nizatidine

Therapeutic Classification: antiulcer agents

Pharmacologic Classification: histamine h2 antagonists

REMS

Duodenal ulcers and benign gastric ulcers.
Maintenance therapy for duodenal ulcers after healing of active ulcer(s).
Gastroesophageal reflux disease (GERD).
Treatment/prevention of heartburn, acid indigestion, and sour stomach (OTC use).

Inhibits the action of histamine at the H₂-receptor site located primarily in gastric parietal cells, resulting in inhibition of gastric acid secretion.

Therapeutic Effects:

Healing and prevention of ulcers.
Decreased symptoms of gastroesophageal reflux.
Decreased secretion of gastric acid.

Absorption: 70–95% absorbed after oral administration.

Distribution: Enters breast milk and cerebrospinal fluid.

Metabolism/Excretion: 60% excreted unchanged by the kidneys; some hepatic metabolism; at least 1 metabolite has histamine blocking activity.

Half-life: 1.6 hr.

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	8–12 hr

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Geri: More susceptible to adverse CNS reactions; dose ↓ recommended
Renal impairment (more susceptible to adverse CNS reactions; ↑ dosage interval recommended if CCr 50 mL/min)
OB: Lactation: Pregnancy or lactation.

CNS: confusion, dizziness, drowsiness, hallucinations, headache.

CV: ARRHYTHMIAS.

GI: constipation, diarrhea, drug-induced hepatitis, nausea.

GU: ↓sperm count, erectile dysfunction.

Endo: gynecomastia.

Hemat: AGRANULOCYTOSIS, APLASTIC ANEMIA, anemia, neutropenia, thrombocytopenia.

Misc: hypersensivity reactions.

Drug-Drug:

↓absorption of ketoconazole.
Antacids andsucralfate↓ absorption.

PO (Adults): Short-term treatment of active ulcers — 300 mg once daily at bedtime. Duodenal ulcer prophylaxis — 150 mg once daily at bedtime.GERD — 150 mg twice daily. OTC use — 75 mg 30–60 min before foods/beverages expected to cause symptoms.

Renal Impairment

PO (Adults): Short-term treatment of active ulcers — CCr 20–50 mL/min — 150 mg once daily; CCr <20 mL/min — 150 mg every other day; Duodenal ulcer prophylaxis — CCr 20–50 mL/min — 150 mg every other day; CCr <20 mL/min — 150 mg every 3 days.

(Generic available)

Tablets: 75 mg OTC;
Capsules: 150 mg; 300 mg;
Oral solution (bubble-gum): 15 mg/mL;

Assess patient for epigastric or abdominal pain and frank or occult blood in the stool, emesis, or gastric aspirate.
Assess geriatric and debilitated patients routinely for confusion. Report promptly.

Lab Test Considerations:

Monitor CBC with differential periodically during therapy.
- Antagonizes effects of pentagastrin and histamine during gastric acid secretion testing. Avoid administration for 24 hr preceding the test.
- May cause false-negative results in skin tests using allergenic extracts. Histamine H antagonists should be discontinued 24 hr before the test.
- May cause an ↑ in serum transaminases and serum creatinine.
- May also cause ↓ parathyroid concentrations.
- May cause ↑ alkaline phosphatase concentrations or false-positive tests for urobilinogen.

If antacids or sucralfate are used concurrently for relief of pain, avoid administration of antacids within 30 min–1 hr of nizatidine and take sucralfate 2 hr after nizatidine; may decrease the absorption of nizatidine.
PO: Solution is clear yellow.

Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses.
- Advise patients taking OTC preparations not to take the maximum dose continuously for more than 2 wk without consulting health care professional. Notify health care professional if difficulty swallowing occurs or abdominal pain persists.
- Inform patient that smoking interferes with the action of histamine antagonists. Encourage patient to quit smoking or at least not to smoke after last dose of the day.
- May cause drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to the drug is known.
- Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
- Inform patient that increased fluid and fiber intake and exercise may minimize constipation.
- Advise patient to report onset of black, tarry stools; fever; sore throat; diarrhea; dizziness; rash; confusion; or hallucinations to health care professional promptly.

Decrease in abdominal pain.
Prevention of gastric irritation and bleeding. Healing of duodenal ulcers can be seen by endoscopy. Therapy is continued for at least 6 wk in treatment of ulcers but not usually longer than 8 wk.
Decreased symptoms of esophageal reflux.

Acute pain (Indications).

NDC Code^*

0185- Eon Labs, Inc.
0185-0150- nizatidine 0185-0150-60- 60 CAPSULE in 1 BOTTLE (0185-0150-60)

0378- Mylan Pharmaceuticals Inc.
0378-5150- Nizatidine 0378-5150-91- 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-5150-91)

0378- Mylan Pharmaceuticals Inc.
0378-5300- Nizatidine 0378-5300-93- 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5300-93)

0591- Actavis Pharma, Inc.
0591-3137- Nizatidine 0591-3137-60- 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60)

0591- Actavis Pharma, Inc.
0591-3138- Nizatidine 0591-3138-30- 30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)

45865- Medsource Pharmaceuticals
45865-374- Nizatidine 45865-374-60- 60 CAPSULE in 1 BOTTLE (45865-374-60)

55111- Dr Reddy's Laboratories Limited
55111-310- Nizatidine 55111-310-01- 100 CAPSULE in 1 BOTTLE (55111-310-01)

55111- Dr Reddy's Laboratories Limited
55111-310- Nizatidine 55111-310-05- 500 CAPSULE in 1 BOTTLE (55111-310-05)

55111- Dr Reddy's Laboratories Limited
55111-310- Nizatidine 55111-310-30- 30 CAPSULE in 1 BOTTLE (55111-310-30)

55111- Dr Reddy's Laboratories Limited
55111-310- Nizatidine 55111-310-60- 60 CAPSULE in 1 BOTTLE (55111-310-60)

55111- Dr Reddy's Laboratories Limited
55111-310- Nizatidine 55111-310-78- 10 BLISTER PACK in 1 CARTON (55111-310-78) > 10 CAPSULE in 1 BLISTER PACK (55111-310-79)

55111- Dr Reddy's Laboratories Limited
55111-311- Nizatidine 55111-311-01- 100 CAPSULE in 1 BOTTLE (55111-311-01)

55111- Dr Reddy's Laboratories Limited
55111-311- Nizatidine 55111-311-05- 500 CAPSULE in 1 BOTTLE (55111-311-05)

55111- Dr Reddy's Laboratories Limited
55111-311- Nizatidine 55111-311-30- 30 CAPSULE in 1 BOTTLE (55111-311-30)

55111- Dr Reddy's Laboratories Limited
55111-311- Nizatidine 55111-311-60- 60 CAPSULE in 1 BOTTLE (55111-311-60)

55111- Dr Reddy's Laboratories Limited
55111-311- Nizatidine 55111-311-78- 10 BLISTER PACK in 1 CARTON (55111-311-78) > 10 CAPSULE in 1 BLISTER PACK (55111-311-79)

60846- Amneal Pharmaceuticals LLC
60846-301- NIZATIDINE 60846-301-15- 480 mL in 1 BOTTLE (60846-301-15)

63187- Proficient Rx LP
63187-249- Nizatidine 63187-249-60- 60 CAPSULE in 1 BOTTLE (63187-249-60)

63629- Bryant Ranch Prepack
63629-2769- Nizatidine 63629-2769-1- 60 CAPSULE in 1 BOTTLE (63629-2769-1)

63629- Bryant Ranch Prepack
63629-2769- Nizatidine 63629-2769-2- 30 CAPSULE in 1 BOTTLE (63629-2769-2)

65162- Amneal Pharmaceuticals LLC
65162-659- Nizatidine 65162-659-90- 480 mL in 1 BOTTLE (65162-659-90)

68071- NuCare Pharmaceuticals,Inc.
68071-1633- Nizatidine 68071-1633-6- 60 CAPSULE in 1 BOTTLE (68071-1633-6)

68071- NuCare Pharmaceuticals,Inc.
68071-5043- Nizatidine 68071-5043-6- 60 CAPSULE in 1 BOTTLE (68071-5043-6)

68462- Glenmark Pharmaceuticals Inc., USA
68462-425- Nizatidine 68462-425-01- 100 CAPSULE in 1 BOTTLE (68462-425-01)

68462- Glenmark Pharmaceuticals Inc., USA
68462-425- Nizatidine 68462-425-60- 60 CAPSULE in 1 BOTTLE (68462-425-60)

68462- Glenmark Pharmaceuticals Inc., USA
68462-426- Nizatidine 68462-426-01- 100 CAPSULE in 1 BOTTLE (68462-426-01)

68462- Glenmark Pharmaceuticals Inc., USA
68462-426- Nizatidine 68462-426-30- 30 CAPSULE in 1 BOTTLE (68462-426-30)

71335- Bryant Ranch Prepack
71335-0086- Nizatidine 71335-0086-1- 60 CAPSULE in 1 BOTTLE (71335-0086-1)

71335- Bryant Ranch Prepack
71335-0086- Nizatidine 71335-0086-2- 30 CAPSULE in 1 BOTTLE (71335-0086-2)

71335- Bryant Ranch Prepack
71335-0086- Nizatidine 71335-0086-3- 56 CAPSULE in 1 BOTTLE (71335-0086-3)

71335- Bryant Ranch Prepack
71335-0086- Nizatidine 71335-0086-4- 6 CAPSULE in 1 BOTTLE (71335-0086-4)

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Pronunciation ⬇

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Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

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Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

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