Olsalazine

What is Olsalazine?

• Olsalazine (Dipentum) 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.

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Olsalazine

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Olsalazine Structure

What are the uses of this medicine?

• Olsalazine (Dipentum) used for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.

How does this medicine work?

• Olsalazine (ol sal’ a zeen) is a prodrug of mesalamine that consists of two molecules of 5-aminocsalicylate (5’5’-azodisalicylate) joined at the amino-terminus with an azo bond that is cleaved by bacterial action in the colon, releasing two molecules of mesalamine.
• The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic.
• Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways (i.e., prostanoids) and through the lipoxygenase pathways (i.e., leukotrienes [LTs] and hydroxyeicosatetraenoic acids [HETEs]) is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to olsalazine, other salicylates, or any of the excipients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as dalteparin (Fragmin), enoxaparin (Lovenox), heparin, or warfarin (Coumadin)
• azathioprine (Azasan, Imuran)
• mercaptopurine (Purixan)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)

Is this medicine FDA approved?

• Olsalazine gained Food and Drug Administration (FDA) approval in 1990.

How should this medicine be used?

Recommended dosage:

• The usual dosage in adults for maintenance of remission is 1.0 g/day in two divided doses.

Administration:

• Olsalazine comes as a capsule to take by mouth.
• It usually is taken twice a day after meals or with food.
• Drink plenty of fluids while taking olsalazine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As hard gelatin capsules for oral administration.

This medicine is available in fallowing brand namesː

• Dipentum

What side effects can this medication cause?

The most common side effects of this medicine include:

• Diarrhea/Loose Stools
• Nausea
• Abdominal Pain
• Rash/Itching
• Headache
• Heartburn
• Rectal Bleeding
• Insomina
• Dizziness
• Anorexia
• Light Headedness
• Depression

What special precautions should I follow?

• Patients receiving olsalazine reported diarrhea sometime during therapy. This diarrhea resulted in withdrawal of treatment in 6% of patients. This diarrhea appears to be dose related, although it may be difficult to distinguish from the underlying symptoms of the disease.
• Exacerbation of the symptoms of colitis thought to have been caused by mesalamine or sulfasalazine has been noted.
• Patients should be instructed to take olsalazine with food. The drug should be taken in evenly divided doses.
• Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be advised to discontinue breastfeeding if using olsalazine.
• Plan to avoid unnecessary or prolonged exposure to the sunlight and to wear protective clothing, sunglasses, and sunscreen. Olsalazine may make your skin sensitive to sunlight.
• olsalazine may cause a serious reaction. Many of the symptoms of this reaction are similar to the symptoms of ulcerative colitis, so it may be difficult to tell if you are experiencing a reaction to the medication or a flare (episode of symptoms) of your disease. Call your doctor if you experience some or all of the following symptoms: stomach pain or cramping, bloody diarrhea, fever, headache, or rash.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting and diarrhea

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• It is recommended to check hematology, acid-base, electrolyte, liver and kidney status, and to provide supportive treatment. There is no specific antidote to Dipentum.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Olsalazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in a pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• OLSALAZINE SODIUM

Inactive ingredients:

• MAGNESIUM STEARATE
• FERROSOFERRIC OXIDE
• CARAMEL
• GELATIN, UNSPECIFIED
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Manufactured for:

• MEDA PHARMACEUTICALS
• Somerset, New Jersey

Manufactured by:

• Societal CDMO Gainesville, LLC
• Gainesville, GA, USA

• Dipentum is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company.

What should I know about storage and disposal of this medication?

• Store at 20-25°C (77°F).
• Excursions permitted to 15° to 30°C (59° to 86°F).

• Dailymed label info on Olsalazine
• FDA Olsalazine

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