therpetic Neuralgia
2.3 Adjunctive Therapy for Adult Patients with Partial Onset Seizures
2.4 Management of Fibromyalgia
2.5 Neuropathic Pain Associated with Spinal Cord Injury
2.6 Patients with Renal Impairment
2.7 Oral Solution Concentration and Dispensing
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Angioedema
5.2 Hypersensitivity
5.3 Withdrawal of Antiepileptic Drugs (AEDs)
5.4 Suicidal Behavior and Ideation
5.5 Peripheral Edema
5.6 Dizziness and Somnolence
5.7 Weight Gain
5.8 Abrupt or Rapid Discontinuation
5.9 Tumorigenic Potential
5.10 Ophthalmological Effects
5.11 Creatine Kinase Elevations
5.12 Decreased Platelet Count
5.13 PR Interval Prolongation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
14.2 Postherpetic Neuralgia
14.3 Adjunctive Therapy for Adult Patients with Partial Onset Seizures
14.4 Management of Fibromyalgia
14.5 Management of Neuropathic Pain Associated with Spinal Cord Injury
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Medication Guide
17.2 Angioedema
17.3 Hypersensitivity
17.4 Suicidal Thinking and Behavior
17.5 Dizziness and Somnolence
17.6 Weight Gain and Edema
17.7 Abrupt or Rapid Discontinuation
17.8 Ophthalmological Effects
17.9 Creatine Kinase Elevations
17.10 CNS Depressants
17.11 Alcohol
17.12 Pregnancy
17.13 Lactation
17.14 Male Fertility
17.15 Dermatopathy
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
LYRICA is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for adult patients with partial onset seizures
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
2 DOSAGE AND ADMINISTRATION
LYRICA is given orally with or without food.
When discontinuing LYRICA, taper gradually over a minimum of 1 week.
2.1 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 [see DOSAGE AND ADMINISTRATION (2.6)].
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 o
