Parlodel

Conservative treatment of prolactin-secreting pituitary micro- or macro-adenomas prior to or after surgery in adults & ped 7-17 yr. Adjunct, or in special cases alternative, to surgery or RT in acromegaly in adults & ped 7-17 yr. Monotherapy or in combination w/ other antiparkinsonian drugs in all stages of idiopathic & postencephalitic Parkinson's disease in adults. Prolactin-related hypogonadism (oligospermia, loss of libido, impotence) in adult men. Prolactin-dependent hyperprolactinemic or apparently normoprolactinemic conditions [eg, amenorrhea (w/ or w/o galactorrhea), oligomenorrhea, luteal phase deficiency, drug-induced hyperprolactinemic disorders (eg, induced by certain psychotropic or antihypertensive agents)] in adults. Prolactin-independent female infertility [eg, polycystic ovary syndrome, anovulatory cycles (supplementary to anti-estrogens eg, clomiphene)] in adults. Prevention or suppression of puerperal lactation in adults. Prevention of lactation after abortion in adults. Incipient puerperal mastitis in adults.

Adult Parkinson's disease Initially 1.25 mg daily, given preferably in the evening for the 1st wk. Daily dose should be gradually increased by 1.25 mg daily each wk & given as 2-3 divided doses, & may be further increased by 2.5 mg daily each wk if no adequate response is reached w/in 6-8 wk. Usual therapeutic range for monotherapy or combined therapy: 10-40 mg daily. Prolactinoma 1.25 mg bid or tid, gradually increased to several tab daily as required. Acromegaly Initially 1.25 mg bid or tid, gradually increased to 10-20 mg daily. Hyperprolactinemia in men 1.25 mg bid-tid, gradually increased to 5-10 mg daily. Menstrual cycle disorder, female infertility 1.25 mg bid or tid, gradually increased to 2.5 mg bid or tid if response is inadequate. Continue treatment until menstrual cycle has returned to normal &/or ovulation is restored. Inhibition of lactation for medical reason 1.25 mg in the morning & evening on 1st day, followed by 2.5 mg bid for 14 days. Incipient puerperal mastitis Same dose as for inhibition of lactation but w/ added antibiotic to the regimen as required. Ped 7-17 yr Prolactinoma 1.25 mg bid or tid, gradually increased to several tab daily as required. Max daily dose: 5 mg in 7-12 yr & 20 mg in 13-17 yr. Acromegaly Initially 1.25 mg bid or tid, gradually increased to several tab daily. Max daily dose: 10 mg in 7-12 yr & 20 mg in 13-17 yr.

Should be taken with food.

Hypersensitivity to bromocriptine or other ergot alkaloids. Uncontrolled HTN, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced HTN), postpartum & puerperal HTN. CAD & other severe CV conditions. Symptoms &/or history of serious psychic disorders.

W/draw use if GI bleeding & gastric ulcer occurs; retroperitoneal fibrotic changes are diagnosed or suspected; HTN, severe, progressive, or unremitting headache (w/ or w/o visual disturbances), or evidence of CNS toxicity develop. Not recommended for routine prevention or suppression of puerperal breast engorgement & for treatment of premenstrual symptoms & benign breast disease. Reports of pleural & pericardial effusions, pleural & pulmonary fibrosis, constrictive pericarditis, & retroperitoneal fibrosis on long-term & high-dose treatment; CSF rhinorrhea in some patients w/ prolactin-secreting adenomas. Closely monitor patients w/ history or evidence of peptic ulceration during treatment. Regularly monitor for development of impulse control disorders. Periodic monitoring of BP is advisable in postpartum women treated for inhibition of lactation, as well as in patients treated for any other condition. Monitor visual fields in patients w/ macroprolactinoma. Perform complete evaluation of pituitary functions & institute appropriate substitution therapy prior to administration. Carefully monitor for evolution of tumour size in patients w/ pituitary macro-adenomas & consider surgery if evidence of tumour expansion develops. Examine patients w/ unexplained pleuropulmonary disorders & consider discontinuation. Not recommended in concomitant use w/ drugs that can alter BP [eg, vasoconstrictors (eg, sympathomimetics) or ergot alkaloids (including ergometrine or methylergometrine)] in puerperium. No studies in patients w/ renal & hepatic impairment. Hypotensive reactions may occur. Has been associated w/ somnolence & episodes of sudden sleep onset, particularly in patients w/ Parkinson's disease. Do not drive a vehicle or operate machines. Give lowest effective dose in women w/ conditions not associated w/ hyperprolactinemia. Women of childbearing age who do not wish to conceive should practice reliable contraception. Discontinue use in patients wishing to conceive when pregnancy is confirmed. Carefully observe adenoma patients if pregnancy occurs after administration. Do not administer to breastfeeding mothers. Dose titration in childn should be done w/ caution. Dose selection in elderly should be cautious.

Headache, somnolence, dizziness; nasal congestion; nausea, constipation, vomiting.

Co-administration w/ strong inhibitors &/or substrates of CYP3A4 eg, azole antimycotics, HIV PIs. Increased plasma levels w/ macrolide antibiotics eg, erythromycin or josamycin; octreotide (in acromegalic patients). May lead to HTN & severe headache w/ sympathomimetics eg, phenylpropanolamine. Additive pharmacological effects w/ sumatriptan which may potentiate risk of vasospastic reactions. May increase dopamine stimulant activity & lead to dopaminergic side effects (eg, headache, nausea, vomiting) w/ ergot alkaloids. Activity may be reduced w/ dopamine antagonists eg, antipsychotics (eg, phenothiazines, butyrophenones & thioxanthenes), metoclopramide & domperidone. Tolerability to Parlodel may be reduced by alcohol.

Antiparkinsonian Drugs / Trophic Hormones & Related Synthetic Drugs

G02CB01 - bromocriptine ; Belongs to the class of prolactine inhibitors. Used to suppress lactation.

Rx