lomotil
Pharmaranks rates Lomotil 2.9/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lomotil is a combination medicine containing Atropine Sulfate and Diphenoxylate Hydrochloride.
Atropine Sulfate and Diphenoxylate Hydrochloride · by Pfizer
Available as a generic: Lo-Trol
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
What is Lomotil?
From the FDA label:Each diphenoxylate hydrochloride and atropine sulfate tablet contains: diphenoxylate hydrochloride 2.5 mg atropine sulfate 0.025 mg Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate hydrochloride tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Chemical Structure Chemical Structure
How to use
Adults The recommended initial dosage is two diphenoxylate hydrochloride tablets four times daily . Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily. Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration. Children Diphenoxylate hydrochloride is not recommended in children under 2 years of age and should be used with special caution in young children (see Warnings and Precautions ). The nutritional status and degree of dehydration must be considered. Do not use diphenoxylate hydrochloride tablets for children under 13 years of age . KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Side effects
At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache. Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus. Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort. The following atropine sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children. THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.
Warnings
Important safety information
Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics. Antiperistaltic agents should not be used in these conditions. In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and diphenoxylate hydrochloride therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop. Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of diphenoxylate hydrochloride with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis. Diphenoxylate hydrochloride should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated. Diphenoxylate hydrochloride may potentiate the action of barbiturates, tranquilizers, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.
Who should not take Lomotil
Diphenoxylate hydrochloride is contraindicated in patients with: Known hypersensitivity to diphenoxylate or atropine. Obstructive jaundice. Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.
Overdose — what happens if you take too much
Diagnosis Initial signs of overdosage may include dryness of the skin and mucous membranes, mydriasis, restlessness, flushing, hyperthermia, and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils, and respiratory depression. Respiratory depression may be evidenced as late as 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. TREAT ALL POSSIBLE DIPHENOXYLATE HYDROCHLORIDE OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE. Treatment In the event of overdose, induction of vomiting, gastric lavage, establishment of a patent airway, and possibly mechanically assisted respiration are advised. In vitro and animal studies indicate that activated charcoal may significantly decrease the bioavailability of diphenoxylate. In noncomatose patients, a slurry of 100 g of activated charcoal can be administered immediately after the induction of vomiting or gastric lavage. A pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by diphenoxylate hydrochloride. When a narcotic antagonist is administered intravenously, the onset of action is generally apparent within two minutes. It may also be administered subcutaneously or intramuscularly, providing a slightly less rapid onset of action but a…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Known drug interactions include barbiturates, tranquilizers, and alcohol. Diphenoxylate hydrochloride may interact with MAO inhibitors (see Warnings ). In studies with male rats, diphenoxylate hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day. Therefore, diphenoxylate has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- How is Lomotil rated?
- pharmaranks gives Lomotil a composite score of 2.9 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Lomotil cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $6.87 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Lomotil?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lomotil. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lomotil?
- Lomotil is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Lomotil a brand-name or generic drug?
- Lomotil is a brand-name product with the active ingredient Atropine Sulfate and Diphenoxylate Hydrochloride. Lower-cost generic equivalents containing Atropine Sulfate and Diphenoxylate Hydrochloride are available — ask your pharmacist.
- Is Lomotil available over the counter?
- No. Lomotil is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lomotil come in?
- Lomotil is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Lomotil FDA-registered?
- Lomotil is on record with the U.S. FDA under application number NDA012462. You can verify this on its official FDA label.
- Has Lomotil been recalled by the FDA?
- Yes. Lomotil has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Lomotil safe?
- There's no single safe-or-not verdict. pharmaranks gives Lomotil a recall-safety score of 58/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lomotil?
- Lomotil's side effects are taken directly from its FDA label. From the label: At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache. Allergic: anaphylaxis,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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lomotil
58/100