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Lomotil
Overview
What is Lomotil?
Each Lomotil tablet and each 5 ml of Lomotil liquid for oral use
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:
Inactive ingredients of Lomotil tablets include acacia, corn starch,
magnesium stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil
liquid include cherry flavor, citric acid, ethyl alcohol 15%, glycerin, sodium phosphate, sorbitol, and water.
What does Lomotil look like?
What are the available doses of Lomotil?
Sorry No records found.
What should I talk to my health care provider before I take Lomotil?
Sorry No records found
How should I use Lomotil?
Lomotil is effective as adjunctive therapy in the management of diarrhea.
DO NOT EXCEED RECOMMENDED DOSAGE.
Adults:
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: Lomotil is not recommended in children under 2
years of age and should be used with special caution in young children
Only the plastic dropper should be used when measuring Lomotil liquid for
administration to children.
Dosage schedule for children:
approximate
These pediatric schedules are the best approximation of an average dose
recommendation which may be adjusted downward according to the overall
nutritional status and degree of dehydration encountered in the sick child.
Reduction of dosage may be made as soon as initial control of symptoms has been
achieved. Maintenance dosage may be as low as one-fourth of the initial daily
dosage. If no response occurs within 48 hours, Lomotil is unlikely to be
effective.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
What interacts with Lomotil?
- Lomotil is contraindicated in patients with
- Known hypersensitivity to diphenoxylate or atropine.
- Obstructive jaundice.
- Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.
What are the warnings of Lomotil?
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
LOMOTIL IS AN INNOCUOUS DRUG AND
DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN.
LOMOTIL IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY
RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT
BRAIN DAMAGE OR DEATH (SEE ). THEREFORE, KEEP THIS MEDICATION OUT
OF THE REACH OF CHILDREN.
THE USE OF LOMOTIL SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE
THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS
PRESENT, LOMOTIL SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS
BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID
RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND
ELECTROLYTE IMBALANCE.
LOMOTIL SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS
AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF
THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.
Antiperistaltic agents may prolong and/or worsen diarrhea associated with
organisms that penetrate the intestinal mucosa (toxigenic ), 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 Lomotil 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 Lomotil with monoamine
oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.
Lomotil 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.
What are the precautions of Lomotil?
Since a subtherapeutic dose of atropine has been added to the
diphenoxylate hydrochloride, consideration should be given to the precautions
relating to the use of atropine. In children, Lomotil should be used with
caution since signs of atropinism may occur even with recommended doses,
particularly in patients with Down's syndrome.
INFORM THE PATIENT (PARENT OR GUARDIAN) NOT TO EXCEED THE
RECOMMENDED DOSAGE AND TO KEEP LOMOTIL OUT OF THE REACH OF CHILDREN AND IN A
CHILD-RESISTANT CONTAINER. INFORM THE PATIENT OF THE CONSEQUENCES OF OVERDOSAGE,
INCLUDING SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT
BRAIN DAMAGE OR DEATH. Lomotil may produce drowsiness or dizziness. The patient
should be cautioned regarding activities requiring mental alertness, such as
driving or operating dangerous machinery. Potentiation of the action of alcohol,
barbiturates, and tranquilizers with concomitant use of Lomotil should be
explained to the patient. The physician should also provide the patient with
other information in this labeling, as appropriate.
Known drug interactions include barbiturates, tranquilizers, and
alcohol. Lomotil may interact with MAO inhibitors (see ).
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.
No long-term study in animals has been performed to evaluate
carcinogenic potential. Diphenoxylate hydrochloride was administered to male and
female rats in their diets to provide dose levels of 4 and 20 mg/kg/day
throughout a three-litter reproduction study. At 50 times the human dose (20
mg/kg/day), female weight gain was reduced and there was a marked effect on
fertility as only 4 of 27 females became pregnant in three test breedings. The
relevance of this finding to usage of Lomotil in humans is unknown.
Pregnancy Category C. Diphenoxylate hydrochloride has been shown
to have an effect on fertility in rats when given in doses 50 times the human
dose (see above discussion). Other findings in this study include a decrease in
maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10
times the human dose (4 mg/kg/day), average litter size was slightly
reduced.
Teratology studies were conducted in rats, rabbits, and mice with
diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to
experimental design and small numbers of litters, embryotoxic, fetotoxic, or
teratogenic effects cannot be adequately assessed. However, examination of the
available fetuses did not reveal any indication of teratogenicity.
There are no adequate and well-controlled studies in pregnant women. Lomotil
should be used during pregnancy only if the anticipated benefit justifies the
potential risk to the fetus.
Caution should be exercised when Lomotil is administered to a
nursing woman, since the physicochemical characteristics of the major
metabolite, diphenoxylic acid, are such that it may be excreted in breast milk
and since it is known that atropine is excreted in breast milk.
Lomotil may be used as an adjunct to the treatment of diarrhea
but should be accompanied by appropriate fluid and electrolyte therapy, if
needed. LOMOTIL IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. Lomotil
should be used with special caution in young children because of the greater
variability of response in this age group. See and . In case of accidental
ingestion by children, see for recommended treatment.
What are the side effects of Lomotil?
At doses, the following
have been reported; they are listed in decreasing order of severity, but not of
frequency:
Nervous system:
Allergic:
Gastrointestinal system:
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.
What should I look out for while using Lomotil?
Lomotil is contraindicated in patients with
LOMOTIL IS AN INNOCUOUS DRUG AND
DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN.
LOMOTIL IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY
RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT
BRAIN DAMAGE OR DEATH (SEE ). THEREFORE, KEEP THIS MEDICATION OUT
OF THE REACH OF CHILDREN.
THE USE OF LOMOTIL SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE
THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS
PRESENT, LOMOTIL SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS
BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID
RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND
ELECTROLYTE IMBALANCE.
LOMOTIL SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS
AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF
THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.
Antiperistaltic agents may prolong and/or worsen diarrhea associated with
organisms that penetrate the intestinal mucosa (toxigenic ), 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 Lomotil 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 Lomotil with monoamine
oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.
Lomotil 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.
What might happen if I take too much Lomotil?
RECOMMENDED DOSAGE SCHEDULES SHOULD BE STRICTLY FOLLOWED. THIS
MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF
CHILDREN, SINCE AN OVERDOSAGE MAY RESULT IN SEVERE, EVEN FATAL, RESPIRATORY
DEPRESSION.
Diagnosis:
Treatment:
In
vitro
A pure narcotic antagonist (eg, naloxone) should be used in the treatment of
respiratory depression caused by Lomotil. 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 more prolonged effect.
To counteract respiratory depression caused by Lomotil overdosage, the
following dosage schedule for the narcotic antagonist naloxone hydrochloride
should be followed:
Adult dosage:
Children:
Following initial improvement of respiratory function, repeated doses of
naloxone hydrochloride may be required to counteract recurrent respiratory
depression. Supplemental intramuscular doses of naloxone hydrochloride may be
utilized to produce a longer-lasting effect.
Since the duration of action of diphenoxylate hydrochloride is longer than
that of naloxone hydrochloride, improvement of respiration following
administration may be followed by recurrent respiratory depression.
Consequently, continuous observation is necessary until the effect of
diphenoxylate hydrochloride on respiration has passed. This effect may persist
for many hours. The period of observation should extend over at least 48 hours,
preferably under continuous hospital care. Although signs of overdosage and
respiratory depression may not be evident soon after ingestion of diphenoxylate
hydrochloride, respiratory depression may occur from 12 to 30 hours later.
How should I store and handle Lomotil?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .TabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx onlyTabletsNDC NumberSize54868-0427-5 bottle of 1054868-0427-4 bottle of 1254868-0427-3 bottle of 3054868-0427-0 bottle of 100 Rx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Diphenoxylate is rapidly and extensively metabolized in man by
ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active
and the major metabolite in the blood. After a 5-mg oral dose of carbon-14
labeled diphenoxylate hydrochloride in ethanolic solution was given to three
healthy volunteers, an average of 14% of the drug plus its metabolites was
excreted in the urine and 49% in the feces over a four-day period. Urinary
excretion of the unmetabolized drug constituted less than 1% of the dose, and
diphenoxylic acid plus its glucuronide conjugate constituted about 6% of the
dose. In a 16-subject crossover bioavailability study, a linear relationship in
the dose range of 2.5 to 10 mg was found between the dose of diphenoxylate
hydrochloride (given as Lomotil liquid) and the peak plasma concentration, the
area under the plasma concentration-time curve, and the amount of diphenoxylic
acid excreted in the urine. In the same study the bioavailability of the tablet
compared with an equal dose of the liquid was approximately 90%. The average
peak plasma concentration of diphenoxylic acid following ingestion of four
2.5-mg tablets was 163 ng/ml at about 2 hours, and the elimination half-life of
diphenoxylic acid was approximately 12 to 14 hours.
In dogs, diphenoxylate hydrochloride has a direct effect on circular smooth
muscle of the bowel that conceivably results in segmentation and prolongation of
gastrointestinal transit time. The clinical antidiarrheal action of
diphenoxylate hydrochloride may thus be a consequence of enhanced segmentation
that allows increased contact of the intraluminal contents with the intestinal
mucosa.
Non-Clinical Toxicology
Lomotil is contraindicated in patients withLOMOTIL IS AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. LOMOTIL IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE ). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
THE USE OF LOMOTIL SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS PRESENT, LOMOTIL SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE.
LOMOTIL SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.
Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic ), 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 Lomotil 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 Lomotil with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.
Lomotil 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.
Since a subtherapeutic dose of atropine has been added to the diphenoxylate hydrochloride, consideration should be given to the precautions relating to the use of atropine. In children, Lomotil should be used with caution since signs of atropinism may occur even with recommended doses, particularly in patients with Down's syndrome.
INFORM THE PATIENT (PARENT OR GUARDIAN) NOT TO EXCEED THE RECOMMENDED DOSAGE AND TO KEEP LOMOTIL OUT OF THE REACH OF CHILDREN AND IN A CHILD-RESISTANT CONTAINER. INFORM THE PATIENT OF THE CONSEQUENCES OF OVERDOSAGE, INCLUDING SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH. Lomotil may produce drowsiness or dizziness. The patient should be cautioned regarding activities requiring mental alertness, such as driving or operating dangerous machinery. Potentiation of the action of alcohol, barbiturates, and tranquilizers with concomitant use of Lomotil should be explained to the patient. The physician should also provide the patient with other information in this labeling, as appropriate.
Known drug interactions include barbiturates, tranquilizers, and alcohol. Lomotil may interact with MAO inhibitors (see ).
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.
No long-term study in animals has been performed to evaluate carcinogenic potential. Diphenoxylate hydrochloride was administered to male and female rats in their diets to provide dose levels of 4 and 20 mg/kg/day throughout a three-litter reproduction study. At 50 times the human dose (20 mg/kg/day), female weight gain was reduced and there was a marked effect on fertility as only 4 of 27 females became pregnant in three test breedings. The relevance of this finding to usage of Lomotil in humans is unknown.
Pregnancy Category C. Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced.
Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity.
There are no adequate and well-controlled studies in pregnant women. Lomotil should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.
Caution should be exercised when Lomotil is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk.
Lomotil may be used as an adjunct to the treatment of diarrhea but should be accompanied by appropriate fluid and electrolyte therapy, if needed. LOMOTIL IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. Lomotil should be used with special caution in young children because of the greater variability of response in this age group. See and . In case of accidental ingestion by children, see for recommended treatment.
At doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency:
Nervous system:
Allergic:
Gastrointestinal system:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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