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Zelnorm
Tablets: 2 mg, 6 mg
Class: 5-HT4 receptor agonist

 Action Binds with high affinity to human 5-HT4 receptors, acting as an agonist at neuronal 5-HT4 receptors to trigger the release of neurotransmitters.

 Indications Short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation.

 Contraindications Severe renal impairment; moderate to severe hepatic impairment; history of bowel obstruction; symptomatic gall bladder disease; suspected sphincter of Oddi dysfunction; abdominal adhesions; known hypersensitivity to the drug or any of its excipients.

 Route/Dosage

ADULTS (WOMEN): PO 6 mg bid before meals for 4 to 6 wk.

 Interactions

Digoxin, oral contraceptives: Plasma concentrations of these drugs may be reduced; however, adjustments in therapy are unlikely to be necessary.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypotension; angina pectoris; syncope; arrhythmia; bundle branch block; supraventricular tachycardia. CNS: Headache; dizziness; migraine; attempted suicide; impaired concentration; emotional lability; increased appetite; sleep disorder; depression; vertigo. DERM: Pruritus; increased sweating; flushing. GI: Abdominal pain; diarrhea; nausea; flatulence; irritable colon; fecal incontinence; tenesmus; eructation; appendicitis; subileus. GU: Ovarian cyst; miscarriage; menorrhagia; albuminuria; frequent micturition; polyuria; renal pain; breast carcinoma. HEPA: Increased AST and ALT, bilirubin, and cholecystitis. RESP: Asthma. OTHER: Back pain; arthropathy; accidental trauma; leg pain; cramps; pain; facial edema.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy in children less than 18 yr not established. Diarrhea: Do not initiate therapy in patients who are experiencing or frequently experience diarrhea.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • For use in women only. Do not administer to men.
  • Administer prescribed dose bid before meals for up to 12 wk.
  • Store tablets at controlled room temperature (59° to 86°F). Protect from moisture.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note severe renal impairment, moderate or severe hepatic impairment, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, abdominal adhesions, or history of bowel obstruction.
  • Do not administer to patient who is experiencing diarrhea or frequently experiences diarrhea.
  • Assess and document effect of medication on IBS symptoms.
  • Monitor patient for CNS, GI, and general body side effects. Report to health care provider if noted and significant.
  • Discontinue use and notify health care provider immediately if patient experiences new or sudden worsening of abdominal pain.
OVERDOSAGE: SIGNS & SYMPTOMS
  Diarrhea, headache, intermittent abdominal pain, flatulence, nausea, vomiting

 Patient/Family Education

  • Explain name, dose, action, and potential side effects of drug.
  • Advise patient to read “Patient Information” provided with medication.
  • Instruct patient to take prescribed dose bid shortly before a meal.
  • Instruct patient that if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Warn patient to not double the dose to make up the missed dose.
  • Warn patient to not start medication if currently or frequently experiencing diarrhea.
  • Advise patient that medication does not cure IBS and should be taken as prescribed and to not stop taking or change the dose unless advised by health care provider.
  • Advise patient to notify health care provider if new or worsening abdominal pain, severe diarrhea, or diarrhea accompanied by severe cramping, stomach pain, or dizziness occurs.
  • Advise patient to inform health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
  • Warn patient not to take any prescription or OTC drugs or dietary supplements without consulting health care provider.
  • Advise patient that follow-up visits may be necessary to monitor therapy and to keep appointments.

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