PREGABALIN capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information reg
Product summary:
Product: 71335-1300 NDC: 71335-1300-1 30 CAPSULE in a BOTTLE NDC: 71335-1300-2 60 CAPSULE in a BOTTLE NDC: 71335-1300-3 90 CAPSULE in a BOTTLE Product: 71335-1459 NDC: 71335-1459-1 30 CAPSULE in a BOTTLE NDC: 71335-1459-2 60 CAPSULE in a BOTTLE NDC: 71335-1459-3 90 CAPSULE in a BOTTLE Product: 71335-1475 NDC: 71335-1475-1 30 CAPSULE in a BOTTLE NDC: 71335-1475-2 90 CAPSULE in a BOTTLE NDC: 71335-1475-3 60 CAPSULE in a BOTTLE Product: 71335-1476 NDC: 71335-1476-1 30 CAPSULE in a BOTTLE NDC: 71335-1476-2 60 CAPSULE in a BOTTLE NDC: 71335-1476-3 90 CAPSULE in a BOTTLE Product: 71335-1505 NDC: 71335-1505-1 60 CAPSULE in a BOTTLE NDC: 71335-1505-2 90 CAPSULE in a BOTTLE NDC: 71335-1505-3 30 CAPSULE in a BOTTLE Product: 71335-1555 NDC: 71335-1555-1 30 CAPSULE in a BOTTLE NDC: 71335-1555-2 60 CAPSULE in a BOTTLE NDC: 71335-1555-3 90 CAPSULE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
71335-1300-1, 71335-1300-2, 71335-1300-3, 71335-1459-1, 71335-1459-2, 71335-1459-3, 71335-1475-1, 71335-1475-2, 71335-1475-3, 71335-1476-1, 71335-1476-2, 71335-1476-3, 71335-1505-1, 71335-1505-2, 71335-1505-3, 71335-1555-1, 71335-1555-2, 71335-1555-3

Bryant Ranch Prepack

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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 capsules?

Pregabalin capsules 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

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:

swelling of your face, mouth, lips, gums, tongue, throat or neck

trouble breathing

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:

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 capsules without first talking to a

healthcare provider.

Stopping pregabalin capsules 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.

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 may harm your unborn baby. You and your

healthcare provider will decide if you should take pregabalin capsules while you are pregnant.

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 1-888-233-2334. 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 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 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 capsules affect 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

blurry vision

dry mouth

weight gain

sleepiness

trouble concentrating

swelling of hands and feet

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 room temperature between 68°F to 77°F (20°C to 25°C) 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 Rising Pharmaceuticals, Inc. at 1-866-562-4597.

What are the ingredients in pregabalin capsules?

Active ingredient: pregabalin

Inactive ingredients:

Pregabalin capsules: pregelatinized starch, talc

Capsule shell: gelatin, sodium lauryl sulfate and titanium dioxide; Orange & Red capsule shell: red iron

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

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.

*The brands listed are trademarks of their respective owners and are not trademarks of Rising

Pharmaceuticals, Inc.

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

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

Manufactured by:

Laurus Labs Limited

Visakhapatnam-531011

India

M. L. No.: 16/VSP/AP/2015/F & B/CC

2000336

Revised: 06/2019

Revised: 9/2020

Document Id: 3d750867-3099-4c53-8ee2-a341b6dc20c9

34391-3

Set id: 72832f05-325e-4a72-8a33-da114e39c52d

Version: 9

Effective Time: 20200920

Bryant Ranch Prepack

PREGABALIN - pregabalin capsule

Bryant Ranch Prepack

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and

effectively. See full prescribing information for PREGABALIN CAPSULES.

PREGABALIN capsules, for oral use, CV

Initial U.S. Approval: 2004

INDICATIONS AND USAGE

Pregabalin capsules are indicated for:

Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)

Postherpetic neuralgia (PHN) (1)

Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (1)

Fibromyalgia (1)

Neuropathic pain associated with spinal cord injury (1)

DOSAGE AND ADMINISTRATION

For adult indications, begin dosing at 150 mg/day. (2.2, 2.3, 2.4, 2.5, 2.6)

Dosing recommendations:

INDICATION

Dosing

Regimen

Maximum Dose

DPN Pain (2.2)

3 divided doses per day

300 mg/day within

1 week

PHN (2.3)

2 or 3 divided doses per day

300 mg/day within

1 week. Maximum dose of 600 mg/day.

Adjunctive Therapy for Partial-Onset

Seizures in Adult Patients 17 years of Age

and Older (2.4)

2 or 3 divided doses per day

Maximum dose of

600 mg/day.

Fibromyalgia (2.5)

2 divided doses per day

300 mg/day within

1 week. Maximum dose of 450 mg/day.

Neuropathic Pain Associated with Spinal

Cord Injury (2.6)

2 divided doses per day

300 mg/day within

1 week. Maximum dose of 600 mg/day.

Dose should be adjusted in adult patients with reduced renal function. (2.7)

DOSAGE FORMS AND STRENGTHS

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. (3)

CONTRAINDICATIONS

Known hypersensitivity to pregabalin or any of its components. (4)

WARNINGS AND PRECAUTIONS

Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening

respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in these cases. (5.1)

Hypersensitivity reactions (e.g. hives, dyspnea, and wheezing) can occur. Discontinue pregabalin immediately in these

patients. (5.2)

Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Withdraw

pregabalin gradually over a minimum of 1 week. (5.3)

Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. (5.4)

Pregabalin may cause peripheral edema. Exercise caution when co-administering pregabalin and thiazolidinedione

antidiabetic agents. (5.5)

Pregabalin may cause dizziness and somnolence and impair patients' ability to drive or operate machinery.(5.6)

ADVERSE REACTIONS

Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry

mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA

at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise of potential risk to the fetus.(8.1)

Lactation: Breastfeeding is not recommended. (8.2)

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.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults

2.3 Postherpetic Neuralgia in Adults

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

2.5 Management of Fibromyalgia in Adults

2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults

2.7 Dosing for Adult Patients with Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

5.2 Hypersensitivity

5.3 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation

5.4 Suicidal Behavior and Ideation

5.5 Peripheral Edema

5.6 Dizziness and Somnolence

5.7 Weight Gain

5.8 Tumorigenic Potential

5.9 Ophthalmological Effects

5.10 Creatine Kinase Elevations

5.11 Decreased Platelet Count

5.12 PR Interval Prolongation

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

14.2 Postherpetic Neuralgia

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

14.4 Management of Fibromyalgia

14.5 Management of Neuropathic Pain Associated with Spinal Cord Injury

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 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.

2 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 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

Sections or subsections omitted from the full prescribing information are not listed.

The recommended dose of pregabalin capsules 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 capsules 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 capsules 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 capsules

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:

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

BID or TID

30 to 60

BID or TID

15 to 30

25 to 50

100 to 150

QD or BID

Less than 15

25 to 50

50 to 75

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.

3 DOSAGE FORMS AND STRENGTHS

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg

[see Description (11) and How Supplied/Storage and Handling (16)]

4 CONTRAINDICATIONS

Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of

its components. Angioedema and hypersensitivity reactions have occurred in patients receiving

pregabalin therapy [see Warnings and Precautions (5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

There have been postmarketing reports of angioedema in patients during initial and chronic treatment

with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and

neck (throat and larynx). There were reports of life-threatening angioedema with respiratory

compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these

symptoms.

Exercise caution when prescribing pregabalin to patients who have had a previous episode of

angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g.,

angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing

angioedema.

5.2 Hypersensitivity

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment

with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing.

Discontinue pregabalin immediately in patients with these symptoms.

5.3 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation

As with all antiepileptic drugs (AEDs), withdraw pregabalin gradually to minimize the potential of

increased seizure frequency in patients with seizure disorders.

Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including

insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

If pregabalin is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue

the drug abruptly.

5.4 Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behavior in

patients taking these drugs for any indication. Monitor patients treated with any AED for any indication

for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual

changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different

AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted

Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to

placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate

of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24%

among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal

thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in

the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about

drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week

after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because

most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or

behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of

indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary

substantially by age (5 to 100 years) in the clinical trials analyzed.

Table 3 shows absolute and relative risk by indication for all evaluated AEDs.

Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

Indication

Placebo Patients

with Events Per

1,000 Patients

Drug Patients with

Events Per 1,000

Patients

Relative Risk:

Incidence of Events in Drug

Patients/Incidence in Placebo

Patients

Risk Difference:

Additional Drug Patients

with Events Per 1,000

Patients

Epilepsy

Psychiatric Other

Total

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in

clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the

epilepsy and psychiatric indications.

Anyone considering prescribing pregabalin or any other AED must balance the risk of suicidal thoughts

or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are

prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal

thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber

needs to consider whether the emergence of these symptoms in any given patient may be related to the

illness being treated.

5.5 Peripheral Edema

Pregabalin treatment may cause peripheral edema. In short-term trials of patients without clinically

significant heart or peripheral vascular disease, there was no apparent association between peripheral

edema and cardiovascular complications such as hypertension or congestive heart failure. Peripheral

edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic

function.

In controlled clinical trials in adult patients, the incidence of peripheral edema was 6% in the

pregabalin group compared with 2% in the placebo group. In controlled clinical trials, 0.5% of

pregabalin patients and 0.2% placebo patients withdrew due to peripheral edema.

Higher frequencies of weight gain and peripheral edema were observed in patients taking both

pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. The

majority of patients using thiazolidinedione antidiabetic agents in the overall safety database were

participants in studies of pain associated with diabetic peripheral neuropathy. In this population,

peripheral edema was reported in 3% (2/60) of patients who were using thiazolidinedione antidiabetic

agents only, 8% (69/859) of patients who were treated with pregabalin only, and 19% (23/120) of

patients who were on both pregabalin and thiazolidinedione antidiabetic agents. Similarly, weight gain

was reported in 0% (0/60) of patients on thiazolidinediones only; 4% (35/859) of patients on

pregabalin only; and 7.5% (9/120) of patients on both drugs.

As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention,

possibly exacerbating or leading to heart failure, exercise caution when co-administering

pregabalin and these agents.

Because there are limited data on congestive heart failure patients with New York Heart Association

(NYHA) Class III or IV cardiac status, exercise caution when using pregabalin in these patients.

5.6 Dizziness and Somnolence

Pregabalin may cause dizziness and somnolence. Inform patients that pregabalin-related dizziness and

somnolence may impair their ability to perform tasks such as driving or operating machinery [see Patient

Counseling Information (17)].

In the pregabalin controlled trials in adult patients, dizziness was experienced by 30% of pregabalin-

treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of

pregabalin-treated patients compared to 8% of placebo-treated patients. Dizziness and somnolence

generally began shortly after the initiation of pregabalin therapy and occurred more frequently at higher

doses. Dizziness and somnolence were the adverse reactions most frequently leading to withdrawal (4%

each) from controlled studies. In pregabalin-treated patients reporting these adverse reactions in short-

term, controlled studies, dizziness persisted until the last dose in 30% and somnolence persisted until

the last dose in 42% of patients [see Drug Interactions (7)].

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.

5.7 Weight Gain

Pregabalin treatment may cause weight gain. In pregabalin controlled clinical trials in adult patients of

up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of pregabalin-treated

patients and 2% of placebo-treated patients. Few patients treated with pregabalin (0.3%) withdrew from

controlled trials due to weight gain. Pregabalin associated weight gain was related to dose and duration

of exposure, but did not appear to be associated with baseline BMI, gender, or age. Weight gain was not

limited to patients with edema [see Warnings and Precautions (5.5)].

Although weight gain was not associated with clinically important changes in blood pressure in short-

term controlled studies, the long-term cardiovascular effects of pregabalin-associated weight gain are

unknown.

Among diabetic patients, pregabalin-treated patients gained an average of 1.6 kg (range: -16 to 16 kg),

compared to an average 0.3 kg (range: -10 to 9 kg) weight gain in placebo patients. In a cohort of 333

diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg.

While the effects of pregabalin-associated weight gain on glycemic control have not been

systematically assessed, in controlled and longer-term open label clinical trials with diabetic patients,

pregabalin treatment did not appear to be associated with loss of glycemic control (as measured by

5.8 Tumorigenic Potential

In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, an unexpectedly high

incidence of hemangiosarcoma was identified in two different strains of mice [see Nonclinical

Toxicology (13.1)]. The clinical significance of this finding is unknown. Clinical experience during

pregabalin's premarketing development provides no direct means to assess its potential for inducing

tumors in humans.

In clinical studies across various patient populations, comprising 6,396 patient-years of exposure in

patients greater than 12 years of age, new or worsening-preexisting tumors were reported in 57 patients.

Without knowledge of the background incidence and recurrence in similar populations not treated with

pregabalin, it is impossible to know whether the incidence seen in these cohorts is or is not affected by

treatment.

5.9 Ophthalmological Effects

In controlled studies in adult patients, a higher proportion of patients treated with pregabalin reported

blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases

with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision-related

events (primarily blurred vision).

Prospectively planned ophthalmologic testing, including visual acuity testing, formal visual field testing

and dilated funduscopic examination, was performed in over 3,600 patients. In these patients, visual

acuity was reduced in 7% of patients treated with pregabalin, and 5% of placebo-treated patients. Visual

field changes were detected in 13% of pregabalin-treated, and 12% of placebo-treated patients.

Funduscopic changes were observed in 2% of pregabalin-treated and 2% of placebo-treated patients.

Although the clinical significance of the ophthalmologic findings is unknown, inform patients to notify

their physician if changes in vision occur. If visual disturbance persists, consider further assessment.

Consider more frequent assessment for patients who are already routinely monitored for ocular

conditions [see Patient Counseling Information (17)].

5.10 Creatine Kinase Elevations

Pregabalin treatment was associated with creatine kinase elevations. Mean changes in creatine kinase

from baseline to the maximum value were 60 U/L for pregabalin-treated patients and 28 U/L for the

placebo patients. In all controlled trials in adult patients across multiple patient populations, 1.5% of

patients on pregabalin and 0.7% of placebo patients had a value of creatine kinase at least three times the

upper limit of normal. Three pregabalin-treated subjects had events reported as rhabdomyolysis in

premarketing clinical trials. The relationship between these myopathy events and pregabalin is not

completely understood because the cases had documented factors that may have caused or contributed

to these events. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness,

particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with

pregabalin if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.

5.11 Decreased Platelet Count

Pregabalin treatment was associated with a decrease in platelet count. Pregabalin-treated subjects

experienced a mean maximal decrease in platelet count of 20 × 10 /µL, compared to 11 × 10 /µL in

placebo patients. In the overall database of controlled trials in adult patients, 2% of placebo patients and

3% of pregabalin patients experienced a potentially clinically significant decrease in platelets, defined

as 20% below baseline value and less than 150 × 10 /µL. A single pregabalin-treated subject developed

severe thrombocytopenia with a platelet count less than 20 × 10 / µL. In randomized controlled trials,

pregabalin was not associated with an increase in bleeding-related adverse reactions.

5.12 PR Interval Prolongation

Pregabalin treatment was associated with PR interval prolongation. In analyses of clinical trial ECG data

in adult patients, the mean PR interval increase was 3 to 6 msec at pregabalin doses greater than or equal

to 300 mg/day. This mean change difference was not associated with an increased risk of PR increase

greater than or equal to 25% from baseline, an increased percentage of subjects with on-treatment PR

greater than 200 msec, or an increased risk of adverse reactions of second or third degree AV block.

Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR

prolongation or in patients taking other PR prolonging medications. However, these analyses cannot be

considered definitive because of the limited number of patients in these categories.

6 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 [seeWarnings 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 [seeWarnings 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, more than 10,000 patients have received pregabalin. 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 and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In

the pregabalin 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 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 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 and 4% 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 (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 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 group for

which the incidence was greater in this combined pregabalin 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

Accidental injury 5

Back pain

Chest pain

Face edema

Digestive system

Dry mouth

Constipation

Flatulence

Metabolic and nutritional disorders

Peripheral edema 4

Weight gain

Edema

Hypoglycemia

Nervous system

Dizziness

Somnolence

Neuropathy

Ataxia

Vertigo

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