Lyrica is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.
Pregabalin is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.
Pregabalin is used to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection. It may also be used to treat nerve pain caused by spinal cord injury.
This medication is also used to treat pain in people with fibromyalgia. Pregabalin is also used with other medications to treat certain types of seizures (partial onset seizures).
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PREGABALIN is used with other medicines to help control partial-onset seizures (convulsions) in the treatment of epilepsy in patients 1 month of age and older. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it.
Pregabalin can cause a severe allergic reaction. Stop taking pregabalin and seek emergency medical help if you have hives or blisters on your skin, trouble breathing, or swelling in your face, mouth, or throat.
Some people have thoughts about suicide while taking pregabalin. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
If you have diabetes or heart problems, call your doctor if you have weight gain or swelling in your hands or feet while taking pregabalin.
Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms.
HOW TO USE PREGABALIN
Pregabalin is indicated for:
|INDICATION||Dosing Regimen||Maximum Dose|
|DPN Pain||3 divided doses per day||300 mg/day within 1 week|
|PHN||2 or 3 divided doses per day||300 mg/day within 1 week.
Maximum dose of 600 mg/day.
|Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More||2 or 3 divided doses per day||Maximum dose of 600 mg/day.|
|Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg||1 month to less than 4 years:
3 divided doses per day
4 years and older:
2 or 3 divided doses per day
|Fibromyalgia||2 divided doses per day||300 mg/day within 1 week.
Maximum dose of 450 mg/day.
|Neuropathic Pain Associated with Spinal Cord Injury||2 divided doses per day||300 mg/day within 1 week.
Maximum dose of 600 mg/day.
Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention).
Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What is the most important information I should know about PREGABALIN?
PREGABALIN may cause serious side effects including:
These serious side effects are described below:
If you have suicidal thoughts or actions, do not stop PREGABALIN without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
Usual Adult Dose for:
PREGABALIN is given orally with or without food.
When discontinuing PREGABALIN, taper gradually over a minimum of 1 week.
Because PREGABALIN is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function.
The maximum recommended dose of PREGABALIN is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing 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.
Although PREGABALIN was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended.
The recommended dose of PREGABALIN 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. Begin dosing 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 PREGABALIN, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily.
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
|Age and Body Weight||Recommended Initial Dosage||Recommended Maximum Dosage||Frequency of Administration|
|Adults (17 years and older)||150 mg/day||600 mg/day||2 or 3 divided doses|
|Pediatric patients weighing 30 kg or more||2.5 mg/kg/day||10 mg/kg/day
(not to exceed 600 mg/day)
|2 or 3 divided doses|
|Pediatric patients weighing less than 30 kg||3.5 mg/kg/day||14 mg/kg/day||1 month to less than 4 years of age:
3 divided doses
4 years of age and older:
2 or 3 divided doses
Both the efficacy and adverse event profiles of PREGABALIN have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of PREGABALIN has not been formally studied.
The efficacy of adjunctive PREGABALIN in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of PREGABALIN with gabapentin cannot be offered.
The recommended dose of PREGABALIN for fibromyalgia is 300 to 450 mg/day. Begin dosing 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). Although PREGABALIN was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended.
The recommended dose range of PREGABALIN for the treatment of neuropathic pain associated with spinal cord injury 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 PREGABALIN may be treated with up to 300 mg two times a day
In view of dose-dependent adverse reactions and since PREGABALIN is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of PREGABALIN in pediatric patients with compromised renal function has not been studied.
Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient's CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:
Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.
(For example: A patient initiating PREGABALIN therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment
|Creatinine Clearance (CLcr)
|Total Pregabalin Daily Dose
|TID= Three divided doses; BID = Two divided doses; QD = Single daily dose.|
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