Generic drug of the therapeutic class: Endocrinology
active ingredients: Bromocriptine
laboratory: Meda Pharma
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· Clinical consequences of hyperprolactinemia
o severe disorders of the menstrual cycle (with or without galactorrhea),
o Gynecomastia and impotence.
o background treatment of prolactinomas: micro or macroadenomas,
o in particular preparation for the surgical procedure in case of macroadenoma where Parlodel can promote the intervention by reducing the tumor volume, especially in the case of extra-limbal extension,
o in case of early or late failure of surgery: reappearance of hyperprolactinemia.
· First-line treatment in monotherapy.
· First-line treatment with levodopa (in this second case, to decrease the dose of each of the active products and to delay the onset of fluctuations in efficacy and abnormal movements).
Association in the course of evolution of the disease in case of:
· Decrease in the effect of levodopa,
· Fluctuations in the therapeutic effect of dopa therapy and other phenomena that occur after several years of treatment with levodopa: dyskinesia, painful dystonia,
· Ineffectiveness from the start of dopa therapy.
The switch from levodopa to bromocriptine should always be done gradually, with reduced doses of levodopa (see section Dosage and method of administration ).
Dosage PARLODEL 2.5 mg scored tablet Box of 30
To improve the digestive tolerance, the administration of the drug must always be done in the middle of meals.
The therapeutic scheme is as follows:
· ½ tablet on the first day, 1 tablet on the 2nd day, then 2 tablets daily for several weeks.
If after 6 weeks the gonadal function is not restored the dosage can be increased to 3 tablets or even later to 4 tablets per day.
The adaptation of the individual dosage will also be a function of tolerance.
The prescription of domperidone 3 days before the beginning of the treatment and during the progression makes it possible to initiate the treatment with a good acceptability (see under Undesirable effects ).
At the beginning of treatment, Parlodel tablets containing 2.5 mg of bromocriptine will be used.
The therapeutic scheme is as follows:
· ½ tablet on the 1st day at the evening meal,
· 1 tablet on the 2nd day, then gradually increase in steps of one tablet every other day.
From 20 mg per day, Parlodel 5 mg then 10 mg capsules replace the tablets.
The average effective doses (to be divided into 3 daily doses) are:
· As monotherapy: 10 mg to 30 mg daily;
· In early combination with levodopa: 10 mg to 25 mg daily.
However, in some patients, higher doses may be exceptionally needed.
In patients after 65 years, the daily dose is between 5 and 15 mg (see section 4.4 ).
In combination with levodopa, Parlodel reduces daily doses of levodopa by 20 to 60%.
· Hypersensitivity to bromocriptine or other ergot alkaloids.
For long-term treatment: sign of cardiac valvulopathy detected during echocardiography performed before treatment.
· Pregnancy, postpartum or postpartum hypertension.
· Coronary insufficiency.
· Patients with severe psychiatric disorders (and / or psychiatric history) with vascular risk factors or peripheral arterial disease.
· Combination with anti- emetic neuroleptics (see section Interactions with other medicinal products and other forms of interaction ).
· Combination with phenylpropanolamine (see section Interactions with other medicinal products and other forms of interaction ).
Parlodel side effects
Adverse events are ranked in descending order of frequency, as follows: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1 / 10, 000, <1/1000); very rare (<1 / 10, 000), including isolated cases
Uncommon: confusion *, psychomotor agitation *, hallucinations *
Rare: psychotic disorders
These psychiatric disorders can be observed more particularly at high doses and mainly in patients already showing signs of mental deterioration. These disorders require the reduction of the dosage, or even the cessation of treatment.
Cases of pathological gambling (compulsive gambling), hypersexuality and increased libido have been reported since marketing mainly at high dosages (see section 4.4 ).
Central nervous system disorders
Common: headache *, dizziness, slumber *
Uncommon: dyskinesia *
Very rare: excessive daytime sleepiness, sudden onset of sleep
Rare: constrictive pericarditis,
Very rare: cardiac valvulopathy (including regurgitation) and associated disorders (pericarditis and pericardial effusion).
Uncommon: hypotension, orthostatic hypotension * (leading exceptionally to collapse requiring reduction of dosage, or even discontinuation of treatment)
Very rare: reversible pallor of the extremities triggered by cold exposure, especially in patients with a history of Raynaud's syndrome
Common: nasal congestion *
Rare: pleural effusion and pleuropulmonary fibrosis in long-term, high-dose, Parkinsonian patients (see section 4.4 ), pleurisy, dyspnoea
Common: nausea, constipation *, vomiting
Uncommon: Dry mouth *
Rare: abdominal pain, retroperitoneal fibrosis
Skin and subcutaneous tissue disorders
Uncommon: hair loss *, hives, eczema, maculopapular rash, erythematous rash.
Muscle, connective tissue and bone disorders
Uncommon: cramps in the legs *
General disorders and administration site conditions
Rare: peripheral edema
Very rare: syndrome resembling the neuroleptic malignant syndrome in case of abrupt cessation of treatment.
* Usually these unwanted effects (*) are dose-dependent and can be controlled by decreasing the dosage.