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07.06.2014

Lyrica treat tinnitus, tinnitus treatment journal - Plans Download

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Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see Dosage and Administration (2.6)]. The effect of dose escalation rate on the tolerability of Lyrica has not been formally studied. The efficacy of add-on Lyrica in patients taking gabapentin has not been evaluated in controlled trials. In view of dose-dependent adverse reactions and since Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.
Lyrica is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. There have been postmarketing reports of angioedema in patients during initial and chronic treatment with Lyrica. Exercise caution when prescribing Lyrica to patients who have had a previous episode of angioedema.
There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with Lyrica.
As with all AEDs, withdraw Lyrica gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. Antiepileptic drugs (AEDs), including Lyrica, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed.
Anyone considering prescribing Lyrica or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Inform patients, their caregivers, and families that Lyrica and other AEDs increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
In controlled clinical trials the incidence of peripheral edema was 6% in the Lyrica group compared with 2% in the placebo group. Higher frequencies of weight gain and peripheral edema were observed in patients taking both Lyrica and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone.
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 Lyrica in these patients. In the Lyrica controlled trials, dizziness was experienced by 30% of Lyrica-treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of Lyrica-treated patients compared to 8% of placebo-treated patients. Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of Lyrica-associated weight gain are unknown. While the effects of Lyrica-associated weight gain on glycemic control have not been systematically assessed, in controlled and longer-term open label clinical trials with diabetic patients, Lyrica treatment did not appear to be associated with loss of glycemic control (as measured by HbA1C). Following abrupt or rapid discontinuation of Lyrica, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.
In standard preclinical in vivo lifetime carcinogenicity studies of Lyrica, an unexpectedly high incidence of hemangiosarcoma was identified in two different strains of mice [see Nonclinical Toxicology (13.1)]. In controlled studies, a higher proportion of patients treated with Lyrica reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing.


In all controlled and uncontrolled trials across various patient populations during the premarketing development of Lyrica, more than 10,000 patients have received Lyrica. In premarketing controlled trials of all populations combined, 14% of patients treated with Lyrica and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with Lyrica and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. Table 3 lists all adverse reactions, regardless of causality, occurring in ≥1% of patients with neuropathic pain associated with diabetic neuropathy in the combined Lyrica group for which the incidence was greater in this combined Lyrica group than in the placebo group. In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with Lyrica and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. Table 4 lists all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined Lyrica group for which the incidence was greater in this combined Lyrica group than in the placebo group. Approximately 15% of patients receiving Lyrica and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions.
Table 5 lists all dose-related adverse reactions occurring in at least 2% of all Lyrica-treated patients.
Consequently, dosing recommendations for the use of Lyrica with gabapentin cannot be offered. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 1). Inform patients that Lyrica-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery [see Patient Counseling Information (17.5)]. Dizziness and somnolence generally began shortly after the initiation of Lyrica therapy and occurred more frequently at higher doses.
In Lyrica controlled clinical trials of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of Lyrica-treated patients and 2% of placebo-treated patients. In a cohort of 333 diabetic patients who received Lyrica for at least 2 years, the average weight gain was 5.2 kg. Taper Lyrica gradually over a minimum of 1 week rather than discontinuing the drug abruptly. Without knowledge of the background incidence and recurrence in similar populations not treated with Lyrica, it is impossible to know whether the incidence seen in these cohorts is or is not affected by treatment. Less than 1% of patients discontinued Lyrica treatment due to vision-related events (primarily blurred vision).
In these patients, visual acuity was reduced in 7% of patients treated with Lyrica, and 5% of placebo-treated patients.
Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years. In the Lyrica treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the Lyrica treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In the Lyrica treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%).


In the Lyrica treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Few patients treated with Lyrica (0.3%) withdrew from controlled trials due to weight gain. Clinical experience during Lyrica's premarketing development provides no direct means to assess its potential for inducing tumors in humans. Visual field changes were detected in 13% of Lyrica-treated, and 12% of placebo-treated patients. In these studies, 758 patients received Lyrica and 294 patients received placebo for up to 12 weeks. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Lyrica may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)]. In Lyrica-treated patients reporting these adverse reactions in short-term, controlled studies, dizziness persisted until the last dose in 30% and somnolence persisted until the last dose in 42% of patients [see Drug Interactions (7)]. Lyrica associated weight gain was related to dose and duration of exposure, but did not appear to be associated with baseline BMI, gender, or age. Funduscopic changes were observed in 2% of Lyrica-treated and 2% of placebo-treated patients. Three Lyrica treated subjects had events reported as rhabdomyolysis in premarketing clinical trials.
Other adverse reactions that led to discontinuation from controlled trials more frequently in the Lyrica group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each). Other reasons for discontinuation from the trials, occurring with greater frequency in the Lyrica group than in the placebo group, were asthenia, confusion, and peripheral edema.
Other reasons for discontinuation from the trials, occurring in greater frequency in the Lyrica group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each). Other adverse reactions that led to discontinuation of at least 1% of patients in the Lyrica group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients). Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to Lyrica alone, or the combination of Lyrica and other AEDs. The relationship between these myopathy events and Lyrica is not completely understood because the cases had documented factors that may have caused or contributed to these events.
In randomized controlled trials, Lyrica was not associated with an increase in bleeding-related adverse reactions. Discontinue treatment with Lyrica if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.



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