Dipentum

Olsalazine, an anti-inflammatory medicine, is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum). Olsalazine reduces the bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Olsalazine comes as a capsule to take by mouth. It usually is taken twice a day after meals or with food to prevent stomach upset. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olsalazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Olsalazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

1. stomach upset
2. bloating
3. loss of appetite
4. blurred vision
5. headache
6. pain in joints
7. dizziness

If you experience any of the following symptoms, call your doctor immediately:

1. skin rash
2. chest pain
3. diarrhea
4. unusual bleeding or bruising

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking olsalazine it is important that your doctor or pharmacist knows:

• If you are pregnant, trying for a baby or breast-feeding.
• If you have any problems with the way your kidneys work.
• If you have asthma and/or experience severe allergies.
• If you have ever had an allergic reaction to a medicine. It is particularly important that you tell your doctor if you have had an unusual reaction to aspirin or to any other salicylate medicine.
• If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

• Try to keep your regular appointments with your doctor and clinic. This is so your doctor can check on your progress. Your doctor will want you to have regular blood tests during this treatment.
• Treatment with olsalazine may be long-term in order to prevent your symptoms from flaring-up from time to time. Continue to take it unless you are advised otherwise by your doctor.
• Your doctor may advise you make some changes to your diet as part of your treatment. This may include a special diet or a nutritional supplement.
• If you have an allergic condition, such as asthma, you should let your doctor know straightaway if you find your allergic symptoms get worse. If this happens, your doctor may want to review your treatment or will arrange to see you more often to keep an eye on your progress.

Common side effects are:

• gastrointestinal disturbances,
• diarrhea,
• abdominal pain, and
• nausea.

Other important side effects include:

• dizziness,
• headache
• depression
• rashes
• joint pain

Gastrointestinal disturbances commonly occur in persons who take olsalazine. Diarrhea occurs in about 1 of every 6 persons who take it; about one in 20 need to discontinue therapy because the diarrhea is severe. Abdominal pain or cramps occur in 1 in 10 persons, and nausea or vomiting occurs in 1 in 20. Other side effects, including dizziness, depression, and headache, occur less frequently than gastrointestinal effects during therapy. Rashes occur in 2.3% of persons and joint pain in 4%.

• Meda Pharmaceuticals, Inc.

Olsalazine affects substances in the body that cause inflammation, tissue damage, and diarrhea.

Olsalazine is used to treat ulcerative colitis.

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

You should not use this medication if you are allergic to olsalazine or to salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others.

Before taking olsalazine, tell your doctor if you have asthma or other allergies, kidney disease, or liver disease.

Call your doctor at once if your colitis symptoms get worse, or if you have chest pain, shortness of breath, fast or pounding heartbeats, nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of olsalazine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of olsalazine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Azathioprine
• Bromfenac
• Bufexamac
• Celecoxib
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mercaptopurine
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Varicella Virus Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tamarind

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The use of olsalazine may cause further damage to the kidneys

Olsalazine is best taken with food, to lessen stomach upset. If stomach or intestinal problems continue or are bothersome, check with your doctor.

Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • To prevent ulcerative colitis from occurring again:
    • Adults and teenagers—500 milligrams (mg) two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Loose stools (diarrhea).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Stomach cramps.
• Upset stomach.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

There are no data on the excretion of olsalazine into human milk. The metabolite of olsalazine, acetyl-5-aminosalicylic acid has been detected in human milk. Harmful infant effects (diarrhea) have been observed when olsalazine was used during breastfeeding. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of olsalazine, taking into account the importance of the drug to the mother.

In one study of a lactating woman given a single 500 mg dose of olsalazine, the parent compound and the metabolites olsalazine-S and 5-aminosalicylic acid were undetectable in breast milk for 48 hours after the dose. Acetyl-5-aminosalicylic acid was detected up to 24 hours. One study mentioned vomiting in a breastfed infant as an adverse effect of olsalazine. No other details were given.

LactMed Record Number

444

Last Revision Date

20160401

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