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PREGABALIN Capsules, Oral Solution, C-V (GREENSTONE LLC)

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PREGABALIN Capsules, Oral Solution, C-V (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Pregabalin is indicated for:

  • Management of neuropathic pain associated with diabetic peripheral neuropathy
  • Management of...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Pregabalin is given orally with or without food.

When discontinuing pregabalin, taper...

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3 DOSAGE FORMS AND STRENGTHS

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
Oral Solution: 20 mg/mL

[see Description (11) and How...

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4 CONTRAINDICATIONS

Pregabalin 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 pregabalin....

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6 ADVERSE REACTIONS

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

  • Angioedema [see

    6.1 Clinical Trials Experience

    ...

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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

Pregabalin is a Schedule V controlled substance.

Pregabalin is not known to be active at receptor sites...

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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

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO...

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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 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The efficacy of the maximum recommended dose of pregabalin for the management...

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16 HOW SUPPLIED/STORAGE AND HANDLING

25 mg capsules:

White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:

...
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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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...
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 4/2020
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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