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Pregabalin (Oral route)

Pronunciation:

pre-GA-ba-lin

Brand Names:

  • Lyrica

Dosage Forms:

  • Capsule
  • Solution

Classifications:

Therapeutic—

Neuropathic Pain Agent

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Pregabalin is used with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. 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. It is 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 in the pediatric population. Safety and efficacy have not been established.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Ketorolac
  • Orlistat

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:

  • Angioedema, history of or
  • Congestive heart failure—May cause side effects to become worse. .
  • Behavior changes, history of or
  • Bleeding disorder or
  • Depression, history of or
  • Edema (fluid retention) or
  • Heart rhythm problem (eg, prolonged PR interval) 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. Ask your doctor if you have any questions.

Pregabalin may be taken with or without food.

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 oral dosage forms (capsules and solution):
    • For diabetic nerve pain:
      • Adults—At first, 50 milligrams (mg) three 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 epilepsy:
      • Adults—At first, 75 milligrams (mg) two times a day or 50 mg three 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.
    • For fibromyalgia:
      • Adults—At first, 75 milligrams (mg) two 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:
      • Adults—At first, 75 to 150 milligrams (mg) two times a day, or 50 to 100 mg three 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.
    • For spinal cord injury nerve pain:
      • Adults—At first, 75 milligrams (mg) two 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.

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 progress at regular visits, especially for the first few months you take pregabalin. This is necessary to allow dose adjustments and to check for any unwanted effects.

Stop using this medicine and call your doctor right away if you have swelling of the face, eyes, lips, gums, or tongue, or problems with swallowing or breathing. Tell your doctor if you have hives or a skin rash, redness, or blisters while you are using this medicine. You may be having a severe allergic reaction or a condition called angioedema.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicines for seizures (eg, barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of these while you are taking pregabalin.

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. If you or your caregiver notice any of these side effects, tell your doctor right away.

Pregabalin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble with thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

This medicine may cause you to have extra fluid or to gain weight. This may cause problems for people with heart failure. If these side effects are bothersome, check with your doctor.

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

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

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
Difficult or labored breathing
shortness of breath
tightness in the chest
Rare
Blistering, peeling, or loosening of the skin
chills
cough
diarrhea
difficulty with swallowing
dizziness
fast heartbeat
hives
itching
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
skin rash
sore throat
sores, ulcers, or white spots in the mouth or on the lips
unusual tiredness or weakness

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
bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
burning, tingling, numbness or pain in the hands, arms, feet, or legs
change in walking and balance
clumsiness
confusion
delusions
dementia
difficulty having a bowel movement (stool)
difficulty with speaking
double vision
dry mouth
fever
headache
hoarseness
increased appetite
lack of coordination
loss of memory
lower back or side pain
painful or difficult urination
problems with memory
rapid weight gain
seeing double
sensation of pins and needles
shakiness and unsteady walk
sleepiness or unusual drowsiness
stabbing pain
swelling
tingling of the hands or feet
trembling, or other problems with muscle control or coordination
unusual weight gain or loss
Less common
Anxiety
bloated or full feeling
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
cold sweats
coma
cool, pale skin
cough producing mucus
decrease or change in vision
depression
excess air or gas in the stomach or intestines
eye disorder
false or unusual sense of well-being
general feeling of discomfort or illness
increased hunger
joint pain
loss of appetite
loss of bladder control
loss of strength or energy
muscle aches and pains
muscle twitching or jerking
muscle weakness
nausea
nervousness
nightmares
noisy breathing
pain
passing gas
rhythmic movement of the muscles
runny nose
seizures
shivering
slurred speech
sweating
trouble sleeping
twitching
uncontrolled eye movements
vomiting

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.


Last Updated: 11/4/2014

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