Nizatidine Drug Information

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. 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 nizatidine for longer than 1 year are not known. 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. 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.

Abdominal pain 7.5 12.5 Pain 4.2 3.8 Asthenia 3.1 2.9 Back pain

2.4

Chest pain 2.3 2.1 Infection 1.7 1.1 Fever 1.6 2.3 Surgical procedure

1.4

Injury, accident 1.2 0.9 Digestive Diarrhea 7.2 6.9 Nausea 5.4 7.4 Flatulence

4.9

Nausea and vomiting 1.2 1.9 Anorexia 1.2 1.6 Gastrointestinal disorder 1.1 1.2

Tooth disorder 1.0

Musculoskeletal Myalgia 1.7 1.5 Nervous Dizziness 4.6 3.8 Insomnia 2.7 3.4 Abnormal

dreams 1.9

Pharyngitis 3.3 3.1 Sinusitis 2.4 2.1 Cough, increased 2.0 2.0 Skin and

Appendages Rash 1.9

Pruritus 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, SGPT, 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 anti-androgenic 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 (e.g., 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. To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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.

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.