crofelemer

Therapeutic Classification: antidiarrheals

Pharmacologic Classification: catechins

Indications ⬆ ⬇

REMS

Symptomatic relief of non-infectious diarrhea in HIV-infected patients currently receiving antiretroviral therapy.

Action ⬆ ⬇

A natural product derived from Croton lechleri, a species of flowering plant.
Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CTFR) chloride ion channels and the calcium-activated chloride channels on luminal membranes of enterocytes. Blocks chloride secretion and water loss by inhibiting chloride channels on the membranes of enterocytes.

Therapeutic effects:

Decreased incidence and severity of diarrhea.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal absorption following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Lactation: Breastfeeding should be avoided in patients with HIV.

Use Cautiously in:

Infectious causes of diarrhea (evaluate and treat prior to use);
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: nasopharyngitis

GI: ↑liver function tests, abdominal distention, flatulence, hemorrhoids, nausea

GU: urinary tract infection

MS: arthralgia, back pain, musculoskeletal pain

Neuro: anxiety

Resp: bronchitis, cough, upper respiratory tract infection

Interactions ⬆ ⬇

Drug-drug:

Due to minimal systemic absorption, interactions are unlikely.

Route/Dosage ⬆ ⬇

PO (Adults ): 125 mg twice daily.

Availability ⬆ ⬇

Delayed-release tablets: 125 mg

Assessment ⬆ ⬇

Assess for abdominal distention, presence of bowel sounds, and usual pattern of bowel function.
Assess color, consistency, and amount of stool produced.

Implementation ⬆ ⬇

PO: Administer tablets twice daily with or without food. Swallow tablets whole; do not crush, break, or chew.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take crofelemer as directed.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased incidence and severity of diarrhea.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

70564- Napo Pharmaceuticals, Inc.
- 70564-802- MYTESI
  - 70564-802-60- 60 TABLET, COATED in 1 BOTTLE (70564-802-60)

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Pronunciation ⬇

Classifications ⬆ ⬇