Pronunciation:

pre-GA-ba-lin

Brand Names:

• Lyrica
• Lyrica CR

Dosage Forms:

• Capsule
• Tablet, Extended Release
• Solution

Classifications:

Therapeutic—

Neuropathic Pain Agent

Pharmacologic—

Gabapentinoid

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Pregabalin is used with other medicines to help control partial-onset seizures (convulsions) in the treatment of epilepsy in patients 1 month of age and older. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it.

Pregabalin is also used for postherpetic neuralgia (pain that occurs after shingles) and pain caused by nerve damage from diabetes or a spinal cord injury.

Pregabalin capsule and oral liquid are also used to treat a condition called fibromyalgia (muscle pain and stiffness).

Pregabalin works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pregabalin capsules and oral liquid in children younger than 1 month of age for partial onset seizures and extended-release tablets in children. Safety and efficacy have not been established for other conditions.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pregabalin in the elderly. However, elderly patients are more likely to have unwanted effects (eg, dizziness, blurred vision, confusion, or clumsiness) and age-related kidney problems, which may require an adjustment in the dose for patients receiving pregabalin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Levorphanol
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug use disorder, history of or
• Angioedema (severe swelling), history of or
• Congestive heart failure or
• Diabetes—May cause side effects to become worse.

• Behavior changes, history of or
• Bleeding disorder or
• Depression, history of or
• Edema (body swelling or fluid retention) or
• Heart rhythm problem (eg, prolonged PR interval) or
• Lung or breathing problems (eg, respiratory depression) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Pregabalin capsule or oral liquid may be taken with or without food.

Take the extended-release tablet after an evening meal. Swallow it whole. Do not crush, break, or chew it.

Measure the oral liquid using a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For diabetic nerve pain:
  • For oral dosage forms (capsules and solution):
    • Adults—At first, 50 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (extended-release tablets):
    • Adults—At first, 165 milligrams (mg) once a day for 1 week. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 330 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For partial-onset seizures:
  • For oral dosage forms (capsules and solution):
    • Adults and children 17 years of age and older—At first, 150 milligrams (mg) per day given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
    • Children 1 month of age and older weighing 30 kilograms (kg) or more—Use is based on body weight and must be determined by your doctor. The usual dose is 2.5 milligram per kilogram (mg/kg) per day given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg/kg (600 mg) per day.
    • Children 1 month of age and older weighing less than 30 kilograms kg—Use is based on body weight and must be determined by your doctor. The usual dose is 3.5 milligram per kilogram (mg/kg) per day given in 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 14 mg/kg per day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.
• For fibromyalgia:
  • For oral dosage forms (capsules and solution):
    • Adults—At first, 75 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 450 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For postherpetic neuralgia:
  • For oral dosage forms (capsules and solution):
    • Adults—At first, 75 to 150 milligrams (mg) 2 times a day, or 50 to 100 mg 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 600 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (extended-release tablets):
    • Adults—At first, 165 milligrams (mg) once a day for 1 week. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 660 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For spinal cord injury nerve pain:
  • For oral dosage forms (capsules and solution):
    • Adults—At first, 75 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of the extended-release tablet after your evening meal, take it before bedtime after a snack. If you miss the dose before bedtime, take it after your morning meal. If you do not take the dose the following morning, then take the next dose at your regular time after your evening meal. Do not take 2 doses at the same time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your and your child's progress at regular visits, especially for the first few months that you take pregabalin. This is necessary to allow for dose adjustments and to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with pregabalin may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficulty or trouble breathing, or irregular, fast or slow, or shallow breathing.

Pregabalin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble with thinking. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these side effects are especially bothersome, check with your doctor.

This medicine may cause you or your child to have edema (body swelling) or to gain weight. This may cause problems for people with heart failure. Talk with your doctor if you have concerns.

This medicine may increase your or your child's risk for cancer (eg, hemangiosarcoma) and bleeding. Talk to your doctor if you have concerns.

Do not suddenly stop taking pregabalin without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely. Stopping the medicine suddenly may cause seizures or side effects including dizziness, diarrhea, nausea, headaches, vomiting, irritability, trouble with sleeping, nightmares, or tingling feelings.

Call your doctor if you or your child have any unexplained muscle pain, tenderness, or weakness, especially with a fever. These may be symptoms of a serious muscle problem called myopathy.

This medicine may cause sores or other skin problems (eg, skin ulcers), which may be more likely to occur in patients with diabetes. Talk to your doctor about proper skin care.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Chest pain or tightness

cold sweats

cool, pale skin

cough producing mucus

difficult or labored breathing

muscle aches, twitching or jerking, or weakness

noisy breathing

seizures

Rare

Blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

chills

cough

diarrhea

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, skin rash

joint or muscle pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

sore throat

sores, ulcers, or white spots in the mouth or on the lips

unusual tiredness or weakness

Incidence not known

Blue lips, fingernails, or skin

irregular, fast or slow, or shallow breathing

loss of consciousness

nausea

severe constipation

stomach cramps or pain

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Accidental injury

blurred vision

burning, tingling, numbness or pain in the hands, arms, feet, or legs

change in walking and balance

clumsiness

confusion

difficulty having a bowel movement

difficulty with speaking

double vision

dry mouth

false beliefs that cannot be changed by facts

fever

headache

hoarseness

increased appetite

lack of coordination

loss of memory

lower back or side pain

painful or difficult urination

poor insight and judgment

problems with memory or speech

rapid weight gain

sensation of pins and needles

shakiness

sleepiness

stabbing pain

trembling, or other problems with muscle control or coordination

trouble recognizing objects

trouble thinking and planning

unsteady walk

unusual drowsiness

unusual weight gain or loss

Less common

Anxiety

bloated or feeling of fullness

decrease or change in vision

depression

excess air or gas in the stomach or bowels

eye disorder

false or unusual sense of well-being

general feeling of discomfort or illness

increased hunger

loss of appetite

loss of bladder control

loss of strength or energy

nervousness

nightmares

pain

passing gas

rhythmic movement of the muscles

runny nose

shivering

slurred speech

sweating

trouble sleeping

twitching

uncontrolled eye movements

Incidence not known

Breast enlargement

swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.