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Prelica 50 mg Cap

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Description

Medicine overview

Indications of Prelica 50 mg

Prelica 50 mg is indicated for: Neuropathic pain linked to diabetic peripheral neuropathy is one condition for which Prelica 50 mg is prescribed (DPN) Neuralgia following shingles (PHN) Treatment of partial-onset seizures in patients older than one month with adjunctive therapy Fibromyalgia neuropathic pain brought on by spinal cord damage. Neuropathic pain linked to diabetic peripheral neuropathy is one condition for which Prelica 50 mg is prescribed (DPN) Neuralgia following shingles (PHN) Treatment of partial-onset seizures in patients older than one month with adjunctive therapy Fibromyalgia the neuropathic pain brought on by spinal cord damage The following conditions are treated with Prelica 50 mg CR tablets: Neuropathic pain brought on by diabetic peripheral neuropathy (DPN) Neuralgia following shingles (PHN)

Theropeutic Class

Supplemental antiepileptic medications

Pharmacology

Gamma-amino butyric acid, an inhibitory neurotransmitter, is the structural basis of the drug Prelica 50 mg (GABA). The GABAA, GABAB, or benzodiazepine receptors are not directly bound by it. In the tissues of the central nervous system, Prelica 50 mg binds to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) with a high affinity. Prelica 50 mg has a 90% oral bioavailability that is dose-independent. In people with normal renal function, it is largely excreted from the body through the kidneys as an unaltered medication with a mean elimination half-life of 6.3 hours.

Dosage & Administration of Prelica 50 mg

Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of Prelica 50 mg is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.Post-herpetic neuralgia: The recommended dose of Prelica 50 mg is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 75 mg two times a day, or 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Adjunctive therapy for adult patients with partial onset seizures: In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.Management of Fibromyalgia: The recommended dose of Prelica 50 mg for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.Neuropathic pain associated with spinal cord injury: The recommended dose range is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Prelica 50 mg capsules can be taken without regards to meals.

Dosage of Prelica 50 mg

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Prelica 50 mg is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Prelica 50 mg CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Prelica 50 mg CR capsule is 330 mg once daily.Postherpetic neuralgia in adults (PHN): The recommended dose of Prelica 50 mg is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Prelica 50 mg, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).Begin dosing of Prelica 50 mg CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Prelica 50 mg CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Prelica 50 mg CR capsule is 660 mg once daily.Management of fibromyalgia in adults: The recommended dose of Prelica 50 mg is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Prelica 50 mg is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Prelica 50 mg may be treated with up to 300 mg two times a day. Conversion from Prelica 50 mg capsules to Prelica 50 mg CR capsule tablet: When switching from Prelica 50 mg capsules to Prelica 50 mg CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Prelica 50 mg capsule as prescribed and initiate Prelica 50 mg CR capsule therapy after an evening meal.Prelica 50 mg tablet total daily dose (dosed 2 or 3 times daily): Prelica 50 mg CR capsule capsule dose (dosed once a day) 75 mg/daily: 82.5 mg/day 150 mg/daily: 165 mg/day 225 mg/daily: 247.5 mg/day 300 mg/daily: 330 mg/day 450 mg/daily: 495 mg/day 600 mg/daily: 660 mg/day

Administration of Prelica 50 mg

Route of administration: Prelica 50 mg is administered orally. Taking it with or without food is acceptable. The Prelica 50 mg CR tablet should be taken after dinner. It shouldn’t be divided, crushed, or chewed; it should be consumed whole. Patients should take their regular dose of Prelica 50 mg CR after a snack if they forget to take their evening mealtime dose of Prelica 50 mg CR. If they forget to take Prelica 50 mg CR before going to bed, they should take their regular dose of Prelica 50 mg CR after breakfast. They should take their regular dose of Prelica 50 mg CR at the regular time that evening after an evening meal if they forget to take their daily dose of Prelica 50 mg CR after the morning meal.

Interaction of Prelica 50 mg

Drug interaction with medication: There are not anticipated to be many significant pharmacokinetic medication interactions involving Prelica 50 mg. No relevant drug-food or other-drug interactions.

Contraindications

Those with a known hypersensitivity to Prelica 50 mg or any of its ingredients should not take Prelica 50 mg.

Side Effects of Prelica 50 mg

Dizziness, somnolence, dry mouth, edema, impaired vision, weight gain, and aberrant thinking (mainly difficulties with concentration/attention) are the most frequent adverse effects in adults. Increased weight and increased hunger are the most frequent adverse reactions in children receiving therapy for partial-onset seizures.

Pregnancy & Lactation

Prelica 50 mg is classified as a C pregnancy drug. Hence, it should only be used if the potential benefits outweigh the hazards to the fetus. Prelica 50 mg should only be administered to nursing mothers if the risks are clearly outweighed by the potential benefits. Prelica 50 mg may be released through breast milk like other medications.

Precautions & Warnings

Angioedema (swelling of the throat, head, and neck, for example) can happen and is sometimes linked to respiratory compromise that requires immediate medical attention. In these circumstances, Prelica 50 mg should be stopped promptly. Also, if hypersensitivity reactions like hives, dyspnea, or wheezing manifest, Prelica 50 mg should be stopped right away. Prelica 50 mg and other antiepileptic medications raise the chance of having suicidal ideas or actions. Prelica 50 mg may cause respiratory depression when used concurrently with CNS depressants or when there is underlying respiratory impairment. Patients must be watched closely, and dosage needs to be modified as necessary. Prelica 50 mg may make a patient drowsy and woozy, making it difficult for them to drive or operate machinery. Prelica 50 mg may become more frequent in seizures or have other negative effects if it is abruptly stopped. Prelica 50 mg should be discontinued gradually over at least two weeks.

Overdose Effects of Prelica 50 mg

Reduced consciousness, melancholy or anxiety, confusional mood, agitation, and restlessness are signs and symptoms of a Prelica 50 mg overdose. As well as heart block and seizures, there have been reports. There isn’t a particular remedy. If necessary, emesis or stomach lavage may be used to try to eliminate any unabsorbed medication; normal safety procedures should be followed to preserve the airway. It is necessary to provide the patient with general supportive care, which includes keeping track of their vital signs and assessing their clinical condition.

Storage Conditions

Maintain in a cool, dry location (below 30°C), away from light and moisture. Keep out of children’s reach.

Use In Special Populations

Prelica 50 mg’s efficacy and safety in pediatric patients have not been shown.

Drug Classes

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Mode Of Action

Gamma-aminobutyric acid, an inhibitory neurotransmitter, is the structural basis of the drug Prelica 50 mg (GABA). It doesn’t directly bind to benzodiazepine, GABAA, or GABAB receptors. In the tissues of the central nervous system, Prelica 50 mg binds to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) with a high affinity. Prelica 50 mg’s mechanism of action is still unknown, although findings from animal research point to a potential role for binding to the alpha2-delta subunit in the drug’s anti-nociceptive and anti-seizure properties.

Pregnancy

Prelica 50 mg use in expectant women has not been adequately and carefully studied. The potential harm to a fetus should be disclosed to expectant mothers. Prelica 50 mg has been found in trace levels in the milk of nursing women. Breastfeeding is not advised while using Prelica 50 mg due to the potential risk of tumorigenicity.

Pediatric Uses

Usage in children and adolescents: Safety and efficacy for the treatment of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with spinal cord injury, and neuropathic pain associated with diabetic peripheral neuropathy in pediatric patients have not been proven. The safety and efficacy of supplementary therapy for partial onset seizures in pediatric children younger than one month of age have not been established. Prelica 50 mg extended-release tablet safety and efficacy in pediatric patients have not been shown.

Brand

Radiant Pharmaceuticals Ltd.