Ramixole 0.25 mg 30 tablets

Ramixole 0.25 mg 30 tablets

Composition

Active ingredient:

Pramipexole dihydrochloride monohydrate 0.25 mg (equivalent to 0.18 mg pramipexole base)

Description

Ramixole is a dopamine receptor agonist indicated for the treatment of Parkinson’s disease and moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. It can be used as monotherapy or in combination with levodopa.

Indications for Use

Treatment of signs and symptoms of idiopathic Parkinson’s disease

Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS)

Dosage and Method of Administration

Parkinson’s disease:

Dose: three equally divided doses per day

Starting dose: 0.264 mg base (0.375 mg salt) daily

Increase by: 0.525 mg base (0.755 mg salt) every 5–7 days

Max dose: 3.3 mg base (4.5 mg salt) per day

Discontinuation: taper by 0.525 mg base daily, then 0.264 mg base daily

Restless Legs Syndrome:

Starting dose: 0.088 mg base (0.125 mg salt) 2–3 hours before bedtime

May increase weekly to 0.525 mg base (0.755 mg salt)

Discontinuation: tapering not required

Renal impairment:

CrCl > 50 ml/min — no adjustment needed

CrCl 20–50 ml/min — 0.088 mg twice daily; max 1.57 mg base

CrCl < 20 ml/min — once daily dosing; max 1.1 mg base

If renal function declines: reduce dose proportionally

Hepatic impairment:

No adjustment generally required

Paediatric population:

Not recommended in children and adolescents under 18 years

Contraindications

Hypersensitivity to pramipexole or any of the excipients

Precautions

Hallucinations, especially visual

Dyskinesia with levodopa combination

Axial dystonia (camptocormia, Pisa syndrome)

Somnolence and sudden sleep onset

Impulse control disorders (gambling, binge eating, hypersexuality)

Mania and delirium

Avoid in psychotic disorders

Ophthalmologic monitoring advised

Monitor blood pressure for postural hypotension

Do not abruptly discontinue due to risk of neuroleptic malignant syndrome

Dopamine agonist withdrawal syndrome: apathy, anxiety, depression, etc.

Augmentation in RLS: earlier onset, worsening of symptoms

Contraindications

Very common (≥1/10):

Nausea

Somnolence

Common (≥1/100 to <1/10):

Headache

Dizziness

Insomnia

Abnormal dreams

Constipation

Vomiting

Fatigue

Peripheral edema

Hallucinations

Libido disorders

Dyskinesia

Amnesia

Hyperkinesia

Visual disturbances (blurred vision, reduced acuity, diplopia)

Postural hypotension

Weight gain or loss

Decreased appetite

Rash

Pruritus

Withdrawal syndrome (apathy, anxiety, depression, fatigue, sweating, pain)

Uncommon (≥1/1000 to <1/100):

Sudden sleep onset

Syncope

Delirium

Mania

Hyperphagia

Delusions

Impulse control disorders, including:

Pathological gambling

Hypersexuality

Compulsive shopping

Binge eating

Visual distortions

Cardiac failure

Dyspnea

Hiccups

Hypersensitivity reactions

Frequency not known:

Pneumonia

Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Pregnancy and Breastfeeding

Pregnancy: Use only if clearly needed

Lactation: Not recommended; may inhibit lactation

Storage Conditions

Store below 30°C in a dry place. Protect from light. Keep out of reach of children.

Packaging

Carton box containing 3 blisters of 10 tablets each with a package insert.