Diphenoxylate/Atropine

Diphenoxylate/Atropine is aprescriptionmedicationused to treatdiarrhea.

• Diphenoxylate/Atropine is available under the following different brand names: Lomotil.

Adult andpediatricdosage

Tablet

• 2.5mg/0.025mg

Solution

• 2.5mg/0.025mg/5mL

Diarrhea

Adult dosage

• 5mgdiphenoxylate/0.05 mg atropine (2 tablets) orally every 6 hours; not to exceed 20 mg diphenoxylate daily until initialcontrolof diarrhea is achieved (usually 48 hours)
• Maintenance: As low as 25% of the initial daily dosage

Pediatric dosage

• Children younger than 2 years of age: Safety and efficacy not established
• Children 2-13 years of age (liquid formulation only):
  • Initial: 0.3-0.4 mg diphenoxylate/kg/dayin分4次
  • 2 years (11-14 kg): 1.5-3 mL orally every 6 hours
  • 3 years (12-16 kg): 2-3 mL orally every 6 hours
  • 4 years (14-20 kg): 2-4 mL orally every 6 hours
  • 5 years (16-23 kg): 2.5-4.5 mL orally every 6 hours
  • 6-8 years (17-32 kg): 2.5-5 mL orally every 6 hours
  • 9-12 years (23-55 kg): 3.5-5 mL orally every 6 hours
• Children 13 years or older: 5 mg diphenoxylate/0.05 mg atropine orally every 6 hours; not to exceed 20 mg diphenoxylate daily until initial control of diarrhea achieved (usually 48 hours)
• Maintenance: As low as 25% of initial dosage

Dosage Considerations – Should be Given as Follows:

• See “Dosages”.

Common side effects of Diphenoxylate/Atropine include:

• drowsiness,
• dizziness,
• restlessness,
• headache,
• 麻木的手或feet,
• depression,
• not feeling well,
• confusion,
• feelings of extreme happiness,
• red or swollen gums,
• dry mouth,nose, orthroat,
• nausea,
• vomiting,
• upsetstomach,
• loss of appetite,
• skinrash,
• dry skin, and
• itching

Serious side effects of Diphenoxylate/Atropine include:

• 荨麻疹,
• difficulty呼吸,
• swelling of the face,lips,tongue, or throat,
• severeconstipation,
• stomachpain,
• bloating,
• ongoing or worsening diarrhea,
• diarrhea that is watery or bloody,
• severe pain in the upper stomach spreading to the back,
• fever,
• flushing (warmth, redness, or tingly feeling),
• hallucinations,
• seizure,
• rapid breathing,
• weak or shallow breathing,
• fastheart rate,
• feeling very thirsty or hot,
• inability to urinate,
• heavysweating, and
• 炎热和干燥skin

Rare side effects of Diphenoxylate/Atropine include:

• none

This is not a complete list of side effects and other serious side effects orhealthproblems may occur as a result of the use of this drug. Call yourdoctorfor medical advice about serious side effects or adverse reactions. You may report side effects or health problems toFDAat 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor orpharmacistmay already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Diphenoxylate/Atropine has severe interactions with the following drug:
  • alvimopan
• Diphenoxylate/Atropine has serious interactions with at least 26 other drugs.
• Diphenoxylate/Atropine has moderate interactions with at least 246 other drugs.
• Diphenoxylate/Atropine hasminorinteractions with at least 31 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with yourphysicianif you have health questions or concerns.

Contraindications

• Hypersensitivity to diphenoxylate or atropine
• Children aged 6 years or younger owing to risks ofrespiratoryandCNSdepression (tablets only)
• Obstructivejaundice
• Diarrhea associated with pseudomembranous enterocolitis or infectious enterotoxin-producingbacteria

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diphenoxylate/Atropine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diphenoxylate/Atropine?”

Cautions

• Cases of severerespiratory depressionandcoma, leading to permanentbraindamage ordeathreported in children younger than 6 years administered tablets (see Contraindications)
• May cause CNS depression; may impair physical or mental abilities; patients should use caution when performing tasks requiring mental alertness, including operating heavy machinery or driving
• Use should be accompanied by appropriate fluid andelectrolytetherapywhen indicated; if severedehydrationor electrolyte imbalance is present, the drug should be withheld until appropriate corrective therapy is initiated; drug-induced inhibition ofperistalsismay result in fluid retention in theintestine, which may further aggravate dehydration and electrolyte imbalance
• Use with extreme caution in patients with advanced hepatorenaldiseaseand all patients withabnormalliverfunction;hepaticcoma may be precipitated
• Therapy may slowGImotility and may enhancebacterialovergrowthand the release of bacterial endotoxins, which have been reported to result in serious GI complications, includingsepsisand prolonged and/or worsening diarrhea
• In patients withacuteulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time reported to induce toxic巨结肠; patients with acute ulcerativecolitisshould be carefully observed and therapy discontinued promptly ifabdominaldistentionoccurs or if other untoward symptoms develop
• Improvement of symptoms is expected within 48 hours; if no improvement within this time, the drug is unlikely to be effective
• Do not exceed recommended dosage; reduce the initial dosage for maintenance
• Consider thedevelopmentof adverse reactions associated with the use of atropine; therapy has caused atropine (hyperthermia,tachycardia,urinaryretention, flushing, dryness of the skin andmucousmembranes) particularly in pediatric patients with Down’ssyndrome; therapy is not indicated for use in pediatric patients; monitor patients for signs of atropine
• Diphenoxylate hydrochloride may potentiate the action of other drugs that cause dizziness or drowsiness, includingbarbiturates,benzodiazepines, and other sedatives/hypnotics, anxiolytics, tranquilizers,musclerelaxants, general anesthetics, antipsychotics, other opioids, andalcohol; thepatientshould be closely observed when any of these are used concomitantly
• Renalimpairment
• Hepatic impairment
• Coadministration with opioids increases the risk ofanticholinergicandopioidtoxicities; initial presenting symptoms may be delayed by up to 30 hours due to prolongedgastricemptying time induced by diphenoxylate
• Therapy contraindicated in patients with diarrhea associated with organisms that penetrate the GImucosa; antiperistaltic agents, slowgastrointestinalmotility and may enhance bacterial overgrowth and release of bacterial exotoxins; the drug has been reported to result in serious GI complications in patients with infectious diarrhea, including sepsis, prolonged and/or worsened diarrhea; prolonged fever and the delay inresolutionof凳子pathogens reported in a study ofShigellosisin adults
• Since the chemical structure of diphenoxylate hydrochloride is similar to that ofmeperidinehydrochloride, concurrent use with monoamine oxidase (MAO) inhibitors may, in theory, precipitatehypertensive crisis

PregnancyandLactation

• There are no adequate and well-controlled studies inpregnantwomen; the drug should be used during pregnancy only if the anticipated benefit justifies the potential risk to thefetus; diphenoxylate hydrochloride was shown toaffectfertilityin rats when given in doses 50 times human dose; a decrease inmaternal体重的30%,20毫克/公斤/天,10% 4mg/kg/day; at 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced
• Exercise caution when the drug is administered tonursingwomen, since physicochemical characteristics ofmajormetabolite, diphenoxylate acid, are such that it may be excreted inbreast milkand since it is known that atropine is excreted inbreastmilk.