually by 1.25 mg/day each week in 2 - 3 divided doses for 6 - 8 weeks. A further increase by 2.5 mg/day each week may be required to achieve adequate therapeutic response; usual range is 10-40 mg per day. To be taken with food.