Supadopa TR 48.75mg+195mg Capsule

✔️ Uses

Treatment of Parkinson

✔️ Dosage & Administration: For Patients Who Have Never Taken Levodopa Before:

• The initial recommended dose for patients new to levodopa therapy is 95 mg of Supadopa TR, taken three times a day for the first three days.
• From the fourth day onward, the dose may be increased to 145 mg three times daily, depending on the patient’s response and tolerance.
• Based on clinical response, the dosage can be further increased up to a maximum of 390 mg per dose, three times a day.
• If necessary, the dosing frequency can be adjusted from three times daily to five times daily, provided the patient tolerates the medication.
• The total maximum allowable daily dose of Supadopa TR is 2,450 mg.
• It is advisable to maintain the lowest effective dose to manage symptoms while minimizing adverse reactions such as dyskinesia and nausea.

✔️ Dosage & Administration: For Patients Switching from Immediate-Release Carbidopa-Levodopa to Supadopa TR:

• The dosage of Supadopa TR is not interchangeable on a 1:1 basis with immediate-release carbidopa-levodopa formulations.
• The total daily levodopa dose from immediate-release formulations should first be calculated before switching to Supadopa TR.
• The recommended conversion dosage is as follows:

• Patients who are already taking a catechol-O-methyl transferase (COMT) inhibitor (such as entacapone) may require a higher initial levodopa dose when switching to Supadopa TR.
• The use of Supadopa TR in combination with other levodopa formulations has not been studied and is therefore not recommended.

✔️ Drug Interactions:

Iron supplements and dopamine D2 receptor antagonists (such as metoclopramide) may reduce the effectiveness of Supadopa TR.

✔️ Contraindications:

• Supadopa TR must not be used in patients currently taking nonselective monoamine oxidase (MAO) inhibitors (such as phenelzine or tranylcypromine).
• A minimum gap of two weeks must be maintained after discontinuing an MAO inhibitor before starting Supadopa TR, as concurrent use may lead to hypertensive crises.

✔️ Possible Side Effects:

The side effects of Supadopa TR vary depending on the stage of Parkinson’s disease.

In Early-Stage Parkinson’s Disease:

The most commonly reported adverse effects (incidence ≥5%) include:

• Nausea
• Dizziness
• Headache
• Insomnia
• Abnormal dreams
• Dry mouth
• Dyskinesia (involuntary movements)
• Anxiety
• Constipation
• Vomiting
• Orthostatic hypotension (drop in blood pressure upon standing)

In Advanced-Stage Parkinson’s Disease:

The most frequently reported side effects in advanced Parkinson’s disease patients, when compared to immediate-release carbidopa-levodopa, include:

• Nausea
• Headache

✔️ Use During Pregnancy & Lactation:

Pregnancy:

• There is insufficient clinical data regarding the safety of Supadopa TR during pregnancy.
• Animal studies have indicated that carbidopa-levodopa may cause developmental toxicity, including teratogenic effects at doses comparable to human usage.
• Supadopa TR should only be used during pregnancy if the potential benefits outweigh the risks.

Lactation:

• Levodopa has been found in human breast milk, whereas the presence of carbidopa is not well-documented.
• The effect of Supadopa TR on infants and breast milk production remains unclear. However, levodopa is known to suppress prolactin secretion, which may inhibit lactation.
• Caution is advised when prescribing this medication to breastfeeding mothers.

✔️ Patients taking Supadopa TR should be closely monitored for:

• Sudden onset of sleep during daily activities
• Withdrawal symptoms, including fever, rigidity, confusion, and autonomic instability
• Cardiovascular events, such as ischemia (restricted blood flow to the heart)
• Hallucinations and psychosis
• Impulse control disorders, including compulsive behaviors
• Dyskinesia (abnormal involuntary movements)
• Peptic ulcer disease
• Glaucoma (increased intraocular pressure)

✔️ Pediatric Use

• The safety and efficacy of Supadopa TR in children have not been established.

✔️ Storage:

• Store in a cool, dry place, away from moisture and direct sunlight.
• Keep out of reach of children to prevent accidental ingestion.