•Tablets: 0.25 mg, 0.5 mg
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
- 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
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)
- 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.
- 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
- 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
- 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
- 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)
- Doses exceeding 1 mg/week — increased risk of valvulopathy
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
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
- Starting dose: 0.25 mg once weekly
- Titration: Slower titration advised (extend intervals to 4–6 weeks)
- 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
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
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
- Nausea and vomiting (especially during initiation)
- 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
Baseline:
- Echocardiogram (mandatory if long-term therapy or doses >1 mg/week anticipated)
- 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
- Caberlin (Serum Institute)
- ₹50–₹80 per 0.25 mg tablet
- ₹80–₹120 per 0.5 mg tablet
- Not under NPPA price control
- 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; dopamine agonist; prolactinoma; hyperprolactinaemia; lactation suppression; ergot derivative; valvulopathy risk; Parkinson's disease; endocrinology; specialist-use
RxIndia v1.0 — 07 May 2025
- CDSCO approved prescribing information
- National Formulary of India (NFI)
- AIIMS Hospital Endocrinology Guidelines
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
- RCTs in Parkinson's disease (off-label use documentation)