Cabergoline Schedule (India)

Schedule H

Cabergoline Routes

Oral

Cabergoline Formulations

•Tablets: 0.25 mg, 0.5 mg

Cabergoline Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Hyperprolactinaemia (including Prolactin-Secreting Pituitary Adenomas)

Parameter Recommendation

Starting dose 0.25 mg twice weekly (or 0.5 mg once weekly)

Titration Increase by 0.25 mg twice weekly at 4-week intervals, guided by serum prolactin levels

Usual maintenance dose 0.5–1.0 mg twice weekly

Maximum dose 2 mg twice weekly (specialist supervision required)

Key Clinical Notes:

Measure serum prolactin monthly during titration, then every 3–6 months once stable

Visual field assessment recommended at baseline and periodically for macroadenomas

Gradual dose tapering recommended before discontinuation to prevent rebound hyperprolactinaemia

MRI pituitary annually for macroadenomas

Postpartum Lactation Suppression (Medically Indicated Cases Only)

Parameter Recommendation

Starting dose 1 mg as a single oral dose within 24 hours postpartum

Titration Not applicable

Usual maintenance dose Not applicable (single dose therapy)

Maximum dose 1 mg single dose

Key Clinical Notes:

Reserve for situations where lactation suppression is medically necessary (e.g., stillbirth, neonatal death, maternal HIV infection, severe medical illness)

Not for routine postpartum use or personal preference

Monitor blood pressure post-administration

Secondary Indications – Adults Only (Off-label)

Parkinson's Disease (Adjunct to Levodopa) — OFF-LABEL

Starting dose: 0.5 mg once daily

Titration: Increase by 0.5–1 mg/day at weekly intervals based on clinical response

Usual maintenance dose: 2–3 mg/day

Maximum dose: 3 mg/day

Duration: Long-term; chronic use under specialist supervision

Specialist only (Neurology)

Evidence: Older RCTs support efficacy; largely replaced by non-ergot dopamine agonists (pramipexole, ropinirole) due to fibrosis risk with long-term ergot use

Cabergoline Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — Cabergoline is not approved for routine paediatric use.

Secondary Indications – Paediatric Doses (Off-label)

Paediatric Prolactinoma — OFF-LABEL

Parameter Recommendation

Minimum age Not recommended below 6 years

Starting dose 0.25 mg once weekly

Titration Increase by 0.25–0.5 mg/week at 4-week intervals based on prolactin response and tolerability

Usual maintenance dose 0.5–1 mg weekly (in divided doses)

Maximum dose 1 mg twice weekly

Duration Long-term; individualized based on tumour response

Specialist only (Paediatric Endocrinology)

Evidence: Limited paediatric data; extrapolated from adult experience and case series

Safety Monitoring (All Paediatric Off-label Use):

Baseline and periodic echocardiography (valvular disease risk with long-term use)

Liver function tests

Serum prolactin levels monthly during titration

Growth and pubertal development assessment

MRI pituitary annually for macroadenomas

Visual field testing if indicated

NOT recommended below 6 years except under specialist supervision.

Cabergoline Renal Adjustments

Mild to moderate impairment: No dosage adjustment required

Severe impairment (eGFR <30 mL/min): Limited data; use with caution under specialist supervision

Haemodialysis: Not significantly dialyzable; no supplemental dosing required

Cabergoline Hepatic adjustment

Mild impairment (Child-Pugh A): Initiate at lowest effective dose (0.25 mg weekly); monitor closely

Moderate impairment (Child-Pugh B): Use with caution; slower titration recommended; monitor liver function

Severe impairment (Child-Pugh C): Avoid use — reduced hepatic metabolism may lead to drug accumulation

Cabergoline Contraindications

Known hypersensitivity to cabergoline or any ergot alkaloid

History of cardiac valvular disease or clinically significant valvulopathy

Uncontrolled hypertension

History of fibrotic disorders (pulmonary, pericardial, retroperitoneal fibrosis)

Severe hepatic impairment

Concurrent use with potent dopamine antagonists (antipsychotics) for the same indication

Cabergoline Cautions

Pre-existing cardiac disease — baseline echocardiogram required before initiating long-term therapy

History of psychosis, impulse control disorders, or mania

Orthostatic hypotension risk — monitor during dose titration

Moderate hepatic impairment

Concurrent use of other ergot derivatives

Peptic ulcer disease (rare exacerbation)

Raynaud's phenomenon

Doses exceeding 1 mg/week — increased risk of valvulopathy

Cabergoline Pregnancy

Parameter Recommendation

Risk category Generally avoided; use only if benefit clearly outweighs risk

Preferred alternatives Bromocriptine (longer safety experience in pregnancy; preferred when conception is anticipated)

When may be used Discontinue upon confirmation of pregnancy unless continued therapy is critically required for tumour control

Monitoring If pre-conception exposure: fetal ultrasound; if macroadenoma: visual field monitoring, MRI if symptoms suggest tumour expansion

Cabergoline Lactation

Parameter Recommendation

Compatibility Contraindicated — suppresses lactation by inhibiting prolactin

Preferred alternatives None suitable if lactation is desired

Expected drug levels in milk Not applicable (lactation suppressed)

Infant monitoring Not applicable; drug should not be used if breastfeeding is intended

Cabergoline Elderly

Starting dose: 0.25 mg once weekly

Titration: Slower titration advised (extend intervals to 4–6 weeks)

Extra risks:

Orthostatic hypotension — increased fall risk

Confusion, hallucinations (particularly in Parkinson's disease use)

Reduced hepatic/renal reserve — monitor for accumulation

Cardiac valvulopathy — baseline echocardiogram recommended

Cabergoline Major drug interactions

Interacting Drug Effect Mechanism Management

Antipsychotics (haloperidol, risperidone, olanzapine) Antagonizes cabergoline's dopaminergic effect Dopamine receptor blockade Avoid concurrent use; therapeutic failure of cabergoline

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Increased cabergoline plasma levels Reduced hepatic metabolism Avoid combination or use lowest cabergoline dose with close monitoring

Other ergot alkaloids (ergotamine, methylergometrine) Additive vasoconstriction, risk of ergotism Synergistic vasoconstrictive effects Avoid concurrent use

Metoclopramide Antagonizes cabergoline's effect Dopamine receptor antagonism Avoid combination

Cabergoline Moderate drug interactions

Interacting Drug Effect Management

Antihypertensives Additive hypotensive effect Monitor blood pressure; adjust antihypertensive dose if needed

Levodopa/carbidopa Synergistic dopaminergic effect Beneficial in Parkinson's; monitor for dyskinesias and psychiatric effects

Macrolide antibiotics (erythromycin, azithromycin) Potential increase in cabergoline levels (CYP3A4 inhibition) Monitor for adverse effects

Domperidone May partially antagonize cabergoline Avoid if possible; use for limited duration if antiemetic needed

Cabergoline Common Adverse effects

Nausea and vomiting (especially during initiation)

Dizziness

Headache

Orthostatic hypotension

Fatigue and asthenia

Constipation

Nasal congestion

Sleep disturbances

Abdominal discomfort

Cabergoline Serious Adverse effects

Cardiac valvulopathy: Regurgitant valvular lesions (especially with doses >2 mg/week or prolonged therapy) — requires baseline and annual echocardiography; discontinue if clinically significant valve disease develops

Fibrotic reactions: Pulmonary fibrosis, retroperitoneal fibrosis, pericardial fibrosis — discontinue immediately if suspected (dyspnoea, abdominal pain, oedema)

Impulse control disorders: Pathological gambling, hypersexuality, compulsive spending — counsel patients; consider dose reduction or discontinuation

Psychosis and hallucinations: Particularly in Parkinson's disease use or elderly

Severe hypotension: Especially during initiation — may require dose reduction

Pleural effusion: Rare; requires investigation and drug discontinuation

Cabergoline Monitoring requirements

Baseline:

Serum prolactin level

Blood pressure

Echocardiogram (mandatory if long-term therapy or doses >1 mg/week anticipated)

Liver function tests

Renal function tests

Visual field assessment (for macroadenomas)

MRI pituitary (for adenomas)

During Therapy:

Blood pressure: Weekly during titration phase

Serum prolactin: Monthly during dose adjustment, then every 3–6 months once stable

Clinical assessment for orthostatic symptoms at each visit

Long-term (Chronic Use):

Echocardiogram: Every 12 months (or sooner if cardiac symptoms develop), especially if dose >1 mg/week

MRI pituitary: Annually for macroadenomas

Periodic assessment for fibrotic symptoms (dyspnoea, abdominal pain, pedal oedema)

Screening for impulse control disorders

Cabergoline Brands in India

Cabgolin (Sun Pharma)

Dostinex (Pfizer)

Caberlin (Serum Institute)

CB-Lin (Intas)

Sogilen (Cipla)

Cabergoline Price range (INR)

₹50–₹80 per 0.25 mg tablet

₹80–₹120 per 0.5 mg tablet

Prices vary by brand

Not included in NLEM

Not under NPPA price control

Cabergoline Clinical pearls

Cabergoline is generally preferred over bromocriptine for prolactinomas due to better efficacy, tolerability, and convenient twice-weekly dosing

Echocardiography is mandatory before initiating long-term therapy and should be repeated annually — risk of valvulopathy increases with cumulative dose and duration

Avoid abrupt withdrawal — gradual tapering prevents rebound hyperprolactinaemia and tumour re-expansion

For women planning pregnancy, consider switching to bromocriptine before conception due to longer pregnancy safety experience

In Parkinson's disease, non-ergot dopamine agonists (pramipexole, ropinirole) are now preferred first-line due to lower fibrosis risk — reserve cabergoline for refractory cases

Always screen for impulse control disorders during treatment — this adverse effect is often underreported by patients

Cabergoline Tags

cabergoline; dopamine agonist; prolactinoma; hyperprolactinaemia; lactation suppression; ergot derivative; valvulopathy risk; Parkinson's disease; endocrinology; specialist-use

Cabergoline Version

RxIndia v1.0 — 07 May 2025

Cabergoline Reference

CDSCO approved prescribing information

Indian Pharmacopoeia

National Formulary of India (NFI)

API Textbook of Medicine

AIIMS Hospital Endocrinology Guidelines

Goodman & Gilman's The Pharmacological Basis of Therapeutics

RCTs in Parkinson's disease (off-label use documentation)

RxIndia

The Drug Registry

Cabergoline