Lomotil

Adequate studies of diphenoxylate in pregnant women have not been done, so diphenoxylate should be used during pregnancy only when clearly needed.

Diphenoxylic acid, a metabolite of diphenoxylate (that is, diphenoxylate that has been changed chemically by the body) is excreted into breast milk, as is atropine. Although there have not been problems reported in the infants of women who breastfeed, the benefits to the mother should be weighed against the potential risks to the nursing infant.

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Atropine affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.

Diphenoxylate is an antidiarrheal medication.

The combination of atropine and diphenoxylate is used to treat diarrhea.

Atropine and diphenoxylate may also be used for other purposes not listed in this medication guide.

If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

Drink extra water while you are taking this medication to keep from getting dehydrated.

It may take up to 48 hours of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

Seek emergency medical attention if you think you have used too much of this medicine, or if a child has accidentally swallowed it. An overdose of atropine and diphenoxylate can cause breathing problems and may result in death or permanent brain damage.

Early overdose symptoms may include dry skin, dry mouth or nose, blurred vision, restless feeling, feeling too warm or cold, tingly feeling, and a fast heart rate.

Progressing symptoms of an atropine and diphenoxylate overdose include weakness, pinpoint pupils in the eyes, weak or shallow breathing, fainting, or coma. Report any early overdose symptoms to your doctor as soon as possible.

Diphenoxylate and atropine is a combination medicine used along with other measures to treat severe diarrhea in adults. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.

Since diphenoxylate is chemically related to some narcotics, it may be habit-forming if taken in doses that are larger than prescribed. To help prevent possible abuse, atropine (an anticholinergic) has been added. If higher than normal doses of the combination are taken, the atropine will cause unpleasant effects, making it unlikely that such doses will be taken again.

Diphenoxylate and atropine combination medicine should not be used in children. Children with diarrhea should be given solutions of carbohydrates (sugars) and important salts (electrolytes) to replace the water, sugars, and important salts that are lost from the body during diarrhea. For more information on these solutions, see the Carbohydrates and Electrolytes (Systemic) monograph.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain diphenoxylate and atropine. It may not be specific to Lomotil. Please read with care.

If this medicine upsets your stomach, your doctor may want you to take it with food.

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

For patients taking the liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.

Importance of diet and fluids while treating diarrhea :

• In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours you should eat gelatin and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs or symptoms of too much fluid loss occur:
  • Decreased urination
  • Dizziness and light-headedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For severe diarrhea:
  • For oral dosage form (oral solution):
    • Adults and teenagers—At first, the dose is 5 milligrams (mg) (2 teaspoonfuls) three or four times a day. Then, the dose is usually 5 mg (2 teaspoonfuls) once a day, as needed.
    • Children up to 12 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults and teenagers—At first, the dose is 5 mg (2 tablets) three or four times a day. Then, the dose is usually 5 mg (2 tablets) once a day, as needed.
    • Children up to 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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:

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 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%, FD&C Yellow No. 6, glycerin, sodium phosphate, sorbitol, and water.

Lomotil is contraindicated in patients with

1. Known hypersensitivity to diphenoxylate or atropine.
2. Obstructive jaundice.
3. Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.

Applies to atropine / diphenoxylate: oral liquid, oral tablet

Nervous system

Frequency not reported: Numbness of extremities, sedation/drowsiness, dizziness, headache, somnolence[Ref]

Gastrointestinal

Frequency not reported: Swelling of the gums, toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, abdominal discomfort, constipation[Ref]

Cardiovascular

Frequency not reported: Tachycardia, cardiac irregularities (e.g. arrhythmias, bradycardia, palpitations)[Ref]

Ocular

Frequency not reported: Increased intraocular pressure, dilation of pupils with loss of accommodation, photophobia, angle closure glaucoma[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficulty in micturition[Ref]

Psychiatric

Frequency not reported: Euphoria, depression, confusion, restlessness, hallucinations[Ref]

Dermatologic

Frequency not reported: Urticaria, pruritus, flushing[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioneurotic edema[Ref]

Metabolic

Frequency not reported: Anorexia[Ref]

Respiratory

Frequency not reported: Respiratory depression in children[Ref]

Other

Frequency not reported: Malaise/lethargy, hyperthermia, dryness of the skin and mucous membranes[Ref]

Some side effects of Lomotil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.