Pregabalin Extended Release

Pregabalin Extended Release is an FDA-registered drug product whose active ingredient is PREGABALIN. It is labelled by ScieGen Pharmaceuticals, INC. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 50228-462, application ANDA215675, label effective 20220919. It is one of 75 FDA drug label records sharing the active ingredient PREGABALIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PREGABALIN are most often described in connection with: pregabalin extended-release, management neuropathic, pain associated, diabetic peripheral, postherpetic neuralgia, fibromyalgia adjunctive, adult patients, partial onset. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

2 DOSAGE AND ADMINISTRATION Pregabalin extended-release tablets should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. ( 2.1 ) Dosing recommendations for pregabalin extended-release tablets: Indication Dosing Regimen Initial Dose Maximum Dose DPN Pain ( 2.2 ) Single dose per day 165 mg/day 330 mg/day within 1 week. PHN ( 2.3 ) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day. Conversion from LYRICA Capsules or Oral Solution to pregabalin extended-release tablets: See full prescribing information. ( 2.4 ) Dose modification recommended in patients with renal impairment. ( 2.5 ) 2.1 Important Dosage and Administration Instructions Pregabalin extended-release tablets should be administered once daily after an evening meal. Pregabalin extended-release tablets should be swallowed whole and should not be split, crushed, or chewed. When discontinuing pregabalin extended-release tablets, taper gradually over a minimum of 1 week. Instruct patients that if they miss taking their dose of pregabalin extended-release tablets after an evening meal, then they should take their usual dose of pregabalin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of pregabalin extended-release tablets prior to bedtime, then they should take their usual dose of pregabalin extended-release tablets following a morning meal. If they miss taking the dose of pregabalin extended-release tablets following the morning meal, then they should take their usual dose of pregabalin extended-release tablets at the usual time that evening following an evening meal [see Patient Counseling Information (17 )] . 2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of pregabalin extended-release tablets is 330 mg once daily. Although LYRICA was studied at 600 mg/day, there was no evidence that this dose conferred additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions with LYRICA, treatment with doses above 330 mg/day is not recommended for pregabalin extended-release tablets. 2.3 Postherpetic Neuralgia Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate pregabalin extended-release tablets, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of pregabalin extended-release tablets is 660 mg once daily. 2.4 Conversion from LYRICA Capsules or Oral Solution to Pregabalin Extended-Release Tablets When switching from LYRICA to pregabalin extended-release tablets on the day of the switch, instruct patients to take their morning dose of LYRICA as prescribed and initiate pregabalin extended-release tablets therapy after an evening meal. Table 1. Conversion from LYRICA Capsules or Oral Solution to Pregabalin Extended-Release Tablets LYRICA Total Daily Dose (dosed 2 or 3 times daily) Pregabalin Extended-Release Tablets Dose (dosed once a day) 75 mg/daily 82.5 mg/day 150 mg/daily 165 mg/day 225 mg/daily 247.5 mg/day 247.5 mg = 3 × 82.5 mg tablets taken once a day. 300 mg/daily 330 mg/day 450 mg/daily 495 mg/day 495 mg = 3 × 165 mg tablets taken once a day. 600 mg/daily 660 mg/day 660 mg = 2 × 330 mg tablets taken once a day. 2.5 Patients with Renal Impairment Use of pregabalin extended-release tablets is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive LYRICA. In view of dose-dependent adverse reactions and because pregabalin is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on CLcr, as indicated in Table 2. To use the dosing tables, 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 extended-release tablets therapy for postherpetic neuralgia with normal renal function [CLcr greater than or equal to 60 mL/min], receives a single daily dose of 165 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a single daily dose of 82.5 mg.) Table 2: Pregabalin Extended-Release Tablets Dosage Adjustment Based on Renal Function Creatinine Clearance (CLcr) (mL/min) Total Pregabalin Extended-Release Tablets Daily Dose (mg/day) Dose Regimen greater than or equal to 60 165 330 495 495 mg = 3 × 165 mg tablets taken once a day. 660 660 mg = 2 × 330 mg tablets taken once a day. Once a day 30–60 82.5 165 247.5 247.5 mg = 3 × 82.5 mg tablets taken once a day 330 Once a day less than 30/hemodialysis Dose with LYRICA PRINCIPAL DISPLAY PANEL - 50 mg/500 mg Tablet Bottle Label

4 CONTRAINDICATIONS Pregabalin extended-release tablets 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 (5.1 , 5.2) , Adverse Reactions (6) ] . Known hypersensitivity to pregabalin or any of its components. ( 4 )

6 ADVERSE REACTIONS 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) ] Respiratory Depression [see Warnings and Precautions (5.4) ] Dizziness and Somnolence [see Warnings and Precautions (5.5) ] Risks Associated with Abrupt or Rapid Discontinuation [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) ] Most common adverse reactions reported in greater than or equal to 4% of patients treated with pregabalin extended-release tablets are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. Two randomized placebo-controlled clinical trials were conducted in patients with postherpetic neuralgia and fibromyalgia in which a total of 1242 patients received pregabalin extended-release tablets. Both studies were randomized withdrawal design where a 6-week single-blind, dose optimization phase was followed by a 13-week double-blind phase. The most common adverse events leading to discontinuation from the single-blind phase of the study occurring in greater than or equal to 0.3% of patients were dizziness, somnolence, peripheral edema, fatigue, blurred vision, and increased weight. Sixty-four percent of patients experienced adverse events during the single-blind phase, with the most common adverse events occurring in greater than or equal to 4% of patients being dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. Controlled Study in Postherpetic Neuralgia Adverse Reactions Leading to Discontinuation In a clinical trial in patients with postherpetic neuralgia, 8.9% of patients treated with pregabalin extended-release tablets discontinued prematurely during the single-blind phase due to adverse reactions. The most common reasons for discontinuation due to adverse reactions were dizziness (2.1%), somnolence (0.87%), and peripheral edema (0.50%). Most Common Adverse Reactions Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with postherpetic neuralgia who received pregabalin extended-release tablets, regardless of the phase of the study. Table 4. Incidence of Adverse Reactions Reported in Greater Than or Equal to 1% of Subjects in Any Phase of the Pregabalin Extended-Release Tablets Study in Patients With Postherpetic Neuralgia Table is limited to adverse reactions that occurred with higher incidence in pregabalin extended-release tablets-treated patients than in placebo-treated patients for the DB Phase of the study. System Organ Class Preferred Term Single-Blind Phase Double-Blind Phase Pregabalin extended-release tablets [N=801] n (%) Pregabalin extended-release tablets [N=208] n (%) Placebo [N=205] n (%) Ear and labyrinth disorders Vertigo 31 (3.9) 2 (1.0) 1 (0.5) Eye disorders Vision blurred 30 (3.7) 1 (0.5) 0 Diplopia 8 (1.0) 1 (0.5) 0 Gastrointestinal disorders Dry mouth 30 (3.7) 1 (0.5) 0 Nausea 24 (3.0) 7 (3.4) 0 Constipation 22 (2.7) 0 0 Diarrhea 11 (1.4) 2 (1.0) 1 (0.5) Vomiting 9 (1.1) 3 (1.4) 1 (0.5) General disorders and administration site conditions Edema peripheral 39 (4.9) 8 (3.8) 1 (0.5) Fatigue 31 (3.9) 3 (1.4) 2 (1.0) Edema 3 (0.4) 3 (1.4) 0 Infections and infestations Nasopharyngitis 12 (1.5) 3 (1.4) 0 Urinary tract infection 11 (1.4) 3 (1.4) 1 (0.5) Bronchitis 4 (0.5) 3 (1.4) 2 (1.0) Respiratory tract infection viral 3 (0.4) 3 (1.4) 1 (0.5) Sinusitis 3 (0.4) 2 (1.0) 0 Gastroenteritis viral 2 (0.2) 2 (1.0) 0 Investigations Weight increased 20 (2.5) 8 (3.8) 2 (1.0) Alanine aminotransferase increased 2 (0.2) 3 (1.4) 0 Aspartate aminotransferase increased 2 (0.2) 2 (1.0) 0 Musculoskeletal and connective tissue disorders Arthralgia 6 (0.7) 2 (1.0) 1 (0.5) Joint swelling 0 4 (1.9) 0 Nervous system disorders Dizziness 137 (17.1) 7 (3.4) 1 (0.5) Somnolence 91 (11.4) 1 (0.5) 0 Headache 31 (3.9) 4 (1.9) 1 (0.5) Balance disorder 21 (2.6) 1 (0.5) 0 Reproductive system and breast disorders Erectile dysfunction 2 (0.6) 1 (1.4) 0 Respiratory, thoracic, and mediastinal disorders Cough 2 (0.2) 2 (1.0) 1 (0.5) Skin and subcutaneous tissue disorders Dermatitis contact 0 2 (1.0) 0 Other Adverse Reactions Observed During Clinical Studies with LYRICA and pregabalin extended-release tablets In addition to the adverse reactions reported during the controlled studies with pregabalin extended-release tablets in postherpetic neuralgia, the following adverse reactions have been reported in patients treated with LYRICA and pregabalin extended-release tablets during all clinical studies. This listing does not include those adverse reactions already listed above. The adverse reactions are categorized by system organ class and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Adverse reactions of major clinical importance are described in the Warnings and Precautions section (5) . Cardiac Disorders – Infrequent: Palpitations, Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: Cardiac failure, Tachycardia Eye Disorders – Infrequent: Periorbital edema Gastrointestinal Disorders – Frequent: Increased appetite; Infrequent: Abdominal distension, Abdominal pain, Dysphagia, Pancreatitis, Tongue edema General Disorders – Frequent: Fever; Infrequent: Chest pain, Face edema; Rare: Facial pain, Mucosal dryness Hemic and Lymphatic System Disorders – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia Infections and Infestations – Infrequent: Otitis media, Pneumonia Investigations – Rare: Glucose urine present, Lipase increased, Neutrophil count increased, Proteinuria Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria Musculoskeletal and Connective Tissue Disorders – Frequent: Leg cramps, Myalgia, Myasthenia; Infrequent: Joint stiffness; Rare: Coccydynia, Myokymia Nervous System Disorders – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Coordination abnormal, Abnormal dreams, Agitation, Amnesia, Apathy, Aphasia, Circumoral paresthesia, Cognitive disorder, Dysarthria, Dysgeusia, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Sciatica, Sleep phase rhythm disturbance; Rare: Addiction, Altered state of consciousness, Bradykinesia, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Depressed level of consciousness, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Psychomotor hyperactivity, Psychomotor skills impaired Psychiatric Disorders – Infrequent: Irritability Respiratory System Disorders – Rare: Lung edema Skin Disorders – Frequent: Pruritus; Rare: Stevens-Johnson syndrome Special Senses – Frequent: Conjunctivitis, Tinnitus Urogenital System Disorders – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Nephritis, Oliguria, Urinary retention 6.2 Postmarketing Experience with LYRICA The following adverse reactions have been identified during post-approval use of LYRICA. These adverse reactions have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: breast enlargement, bullous pemphigoid, gynecomastia. There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking pregabalin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment. In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when LYRICA was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.

FDA lists 75 drug label records with PREGABALIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Pregabalin Extended Release used for?
1 INDICATIONS AND USAGE Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release …

Who makes Pregabalin Extended Release?
ScieGen Pharmaceuticals, INC. is the labeler of record for Pregabalin Extended Release. 75 FDA label records share the active ingredient PREGABALIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pregabalin Extended Release come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pregabalin Extended Release prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PREGABALIN?
Yes. 75 FDA drug label records list PREGABALIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pregabalin Extended Release been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.