| Drug UPDATES: FULYZAQ ™ (crofelemer) delayed-release tablets for oral use
[Drug information / PDF]
Dosing: Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH – SEE PACKAGE INSERT.
Initial U.S. Approval: 2012
Mechanism of Action: Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel, and the calcium-activated Cl- channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl- channel and CaCC regulate Cl- and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.
INDICATIONS AND USAGE: FULYZAQ is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
DOSAGE AND ADMINISTRATION
In 2003, the active ingredient in Kaopectate was reformulated to contain bismuth subsalicylate, replacing attapulgite as the active ingredient. The FDA found attapulgite efficacy data to be inadequate.
Mechanism of Action: not completely understood. Antimicrobial and antisecretory action.
Children >12 years and Adults: 2 tablets or 30 mL every 30 minutes to 1 hour as needed up to 8 doses/24 hours
Liquid, as subsalicylate: 262 mg/15 mL (240 mL, 360 mL, 480 mL); 525 mg/15 mL (240 mL, 360 mL)
| Adults: DOSING: Diarrhea: Oral: The initial oral dose of diphenoxylate is 2 tablets (5 mg) or (10 ml) 4 times daily. Most patients will require this dosage until control has been attained, after which the dose may be adjusted according to the individual response. Control may be maintained with 2 tablets or 10 mL daily
If there is no response with 48 hours, the drug is unlikely to be effective and should be discontinued; if chronic diarrhea is not improved symptomatically within 10 days at maximum dosage of 20 mg/day, control is unlikely with further use.
| Adults: DOSING: [2 mg capsule /tablet]
Acute diarrhea: Oral: Initial: 4 mg, followed by 2 mg after each loose stool, up to 16 mg/day
Chronic diarrhea: Oral: Initial: Follow acute diarrhea; maintenance dose should be slowly titrated downward to minimum required to control symptoms (typically, 4-8 mg/day in divided doses)
Traveler’s diarrhea: Oral: Initial: 4 mg after first loose stool, followed by 2 mg after each subsequent stool (maximum dose: 8 mg/day)
| DOSING: ADULTS
Treatment of nonspecific diarrhea, control/relieve traveler’s diarrhea: Oral: Subsalicylate (doses based on 262 mg/15 mL liquid or 262 mg tablets): 2 tablets or 30 mL every 30 minutes to 1 hour as needed up to 8 doses/24 hours.
Helicobacter pylori eradication: Oral: 524 mg 4 times/day with meals and at bedtime; requires combination therapy.
Control of fecal odor in ileostomy or colostomy: Oral: Subgallate: 200-400 mg up to 4 times/day.
| Drug UPDATES: XERMELO ™ (telotristat ethyl) tablets
[Drug information / PDF] REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
Initial U.S. Approval: 2017
Mechanism of Action:
INDICATIONS AND USAGE:
DOSAGE AND ADMINISTRATION: PDF
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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