Colazal

Generic name: Balsalazide disodium

What is Colazal?

Colazal is used to treat the signs and symptoms of mild to moderate chronic inflammation and ulceration of the lower intestine (ulcerative colitis). Safety and effectiveness beyond 12 weeks of use have not been established.

What is the most important information I should know about Colazal?

Although there have been no reports of kidney damage from Colazal, other products containing mesalamine are known to have caused this problem. If you have kidney disease, your doctor will monitor your condition closely during treatment with Colazal. Report any problems or unusual symptoms immediately.

Do NOT take more Colazal than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better of if they get worse, check with your doctor.

Who should not take Colazal?

Do not take Colazal if you are allergic to the drug or any of its components, or if you are allergic to medicines such as aspirin or mesalamine.

What should I tell my doctor before I take the first dose of Colazal?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Colazal. Also, talk to your doctor about your complete medical history, especially if you have kidney disease, a history of kidney problems, intestinal problems, or a narrowing of the muscle that controls the emptying of the stomach (pyloric stenosis).

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual dose is three 750-milligram (mg) capsules taken 3 times a day for 8 to 12 weeks.

Children 5 to 17 years: The usual dose is three 750-mg capsules taken 3 times a day for up to 8 weeks of treatment OR one 750-mg capsule 3 times a day for up to 8 weeks. Use of Colazal in the pediatric population for more than 8 weeks has not been evaluated in clinical trials.

How should I take Colazal?

Colazal can be taken by mouth with or without food. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. You may crush or chew the medicine before swallowing if necessary. Do not store the mixture for future use. Teeth and/or tongue staining may occur in some patients who use Colazal in sprinkle form with food.

What should I avoid while taking Colazal?

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

What are possible food and drug interactions associated with Colazal?

If Colazal is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important that you check with your doctor before combining Colazal with the following: angiotensin-converting enzyme (ACE) inhibitors, antidiabetic drugs, meglitinide, oral antibiotics, sulfinpyrazone, sulfonylureas, valproic acid

What are the possible side effects of Colazal?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: abdominal pain, diarrhea, headache, joint pain, nausea, respiratory infection, vomiting, heartburn, muscle pain, stomach pain, loss of appetite, runny or stuffy nose, dark urine, fever, yellowing of skin or eyes

Can I receive Colazal if I am pregnant or breastfeeding?

The effects of Colazal during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Colazal?

Take it as soon as possible. If it is within 2 hours of your next dose, skip the dose you missed and go back to your regular schedule. Do not take 2 doses at once.

How should I store Colazal?

Store Colazal at room temperature, between 68° and 77°F. Brief storage between 59° and 86°F is permitted. Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom.