Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy • Postherpetic neuralgia Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Extended-release tablets: 82.5 mg, 165 mg, and 330 mg [see Description (11) and How Supplied/Storage and Handling (16) ] . LYRICA CR Tablets Tablet Strength (mg) Tablet Description 82.5 mg Light blue, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 82.5” on the other side 165 mg Beige, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 165” on the other side 330 mg Rose, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 330” on the other side
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
LYRICA CR is 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 (5.1 , 5.2) , Adverse Reactions (6) ] .
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions [see Clinical Pharmacology (12) ] . The interactions of LYRICA CR with co-administration of other drugs have not been systematically evaluated. Co-administration of the prokinetic drug erythromycin with LYRICA CR did not result in any clinically important changes in the pharmacokinetics of LYRICA CR [see Clinical Pharmacology (12) ] . Additional studies have been performed with LYRICA. No pharmacokinetic interactions were observed between LYRICA and carbamazepine, gabapentin, lamotrigine, oral contraceptive, phenobarbital, phenytoin, topiramate, and valproic acid. A similar lack of pharmacokinetic interactions would be expected to occur with LYRICA CR. Pharmacodynamics Although no pharmacokinetic interactions were seen with LYRICA and ethanol, lorazepam, or oxycodone, additive effects on cognitive and gross motor functioning were seen when LYRICA was co-administered with these drugs. No clinically important effects on respiration were seen in studies of LYRICA.
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone LYRICA overdose and in combination with other CNS depressants. Treatment or Management of Overdose There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin. Pregabalin can be removed by hemodialysis. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
11 DESCRIPTION
DESCRIPTION SECTION
LYRICA CR (pregabalin extended-release) tablets are for oral use and contain pregabalin. Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. LYRICA CR extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with carbomer, colorants, crospovidone, Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, talc, and titanium dioxide as inactive ingredients.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
LYRICA CR is supplied in the following strengths and package configurations: LYRICA CR Tablets Package Configuration Tablet Strength (mg) NDC Tablet Description Bottles of 30 tablets 82.5 mg NDC 58151-245-93 Light blue, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 82.5” on the other side Bottles of 30 tablets 165 mg NDC 58151-246-93 Beige, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 165” on the other side Bottles of 30 tablets 330 mg NDC 58151-247-93 Rose, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 330” on the other side Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package. (See USP Controlled Room Temperature)
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Angioedema Advise patients that LYRICA CR may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue LYRICA CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1) ] . Hypersensitivity Advise patients that LYRICA CR has been associated with hypersensitivity reactions such as skin redness, blisters, hives, rash, dyspnea, and wheezing. Instruct patients to discontinue LYRICA CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including pregabalin, the active ingredient in LYRICA CR, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to a healthcare provider. Also inform patients who plan to or have discontinued LYRICA CR that suicidal thoughts and behavior can appear even after the drug is stopped [see Warnings and Precautions (5.3) ] . Respiratory Depression Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.5) ] . Dizziness and Somnolence Inform patients that LYRICA CR may cause dizziness, somnolence, blurred vision, and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on LYRICA CR to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.6) ] . CNS Depressants Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.5 , 5.6) and Drug Interactions (7) ] . Advise patients to avoid consuming alcohol while taking LYRICA CR, as LYRICA CR may potentiate the impairment of motor skills and sedating effects of alcohol [see Drug Interactions (7) ] . Abrupt or Rapid Discontinuation Advise patients to take LYRICA CR as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, or diarrhea. Advise patients with seizure disorders that abrupt or rapid discontinuation may increase seizure frequency [see Warnings and Precautions (5.4) ] . Missed Dose Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a morning meal. If they miss taking the dose of LYRICA CR following the morning meal, then they should take their usual dose of LYRICA CR at the usual time that evening following an evening meal. Weight Gain and Edema Inform patients that LYRICA CR may cause edema and weight gain. Advise patients that concomitant treatment with LYRICA CR and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. Advise patients with preexisting cardiac conditions that this may increase the risk of heart failure [see Warnings and Precautions (5.7 , 5.8) ] . Ophthalmological Effects Counsel patients that LYRICA CR may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10) ] . Creatine Kinase Elevations Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever [see Warnings and Precautions (5.11) ] . Use in Pregnancy Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy [see Use in Specific Populations (8.1) and (8.2) ] . Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1) ] . Lactation Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA CR [see Use in Specific Populations (8.2) ] . Male Fertility Inform men being treated with LYRICA CR who plan to father a child of the potential risk of male-mediated teratogenicity [see Nonclinical Toxicology (13.1) and Use in Specific Populations (8.3) ] . Dermatopathy Instruct diabetic patients to pay particular attention to skin integrity while being treated with LYRICA CR [see Nonclinical Toxicology (13.2) ] . Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2025 Viatris Inc. LYRICA is a registered trademark of Viatris Specialty LLC, a Viatris Company. The brands listed are trademarks of their respective owners. UPJ:LYRCCR:R3
MEDICATION GUIDE
SPL MEDGUIDE SECTION
LYRICA (LEER-i-kah) CR (pregabalin) extended-release tablets, CV Read this Medication Guide before you start taking LYRICA CR 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 LYRICA CR, ask your healthcare provider or pharmacist. What is the most important information I should know about LYRICA CR? LYRICA CR may cause serious side effects including: • Serious, even life-threatening, allergic reactions • Suicidal thoughts or actions • Serious breathing problems • 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 LYRICA CR 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 o skin redness • Like other antiepileptic drugs, LYRICA CR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take LYRICA CR or after stopping. 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 attempts to commit suicide o new or worse depression o new or worse anxiety o feeling agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood If you have suicidal thoughts or actions, do not stop LYRICA CR without first talking to a healthcare provider. o Stopping LYRICA CR 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? o Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. o Call your healthcare provider between visits as needed, especially if you are worried about symptoms. • Serious breathing problems can occur when LYRICA is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting LYRICA or when the dose is increased. Get help right away if breathing problems occur. • Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems. • Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA CR affects you. Ask your healthcare provider about when it will be okay to do these activities. What is LYRICA CR? LYRICA CR is a prescription medicine used to treat: • pain from damaged nerves (neuropathic pain) that happens with diabetes • pain from damaged nerves (neuropathic pain) that follows healing of shingles It is not known if LYRICA CR is safe and effective in children. It is not known if LYRICA CR is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures. Who should not take LYRICA CR? Do not take LYRICA CR if you are allergic to pregabalin or any of the ingredients in LYRICA CR. See “What is the most important information I should know about LYRICA CR?” for the signs of an allergic reaction. See the end of this leaflet for a complete list of ingredients in LYRICA CR. What should I tell my healthcare provider before taking LYRICA CR? Before taking LYRICA CR, tell your healthcare provider about all your medical conditions, including if you: • have or have had depression, mood problems or suicidal thoughts or behavior • have breathing problems • have kidney problems or get kidney dialysis • have heart problems including heart failure • have a bleeding problem or a low blood platelet count • have abused prescription medicines, street drugs, or alcohol in the past • have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema) • plan to father a child. Animal studies have shown that pregabalin, the active ingredient in LYRICA CR, 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 LYRICA CR. • are pregnant or plan to become pregnant. It is not known if LYRICA CR will harm your unborn baby. You and your healthcare provider will have to decide if you should take LYRICA CR while you are pregnant. o If you become pregnant while taking LYRICA CR, 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, including pregabalin, the active ingredient in LYRICA CR. Information about the registry can be found at the website, http://www.aedpregnancyregistry.org/. • are breastfeeding or plan to breastfeed. LYRICA CR passes into your breast milk. It is not known if LYRICA CR can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take LYRICA CR. Breastfeeding is not recommended while taking LYRICA CR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. LYRICA CR 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 LYRICA CR. See “What is the most important information I should know about LYRICA CR?” • Avandia ® (rosiglitazone), Avandamet ® (contains rosiglitazone and metformin), 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 LYRICA CR. See “What are the possible side effects of LYRICA CR.” • any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with LYRICA CR. • 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 LYRICA CR? • Take LYRICA CR exactly as prescribed. Your healthcare provider will tell you how much LYRICA CR to take and when to take it. • Take LYRICA CR at the same time each day. • LYRICA CR must be taken after your evening meal. Swallow the tablet whole and do not split, crush or chew the tablet. • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider. • Do not stop taking LYRICA CR without talking to your healthcare provider. If you stop taking LYRICA CR suddenly you may have headaches, nausea, diarrhea, trouble sleeping, or you may feel anxious. If you have epilepsy, are taking LYRICA CR for pain, and stop taking LYRICA CR suddenly, you may have seizures more often. ...
PRINCIPAL DISPLAY PANEL – 82.5 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 58151-245-93 Lyrica ® CR CV (pregabalin) extended release tablets 82.5 mg ALWAYS DISPENSE WITH MEDICATION GUIDE 30 Tablets Rx only Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package. [See USP Controlled Room Temperature] Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See accompanying prescribing information. Each tablet contains 82.5 mg pregabalin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made in Germany RUPJ245H
PRINCIPAL DISPLAY PANEL – 165 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 58151-246-93 Lyrica ® CR CV (pregabalin) extended release tablets 165 mg ALWAYS DISPENSE WITH MEDICATION GUIDE 30 Tablets Rx only Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package. [See USP Controlled Room Temperature] Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See accompanying prescribing information. Each tablet contains 165 mg pregabalin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made in Germany RUPJ246H
PRINCIPAL DISPLAY PANEL – 330 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 58151-247-93 Lyrica ® CR CV (pregabalin) extended release tablets 330 mg ALWAYS DISPENSE WITH MEDICATION GUIDE 30 Tablets Rx only Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package. [See USP Controlled Room Temperature] Dispense in tight (USP), child-resistant containers. DOSAGE AND USE See accompanying prescribing information. Each tablet contains 330 mg pregabalin. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made in Germany RUPJ247H
