Medicinal Products

ADARTREL 0.5 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Ropinirole
laboratory: Glaxosmithkline

Coated tablet
Box of 28
All forms

Indication

Symptomatic treatment of moderate to severe Idiopathic Restless Legs Syndrome (see section 5.1 ).

Dosage ADARTREL 0.5 mg Film-coated tablet Box of 28

Oral way.

adults

The dosage should be individually adjusted, depending on efficacy and tolerability.

Ropinirole should be administered at bedtime but not more than 3 hours before bedtime. Ropinirole can be taken during the meal to improve gastrointestinal tolerance.

Start of treatment (week 1):

The recommended starting dose is 0.25 mg once daily (as indicated below) for two days. If this dose is well tolerated, it will be increased to 0.5 mg once a day until the end of the first week.

Continuation of treatment (from week 2):

After the initiation phase of the treatment, the daily dose will be increased until an optimal therapeutic response is obtained. In clinical trials, the average dose used in patients with moderate-to-severe Restless Legs Syndrome was 2 mg once daily.

The dose can be increased to 1 mg once a day by the second week. The dose may then be increased by 0.5 mg per week for the next two weeks until a dose of 2 mg once daily is reached. In some patients, for optimal improvement, the dose may be increased gradually to a maximum of 4 mg once daily. In clinical trials, the dose was increased from 0.5 mg per week to 3 mg once daily and then to 1 mg until the maximum recommended dose of 4 mg once daily. day, as shown in Table 1.

Doses greater than 4 mg once daily have not been studied in patients with Rest Without Leg Syndrome.

Table 1: Dosage Scheme

* To achieve optimal improvement in some patients.

The efficacy of ropinirole has not been demonstrated beyond 12 weeks (see section 5.1 ). After 12 weeks of treatment, the patient's response and the need for further treatment should be re-evaluated.

If the treatment is interrupted for more than a few days, the resumption of treatment should follow the same dosing regimen as described above.

Children and adolescents

ADARTREL is not recommended for children under 18 years of age due to lack of tolerance and efficacy data.

Elderly

The clearance of ropinirole is decreased by approximately 15% in patients 65 years of age and older. Although dose adjustment is not necessary, the dosage of ropinirole should be individually adjusted for optimal clinical response with close monitoring of tolerance.

Renal insufficiency

In patients with mild to moderate renal impairment (creatinine clearance 30-50 ml / min), dosage adjustment is not required.

A study of the use of ropinirole in patients with end-stage renal disease (hemodialysis patients) has shown that dose adjustment in these patients is necessary as described below: the recommended initial dose of ADARTREL is 0.25 mg once a day. Then the dose increases will be based on tolerance and effectiveness. In patients on regular hemodialysis, the maximum recommended dose of ADARTREL is 3 mg daily. After hemodialysis, additional doses are not necessary (see section 5.2 ).

The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml / min) without regular hemodialysis has not been studied.

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

· Severe renal insufficiency (creatinine clearance <30 ml / min) without regular hemodialysis.

· Hepatic insufficiency.

Adartrel Adverse Effects

The undesirable effects listed below are classified by organ system and frequency. Frequencies from clinical trials are determined to have a higher incidence than placebo and are classified as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1 / 1000 to <1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), indeterminate (frequency can not be estimated with available data).

Within each frequency group, adverse effects are presented in order of decreasing severity.

Use of ropinirole in Restless Legs Syndrome

In clinical trials in patients with Restless Legs Syndrome, the most commonly observed adverse events were nausea (approximately 30% of patients). In general, the side effects were mild to moderate and occurred at the start of treatment or when the dose was increased. Few patients have gone out of testing because of adverse effects.

Table 2 below presents the adverse effects reported at a frequency of 1% or more compared to that of placebo in 12-week clinical trials in patients treated with ropinirole, or those reported infrequently but known to be associated with ropinirole.

Table 2: Adverse Reactions Reported in 12-Week Clinical Trials in Patients With Rest Without Leg Syndrome (ropinirole: n = 309, placebo: n = 307)

Psychiatric disorders

· Frequent

Nervousness.

· Rare

Confusion.

Nervous system disorders

· Frequent

Syncope, drowsiness, vertigo.

Vascular disorders

· Rare

Orthostatic hypotension, hypotension.

Gastrointestinal disorders

· Very common

Vomiting, nausea.

· Frequent

Abdominal pain.

General disorders

· Frequent

Tired

Table 3: Adverse Reactions Reported in Other Clinical Trials in Subjects With Restless Legs Syndrome

Psychiatric disorders

· Rare

Hallucinations.

Nervous system disorders

· Frequent

Increase, Bounce in the early morning (see Warnings and precautions for use ).

Management of adverse effects

Dose reduction should be considered if significant adverse events occur. After improvement of the undesirable effect, the dosage can be gradually increased. Anti-nausea drugs that are not centrally acting dopaminergic antagonists, such as domperidone, may be used if necessary.

Other clinical experience with ropinirole

Ropinirole is also indicated for the treatment of Parkinson's disease. Adverse reactions reported with greater incidence than placebo in patients with Parkinson's disease treated with ropinirole, monotherapy or combination therapy, at doses up to 24 mg daily, are presented below.

Table 4: Adverse reactions reported in clinical trials in Parkinson's disease at doses up to 24 mg daily.

Psychiatric disorders

· Frequent

Hallucinations, confusion.

· Rare

Increased libido.

Nervous system disorders

· Very common

Syncope, dyskinesia, drowsiness.

Gastrointestinal disorders

· Very common

Nausea.

· Frequent

Vomiting, abdominal pain, heartburn.

General disorders

· Frequent

Edema of the lower limbs.

Post-marketing data

Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus)

Psychotic reactions (other than hallucinations) including delusions, delusions, paranoia have been observed.

Impulse control disorders (including pathological gambling and hypersexuality), and an increase in libido, have been reported (see Warnings and Precautions section ).

Ropinirole used in Parkinson's disease is associated with somnolence and has been infrequently (≥ 1/1000 to <1/100) associated with excessive daytime sleepiness and sudden onset of sleep onset. However, these effects are very rare (<1 / 10, 000) in Restless Legs Syndrome.

Following ropinirole administration, orthostatic hypotension or hypotension, rarely severe, was reported infrequently (≥ 1/1000 to <1/100).

Very rare cases (<1 / 10, 000) of hepatic reactions, mainly elevated liver enzymes, have been reported.

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