Pregabalin - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment.

Discontinue pregabalin capsules immediately in these cases.

Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur.

Discontinue pregabalin capsules immediately in these patients.

Antiepileptic drugs, including pregabalin, the active ingredient in pregabalin capsule, increase the risk of suicidal thoughts or behavior.

Abrupt or rapid discontinuation may increase the risk for seizures.

Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation.

Taper pregabalin capsules gradually over a minimum of 1 week.

Respiratory depression: May occur with pregabalin capsules, when used with concomitant CNS depressants or in the setting of underlying respiratory impairment.

Monitor patients and adjust dosage as appropriate.

Pregabalin capsules may cause dizziness and somnolence and impair patients’ ability to drive or operate machinery.

Pregabalin capsules may cause peripheral edema.

Exercise caution when co-administering pregabalin capsules and thiazolidinedione antidiabetic agents.

5.1 Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin capsules.

Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx).

There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment.

Discontinue pregabalin capsules immediately in patients with these symptoms.

Exercise caution when prescribing pregabalin capsules to patients who have had a previous episode of angioedema.

In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.

5.2 Hypersensitivity There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin capsules.

Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing.

Discontinue pregabalin capsules immediately in patients with these symptoms.

5.3 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin capsule increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions ].

Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.