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In adults with postherpetic neuralgia, gabapentin tablets may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical NEW ZEALAND DATA SHEET 1. PRODUCT NAME Gabapentin medsurge 100 mg, 300 mg and 400 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg of gabapentin. Each 300 mg capsule contains 300 mg of gabapentin. Each 400 mg capsule contains 400 mg of gabapentin. Excipient(s) with known effect: MATERIAL SAFETY DATA SHEET _____ Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) Revision date: 02-Jan-2007 Page 3 of 6 Version: 1.2 8. EXPOSURE CONTROLS / PERSONAL PROTECTION The exposure limit(s) listed for solid components are only relevant if dust may be generated. Analytical Method: Analytical method available for gabapentin Gabapentin 100 mg capsules, hard Gabapentin 300 mg capsules, hard Gabapentin 400 mg capsules, hard gabapentin Read all of this lea˜et carefully before you start taking this medicine because it contains important information for you. • Keep this lea˜et. You may need to read it again. Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) Trade Name: NEURONTIN; NEUGABA; GANTIN; PARKETIN; GABAPENTIN PFIZER Chemical Family: Mixture Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product used as anticonvulsant Details of the Supplier of the Safety Data Sheet 2. carcinoma were found in male rats receiving the highest dose (2000 mg/kg), but not at doses of 250 or 1000 mg/kg/day. At 1000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 5 times that in humans at the MRHD. Studies designed to investigate the mechanism of gabapentin-induced pancreatic Neurontin®, but often will just be called gabapentin. What is gabapentin? Gabapentin belongs to a group of medicines that are called anti-epileptics. These drugs act on the brain to prevent epileptic seizures (fits). Some anti-epileptic drugs, such as gabapentin, can also help relieve anxiety, chronic pain and neuropathic pain (pain originating (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin. NEW ZEALAND DATA SHEET . 1. PRODUCT NAME Gabapentin 100 mg, 300 mg and 400 mg capsules . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (mg/day) 17 - 25 600 26 - 36 Trade Name(s): Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg. Therapeutic Category : Used to relieve pain, especially neuropathic pain, Anticonvulsant. Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation models, spinal cord injury model, acute herpes zoster infection model). The effective dose of gabapentin is 25 mg/kg/day to 35 mg/kg/day given in divided doses (3 times a day) as described in Table 1. Initial titration to an effective dose can take place over 3 days by giving 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2, and 30 mg/kg/day on Day 3. Thereafter, the dose Material Name: Gabapentin Tablets (Neurontin) Trade Name: NEURONTIN; NORMATOL; GABAPENTIN Pfizer Chemical Family: Mixture Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product used as anticonvulsant Details of the Supplier of the Safety Data Sheet 2. HAZARDS IDENTIFICATION 1.3. Details of the supplier of the safety data sheet Manufacturer, Supplier ACTAVIS, Inc. 400 Interpace Parkway, Morris Corporate Center III Parsippany, NJ 07054 800-272-5525 [08:00 AM --> 05:00 PM] TEVA 1090 Horsham Road North Wales, PA 19454 215-591-3000 [08:00 AM --> 05:00 PM] For further information, please contact Administer NEURONTIN three times a day using 300 mg or 400 mg capsules, or 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours. NEW ZEALAND DATA SHEET 1. PRODUCT NAME NEURONTIN 100 mg, 300 mg and 400 mg capsules NEURONTIN 600 mg and 800 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg of gabapentin. Each 300 mg capsule contains 300 mg of gabapentin. Each 400 mg capsule contains 400 mg of gabapentin. Each 600 mg SAFETY DATA SHEET Section 1: Identification Material Recommended use Gabapentin Capsules USP 100 mg, 300 mg and 400 mg Pharmaceutical product used as anticonvulsant. Manufacturer Hetero Labs Limited, Plot No. 28P1 to 36P1 and 37 to 54, Vemagal Industries Area, Hobli Vemagal Kolar - 563102, Karnataka, India. AEROBIC: The anticonvulsant drug Gabapentin (GAB) and photolytic mixtures were submitted to the Closed Bottle Test (CBT; OECD 301 D) to assess biodegradability. Furthermore, the toxicity of GAB and its photolytic mixtures was initially addressed on screening level using a MATERIAL SAFETY DATA SHEET. 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING. 2. HAZARDS IDENTIFICATION. Non-hazardous in accordance with international standards for workplace safety. Dust may cause irritation (based on components) The active ingredient is not acutely toxic. Show this safety data sheet to the doctor in attendance. Immediate medical attention is required. Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

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