Pregabalin( LYRICA)

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Lyrica (Pregabalin) is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.It is also used with other medications to treat certain types of seizures (focal seizures).

LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

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Description

DOSAGE AND ADMINISTRATION

Lyrica (Pregabalin) is given orally with or without food.

When discontinuing LYRICA, taper gradually over a minimum of 1 week.

Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
The maximum recommended dose of LYRICA 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. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Although LYRICA 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.

HOW SUPPLIED

Capsules: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, and 300 mg Oral Solution

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Angioedema
Hypersensitivity
Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation
Suicidal Behavior and Ideation
Peripheral Edema
Dizziness and Somnolence
Weight Gain
Tumorigenic Potential
Ophthalmological Effects
Creatine Kinase Elevations
Decreased Platelet Count

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