diphenoxylate/atropine (Rx)Brand and Other Names:Lomotil, Lonox

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

diphenoxylate HCl/atropine

oral solution: Schedule V

  • (2.5mg/0.025mg)/5mL

tablet/capsule: Schedule V

  • 2.5mg/0.025mg
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Diarrhea

5 mg diphenoxylate/0.05 mg atropine PO q6hr; not to exceed 20 mg diphenoxylate daily

Maintenance: As low as ¼ of initial dosage

Dosage Forms & Strengths

diphenoxylate HCl/atropine

oral solution: Schedule V

  • (2.5mg/0.025mg)/5mL

tablet/capsule: Schedule V

  • 2.5mg/0.025mg
more...

Diarrhea

<2 years: Safety and efficacy not established

2-12 years (use liquid only): diphenoxylate 0.3-0.4 mg/kg/day divided q6hr PO; not to exceed 10 mg/day 

>12 years: 5 mg diphenoxylate/0.05 mg atropine PO q6hr; not to exceed 20 mg diphenoxylate daily

Maintenance: As low as ¼ of initial dosage

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Interactions

Interaction Checker

diphenoxylate/atropine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Anticholinergic effects

            Blurred vision

            Sedation

            Nausea

            Vomiting

            Abdominal discomfort

            Dryness of skin or mouth

            Frequency Not Defined

            Pancreatitis

            Toxic megacolon

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            Warnings

            Contraindications

            Hypersensitivity to diphenoxylate or atropine

            Obstructive jaundice

            Diarrhea associated with pseudomembranous enterocolitis or infectious enterotoxin-producing bacteria

            Cautions

            Hepatorenal disease and abnormal liver function

            Ulcerative colitis

            Improvement of symptoms expected within 48 hours; if no improvement within this time, drug is unlikely to be effective

            Do not exceed recommended dosage; reduce initial dosage for maintenance

            Renal impairment

            Hepatic impairment

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Atropine and, possibly, diphenoxylate metabolite distributed into breast milk; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Diphenoxylate: Acts on smooth muscle of intestinal tract, inhibiting GI motility and excessive GI propulsion (like morphine)

            Atropine: Subtherapeutic quantity of atropine is added to discourage deliberate overdose of diphenoxylate

            Absorption

            Onset: 45 min-1 hr 

            Duration: 3-4 hr 

            Peak plasma time: 2 hr 

            Bioavailability: 90% 

            Distribution

            Vd: 324.2 L

            Metabolism

            Extensively metabolized in liver to active metabolite, diphenoxylic acid (difenoxin), which is 5 times more potent than diphenoxylate 

            Metabolites: Diphenoxylic acid (active), hydroxydiphenoxylic acid (inactive)

            Elimination

            Half-life: 2.5 hr (diphenoxylate); 3-14 hr (diphenoxylic acid)

            Renal clearance: 1483 mL/min 

            Excretion: Feces via bile (49%), urine (14%) 

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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