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When prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., development of tolerance, self-dose escalation, and drug-seeking behavior). PRODUCT MONOGRAPH Pr NEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada ULC Date of Revision: 17,300 Trans-Canada Highway January 27, 2020 Kirkland, Quebec H9J 2M5 www.pfizer.ca Submission Control No: 232770 ®TM Warner-Lambert Company LLC Pfizer Canada ULC, Licensee ©Pfizer Canada ULC 2019 NEURONTIN® (gabapentin) Product Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 9.1 Controlled Substance - Gabapentin tablet contains gabapentin, which is not a controlled substance. 9.2 Abuse - Abuse is the intentional, non-therapeutic use of a drug, even once, for its Gabapentin reference guide for safe and effective use from the American Society of Health-System Pharmacists (AHFS DI). Official Monographs / Gabapentin 3297 . Gabapentin Capsules » Gabapentin Capsules contain not less than 90.0 percent and not more than 110.0 per cent of the labeled amount of gabapentin (C 9H17NO2). Packaging and storage—Preserve in well-closed containers. Store at controlled room temperature. Gabapentin does not induce or inhibit hepatic mixed function oxidase enzymes responsible for drug metabolism and does not interfere with the metabolism of commonly coadministered antiepileptic drugs. ptic drugs. (See 9.4 Drug-Drug Interactions ). Gabapentin also shows a low level of binding to plasma proteins (approximately 3%) and is elimin ed solely by renal excretion It is not necessary to monitor gabapentin plasma concentrations in order to optimize GABAPENTIN therapy. Further, as there are no drug interactions with commonly used antiepileptic drugs, GABAPENTIN may be used in combination with these drugs without concern for alteration of plasma concentrations of either gabapentin or other antiepileptic drugs. Gabapentin Drug Classes: Central Nervous System Agent, Gamma Aminobutyric Acid (class), Gabapentinoid, Anticonvulsant, Neuropathic Pain Agent View all Routes: oral, topical Gabapentin is an anticonvulsant structurally related to the inhibitory CNS neurotransmitter γ -aminobutyric acid (GABA); the drug also possesses analgesic activity. Gabapentin enacarbil is a prodrug of gabapentin. This is a quick reference drug monograph for the antiepileptic, gabapentin (Neurontin). When prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., development of tolerance, self-dose escalation, and drug-seeking behavior). Page headings Overview Primary Characterstics Indications Pharmacokinetics Contraindications Drug Interactions Side Effects Dosage High Risk Groups Warning / Precautions Storage Conditions Interference in Pathology Brands of Gabapentin Manufacturers of Gabapentin As with any CNS active drug, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of abuse or misuse of gabapentin (e.g. development of tolerance, self-dose escalation, and drug-seeking behavior). DEFINITION Gabapentin contains NLT 98.0% and NMT 102.0% of gabapentin (C 9 H 17 NO 2), calculated on the anhydrous basis. Pharmacokinetics and Drug Metabolism All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans. Oral Bioavailability: Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. h the drug is not indicated. Such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. Most of these individuals had a history of poly-substance abuse or used gabapentin to relieve symptoms of with Find medical information for gabapentin on epocrates online, including its dosing, contraindications, drug interactions, and pill pictures. United States Pharmacopeia (). USP Monographs, Gabapentin Capsules. USP-NF. Rockville, MD: United States Pharmacopeia.
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