Balsalazide

Name: Balsalazide

About balsalazide

Type of medicineAminosalicylate
Used forUlcerative colitis in adults
Also calledColazide®
Available asCapsules

Ulcerative colitis causes inflammation of the large intestine. This leads to problems such as ulceration and bleeding, and causes symptoms of abdominal pain and diarrhoea.

Although it is not clear exactly how balsalazide works, it is thought to act on the cells which line your intestine to change the way that they make and release certain chemicals. These chemicals are thought to be a factor in causing the symptoms of ulcerative colitis. Balsalazide allows the damaged areas of your intestine to recover, and then helps to prevent your symptoms from flaring up again at a later date.

How supplied

Dosage Forms And Strengths

COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.

Storage And Handling

COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.

NDC 65649-101-02 Bottles of 280 capsules.
NDC 65649-101-50 Bottles of 500 capsules.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.

Manufactured for Salix Pharmaceuticals, Inc., Raleigh, NC 27615. Revised: May 2008.

Overdose

No case of overdose has occurred with COLAZAL. A 3-year-old boy is reported to have ingested 2 g of another mesalamine product. He was treated with ipecac and activated charcoal with no adverse reactions.

If an overdose occurs with COLAZAL, treatment should be supportive, with particular attention to correction of electrolyte abnormalities.

Balsalazide Overview

Balsalazide is a prescription medication used to treat ulcerative colitis, or inflammation of the lining of the colon. It helps relieve the symptoms of ulcerative colitis including diarrhea, rectal bleeding, and stomach pain. 

Balsalazide belongs to a group of drugs called aminosalicylates. It works by stopping the body from producing a certain substance that may cause pain or inflammation in the colon.

This medication comes in capsule and tablet forms. Balsalazide capsules are usually taken up to 3 times a day, with or without food, for 8 to 12 weeks. Balsalazide tablets are taken up to 2 times a day, with or without food, for up to 8 weeks.

Common side effects of balsalazide tablets are headache, diarrhea, and stomach pain.

Common side effects of balsalazide capsules are diarrhea, throat pain, and anemia.

What is balsalazide?

Balsalazide affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Balsalazide dosing information

Usual Adult Dose for Ulcerative Colitis -- Active:

Mildly to moderately active:
Capsules: 2250 mg orally 3 times a day for up to 8 weeks
In clinical trials, some patients required treatment for up to 12 weeks.

Tablets:
Male patients: 3.3 g orally twice a day for up to 8 weeks
Female patients: Effectiveness has not been established.

Usual Pediatric Dose for Ulcerative Colitis -- Active:

Mildly to moderately active:
Capsules:
5 years or older: 2250 mg orally 3 times a day or 750 mg orally 3 times a day for up to 8 weeks

Precautions While Using balsalazide

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if balsalazide is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using balsalazide. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

If your symptoms do not improve or if they become worse, check with your doctor.

Use in specific populations

Pregnancy

Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to Balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Balsalazide disodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Balsalazide is administered to a nursing woman.

Pediatric Use

Use of Balsalazide disodium in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by:

  • extrapolation of results from clinical studies that supported the approval of Balsalazide disodium for adults.
  • a clinical trial of 68 patients ages 5 to 17 years comparing two doses of Balsalazide disodium (6.75 g/day and 2.25 g/day), and
  • a pharmacokinetic study performed on a subset of the pediatric study population. [See Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day.

Safety and efficacy of Balsalazide disodium in pediatric patients below the age of 5 years have not been established.

Package label.principal display panel

AvKARE

NDC 42291-157-28

Balsalazide Disodium Capsules, USP

750 mg

280 Capsules        Rx Only

Each capsule contains 750 mg of Balsalazide disodium.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container [see USP].

Usual Dosage: See package insert.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/16          AV 06/16 (P)

N3   42291 15728   6

Balsalazide DISODIUM  
Balsalazide disodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-157(NDC:60505-2575)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Balsalazide DISODIUM (Balsalazide) Balsalazide DISODIUM 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
MAGNESIUM STEARATE  
TITANIUM DIOXIDE  
PROPYLENE GLYCOL  
AMMONIA  
SHELLAC  
FERRIC OXIDE RED  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code APO;B750
Contains     
Packaging
# Item Code Package Description
1 NDC:42291-157-28 280 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077883 06/29/2016
Labeler - AvKARE, Inc. (796560394)
Revised: 07/2016   AvKARE, Inc.

Onset of Action

Delayed; may require several days to weeks (2 weeks); similar in adults and children

Time to Peak

Balsalazide: Capsule: 1 to 2 hours; Tablet: 0.5 hours

Half-Life Elimination

Primary effect is topical (colonic mucosa); therapeutic effect appears not to be influenced by the systemic half-life of balsalazide (1.9 hours) or its metabolites (5-ASA [9.5 hours], N-Ac-5-ASA [10.4 hours])

Protein Binding

Balsalazide: ≥99%

Off Label Uses

Ulcerative colitis, remission maintenance

Data from a meta-analysis of randomized, double-blind, placebo controlled trials support the use of balsalazide at standard doses for 6 to 12 months for remission maintenance in ulcerative colitis. Additional trials may be necessary to further define the role of balsalazide for remission maintenance in ulcerative colitis [Ford 2011].

Drug Interactions

Cardiac Glycosides: 5-ASA Derivatives may decrease the serum concentration of Cardiac Glycosides. Monitor therapy

Heparin: 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin. Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Heparin (Low Molecular Weight): 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin (Low Molecular Weight). Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-ASA Derivatives. Monitor therapy

Thiopurine Analogs: 5-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Monitor therapy

Varicella Virus-Containing Vaccines: 5-ASA Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Consider therapy modification

Warnings/Precautions

Concerns related to adverse effects:

• Colitis: Symptomatic worsening of ulcerative colitis may occur following initiation of treatment.

• Intolerance syndrome: May cause an acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea; sometimes fever, headache, rash); discontinue if this occurs.

• Staining: May cause staining of teeth or tongue if capsule is opened and sprinkled on food.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with hepatic dysfunction; hepatic failure has been observed with other mesalamine (5-aminosalicylic acid) products.

• Pyloric stenosis: Use with caution in patients with pyloric stenosis; prolonged gastric retention may occur and delay release of drug in the colon.

• Renal impairment: Use with caution in patients with renal impairment; renal toxicity has been observed with other mesalamine (5-aminosalicylic acid) products.

Pregnancy Risk Factor B Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Mesalamine (5-aminosalicylic acid) is the active metabolite of balsalazide; mesalamine is known to cross the placenta. Refer to the mesalamine monograph for additional information.

What is the most important information i should know about balsalazide (colazal)?

Do not use this medication if you are allergic to balsalazide or to salicylates (such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before taking balsalazide, tell your doctor if you have a stomach disorder called pyloric stenosis, kidney disease, or an infection that you are treating with antibiotics.

Tell your doctor if your symptoms get worse after you start taking balsalazide.

Balsalazide may interact with antibiotics. Tell your doctor if you need to take an antibiotic during treatment with balsalazide.

  • Colitis (Symptoms, Types, and Treatments)
  • Crohn's Disease
  • Ulcerative Colitis

For Healthcare Professionals

Applies to balsalazide: oral capsule, oral tablet

General

During clinical trials, the most common side effects reported with the capsule formulation were headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. Some side effects (including abdominal pain, fatigue, and nausea) were reported more often in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

During a clinical trial, the most common side effects reported in male patients taking the tablet formulation were headache, nasopharyngitis, anemia, diarrhea fatigue, pharyngolaryngeal pain, and urinary tract infection. Most side effects were mild to moderate in severity. The most common serious side effects were gastrointestinal disorders, which were primarily associated with symptoms of ulcerative colitis.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (up to 6%), diarrhea (up to 5%), nausea (5%), vomiting (up to 4%), dyspepsia (2%), flatulence (up to 2%), anorexia (2%), dry mouth (up to 1%), constipation (up to 1%), defecation urgency (less than 1%), hard feces (less than 1%), gastroesophageal reflux disease (less than 1%), and gastroenteritis (less than 1%). Pancreatitis has been reported during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 4%), musculoskeletal pain (2.4%), myalgia (up to 1%), and back pain (less than 1%).[Ref]

Respiratory

Respiratory side effects have included nasopharyngitis, respiratory infection (4%), pharyngolaryngeal pain (3.7%), coughing (2%), pharyngitis (2%), rhinitis (2%), dyspnea (less than 1%), and upper respiratory infection (less than 1%). Pleural effusion, pneumonia (with and without eosinophilia), and alveolitis have been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included headache (8%), insomnia (up to 2.4%), lethargy (less than 1%), and dizziness (less than 1%).[Ref]

Hepatic

Hepatic side effects have included elevated aspartate aminotransferase (less than 1%). Hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage (including liver necrosis and liver failure), and Kawasaki-like syndrome (including hepatic function changes) have been reported during postmarketing experience of products that contain (or are metabolized to) mesalamine; some cases were fatal.[Ref]

Hematologic

Hematologic side effects have included anemia (3.7%), thrombocythemia, and prothrombin changes. A higher incidence of blood dyscrasias (i.e., neutropenia and pancytopenia) has been reported during uncontrolled clinical trials and postmarketing experience in patients 65 years or older receiving mesalamine-containing products.[Ref]

Cardiovascular

Cardiovascular side effects have included increased blood pressure (less than 1%), increased heart rate (less than 1%), hypertension, palpitations, and bradycardia. Myocarditis, pericarditis, and vasculitis have been reported during postmarketing experience.[Ref]

Renal

Renal side effects have included renal failure and interstitial nephritis during postmarketing experience.

Other

Other side effects have included fatigue (up to 2%), fever (2%), cramps (1%), influenza-like disorder (1%), pyrexia (less than 1%), face edema (less than 1%), malaise (less than 1%), pain (less than 1%), and swelling (less than 1%).

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 3.7%).

Dermatologic

Dermatologic side effects have included erythema nodosum (less than 1%) and rash (less than 1%). Pruritus and alopecia have been reported during postmarketing experience.[Ref]

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

Dialysis

Data not available

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