Description
Diphenoxylate and atropine combination is used along with other measures (eg, fluid and electrolyte treatment) to treat severe diarrhea. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.
Diphenoxylate is chemically related to some narcotics and may be habit-forming if taken in doses that are larger than prescribed. If higher than normal doses of the combination are taken, the atropine will cause unpleasant effects.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of diphenoxylate and atropine combination in children 13 years of age and older. Safety and efficacy have not been established in children younger than 13 years of age. This medicine should not be used in children younger than 6 years of age because of the risk for respiratory depression (severe breathing problem) or coma (loss of consciousness).
Geriatric
No information is available on the relationship of age to the effects of diphenoxylate and atropine combination in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ambenonium
- Isocarboxazid
- Naltrexone
- Potassium Chloride
- Potassium Citrate
- Safinamide
- Samidorphan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Amantadine
- Amifampridine
- Amphetamine
- Benzhydrocodone
- Benzphetamine
- Bromazepam
- Bromopride
- Buprenorphine
- Bupropion
- Butalbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Cetirizine
- Citalopram
- Clobazam
- Clonazepam
- Clopidogrel
- Clozapine
- Codeine
- Cyclobenzaprine
- Cyproheptadine
- Daridorexant
- Desmopressin
- Desvenlafaxine
- Dexmedetomidine
- Dextroamphetamine
- Dextromethorphan
- Diazepam
- Dihydrocodeine
- Donepezil
- Doxylamine
- Duloxetine
- Escitalopram
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Arbutamine
- Desflurane
- Tizanidine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea caused by antibiotics or an infection, including sepsis or
- Obstructive jaundice—Should not be used in patients with these conditions.
- Down's syndrome—May cause side effects to become worse.
- Enlarged prostrate or
- Gallbladder disease or
- Glaucoma or
- Heart disease or
- Hypertension (high blood pressure) or
- Kidney disease or
- Liver disease or
- Myasthenia gravis (severe muscle weakness) or
- Problems passing urine or
- Stomach or bowel problems (eg, blockage, hiatal hernia, ulcerative colitis) or
- Thyroid problems—Use with caution. May make these conditions worse.
Proper Use
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.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.
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.
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 liquid):
- Adults—At first, the dose is 5 milligrams (mg) (2 teaspoonfuls) three or four times a day. Then, your doctor may decrease your dose to 5 mg (2 teaspoonfuls) once a day, as needed.
- Children 12 years of age or younger—Use is not recommended.
- For oral dosage form (tablets):
- Adults and children 13 years of age and older—At first, the dose is 5 milligrams (mg) (2 tablets) four times a day. Then, your doctor may decrease your dose to 5 mg (2 tablets) once a day, as needed.
- Children 6 to younger than 13 years of age—Use and dose must be determined by your doctor.
- Children younger than 6 years of age—Use is not recommended.
- For oral dosage form (oral liquid):
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Diarrhea usually stops 2 days after treatment with this medicine. If your symptoms do not improve or if they get worse within 10 days of treatment, check with your doctor.
This medicine may cause serious stomach or bowel problems (eg, toxic megacolon). This is more likely if you also have ulcerative colitis. Check with your doctor right away if you have bloating, constipation, loss of appetite, nausea, vomiting, or stomach pain.
Check with your doctor if you have dizziness, fast, shallow breathing, a fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, thirst, extremely high fever or body temperature, decrease in urine volume, decrease in frequency of urination, difficulty in passing urine, painful urination, dry skin and mouth. This may be signs of condition called atropinism.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with diphenoxylate and atropine combination may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may lead to unconsciousness and possibly death. Signs or symptoms of overdose include severe drowsiness, shortness of breath or troubled breathing, fast heartbeat, and unusual warmth, dryness, and flushing of the skin.
This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bloating
- confusion
- constipation
- cough
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficulty in passing urine (dribbling)
- difficulty swallowing
- discouragement
- dizziness
- drowsiness
- dry skin and mouth
- extremely high fever or body temperature
- false or unusual sense of well-being
- fast, shallow breathing
- fast, weak heartbeat
- feeling of warmth
- feeling sad or empty
- headache
- hives, itching, skin rash
- irritability
- loss of appetite
- loss of interest or pleasure
- muscle cramps
- nausea
- numbness of the arms and legs
- painful urination
- pale, clammy skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms and occasionally, upper chest
- restlessness
- seeing, hearing, or feeling things that are not there
- stomach cramps or pain
- thirst
- tightness in the chest
- trouble concentrating
- trouble sleeping
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual tiredness or weakness
- vomiting
- weight loss
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- back pain
- bigger, dilated, or enlarged pupils (black part of eye)
- blurred vision
- difficult or troubled breathing
- feeling of warmth
- fever
- garbled speech
- increased sensitivity of the eyes to light
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- mood or mental changes
- pale or blue lips, fingernails, or skin
- seizures
- speech that is not understood
- stiff neck
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20061751
