AA PHARMA BROMOCRIPTINE TABLET 2.5 mg

PHARMAFORTE SINGAPORE PTE LTD

PHARMAFORTE SINGAPORE PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**DOSAGE AND DIRECTIONS FOR USE:** AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) should always be taken with food. In order to establish tolerance, the first dose of 1.25–2.5mg (½ – 1 tablet), depending on the indication should be given at bedtime with food. Please consult the detailed dosage recommendations for each indication. Galactorrhea with or without amenorrhea due to hyperprolactinemia: 1.25–2.5mg (½ – 1 tablet) at bedtime to establish tolerance; gradually increase after 2–3 days to 2.5mg (1 tablet) twice daily with meals. If required the dose may be increased to 2.5mg (1 tablet) t.i.d. Continue treatment until milk secretion has ceased completely or, in the case of menstrual dysfunction, until the menstrual cycle has returned to normal. Prolactin-dependent menstrual disorders and infertility: 1.25–2.5mg (½ – 1 tablet) at bedtime to establish tolerance. Gradually increase after 2–3 days to one tablet twice daily with meals. If required the dose may be increased to 2.5mg (1 tablet) t.i.d. Prolactin secreting adenomas: 1.25mg (½ a tablet) 2 or 3 times daily, increasing gradually (average maintenance dose: 5–7.5 mg (2 to 3 tablets) daily). If necessary to keep plasma protein adequately suppressed, dosage may be increased gradually over a period of several weeks to 10–20mg (4 to 8 tablets) daily with meals. Prolactin dependent male hypogonadism: 1.25–2.5mg (½ – 1 tablet) at bedtime to establish tolerance. Gradually increase after 2–3 days to one tablet twice daily with meals or more, as required to 2.5mg (1 tablet) three times per day with meals. Acromegaly: A starting dose of 1.25–2.5mg (½ – 1 tablet) at bedtime to establish tolerance is recommended, increasing gradually over a period of 2 to 4 weeks to 10–20mg (4 to 8 tablets) daily with meals, depending on clinical response. Daily requirements of 20mg should be taken in four equally divided doses. The maximum recommended daily dose is 20mg (eight 2.5mg tablets). In the event of serious or persistent adverse effects, the dosage should be reduced to 1.25mg (½ tablet) and increased again gradually to the recommended dose. If reactions such as nausea, vomiting, vertigo or headaches continue to be severe, AA PHARMA BROMOCRIPTINE should be discontinued. Parkinson’s Disease: Although bromocriptine has been clinically useful in decreasing the severity and frequency of “on-off” fluctuations of late levodopa therapy, the decision to use bromocriptine as adjunctive treatment and the selection of dosage must be individualized in each case. A low dose is recommended. The initial dose of AA PHARMA BROMOCRIPTINE is one half of a 2.5mg tablet (1.25mg) at bedtime, with food, to establish tolerance. Thereafter, the recommended dosage is 2.5mg daily in two divided doses, with meals, (half a 2.5mg tablet twice daily). The dosage may be increased very gradually, if necessary, by adding an additional 2.5mg per day, once every 2 to 4 weeks, to be taken always in divided doses with meals. Increments should usually never exceed 2.5mg. Clinical assessments are recommended at two-week intervals or less during titration, to ensure that the lowest effective dosage is not exceeded. The usual dosage range is from a few milligrams to 40mg daily in two or three divided doses with meals. The median dose varies with the experience of individual investigators, but can be around 10mg daily or higher. During initial titration, it is recommended that the dosage of levodopa should be maintained, if possible. Subsequently, it might be desirable to combine a slow increase of bromocriptine with a concomitant, limited and gradual reduction of levodopa.