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Axid AR
(nizatidine) Tablets
Nizatidine 75 mg
Axid® (Nizatidine, USP) is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thia-zolyl]methyl]thio]ethyl]-Ni-methyl-2-nitro-1,1-ethenediamine.
The structural formula is as follows:
Nizatidine
Nizatidine has the empirical formula C12H21N5O2S2 representing a molecular weight of 331.47. 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 Pulvule®(capsule) contains for oral administration gelatin, pregelatinized starch, dimethicone, starch, titanium dioxide, yellow iron oxide, 150 mg (0.45 mmol) or 300 mg (0.91 mmol) of nizatidine, and other inactive ingredients. The 150-mg Pulvule also contains magnesium stearate, and the 300-mg Pulvule also contains croscarmellose sodium, povidone, red iron oxide, and talc.
Axid (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.
Axid (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 Axid (nizatidine) for longer than 1 year are not known.
Axid (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.
Axid (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.
Active Duodenal Ulcer — The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer — The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease — The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150mg twice daily.
Active Benign Gastric Ulcer — The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency — The dose for patients with renal dysfunction should be reduced as follows:
Active Duodenal Ulcer, GERD and Benign Gastric Ulcer
| Ccr | Dose |
| 20-50 mL/min | 150 mg daily |
| |
