Pregabalin extended-release tablets are usually taken once daily after an evening meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not suddenly stop taking pregabalin without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely. Stopping the medicine suddenly may cause seizures or side effects including changes in behavior, dizziness, diarrhea, nausea, headaches, vomiting, irritability, thoughts of killing oneself, trouble with sleeping, nightmares, or tingling feelings. Pregabalin is used with other medicines to help control partial-onset seizures (convulsions) in the treatment of epilepsy in patients 1 month of age and older.

Clinical experience during pregabalin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans. If you are taking the extended-release tablets and forget to take a dose after your evening meal, take the missed dose before bedtime after a snack. If you miss taking the dose prior to bedtime, take your dose the following day after breakfast.

• Subset evaluations of the antiseizure efficacy of pregabalin capsules showed no clinically important differences as a function of age, gender, or race.
• See the end of this Medication Guide for a complete list of ingredients in pregabalin capsules.
• Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.
• In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate.

3 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older

The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race. ‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Choosing an OTC Pain Reliever: What to Consider

• The effect on offspring survival was pronounced at doses greater than or equal to 1,250 mg/kg, with 100% mortality in high-dose litters.
• 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.
• Single-dose administration of oxycodone (10 mg) had no effect on the steady-state pharmacokinetics of pregabalin.
• Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
• When considering return of pain or withdrawal due to adverse events as loss of response (LTR), treatment with pregabalin resulted in a longer time to loss of therapeutic response than treatment with placebo.

Discontinue pregabalin immediately in patients with these symptoms. Pregabalin may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of pregabalin. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least 1 week.

6 Renal Impairment

Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine. It is very important that your doctor check your and your child’s progress at regular visits, especially for the first few months that you take pregabalin. This is necessary to allow for dose adjustments and to make sure this medicine is working properly. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Clinical Pharmacology

Patients were enrolled who had partial-onset seizures with or without secondary generalization and were not adequately controlled with 1 to 3 concomitant antiepileptic drugs (AEDs). Patients taking gabapentin were required to discontinue gabapentin treatment 1 week prior to entering baseline. During an 8-week baseline period, patients had to experience at least 6 partial-onset seizures with no seizure-free period exceeding 4 weeks. The mean duration of epilepsy was 25 years in these 3 studies and the mean and median baseline seizure frequencies were 22.5 and 10 seizures per month, respectively. Approximately half of the patients were taking 2 concurrent AEDs at baseline.

Pregabalin capsules, 225 mg are supplied as white/light orange, hard gelatin capsule printed with black ink “AN” on cap & “1316” on body. Pregabalin capsules, 300 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1317” on body. This medicine may cause sores or other skin problems (eg, skin ulcers), which may be more likely to occur in patients with diabetes. This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficulty or trouble breathing, or irregular, fast or slow, or shallow breathing. This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention.

4 Suicidal Behavior and Ideation

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Avoid taking pregabalin extended-release tablets on an empty stomach. You can take pregabalin capsules or solution with or without food.

The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. In preclinical studies, pregabalin (S-enantiomer) did not undergo racemization to the R-enantiomer in mice, rats, rabbits, or monkeys. The apparent volume of distribution of pregabalin following oral administration is approximately 0.5 L/kg.

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy see Use in Specific Populations (8.1).

Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin capsules, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day).

Contact your healthcare provider right away if your vision changes. Pregabalin may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Contact your healthcare provider right away Pregabalin Oral Route Description if you have any of the following symptoms. It is believed that pregabalin also blocks abnormal electrical activity in the brain that causes seizures, which slows down the spread of seizures.