Schedule H

Oral

Formulation Strength

Tablet 1.25 mg

Tablet 2.5 mg

Tablet 5 mg (less commonly available)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hyperprolactinaemia (including Prolactinoma and Idiopathic)

Parameter Details

Starting dose 1.25 mg once daily at bedtime with food

Titration Increase by 1.25 mg every 3–7 days based on prolactin levels and tolerability

Usual maintenance dose 2.5–7.5 mg/day in 2–3 divided doses

Maximum dose 15 mg/day

Clinical notes:

• Monitor serum prolactin every 4–6 weeks during titration

• For macroprolactinomas, visual field assessment recommended

• Bedtime administration minimises postural hypotension and nausea

1. Acromegaly

Parameter Details

Starting dose 1.25–2.5 mg at bedtime

Titration Increase by 2.5 mg every 3–7 days based on GH/IGF-1 response and tolerability

Usual maintenance dose 10–20 mg/day in 2–4 divided doses

Maximum dose 30 mg/day

Clinical notes:

• Used when surgery/radiotherapy not feasible or inadequate

• Often adjunctive therapy; less effective than somatostatin analogues

• Monitor GH and IGF-1 levels for response assessment

1. Parkinson's Disease (Adjunct to Levodopa or Monotherapy)

Parameter Details

Starting dose 1.25 mg at bedtime

Titration Increase by 1.25 mg every 3–7 days as tolerated

Usual maintenance dose 10–40 mg/day in 3–4 divided doses

Maximum dose 100 mg/day (rarely required)

Clinical notes:

• Specialist (neurologist) initiation only

• May allow levodopa dose reduction when used as adjunct

• Higher psychosis risk in elderly patients

1. Type 2 Diabetes Mellitus (Adjunctive Therapy)

Parameter Details

Starting dose 0.8 mg once daily within 2 hours of waking, with food

Titration Increase by 0.8 mg weekly until glycaemic target achieved or maximum tolerated dose

Usual maintenance dose 1.6–4.8 mg/day

Maximum dose 4.8 mg/day

Clinical notes:

• Brand-specific quick-release formulation (Cycloset-type)

• Must be taken with food in the morning

• Used as adjunct to diet/exercise, not first-line

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Neuroleptic-induced hyperprolactinaemia 1.25–5 mg/day in divided doses As required while on antipsychotic OFF-LABEL; Specialist only; Evidence from clinical studies showing prolactin normalisation

Postpartum lactation suppression 2.5 mg twice daily 14 days OFF-LABEL; Use only when medically necessary (e.g., stillbirth, maternal contraindication to breastfeeding); Risk of hypertension/stroke — monitor BP closely

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Hyperprolactinaemia / Pituitary Adenoma (Paediatric Endocrinologist Only)

≥7 years 1.25 mg once at bedtime Increase by 1.25 mg every 3–7 days 2.5–5 mg/day 10 mg/day (case-based)

Safety Monitoring:

• Serum prolactin levels every 4–6 weeks during titration

• Growth velocity and pubertal staging

• Blood pressure monitoring

• Hepatic function if prolonged use

Secondary Indications — Paediatric (Off-label)

Indication Dose Notes

Acromegaly/Gigantism in adolescents 1.25–2.5 mg/day, titrated to GH/IGF-1 levels OFF-LABEL; Specialist only; Not first-line; use when surgery or somatostatin analogues not feasible

Age Restrictions:

• Not recommended below 7 years of age except under specialist supervision in tertiary care settings

Severe impairment (eGFR <30) Use with caution; consider lower starting dose and slower titration

Haemodialysis Not significantly dialysable; use with caution due to prolonged half-life

• Uncontrolled hypertension

• History of pregnancy-induced hypertension, preeclampsia, or eclampsia (when used for lactation suppression)

• Known hypersensitivity to bromocriptine or ergot alkaloids

• Severe ischaemic heart disease

• Significant peripheral vascular disease

• History of coronary artery disease when used for type 2 diabetes

• Concurrent use with other ergot alkaloids

• Cardiovascular disease (arrhythmias, valvular heart disease)

• History of psychiatric illness (increased risk of hallucinations, psychosis)

• Hepatic impairment

• Peptic ulcer disease

• Raynaud's phenomenon

• Concurrent use of dopamine antagonists (may reduce efficacy)

• May impair alertness — advise caution with driving or operating machinery

• Risk of sudden sleep onset (particularly in Parkinson's disease)

Parameter Details

Risk category No formal Indian categorisation; animal studies and human experience suggest no significant teratogenic risk

Use recommendation Generally discontinued once pregnancy confirmed; may continue if macroprolactinoma with risk of tumour expansion — specialist decision required

Preferred alternatives Cabergoline (similar safety profile, longer action); surgery for large tumours if indicated

Monitoring Visual field assessment; pituitary MRI if symptoms of tumour expansion; maternal blood pressure

Parameter Details

Compatibility Not compatible — suppresses lactation through prolactin inhibition

Drug levels in milk Low (minimal infant exposure if any lactation occurs)

Preferred alternatives None if lactation suppression is the goal

Monitoring Mother: blood pressure, headache, neurological symptoms; avoid if spontaneous breastfeeding desired

Parameter Recommendation

Recommended starting dose 1.25 mg once daily

Titration Slower than standard — increase every 7–14 days

Extra risks Increased sensitivity to orthostatic hypotension; higher risk of hallucinations and confusion; fall risk; underlying renal/hepatic reserve should be assessed

Additional notes Psychiatric monitoring essential; avoid high doses; consider alternatives like cabergoline for prolactinoma

Interacting Drug Mechanism/Effect Recommendation

Antipsychotics (haloperidol, risperidone, olanzapine) Antagonise dopaminergic action; reduced bromocriptine efficacy Avoid combination or use with specialist supervision

Macrolide antibiotics (erythromycin, clarithromycin) CYP3A4 inhibition; increased bromocriptine levels Avoid or reduce bromocriptine dose; monitor for toxicity

Other ergot alkaloids (ergotamine, dihydroergotamine) Additive vasoconstrictive effects Contraindicated combination

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) Significantly increased bromocriptine levels Avoid or use lowest bromocriptine dose with monitoring

Interacting Drug Mechanism/Effect Recommendation

Antihypertensives Additive hypotensive effect Monitor blood pressure; may need dose adjustment

Levodopa Additive dopaminergic effects May allow levodopa dose reduction; monitor for dyskinesias

Metoclopramide / Domperidone Dopamine antagonism reduces bromocriptine efficacy Avoid if possible; consider alternative antiemetic

Oral contraceptives May elevate prolactin levels Monitor prolactin response; adjust bromocriptine dose if needed

Alcohol Enhanced hypotension and sedation Advise moderation

• Nausea and vomiting (especially initial therapy)

• Postural hypotension

• Headache

• Dizziness

• Nasal congestion

• Fatigue and drowsiness

• Constipation

• Leg cramps

Adverse Effect Clinical Action

Hallucinations / psychosis (especially high doses or elderly) Reduce dose or discontinue; psychiatric evaluation

Digital vasospasm / Raynaud's phenomenon Discontinue immediately; avoid ergot derivatives

Pulmonary fibrosis (long-term high-dose use) Discontinue; chest imaging; pulmonology referral

Retroperitoneal fibrosis (long-term high-dose use) Discontinue; abdominal imaging; urology/surgery referral

Sudden sleep episodes Discontinue; advise against driving

Stroke / myocardial infarction (rare, especially postpartum use) Emergency management; discontinue permanently

Cardiac valvulopathy (with prolonged high doses) Echocardiography; discontinue if significant

Phase Parameters

Baseline Blood pressure; serum prolactin; liver function tests; ECG if cardiac risk factors; visual field assessment for macroprolactinoma

After initiation/dose change Blood pressure (first week); prolactin levels (4–6 weeks); psychiatric symptoms assessment

Long-term Prolactin levels every 3–6 months; annual visual field (macroprolactinoma); hepatic function annually for high-dose use; echocardiography if prolonged high-dose therapy (>2 years); chest imaging if respiratory symptoms

Proctinal Zydus 1.25 mg, 2.5 mg

Sicriptin Serum Institute 1.25 mg, 2.5 mg

Brotin Micro Labs 2.5 mg

Encript Sun Pharma 2.5 mg

Bromocriptine Various generics 1.25 mg, 2.5 mg

Note: Dostinex is cabergoline (different drug) — do not confuse

Strength Approximate Price

1.25 mg tablet ₹4–8 per tablet

2.5 mg tablet ₹6–12 per tablet

• Generally affordable

• Not currently under NPPA price control for standard formulations

• Available in government supply in some states

1. Start low, go slow: Begin with 1.25 mg at bedtime to minimise nausea and postural hypotension; titrate gradually based on response and tolerance.

1. Bedtime dosing advantage: Initial doses at bedtime reduce symptomatic hypotension and nausea; once stabilised, divide doses through the day.

1. Cost-effective for prolactinoma: In India, bromocriptine remains first-line for prolactinomas due to significantly lower cost compared to cabergoline, despite cabergoline's better tolerability.

1. Lactation suppression caution: Reserve for strict medical indications only (stillbirth, maternal HIV) — not for routine suppression; monitor blood pressure closely due to stroke risk.

1. Parkinson's disease psychiatric risk: Higher rates of hallucinations and psychosis in elderly — prefer non-ergot dopamine agonists (pramipexole, ropinirole) when available.

1. Long-term fibrosis monitoring: Patients on high doses (>30 mg/day) for extended periods require periodic chest imaging and renal function assessment for fibrotic complications.

Bromocriptine; hyperprolactinaemia; prolactinoma; Parkinson's disease; acromegaly; dopamine agonist; ergot derivative; lactation suppression; type 2 diabetes; pituitary adenoma

RxIndia v1.0 — 05 Jun 2025

• CDSCO (Product Information)

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Endocrinology Protocols

• AIIMS Neurology Guidance (Parkinson's disease dosing)

• ICMR Type 2 Diabetes Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian Psychiatry Specialist Practice (off-label neuroleptic-induced hyperprolactinaemia)