Prelica 25mg Capsule 10pcs

✔️ Prelica Film-Coated Tablets are indicated for the treatment of:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia
• Adjunctive therapy for partial-onset seizures in patients aged 1 month and older
• Fibromyalgia
• Neuropathic pain associated with spinal cord injury

✔️ Prelica Controlled-Release Tablets are indicated for the treatment of:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia

✔️ Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN) in Adults

• Start at 50 mg three times daily (150 mg/day).
• The dosage may be increased to 100 mg three times daily (300 mg/day) within 1 week based on response and tolerability.
• For controlled-release tablets: Start at 165 mg once daily and increase to 330 mg once daily within 1 week, based on response. Maximum dose: 330 mg/day.

✔️ Postherpetic Neuralgia (PHN) in Adults

• Initial dose: 75–150 mg twice daily or 50–100 mg three times daily (150–300 mg/day).
• The dosage may be increased to 300 mg/day within 1 week.
• For patients requiring higher doses, 300 mg twice daily or 200 mg three times daily (600 mg/day) may be prescribed.
• Controlled-release tablets: Start at 165 mg once daily and increase to 330 mg within 1 week. If insufficient pain relief occurs, doses up to 660 mg/day may be considered in select cases.

✔️ Neuropathic Pain Associated with Spinal Cord Injury in Adults

• Start with 75 mg twice daily (150 mg/day).
• Increase to 150 mg twice daily (300 mg/day) within 1 week based on efficacy and tolerability.
• If needed, further increase to 300 mg twice daily (600 mg/day).

✔️ Fibromyalgia in Adults

• Initial dose: 75 mg twice daily (150 mg/day).
• The dosage may be increased to 150 mg twice daily (300 mg/day) within 1 week.
• If needed, increase to 225 mg twice daily (450 mg/day).

✔️ Switching to Controlled-Release Tablets

• On the day of switching, take the usual morning dose of Pregabalin capsules and start the controlled-release tablet after an evening meal. Adjust doses according to the following equivalence:
  • 75 mg/day: 82.5 mg/day
  • 150 mg/day: 165 mg/day
  • 225 mg/day: 247.5 mg/day
  • 300 mg/day: 330 mg/day
  • 450 mg/day: 495 mg/day
  • 600 mg/day: 660 mg/day

✔️ Pediatric use:

Safety and efficacy for managing DPN, PHN, spinal cord injury pain, and fibromyalgia in children and adolescents have not been established.

✔️ Partial-onset seizures:

Safety in infants below 1 month of age is not established.

✔️ Side Effects

Common side effects in adults include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and cognitive difficulties (e.g., trouble concentrating). In pediatric patients treated for partial-onset seizures, increased appetite, and weight gain are common.

✔️ Administration

• Pregabalin is taken orally and may be consumed with or without food.
• Controlled-release tablets should be taken after an evening meal, swallowed whole, without splitting, crushing, or chewing.
• If a dose is missed, follow specific timing instructions to take the medication with food.

When discontinuing Pregabalin, taper the dose gradually over at least 1 week to avoid withdrawal symptoms.

✔️ Drug Interactions

• With medications: No significant pharmacokinetic interactions have been reported.
• With food and others: Not applicable.

✔️ Contraindications

Pregabalin is contraindicated in individuals with known hypersensitivity to the drug or its components.

✔️ Pregnancy and Lactation

• There are no well-controlled studies on Pregabalin use during pregnancy. Pregnant women should be informed of potential risks to the fetus.
• Small amounts of Pregabalin have been found in breast milk. Due to potential tumorigenic risks, breastfeeding is not recommended during treatment.

✔️ Precautions and Warnings

• Angioedema: Pregabalin may cause swelling of the throat, head, and neck, potentially leading to life-threatening respiratory issues. Immediate discontinuation and emergency treatment are necessary.
• Hypersensitivity reactions: If symptoms such as hives, wheezing, or difficulty breathing occur, discontinue immediately.
• Suicide risk: Pregabalin, like other antiepileptic drugs, may increase suicidal thoughts or behavior.
• Respiratory depression: May occur when combined with CNS depressants or in patients with respiratory impairments.
• Peripheral edema: Caution is advised when coadministering Pregabalin with thiazolidinedione antidiabetic agents.

Patients should be cautious when driving or operating machinery due to potential dizziness and drowsiness. Discontinuation of Pregabalin should be gradual to prevent withdrawal or adverse effects.

✔️ Storage Condition

Store below 30°C in a cool, dry place, protected from light and moisture. Keep out of the reach of children.