Version May 2024
Hyperprolactinemia: Oral:
Initial: 0.025 mg once daily for 3 days followed by 0.05 mg once daily for 3 days (starter pack).
Maintenance (beginning on day 7): 0.075 mg once daily; if needed, a further stepwise titration may occur at intervals of ≥1 week; usual maintenance range: 0.075 to 0.15 mg/day; if higher doses are needed, titrate in increments of 0.075 to 0.15 mg/day at intervals ≥4 weeks up to a maximum of 0.9 mg/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Use in contraindicated.
Use in contraindicated.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Nausea, vomiting
Nervous system: Dizziness, fatigue, headache
1% to 10%:
Cardiovascular: Edema (2%), hypotension (1%)
Gastrointestinal: Abdominal distress (3%), abdominal pain (3%), anorexia (2%), constipation (3%), dyspepsia (2%)
Nervous system: Insomnia (2%), malaise (1%), sedated state (3%)
Neuromuscular & skeletal: Asthenia(3%)
Respiratory: Nasal congestion (2%)
Ophthalmic: Eye disease (2%)
<1%:
Cardiovascular: Flushing, palpitations, syncope
Endocrine & metabolic: Weight gain
Gastrointestinal: Diarrhea
Genitourinary: Mastalgia
Nervous system: Acute psychosis, drowsiness, emotional lability, lack of concentration
Neuromuscular & skeletal: Limb pain
Frequency not defined:
Endocrine & metabolic: Increased creatinine phosphokinase in blood specimen, increased serum potassium, increased serum triglycerides
Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin, neutropenia
Hepatic: Increased serum bilirubin, increased serum transaminases
Postmarketing: Nervous system: Withdrawal syndrome (dopamine agonist withdrawal syndrome [DAWS]) (Health Canada 2021)
Hypersensitivity to quinagolide or any component of the formulation; hepatic or renal impairment
Concerns related to adverse effects:
• CNS depression: May cause CNS depression (eg, sudden sleep onset and somnolence) particularly in patients with Parkinson disease which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving). Use with other agents known to induce somnolence or sleep may be expected to potentiate these risks. Dose reduction or therapy discontinuation may be needed if sudden onset of sleep develops.
• Gastrointestinal distress: Use may be associated with frequent (but transient) nausea and vomiting early in therapy; during initial therapy, premedication with a peripheral dopamine antagonist may alleviate these effects and improve tolerance.
• Hypotension: Hypotensive episodes along with syncope may occur with the onset of therapy; monitor blood pressure early in therapy.
• Impulse control disorders: Monitor for development of impulse control disorders (eg, pathological gambling, increased libido, hypersexuality, compulsive spending, or binge and compulsive eating). Consider dose reduction or tapered discontinuation if symptoms develop.
Disease-related concerns:
• Psychosis: Use with caution in patients with prior psychotic disorders; the onset of acute psychosis has rarely been observed with use of quinagolide (reversible upon discontinuation).
Other warnings/precautions:
• Radiotherapy/Surgery: Treatment with quinagolide may not exclude the need for radiation and/or surgical intervention if appropriate.
Not available in the US
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Norprolac: 0.025 mg [DSC], 0.05 mg [DSC], 0.075 mg [DSC], 0.15 mg [DSC]
Oral: Administer once daily with snack at bedtime. Nausea and vomiting may be alleviated by premedicating with a peripheral dopamine antagonist.
Note: Not approved in the US
Hyperprolactinemia: Treatment of hyperprolactinemia (idiopathic or due to a prolactin-secreting pituitary microadenoma or macroadenoma)
Quinagolide may be confused with quinapril
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the adverse/toxic effect of Quinagolide. Risk C: Monitor therapy
Antipsychotic Agents: May diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
Blood Pressure Lowering Agents: Quinagolide may enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromopride: May diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
Metoclopramide: May diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
Pipamperone [INT]: Quinagolide may diminish the therapeutic effect of Pipamperone [INT]. Pipamperone [INT] may diminish the therapeutic effect of Quinagolide. Risk X: Avoid combination
Sulpiride: Quinagolide may diminish the therapeutic effect of Sulpiride. Sulpiride may diminish the therapeutic effect of Quinagolide. Risk X: Avoid combination
Quinagolide is approved for the treatment of hyperprolactinemia. Increased prolactin concentrations due to a prolactinoma may cause galactorrhea, amenorrhea, oligomenorrhea, or luteal phase insufficiency (ES [Melmed 2011]; ESE [Luger 2021]). Fertility may be restored with treatment; contraception should be used by patients of reproductive potential who do not wish to conceive.
Treatment with a dopamine agonist is recommended for patients with a prolactinoma who are trying to conceive. However, quinagolide is not preferred if treatment is needed during pregnancy (ES [Melmed 2011]; ESE [Luger 2021]).
Normalizing prolactin concentrations during dopamine agonist treatment for a micro- or macroadenoma also improves fertility by restoring nocturnal penile tumescence, sperm count, and sperm motility (ES [Melmed 2011]).
Quinagolide is approved for the treatment of hyperprolactinemia. Information related to the use of quinagolide during pregnancy is limited (ESE [Luger 2021]).
Based on known safety data, if treatment of a prolactinoma during pregnancy is required, a dopamine agonist other than quinagolide may be preferred (ES [Melmed 2011]; ESE [Luger 2021]). Discontinue use with confirmed pregnancy unless medically necessary to continue. The reinstitution of therapy may be necessary in patients who display symptoms of tumor enlargement (headaches, visual field changes).
Serum prolactin concentrations are increased during pregnancy; monitoring prolactin levels may not be reliable for tumor progression (ES [Melmed 2011]; ESE [Luger 2021]).
Quinagolide suppresses lactation.
Prolactin levels; blood pressure; sedation, mental changes
Selective dopamine D2 receptor agonist that exerts a direct inhibitory effect on cells (lactotrophs) in the anterior pituitary gland which synthesize and secrete prolactin; not an ergot alkaloid
Onset of action: 2 hours; maximum effect: 4 to 6 hours
Duration: >24 hours
Absorption: Rapid
Distribution: Vd: 100 L
Protein binding: ~90%
Metabolism: Hepatic; via conjugation (glucuronide and sulfate)
Bioavailability: 4%
Half-life elimination: 11.5 hours; steady state: 17 hours
Time to peak, serum: 30 to 60 minutes
Excretion: Urine (50%); feces (40%); >95% as metabolites
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