Axid Oral Solution

Name: Axid Oral Solution

Patient information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Adverse Reactions in Adults

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. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group.

Incidence in Placebo-Controlled Clinical Trials in the United States and CanadaTable 7 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and non-drug factors to the side-effect incidence rate in the population studied.

Table 7. Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled Clinical Trials in the United States and Canada

*Events reported by at least 1% of nizatidine-treated patients are included.

Percentage of
Patients Reporting
Event
Percentage of
Patients Reporting
Event
Body System/
Adverse Event*
Nizatidine
(N=2,694)
Placebo
(N=1,729)
Body System/
Adverse Event*
Nizatidine
(N=2,694)
Placebo
(N=1,729)
Body as a Whole Nervous
     Headache 16.6 15.6      Dizziness 4.6 3.8
     Pain 4.2 3.8      Insomnia 2.7 3.4
     Asthenia 3.1 2.9      Abnormal dreams 1.9 1.9
     Chest pain 2.3 2.1      Somnolence 1.9 1.6
     Infection 1.7 1.1      Anxiety 1.8 1.4
     Injury, accident 1.2 0.9      Nervousness 1.1 0.8
Digestive Respiratory
     Diarrhea 7.2 6.9      Rhinitis 9.8 9.6
     Dry mouth 1.4 1.3      Pharyngitis 3.3 3.1
     Tooth disorder 1.0 0.8      Sinusitis 2.4 2.1
Musculoskeletal      Cough, increased 2.0 2.0
     Myalgia 1.7 1.5 Skin and Appendages
     Rash 1.9 2.1
     Pruritis 1.7 1.3
Special Senses
     Amblyopia 1.0 0.9

A variety of less common events were also reported; it was not possible to determine whether these were caused by nizatidine.

HepaticHepatocellular 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.

CardiovascularIn clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in 2 individuals administered nizatidine and in 3 untreated subjects.

CNSRare cases of reversible mental confusion have been reported.

EndocrineClinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic 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.

HematologicAnemia 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 H2-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 H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal edema, rash, and eosinophilia) have been reported.

Body as a WholeSerum sickness-like reactions have occurred rarely in conjunction with nizatidine use.

GenitourinaryReports of impotence have occurred.

OtherHyperuricemia unassociated with gout or nephrolithiasis was reported. Eosinophilia, fever, and nausea related to nizatidine administration have been reported.

Postmarketing

Respiratorypneumonia

Adverse Reactions (Pediatric)

In controlled clinical trials in pediatric patients (age 2 to 18 years), nizatidine was found to be generally safe and well tolerated. The principal adverse experiences (> 5%) were pyrexia, nasopharyngitis, diarrhea, vomiting, irritability, nasal congestion and cough. Most adverse events were mild or moderate in severity. Mild elevations in serum transaminase (1-2 x ULN) were noted in some patients. One subject experienced a seizure by EEG diagnosis after taking Axid Oral Solution 2.5 mg/kg b.i.d. for 23 days. The adverse reactions reported for nizatidine may also occur with Axid Oral Solution.

How Supplied

Axid (nizatidine) Oral Solution 15 mg/mL is formulated as a clear, yellow, oral solution with bubble gum flavor, available as:

Bottles of 480 mL (16 fl. oz.) – NDC# 52268-147-62

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant container.

Manufactured for:
Braintree Laboratories, Inc.
Braintree, MA 02185

By:
Lyne Laboratories, Inc.
Brockton, MA 02301, USA

Address Medical Inquiries to:
Braintree Laboratories, Inc.

Medical Affairs

P.O. Box 850929 Braintree, MA 02185

PRINTED IN USA 7/08

©2005 Braintree Laboratories, Inc.

Principal Display Panel – 15mg Bottle Label

NDC 52268-147-62

Axid®

(nizatidine)

Oral Solution

15 mg/mL

480 mL

Rx only

Braintree Laboratories Inc

AXID 
nizatidine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52268-147
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nizatidine (nizatidine) nizatidine 15 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
methylparaben  
propylparaben  
glycerin  
sodium alginate  
saccharin sodium dihydrate  
trisodium citrate dihydrate  
anhydrous citric acid  
sodium hydroxide  
sucrose  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:52268-147-62 480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021494 06/30/2005
Labeler - Braintree Laboratories, Inc. (107904591)
Establishment
Name Address ID/FEI Operations
Lyne Laboratories, Inc. 053510459 ANALYSIS, MANUFACTURE, PACK
Revised: 01/2012   Braintree Laboratories, Inc.

What is nizatidine (axid, axid ar, axid pulvules)?

Nizatidine is in a group of drugs called histamine-2 blockers. Nizatidine works by decreasing the amount of acid the stomach produces.

Nizatidine is used to treat ulcers in the stomach and intestines. Nizatidine also treats heartburn and erosive esophagitis caused by gastroesophageal reflux disease (GERD), a condition in which acid backs up from the stomach into the esophagus.

Nizatidine may also be used for purposes not listed in this medication guide.

What happens if i miss a dose (axid, axid ar, axid pulvules)?

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.

Where can i get more information?

Your pharmacist can provide more information about nizatidine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.02. Revision date: 12/15/2010.

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For Healthcare Professionals

Applies to nizatidine: oral capsule, oral solution, oral tablet

General

Nizatidine (the active ingredient contained in Axid Oral Solution) is generally well tolerated.[Ref]

Endocrine

Endocrine side effects have included rare cases of gynecomastia although the drug is not known to have any antiandrogenic activity. Impotence and decreased libido have also been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rare cases of anaphylaxis, bronchospasm, laryngeal edema, rash, and eosinophilia.[Ref]

Hematologic

Hematologic side effects have included eosinophilia, anemia, rare cases of thrombocytopenic purpura, and a fatal case of thrombocytopenia.[Ref]

Hepatic

Hepatic side effects have included elevations in serum transaminases and rare reports of hepatitis, jaundice, and cholestatic or mixed hepatocellular or cholestatic injury. Abnormalities have been reversible with discontinuation of nizatidine (the active ingredient contained in Axid Oral Solution) [Ref]

Cardiovascular

Cardiovascular side effects have included reports of chest pain (2.3%) and short episodes of asymptomatic ventricular tachycardia, although causality is unknown.[Ref]

Dermatologic

Dermatologic side effects have included rash (1.9%), pruritus (1.7%), urticaria, exfoliative dermatitis, and sweating.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (7.5%), diarrhea (4% to 7.2%), nausea (5.4%), flatulence (4.9%), vomiting (3.6% to 4%), dyspepsia (3.6%), constipation (2.5%), dry mouth (1.4%), anorexia (1.2%), GI disorder (1.1%), and tooth disorder (1%).[Ref]

Nervous system

A 16-year-old female with schizophrenia experienced extrapyramidal symptoms (EPS) coincident with nizatidine (the active ingredient contained in Axid Oral Solution) therapy. She had been receiving quetiapine and paroxetine for schizophrenia and depression and developed EPS after taking nizatidine 150 mg twice daily for weight loss. Over the ensuing 4 weeks, her weight decreased substantially. Because of these initial positive effects, the nizatidine dosage was increased to 300 mg twice daily. Within 4 days of this dosage increase, the patient started pacing and could not sit still. Examination revealed moderate akithisia and mild parkinsonism. Due to concerns about EPS, the nizatidine dosage was decreased to the original 150 mg twice daily. Over the next five days, the patients EPS resolved .[Ref]

Nervous system side effects have included headache (16.6%), dizziness (4.6%), pain 4.2%, back pain (2.4%), insomnia (2.7%), abnormal dreams (1.9%), somnolence (1.9%), anxiety (1.6%), and nervousness (1.1%). Rarely, reports of mental confusion, disorientation, agitation, and psychosis have been reported. At least one case of extrapyramidal symptoms has also been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including myalgia (1.7%) and hyperuricemia associated with gout have been reported.

Respiratory

Respiratory side effects including rhinitis (9.8%), upper respiratory tract infections (8%), nasopharyngitis (6%), cough (5%), pharyngitis (3.3%), sinusitis (2.4%), and increased cough (2%) have been reported.

Ocular

Ocular side effects including amblyopia (1%) have been reported.

Renal

Renal side effects including nephrolithiasis have been reported.

Other

Other side effects have included otitis media (6%), fever (1.6% to 6%), asthenia (3.1%), infection (1.7%), and, rarely, serum sickness-like reactions.

Some side effects of Axid Oral Solution may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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