Pexola 0.25mg Tablets

Pexola 0.25mg tablets contains Pramipexole 0.25mg, which treats Parkinson’s disease and restless leg syndrome. It works by increasing the action of dopamine, a chemical messenger that controls movement in the brain.

CLINICAL FEATURES OF PEXOLA 0.25MG TABLETS

Therapeutic indications

PEXOLA tablet treats signs and symptoms of idiopathic Parkinson’s disease in adults. One can use it alone in the course of the disease, when late effects of levodopa begin to decrease, or when the therapeutic effect fluctuates as the change becomes apparent.

Posology and method of administration

Posology/frequency and duration of administration:

PEXOLA ER is an oral release formulation of pramipexole once daily.

Forgotten doses:

Suppose one misses a dose of PEXOLA 0.25mg tablets. Take it within 12 hours of the time that patients should take the amount. If more than 12 hours have passed, skip the missed dose and take it on the next day.

Termination of Treatment:

Sudden discontinuation of dopaminergic treatment may lead to the development of the neuroleptic malignant syndrome.

Application:

Swallow PEXOLA 0.25mg tablets whole with water, do not chew, break, or crush. In addition, one can take the tablets with or without food at the same time every day.

Additional information on specific populations:

Renal failure:

Elimination of pramipexole is dependent on renal function. Use the following dose scheme:

• In patients with creatinine clearance greater than 50 ml/min, reducing the daily dose or dosing frequency is unnecessary.
• Patients with creatinine clearance between 30 and 50 ml/min start treatment every day with 0.35 mg of salt (0.26 mg base) PEXOLA 0.25mg tablets. After one week, the caregiver should be cautious before increasing the dose to the daily administration. In addition, caregivers should carefully evaluate the therapeutic response and tolerability.

If the kidney function decreases during maintenance therapy, caregivers should use the above recommendations.

Hepatic impairment:

Since approximately 90% of the absorbed active substance excretes through the kidneys, dose adjustment in patients with a hepatic impairment will probably not be necessary. However, investigations on the potential effect of liver failure on PEXOLA pharmacokinetics are yet to happen.

Pediatric population:

 The PEXOLA 0.25mg tablets have no use in the pediatric population in Parkinson’s disease.

Special warnings and precautions for the use of pexola 0.25mg tablets

Hallucinations

It is a known side effect of dopamine agonists or levodopa therapy. Caregivers should warn patients that hallucinations (primarily visual) may occur.

Somnolence.

Pramipexole was associated with drowsiness and sudden onset of falling asleep, especially in patients with Parkinson’s disease. Sudden onset of sleep seizures occurring during daily living activities and without any symptoms have are uncommon; this may happen in some cases without awareness or any stimulatory symptoms.

Caregivers should warn patients about this issue. In addition, they should be careful using this medicine, mainly operating vehicles and machines.

Patients who experience drowsiness or sudden sleep seizures should avoid using tools and machinery. It may also be an excellent option to reduce the dose or terminate the treatment. Due to possible additive effects, patients should be careful when taking other sedative drugs or alcohol when using a medication containing pramipexol.

Impulse control disorder

Caregivers should monitor Patients regularly for the possibility of developing impulse control disorders.

Individuals interested in the Care and Treatment of patients should be made aware of the behavioral symptoms of impulse control disorders such as pathological gambling, increased libido, hypersexuality, compulsive spending or shopping, obstructive eating, and over-eating in patients treated with dopamine agonists, including PEXOLA.

If such symptoms develop, the dose should be reduced or stepped down in steps.

Mania and delirium

Patients should monitor and be monitored regularly for the risk of mania and delirium development. Patients and those caring for the patient should be aware that mania and delirium may occur in patients treated with pramipexole. If such symptoms develop, discontinuation of the drug by dose reduction/dose reduction should be an option.

Patients with psychotic disorders

Treatment with dopamine agonists in patients with psychotic disorders should only happen if the potential benefit from treatment is higher than the potential risk. Patients should avoid the simultaneous use of pramipexole and antipsychotic drugs.

Ophthalmological monitoring

In case of regular or visual abnormalities, ophthalmological monitoring should take place.

Severe cardiovascular disease

Patients should take care in case of severe cardiovascular disease. Due to the risk of postural hypotension associated with dopaminergic therapy, it is recommended to monitor blood pressure, especially at the beginning of treatment.

Stool remnants

Some patients have reported residues in their feces that resemble intact PEXOLA ER tablets. If the patient reports such an observation, the doctor should re-evaluate the patient’s response to treatment.

Pregnancy and lactation

General recommendation

Women with childbearing potential /Contraception;  The women with childbearing potential should use contraceptive methods considered medically adequate during treatment.

PEXOLA 0.25mg tablets should not be used unless explicitly necessary during pregnancy. Patients should use it only if its potential benefits outweigh the potential risk to the fetus.

Lactation

Inhibition of lactation often occurs because pramipexole therapy inhibits prolactin secretion in humans.

Patients should not use PEXOLA 0.25mg tablets during breastfeeding. However, if patients cannot avoid its use, discontinue breastfeeding.

Effects on driving and use of machines

PEXOLA 0.25mg tablets can have significant effects on the ability to drive and use machines.

Hallucinations or drowsiness may occur.

Patients who use PEXOLA 0.25mg tablets with tired and sleepy episodes should avoid cautionary activities. Be warned that there is a risk of severe injury or death to himself or others due to impaired eye.

Undesirable effects

Expected adverse reactions

The following adverse reactions are expected during PEXOLA 0.25mg tablets use;

• abnormal dreams.
• Amnesia.
• Behavioral symptoms of impulse control disorders and compulsions, such as overeating, compulsive shopping.
• Hypersexuality, and pathological gambling.
• Heart failure.
• Confusion.
• Constipation. to mention a few.

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