categorized [0.01:<0.05 as compared with placebo. Nizatidine Placebo 300 mg h.s. 150 mg b.i.d. Number Entered Healed/ Evaluable Number Entered Healed/ Evaluable Number Entered Healed/ Evaluable STUDY 1 Week 2 276 93/265 (35%)* 279 55/260 (21%) Week 4 198/259 (76%)* 95/243 (39%) STUDY 2 Week 2 108 24/103 (23%)* 106 27/101 (27%)* 101 9/93 (10%) Week 4 65/97 (67%)* 66/97 (68%)* 24/84 (29%) STUDY 3 Week 2 92 22/90 (24%) 98 13/92 (14%) Week 4 52/85 (61%)* 29/88 (33%) Week 8 68/83 (82%)* 39/79 (49%) 2. Maintenance of Healed Duodenal Ulcer : Treatment with a reduced dose of nizatidine has been shown to be effective as maintenance therapy following healing of active duodenal ulcers. In multicenter, double-blind, placebo-controlled studies conducted in the United States, 150 mg of nizatidine taken at bedtime resulted in a significantly lower incidence of duodenal ulcer recurrence in patients treated for up to 1 year ( Table 5 ). Table 5. Percentage of Ulcers Recurring by 3, 6, and 12 Months in Double-Blind Studies Conducted in the United States * P> <0.001 as compared with placebo. Month Nizatidine, 150 mg h.s. Placebo 3 13% (28/208)* 40% (82/204) 6 24% (45/188)* 57% (106/187) 12 34% (57/166)* 64% (112/175) 3. Gastroesophageal Reflux Disease (GERD) : In 2 multicenter, double-blind, placebo-controlled clinical trials performed in the United States and Canada, nizatidine was more effective than placebo in improving endoscopically diagnosed esophagitis and in healing erosive and ulcerative esophagitis. In patients with erosive or ulcerative esophagitis, 150 mg b.i.d. of nizatidine given to 88 patients compared with placebo in 98 patients in Study 1 yielded a higher healing rate at 3 weeks (16% vs 7%) and at 6 weeks (32% vs 16%, P> <0.05). Of 99 patients on nizatidine and 94 patients on placebo, Study 2 at the same dosage yielded similar results at 6 weeks (21% vs 11%, P> <0.05) and at 12 weeks (29% vs 13%, P> <0.01). In addition, relief of associated heartburn was greater in patients treated with nizatidine. Patients treated with nizatidine consumed fewer antacids than did patients treated with placebo. 4. Active Benign Gastric Ulcer : In a multicenter, double-blind, placebo-controlled study conducted in the United States and Canada, endoscopically diagnosed benign gastric ulcers healed significantly more rapidly following administration of nizatidine than of placebo ( Table 6 ). Table 6. *P-values are one-sided, obtained by Chi-square test, and not adjusted for multiple comparisons. Week Treatment Healing Rate vs. Placebo P-value* 4 Nizatidine 300 mg h.s. 52/153 (34%) 0.342 Nizatidine 150 mg b.i.d. 65/151 (43%) 0.022 Placebo 48/151 (32%) 8 Nizatidine 300 mg h.s. 99/153 (65%) 0.011 Nizatidine 150 mg b.i.d. 105/151 (70%)> <0.001 Placebo 78/151 (52%) In a multicenter, double-blind, comparator-controlled study in Europe, healing rates for patients receiving nizatidine (300 mg h.s. or 150 mg b.i.d.) were equivalent to rates for patients receiving a comparator drug, and statistically superior to historical placebo control rates. Indications and Usage Axid Oral Solution 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 Oral Solution 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 nizatidine for longer than 1 year are not known. Axid Oral Solution 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 Oral Solution 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. In pediatric patients, Axid Oral Solution is indicated for ages 12 years and older. Axid Oral Solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Contraindication Axid Oral Solution is contraindicated in patients with known hypersensitivity to the drug. Because cross-sensitivity in this class of compounds has been observed, H 2 -receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists. Precautions 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. Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day (about 13 times the recommended human dose based on body surface area) showed no evidence of a carcinogenic effect. There was a dose-related increase in the density of enterochromaffin-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 nizatidine (2,000 mg/kg/day, about 27 times the recommended human dose based on body surface area) 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 360 mg/kg/day, about 5 times the recommended human dose based on body surface area), and a negative mutagenicity battery are not considered evidence of a carcinogenic potential for nizatidine. 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 (about 17.5 times the recommended human dose based on body surface area) 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 (about 40.5 times the recommended human dose based on body surface area) and in pregnant rabbits at doses up to 275 mg/kg/day (about 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 Effectiveness in pediatric patients> <12 years of age has not been established. Use of nizatidine in pediatric patients from 12 to 18 years of age is supported by evidence from published pediatric literature, adequate and well-controlled published studies in adults, and by the following adequate and well-controlled studies in pediatric patients: (see DOSAGE AND ADMINISTRATION ) Clinical Trials (Pediatric). In randomized studies, nizatidine was administered to pediatric patients for up to eight weeks, using age appropriate formulations. A total of 230 pediatric patients from 2 to 18 years of age were administered nizatidine at a dose of either 2.5 mg/kg b.i.d, or 5.0 mg/kg b.i.d, (patients 12 years and under) or 150 mg b.i.d (12 to 18 years). Patients were required to have either symptomatic, clinically suspected or endoscopically diagnosed GERD with age-relevant symptoms. In patients 2 to 18 years of age, nizatidine was found generally safe and well-tolerated. In these studies in patients 12 years and older, nizatidine was found to reduce the severity and frequency of GERD symptoms, improve physical well-being, and reduce the frequency of supplemental antacid consumption. No efficacy in pediatric patients> <12 years of age has been established. Clinical studies in patients 2 to 12 years of age with GERD, demonstrated no difference in either symptom improvements or healing rates between nizatidine and placebo or between different doses of nizatidine. 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 ). Adverse Reactions in Adults 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 7 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 non-drug factors to the side-effect incidence rate in the population studied. Table 7. Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials in the United States and Canada *Events reported by at least 1% of nizatidine-treated patients are included. Percentage of Patients Reporting Event Percentage of Patients Reporting Event Body System/ Adverse Event* Nizatidine (N=2,694) Placebo (N=1,729) Body System/ Adverse Event* Nizatidine (N=2,694) Placebo (N=1,729) Body as a Whole Nervous Headache 16.6 15.6 Dizziness 4.6 3.8 Pain 4.2 3.8 Insomnia 2.7 3.4 Asthenia 3.1 2.9 Abnormal dreams 1.9 1.9 Chest pain 2.3 2.1 Somnolence 1.9 1.6 Infection 1.7 1.1 Anxiety 1.8 1.4 Injury, accident 1.2 0.9 Nervousness 1.1 0.8 Digestive Respiratory Diarrhea 7.2 6.9 Rhinitis 9.8 9.6 Dry mouth 1.4 1.3 Pharyngitis 3.3 3.1 Tooth disorder 1.0 0.8 Sinusitis 2.4 2.1 Musculoskeletal Cough, increased 2.0 2.0 Myalgia 1.7 1.5 Skin and Appendages Rash 1.9 2.1 Pruritis 1.7 1.3 Special Senses Amblyopia 1.0 0.9 A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine. Hepatic Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine. In some cases, there was marked elevation of SGOT, SGPT enzymes (greater than 500 IU/L) and, in a single instance, SGPT was greater than 2,000 IU/L. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not significantly differ from the rate of liver enzyme abnormalities in placebo-treated patients. All abnormalities were reversible after discontinuation of nizatidine. Since market introduction, hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported with reversal of the abnormalities after discontinuation of nizatidine. Cardiovascular In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects. CNS Rare cases of reversible mental confusion have been reported. Endocrine Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to nizatidine. Impotence and decreased libido were reported with similar frequency by patients who received nizatidine and by those given placebo. Rare reports of gynecomastia occurred. Hematologic Anemia was reported significantly more frequently in nizatidine- than in placebo-treated patients. Fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H 2 -receptor antagonist. On previous occasions, this patient had experienced thrombocytopenia while taking other drugs. Rare cases of thrombocytopenic purpura have been reported. Integumental Sweating and urticaria were reported significantly more frequently in nizatidine- than in placebo-treated patients. Rash and exfoliative dermatitis were also reported. Vasculitis has been reported rarely. Hypersensitivity As with other H 2 -receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal edema, rash, and eosinophilia) have been reported. Body as a Whole Serum sickness-like reactions have occurred rarely in conjunction with nizatidine use. Genitourinary Reports of impotence have occurred. Other Hyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported. Postmarketing Respiratory pneumonia Adverse Reactions (Pediatric) In controlled clinical trials in pediatric patients (age 2 to 18 years), nizatidine was found to be generally safe and well tolerated. The principal adverse experiences (> 5%) were pyrexia, nasopharyngitis, diarrhea, vomiting, irritability, nasal congestion and cough. Most adverse events were mild or moderate in severity. Mild elevations in serum transaminase (1-2 x ULN) were noted in some patients. One subject experienced a seizure by EEG diagnosis after taking Axid Oral Solution 2.5 mg/kg b.i.d. for 23 days. The adverse reactions reported for nizatidine may also occur with Axid Oral Solution. Overdosage Overdoses of 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 overdosage of 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. In the two 8-week pediatric exposure trials of nizatidine in 256 pediatric patients, there were no cases of deliberate overdosage. In one study of nizatidine 10 mg/kg/day, drug compliance rates up to 7.5% above 100% compliance were not associated with clinically significant adverse events. 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. Dosage and Administration: 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 150 mg 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. Each mL of Axid Oral Solution contains 15 mg of nizatidine. In adults, Axid Oral Solution may be substituted for any of the above indications using equivalent doses of the oral solution. Pediatric Dosing Each mL of oral solution contains 15 mg of nizatidine. Axid Oral Solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.) The following dosage recommendations are provided: Erosive Esophagitis For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks. Gastroesophageal Reflux Disease For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks. 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 Creatine Clearance Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Creatine Clearance Dose 20-50 mL/min 150 mg every other day> <20 mL/min 150 mg every 3 days Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated. Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated. How Supplied Axid (nizatidine) Oral Solution 15 mg/mL is formulated as a clear, yellow, oral solution with bubble gum flavor, available as: Bottles of 480 mL (16 fl. oz.) NDC# 52268-147-62 Store at 25 C (77 F); excursions permitted to 15 - 30 C (59 - 86 F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant container. Manufactured for: Braintree Laboratories, Inc. Braintree, MA 02185 By: Lyne Laboratories, Inc. Brockton, MA 02301, USA Address Medical Inquiries to: Braintree Laboratories, Inc. Medical Affairs P.O. Box 850929 Braintree, MA 02185 PRINTED IN USA 7/08 2005 Braintree Laboratories, Inc. Principal Display Panel 15mg Bottle Label NDC 52268-147-62 Axid (nizatidine) Oral Solution 15 mg/mL 480 mL Rx only Braintree Laboratories Inc AXID nizatidine solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52268-147 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nizatidine (nizatidine) nizatidine 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength methylparaben propylparaben glycerin sodium alginate saccharin sodium dihydrate trisodium citrate dihydrate anhydrous citric acid sodium hydroxide sucrose Product Characteristics Color Score Shape Size Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code Contains Packaging # Item Code Package Description 1 NDC:52268-147-62 480 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021494 06/30/2005 Labeler - Braintree Laboratories, Inc. (107904591) Establishment Name Address ID/FEI Operations Lyne Laboratories, Inc. 053510459 ANALYSIS, MANUFACTURE, PACK Revised: 01/2012 Braintree Laboratories, Inc. Next Interactions Print this page Add to My Med List More about Axid Oral Solution (nizatidine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions 0 Reviews Add your own review/rating Drug class: H2 antagonists Consumer resources Professional resources Nizatidine (AHFS Monograph) Nizatidine Solution (FDA) Other brands: Axid Other Formulations Axid AR> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Discontinued B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class H2 antagonists Related Drugs H2 antagonists ranitidine , famotidine , Zantac , Pepcid , cimetidine , Tagamet Axid Oral Solution Rating No Reviews - Be the first! 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