Pregabalin

Pregabalin is used to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection. It may also be used to treat nerve pain caused by spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.

Pregabalin is also used with other medications to treat certain types of seizures (partial onset seizures).

Pregabalin is available under the following different brand names: Lyrica

Adult Dosage Forms and Strengths

Capsule: Schedule V

• 25 mg
• 50 mg
• 75 mg
• 100 mg
• 150 mg
• 200 mg
• 225 mg
• 300 mg

Oral Solution: Schedule V

• 20 mg/mL

Along with its benefits, this medication may very rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Diabetic Peripheral Neuropathic Pain

• Initial: 50 mg orally every 8 hours
• Maintenance: May increase to 100 mg orally every 8 hours within 1 week, as needed; not to exceed 300 mg/day

Postherpetic Neuralgia

• Initial: 150-300 mg/day orally divided every 8-12 hours
• Maintenance: May increase to 300 mg/day divided every 8-12 hours after 1 week, as needed

Fibromyalgia

• Adult, Initial: 150 mg/day orally divided every 12 hours
• Adult, Maintenance: May increase to 300-450 mg/day divided every 12 hours after 1 week, as needed
• Pediatric: Safety and efficacy not established
• A 15-week, placebo-controlled trial (n=107) was conducted in pediatric patients with fibromyalgia aged 12-17 years with pregabalin (75-450 mg/day)
• The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity (derived from an 11-point numeric rating scale) showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients but did not reach statistical significance

Epilepsy

• Initial: 150 mg/day divided every 8-12 hours orally
• Maintenance: May increase to 600 mg/day orally divided every 8-12 hours, as needed

Neuropathic Pain With Spinal Cord Injury

• Initial: 150 mg/day orally divided every 12 hours; may increase within 1 week to 300 mg/day orally divided every 12 hours
• If there is insufficient pain relief after 2-3 weeks and 300 mg/day dose is tolerated, may increase the dose again up to 600 mg/day orally divided every 12 hours

Dosing Modifications

Renal impairment (CrCl 30-60 mL/min)

• Decrease dose by 50% divided two to three times daily

Renal impairment (CrCl 15-30 mL/min)

• If 150 mg/day in normal renal function: Decrease dose to 25-50 mg/day; administer once/day or divided twice daily
• If 300 mg/day in normal renal function: Decrease dose to 75 mg/day; administer once/day or divided twice daily
• If 450 mg/day in normal renal function: Decrease dose to 100-150 mg/day; administer once/day or divided twice daily
• If 600 mg/day in normal renal function: Decrease dose to 150 mg/day; administer once/day or divided twice daily

Renal impairment (CrCl less than 15 mL/min)

• If 150 mg/day in normal renal function: Decrease dose to 25 mg/day; single daily dose
• If 300 mg/day in normal renal function: Decrease dose to 25-50 mg/day; single daily dose
• If 450 mg/day in normal renal function: Decrease dose to 50-75 mg/day; single daily dose or divided twice daily
• If 600 mg/day in normal renal function: Decrease dose to 75 mg/day; single daily dose

Renal impairment (supplemental dosage following hemodialysis)

• 25 mg once/day regimen: Take 1 supplemental dose of 25 mg or 50 mg
• 25-50 mg once/day regimen: Take 1 supplemental dose of 50 mg or 75 mg
• 50-75 mg once/day regimen: Take 1 supplemental dose of 75 mg or 100 mg
• 75 mg once/day regimen: Take 1 supplemental dose of 100 mg or 150 mg

Common side effects of Pregabalin include:

• Dizziness
• Drowsiness
• Swelling of extremities
• Loss of control of bodily movements
• Fatigue
• Dry mouth
• Weight gain
• Tremor
• Blurred vision
• Double vision
• Weakness/lack of energy
• Swelling (edema)
• Facial swelling/puffiness
• Low blood pressure (hypotension)
• Nerve pain
• Pain
• Disorientation
• Constipation
• Weight gain
• Accidental injury
• Abnormal thinking
• Confusion
• Amnesia/forgetfulness
• Spinning sensation (vertigo)
• Decreased sense of touch
• Euphoria
• Decreased sex drive (libido)
• Loss of balance or coordination
• Vomiting
• Balance disorder
• Muscle twitching
• Sore throat
• Nasal irritation
• Flu-like syndrome
• Difficulty concentrating

Less common side effects of pregabalin include:

• Addiction
• Anemia
• Diarrhea
• Breast enlargement in males and females
• Epididymitis
• Esophagitis
• Menstrual cramps
• Involuntary muscle contractions
• Heart failure
• Male-pattern hair growth in women
• Eye inflammation

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Pregabalin has no known severe interactions with other drugs.

Serious interactions of pregabalin include:

• benazepril
• captopril
• enalapril
• everolimus
• fosinopril
• imidapril
• lisinopril
• moexipril
• perindopril
• quinapril
• ramipril
• sirolimus
• temsirolimus
• trandolapril

Moderate interactions of pregabalin include:

• clobazam
• deutetrabenazine
• lurasidone
• orlistat

Pregabalin has no known mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains pregabalin. Do not take Lyrica if you are allergic to pregabalin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• Along with its benefits, this medication may very rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
• Monitor for physical dependence and withdrawal symptoms.

Short-Term Effects

• Increased risk of swelling of extremities (peripheral edema), dizziness, drowsiness (somnolence), blurred vision, and weight gain.
• May impair ability to drive or perform hazardous tasks.
• See "What Are Side Effects Associated with Using Pregabalin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Pregabalin?"

Cautions

• Discontinue gradually over at least 1 week.
• Monitor for physical dependence and withdrawal symptoms.
• Monitor for decreased platelet count (rare) and increased creatinine kinase levels.
• May cause prolongation of PR interval.
• May potentiate effects of other sedatives.
• Muscle wasting (rhabdomyolysis) reported (monitor for muscle pain).
• History of angioedema, concurrency with drugs associated with angioedema risk (e.g., ACEIs).
• Increased risk of swelling of extremities (peripheral edema), dizziness, drowsiness (somnolence), blurred vision, and weight gain.
• Potential risk of male-mediated teratogenicity.
• Use caution in cardiovascular disease (heart failure) and renal impairment.
• May impair ability to drive or perform hazardous tasks.
• Discontinue treatment if hypersensitivity occurs.
• Do not discontinue anticonvulsants abruptly as that may increase seizure frequency.
• Antiepileptic drugs increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
• Angioedema (skin swelling):
• Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported during initial and chronic treatment, including reports of life-threatening angioedema with respiratory compromise requiring emergency intervention.
• If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue therapy and institute appropriate therapy immediately.
• Coadministration of ACE inhibitors or mTOR (mammalian target of rapamycin) inhibitors (e.g.), temsirolimus, sirolimus, everolimus), or previous history of angioedema may increase risk.

Pregnancy and Lactation

• Use pregabalin with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown if iregabalin is excreted in breast milk; it is not recommended for use while breastfeeding.