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It is not known if Lyrica is safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury. For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if Lyrica is safe and effective in children under 1 month of age.
Stop taking Lyrica and call your healthcare provider right away if you have any of these s of a serious allergic reaction:. If you have suicidal thoughts or actions, do not stop Lyrica without first talking to a healthcare provider. Pregabalin is described chemically as S aminomethyl methylhexanoic acid.
The molecular formula is C 8 H 17 NO 2 and the molecular weight is The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4. It is freely soluble in water and both basic and acidic aqueous solutions. Lyrica pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75,, and mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide.
In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be Pregabalin 50 mg tablets in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1.
In pediatric patients, the recommended dosing regimen is dependent upon body weight.
Based on clinical response and tolerability, dosage may be increased, approximately weekly. Table 1. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with mg two times a day and who tolerate LYRICA may be treated with up to mg two times a day [see Clinical Studies ]. In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal Pregabalin 50 mg tablets, adjust the dose in adult patients with reduced renal function.
Base the dose adjustment in patients with renal impairment on creatinine clearance CLcras indicated in Table 2. Then refer to Table 2 to determine the corresponding renal adjusted dose. For patients undergoing hemodialysisadjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment see Table 2.
White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:. White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:. Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN " on the body, available in:.
White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN " on the body, available in:. Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN " on the body, available in:. Revised: Apr Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Approximately patients were treated for 6 months or more, over patients were treated for 1 year or longer, and over patients were treated for at least 2 years.
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. Overall, Approximately 2. In the LYRICA treatment group, the adverse reactions leading to discontinuation were somnolence 3 patientsworsening of epilepsy 1 patientand hallucination 1 patient. Includes patients less than 30 kg for whom dose was adjusted to 3.
Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. 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. Following is a list of treatment-emergent adverse reactions reported by patients treated with LYRICA during all clinical trials.
The listing does not include Pregabalin 50 mg tablets events already listed in the tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening. Events of major clinical importance are described in the Warnings and Precautions section 5. The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function e. There are also postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
In vitro and in vivo studies showed that LYRICA is unlikely to be involved in ificant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acidlamotrigine, phenytoin, phenobarbital, and topiramate. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when LYRICA was co-administered with these drugs. No clinically important effects on respiration were seen. In the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis.
Specific symptoms included swelling of the face, mouth tongue, lips, and gumsand neck throat and larynx. There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. In addition, patients who are taking other drugs associated with angioedema e. There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA.
Adverse reactions included skin redness, blisters, hives, rash, dyspnea Pregabalin 50 mg tablets, and wheezing. Pooled analyses of placebo-controlled clinical trials mono-and adjunctive therapy of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk adjusted Relative Risk 1.
In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27, AED-treated patients was 0. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the is too small to allow any conclusion about drug effect on suicide.
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. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication.
The risk did not vary substantially by age years in the clinical trials analyzed. 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. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may Pregabalin 50 mg tablets related Pregabalin 50 mg tablets the illness being treated.
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 s and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers. In short-term trials of patients without clinically ificant heart or peripheral vascular diseasethere was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure.
Peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function. In controlled clinical trials, 0. 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. The majority of patients using thiazolidinedione antidiabetic agents in the overall safety database were participants in studies of pain associated with diabetic peripheral neuropathy. Dizziness and somnolence generally began shortly after the initiation of LYRICA therapy and occurred more frequently at higher doses.
Weight gain was not limited to patients with edema [see Peripheral Edema ]. 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, hyperhidrosisand 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 ].
The clinical ificance of this finding is unknown.
Clinical experience during LYRICA's premarketing development provides no direct means to assess its potential for inducing tumors in humans. In clinical studies across various patient populations, comprising patient-years of exposure in patients greater than 12 years of age, new or worsening-preexisting tumors were reported in 57 patients.
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 Pregabalin 50 mg tablets is not affected by treatment. Prospectively planned ophthalmologic testing, including visual acuity testing, formal visual field testing and dilated funduscopic examination, was performed in over patients.
Although the clinical ificance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur. If visual disturbance persists, consider further assessment. In all controlled trials across multiple patient populations, 1. 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.
Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with LYRICA if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or in patients taking other PR prolonging medications.
However, these analyses cannot be considered definitive because of the limited of patients in these. Advise patients that LYRICA may cause angioedema, with swelling of the face, mouth lip, gum, tongue and neck larynx and pharynx that can lead to life-threatening respiratory compromise. Advise patients that LYRICA has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters.
Patients, their caregivers, and families should be counseled that AEDs, Pregabalin 50 mg tablets LYRICA, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Advise patients that concomitant treatment with LYRICA 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. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Inform men being treated with LYRICA who plan to father of the potential risk of male-mediated teratogenicity.
In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical ificance of this finding is uncertain [see Nonclinical Toxicology and Use in specific populations ]. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with LYRICA was observed in clinical trials [see Nonclinical Toxicology ]. A no-effect dose for induction of hemangiosarcomas in mice was not established. Pregabalin was not mutagenic in bacteria or in mammalian cells in vitrowas not clastogenic in mammalian systems in vitro and in vivoand did not induce unscheduled DNA synthesis in mouse or rat hepatocytes.
These included decreased sperm counts and sperm motilityincreased sperm abnormalities, reduced fertility, increased preimplantation embryo loss, decreased litter size, decreased fetal body weights, and an increased incidence of fetal abnormalities. Effects on sperm and fertility parameters were reversible in studies of this duration months. 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. This can be done by calling the toll freeand must be done by patients themselves.
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.Pregabalin 50 mg tablets
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