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Crofelemer

Medically reviewed by Drugs.com. Last updated on Mar 24, 2020.

Pronunciation

(kroe FEL e mer)

Index Terms

  • Croton lechleri
  • Provir
  • SP-303

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Delayed Release, Oral:

Mytesi: 125 mg [contains methylparaben, propylparaben]

Brand Names: U.S.

  • Mytesi

Pharmacologic Category

  • Antidiarrheal

Pharmacology

Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel and calcium activated chloride ion channels at the enterocyte luminal membrane. This regulates fluid secretion and water loss (high volume) due to diarrhea, normalizing chloride ion and water flow in the GI tract.

Absorption

Minimal systemic absorption

Use: Labeled Indications

Diarrhea, HIV/AIDs-related (receiving antiretroviral therapy): Symptomatic relief of noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Diarrhea, HIV/AIDs-related (receiving antiretroviral therapy): Oral: 125 mg twice daily. Note: Before starting treatment, rule out infectious etiologies of diarrhea.

Administration

Oral:

May administer without regard to food. Swallow whole; do not crush or chew.

Bariatric surgery: Tablet, delayed release: Refer to institutional protocols as appropriate.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%:

Central nervous system: Anxiety (2%), depression (1% to 2%), dizziness (1% to 2%)

Dermatologic: Acne vulgaris (1% to 2%), dermatitis (1% to 2%)

Gastrointestinal: Flatulence (3%), nausea (3%), abdominal distention (2%), giardiasis (2%), hemorrhoids (2%), abdominal pain (1% to 2%), constipation (1% to 2%), dyspepsia (1% to 2%), gastroenteritis (1% to 2%), xerostomia (1% to 2%)

Genitourinary: Urinary tract infection (2%), pollakiuria (1% to 2%)

Hematologic & oncologic: Decreased white blood cell count (1% to 2%)

Hepatic: Increased serum bilirubin (3%), increased serum ALT (2%), increased direct serum bilirubin (1% to 2%), increased indirect serum bilirubin (1% to 2%), increased serum AST (1% to 2%)

Infection: Herpes zoster (1% to 2%)

Neuromuscular & skeletal: Arthralgia (3%), back pain (3%), musculoskeletal pain (2%), limb pain (1% to 2%)

Renal: Nephrolithiasis (1% to 2%)

Respiratory: Upper respiratory tract infection (6%), bronchitis (4%), cough (4%), nasopharyngitis (2%), sinusitis (1% to 2%)

Warnings/Precautions

Disease-related concerns:

• HIV/AIDS: CD4 cell count and viral load do not have a clinical impact on crofelemer treatment; no adjustments are necessary based on CD4 cell count or viral load.

• Infectious diarrhea: Crofelemer is not indicated for infectious diarrhea; there is a risk of inadequate or delayed treatment if used when infectious diarrhea is present. Rule out infectious causes for diarrhea prior to initiating treatment.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Systemic absorption following oral administration is limited.

Patient Education

What is this drug used for?

• It is used to treat diarrhea in patients taking HIV drugs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Passing gas

• Cough

• Common cold symptoms

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.