Have or have had depression, mood problems or suicidal thoughts or behavior. Have abused prescription medicines, street drugs, or alcohol in the past. Have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema).
In addition, the orange capsule shells contain red iron oxide and white Pregabalin Oral Route Description capsule shells contain sodium lauryl sulfate. Safety and effectiveness in pediatric patients have not been established. Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using pregabalin in these patients.
Pregabalin can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Having a low level of platelets may increase your risk of bleeding. Tell your healthcare provider if you have any of the following symptoms of low platelet levels. Stop taking pregabalin and get help right away if you have any of the following symptoms of a serious allergic reaction. While less common, the most serious side effects of pregabalin are described below, along with what to do if they happen. Tell your healthcare provider if you have any of these side effects that bother you.
9 Ophthalmological Effects
Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier. Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats. The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in Cmax of approximately 25% to 30% and an increase in Tmax to approximately 3 hours.
DRUG INTERACTIONS
Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea. There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx).
1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
No overall differences in safety and efficacy were observed between these patients and younger patients. Safety and effectiveness in pediatric patients below the age of 1 month have not been established. There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregabalin capsules, 25 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1310” on body. Pregabalin capsules, 50 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1311” on body. Pregabalin capsules, 75 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1312” on body.
Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with pregabalin may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Subset evaluations of the antiseizure efficacy of pregabalin capsules showed no clinically important differences as a function of age, gender, or race. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin capsules are safe and effective in children under 1 month of age.
- Safely throw away any pregabalin capsules that is out of date or no longer needed.
- Pregabalin is eliminated primarily by renal excretion and dose adjustment is recommended for adult patients with renal impairment see Dosage and Administration (2.7) and Clinical Pharmacology (12.3).
- Measure the oral liquid using a marked measuring spoon, oral syringe, or medicine cup.
- However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
- Pregabalin capsules and oral solution are used along with other medications to treat certain types of seizures in adults and children 1 month of age and older.
The extent of pregabalin absorption was unaffected by gabapentin coadministration, although there was a small reduction in rate of absorption. If you miss a dose of pregabalin extended-release tablets after your evening meal, take it after a snack before you go to bed. If you do not take it before bed, take it the next morning after breakfast. If you do not take it after breakfast, take your usual dose after your evening meal. Drinking alcohol while taking pregabalin can increase your risk of side effects such as dizziness and sleepiness. Stopping pregabalin suddenly can increase your risk for seizures or withdrawal reactions such as anxiety, diarrhea, headache, trouble sleeping, and nausea.
Dosage and Administration Section
A pharmacokinetic study in ten lactating women, who were at least 12 weeks postpartum, evaluated the concentrations of pregabalin in plasma and breast milk. The study did not evaluate the effects of pregabalin on milk production. Infants did not receive breast milk obtained during the dosing period, therefore, the effects of pregabalin on the breast fed infant were not evaluated. In controlled clinical trials in adult patients, the incidence of peripheral edema was 6% in the pregabalin group compared with 2% in the placebo group. In controlled clinical trials, 0.5% of pregabalin patients and 0.2% placebo patients withdrew due to peripheral edema.
- Although the clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur.
- Pregabalin capsules, 100 mg are supplied as orange, hard gelatin capsule printed with black ink “AN” on cap & “1313” on body.
- This is necessary to allow for dose adjustments and to make sure this medicine is working properly.
- Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS).
- Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules.
- O Stopping pregabalin capsules suddenly can cause serious problems.
Treatment or Management of Overdose There is no specific antidote for overdose with pregabalin capsules. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Tell your healthcare provider if you develop severe sleepiness or trouble breathing, especially when you start pregabalin or when your dose is increased. Get emergency help right away if you experience any of the following symptoms. 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. Following a dose of radiolabeled pregabalin, approximately 90% of the administered dose was recovered in the urine as unchanged pregabalin.
Safety and efficacy have not been established for other conditions. When discontinuing pregabalin capsules, taper gradually over a minimum of 1 week see Warnings and Precautions (5.3). Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function see Dosage and Administration (2.7).
Do not stop taking pregabalin without talking with your healthcare provider. Your healthcare provider will tell you how to slowly stop pregabalin. Pregabalin may cause heart rhythm problems that can lead to an irregular heartbeat and fainting. In rare cases, this may cause the heart to suddenly stop beating (cardiac arrest). Some people have a higher risk of this, including people with existing heart disease or who take other medicines that affect the heart. Call your healthcare provider right away or go to the nearest emergency room if you experience any of the following serious symptoms of heart rhythm changes.
Pregabalin was detected 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. The study did not evaluate the effects of pregabalin capsules on milk production.