Colazal

The active ingredient in Colazal is balsalazide disodium, which belongs to the drug class called aminosalicylates. Colazal is a prodrug of mesalazine, also known as 5-aminosalicylic acid (5-ASA). Once converted to mesalamine, it acts directly on the inflamed intestinal lining, inhibiting the formation of natural chemicals such as prostaglandins and leukotrienes, which cause swelling, discomfort, and tissue damage. This helps relieve ulcerative colitis symptoms such as diarrhea, rectal bleeding, and stomach pain.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Colazal. However, the following is a synopsis of the general guidelines for the use of Colazal:

• Colazal may be taken with or without food.
• If you can't take a capsule whole, open it and mix the drug with a tablespoon of applesauce. Swallow the concoction immediately. When the medicine in the capsule is taken with food, it may tint your teeth or tongue yellow/orange. Do not store the mixture for later use.
• Call your doctor if your symptoms do not improve or worsen.
• Colazal is normally taken for a brief period of time (8 to 12 weeks). Follow your doctor's dosing recommendations carefully.

Some mild or common side effects of Colazal seen in clinical trials include:

• Headaches.
• Nausea or vomiting.
• Joint pain.
• Stomach pain.
• Cold symptoms such as a stuffy nose, sneezing, or a sore throat.
• Fevers.
• Loss of appetite.

Some individuals may experience serious side effects while using Colazal. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reaction to the medication, such as hives, skin rash, trouble breathing, or swelling.
• Acute intolerance syndrome. This can cause worsening colitis symptoms such as a fever, abdominal pain, bloody diarrhea, and cramps.
• Liver problems such as bloating, right-sided stomach pain, dark urine, and jaundice (yellowing of your skin or eyes).
• Kidney problems such as kidney stones, little or no urinating, blood in the urine, swelling, and rapid weight gain.
• Low red blood cells (anemia), such as pale skin, tiredness, and lightheadedness.
• Severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. Symptoms include blisters, rash, peeling skin, or redness. You may also experience a fever, sore throat, and fatigue.

These are not all of the possible adverse reactions of Colazal. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Colazal, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney problems such as kidney stones.
• Liver disease.
• A stomach problem such as pyloric stenosis or other gut blockage.
• Colazal pills contain sodium. If you are following a low salt diet, see your doctor before taking this kind of balsalazide.
• Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.
• A skin condition called atopic dermatitis or eczema.

Hypersensitivity to salicylates, balsalazide, or mesalamine.

Colazal does not act immediately; it typically takes several days to a few weeks to see symptom improvement in ulcerative colitis, such as less bleeding or diarrhea. Depending on the severity of the problem and individual reaction, it may take up to 8 to 12 weeks of constant treatment to get the desired anti-inflammatory effects.

When Colazal is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Sulfasalazine.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.
• Azathioprine.
• 6-mercaptopurine.

Colazal (balsalazide disodium) is available in the following dosage form and strength: 750 mg capsules.

Typical dosage:

Adults should take 3 capsules three times every day for 8 to 12 weeks.

Children (ages 5-17) should take 1 to 3 capsules 3 times daily for up to 8 weeks.

Store at room temperature and keep out of reach of children.

Salix Pharmaceuticals, a subsidiary of Bausch Health Companies Inc., is the company that manufactures Colazal.

There are several generic name versions available of Colazal.

You should not discontinue taking Colazal (balsalazide disodium) without consulting your doctor. Stopping abruptly may cause ulcerative colitis symptoms to return or worsen. If your doctor decides you can stop taking it, they may suggest tapering or switching to a maintenance therapy to help keep inflammation under control.

Talk to your doctor if you are pregnant or intend to get pregnant. It is unclear whether Colazal will harm an unborn baby. However, active ulcerative colitis during pregnancy might result in premature delivery or low birth weight. The benefits of treating ulcerative colitis may exceed the potential dangers to the fetus.

Mesalamine can be passed into breast milk in small amounts during lactation. While generally considered safe, you should monitor the infant for diarrhea while taking Colazal.

As always, talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.