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Parlodel

Parlodel Dosage/Direction for Use

bromocriptine

Manufacturer:

Novartis Farma

Distributor:

Sandoz
Full Prescribing Info
Dosage/Direction for Use
Tablets or capsules (standard forms): Parlodel should always be taken with food.
General target population: Adults: Parkinson's disease: In order to ensure optimal tolerability, treatment should be started with a low dose of 1.25 mg (½ tablet) per day, given preferably in the evening, for the first week. Parlodel should be titrated slowly in order to arrive at the minimal effective dose for each patient. The daily dosage should be increased gradually by 1.25 mg/day each week, and given as 2 to 3 divided doses. An adequate therapeutic response may be reached within 6 to 8 weeks; if it is not, the daily dose may be further increased by 2.5 mg/day each week.
The usual therapeutic range for monotherapy or combined therapy is 10-40 mg bromocriptine per day, but higher doses may be required in some patients.
Should undesirable reactions occur during the titration phase, the daily dose should be reduced and maintained at the lower level for at least a week. If the adverse reactions disappear, the dose can be increased again.
For patients exhibiting motor disorders on levodopa therapy, it is suggested that the levodopa dosage should be reduced before Parlodel treatment is initiated. When a satisfactory response to Parlodel has been obtained, a further stepwise reduction in levodopa dosage can be made. In certain patients, levodopa may be withdrawn completely.
Prolactinomas: 1.25 mg (½ tablet) 2 or 3 times daily, gradually increasing to several tablets or capsules daily as required to keep plasma prolactin adequately suppressed.
Acromegaly: Initially 1.25 mg (½ tablet) 2 or 3 times daily, gradually increasing to 10 to 20 mg daily, depending on clinical response and side effects.
Hyperprolactinemia in men: 1.25 mg (½ tablet) 2 or 3 times daily, gradually increasing to 5 to 10 mg per day.
Menstrual cycle disorders, female infertility: 1.25 mg (½ tablet) 2 or 3 times daily; if this proves inadequate, gradually increase to 2.5 mg 2 or 3 times daily. Continue treatment until the menstrual cycle has returned to normal and/or ovulation is restored. If required, treatment may be continued over several cycles to prevent relapse.
Inhibition of lactation for medical reasons: On the first day, 1.25 mg (½ tablet) with food in the morning and evening, followed by 2.5 mg (1 tablet) twice a day for 14 days. To prevent the onset of lactation, treatment should be instituted within a few hours of parturition or abortion, but not before vital signs have stabilised. Slight milk secretion occasionally occurs 2 or 3 days after treatment has been withdrawn. This can be stopped by resuming treatment at the same dosage for a further week.
Incipient puerperal mastitis: Same dosage as for inhibition of lactation. An antibiotic should be added to the regimen, as required.
Pediatric patients (aged 7-17 years): Prolactinomas: Pediatric population older than 7 years: 1.25 mg (½ tablet) 2 or 3 times daily, gradually increasing to several tablets or capsules daily as required to keep plasma prolactin adequately suppressed. Maximum daily dose recommended in children aged 7 to 12 years is 5 mg. Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Acromegaly: Pediatric population older than 7 years: Initially 1.25 mg (½ tablet) 2 or 3 times daily, gradually increasing to several tablets or capsules daily, depending on clinical response and side effects. Maximum daily dose recommended in children aged 7 to 12 years is 10 mg. Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Special populations: Geriatric patients (aged 65 years of age or above): Even though no variation in efficacy or adverse reaction profile in elderly patients taking Parlodel has been observed, greater sensitivity in some elderly individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, starting at the lower end of the dose range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy in this population.
Renal impairment: No studies have been performed in renally impaired patients.
Hepatic impairment: No studies have been performed in hepatically impaired patients.
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