Lyrica CR 330 mg/1
PREGABALIN · TABLET, FILM COATED, EXTENDED RELEASE · Viatris Specialty LLC
Lyrica CR is a tablet, film coated, extended release containing pregabalin at 330 mg/1, taken oral. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- Lyrica CR
- Generic Name
- PREGABALIN
- NDC Code (Product)
58151-247- Manufacturer
- Viatris Specialty LLC
- Strength
- 330 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- NDA209501
- Marketing Start
- 07/11/2024
Recall History
Viatris
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy • Postherpetic neuralgia Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic neuralgia (PHN) ( 1 ) Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • LYRICA CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. ( 2.1 ) • Dosing recommendations for LYRICA CR: Indication Dosing Regimen Initial Dose Maximum Dose DPN Pain ( 2.2 ) Single dose per day 165 mg/day 330 mg/day within 1 week. PHN ( 2.3 ) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day. • Conversion from LYRICA Capsules or Oral Solution to LYRICA CR: See full prescribing information. ( 2.4 ) • Dose modification recommended in patients with renal impairment. ( 2.5 ) 2.1 Important Dosage and Administration Instructions LYRICA CR should be administered once daily after an evening meal. LYRICA CR should be swallowed whole and should not be split, crushed, or chewed. When discontinuing LYRICA CR, taper gradually over a minimum of 1 week. Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a m…
Contraindications
4 CONTRAINDICATIONS LYRICA CR is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.1 , 5.2) , Adverse Reactions (6) ] . Known hypersensitivity to pregabalin or any of its components. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions [see Clinical Pharmacology (12) ] . The interactions of LYRICA CR with co-administration of other drugs have not been systematically evaluated. Co-administration of the prokinetic drug erythromycin with LYRICA CR did not result in any clinically important changes in the pharmacokinetics of LYRICA CR [see Clinical Pharmacology (12) ] . Additional studies have been performed with LYRICA. No pharmacokinetic interactions were observed between LYRICA and carbamazepine, gabapentin, lamotrigine, oral contraceptive, phenobarbital, phenytoin, topiramate, and valproic acid. A similar lack of pharmacokinetic interactions would be expected to occur with LYRICA CR. Pharmacodynamics Although no pharmacokinetic interactions were seen…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ] Most common adverse reactions reported in greater than or equal to 4% of patients treated with LYRICA CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch…
Frequently Asked Questions
What is Lyrica CR used for?
Lyrica CR contains PREGABALIN. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Lyrica CR a controlled substance?
Yes, Lyrica CR is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Lyrica CR?
The generic name for Lyrica CR is PREGABALIN. There are 12 other brand versions of PREGABALIN.
What is the NDC code for Lyrica CR 330 mg/1?
The NDC (National Drug Code) for Lyrica CR 330 mg/1 is 58151-247, listed by Viatris Specialty LLC.