Description

Ramipex 1mg Tablets

Ramipex 1mg tablets contain pramipexole. Therefore, Ramipex helps manage Parkinson’s disease alone or adjunct to levodopa therapy to reduce “end-of-dose” or “on-off” fluctuations in response. As a result, it is a dopamine agonist that treats primary Parkinson’s disease symptoms and Restless Legs Syndrome.

 Therapeutic indications of Ramipex 1mg tablets

RAMIPEX is for the treatment of signs and symptoms of idiopathic Parkinson’s disease. It may be
used as monotherapy or in combination with levodopa.
RAMIPEX is for the symptomatic treatment of idiopathic Restless Legs Syndrome.
4.2 Posology and method of administration
Posology
Parkinson’s disease
The daily dosage is administered in equally divided doses three times per day.

Additional information on special populations

• Dosing patients with concomitant levodopa therapy

Medical personnel should reduce levodopa dosage during the dose-escalation and maintenance treatment with RAMIPEX to avoid excessive dopamine stimulation.

• Dosing in patients with renal impairment

The elimination of pramipexole is dependent on renal function. Use the following dosage scheme for initiation of therapy:-

• Patients with creatinine clearance above 50 ml/min require no reduction in a daily dose.

In patients with creatinine clearance between 20 and 50 ml/min, the initial daily dose of RAMIPEX 1mg tablets should
be administered in two divided doses, starting at 125 µg twice a day.

In patients with a creatinine clearance
of less than 20 ml/min, the daily dose of RAMIPEX should be administered in a single dose, starting at 125
µg daily.
If renal function declines during maintenance therapy, reduce the RAMIPEX 1mg tablets daily dose by the same
percentage as the decline in creatinine clearance, i.e., if creatinine clearance declines by 30%, then reduce the
RAMIPEX daily dose by 30%.

The daily dose can be administered in two divided doses if creatinine
clearance is between 20 and 50 ml/min, and as a single daily dose, if creatinine clearance is less than 20
ml/min.

• Dosing in patients with hepatic impairment

Dose adjustment in patients with hepatic impairment is not necessary.
Restless Legs Syndrome
The recommended starting dose RAMIPEX is 0.125 mg taken once daily 2 – 3 hours before bedtime. For
patients requiring additional symptomatic relief, the dose may be increased every 4 – 7 days to a maximum
of 0.75 mg per day

Special warnings and precautions for use

1. When prescribing RAMIPEX 1mg tablets in a patient with renal impairment, a reduced dose is better.
2. Hallucinations and confusion are side effects of treatment with dopamine agonists and levodopa in
   Parkinson’s disease patients. Care providers should inform patients that (primarily visual) hallucinations could occur.
3. Patients and caregivers should be aware that behavioral changes can occur (e.g., pathological
   gambling, hypersexuality, increased libido, binge eating). Health care professionals should inform patients to
   seek help from their doctor if they, their family, or carer notice that their behavior is unusual.
4. In case of severe cardiovascular disease, patients should take care. It is an excellent recommendation to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
5. Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to
   approximately 6-fold higher). Whether the increased
   risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease,
   is unclear.

Parkinson’s disease

Abrupt withdrawal of dopaminergic therapy show symptoms suggestive of a neuroleptic malignant syndrome.

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