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|Atropine/Diphenoxylate Solution

Atropine/Diphenoxylate Solution

Atropine/Diphenoxylate Solution is used for:

Treating diarrhea. It may also be used for other conditions as determined by your doctor.

Atropine/Diphenoxylate Solution is an antidiarrheal and anticholinergic combination. It works by decreasing the motion of muscles in the intestines and prolonging the time it takes to move the contents through the body.

Do NOT use Atropine/Diphenoxylate Solution if:

• you are allergic to any ingredient in Atropine/Diphenoxylate Solution
• you have diarrhea caused by certain conditions (eg, pseudomembranous colitis, enterotoxin-producing bacteria, food poisoning)
• you have jaundice (yellowing of the eyes or skin)
• you have a blockage of the stomach or bowel, angle-closure glaucoma, myasthenia gravis, urinary blockage, excess acid in the stomach or throat, esophagus problems (eg, difficulty swallowing, inflammation), bowel muscle weakness, or heart problems with severe bleeding
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Atropine/Diphenoxylate Solution:

Some medical conditions may interact with Atropine/Diphenoxylate Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of jaundice (yellowing of the eyes or skin) or megacolon
• if you have abnormal blood levels of electrolytes (eg, potassium, sodium), ulcerative colitis, liver or kidney problems, Down syndrome, numbness due to nerve damage, prostate problems (enlarged prostate), a blockage of the bladder, trouble urinating, heart problems (eg, congestive heart failure, irregular heartbeat), hiatal hernia, asthma, open-angle glaucoma, or risk factors for glaucoma
• if you are dehydrated

Some MEDICINES MAY INTERACT with Atropine/Diphenoxylate Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antihistamines (eg, diphenhydramine), medicine for Parkinson disease (eg, benztropine), or tricyclic antidepressants (eg, amitriptyline) they may increase the risk of Atropine/Diphenoxylate Solution"s side effects
• Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of their side effects may be increased by this medicine
• Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of serious side effects, including severe high blood pressure, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Atropine/Diphenoxylate Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Atropine/Diphenoxylate Solution:

Use Atropine/Diphenoxylate Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Atropine/Diphenoxylate Solution by mouth with or without food.
• Use the dropper than comes with Atropine/Diphenoxylate Solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Atropine/Diphenoxylate Solution and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Atropine/Diphenoxylate Solution.

Important safety information:

• Atropine/Diphenoxylate Solution may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Atropine/Diphenoxylate Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Atropine/Diphenoxylate Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. This could increase the risk of serious side effects.
• If your symptoms do not get better within 10 days (2 days for children) or if they get worse, check with your doctor.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Report any symptoms of fluid or electrolyte loss to your doctor: dry mouth; thirst; weakness; lethargy; drowsiness; restlessness; muscle pain or cramps; muscle weakness; low blood pressure; infrequent urination; rapid heartbeat; stomach disorders such as nausea and vomiting.
• Atropine/Diphenoxylate Solution may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Atropine/Diphenoxylate Solution before you receive any medical or dental care, emergency care, or surgery.
• Use Atropine/Diphenoxylate Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
• Atropine/Diphenoxylate Solution should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Atropine/Diphenoxylate Solution in CHILDREN 2 years of age and older; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Atropine/Diphenoxylate Solution while you are pregnant. Atropine/Diphenoxylate Solution is found in breast milk. If you are or will be breast-feeding while you use Atropine/Diphenoxylate Solution, check with your doctor. Discuss any possible risks to your baby.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Atropine/Diphenoxylate Solution. This is known as DEPENDENCE or addiction. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Possible side effects of Atropine/Diphenoxylate Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth, nose, or skin; headache; loss of appetite; loss of taste; nausea; nervousness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal bloating or swelling; agitation; changes in heartbeat; confusion; continued or severe diarrhea; delirium; difficulty focusing your eyes; difficulty urinating; exaggerated sense of well-being; excitement; fast/irregular heartbeat; fever; hallucinations; numbness of the hands or feet; severely enlarged pupils; severe or prolonged restlessness; speech disturbance; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; difficulty breathing; dilated or constricted pupils; disorientation; fever; flushing; hallucinations; hyperactivity; muscle weakness; restlessness; seizures; severe dizziness; unusual eye movements; urinary retention; vomiting.

Store Atropine/Diphenoxylate Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Atropine/Diphenoxylate Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Atropine/Diphenoxylate Solution, please talk with your doctor, pharmacist, or other health care provider.
• Atropine/Diphenoxylate Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Atropine/Diphenoxylate Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.