- Approval Id
- 802059806f8853a5
- Drug Name
- PREZEL 75 CAPSULE 75MG
- Product Name
- PREZEL 75 CAPSULE 75MG
- Approval Number
- SIN17143P
- Approval Date
- 2024-11-28
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION:</strong><br>
<strong>Posology</strong><br>
The dose range is 150 to 600 mg per day given in either two or three divided doses.</p>
<p><strong>Neuropathic pain</strong><br>
Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.</p>
<p><strong>Epilepsy</strong><br>
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.</p>
<p><strong>Generalised Anxiety Disorder</strong><br>
The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.<br>
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.</p>
<p><strong>Fibromyalgia</strong><br>
The recommended dose of pregabalin is 300 to 450 mg per day. Dosing should begin at 75 mg two times a day (150 mg per day) and may be increased to 150 mg two times a day (300 mg per day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg per day may be further increased to 225 mg two times a day (450 mg per day). Although pregabalin was also studied at 600 mg per day, there is no evidence that this dose confers additional benefit and that this dose was less tolerated.<br>
In view of the dose-dependent adverse reactions, treatment with doses above 450 mg per day is not recommended.</p>
<p><strong>Discontinuation of pregabalin</strong><br>
If pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.</p>
<p><strong>Renal impairment</strong><br>
Dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CL<sub>cr</sub>) (see <strong>Pharmacokinetics, Pharmacokinetics in special patient groups, Renal impairment</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), as indicated in Table 1 determined using the following formula:</p>
<img src="/TGIF/Prezel-Formula1.png" alt="Prezel Dosage Formula 1" /><br><br>
<p>For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment (see Table 1).</p>
<img src="/TGIF/Prezel-Table1.png" alt="Prezel Dosage Table 1" /><br><br>
<p><strong>Hepatic impairment</strong><br>
No dose adjustment is required for patients with hepatic impairment (see <strong>Pharmacokinetics, Pharmacokinetics in special patient groups, Hepatic impairment</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Children and adolescents (12 to 17 years of age)</strong><br>
The safety and efficacy of Pregabalin Capsules in children below the age of 12 years and in adolescents (12–17 years of age) have not been established. The use in children and adolescents is not recommended (see <strong>Preclinical safety data</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Elderly (over 65 years of age)</strong><br>
Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (<strong>see Pharmacokinetics, Pharmacokinetics in special patient groups, Elderly</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of administration</strong><br>
Pregabalin Capsules may be taken with or without food.<br>
Pregabalin Capsules is for oral use only.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS & USAGE:</strong><br>
<strong>Neuropathic Pain</strong><br>
Pregabalin Capsules is indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia, in adults.</p>
<p><strong>Epilepsy</strong><br>
Pregabalin Capsules is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.</p>
<p><strong>Generalised Anxiety Disorder</strong><br>
Pregabalin Capsules is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.</p>
<p><strong>Fibromyalgia</strong><br>
Pregabalin is indicated for the management of fibromyalgia.</p>
- Contraindications
- <p><strong>CONTRAINDICATION:</strong><br>
Hypersensitivity to the active substance or to any of the excipients of the medicine.</p>
- Atc Code
- N02BF02
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
