Loading…
PMS-NIZATIDINE is a brand name for Nizatidine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-NIZATIDINE (nizatidine capsules) is indicated for: the treatment of conditions where a controlled reduction of gastric acid secretion is required such as for ulcer healing and/or pain relief: acute duodenal ulcer, acute benign gastric ulcer, gastroesophageal reflux disease and prophylactic use in duodenal ulcer.…
Verbatim from this product's HC label. Tap a section to expand.
3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination. 2 CONTRAINDICATIONS pms-NIZATIDINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
1 Adverse Reaction Overview The following common adverse events were reported by patients taking nizatidine in clinical trials: sweating, urticaria and somnolence. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
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.
1%) were significantly more common in the nizatidine group. Table 2 lists adverse events that occurred at a frequency of 1% or more among nizatidine- treated patients who participated in placebo-controlled trials in the United States and Canada.
9 *Events reported by at least 1% of nizatidine-treated patients are included. 3 Less Common Clinical Trial Adverse Reactions A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine.
Body as a Whole:
Serum sickness-like reactions have occurred rarely in conjunction with nizatidine use.
Cardiovascular:
In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects.
3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination. 2 CONTRAINDICATIONS pms-NIZATIDINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. pms-NIZATIDINE is contraindicated in patients with a history of previous hypersensitivity to other H2-receptor antagonist agents (cross sensitivity in this class of compounds has been observed).
2 Recommended Dose and Dosage Adjustment Duodenal or Gastric Ulcer: One 300 mg capsule or two 150 mg capsules once daily at bedtime. Alternatively, 150 mg twice daily may be used. Healing occurs within 4 weeks in most cases of pms-NIZATIDINE (nizatidine) Page 5 of 27 duodenal ulcer; but if healing is not documented or has not occurred, therapy should be given for 8 weeks.
Maintenance Therapy in Duodenal Ulcer:
One 150 mg capsule once daily at bedtime for 6 - 12 months depending on the severity of the condition.
Gastroesophageal Reflux Disease:
One 150 mg capsule twice daily for the treatment of erosions, ulcerations and associated heartburn. Antacids may be given concomitantly if needed. 4 Administration Take this medicine with a full glass of water. 5 Missed Dose Take the missed dose as soon as you remember.
Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. 5 OVERDOSAGE There is little clinical experience with deliberate 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.
pms-NIZATIDINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
pms-NIZATIDINE is contraindicated in patients with a history of previous hypersensitivity to other H2-receptor antagonist agents (cross sensitivity in this class of compounds has been observed).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nizatidine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Central Nervous System:
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 equal frequency by patients who received nizatidine and by those given placebo.
Rare reports of gynecomastia occurred.
Genitourinary:
Reports of impotence have occurred.
Hematologic:
Anemia was reported significantly more frequently in nizatidine- than in pms-NIZATIDINE (nizatidine) Page 11 of 27 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.
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.
Hypersensitivity:
As with other H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. , bronchospasm, laryngeal edema, rash, and eosinophilia) have been reported. Because cross sensitivity in this class of compounds has been observed, H2-receptor antagonist should not be administered to individuals with a history of previous hypersensitivity to these agents.
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.
Other:
Hyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported.
Should overdosage occur, use of activated charcoal, emesis, or lavage should be considered along with clinical monitoring and supportive therapy. Renal dialysis does not substantially increase clearance of nizatidine due to its large volume of distribution.
For management of a suspected drug overdose, contact your regional poison control centre. pms-NIZATIDINE (nizatidine) Page 6 of 27 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Capsules 150 mg: Hard gelatin size #2 capsules with an opaque yellow cap and a lighter yellow opaque body.
Capsules are printed in black ink; the cap is printed “ab” and the body is printed “N 150”. Capsules are filled with light yellow powder. Capsules contain 150 mg nizatidine and are available in natural HDPE bottles of 100.
Capsules 300 mg:
Hard gelatin size#1 capsules with an opaque brown cap and an opaque yellow body. Capsules are printed in black ink with “AXID over 300 mg” on one half and “AXID over 3145” on the other. Capsules are filled with light yellow powder. Capsules contain 300 mg nizatidine and are available in natural HDPE bottles of 100.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsules 150 mg Corn starch, magnesium stearate, pregelatinized starch and silicon fluid. The printed capsule shells contain also benzyl alcohol, butylparaben, calcium disodium edetate, carboxy-methylcellulose sodium, gelatin, iron oxide black, iron oxide yellow, methylparaben, potassium hydroxide, propylparaben, shellac, sodium lauryl sulfate, sodium propionate and titanium dioxide Oral Capsules 300 mg Corn starch, carboxymethylcellulose sodium, pregelatinized starch, povidone, silicon fluid and talc.
The printed capsule shells contain also benzyl alcohol, butylparaben, calcium disodium edetate, gelatin, iron oxide black, iron oxide red, iron oxide yellow, methylparaben, potassium hydroxide, propylparaben, shellac, sodium lauryl sulfate, sodium propionate and titanium dioxide pms-NIZATIDINE (nizatidine) Page 7 of 27 7 WARNINGS AND PRECAUTIONS Endocrine and Metabolism The prolonged use of H2-receptor antagonists may impair the absorption of protein-bound Vitamin B12 and may contribute to the development of cyanocobalamin (vitamin B12) deficiency.
Gastrointestinal Where gastric ulcer is suspected the possibility of malignancy should be excluded before therapy with pms-NIZATIDINE is instituted. Hepatic/Biliary/Pancreatic Nizatidine is partially metabolized in the liver; however, in patients with mild to moderate hepatic dysfunction, disposition of nizatidine is similar to that of normal subjects.
Monitoring and Laboratory Tests False-positive tests for urobilinogen with Multistix® may occur during therapy with nizatidine. 3 Pharmacokinetics, Elimination). 1 Pregnant Women The safety of nizatidine during pregnancy has not been established.
Reproduction studies performed in rats and rabbits at doses up to 300 times the human dose have revealed no evidence of impaired fertility or teratogenicity. If the administration of pms-NIZATIDINE is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the fetus.
1%); therefore, pms-NIZATIDINE should not be used in lactating women except when the anticipated benefits clearly outweigh the potential risks to the infant. Caution should be exercised when pms-NIZATIDINE is administered to nursing mothers.
3 Pediatrics Pediatrics (under 18 […]