Lomotil

DRUG DESCRIPTION

Each Lomotil (diphenoxylate and atropine) tablet and each 5 ml of Lomotil (diphenoxylate and atropine) 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:

Lomotil (Diphenoxylate hydrochloride) structural formula illustration 1

Atropine sulfate, an anticholinergic, is endo-()-?-(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:

Lomotil (Diphenoxylate hydrochloride) structural formula illustration 2

A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

Inactive ingredients of Lomotil (diphenoxylate and atropine) tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil (diphenoxylate and atropine) liquid include cherry flavor, citric acid, ethyl alcohol 15%, FD&C Yellow No. 6, glycerin, sodium phosphate, sorbitol, and water.

What are the possible side effects of atropine and diphenoxylate (Lomotil, Lonox, Vi-Atro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • stomach pain or bloating;
  • ongoing or worsening diarrhea;
  • diarrhea that is watery or bloody;
  • numbness in your hands or feet;
  • depressed mood;
  • confusion, unusual thoughts or...

Read All Potential Side Effects and See Pictures of Lomotil

What are the precautions when taking diphenoxylate and atropine (Lomotil)?

Before taking diphenoxylate with atropine, tell your doctor or pharmacist if you are allergic to either drug; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., obstructive jaundice, cirrhosis), diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella).

Before using this medication, tell your doctor or pharmacist your medical history,...

Read All Potential Precautions of Lomotil


Lomotil Consumer (continued)

SIDE EFFECTS: See also Precautions for side effects seen in children.

Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach/abdominal pain or swelling, severe nausea, vomiting, mental/mood changes (e.g., confusion, depression), restlessness, numbness/tingling of arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diphenoxylate with atropine, tell your doctor or pharmacist if you are allergic to either drug; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., obstructive jaundice, cirrhosis), diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current dehydration or mineral imbalance, a certain type of bowel disease (acute ulcerative colitis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid forms of this product may contain alcohol. Caution is advised if you have alcohol dependence or liver disease. Ask your doctor or pharmacist about using this product safely.

This drug is not recommended for use in children younger than 2 years. Caution is advised when using this drug in children, particularly those with Down's syndrome, because they may be more sensitive to the following side effects: high fever, fast heartbeat, decreased urination, flushing, dry skin/mouth, thirst. Very serious (possibly life-threatening) effects may occur if too much of this medication is taken by children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Lomotil Patient Information Including Side Effects

Brand Names: Lomotil, Lonox, Vi-Atro

Generic Name: atropine and diphenoxylate (Pronunciation: A troe peen and DYE fen OX i late)

  • What is atropine and diphenoxylate (Lomotil)?
  • What are the possible side effects of atropine and diphenoxylate (Lomotil)?
  • What is the most important information I should know about atropine and diphenoxylate (Lomotil)?
  • What should I discuss with my healthcare provider before taking atropine and diphenoxylate (Lomotil)?
  • How should I take atropine and diphenoxylate (Lomotil)?
  • What happens if I miss a dose (Lomotil)?
  • What happens if I overdose (Lomotil)?
  • What should I avoid while taking atropine and diphenoxylate (Lomotil)?
  • What other drugs will affect atropine and diphenoxylate (Lomotil)?
  • Where can I get more information?

What is atropine and diphenoxylate (Lomotil)?

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.

What are the possible side effects of atropine and diphenoxylate (Lomotil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • stomach pain or bloating;
  • ongoing or worsening diarrhea;
  • diarrhea that is watery or bloody;
  • numbness in your hands or feet;
  • depressed mood;
  • confusion, unusual thoughts or behavior;
  • fast heart rate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • drowsiness, dizziness, headache;
  • tired or restless feeling;
  • nausea, vomiting, upset stomach, loss of appetite; or
  • skin rash, or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about atropine and diphenoxylate (Lomotil)?

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.

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