Call your healthcare provider if you have any changes in your eyesight. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
12 Decreased Platelet Count
This decrease in pregabalin oral clearance is consistent with age-related decreases in CLcr. Reduction of pregabalin dose may be required in patients who have age-related compromised renal function see Dosage and Administration (2.7). Pregabalin is known to be substantially excreted by Pregabalin Oral Route Description the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function.
2Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults
In clinical trials in adults with postherpetic neuralgia, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. 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 patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the pregabalin group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each). In controlled studies in adult patients, a higher proportion of patients treated with pregabalin capsules reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin capsules treatment due to vision-related events (primarily blurred vision).
- The following information includes only the average doses of this medicine.
- Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to pregabalin.
- A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.
- Pregabalin is also used in people with epilepsy to treat and prevent seizures, sometimes called convulsions.
5 Management of Neuropathic Pain Associated with Spinal Cord Injury
However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150 to 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%).
Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to pregabalin. The following adverse reactions have been identified during postapproval use of pregabalin capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There are also postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications. In the first study (E1), there was evidence of a dose-response relationship for total daily doses of pregabalin between 150 and 600 mg/day; a dose of 50 mg/day was not effective.
3 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older
The recommended dose of pregabalin capsule is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. 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. Fifty-three percent of the pregabalin-treated subjects compared to 33% of placebo patients remained on study drug and maintained a therapeutic response to Week 26 of the study. Treatment with pregabalin also resulted in a longer time to loss of response based on the FIQ1, and longer time to loss of overall assessment of patient status, as measured by the PGIC2. Off-label applications include generalized anxiety disorder, social anxiety disorder, bipolar disorder, insomnia, and chronic pain conditions not sanctioned by the FDA. This activity prioritizes understanding pregabalin’s mechanism of action, adverse event profile, and other pivotal factors such as off-label uses, dosing, monitoring, and pertinent interactions.
If pregabalin is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
- Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier.
- The baseline mean pain scores across the 3 studies ranged from 6 to 7.
- If you miss a dose of pregabalin extended-release tablets after your evening meal, take it after a snack before you go to bed.
- See “What is the most important information I should know about pregabalin capsules?
- In these cases, your doctor may want to change the dose, or other precautions may be necessary.
1 Important Administration Instructions
† 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. Your doctor may order certain lab tests to check your body’s response to pregabalin. If you have diabetes, you should know that pregabalin has caused skin sores in animals. Pay extra attention to your skin while taking pregabalin, and tell your doctor if you have any sores, redness, or skin problems.
Pregabalin may cause muscle problems, including muscle pain, weakness, and tenderness called myopathy. In some people, the muscle may break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. Stop taking pregabalin and get help right away if you have any of the following symptoms of myopathy or rhabdomyolysis. Pregabalin can cause fluid retention and weight gain, especially when used with other medicines, such as certain medicines used to treat diabetes, like pioglitazone. Contact your healthcare provider if you have swelling in your feet, hands, or legs or if you are gaining weight. Keep pregabalin capsules and all medicines out of the reach of children.
Report behaviors of concern immediately to healthcare providers see Warnings and Precautions (5.4). In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5,000 patients were treated for 6 months or more, over 3,100 patients were treated for 1 year or longer, and over 1,400 patients were treated for at least 2 years. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when co-administering pregabalin and these agents. As with all antiepileptic drugs (AEDs), withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin.
These may be symptoms of a serious muscle problem called myopathy. Read it again each time you refill your prescription in case there is new information. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Risk Summary Small amounts of pregabalin have been detected in the milk of lactating women. A pharmacokinetic study in lactating women detected pregabalin in breast milk at average steady state concentrations approximately 76% of those in maternal plasma. The estimated average daily infant dose of pregabalin from breast milk (assuming mean milk consumption of 150 mL/kg/day) was 0.31 mg/kg/day, which on a mg/kg basis would be approximately 7% of the maternal dose see Data. The study did not evaluate the effects of pregabalin capsules on milk production or the effects of pregabalin capsules on the breastfed infant. Data A pharmacokinetic study in ten lactating women, who were at least 12 weeks postpartum, evaluated the concentrations of pregabalin in plasma and breast milk. Pregabalin 150 mg oral capsule was given every 12 hours (300 mg daily dose) for a total of four doses.
