Dipentum


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Related to Dipentum: Azulfidine, Colazal

olsalazine sodium

Dipentum

Pharmacologic class: Salicylate

Therapeutic class: Anti-inflammatory

Pregnancy risk category C

Action

Unknown. Converts to active form, mesalamine, which blocks cyclooxygenase and inhibits prostaglandin production in colon.

Availability

Capsules: 250 mg

Indications and dosages

Ulcerative colitis in patients who can't tolerate sulfasalazine

Adults: 500 mg P.O. b.i.d.

Contraindications

• Hypersensitivity to drug or other salicylates

Precautions

Use cautiously in:
• hepatic or renal impairment, severe allergy, bronchial asthma
• pregnant or breastfeeding patients
• children younger than age 14.

Administration

• Give with meals to reduce GI irritation.

Adverse reactions

CNS: headache, fatigue, depression, vertigo

GI: nausea, vomiting, diarrhea, abdominal pain, cramps, dyspepsia, bloating, stomatitis

Musculoskeletal: joint pain

Respiratory: upper respiratory infection

Skin: rash, itching

Interactions

Drug-drug.Anticoagulants, coumarin derivatives: prolonged prothrombin time, increased International Normalized Ratio

Drug-food.Any food: decreased GI irritation

Patient monitoring

• Monitor neurologic status. Stay alert for depression.
• Assess GI symptoms. Encourage adequate fluid intake to avoid dehydration.
• Monitor urinalysis, blood urea nitrogen, and creatinine in patients with renal impairment.

Patient teaching

• Instruct patient to take with food and to continue taking drug even after symptoms improve.
• Tell patient to eat appropriate foods in small, frequent servings to minimize GI upset.
• Advise patient to contact prescriber if symptoms worsen or don't improve after 1 to 2 months of therapy.
• Tell patient he may require periodic proctoscopy and sigmoidoscopy to determine response to drug.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects mood and wakefulness.
• As appropriate, review all significant adverse reactions and interactions, especially those related to the drugs and foods mentioned above.

olsalazine

(ole-sal-a-zeen) ,

Dipentum

(trade name)

Classification

Therapeutic: gastroinestinal anti inflammatories
Pregnancy Category: C

Indications

Ulcerative colitis (when patients cannot tolerate sulfasalazine).

Action

Locally acting anti-inflammatory action in the colon, where activity is probably due to inhibition of prostaglandin synthesis.

Therapeutic effects

Reduction in the symptoms of inflammatory bowel disease.

Pharmacokinetics

Absorption: Acts locally in colon, where 98–99% is converted to mesalamine (5-aminosalicylic acid).
Distribution: Action is primarily local and remains in the colon.
Metabolism and Excretion: 2% absorbed into systemic circulation is rapidly metabolized; mostly eliminated as mesalamine in the feces.
Half-life: 0.9 hr.

Time/action profile (levels)

ROUTEONSETPEAKDURATION
POunknown1 hr; 4–8 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity reactions to salicylates;Cross-sensitivity with furosemide, sulfonylurea hypoglycemic agents, or carbonic anhydrase inhibitors may exist;Glucose-6–phosphate dehydrogenase (G6PD) deficiency;Urinary tract or intestinal obstruction;Porphyria; Lactation: Lactation; Pediatric: Children <2 yr (safety not established).
Use Cautiously in: Severe hepatic or renal impairment;Renal impairment (↑ risk of renal tubular damage); Obstetric: Pregnancy; Geriatric: Consider ↓ body mass, hepatic/renal/cardiac function, intercurrent illness and drug therapies.

Adverse Reactions/Side Effects

Central nervous system

  • ataxia
  • confusion
  • dizziness
  • drowsiness
  • headache
  • mental depression
  • psychosis
  • restlessness

Gastrointestinal

  • diarrhea (most frequent)
  • abdominal pain
  • anorexia
  • exacerbation of colitis
  • drug-induced hepatitis
  • nausea
  • vomiting

Dermatologic

  • itching
  • rash

Hematologic

  • blood dyscrasias

Interactions

Drug-Drug interaction

↑ risk of bleeding after neuraxial anesthesia with low molecular weight heparins and heparinoids ; discontinue olsalazine before initiation of therapy or monitor closely if discontinuation not possible.May ↓ metabolism, and ↑ effects/toxicity of mercaptopurine or thioguanine with and ↑ risk of myelosuppression (use lowest possible dose and monitor closely).↑ risk of developing Reye's syndrome; avoid olsalazine during 6 wk after varicella vaccine.

Route/Dosage

Oral (Adults) 500 mg twice daily.

Availability

Capsules: 250 mg

Nursing implications

Nursing assessment

  • Assess patient for allergy to sulfonamides and salicylates. Patients allergic to sulfasalazine may take mesalamine or olsalazine without difficulty, but therapy should be discontinued if rash or fever occur.
  • Monitor intake and output ratios. Fluid intake should be sufficient to maintain a urine output of at least 1200–1500 mL daily to prevent crystalluria and stone formation.
  • Inflammatory Bowel Disease: Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and throughout therapy.
  • Lab Test Considerations: Monitor urinalysis, BUN, and serum creatinine prior to and periodically during therapy.
    • Olsalazine may cause ↑ AST and ALT levels.
  • Lab Test Considerations: Monitor CBC prior to and every 3–6 mo during prolonged therapy. Discontinue olsalazine if blood dyscrasias occur.

Potential Nursing Diagnoses

Acute pain (Indications)
Diarrhea (Indications)

Implementation

  • Oral: Administer with food in evenly divided doses every 12 hr.

Patient/Family Teaching

  • Instruct patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
  • May cause dizziness. Caution patient to avoid driving or other activities that require alertness until response to medication is known.
  • Advise patient to notify health care professional if skin rash, sore throat, fever, mouth sores, unusual bleeding or bruising, wheezing, fever, or hives occurs.
  • Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.
  • Instruct patient to notify health care professional if symptoms worsen or do not improve. If symptoms of acute intolerance (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) occur, discontinue therapy and notify health care professional immediately.
  • Inform patient that proctoscopy and sigmoidoscopy may be required periodically during treatment to determine response.

Evaluation/Desired Outcomes

  • Decrease in diarrhea and abdominal pain.
  • Return to normal bowel pattern in patients with inflammatory bowel disease. Effects may be seen within 3–21 days. The usual course of therapy is 3–6 wk.
  • Maintenance of remission in patients with inflammatory bowel disease.
  • Decrease in pain and inflammation, and increase in mobility in patients with rheumatoid arthritis.

Dipentum

A brand name for OLSALAZINE.
References in periodicals archive ?
I've seen the benefit of taking a second look at effective therapies in the 5-ASA class that may have been overlooked in the past, and Dipentum may be such an example.
marketing rights for Dipentum from Pharmacia Corporation in July 2002.
Dipentum combines proven efficacy with convenient dosing and tolerability.
Patients find Dipentum convenient to take with a manageable side effect profile.
The consent decree does not question the safety or efficacy of Dipentum when used as directed in the approved labeling, nor does it require any discontinuation of its sales and availability," a Kabi spokesman said.
FDA alleged that promotional activities for Dipentum were violative of FDA law and regulations that prohibit false and misleading advertising and promotion of drugs, including for uses not in the official labeling.
retrieve from its sales representatives and destroy all promotional materials for Dipentum regarded by FDA as violative;
submit to FDA for advance approval all advertising and promotion materials for Dipentum for the next year;
District Court in New Jersey entered a permanent injunction against Kabi and its president and chief executive officer Anders Wiklund, with regard to the marketing of Dipentum, and it specifically calls for the company to do the following:
revise its promotional and advertising materials for Dipentum and for one year seek FDA approval for them while destroying existing promotional and advertising materials;
begin a six-month corrective advertising campaign that will include remedial advertisements in medical journals and letters to each physician contacted about Dipentum by the company's sales force; and
In a complaint filed with the consent decree of permanent injunction, the government maintained that the company illegally promoted Dipentum as being indicated for the treatment of mild, moderate and severe active ulcerative colitis; for use in children; as superior to sulfasalazine, and as a "first choice" therapy in the treatment of ulcerative colitis.