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LYRICA® CR, CV (pregabalin extended-release)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

LYRICA® CR, CV Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

LYRICA CR should be administered once daily after an evening meal.

LYRICA CR...

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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...

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5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific...

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

  • Angioedema [see

    6.1 Clinical Trials Experience

    Because...

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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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

LYRICA CR contains pregabalin, a Schedule V controlled substance.

...
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10 OVERDOSAGE

Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans

In the postmarketing experience, the most commonly...

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11 DESCRIPTION

LYRICA CR (pregabalin extended-release) tablets are for oral use and contain pregabalin. Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Management of Postherpetic Neuralgia (Study PHN CR)

Support for efficacy of LYRICA CR for the management of PHN and diabetic peripheral...

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16 HOW SUPPLIED/STORAGE AND HANDLING

LYRICA CR is supplied in the following strengths and package configurations:

...
LYRICA CR Tablets
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Angioedema...

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...
MEDICATION GUIDE
LYRICA (LEER-i-kah) CR
(pregabalin)
extended-release tablets, CV
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

...

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