balsalazide (Colazal, Giazo)

Brand Names: Colazal, Giazo

Generic Name: balsalazide

• What is balsalazide (Colazal, Giazo)?
• What are the possible side effects of balsalazide (Colazal, Giazo)?
• What is the most important information I should know about balsalazide (Colazal, Giazo)?
• What should I discuss with my healthcare provider before taking balsalazide (Colazal, Giazo)?
• How should I take balsalazide (Colazal, Giazo)?
• What happens if I miss a dose (Colazal, Giazo)?
• What happens if I overdose (Colazal, Giazo)?
• What should I avoid while taking balsalazide (Colazal, Giazo)?
• What other drugs will affect balsalazide (Colazal, Giazo)?
• Where can I get more information (Colazal, Giazo)?

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.

000540079_PB

capsule, orange, imprinted with 54 795, 54 795

656490101_PB

capsule, white, imprinted with CZ

Balsalazide 750 mg-APO

capsule, white, imprinted with APO, B750

Balsalazide 750 mg-MYL

capsule, orange, imprinted with MYLAN 6750, MYLAN 6750

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate;
• worsening colitis symptoms--fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems--little or no urinating, swelling, rapid weight gain;
• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Balsalazide capsules should not be given to a child younger than 5 years old. Balsalazide tablets should not be given to anyone under 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Balsalazide can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

Call your doctor if your symptoms do not improve, or if they get worse.

Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture and heat.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect balsalazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about balsalazide.

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