DOSTINEX 0.5MG 2TAB

Indications

Approved Uses

Treatment of hyperprolactinemic disorders (idiopathic hyperprolactinemia or due to pituitary adenomas/prolactinomas).

Dosage & Administration

Dosing by Condition

Hyperprolactinemia: start 0.25 mg twice weekly (or 0.5 mg/week total), then increase by 0.25 mg twice weekly (0.5 mg/week) at intervals of at least 4 weeks based on prolactin/tolerability; usual maintenance 0.5-1 mg/week; maximum commonly referenced 2 mg/week (some references allow higher under specialist supervision).

Initial Dose

0.25 mg orally twice a week.

Maintenance Dose

Maximum recommended maintenance dose is 1 mg twice weekly (2 mg per week total); usual maintenance varies by individual response.

Maximum Dose

Maximum for hyperprolactinemia: 2 mg per week (1 mg twice weekly), titrated based on prolactin/clinical response.

Children's Dosage

Safety and efficacy have not been established in patients younger than 18 years.

Dose Adjustment Notes

Titrate based on serum prolactin and tolerability; increase in small increments no more frequently than every 4 weeks. Use caution in hepatic impairment (especially severe) and consider lower starting dose/slower titration.

How to Take

Oral tablet; may be taken with or without food (taking with food can reduce nausea). For hyperprolactinemia, the weekly dose may be taken as a single weekly dose or divided into 2 doses on separate days each week (e.g., twice weekly).

Side Effects

Common Side Effects

Nausea, headache, dizziness/vertigo, fatigue/asthenia, constipation, abdominal pain/dyspepsia, vomiting; may also cause orthostatic hypotension.

Side Effect Frequency

Common (≥1% to <10%): nausea, headache, dizziness/vertigo, abdominal pain/dyspepsia/gastritis, constipation, vomiting, fatigue/asthenia. Uncommon (≥0.1% to <1%): somnolence, orthostatic hypotension, hot flushes, depression. Rare/very rare (serious): fibrotic reactions (pleural/pulmonary/retroperitoneal), cardiac valvulopathy (risk increases with higher cumulative doses), and psychiatric/impulse-control effects.

Safety & Warnings

Contraindications

Hypersensitivity to cabergoline or other ergot derivatives; history of cardiac valvulopathy; history/evidence of pulmonary, pericardial, or retroperitoneal fibrotic disorders; uncontrolled hypertension (including pregnancy-induced hypertension such as pre-eclampsia/eclampsia and postpartum hypertension).

Warnings & Precautions

Baseline cardiovascular evaluation including echocardiography before starting and periodically during therapy (especially long-term/high dose); monitor for signs/symptoms of fibrotic disorders (pulmonary/pleural, pericardial, retroperitoneal) and discontinue if suspected; monitor blood pressure (risk of orthostatic hypotension and postpartum/pregnancy-related hypertension concerns); caution in hepatic impairment; caution in patients with history of severe psychiatric disorders; counsel/monitor for somnolence and impulse control disorders.

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No clinically significant food restriction; may be taken with or without food, but taking with food can reduce nausea/GI upset.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Safety and efficacy have not been established in patients younger than 18 years.

Liver Impairment

Severe hepatic impairment: use with caution and consider lower doses (exposure increases); mild-moderate impairment: no routine adjustment but monitor tolerability/response.

Storage & Patient Advice

Overdose

Symptoms may include nausea/vomiting, dizziness, hypotension/orthostasis, syncope, nasal congestion, confusion/hallucinations; management is supportive (airway/BP monitoring, IV fluids/vasopressors as needed), consider activated charcoal if early, and a dopamine antagonist may be used for severe CNS effects under medical supervision-seek urgent care.

Patient Counseling

Take exactly as prescribed on the same day(s) each week; may take with food if nausea occurs. Rise slowly (risk of dizziness/orthostatic hypotension) and avoid driving until effects are known. Report shortness of breath, chest pain, persistent cough, leg swelling, or back pain (possible fibrotic/valvular complications) and report new impulse-control symptoms (e.g., gambling, hypersexuality). Keep follow-up for prolactin tests and cardiac monitoring.

Monitoring Requirements

Monitor serum prolactin to guide titration and maintenance. Baseline cardiovascular assessment including echocardiogram, with periodic follow-up echocardiography during long-term therapy (commonly every 6-12 months) and monitor blood pressure (especially during initiation/titration).

Pharmacology

Mechanism of Action

Long-acting dopamine D2-receptor agonist that inhibits prolactin secretion by stimulating D2 receptors on pituitary lactotroph cells.

Bioavailability

Absolute oral bioavailability in humans is not established (unknown).

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 0.5 mg cabergoline

OTC Alternatives

No OTC alternative

Hormone Type

Non-hormonal

Method

Oral

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