Bromocriptine Schedule (India)

Schedule H

Bromocriptine Routes

Oral

Bromocriptine Formulations

Formulation Strength

Tablet 1.25 mg

Tablet 2.5 mg

Tablet 5 mg (less commonly available)

Bromocriptine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

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

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

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

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

Bromocriptine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Hyperprolactinaemia / Pituitary Adenoma (Paediatric Endocrinologist Only)

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

≥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

Bromocriptine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

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

Bromocriptine Hepatic adjustment

Severity	Recommendation
Mild impairment	No dose adjustment necessary
Moderate impairment Use lower starting dose (1.25 mg)	; slower titration; monitor hepatic function
Severe impairment	Avoid use — extensive hepatic metabolism leads to unpredictable drug levels

Bromocriptine Contraindications

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

Bromocriptine Cautions

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)

Bromocriptine Pregnancy

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

Bromocriptine Lactation

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

Bromocriptine Elderly

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

Bromocriptine Major drug interactions

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

Bromocriptine Moderate drug interactions

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

Bromocriptine Common Adverse effects

Nausea and vomiting (especially initial therapy)

Postural hypotension

Headache

Dizziness

Nasal congestion

Fatigue and drowsiness

Constipation

Leg cramps

Bromocriptine Serious Adverse effects

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

Bromocriptine Monitoring requirements

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

Bromocriptine Brands in India

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

Bromocriptine Price range (INR)

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

Bromocriptine Clinical pearls

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

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

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.

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

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

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 Tags

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

Bromocriptine Version

RxIndia v1.0 — 05 Jun 2025

Bromocriptine Reference

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)

RxIndia

The Drug Registry

Bromocriptine