Pregabalin Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

If you have trouble swallowing Lyrica capsules, talk with your doctor or pharmacist. Or, your doctor may have you try a different treatment for your condition. However, it isn’t known what effects, if any, this can have on a breastfed child.

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The use of pregabalin in pediatric patients with compromised renal function has not been studied. Both the efficacy and adverse event profiles of pregabalin have been shown to be dose-related. The effect of dose escalation rate on the tolerability of pregabalin has not been formally studied. The efficacy of adjunctive pregabalin in patients taking gabapentin has not been evaluated in controlled trials.

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In the animal fertility study with pregabalin in male rats, adverse reproductive and developmental effects were observed [see NONCLINICAL TOXICOLOGY (13.1)]. In the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures greater than or equal to 50 times the mean human exposure (AUC (0–24) of 123 μg∙hr/mL) at the MRD. Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

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For children ages 4 years and older, this may be divided into two or three doses per day. After 1 week, your doctor may increase your dosage to 150 mg twice per day (a total of 300 mg per day). Whether or not your dosage is increased will depend on how well the drug is working for you and any side effects that you may experience. A clinical study found that pregabalin (the active drug in Lyrica) was more effective than a placebo in treating the symptoms of RLS.

The relationship is similar in pediatric and adult subjects. When normalized per body weight, CL/F (mL/min/kg) in pediatric subjects weighing less than 30 kg is approximately 40% higher in comparison to subjects weighing greater than or equal to 30 kg [see Dosage and Administration (2.4)]. In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. 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 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Drug forms and administration

During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988. If you’re concerned about sexual side effects during your Lyrica treatment, talk with your doctor. They can help determine the cause and discuss the best treatment for you. If you’re concerned about gaining weight during your treatment, talk with your doctor. You can use this card to save money on most medications available at local U.S. pharmacies. The U.S. Prescription Discount Card provides Americans with significant discounts at all major chains and most independent pharmacies nationwide.

Reduction of pregabalin dose may be required in patients who have age-related compromised renal function [see Dosage and Administration (2.7)]. Population pharmacokinetic analyses of the clinical studies showed that the relationship between daily dose and LYRICA drug exposure is similar between genders. LYRICA (pregabalin) binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Deaths have been reported in the setting of lone LYRICA overdose and in combination with other CNS depressants. LYRICA 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)]. In controlled clinical studies of LYRICA in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older.

Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants. 8.6 Renal Impairment
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)]. Information describing a clinical study in which efficacy was not demonstrated in patients is approved for Pfizer Inc.’s Lyrica® (pregabalin) products. Additional pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see ADVERSE REACTIONS (6.1)]. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of «mild» or «moderate». For patients 1 month to less than 4 years of age, somnolence includes related terms lethargy, sluggishness, and hypersomnia.

• Clinical experience during pregabalin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans.
• 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.
• The value of this card is limited to $250 per month per prescription (“offering period”) or the amount of your co-pay, whichever is less (maximum annual savings of $3000).
• For children ages 4 years and older, this may be divided into two or three doses per day.

One study compared Lyrica taken three times per day with a placebo (a treatment with no active drug). People in this study had diabetic nerve pain as a result of either type 1 or type 2 diabetes. Researchers wanted to see how effective each treatment was at reducing nerve pain. It was noted in clinical trials that some people where can i get generic pregabalin without prescription experienced an increase or decrease in their libido (sex drive) while taking Lyrica. It isn’t known how often this side effect may have occurred in people taking either Lyrica or a placebo (a treatment with no active drug). It’s also not known for certain whether these sexual side effects were due to Lyrica or another cause.