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IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

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, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs), including LYRICA, increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately 1 patient for every 530 patients treated with an AED.

There is evidence from case reports, human studies, and animal studies associating LYRICA with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe LYRICA with another CNS depressant, particularly an opioid, or to prescribe LYRICA to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating LYRICA at a low dose.

There is more limited evidence from case reports, animal studies, and human studies associating LYRICA with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.

The most common adverse reactions across all LYRICA clinical trials in adults were dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention). The most common adverse reactions in pediatric patients for the treatment of partial-onset seizures were somnolence, weight gain, and increased appetite.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks, such as driving or operating complex machinery, until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

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. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema, such as angiotensin-converting enzyme inhibitors (ACE inhibitors), may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

As with all antiepileptic drugs (AEDs), withdraw LYRICA gradually over a minimum of 1 week to lessen the potential of increased seizure frequency in patients with seizure disorders.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for adult patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment. The use of LYRICA in pediatric patients with compromised renal function has not been studied.

Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

If LYRICA is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients greater than 12 years of age, new or worsening preexisting tumors were reported in 57 patients.

LYRICA is available in doses ranging from 25 mg to 300 mg and as a 20 mg/mL oral solution.

INDICATIONS

LYRICA is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, management of fibromyalgia, and management of neuropathic pain associated with spinal cord injury in adult patients, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.

Please see Full Prescribing Information and Medication Guide.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy

IMPORTANT SAFETY INFORMATION

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

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, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs), including LYRICA, increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately 1 patient for every 530 patients treated with an AED.

There is evidence from case reports, human studies, and animal studies associating LYRICA with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe LYRICA with another CNS depressant, particularly an opioid, or to prescribe LYRICA to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating LYRICA at a low dose.

There is more limited evidence from case reports, animal studies, and human studies associating LYRICA with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.

The most common adverse reactions across all LYRICA clinical trials in adults were dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention). The most common adverse reactions in pediatric patients for the treatment of partial-onset seizures were somnolence, weight gain, and increased appetite.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks, such as driving or operating complex machinery, until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

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. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema, such as angiotensin-converting enzyme inhibitors (ACE inhibitors), may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

As with all antiepileptic drugs (AEDs), withdraw LYRICA gradually over a minimum of 1 week to lessen the potential of increased seizure frequency in patients with seizure disorders.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for adult patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment. The use of LYRICA in pediatric patients with compromised renal function has not been studied.

Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

If LYRICA is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients greater than 12 years of age, new or worsening preexisting tumors were reported in 57 patients.

LYRICA is available in doses ranging from 25 mg to 300 mg and as a 20 mg/mL oral solution.

INDICATIONS

LYRICA is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, management of fibromyalgia, and management of neuropathic pain associated with spinal cord injury in adult patients, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.

Please see Full Prescribing Information and Medication Guide.