Label: NIZATIDINE- nizatidine capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/12

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  • DESCRIPTION

    Nizatidine, USP is a histamine H -receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. 2

    The structural formula is as follows:

    Structure

    Nizatidine has the empirical formula C H N O S representing a molecular weight of 331.46. 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 capsule contains for oral administration 150 mg (0.45 mmol) or 300 mg (0.91 mmol) of nizatidine and the following inactive ingredients: croscarmellose sodium, povidone, starch, dimethicone and talc. The capsule shells contain D&C yellow no. 10, Titanium Dioxide, Gelatin, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40 (for 150 mg) and Titanium Dioxide, Gelatin, D&C yellow no.10, FD&C blue no.1, FD&C red no. 40 (for 300 mg). The imprinting ink contains Shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, FD&C blue no. 2, FD&C red no. 40, FD&C blue no. 1, D&C yellow no. 10, SDA 3A Alcohol (for 150 mg) and Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Black Iron Oxide, Potassium Hydroxide (for 300 mg). 1221522

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  • CLINICAL PHARMACOLOGY

    Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H -receptors, particularly those in the gastric parietal cells. 2

    Clinical Trials

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  • INDICATIONS AND USAGE

    Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.

    Nizatidine capsules are 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.

    Nizatidine capsules are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

    Nizatidine capsules are 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.

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  • CONTRAINDICATION

    Nizatidine capsules are contraindicated in patients with known hypersensitivity to the drug. Because cross sensitivity in this class of compounds has been observed, H -receptor antagonists, including nizatidine, should not be administered to patients with a history of hypersensitivity to other H -receptor antagonists. 22

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  • 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 ( ). seeDOSAGE 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 80 times the recommended daily therapeutic dose) 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 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 360 mg/kg/day, about 60 times the human dose), 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 produced no adverse effects on the reproductive performance of parental animals or their progeny.

    Pregnancy

    Teratogenic Effects

    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 ( ). seeDOSAGE AND ADMINISTRATION

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  • ADVERSE REACTIONS

    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.

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  • OVERDOSAGE

    Overdoses of nizatidine have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered.

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  • DOSAGE AND ADMINISTRATION
  • Nizatidine 300mg Capsule
  • INGREDIENTS AND APPEARANCE
    NIZATIDINE 
    nizatidine capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-2769(NDC:55111-311)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIZATIDINE (NIZATIDINE) NIZATIDINE 300 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    POVIDONES  
    STARCH, CORN  
    DIMETHICONE  
    TALC  
    TITANIUM DIOXIDE  
    GELATIN  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    SHELLAC  
    ALCOHOL  
    ISOPROPYL ALCOHOL  
    BUTYL ALCOHOL  
    PROPYLENE GLYCOL  
    AMMONIA  
    FERROSOFERRIC OXIDE  
    Product Characteristics
    Color PINK (pink opaque cap) , WHITE (white opaque body) Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code RDY;311
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-2769-1 60 in 1 BOTTLE
    2 NDC:63629-2769-2 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077314 09/15/2005
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-2769), RELABEL(63629-2769)
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