olsalazine (Rx)

Brand and Other Names:Dipentum
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 250mg
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Ulcerative Colitis

Maintenance: 1g PO qDay in 2 divided doses

Administration

Take with food

Other Indications & Uses

Maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine

Safety & efficacy not established

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Adverse Effects

>10%

Diarrhea (17%)

Abdominal pain (11%)

1-10%

Nausea/vomiting (6%)

Headache (5%)

Arthralgia (4%)

Dyspepsia (4%)

Joint pain (4%)

Rash/itching (3.6%)

Fatigue (1.8%)

Bloating (1.5%)

Depression (1.5%)

Upper respiratory infection (1.5%)

Anorexia (1.3%)

Dizziness (1%)

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Warnings

Contraindications

Hypersensitivity to salicylates

Cautions

Kidney disease, hepatic impairment

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Pregnancy & Lactation

Pregnancy Category: C

Lactation

Not known whether drug distributed into breast milk, use caution

5-ASA is excreted in breast milk & may cause diarrhea in infant

However little is absorbed from oral olsalazine

Avoid

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Absorption: ~2.4% of a single 1 g dose

Peak Plasma (single 1 g dose)

Olsalazine: 1.6-6.2 umol/L

5-aminosalicylic acid (5-ASA): 0-4.3umol/L

N-acetyl-5-ASA: 1.7-8.7 umol/L

Half-Life

Olsalazine: 0.9 hr

5-ASA: 45 min

N-Ac-5-ASA: 80 min

Olsalazine-S (~0.1%): 7 d

Metabolism

>90% converted to 5-ASA in the gut

5-ASA is deactivated to N-Ac-5-ASA in colonic epithelium & liver

Approx. 0.1% converted to olsalazine-O-sulfate (Olsalazine-S) in liver

Excretion

Urine: 20% (mostly N-Ac-5-ASA)

Feces: 80% (both 5-ASA & N-Ac-5-ASA)

Other Information

Protein Bound: 99%

Mechanism of Action

Converted to 5-aminosalicylic acid (mesalamine) by gastrointestinal flora which is thought to be the therapeutically active component; works topically rather tha systemically

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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