NOSTIFIX 0.5/MG TAB 2/TAB

Indications

Approved Uses

Treatment of hyperprolactinemic disorders (idiopathic hyperprolactinemia or due to prolactin-secreting pituitary adenomas), including associated clinical manifestations such as amenorrhea/oligomenorrhea, anovulation/infertility, and galactorrhea.

Off-Label Uses

Off-label examples: adjunct treatment in Cushing disease (pituitary-dependent), acromegaly (adjunct), and occasional use for medication-induced hyperprolactinemia under specialist care; Parkinson disease use is uncommon today and generally not preferred. Lactation suppression may be on-label for some products but should be verified locally for NOSTIFIX.

Dosage & Administration

Dosing by Condition

Hyperprolactinemia (adults): start 0.25 mg twice weekly (or 0.5 mg once weekly); increase by 0.25 mg twice weekly (i.e., +0.5 mg/week) at intervals of at least 4 weeks to normalize prolactin; usual maintenance 0.5-1 mg/week (range up to 2 mg/week in many patients). Higher weekly doses may be used in selected cases under specialist supervision; do not exceed product-specific maximum.

Initial Dose

0.25 mg orally twice a week.

Maintenance Dose

1-2 mg per week (hyperprolactinemia), administered as divided doses 2-3 times per week

Maximum Dose

Maximum: 4.5 mg per week (for hyperprolactinemia), given in divided doses.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Titrate gradually based on prolactin and tolerability; dose increases should occur no more frequently than every 4 weeks. Use caution in hepatic impairment and consider slower titration/lower doses if not tolerated.

How to Take

Oral: take with food (or at bedtime with food) to reduce nausea; swallow with water. For hyperprolactinemia, take the weekly dose as divided doses (e.g., twice weekly) on the same days each week.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): nausea, headache, dizziness. Common (1-10%): constipation, abdominal pain/dyspepsia, vomiting, fatigue/asthenia, somnolence, postural/orthostatic hypotension, hot flushes. Uncommon/rare: cardiac valvulopathy and fibrotic reactions (risk increases with higher cumulative doses, more typical in Parkinson’s dosing), psychiatric effects (e.g., hallucinations/impulse-control disorders).

Safety & Warnings

Warnings & Precautions

Baseline and periodic cardiovascular evaluation including echocardiography for valvulopathy (especially long-term use); monitor for fibrotic disorders (pulmonary/pleural/pericardial/retroperitoneal) and stop if suspected; monitor BP for orthostatic/first-dose hypotension; caution with history of psychosis and monitor for hallucinations/somnolence and impulse-control disorders; avoid use in pregnancy-induced hypertension.

Age Restriction

Pediatric use: safety and efficacy not established (<18 years); generally avoid routine use in children/adolescents unless specialist-directed.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Dopamine antagonists (e.g., antipsychotics, metoclopramide/domperidone) may reduce effect; strong CYP3A4 inhibitors (e.g., macrolides like erythromycin/clarithromycin, azoles like ketoconazole/itraconazole) may increase exposure; antihypertensives/additive hypotension; other ergot alkaloids should be avoided due to additive ergot/fibrosis risk.

Food Interaction

No clinically meaningful food interaction affecting efficacy; taking with food is recommended to reduce nausea/GI intolerance.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Not approved for children.

Elderly

Start at lower dose, titrate slowly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.

Kidney Impairment

No dose adjustment generally required; use caution in severe renal impairment due to limited data.

Liver Impairment

Severe hepatic impairment (Child-Pugh C / >10): use with caution and consider lower doses; mild-moderate impairment: generally no formal adjustment but use caution and titrate to response/tolerability.

Storage & Patient Advice

Missed Dose

If a dose is missed, take it as soon as remembered unless it is close to the next scheduled dose; then skip and resume the regular schedule-do not double doses.

Stopping the Medicine

Discontinue only under prescriber guidance; in hyperprolactinemia, treatment may be stopped after prolactin is normalized and maintained for ~6 months with ongoing monitoring for recurrence.

Overdose

Symptoms: nausea/vomiting, dizziness, hypotension/syncope, nasal congestion, confusion/hallucinations; management: supportive care with BP monitoring, consider activated charcoal if early, and a dopamine antagonist (e.g., metoclopramide) may be used for severe symptoms-seek urgent medical care.

Patient Counseling

Take with food to reduce nausea; take doses on the same day(s) each week. Rise slowly to reduce dizziness/orthostatic hypotension; avoid driving/operating machinery until effects are known (may cause dizziness/somnolence). Report shortness of breath, persistent cough, chest pain, leg swelling, or new/worsening heart symptoms (valvulopathy/fibrosis risk), and report impulse-control changes (e.g., gambling, hypersexuality). Keep follow-up for prolactin checks, blood pressure, and echocardiography during long-term therapy; discuss pregnancy intentions and use only as directed by the prescriber.

Monitoring Requirements

Monitor serum prolactin (and clinical symptoms) periodically; monitor blood pressure (especially at initiation/titration). For long-term therapy, perform baseline cardiovascular assessment and echocardiography and repeat periodically (commonly every 6-12 months) to screen for valvular disease; monitor for symptoms/signs of fibrotic reactions and assess as clinically indicated.

Pharmacology

Mechanism of Action

Long-acting dopamine D2-receptor agonist that inhibits prolactin secretion from lactotroph cells in the anterior pituitary, lowering serum prolactin.

Duration of Effect

Prolactin-lowering effect is prolonged; a single dose can suppress prolactin for about 7 days, and in some patients effects may persist up to ~14 days depending on dose and baseline prolactin.

Bioavailability

Unknown (absolute oral bioavailability in humans has not been established)

Excretion

Primarily fecal (~60%) with a smaller renal component (~22%)

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: 0.5 mg cabergoline

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Hormone Type

Non-hormonal

Method

Oral

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