AA PHARMA BROMOCRIPTINE TABLET 2.5 MG

APOTEX INC (CANADA)🇸🇬 Health Sciences Authority

Approval Date: Nov 28, 1996
Approval ID: 340d754e61b7e624
Company: APOTEX INC (CANADA)
Type: Therapeutic

Approval Details

Approval Id: 340d754e61b7e624
Drug Name: AA PHARMA BROMOCRIPTINE TABLET 2.5 MG
Product Name: AA PHARMA BROMOCRIPTINE TABLET 2.5 MG
Approval Number: SIN09036P
Approval Date: 1996-11-28
Registrant: PHARMAFORTE SINGAPORE PTE LTD
Licence Holder: PHARMAFORTE SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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.
Route Of Administration: ORAL
Indication Info: INDICATIONS: Galactorrhea with or with amenorrhea due to hyperprolactinemia. Prolactin-dependent menstrual disorders and infertility: e.g. secondary amenorrhea, ovulatory insufficiency and short luteal phase. Prolactin-secretin adenomas: as a treatment for inoperable macroadenomas or prior to surgery in order to facilitate removal, and as an alternative to surgery in patients with microadenomas. Prolactin-dependent male hypogonadism. Acromegaly: the first line-treatment of this condition is by surgery or radiotherapy. AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) may be a useful adjunct to such treatment and can be used as monotherapy in special cases. Parkinson’s Disease: AA PHARMA BROMOCRIPTINE has been found to be clinically useful as an adjunct to levodopa (usually with a decarboxylate inhibitor) in the symptomatic management of selected patients with Parkinson’s Disease who experience prominent dyskinesia or wearing off reactions on long-term levodopa therapy. Patients on long-term treatment who are beginning to deteriorate on levodopa therapy may be controlled by reducing the dose of levodopa and adjusting the frequency and schedule of drug administration. Patients maintained on optimal dosages of levodopa who still experience prominent dyskinesia and/or end-of-dose failure may benefit from the concomitant use of bromocriptine, by decreasing the occurrence and/or severity of these manifestations. Since rapid escalation of bromocriptine doses causes severe adverse reactions, it is usually recommended to combine a slow increase of bromocriptine, with a concomitant, gradual and limited reduction of levodopa dosage. Continued efficacy of bromocriptine for more than two years has not been established and there is some evidence that its efficacy tends to wane. Evidence available indicates that there is no consistent benefit from bromocriptine in patients who have not responded previously to levodopa, and studies have shown significantly more adverse reactions in bromocriptine treated patients than in patients treated with levodopa. AA PHARMA BROMOCRIPTINE is not recommended in the treatment of newly diagnosed patients or as the sole medication in Parkinson’s Disease.
Contraindications: CONTRA-INDICATIONS: Uncontrolled hypertension of pregnancy, toxemia of pregnancy, sensitivity to ergot alkaloids. For procedure during pregnancy see “Use in Pregnancy” under PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: G02CB01
Atc Item Name: bromocriptine
Pharma Manufacturer Name: PHARMAFORTE SINGAPORE PTE LTD
Company Detail Path: /organization/pharmaforte-singapore-pte-ltd

Active Ingredients

BROMOCRIPTINE MESYLATE EQV BROMOCRIPTINE

2.5 mg

BROMOCRIPTINE MESYLATE EQV BROMOCRIPTINE

2.5 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 28, 1996

Approval ID

340d754e61b7e624

Type

Therapeutic

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