Atropine and diphenoxylate

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.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while you are taking this medication. Alcohol can increase some of the side effects of atropine and diphenoxylate.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by atropine and diphenoxylate. Tell your doctor if you regularly use any of these other medicines.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.

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.

2 years and older:
Initial dose: 0.3 to 0.4 mg/kg of diphenoxylate, orally, in 4 divided doses
Maintenance dose: Once control is achieved, reduce dose to individual requirements, to as little as one quarter of the initial daily dosage
Maximum dose: 20 mg diphenoxylate per day

Comments:
-These doses are approximate; adjust downward according to nutritional status and degree of dehydration.
-Reduce dose as soon as initial control of symptoms has been achieved.
-If no response within 48 hours, this medicine is unlikely to be effective.
-Use only the liquid medication in children under 13 years old; do not use tablets.

Data not available

Patient advice:
-Do not exceed the recommended dosage.
-Keep out of reach of children and in a child resistant container.
-Overdosage may cause severe respiratory depression and coma, possibly leading to permanent brain damage or death.
-May cause drowsiness or dizziness; use caution regarding activities requiring mental alertness, such as driving or operating dangerous machinery.
-May potentiate the effects of alcohol, barbiturates, and tranquilizers.

Caution is recommended. Excreted into human milk: Yes Comments: -Atropine is excreted in breast milk. -The major metabolite of diphenoxylate (diphenoxylic acid) may be excreted in breast milk. -Infants of nursing mothers taking this medication may exhibit some of the side effects of the drug.