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Axid Oral Solution

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Axid Oral Solution

WARNINGS

No information provided.

PRECAUTIONS

General

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.

Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency (see DOSAGE AND ADMINISTRATION).

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 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. Placebocontrolled 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 placebocontrolled 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

Body System/ Adverse Event* Percentage of Patients Reporting Event
Nizatidine
(N=2,694)
Placebo
(N=1,729)
Body as a Whole
  Headache 16.6 15.6
  Pain 4.2 3.8
  Asthenia 3.1 2.9
  Chest pain 2.3 2.1
  Infection 1.7 1.1
  Injury, accident 1.2 0.9
Digestive
  Diarrhea 7.2 6.9
  Dry mouth 1.4 1.3
  Tooth disorder 1.0 0.8
Musculoskeletal
  Myalgia 1.7 1.5
Nervous
  Dizziness 4.6 3.8
  Insomnia 2.7 3.4
  Abnormal dreams 1.9 1.9
  Somnolence 1.9 1.6
  Anxiety 1.8 1.4
  Nervousness 1.1 0.8
Respiratory
  Rhinitis 9.8 9.6
  Pharyngitis 3.3 3.1
  Sinusitis 2.4 2.1
  Cough, increased 2.0 2.0
Skin and Appendages
  Rash 1.9 2.1
  Pruritis 1.7 1.3
Special Senses
  Amblyopia 1.0 0.9
*Events reported by at least 1% of nizatidine –treated patients are included.

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 H2-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 H2-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.

Last reviewed on RxList: 8/24/2012
This monograph has been modified to include the generic and brand name in many instances.

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