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You can ask your healthcare provider or pharmacist for information about pregabalin capsules that is written for health professionals. Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin capsules affects you. Talk to your healthcare provider about the best way to feed your baby if you take pregabalin capsules.

3 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation

If you have diabetes, you should pay attention to your skin while taking pregabalin capsules and tell your healthcare provider about any sores or skin problems. Read this Medication Guide before you start taking pregabalin capsules and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist. 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).

Partial Onset Seizures

Prospectively planned ophthalmologic testing, including visual acuity testing, formal visual field testing and dilated funduscopic examination, was performed in over 3,600 patients. In these patients, visual acuity was reduced in 7% of patients treated with pregabalin capsules, and 5% of placebo-treated patients. Visual field changes were detected in 13% of pregabalin capsules-treated, and 12% of placebo-treated patients. Funduscopic changes were observed in 2% of pregabalin capsules-treated and 2% of placebo-treated patients.

Choosing an OTC Pain Reliever: What to Consider

Angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure. You may have a higher chance for swelling and hives if these medicines are taken with pregabalin capsules. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with pregabalin capsules. Any narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam). You may have a higher chance for dizziness and sleepiness if these medicines are taken with pregabalin capsules. Counsel patients that pregabalin may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms.

DOSAGE AND ADMINISTRATION

It is not known if pregabalin capsules are safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury. For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2). Your healthcare provider will tell you how much pregabalin capsules to take and when to take it.

The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Table 9 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the ‘all pregabalin’ treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”. The recommended dose of pregabalin capsules for fibromyalgia is 300 mg to 450 mg/day.

Because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment see Dosage and Administration (2.7). Information describing a clinical study in which efficacy was not demonstrated in patients is approved for Pfizer Inc.’s Pregabalin Oral Route Description Lyrica® (pregabalin) products. Additional pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. The following adverse reactions have been identified during postapproval use of pregabalin.

  • Before using pregabalin, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
  • Therefore, an increase in the metabolism of co-administered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP 3A4 substrates (e.g., midazolam, testosterone) is not anticipated.
  • However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Following repeated administration, steady-state is achieved within 24 to 48 hours.
  • Approximately half of the patients were taking 2 concurrent AEDs at baseline.

5 Dizziness and Somnolence

This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. Pregabalin capsules and alcohol can affect each other and increase side effects such as sleepiness and dizziness. • Do not stop taking pregabalin capsules without talking to your healthcare provider. O Stopping pregabalin capsules suddenly can cause serious problems. O Suicidal thoughts or actions can be caused by things other than medicines.

  • There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.
  • Reduction of pregabalin dose may be required in patients who have age-related compromised renal function see Dosage and Administration (2.7).
  • The average household teaspoon may not hold the right amount of liquid.
  • In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%).

In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients. The recommended dose of pregabalin capsules is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 mg to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter OTC) medicines and herbal or vitamin supplements. Call your doctor if you or your child have any unexplained muscle pain, tenderness, or weakness, especially with a fever.

If you take too much pregabalin capsules, call your healthcare provider or poison control center, or go to the nearest emergency room right away. A secondary outcome measure included the responder rate (proportion of patients with greater than or equal to 50% reduction from baseline in partial seizure frequency). The following figure displays responder rate by dose for two of the studies. Pregabalin oral clearance tended to decrease with increasing age.

In vitro drug interaction studies demonstrate that pregabalin does not induce CYP1A2 or CYP3A4 activity. Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g. theophylline, caffeine) or CYP 3A4 substrates (e.g., midazolam, testosterone) is not anticipated. See “What is the most important information I should know about pregabalin capsules?” Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.