Pregablin 75 mg/1
Pregablin · CAPSULE · Macleods Pharmaceuticals Limited
Pregabalin is a prescription medication taken by mouth that is used to treat nerve pain, seizures, and anxiety disorders. It works by calming overactive nerves in the body and brain.
Key Facts
- Brand Name
- Pregablin
- Generic Name
- Pregablin
- NDC Code (Product)
33342-167- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 75 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- ANDA205924
- Marketing Start
- 11/13/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury 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 1 month of age and older ( 1 ) Fibromyalgia ( 1 ) Neuropathic pain associated with spinal cord injury ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4 . (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 Pediatric and Adult Patients Weighing 30 kg or More (2.4 ) 2 or 3 divided doses per day Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg ( 2.4 ) 1 month to less than 4 years: 3 divided doses per day 4 years and older: 2 or 3 divided doses per day 14 mg/kg/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 ) 2.1 Important Administration Instructions Pregabalin capsules is …
Contraindications
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 )]. Known hypersensitivity to pregabalin or any of its components. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Since pregabalin capsules are 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 and in vivo studies showed that pregabalin capsules are unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin capsules and commonly used antiepileptic drugs [see Clinical Pharmacology ( 12 )] . Pharmacodynamics Multiple oral doses of pregabalin capsules were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin capsules was co-administered with these drugs. No clinically i…
Adverse Reactions
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 )] 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 )] Tumorigenic Potential [see Warnings and Precautions ( 5.9 )] 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 )] PR Interval Prolongation [see Warnings and Precautions ( 5.13 )] 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 ) Most commo…
Frequently Asked Questions
What is Pregablin used for?
Pregabalin is a prescription medication taken by mouth that is used to treat nerve pain, seizures, and anxiety disorders. It works by calming overactive nerves in the body and brain.
Is Pregablin a controlled substance?
Yes, Pregablin is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Pregablin?
The generic name for Pregablin is Pregablin. There are no other listed brand versions of Pregablin.
What is the NDC code for Pregablin 75 mg/1?
The NDC (National Drug Code) for Pregablin 75 mg/1 is 33342-167, listed by Macleods Pharmaceuticals Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)