Nizatidine (Page 3 of 3)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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 150 mg 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
<20 mL/min 150 mg every other day
Maintenance Therapy
Ccr Dose
20-50 mL/min 150 mg every other day
<20 mL/min 150 mg every 3 days

Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

HOW SUPPLIED

Nizatidine Capsules, USP 150 mg are #2, buff opaque capsules imprinted “W PI ” and “3137 ” supplied in bottles of 60.

Nizatidine Capsules, USP 300 mg are #0, light brown opaque capsules imprinted “W PI ” and “3138 ” supplied in bottles of 30.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: March 2016

190938-1

PRINCIPAL DISPLAY PANEL-150 mg

NDC 0591-3137-60
Nizatidine
Capsules, USP
150 mg
60 Capsules Rx only

Nizatidine Capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL-300 mg

NDC 0591-3138-30
Nizatidine
Capsules, USP
300 mg
30 Capsules Rx only

Nizatidine Capsules
(click image for full-size original)
NIZATIDINE nizatidine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIZATIDINE (NIZATIDINE) NIZATIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
AMMONIA
FERROSOFERRIC OXIDE
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color WHITE (Buff Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code WPI;3137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3137-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075616 07/09/2002
NIZATIDINE nizatidine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3138
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
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
AMMONIA
FERROSOFERRIC OXIDE
GELATIN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (Light Brown Opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code WPI;3138
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3138-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075616 07/09/2002
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 03/2016 Actavis Pharma, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.