Pregabalin clearance is nearly proportional to creatinine clearance (CLcr). Dosage reduction in patients with renal dysfunction is necessary. Following a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%. For patients on hemodialysis, dosing must be modified see Dosage and Administration (2.7).
Are you currently using Pregabalin (Lyrica)?
If you have suicidal thoughts or actions, do not stop pregabalin capsules without first talking to a healthcare provider. Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin see Use in Specific Populations (8.2). Tell patients to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol. 1 Time to worsening of the FIQ was defined as the time to a 1-point increase from double-blind baseline in each of the subscales, and a 5-point increase from double-blind baseline evaluation for the FIQ total score. Subset evaluations of the antiseizure efficacy of pregabalin showed no clinically important differences as a function of age, gender, or race. The drug interaction studies described in this section were conducted in healthy adults, and across various patient populations.
4 Suicidal Behavior and Ideation
- Studies F1 and F2 enrolled patients with a diagnosis of fibromyalgia using the American College of Rheumatology (ACR) criteria (history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites).
- Stop taking pregabalin and contact your healthcare provider if you have this type of swelling.
- Pregabalin may cause suicidal thoughts or actions in a small number of people.
- 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).
- If you have diabetes, weight gain may affect the management of your diabetes.
- A pharmacokinetic study in lactating women detected pregabalin in breast milk at average steady-state concentrations approximately 76% of those in maternal plasma.
However, administration of pregabalin with food has no clinically relevant effect on the total absorption of pregabalin. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin. In the animal fertility study with pregabalin in male rats, adverse reproductive and developmental effects were observed see Nonclinical Toxicology (13.1). The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Pediatric
It may also cause some people to have suicidal thoughts or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away. The dose of this medicine will be different for different patients. The following information includes only the average doses of this medicine.
If pregabalin capsules are discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly. Both the efficacy and adverse event profiles of pregabalin capsules have been shown to be dose-related. The effect of dose escalation rate on the tolerability of pregabalin capsules Pregabalin Oral Route Description has not been formally studied. The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules with gabapentin cannot be offered. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. The usual symptoms of this reaction include swelling of the lips, face, tongue, or throat. Stop taking pregabalin and contact your healthcare provider if you have this type of swelling. If it is causing problems breathing, seek immediate medical attention. Store pregabalin capsules at room temperature, 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) in its original package.
Pregabalin Capsules
- The extent of pregabalin absorption was unaffected by gabapentin coadministration, although there was a small reduction in rate of absorption.
- If you take too much pregabalin capsules, call your healthcare provider or poison control center, or go to the nearest emergency room right away.
- Partial-onset seizures when taken together with other seizure medicines.
- As with all antiepileptic drugs (AEDs), withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders.
- In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended see Adverse Reactions (6.1).
- If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist.
In these patients, visual acuity was reduced in 7% of patients treated with pregabalin, and 5% of placebo-treated patients. Visual field changes were detected in 13% of pregabalin-treated, and 12% of placebo-treated patients. Funduscopic changes were observed in 2% of pregabalin-treated and 2% of placebo-treated patients. Without knowledge of the background incidence and recurrence in similar populations not treated with pregabalin, it is impossible to know whether the incidence seen in these cohorts is or is not affected by treatment. As with all antiepileptic drugs (AEDs), withdraw pregabalin capsules gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. Following abrupt or rapid discontinuation of pregabalin capsules, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.
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 (5.5 and 5.7). The low dose in this study produced a plasma exposure approximately 9 times that in humans receiving the MRD. A no-effect dose for female reproductive toxicity in rats was not established.
Label: PREGABALIN capsule
In the third study (E3), the same total daily dose was divided into two equal doses for one group (twice a day dosing) and three equal doses for another group (three times a day dosing). While the three times a day dosing group in Study E3 performed numerically better than the twice a day dosing group, this difference was small and not statistically significant. Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans There is limited experience with overdose of pregabalin capsules. The highest reported accidental overdose of pregabalin capsules during the clinical development program was 8000 mg, and there were no notable clinical consequences.
The article also discusses the intricacies of administration, pharmacokinetics, and clinical toxicology, spotlighting the imperative role of the interprofessional healthcare team in overseeing pregabalin therapy. Ocular lesions (characterized by retinal atrophy including loss of photoreceptor cells and/or corneal inflammation/mineralization) were observed in two lifetime carcinogenicity studies in Wistar rats. These findings were observed at plasma pregabalin exposures (AUC) greater than or equal to 2 times those achieved in humans given the maximum recommended dose of 600 mg/day.
Pregabalin co-administration (200 mg three times a day) had no effect on the steady-state pharmacokinetics of norethindrone and ethinyl estradiol (1 mg/35 mcg, respectively) in healthy subjects. Gabapentin pharmacokinetics following single- and multiple-dose administration were unaltered by pregabalin co-administration. The extent of pregabalin absorption was unaffected by gabapentin co-administration, although there was a small reduction in rate of absorption. In population pharmacokinetic analyses of the clinical studies in various populations, the pharmacokinetics of pregabalin were not significantly affected by race (Caucasians, Blacks, and Hispanics). In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, an unexpectedly high incidence of hemangiosarcoma was identified in two different strains of mice see Nonclinical Toxicology (13.1).
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. Population pharmacokinetic analyses of the clinical studies showed that the relationship between daily dose and pregabalin drug exposure is similar between genders. Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function. Mean renal clearance was estimated to be 67.0 to 80.9 mL/min in young healthy subjects. Because pregabalin is not bound to plasma proteins this clearance rate indicates that renal tubular reabsorption is involved.