Drug: Axid

Axid® (Nizatidine, USP) is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thia-zolyl]methyl]thio]ethyl]-Ni-methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine Nizatidine has the empirical formula C12H21N5O2S2 representing a molecular weight of 331.47. It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Each Pulvule®(capsule) contains for oral administration gelatin, pregelatinized starch, dimethicone, starch, titanium dioxide, yellow iron oxide, 150 mg (0.45 mmol) or 300 mg (0.91 mmol) of nizatidine, and other inactive ingredients. The 150-mg Pulvule also contains magnesium stearate, and the 300-mg Pulvule also contains croscarmellose sodium, povidone, red iron oxide, and talc.

Source: http://www.rxlist.com

Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group. Incidence in Placebo-Controlled Clinical Trials in the United States and Canada - Table 5 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied. Table 5 INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS IN PLACEBO-CONTROLLED CLINICAL TRIALS IN THE UNITED STATES AND CANADA

Source: http://www.rxlist.com

Active Duodenal Ulcer — The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Maintenance of Healed Duodenal Ulcer — The recommended oral dosage for adults is 150 mg once daily at bedtime. Gastroesophageal Reflux Disease — The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150mg twice daily. Active Benign Gastric Ulcer — The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency — The dose for patients with renal dysfunction should be reduced as follows: Active Duodenal Ulcer, GERD and Benign Gastric Ulcer Ccr

Source: http://www.rxlist.com

No interactions have been observed between Axid (nizatidine) and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. Axid (nizatidine) does not inhibit the cytochrome P-450-linked drug-metabolizing enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently.Last reviewed on RxList: 2/14/2006
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Axid (nizatidine) is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Axid (nizatidine) is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with Axid (nizatidine) for longer than 1 year are not known. Axid (nizatidine) is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Axid (nizatidine) is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

Source: http://www.rxlist.com

Axid (nizatidine) is contraindicated in patients with known hypersensitivity to the drug. Because cross sensitivity in this class of compounds has been observed, H2-receptor antagonists, including Axid (nizatidine) , should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.Last reviewed on RxList: 2/14/2006
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Overdoses of Axid (nizatidine) have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered. Signs and Symptoms — There is little clinical experience with over-dosage of Axid (nizatidine) in humans. Test animals that received large doses of nizatidine have exhibited cholinergic-type effects, including lacrimation, salivation, emesis, miosis, and diarrhea. Single oral doses of 800 mg/kg in dogs and of 1,200 mg/kg in monkeys were not lethal. Intravenous median lethal doses in the rat and mouse were 301 mg/kg and 232 mg/kg respectively. Treatment — To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. If overdosage occurs, use of activated charcoal, emesis, or lavage should be considered along with clinical monitoring and supportive therapy. The ability of hemodialysis to remove nizatidine from the body has not been conclusively demonstrated; however, due to its large volume of distribution, nizatidine is not expected to be efficiently removed from the body by this method.

Source: http://www.rxlist.com

Axid (nizatidine) ® Pulvules®* are available in: The 150-mg Pulvules are imprinted with "150" on the opaque dark yellow cap and "AXID (nizatidine) " and "Reliant" on the opaque pale yellow body, using black ink. They are available as follows: Bottles of 60Â NDC 65726-144-15   The 300-mg Pulvules are imprinted with "300" on the opaque brown cap and "AXID (nizatidine) " and "Reliant" on the opaque pale yellow body, using black ink. They are available as follows: Bottles of 30 NDC 65726-145-10 *Pulvules® (filled gelatin capsules, Lilly) Store at controlled room temperature 20° to 25°C (68° to 77°F) in a tightly closed container [see USP]. The USP defines controlled room temperature as: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. March 2005
Distributed by: Reliant Pharmaceuticals, Inc. Liberty Corner, NJ 07938, USA
Address Medical Inquiries to: Reliant Pharmaceuticals, Inc.
Medical Affairs 110 Allen Road
Liberty Corner, NJ 07938, USA © 2005 Reliant Pharmaceuticals, Inc., 214R400, PRINTED IN U.S.A.
FDA revision date:12/23/05 Last reviewed on RxList: 2/14/2006
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General — 1. Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy. 2. Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency (see DOSAGE AND ADMINISTRATION). 3. Pharmacokinetic studies in patients with hepatorenal syndrome have not been done. Part of the dose of nizatidine is metabolized in the liver. In patients with normal renal function and uncomplicated hepatic dysfunction, the disposition of nizatidine is similar to that in normal subjects. Laboratory Tests — False-positive tests for urobilinogen with Multistix® may occur during therapy with nizatidine. Carcinogenesis, Mutagenesis, Impairment of Fertility — A 2-year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day (about 80 times the recommended daily therapeutic dose) showed no evidence of a carcinogenic effect. There was a dose-related increase in the density of enterochromaf-fin-like (ECL) cells in the gastric oxyntic mucosa. In a 2-year study in mice, there was no evidence of a carcinogenic effect in male mice; although hyperplastic nodules of the liver were increased in the high-dose males as compared with placebo. Female mice given the high dose of Axid (nizatidine) (2,000 mg/kg/day, about 330 times the human dose) showed marginally statistically significant increases in hepatic carcinoma and hepatic nodular hyperplasia with no numerical increase seen in any of the other dose groups. The rate of hepatic carcinoma in the high-dose animals was within the historical control limits seen for the strain of mice used. The female mice were given a dose larger than the maximum tolerated dose, as indicated by excessive (30%) weight decrement as compared with concurrent controls and evidence of mild liver injury (transaminase elevations). The occurrence of a marginal finding at high dose only in animals given an excessive and somewhat hepatotoxic dose, with no evidence of a carcinogenic effect in rats, male mice, and female mice (given up to 360mg/kg/day, about 60 times the human dose), and a negative mutagenicity battery are not considered evidence of a carcinogenic potential for Axid (nizatidine) . Axid (nizatidine) was not mutagenic in a battery of tests performed to evaluate its potential genetic toxicity, including bacterial mutation tests, unscheduled DNA synthesis, sister chromatid exchange, mouse lymphoma assay, chromosome aberration tests, and a micronucleus test. In a 2-generation, perinatal and postnatal fertility study in rats, doses of nizatidine up to 650 mg/kg/day produced no adverse effects on the reproductive performance of parental animals or their progeny. Pregnancy — Teratogenic Effects— Pregnancy Category B— Oral reproduction studies in pregnant rats at doses up to 1500 mg/kg/day (9000 mg/m2/day, 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (3245 mg/m2/day, 14.6 times the recommended human dose based on body surface area) have revealed no evidence of impaired fertility or harm to the fetus due to nizatidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers — Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use — Safety and effectiveness in pediatric patients have not been established. Geriatric Use — Of the 955 patients in clinical studies who were treated with nizatidine, 337 (35.3%) were 65 and older. No overall differences in safety or effectiveness were observed between these and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION).Last reviewed on RxList: 2/14/2006
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Women's Health Care an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Axid. Find what medications you are taking today.