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NIPRO JMI Pharma Ltd.Product Description
**Active Ingredient & Class**
* **Active Ingredient:** Pregabalin (a GABA structural derivative that binds to central $\alpha_2$-$\delta$ voltage-gated calcium channels)
* **Therapeutic Class:** Primary & Adjunct Anti-epileptic / Anticonvulsant
**Indications & Formulations**
* **Standard Film-Coated Form:** Diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), fibromyalgia, neuropathic pain from spinal cord injury, and adjunctive therapy for partial-onset seizures ($\ge$1 month old).
* **Controlled-Release (CR) Form:** Diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN) in adults.
**Dosage Guidelines & Conversion**
| Condition | Immediate-Release (IR) Dosing | Controlled-Release (CR) Dosing |
| --- | --- | --- |
| **DPN** | Start: 50 mg 3x/day. Max: 300 mg/day. | Start: 165 mg 1x/day. Max: 330 mg/day. |
| **PHN** | Start: 150 mg/day (split 2–3 doses). Max: 600 mg/day. | Start: 165 mg 1x/day. Max: 660 mg/day. |
| **Fibromyalgia** | Start: 75 mg 2x/day. Target/Max: 300–450 mg/day. | *Not indicated for CR.* |
| **Spinal Cord Injury** | Start: 75 mg 2x/day. Target/Max: 150–600 mg/day. | *Not indicated for CR.* |
* **IR to CR Conversion Equivalents (Once Daily CR):**
* 75 mg/day IR $\rightarrow$ 82.5 mg CR
* 150 mg/day IR $\rightarrow$ 165 mg CR
* 225 mg/day IR $\rightarrow$ 247.5 mg CR
* 300 mg/day IR $\rightarrow$ 330 mg CR
* 450 mg/day IR $\rightarrow$ 495 mg CR
* 600 mg/day IR $\rightarrow$ 660 mg CR
**Administration Instructions**
* **IR Tablets:** Taken orally with or without food.
* **CR Tablets:** Take once daily after an evening meal. Swallow whole—do not crush, split, or chew.
* **Discontinuation:** Never stop abruptly. Taper gradually over a minimum of 1 week to avoid withdrawal symptoms or increased seizure frequency.
**Key Safety Considerations**
| Category | Details |
| --- | --- |
| **Contraindications** | Known hypersensitivity to Pregabalin or any excipients. |
| **Common Adverse Effects** | Dizziness, somnolence (sleepiness), dry mouth, blurred vision, weight gain, peripheral edema, and impaired concentration. |
| **Warnings & Risks** | Risk of angioedema, suicidal ideation, and severe respiratory depression (especially when combined with other CNS depressants). |
| **Pregnancy & Breastfeeding** | Potential fetal risk. Breastfeeding is **not recommended** due to active drug excretion in breast milk and tumorigenicity concerns. |
**Storage Conditions**
* Store below 30°C in a dry place, protected from direct light and moisture. Keep safely out of reach of children.
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