Prescription Drug Information: Pregabalin (Page 8 of 10)

14.5 Management of Neuropathic Pain Associated with Spinal Cord Injury

The efficacy of pregabalin for the management of neuropathic pain associated with spinal cord injury was established in two double-blind, placebo-controlled, multicenter studies. Patients were enrolled with neuropathic pain associated with spinal cord injury that persisted continuously for at least three months or with relapses and remissions for at least six months. A total of 63% of patients completed study 1 and 84% completed study 2. The patients had a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). The baseline mean pain scores across the two studies ranged from 6.5 to 6.7.

Patients were allowed to take opioids, non-opioid analgesics, antiepileptic drugs, muscle relaxants, and antidepressant drugs if the dose was stable for 30 days prior to screening. Patients were allowed to take acetaminophen and nonsteroidal anti-inflammatory drugs during the studies.

Study SCI 1: This 12-week, randomized, double-blind, parallel-group, multicenter, flexible dose (150-600 mg/day) study compared pregabalin with placebo. The 12-week study consisted of a 3­ week dose adjustment phase and a 9-week dose maintenance phase. Treatment with pregabalin150-600 mg/day statistically significantly improved the endpoint weekly mean pain score, and increased the proportion of patients with at least a 30% and 50% reduction in pain score from baseline. The fraction of patients achieving various levels of improvement in pain intensity from baseline to Week 12 is presented in Figure 11. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the study.

Figure 11: Patients Achieving Various Levels of Improvement in Pain Intensity – Study SCI 1

fig-11
(click image for full-size original)
Study SCI 2: This 16-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, flexible dose (150-600 mg/day, in increments of 150 mg) study compared the efficacy, safety and tolerability of pregabalin with placebo. The 16-week study consisted of a 4­-week dose adjustment phase and a 12-week dose maintenance phase. Treatment with pregabalin statistically significantly improved the endpoint weekly mean pain score, and increased the proportion of patients with at least a 30% and 50% reduction in pain score from baseline. The fraction of patients achieving various levels of improvement in pain intensity from baseline to Week 16 is presented in Figure 12. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the study.

Figure 12: Patients Achieving Various Levels of Improvement in Pain Intensity – Study SCI 2

fig-12
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

25 mg capsules:

White to off White color granular powder filled in Size “4” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “25” with black ink available in:

Bottles of 90: NDC 72205-011-90

Bottles of 1000: NDC 72205-011-99

Unit-Dose Blister Packages of 100: NDC 72205-011-06

50 mg capsules:

White to off White color granular powder filled in Size “4” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “50” with black ink available in:

Bottles of 90: NDC 72205-012-90

Bottles of 1000: NDC 72205-012-99

Unit-Dose Blister Packages of 100: NDC 72205-012-06

75 mg capsules

White to off White color granular powder filled in Size “4” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “75” with black ink available in:

Bottles of 90: NDC 72205-013-90

Bottles of 1000: NDC 72205-013-99

Unit-Dose Blister Packages of 100: NDC 72205-013-06

100 mg capsules:

White to off White color granular powder filled in Size “3” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “100” with black ink available in:

Bottles of 90: NDC 72205-014-90

Bottles of 1000: NDC 72205-014-99

Unit-Dose Blister Packages of 100: NDC 72205-014-06

150 mg capsules:

White to off White color granular powder filled in Size “2” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “150” with black ink available in:

Bottles of 90: NDC 72205-015-90

Bottles of 500: NDC 72205-015-05

Unit-Dose Blister Packages of 100: NDC 72205-015-06

200 mg capsules:

White to off White color granular powder filled in Size “1” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “200” with black ink available in:

Bottles of 90: NDC 72205-016-90

Bottles of 1000: NDC 72205-016-99

Unit-Dose Blister Packages of 100: NDC 72205-016-06

225 mg capsules:

White to off White color granular powder filled in Size “1” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “225” with black ink available in:

Bottles of 90: NDC 72205-017-90

Bottles of 1000: NDC 72205-017-99

Unit-Dose Blister Packages of 100: NDC 72205-017-06

300 mg capsules:

White to off White color granular powder filled in Size “0” hard gelatin capsules with White Opaque body imprinted “PGBN” and light blue Opaque cap imprinted “300” with black ink available in:

Bottles of 90: NDC 72205-018-90

Bottles of 500: NDC 72205-018-05

Unit-Dose Blister Packages of 100: NDC 72205-018-06

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)].

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 (5.3)].
Respiratory Depression
Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [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 (5.5)].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 respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.4, 5.5) and Drug Interactions (7)].Advise patients to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol.
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 (5.6)].
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.

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 (5.7 and 5.8)].

Ophthalmological Effects
Counsel patients that pregabalin capsule may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [ see Warnings and Precautions (5.10)].

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 (5.11)].

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)].

Manufactured by:
MSN Laboratories Private Limited
Telangana – 509 228, INDIA

Distributed by:
Novadoz Pharmaceuticals LLC
Piscataway, NJ 08854-3714

Issued on: June 2020

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