Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Treatment of idiopathic Parkinson's Disease: Ropinirole may be used alone (without levodopa) in the treatment of idiopathic Parkinson's disease. Addition of ropinirole to levodopa may be used to control "on-off" fluctuations and permit a reduction in the total daily dose of levodopa.

Adult Dosage

Individual dose titration against efficacy and tolerability is recommended.

Ropinirole should be taken three times a day, preferably with meals to improve gastrointestinal tolerance.

Treatment initiation: The initial dose should be 0.25 mg t.i.d. A guide for the titration regimen for the first four weeks of treatment is given in the table below:

Therapeutic regimen: After the initial titration, weekly increments of up to 3 mg/day may be given. Ropinirole is usually given in divided doses three times per day.

If using the “Follow on Titration” pack, follow the proposed titration regime:

A therapeutic response may be seen between 3 and 9 mg/day, although adjunct therapy patients may require higher doses. If sufficient symptomatic control is not achieved, or maintained, the dose of ropinirole may be increased until an acceptable therapeutic response is established. Doses above 24 mg/day have not been investigated in clinical trials and this dose should not be exceeded.

When ropinirole is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be reduced gradually by around 20% in total. In patients with advanced Parkinson's disease receiving ropinirole in combination with L-dopa, dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia.

When switching treatment from another dopamine agonist to ropinirole, the manufacturer's guidance on discontinuation should be followed before initiating ropinirole.

Ropinirole should be discontinued gradually by reducing the number of daily doses over the period of one week.

In parkinsonian patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population

The use of ropinirole in patients with severe renal (creatinine clearance <30 ml/min) or hepatic impairment has not been studied. Administration of ropinirole to such patients is not recommended.

Elderly: The clearance of ropinirole is decreased in patients over 65 years of age, but the dose of ropinirole for elderly patients can be titrated in the normal manner.

Children: Parkinson's disease does not occur in children. The use of ropinirole in this population has therefore not been studied and it should not be given to children.

Child Dosage

Contra Indications

Hypersensitivity to ropinirole or to any of the excipients.

In light of the results of animal studies and the lack of studies in human pregnancy, ropinirole is contra-indicated in pregnancy, lactation and in women of child-bearing potential unless adequate contraception is used.

Special Precautions

Due to the pharmacological action of ropinirole, patients with severe cardiovascular disease should be treated with caution.

Co-administration of ropinirole with anti-hypertensive and anti-arrhythmic agents has not been studied. Caution should be exercised when these compounds are given concomitantly with ropinirole because of the unknown potential for the occurrence of hypotension, bradycardias or other arrhythmias.

Patients with a history or presence of major psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's disease, including ropinirole.

Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's Disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.

Interactions

Neuroleptics and other centrally active dopamine antagonists, such as sulpiride or metoclopramide, may diminish the effectiveness of ropinirole and, therefore, concomitant use of these drugs with ropinirole should be avoided.

No pharmacokinetic interaction has been seen between ropinirole and L-dopa or domperidone which would necessitate dosage adjustment of either drug. No interaction has been seen between ropinirole and other drugs commonly used to treat Parkinson's disease but, as is common practice, care should be taken when adding a new drug to a treatment regimen. Other dopamine agonists may be used with caution.

In a study in parkinsonian patients receiving concurrent digoxin, no interaction was seen which would require dosage adjustment.

It has been established from in vitro experiments that ropinirole is metabolised by the cytochrome P450 enzyme CYP1A2. There is, therefore, the potential for an interaction between ropinirole and substrates (such as theophylline) or inhibitors (such as ciprofloxacin, fluvoxamine and cimetidine) of this enzyme. In patients already receiving ropinirole, the dose of ropinirole may need to be adjusted when these drugs are introduced or withdrawn.

Increased plasma concentrations of ropinirole have been observed in patients treated with high doses of oestrogens. In patients already receiving hormone replacement therapy (HRT), ropinirole treatment may be initiated in the normal manner. However, if HRT is stopped or introduced during treatment with ropinirole, dosage adjustment may be required.

No information is available on the potential for interaction between ropinirole and alcohol. As with other centrally active medications, patients should be cautioned against taking ropinirole with alcohol.

Adverse Reactions

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000), including isolated reports. Common and uncommon events were generally determined from pooled safety data from clinical trial populations of ropinirole and are quoted as excess incidence over placebo. Rare and very rare events were generally determined from post-marketing data and refer to reporting rate rather than true frequency.

The most commonly reported undesirable effects are nausea, somnolence, dyskinesia and syncope.

Adverse Drug Reactions Reported from Patients taking ropinirole

1 Adjunct therapy studies

2 Monotherapy studies

3 Post-marketing data

* In patients with advanced Parkinson's disease, dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia

Manufacturer

Drug Availability

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