There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.The following adverse reactions have been identified during postapproval use of pregabalin. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABAPregabalin is well absorbed after oral administration, is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours.Following oral administration of pregabalin under fasting conditions, peak plasma concentrations occur within 1.5 hours.
In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%).
To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, or diarrhea.
Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms Advise patients that pregabalin has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters.
In the first study (E1), each daily dose was divided into two equal doses (twice a day dosing). In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). The low effect dose for developmental neurotoxicity and reproductive impairment in juvenile rats (50 mg/kg) was associated with a plasma pregabalin exposure (AUC) approximately equal to human exposure at the maximum recommended dose of 600 mg/day.
Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. (For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr ≥60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants.There is no specific antidote for overdose with pregabalin. When discontinuing pregabalin, taper gradually over a minimum of 1 week Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function The maximum recommended dose of pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Breathing problems may be more likely in older adults or in people with COPD.If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.This is not a complete list of side effects and others may occur. In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.Pregabalin undergoes negligible metabolism in humans. Peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function.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. 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.Tell your healthcare provider about any side effect that bothers you or that does not go away.These are not all the possible side effects of Pregabalin Capsules.
Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin.
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