Dipentum

DRUG DESCRIPTION

The active ingredient in DIPENTUM Capsules (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity in ulcerative colitis. Its empirical formula is C14H8N2N2O6 with a molecular weight of 346.21.

The structural formula is:

DIPENTUM® (olsalazine sodium capsules) 
  (olsalazine) Structural Formula Illustration

Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions.

DIPENTUM (olsalazine sodium capsules) is supplied in hard gelatin capsules for oral administration. The inert ingredient in each 250 mg capsule of olsalazine sodium is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.

What are the possible side effects of olsalazine (Dipentum)?

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

Stop using olsalazine and call your doctor at once if you have any of these serious side effects:

  • worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
  • chest pain, shortness of breath, fast or pounding heartbeats; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin...

Read All Potential Side Effects and See Pictures of Dipentum »

What are the precautions when taking olsalazine sodium capsules (Dipentum)?

Before taking olsalazine, tell your doctor or pharmacist if you are allergic to it; or to aspirin or related drugs (salicylates such as mesalamine, NSAIDs such as ibuprofen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, growths in the nose (nasal polyps), kidney problems, liver problems, radiation treatment in the pelvic area.

This medicine may cause stomach bleeding. Daily use of alcohol may increase your risk for stomach bleeding, especially when combined with this medicine. Check with your doctor or pharmacist for more...

Read All Potential Precautions of Dipentum »


Dipentum Consumer (continued)

SIDE EFFECTS: Headache, nausea, vomiting, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if diarrhea occurs. Your doctor may need to lower your dose or prescribe another medication to treat the diarrhea.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, pale stools, unusual tiredness, persistent nausea/vomiting, change in the amount of urine, dark urine, yellowing eyes/skin, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking olsalazine, tell your doctor or pharmacist if you are allergic to it; or to aspirin or related drugs (salicylates such as mesalamine, NSAIDs such as ibuprofen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, growths in the nose (nasal polyps), kidney problems, liver problems, radiation treatment in the pelvic area.

This medicine may cause stomach bleeding. Daily use of alcohol may increase your risk for stomach bleeding, especially when combined with this medicine. Check with your doctor or pharmacist for more information.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During pregnancy, this drug should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Dipentum Patient Information Including Side Effects

Brand Names: Dipentum

Generic Name: olsalazine (Pronunciation: ole SAL a zeen)

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

What is olsalazine (Dipentum)?

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.

What are the possible side effects of olsalazine (Dipentum)?

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

Stop using olsalazine and call your doctor at once if you have any of these serious side effects:

  • worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
  • chest pain, shortness of breath, fast or pounding heartbeats; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach discomfort;
  • nausea, heartburn;
  • skin rash, itching;
  • headache;
  • muscle or joint pain; or
  • urinating more often than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about olsalazine (Dipentum)?

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).

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