Pregaba ER

Pregaba ER82.5 mg

Tablet

Pregabalin

Opsonin Pharma Ltd.

Product Code : 20251
MRP 250.00
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Medicine overview

Indications of Pregaba ER 82.5 mg

Pregaba ER 82.5 mg is indicated for: Neuropathic pain linked to diabetic peripheral neuropathy is one condition for which Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 mg (GABA). The GABAA, GABAB, or benzodiazepine receptors are not directly bound by it. In the tissues of the central nervous system, Pregaba ER 82.5 mg binds to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) with a high affinity. Pregaba ER 82.5 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 Pregaba ER 82.5 mg

Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 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. Pregaba ER 82.5 mg capsules can be taken without regards to meals.

Dosage of Pregaba ER 82.5 mg

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 mg CR capsule is 330 mg once daily.Postherpetic neuralgia in adults (PHN): The recommended dose of Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 mg CR capsule is 660 mg once daily.Management of fibromyalgia in adults: The recommended dose of Pregaba ER 82.5 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 Pregaba ER 82.5 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 Pregaba ER 82.5 mg may be treated with up to 300 mg two times a day. Conversion from Pregaba ER 82.5 mg capsules to Pregaba ER 82.5 mg CR capsule tablet: When switching from Pregaba ER 82.5 mg capsules to Pregaba ER 82.5 mg CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregaba ER 82.5 mg capsule as prescribed and initiate Pregaba ER 82.5 mg CR capsule therapy after an evening meal.Pregaba ER 82.5 mg tablet total daily dose (dosed 2 or 3 times daily): Pregaba ER 82.5 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 Pregaba ER 82.5 mg

Route of administration: Pregaba ER 82.5 mg is administered orally. Taking it with or without food is acceptable. The Pregaba ER 82.5 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 Pregaba ER 82.5 mg CR after a snack if they forget to take their evening mealtime dose of Pregaba ER 82.5 mg CR. If they forget to take Pregaba ER 82.5 mg CR before going to bed, they should take their regular dose of Pregaba ER 82.5 mg CR after breakfast. They should take their regular dose of Pregaba ER 82.5 mg CR at the regular time that evening after an evening meal if they forget to take their daily dose of Pregaba ER 82.5 mg CR after the morning meal.

Interaction of Pregaba ER 82.5 mg

Drug interaction with medication: There are not anticipated to be many significant pharmacokinetic medication interactions involving Pregaba ER 82.5 mg. No relevant drug-food or other-drug interactions.

Contraindications

Those with a known hypersensitivity to Pregaba ER 82.5 mg or any of its ingredients should not take Pregaba ER 82.5 mg.

Side Effects of Pregaba ER 82.5 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

Pregaba ER 82.5 mg is classified as a C pregnancy drug. Hence, it should only be used if the potential benefits outweigh the hazards to the fetus. Pregaba ER 82.5 mg should only be administered to nursing mothers if the risks are clearly outweighed by the potential benefits. Pregaba ER 82.5 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, Pregaba ER 82.5 mg should be stopped promptly. Also, if hypersensitivity reactions like hives, dyspnea, or wheezing manifest, Pregaba ER 82.5 mg should be stopped right away. Pregaba ER 82.5 mg and other antiepileptic medications raise the chance of having suicidal ideas or actions. Pregaba ER 82.5 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. Pregaba ER 82.5 mg may make a patient drowsy and woozy, making it difficult for them to drive or operate machinery. Pregaba ER 82.5 mg may become more frequent in seizures or have other negative effects if it is abruptly stopped. Pregaba ER 82.5 mg should be discontinued gradually over at least two weeks.

Overdose Effects of Pregaba ER 82.5 mg

Reduced consciousness, melancholy or anxiety, confusional mood, agitation, and restlessness are signs and symptoms of a Pregaba ER 82.5 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

Pregaba ER 82.5 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 Pregaba ER 82.5 mg (GABA). It doesn't directly bind to benzodiazepine, GABAA, or GABAB receptors. In the tissues of the central nervous system, Pregaba ER 82.5 mg binds to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) with a high affinity. Pregaba ER 82.5 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

Pregaba ER 82.5 mg use in expectant women has not been adequately and carefully studied. The potential harm to a fetus should be disclosed to expectant mothers. Pregaba ER 82.5 mg has been found in trace levels in the milk of nursing women. Breastfeeding is not advised while using Pregaba ER 82.5 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. Pregaba ER 82.5 mg extended-release tablet safety and efficacy in pediatric patients have not been shown.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.