Pregabalin (Page 10 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Pregabalin Capsules are available containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of pregabalin, USP.

25 mg capsules are opaque white/opaque white, size ‘4’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘140’ on body with black ink, filled with white to off-white powder.

NDC 46708-119-30 bottle of 30 capsules

NDC 46708-119-90 bottle of 90 capsules

NDC 46708-119-91 bottle of 1000 capsules

NDC 46708-119-10 carton of 100 (10 x 10) unit-dose capsules

50 mg capsules are opaque white/opaque orange, size ‘2’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘141’ on body with black ink, filled with white to off-white powder.

NDC 46708-120-30 bottle of 30 capsules

NDC 46708-120-90 bottle of 90 capsules

NDC 46708-120-91 bottle of 1000 capsules

NDC 46708-120-10 carton of 100 (10 x 10) unit-dose capsules

75 mg capsules are opaque white/orange opaque, size ‘4’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘142’ on body with black ink, filled with white to off-white powder.

NDC 46708-121-30 bottle of 30 capsules

NDC 46708-121-90 bottle of 90 capsules

NDC 46708-121-91 bottle of 1000 capsules

NDC 46708-121-10 carton of 100 (10 x 10) unit-dose capsules

100 mg capsules are orange opaque/orange opaque, size ‘3’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘143’ on body with black ink, filled with white to off-white powder.

NDC 46708-122-30 bottle of 30 capsules

NDC 46708-122-90 bottle of 90 capsules

NDC 46708-122-91 bottle of 1000 capsules

NDC 46708-122-10 carton of 100 (10 x 10) unit-dose capsules

150 mg capsules are opaque white/opaque white, size ‘2’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘144’ on body with black ink, filled with white to off-white powder.

NDC 46708-123-30 bottle of 30 capsules

NDC 46708-123-90 bottle of 90 capsules

NDC 46708-123-91 bottle of 1000 capsules

NDC 46708-123-10 carton of 100 (10 x 10) unit-dose capsules

200 mg capsules are orange/orange, size ‘1’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘145’ on body with black ink, filled with white to off-white powder.

NDC 46708-124-30 bottle of 30 capsules

NDC 46708-124-90 bottle of 90 capsules

NDC 46708-124-91 bottle of 1000 capsules

NDC 46708-124-10 carton of 100 (10 x 10) unit-dose capsules

225 mg capsules are opaque white/light orange, size ‘1’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘146’ on body with black ink, filled with white to off-white powder.

NDC 46708-125-30 bottle of 30 capsules

NDC 46708-125-90 bottle of 90 capsules

NDC 46708-125-91 bottle of 1000 capsules

NDC 46708-125-10 carton of 100 (10 x 10) unit-dose capsules

300 mg capsules are opaque white/orange, size ‘0’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘147’ on body with black ink, filled with white to off-white powder.

NDC 46708-126-30 bottle of 30 capsules

NDC 46708-126-90 bottle of 90 capsules

NDC 46708-126-71 bottle of 500 capsules

NDC 46708-126-10 carton of 100 (10 x 10) unit-dose capsules

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

17 PATIENT COUNSELING INFORMATION

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

Angioedema

Advise patients that pregabalin may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients that pregabalin has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2) ].

Adverse Reactions with Abrupt or Rapid Discontinuation

Advise patients to take pregabalin as prescribed. Abrupt or rapid discontinuation may result in increased seizure frequency in patients with seizure disorders, and insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea [see Warnings and Precautions (5.3)].

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including pregabalin, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.4)].

Dizziness and Somnolence

Counsel patients that pregabalin may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on pregabalin to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.6)].

Weight Gain and Edema

Counsel patients that pregabalin may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure [see Warnings and Precautions (5.5 and 5.7)].

Ophthalmological Effects

Counsel patients that pregabalin may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.9)].

Creatine Kinase Elevations

Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever [see Warnings and Precautions (5.10)].

CNS Depressants

Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as somnolence [see Warnings and Precautions (5.6) and Drug Interactions (7)].

Alcohol

Tell patients to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol.

Missed Dose

Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin[ see Use in Specific Populations (8.2)].

Male Fertility

Inform men being treated with pregabalin who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain [see Nonclinical Toxicology (13.1) and Use in Specific Populations (8.3)].

Dermatopathy

Instruct diabetic patients to pay particular attention to skin integrity while being treated with pregabalin and to inform their healthcare provider about any sores or skin problems. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with pregabalin was observed in clinical trials [see Nonclinical Toxicology (13.2)].

Alembic Pharmaceuticals Limited
Manufactured in India

Revised: 01/2023