Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh
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Drug UPDATES: FULYZAQ ™ (crofelemer) delayed-release tablets for
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
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
The recommended dose of FULYZAQ is one 125 mg delayed-release tablet taken
orally two times a day, with or without food. FULYZAQ tablets should not be
crushed or chewed. Tablets should be swallowed whole.
HOW SUPPLIED: Delayed-Release Tablets: 125 mg
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.
Symptomatic treatment of mild, nonspecific diarrhea; control of
traveler's diarrhea (enterotoxigenic Escherichia coli ); as part of a
multidrug regimen for H. pylori eradication to reduce the risk of
duodenal ulcer recurrence
Mechanism of Action: not completely understood.
Antimicrobial and antisecretory action.
Treatment of nonspecific diarrhea, control/relieve traveler's diarrhea:
Subsalicylate (doses based on 262 mg/15 mL liquid or 262 mg tablets):
Children >12 years and Adults: 2 tablets or 30 mL every 30 minutes to 1
hour as needed up to 8 doses/24 hours
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.
Solution, oral: Diphenoxylate hydrochloride 2.5 mg and atropine sulfate
0.025 mg per 5 mL. Tablet (Lomotil®, Lonox®): Diphenoxylate
hydrochloride 2.5 mg and atropine sulfate 0.025 mg.
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.
Listed dosages are for - Adult patients ONLY. PLEASE READ THE
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