Label: LYRICA- pregabalin 100mg capsule

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

Drug Label Information

Updated August 12, 2021

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

  • Medication Guide Section

    MEDICATION GUIDE


    Pregabalin Capsules CV
    (pre-GAB-a-lin)

    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 capsules?
    Pregabalin capsules may cause serious side effects including:
    • serious, even life-threatening, allergic reactions • swelling of your hands, legs and feet
    • suicidal thoughts or actions • dizziness and sleepiness
    These serious side effects are described below:
    • Serious, even life-threatening, allergic reactions.
    Stop taking pregabalin capsules and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:
    o swelling of your face, mouth, lips, gums, tongue, throat or neck
    o trouble breathing
    o rash, hives (raised bumps) or blisters
    • Like other antiepileptic drugs, pregabalin capsules 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:
    o thoughts about suicide or dying
    o trouble sleeping (insomnia)
    o attempts to commit suicide
    o new or worse irritability
    o new or worse depression
    o acting aggressive, being angry, or violent
    o new or worse anxiety
    o acting on dangerous impulses
    o feeling agitated or restless
    o an extreme increase in activity and talking (mania)
    o panic attacks
    o other unusual changes in behavior or mood

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

    o Stopping pregabalin capsules suddenly can cause serious problems.
    o 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.

    • 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 capsules affects you. Ask your healthcare provider about when it will be okay to do these activities.
    What are pregabalin capsules?
    Pregabalin capsules are 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 capsules are 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 capsules are 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 capsules are 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 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 capsules.
    • are pregnant or plan to become pregnant. Pregabalin capsules may harm your unborn baby. You and your healthcare provider will decide if you should take pregabalin capsules while you are pregnant.
    o If you become pregnant while taking pregabalin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233­2334. 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 capsules can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take pregabalin capsules. 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 capsules 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 capsules.
    • 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 capsules.
    • any narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam). You may have a higher chance for dizziness and sleepiness if these medicines are taken with pregabalin capsules.
    • 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 capsules exactly as prescribed. Your healthcare provider will tell you how much pregabalin 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, 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 capsules affects you.

    • Do not drink alcohol while taking pregabalin capsules. Pregabalin capsules 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 capsules?"

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

    Pregabalin capsules 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 capsules 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 capsules. 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 68º to 77ºF (20º to 25ºC) in its original package.
    • Safely throw away any pregabalin capsules that are 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.
    For more information call Hetero Labs Limited at 1-866-495-1995.

    What are the ingredients in pregabalin capsules?
    Active ingredient: pregabalin
    Inactive ingredients: corn starch, mannitol and talc
    Capsule shell: gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red.

    Imprinting ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

    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.

    The brands listed are the trademarks of their respective owners and are not trademarks of Hetero Labs Limited.

    Medication Guide available at
    http://camberpharma.com/medication-guides

    [logo]

    Manufactured for:
    Camber Pharmaceuticals, Inc.
    Piscataway, NJ 08854

    By: HETEROTM
    Hetero Labs Limited
    Jeedimetla, Hyderabad-500055, India

    Revised: 07/2019

  • Overdosage Section

    OVERDOSAGE

    Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
    There is limited experience with overdose of pregabalin capsules. The highest reported accidental overdose of pregabalin capsules during the clinical development program was 8000 mg, and there were no notable clinical consequences.
    Treatment or Management of Overdose
    There is no specific antidote for overdose with pregabalin capsules. 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 capsules.
    Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).

  • Adverse Reactions Section

    ADVERSE REACTIONS

    The following serious adverse reactions are described elsewhere in the labeling:
    • Angioedema [see Warnings and Precautions (5.1)]
    • Hypersensitivity [see Warnings and Precautions (5.2)]
    • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.3)]
    • Suicidal Behavior and Ideation [see Warnings and Precautions (5.4)]
    • Peripheral Edema [see Warnings and Precautions (5.5)]
    • Dizziness and Somnolence [see Warnings and Precautions (5.6)]
    • Weight Gain [see Warnings and Precautions (5.7)]
    • Tumorigenic Potential [see Warnings and Precautions (5.8)]
    • Ophthalmological Effects [see Warnings and Precautions (5.9)]
    • Creatine Kinase Elevations [see Warnings and Precautions (5.10)]
    • Decreased Platelet Count [see Warnings and Precautions (5.11)]
    • PR Interval Prolongation [see Warnings and Precautions (5.12)]

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin capsules, more than 10,000 patients have received pregabalin capsules. Approximately 5,000 patients were treated for 6 months or more, over 3,100 patients were treated for 1 year or longer, and over 1,400 patients were treated for at least 2 years.

    Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies
    In premarketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin capsules and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin capsules treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin capsules group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).
    Most Common Adverse Reactions in All Controlled Clinical Studies in Adults
    In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin capsules than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).
    Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
    Adverse Reactions Leading to Discontinuation
    In clinical trials in adults with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin capsules and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin capsules treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin capsules group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.

    Most Common Adverse Reactions

    Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin capsules group for which the incidence was greater in this combined pregabalin capsules group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate”.


    Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy


    Body system Preferred term


    75
    mg/day [N=77]
    %

    150
    mg/day [N=212]
    %

    300
    mg/day
    [N=321]
    %

    600
    mg/day [N=369]
    %
    All PGB*
    [N=979]
    %

    Placebo
    [N=459] %
    Body as a whole

    Asthenia


    4


    2


    4


    7


    5


    2


    Accidental injury

    5


    2


    2


    6


    4


    3


    Back pain

    0

    2


    1


    2


    2


    0


    Chest pain

    4

    1


    1


    2


    2


    1


    Face edema

    0


    1


    1


    2


    1


    0

    Digestive system







    Dry mouth

    3

    2


    5


    7


    5


    1


    Constipation

    0


    2


    4


    6


    4


    2


    Flatulence

    3


    0


    2


    3


    2


    1

    Metabolic and nutritional disorders

    Peripheral edema

    4

    6


    9


    12


    9


    2


    Weight gain

    0

    4


    4


    6


    4


    0


    Edema

    0

    2


    4


    2


    2


    0


    Hypoglycemia

    1


    3


    2


    1


    2


    1

    Nervous system







    Dizziness

    8


    9


    23


    29


    21


    5


    Somnolence

    4


    6


    13


    16


    12


    3


    Neuropathy

    9

    2


    2


    5


    4


    3


    Ataxia

    6

    1


    2


    4


    3


    1


    Vertigo

    1


    2


    2


    4


    3


    1

    Confusion

    0

    1


    2


    3


    2


    1


    Euphoria

    0

    0


    3


    2


    2


    0


    Incoordination

    1


    0


    2


    2


    2


    0


    Thinking abnormal†

    1

    0


    1


    3


    2


    0


    Tremor

    1


    1


    1


    2


    1


    0


    Abnormal gait

    1

    0


    1


    3


    1


    0


    Amnesia

    3


    1


    0


    2


    1


    0


    Nervousness

    0

    1


    1


    1


    1


    0

    Respiratory system

    Dyspnea

    3


    0


    2


    2


    2


    1

    Special senses
    Blurry vision‡


    3


    1


    3


    6


    4


    2


    Abnormal vision

    1


    0


    1


    1


    1


    0

    * PGB: pregabalin
    † Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
    ‡ Investigator term; summary level term is amblyopia

    Controlled Studies in Postherpetic Neuralgia

    Adverse Reactions Leading to Discontinuation

    In clinical trials in adults with postherpetic neuralgia, 14% of patients treated with pregabalin capsules and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin capsules treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the pregabalin capsules group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

    Most Common Adverse Reactions

    Table 5 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined pregabalin capsules group for which the incidence was greater in this combined pregabalin capsules group than in the placebo group. In addition, an event is included, even if the incidence in the all pregabalin capsules group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate". Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

    Table 5. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia

    Body system
    Preferred term
    75 mg/d [N=84]
    %
    150 mg/d [N=302] %
    300 mg/d [N=312] %
    600 mg/d [N=154]
    %
    All PGB* [N=852]
    %
    Placebo [N=398] %
    Body as a whole



    Infection
    14
    8
    6
    3
    7
    4
    Headache
    5
    9
    5
    8
    7
    5
    Pain
    5
    4
    5
    5
    5
    4
    Accidental injury
    4
    3
    3
    5
    3
    2
    Flu syndrome
    1
    2
    2
    1
    2
    1
    Face edema
    0
    2
    1
    3
    2
    1
    Digestive system






    Dry mouth
    7
    7
    6
    15
    8
    3
    Constipation
    4
    5
    5
    5
    5
    2
    Flatulence
    2
    1
    2
    3
    2
    1
    Vomiting
    1
    1
    3
    3
    2
    1
    Metabolic and nutritional disorders
    Peripheral edema
    0
    8
    16
    16
    12
    4
    Weight gain
    1
    2
    5
    7
    4
    0
    Edema
    0
    1
    2
    6
    2
    1
    Musculoskeletal system
    Myasthenia
    1
    1
    1
    1
    1
    0
    Nervous system






    Dizziness
    11
    18
    31
    37
    26
    9
    Somnolence
    8
    12
    18
    25
    16
    5
    Ataxia
    1
    2
    5
    9
    5
    1
    Abnormal gait
    0
    2
    4
    8
    4
    1
    Confusion
    1
    2
    3
    7
    3
    0
    Thinking abnormal†
    0
    2
    1
    6
    2
    2
    Incoordination
    2
    2
    1
    3
    2
    0
    Amnesia
    0
    1
    1
    4
    2
    0
    Speech disorder
    0
    0
    1
    3
    1
    0
    Respiratory system






    Bronchitis
    0
    1
    1
    3
    1
    1
    Special senses






    Blurry vision‡
    1
    5
    5
    9
    5
    3
    Diplopia
    0
    2
    2
    4
    2
    0
    Abnormal vision
    0
    1
    2
    5
    2
    0
    Eye Disorder
    0
    1
    1
    2
    1
    0
    Urogenital System
    Urinary Incontinence
    0
    1
    1
    2
    1
    0

    * PGB: pregabalin
    † Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
    ‡ Investigator term; summary level term is amblyopia

    Controlled Studies of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients

    Adverse Reactions Leading to Discontinuation

    Approximately 15% of patients receiving pregabalin capsules and 6% of patients receiving placebo in trials of adjunctive therapy for partial-onset seizures discontinued prematurely due to adverse reactions. In the pregabalin capsules treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the pregabalin capsules group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

    Most Common Adverse Reactions

    Table 6 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin capsules-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received pregabalin capsules and 294 patients received placebo for up to 12 weeks. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate”.


    Table 6. Dose-related Adverse Reaction Incidencein ControlledTrials ofAdjunctive Therapy for Partial-Onset Seizures in Adult Patients


    Body System Preferred Term


    150 mg/d
    [N = 185] %
    300 mg/d
    [N = 90]
    %

    600 mg/d
    [N = 395]
    %
    All PGB*
    [N = 670]†
    %
    Placebo
    [N = 294]
    %
    Body as a Whole





    Accidental Injury
    7
    11

    10

    9

    5

    Pain
    3

    2

    5

    4

    3

    Digestive System





    Increased Appetite
    2

    3

    6

    5

    1

    Dry Mouth
    1

    2

    6

    4

    1
    Constipation
    1

    1

    7

    4

    2

    Metabolic and Nutritional Disorders
    Weight Gain
    5

    7

    16

    12

    1

    Peripheral Edema
    3

    3

    6

    5

    2

    Nervous System





    Dizziness
    18

    31

    38

    32

    11

    Somnolence
    11

    18

    28

    22

    11

    Ataxia
    6

    10

    20

    15

    4

    Tremor
    3

    7

    11

    8

    4

    Thinking Abnormal‡

    4

    8

    9

    8

    2

    Amnesia
    3

    2

    6

    5

    2

    Speech Disorder
    1

    2

    7

    5

    1

    Incoordination
    1

    3

    6

    4

    1

    Abnormal Gait
    1

    3

    5

    4

    0

    Twitching
    0

    4

    5

    4

    1

    Confusion
    1

    2

    5

    4

    2

    Myoclonus

    1


    0


    4


    2


    0

    Special Senses





    Blurred Vision§

    5

    8

    12

    10

    4
    Diplopia
    5

    7

    12

    9

    4

    Abnormal Vision
    3

    1

    5

    4

    1

    * PGB: pregabalin
    † Excludes patients who received the 50 mg dose in Study E1.
    ‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
    § Investigator term; summary level term is amblyopia.

    Controlled Studies with Fibromyalgia

    Adverse Reactions Leading to Discontinuation

    In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150 mg to 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

    Most Common Adverse Reactions

    Table 9 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the ‘all pregabalin’ treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

    Table 9. Adverse Reaction Incidence in Controlled Trials in Fibromyalgia


    System Organ Class Preferred term

    150
    mg/d [N=132] %

    300
    mg/d [N=502]
    %

    450
    mg/d [N=505]
    %

    600
    mg/d [N=378]
    %



    All PGB*
    [N=1,517]
    %


    Placebo
    [N=505] %
    Ear and Labyrinth Disorders
    Vertigo
    2
    2
    2
    1
    2
    0
    Eye Disorders






    Vision blurred
    8
    7
    7
    12
    8
    1
    Gastrointestinal Disorders
    Dry mouth
    7
    6
    9
    9
    8
    2
    Constipation
    4
    4
    7
    10
    7
    2
    Vomiting
    2
    3
    3
    2
    3
    2
    Flatulence
    1
    1
    2
    2
    2
    1
    Abdominal distension
    2
    2
    2
    2
    2
    1
    General Disorders and Administrative Site Conditions
    Fatigue
    5
    7
    6
    8
    7
    4
    Edema peripheral
    5
    5
    6
    9
    6
    2
    Chest pain
    2
    1
    1
    2
    2
    1
    Feeling abnormal
    1
    3
    2
    2
    2
    0
    Edema
    1
    2
    1
    2
    2
    1
    Feeling drunk
    1
    2
    1
    2
    2
    0
    Infections and Infestations
    Sinusitis
    4
    5
    7
    5
    5
    4
    Investigations
    Weight increased
    8
    10
    10
    14
    11
    2
    Metabolism and Nutrition Disorders
    Increased appetite
    4
    3
    5
    7
    5
    1
    Fluid retention
    2
    3
    3
    2
    2
    1
    Musculoskeletal and Connective Tissue Disorders
    Arthralgia
    4
    3
    3
    6
    4
    2
    Muscle spasms
    2
    4
    4
    4
    4
    2
    Back pain
    2
    3
    4
    3
    3
    3
    Nervous System Disorders
    Dizziness
    23
    31
    43
    45
    38
    9
    Somnolence
    13
    18
    22
    22
    20
    4
    Headache
    11
    12
    14
    10
    12
    12
    Disturbance in attention
    4
    4
    6
    6
    5
    1
    Balance disorder
    2
    3
    6
    9
    5
    0
    Memory impairment
    1
    3
    4
    4
    3
    0
    Coordination abnormal
    2
    1
    2
    2
    2
    1
    Hypoesthesia
    2
    2
    3
    2
    2
    1
    Lethargy
    2
    2
    1
    2
    2
    0
    Tremor
    0
    1
    3
    2
    2
    0
    Psychiatric Disorders
    Euphoric Mood
    2
    5
    6
    7
    6
    1
    Confusional state
    0
    2
    3
    4
    3
    0
    Anxiety
    2
    2
    2
    2
    2
    1
    Disorientation
    1
    0
    2
    1
    2
    0
    Depression
    2
    2
    2
    2
    2
    2
    Respiratory, Thoracic and Mediastinal Disorders
    Pharyngolaryngeal pain
    2
    1
    3
    3
    2
    2

    * PGB: pregabalin

    Controlled Studies in Neuropathic Pain Associated with Spinal Cord Injury

    Adverse Reactions Leading to Discontinuation

    In clinical trials of adults with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

    Most Common Adverse Reactions

    Table 10 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients for which the incidence was greater than in the placebo treatment group with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".


    Table 10. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Spinal Cord Injury

    System Organ Class
    Preferred term
    PGB* (N=182)
    Placebo (N=174)
    %
    %
    Ear and labyrinth disorders
    Vertigo
    2.7
    1.1
    Eye disorders


    Vision blurred
    6.6
    1.1
    Gastrointestinal disorders


    Dry mouth
    11.0
    2.9
    Constipation
    8.2
    5.7
    Nausea
    4.9
    4.0
    Vomiting
    2.7
    1.1
    General disorders and administration site conditions
    Fatigue
    11.0
    4.0
    Edema peripheral
    10.4
    5.2
    Edema
    8.2
    1.1
    Pain
    3.3
    1.1
    Infections and infestations
    Nasopharyngitis
    8.2
    4.6
    Investigations


    Weight increased
    3.3
    1.1
    Blood creatine phosphokinase increased
    2.7
    0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
    4.9
    1.7
    Pain in extremity
    3.3
    2.3
    Neck pain
    2.7
    1.1
    Back pain
    2.2
    1.7
    Joint swelling
    2.2
    0
    Nervous system disorders
    Somnolence
    35.7
    11.5
    Dizziness
    20.9
    6.9
    Disturbance in attention
    3.8
    0
    Memory impairment
    3.3
    1.1
    Paresthesia
    2.2
    0.6
    Psychiatric disorders


    Insomnia
    3.8
    2.9
    Euphoric mood
    2.2
    0.6
    Renal and urinary disorders
    Urinary incontinence
    2.7
    1.1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
    2.7
    1.1
    Vascular disorders
    Hypertension
    2.2
    1.1
    Hypotension
    2.2
    0

    * PGB: Pregabalin


    Other Adverse Reactions Observed During the Clinical Studies of Pregabalin Capsules

    Following is a list of treatment-emergent adverse reactions reported by patients treated with pregabalin capsules during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

    Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients. Events of major clinical importance are described in the Warnings and Precautions section (5).

    Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

    Cardiovascular System – Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

    Digestive System – Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

    Hemic and Lymphatic System – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia, Alanine aminotransferase increased, Aspartate aminotransferase increased

    Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria

    Musculoskeletal System – Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent:

    Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

    Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia; Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

    Respiratory System – Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

    Skin and Appendages – Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

    Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

    Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

    Comparison of Gender and Race

    The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

    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.

    6.2 Postmarketing Experience

    The following adverse reactions have been identified during postapproval use of pregabalin capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Nervous System Disorders – Headache
    Gastrointestinal Disorders – Nausea, Diarrhea
    Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
    In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin capsules were co-administered with medications that have the potential to produce constipation, such as opioid analgesics. There are also postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.

    CLOSE

  • Dosage and Administration Section

    DOSAGE AND ADMINISTRATION

    2.1 Important Administration Instructions

    Pregabalin capsules are given orally with or without food.

    When discontinuing pregabalin capsules, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.3)].
    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 capsules 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 capsules were 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 capsules is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 mg 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 capsules, 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 capsules have been shown to be dose-related.

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

    The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules 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 capsules for fibromyalgia is 300 mg 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 capsules were 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 capsules for the treatment of neuropathic pain associated with spinal cord injury is 150 mg 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 capsules 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:

    CLCr = [140- age (years) ] x weight (kg) ( X 0.85 for female patients)
    72 x serum creatinine (mg/dL)

    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 capsules 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
    30–60
    75
    150
    225
    300
    BID or TID
    15–30
    25–50
    75
    100–150
    150
    QD or BID
    Less than 15
    25
    25–50
    50–75
    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 25–50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg
    Patients on the 50–75 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 AND USAGE

    Pregabalin capsules are 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 100mgPregabalin 100mgPregabalin 100mg

  • INGREDIENTS AND APPEARANCE
    LYRICA 
    pregabalin 100mg capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0170(NDC:31722-613)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M) PREGABALIN100 mg
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 141;J
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0170-390 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20691210/08/2019
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0170)