Pregabalin (generic)

Lyrica (brand)

Classification: Antiepileptic, anticonvulsant.

Common usage: Pregabalin is approved for treating neuropathic pain (pain from damaged nerves) from diabetes or herpes zoster (shingles), partial seizures in adults as add-on treatment with other medications, and fibromyalgia. Pregabalin also is approved for treating generalized anxiety disorder (GAD) in countries in the European Union. Although pregabalin is not approved in the United States for treating GAD, it is sometimes prescribed “off-label” for this disorder.

Warnings and precautions:

Angioedema: Pregabalin may cause serious allergic reactions. Stop taking pregabalin immediately and seek medical attention if you have any serious allergic reactions, such as swelling of the face, mouth, lips, gums, tongue, or neck; rash; hives; blisters; or problems with breathing, such as wheezing, shortness of breath, or chest tightness.

Suicidal thoughts and behavior: Antiepileptic drugs, including pregabalin, may increase the risk of suicidal behavior in patients taking these drugs for any indication. Patients taking any antiepileptic drug should be closely monitored for emerging or worsening depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. In clinical trials, the increased risk of suicidal thoughts or behavior with antiepileptic drugs was observed as early as one week after starting drug treatment. Call your doctor right away if you have any of the following symptoms, especially if they are new, become worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worsening depression, new or worsening anxiety, feeling agitated or restless, panic attacks, insomnia, new or worsening irritability, acting aggressively, being angry or violent, acting on dangerous impulses, mania, or any other unusual changes in behavior or mood. Some patients may experience hallucinations (seeing or hearing things that are not actually there) and delusions (false or strange thoughts or beliefs).

Withdrawal seizures: Antiepileptic drugs, such as pregabalin, should be slowly discontinued to reduce the risk of withdrawal seizure. Suddenly stopping a seizure medication can cause status epilepticus (seizures that do not stop).

Important safety information: Before taking pregabalin, tell your doctor if you have a history of drug abuse or dependence, heart rhythm problems, congestive heart failure, thrombocytopenia (low blood platelet count), diabetes mellitus, edema (fluid retention), angioedema (swelling of the face, mouth, or neck), or kidney disease, or receive dialysis treatment.

Tell your doctor if you have muscle pain with fever or fatigue, or any changes in your eyesight, such as blurred vision. If you have diabetes, tell your doctor if you have any skin sores.

Common side effects: The most common side effects of pregabalin are dizziness, somnolence (drowsiness), dry mouth, swelling of hands or feet, blurred vision, weight gain, and abnormal thinking (especially trouble with concentration/attention).

This is not a complete list of all known or potential adverse effects. Notify your prescriber or pharmacist of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task that requires your attention (such as driving or operating machinery) until you have experience with this drug and are confident that you can perform the task safely.

Special populations:

Pregnancy: Tell your doctor if you are pregnant, planning pregnancy, or breastfeeding. The effects of pregabalin on labor and delivery in pregnant women are unknown. Pregabalin should be used during pregnancy only if the benefits outweigh the risks to the unborn child.

Male patients: If you are taking pregabalin, tell your doctor if you are planning to father a child. Animal studies of pregabalin showed lower male fertility, sperm changes, and birth defects in the offspring of male animals. It is not known if these problems also occur in humans who take pregabalin.

Pediatric: The safety and effectiveness of pregabalin in patients under 18 years of age have not been established.

Elderly: In fibromyalgia patients ages 65 and older, blurred vision, dizziness, balance disorder, tremor, confusion, abnormal coordination, and lethargy were reported more often than in younger patients. For elderly patients with kidney disease, pregabalin dosages may need to be lowered.

If you have renal impairment (kidney disease) or receive dialysis, your doctor may need to adjust your dose according to the instructions provided in the official prescribing information.

Interactions with other medications: You should not drink alcohol while taking pregabalin. If you are taking pregabalin with medications that depress the central nervous system, such as narcotic pain medicine (e.g., oxycodone) or benzodiazepines (e.g., lorazepam), you may have a higher risk of dizziness and sleepiness. Before starting pregabalin, you should let your doctor know if you are taking angiotensin-converting enzyme inhibitors (e.g., lisinopril, ramipril), used for treating congestive heart failure and high blood pressure, as this may increase your chance for swelling or hives. Taking certain diabetes medications, such as rosiglitazone (Avandia) or pioglitazone (Actos), with pregabalin may increase your chance of swelling or weight gain.

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that your pharmacist and all prescribers know about all medications you are taking, including over-the-counter drugs; dietary herbal supplements; folk or home remedies; or unusual foods, drinks, or dietary habits.

Common dosages: Pregabalin may be taken with or without food, on a full or empty stomach. Doses are generally taken two or three times a day depending on your condition, but may vary according to each patient. Do not change your dose unless your doctor tells you to do so. General recommendations for dosing are as follows:

Diabetic nerve pain: The starting dose is 150 mg daily (50 mg three times a day). Your doctor may increase your dose to a maximum dose of 300 mg daily (100 mg three times a day) within one week.

Postherpetic neuralgia (pain from shingles): The starting dose is 150 mg daily (50 mg three times a day or 75 mg twice a day). Your doctor may increase your dose to 300 mg daily (100 mg three times a day or 150 mg twice a day) within one week, and increase it to a maximum dose of 600 mg daily (200 mg three times a day or 300 mg twice a day).

Adjunctive treatment for partial seizure epilepsy: The starting dose is 150 mg daily (50 mg three times a day or 75 mg twice a day). Your doctor may increase your dose to a maximum dose of 600 mg daily (200 mg three times a day or 300 mg twice a day).

Fibromyalgia: The starting dose is 150 mg daily (75 mg twice a day). Your doctor may increase your dose to 300 mg daily (150 mg twice a day) within one week, to a maximum dose of 450 mg daily (225 mg twice a day).

Abrupt or rapid discontinuation of pregabalin may cause insomnia, nausea, headache, or diarrhea. For patients with seizure disorders, abrupt discontinuation may cause increased seizures. Pregabalin should be withdrawn slowly for at least one week.

Identification: Lyrica is supplied as hard-gelatin capsules, with “Pfizer” printed in black on the cap of the capsule and “PGN” and the number of milligrams printed on the body of the capsule, in the following doses:

  • 25 mg: white, printed with “Pfizer” and “PGN 25.”
  • 50 mg: white, printed with “Pfizer” and “PGN 50” (with an ink band on the body of the capsule).
  • 75 mg: white/orange, printed with “Pfizer” and “PGN 75.”
  • 100 mg: orange, printed with “Pfizer” and “PGN 100.”
  • 150 mg: white, printed with “Pfizer” and “PGN 150.”
  • 200 mg: light orange, printed with “Pfizer” and “PGN 200.”
  • 225 mg: white/light orange, printed with “Pfizer” and “PGN 225.”
  • 300 mg: white/orange, printed with “Pfizer” and “PGN 300.”

Pregabalin is also supplied as a 20-mg/mL oral solution.

Storage: Lyrica capsules and oral solution should be stored at room temperature (59°F to 86°F) in a tightly closed, child-, light-, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep the medication out of direct sunlight and avoid storing it in a warm and humid area, such as the bathroom or kitchen, to avoid deterioration. To prevent accidental poisoning, keep all medications out of the reach of children or adults with dementia. Do not take expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children or adults with dementia cannot find it.

For more information: www.lyrica.com.