Label: PREGABALIN capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 17, 2021

If you are a consumer or patient please visit this version.

  • Medication Guide Section

    MEDICATION GUIDE

    PREGABALIN (pre gab' a lin) capsules, CV

    Read this Medication Guide before you start taking pregabalin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about pregabalin capsules, ask your healthcare provider or pharmacist.

    What is the most important information I should know about pregabalin?

    Pregabalin may cause serious side effects including:

    serious, even life-threatening, allergic reactions
    suicidal thoughts or actions
    swelling of your hands, legs and feet
    dizziness and sleepiness
    serious breathing problems

    These serious side effects are described below:

    Serious, even life-threatening, allergic reactions.

    Stop taking pregabalin and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:

    swelling of your face, mouth, lips, gums, tongue, throat or neck
    trouble breathing
    rash, hives (raised bumps) or blisters

    Like other antiepileptic drugs, pregabalin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    thoughts about suicide or dying
    attempts to commit suicide
    new or worse depression
    new or worse anxiety
    feeling agitated or restless
    panic attacks
    trouble sleeping (insomnia)
    new or worse irritability
    acting aggressive, being angry, or violent
    acting on dangerous impulses
    an extreme increase in activity and talking (mania)
    other unusual changes in behavior or mood

    If you have suicidal thoughts or actions, do not stop pregabalin without first talking to a healthcare provider.

    Stopping pregabalin suddenly can cause serious problems.

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

    How can I watch for early symptoms of suicidal thoughts and actions?

    Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    Keep all follow-up visits with your healthcare provider as scheduled.
    Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
    Serious breathing problems can occur when pregabalin is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting pregabalin or when the dose is increased. Get help right away if breathing problems occur.
    Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.
    Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin affects you. Ask your healthcare provider about when it will be okay to do these activities.

    What is pregabalin capsule?

    Pregabalin capsule is a prescription medicine used in adults, 18 years of age and older, to treat:

    pain from damaged nerves (neuropathic pain) that happens with diabetes
    pain from damaged nerves (neuropathic pain) that follows healing of shingles
    fibromyalgia (pain all over your body)
    pain from damaged nerves (neuropathic pain) that follows spinal cord injury.

    It is not known if pregabalin is safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.

    Pregabalin capsule is a prescription medicine used in people 17 years of age and older to treat:

    partial-onset seizures when taken together with other seizure medicines.

    For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin is safe and effective in children under 1 month of age.

    Who should not take pregabalin capsules?

    Do not take pregabalin capsules if you are allergic to pregabalin or any of the ingredients in pregabalin capsules.

    See “What is the most important information I should know about pregabalin capsules?” for the signs of an allergic reaction.

    See the end of this medication guide for a complete list of ingredients in pregabalin capsules.

    What should I tell my healthcare provider before taking pregabalin capsules?

    Before taking pregabalin capsules, tell your healthcare provider about all your medical conditions, including if you:

    have or have had depression, mood problems or suicidal thoughts or behavior
    have breathing problems.
    have kidney problems or get kidney dialysis
    have heart problems including heart failure
    have a bleeding problem or a low blood platelet count
    have abused prescription medicines, street drugs, or alcohol in the past
    have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema)
    plan to father a child. Animal studies have shown that pregabalin, the active ingredient in pregabalin capsules, made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring (babies) of male animals treated with pregabalin. It is not known if these problems can happen in people who take pregabalin.
    are pregnant or plan to become pregnant. Pregabalin may harm your unborn baby. You and your healthcare provider will decide if you should take pregabalin while you are pregnant.

    If you become pregnant while taking pregabalin, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Information about the registry can also be found at the website, http://www.aedpregnancyregistry.org/.

    are breastfeeding or plan to breastfeed. Pregabalin passes into your breast milk. It is not known if pregabalin can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take pregabalin. Breastfeeding is not recommended while taking pregabalin capsules.

    Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

    angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure. You may have a higher chance for swelling and hives if these medicines are taken with pregabalin.
    Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with pregabalin.
    any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with pregabalin.
    any medicines that make you sleepy

    Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

    How should I take pregabalin capsules?

    Take pregabalin exactly as prescribed. Your healthcare provider will tell you how much pregabalin capsules to take and when to take it.
    Pregabalin capsules may be taken with or without food.
    Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
    Do not stop taking pregabalin capsules without talking to your healthcare provider. If you stop taking pregabalin capsules suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking pregabalin capsules suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop pregabalin capsules slowly.
    If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
    If you take too much pregabalin capsules, call your healthcare provider or poison control center, or go to the nearest emergency room right away.

    What should I avoid while taking pregabalin capsules?

    Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin affects you.
    Do not drink alcohol while taking pregabalin. Pregabalin and alcohol can affect each other and increase side effects such as sleepiness and dizziness.

    What are the possible side effects of pregabalin capsules?

    Pregabalin capsules may cause serious side effects, including:

    See “What is the most important information I should know about pregabalin?"
    Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.
    Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight.
    Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
    Feeling “high”

    The most common side effects of pregabalin capsules in adults are:

    dizziness
    blurry vision
    weight gain
    sleepiness
    trouble concentrating
    swelling of hands and feet
    dry mouth

    Pregabalin caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin and tell your healthcare provider about any sores or skin problems.

    Tell your healthcare provider about any side effect that bothers you or that does not go away.

    These are not all the possible side effects of pregabalin. For more information, ask your healthcare provider or pharmacist.

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

    How should I store pregabalin capsules?

    Store pregabalin capsules at room temperature between 68oF to 77°F (20oC to 25°C) in its original package.
    Safely throw away any pregabalin capsules that is out of date or no longer needed.

    Keep pregabalin capsules and all medicines out of the reach of children.

    General information about the safe and effective use of pregabalin capsules.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin capsules for a condition for which it was not prescribed. Do not give pregabalin capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about pregabalin capsules that is written for health professionals.

    You can also call on Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901).

    What are the ingredients in pregabalin capsules?

    Active ingredient: pregabalin

    Inactive ingredients:

    Pregabalin capsules: Pregelatinized starch, talc

    Capsule shell: gelatin, sodium lauryl sulphate and titanium dioxide; orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg): red iron oxide; yellow iron oxide

    Imprinting ink: black iron oxide, potassium hydroxide, propylene glycol and shellac.

    Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by:

    Alkem Laboratories Ltd.

    Mumbai - 400 013, INDIA

    Distributed by:

    Ascend Laboratories, LLC

    Parsippany, NJ 07054

    Revised: June, 2020

    PT 3213-03

  • Overdosage Section

    OVERDOSAGE

    Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans

    In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants.

    Treatment or Management of Overdose

    There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin.

    Pregabalin can be removed by hemodialysis.Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).

  • Dosage and Administration Section

    DOSAGE & ADMINISTRATION

    2.1 Important Administration Instructions

    Pregabalin is given orally with or without food.
    When discontinuing pregabalin, taper gradually over a minimum of 1 week. [see Warnings and Precautions (5.6)].
    Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].

    2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults

    The maximum recommended dose of pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
    Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].

    2.3 Postherpetic Neuralgia in Adults

    The recommended dose of pregabalin is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
    Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].

    2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 17 Years of Age and Older

    The recommended dosage for adult patients 17 years of age and older is included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. Based on clinical response and tolerability, dosage may be increased, approximately weekly.

    Table 1: Recommended Dosage for Adult Patients 17 Years and Older

    Age and Body Weight
    Recommended Initial Dosage
    Recommended Maximum Dosage
    Frequency of Administration
    Adults (17 years and older)
    150 mg/day
    600 mg/day
    2 or 3 divided doses

    Both the efficacy and adverse event profiles of pregabalin have been shown to be dose-related.

    The effect of dose escalation rate on the tolerability of pregabalin has not been formally studied.

    The efficacy of adjunctive pregabalin in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin with gabapentin cannot be offered.

    Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

    2.5 Management of Fibromyalgia in Adults

    The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].

    2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults

    The recommended dose range of pregabalin for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate pregabalin may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].

    2.7 Dosing for Adult Patients with Renal Impairment

    In view of dose-dependent adverse reactions and since pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of pregabalin in pediatric patients with compromised renal function has not been studied.
    Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient's CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:
    [pregabalin-equation]

    Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.

    (For example: A patient initiating pregabalin therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)

    For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).

    Table 2. Pregabalin Dosage Adjustment Based on Renal Function

    Creatinine Clearance (CLcr) (mL/min)
    Total Pregabalin Daily Dose (mg/day)*

    Dose Regimen
    Greater than or equal to 60
    150
    300
    450
    600

    BID or TID
    30 to 60
    75
    150
    225
    300

    BID or TID
    15 to 30
    25 to 50
    75
    100 to 150
    150

    QD or BID
    Less than 15
    25
    25 to 50
    50 to 75
    75

    QD
    Supplementary dosage following hemodialysis (mg)†

    Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg
    Patients on the 25 to 50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg
    Patients on the 50 to 75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg
    Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg

    TID= Three divided doses; BID = Two divided doses; QD = Single daily dose.

    * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.

    † Supplementary dose is a single additional dose.

  • Indications and Usage Section

    INDICATIONS & USAGE

    Pregabalin is indicated for:
    • Management of neuropathic pain associated with diabetic peripheral neuropathy
    • Management of postherpetic neuralgia
    • Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
    • Management of fibromyalgia
    • Management of neuropathic pain associated with spinal cord injury

    Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  • Principal Display Panel

    Pregabalin 300mg

  • INGREDIENTS AND APPEARANCE
    PREGABALIN 
    pregabalin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0160(NDC:67877-469)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M) PREGABALIN300 mg
    Product Characteristics
    Colorwhite, orangeScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code A014;PREG300
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0160-390 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20779907/21/2019
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0160)