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Drug overview for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
Generic name: loperamide HCl/simethicone (low-PAIR-uh-mide/sye-METH-ih-cone)
Drug class: Antiflatulents
Therapeutic class: Gastrointestinal Therapy Agents
Loperamide hydrochloride, a synthetic piperidine-derivative, is an Simethicone, a mixture of fully methylated linear siloxane polymers, is an antiflatulent secondary to its antifoam properties. antiperistaltic antidiarrhea agent.
No enhanced Uses information available for this drug.
Generic name: loperamide HCl/simethicone (low-PAIR-uh-mide/sye-METH-ih-cone)
Drug class: Antiflatulents
Therapeutic class: Gastrointestinal Therapy Agents
Loperamide hydrochloride, a synthetic piperidine-derivative, is an Simethicone, a mixture of fully methylated linear siloxane polymers, is an antiflatulent secondary to its antifoam properties. antiperistaltic antidiarrhea agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
IMODIUM MULTI-SYMPTOM REL CPLT
The following indications for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone) have been approved by the FDA:
Indications:
Diarrhea secondary to inflammatory bowel disease
Diarrhea
Traveler's diarrhea
Professional Synonyms:
Diarrhea due to inflammatory bowel diseases
Diarrhea secondary to IBD
Indications:
Diarrhea secondary to inflammatory bowel disease
Diarrhea
Traveler's diarrhea
Professional Synonyms:
Diarrhea due to inflammatory bowel diseases
Diarrhea secondary to IBD
The following dosing information is available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
Dosage of loperamide hydrochloride is expressed in terms of the salt. The usual dosage of simethicone for adults and children older than 12 years
of age is 40-125 mg 4 times daily after meals and at bedtime. The drug also may be taken as necessary or as directed by a physician; higher than usual dosages have been used. For self-medication, total dosage should not exceed 500 mg daily.
A simethicone dosage of 20 mg 4 times daily after meals and at bedtime (with a maximum dosage for self-medication of 120 mg daily) is recommended for children younger than 2 years of age, and a dosage of 40 mg 4 times daily after meals and at bedtime (with a maximum dosage for self-medication of 240 mg daily) is recommended for children 2-12 years of age.
Prior to gastroscopy or radiography of the intestine, adults have been given a single dose of 67 mg of simethicone as the oral suspension, in 2.5 mL of water.
Dosage adjustments are not necessary when loperamide hydrochloride is used in patients with renal impairment.
Loperamide hydrochloride should be used with caution in patients with hepatic impairment since first-pass metabolism may be decreased in such patients. (See Cautions: Precautions and Contraindications.)
of age is 40-125 mg 4 times daily after meals and at bedtime. The drug also may be taken as necessary or as directed by a physician; higher than usual dosages have been used. For self-medication, total dosage should not exceed 500 mg daily.
A simethicone dosage of 20 mg 4 times daily after meals and at bedtime (with a maximum dosage for self-medication of 120 mg daily) is recommended for children younger than 2 years of age, and a dosage of 40 mg 4 times daily after meals and at bedtime (with a maximum dosage for self-medication of 240 mg daily) is recommended for children 2-12 years of age.
Prior to gastroscopy or radiography of the intestine, adults have been given a single dose of 67 mg of simethicone as the oral suspension, in 2.5 mL of water.
Dosage adjustments are not necessary when loperamide hydrochloride is used in patients with renal impairment.
Loperamide hydrochloride should be used with caution in patients with hepatic impairment since first-pass metabolism may be decreased in such patients. (See Cautions: Precautions and Contraindications.)
Loperamide hydrochloride is administered orally. Simethicone is administered orally. Simethicone chewable tablets should be chewed thoroughly before swallowing.
Simethicone liquid-filled capsules should not be chewed. The oral solution or suspension should be administered using only the calibrated measuring cup provided by the manufacturer; the suspension should be shaken well prior to each dose. Patients should receive appropriate fluid and electrolyte replacement as needed. Patients using the drug for self-medication should be advised to drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
Simethicone liquid-filled capsules should not be chewed. The oral solution or suspension should be administered using only the calibrated measuring cup provided by the manufacturer; the suspension should be shaken well prior to each dose. Patients should receive appropriate fluid and electrolyte replacement as needed. Patients using the drug for self-medication should be advised to drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Selected P-glycoprotein (P-gp) Substrates/Capmatinib SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Capmatinib is an inhibitor of the P-glycoprotein (P-gp) system. P-gp substrates with a narrow therapeutic index may be increased.(1) CLINICAL EFFECTS: Concurrent use of capmatinib with narrow therapeutic index P-gp substrates may result in elevated levels of the substrate, increasing the risk for adverse effects.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of capmatinib states that the concurrent use of narrow therapeutic index P-gp substrates should be avoided. If concurrent therapy cannot be avoided, the dosage of the narrow therapeutic index P-gp substrate should be decreased according to the substrate prescribing information.(1) DISCUSSION: In a study, capmatinib increased digoxin's area-under-curve (AUC) by 47% and maximum concentration (Cmax) by 74%.(1) Selected narrow therapeutic index P-gp substrates include: afatinib, betrixaban, digoxin, etoposide, everolimus, loperamide, sirolimus, and ubrogepant.(1,2) |
TABRECTA |
| Selected P-glycoprotein (P-gp) Substrates/Sotorasib SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sotorasib is an inhibitor of the P-glycoprotein (P-gp) system. P-gp substrates with a narrow therapeutic index may be increased.(1) CLINICAL EFFECTS: Concurrent use of sotorasib with narrow therapeutic index P-gp substrates may result in elevated levels of the substrate, increasing the risk for adverse effects.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sotorasib states that the concurrent use of narrow therapeutic index P-gp substrates should be avoided. If concurrent therapy cannot be avoided, the dosage of the narrow therapeutic index P-gp substrate should be decreased according to the substrate prescribing information.(1) DISCUSSION: In a study, sotorasib increased digoxin's area-under-curve (AUC) by 21% and maximum concentration (Cmax) by 91%.(1) Selected narrow therapeutic index P-gp substrates include: afatinib, betrixaban, digoxin, edoxaban, etoposide, and loperamide.(1,2) |
LUMAKRAS |
| Selected P-glycoprotein (P-gp) Substrates/Selpercatinib SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Selpercatinib is an inhibitor of the P-glycoprotein (P-gp) transporter and may increase the plasma concentrations of P-gp substrates.(1) CLINICAL EFFECTS: Concurrent use of selpercatinib with P-gp substrates may result in elevated levels of the substrate, increasing the risk for adverse effects.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of selpercatinib states that the concurrent use of narrow therapeutic index P-gp substrates should be avoided. If concurrent therapy cannot be avoided, follow recommendations for the narrow therapeutic index P-gp substrate according to the substrate's prescribing information.(1) DISCUSSION: In a study, selpercatinib increased dabigatran's area-under-curve (AUC) by 38% and maximum concentration (Cmax) by 43%.(1) Selected narrow therapeutic index P-gp substrates include: afatinib, betrixaban, bilastine, dabigatran, digoxin, edoxaban, etoposide, everolimus, loperamide, rimegepant, rivaroxaban, sirolimus, and ubrogepant.(1,2) |
RETEVMO |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Loperamide/CYP3A4; CYP2C8; P-glycoprotein (P-gp) Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Inhibitors of CYP3A4, CYP2C8, and/or P-gp may increase loperamide systemic absorption and facilitate entry into central nervous system (CNS).(1) CLINICAL EFFECTS: Concurrent use of inhibitors of CYP3A4, CYP2C8, and/or P-gp may increase levels of loperamide, resulting in respiratory depression.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Use loperamide with caution in patients receiving inhibitors of CYP3A4, CYP2C8, and/or P-gp. Consider lower doses of loperamide in these patients and monitor for adverse effects. The manufacturer of lonafarnib recommends starting loperamide at a dose of 1 mg and slowly increasing the dose as needed.(2) DISCUSSION: In a randomized, cross-over study in 12 healthy subjects, itraconazole (100 mg twice daily for 5 days - first dose 200 mg), gemfibrozil (600 mg twice daily), and the combination of itraconazole and gemfibrozil (same dosages) increased the area-under-curve (AUC) of single doses of loperamide (4 mg) by 2.9-fold, 1.6-fold, and 4.2-fold, respectively.(3) In a study of healthy subjects, lonafarnib (100 mg twice daily for 5 days) increased the AUC and maximum concentration (Cmax) of single dose loperamide (2 mg) by 299% and 214%, respectively.(3) In a study in 18 healthy males, quinidine increased the AUC of a single dose of loperamide by 2.2-fold and markedly decreased pupil size.(4) In a study in 8 healthy subjects, subjects experienced respiratory depression when a single dose of loperamide (16 mg) was administered with a single dose of quinidine (600 mg) but not when loperamide was administered alone.(6) Loperamide plasma levels increased 2-fold to 3-fold.(5) |
ADDYI, ALYFTREK, AMIODARONE HCL, AMIODARONE HCL-D5W, ASPRUZYO SPRINKLE, ATAZANAVIR SULFATE, AZITHROMYCIN, BELSOMRA, BRILINTA, CARDIZEM, CARDIZEM CD, CARDIZEM LA, CARTIA XT, CHLORAMPHENICOL, CHLORAMPHENICOL PALMITATE, CHLORAMPHENICOL SOD SUCCINATE, CIMETIDINE, CLARITHROMYCIN, CLARITHROMYCIN ER, CLOPIDOGREL, CLOPIDOGREL BISULFATE, CONIVAPTAN-D5W, CRESEMBA, DANZITEN, DILT-XR, DILTIAZEM 12HR ER, DILTIAZEM 24HR ER, DILTIAZEM 24HR ER (CD), DILTIAZEM 24HR ER (LA), DILTIAZEM 24HR ER (XR), DILTIAZEM HCL, DILTIAZEM HCL-0.7% NACL, DILTIAZEM HCL-0.9% NACL, DILTIAZEM HCL-NACL, DILTIAZEM-D5W, E.E.S. 200, E.E.S. 400, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, EVOTAZ, FLIBANSERIN, FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER, GEMFIBROZIL, GENVOYA, HARVONI, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, JAYPIRCA, JYNARQUE, KALETRA, KALYDECO, KETOCONAZOLE, LANSOPRAZOL-AMOXICIL-CLARITHRO, LEDIPASVIR-SOFOSBUVIR, LOPID, LOPINAVIR-RITONAVIR, LUPKYNIS, MATZIM LA, MAVYRET, MULTAQ, NEFAZODONE HCL, NEXTERONE, NILOTINIB HCL, NORVIR, NOXAFIL, NUEDEXTA, OMECLAMOX-PAK, ORLADEYO, PACERONE, PAXLOVID, PLAVIX, POSACONAZOLE, PREVYMIS, PREZCOBIX, PROPAFENONE HCL, PROPAFENONE HCL ER, QUALAQUIN, QUINIDINE GLUCONATE, QUINIDINE SULFATE, QUININE HCL, QUININE SULFATE, QUVIVIQ, RANOLAZINE ER, RECORLEV, REYATAZ, REZUROCK, RITONAVIR, ROMVIMZA, SAMSCA, SPORANOX, STRIBILD, SYMDEKO, SYMTUZA, TAGRISSO, TASIGNA, TAVALISSE, TEPMETKO, TIADYLT ER, TIAZAC, TICAGRELOR, TOLSURA, TOLVAPTAN, TRANDOLAPRIL-VERAPAMIL ER, TRIKAFTA, TYBOST, VAPRISOL-5% DEXTROSE, VERAPAMIL ER, VERAPAMIL ER PM, VERAPAMIL HCL, VERAPAMIL SR, VFEND, VFEND IV, VIRACEPT, VOQUEZNA TRIPLE PAK, VORICONAZOLE, VOSEVI, VOYDEYA, XOLREMDI, ZITHROMAX, ZITHROMAX TRI-PAK, ZOKINVY, ZYDELIG |
The following contraindication information is available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Paralytic ileus |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bloody diarrhea |
| Infectious diarrhea |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| No disease contraindications |
The following adverse reaction information is available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anaphylaxis Angioedema Erythema multiforme Paralytic ileus Skin rash Stevens-johnson syndrome Toxic epidermal necrolysis Toxic megacolon Urinary retention |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abdominal distension Abdominal pain with cramps Constipation Dizziness Pruritus of skin |
| Rare/Very Rare |
|---|
|
Anticholinergic toxicity Drowsy Dyspepsia Flatulence Nausea Urticaria Vomiting Xerostomia |
The following precautions are available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies using loperamide in pregnant women, and the drug should be used during pregnancy only if potential benefits to the woman justify potential risks to the fetus. Reproduction studies in rats and rabbits using loperamide hydrochloride dosages up to 40 mg/kg daily (43 times the human dosage based on body surface comparison) did not reveal evidence of teratogenicity; however, a dosage of 40 mg/kg daily in rats produced impaired growth and survival of offspring.
Because loperamide is distributed into milk in low concentrations, the drug is not recommended in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone):
WARNING: Improper use of this product (overuse or abuse) may cause serious harm, such as fast/irregular heartbeat or death. Do not increase your dose, take it more often, or take it for longer than directed. Taking loperamide with certain other medications may also cause harm.
See also Precautions, Drug Interactions, and Overdose sections. This medication should not be used by children younger than 2 years due to an increased risk of side effects (such as slow/shallow breathing, fast/irregular heartbeat).
WARNING: Improper use of this product (overuse or abuse) may cause serious harm, such as fast/irregular heartbeat or death. Do not increase your dose, take it more often, or take it for longer than directed. Taking loperamide with certain other medications may also cause harm.
See also Precautions, Drug Interactions, and Overdose sections. This medication should not be used by children younger than 2 years due to an increased risk of side effects (such as slow/shallow breathing, fast/irregular heartbeat).
The following icd codes are available for IMODIUM MULTI-SYMPTOM RELIEF (loperamide hcl/simethicone)'s list of indications:
| Diarrhea | |
| K59.1 | Functional diarrhea |
| P78.3 | Noninfective neonatal diarrhea |
| R19.7 | Diarrhea, unspecified |
| Diarrhea secondary to inflammatory bowel disease | |
| R19.7 | Diarrhea, unspecified |
| Traveler's diarrhea | |
| A02.0 | Salmonella enteritis |
| A03 | Shigellosis |
| A03.0 | Shigellosis due to shigella dysenteriae |
| A03.1 | Shigellosis due to shigella flexneri |
| A03.2 | Shigellosis due to shigella boydii |
| A03.3 | Shigellosis due to shigella sonnei |
| A03.8 | Other shigellosis |
| A03.9 | Shigellosis, unspecified |
| A04.0 | Enteropathogenic escherichia coli infection |
| A04.1 | Enterotoxigenic escherichia coli infection |
| A04.2 | Enteroinvasive escherichia coli infection |
| A04.3 | Enterohemorrhagic escherichia coli infection |
| A04.4 | Other intestinal escherichia coli infections |
| A04.5 | Campylobacter enteritis |
| A09 | Infectious gastroenteritis and colitis, unspecified |
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