Drug Information

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Difenoxin Hcl with Atropine Hcl - Antidiarrheals

Drug Name:
Difenoxin Hcl with Atropine Hcl - Antidiarrheals

List Of Brands:

MOTOFEN *

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pregnancy and lactation

Drug Interaction:

Drug interactions -summary-

Difenoxin +

Barbiturates, tranquilizers, narcotics, and alcohol -
barbiturates, tranquilizers, narcotics, alcohol may be potentiated by coadministration.
Closely monitor patients

MAOIs -
concurrent use with MAOIs may precipitate hypertensive crisis

Indication:

Acute non specific diarrhea
Acute exacerbation of chronic functional diarrhea

Adverse Reaction:

Adverse reactions-

CNS - dizziness, lightheadedness 5% , drowsiness 3% headache 2%
tiredness, nervousness, insomnia, confusion < 1%

GI - nausea 6% vomiting , dry mouth, 2% epigastric distress , constipation < 1%

Ophthalmic - buring eyes, blurred vision, (infrequent )

Contra-Indications:

Diarrhea asssociated with organisms that penetrate mucosa eg Toxigenic E.Coli,
Salmonella sp, Shigella

Special precautions-
Fluid and electrolyte balance - if severe dehydration or electrolye balance is manifested,
withhold the drug until appropiate corrective therapy hs been initiated

Ulcerative colitis- discontinue promptly if abdominal distention occurs, or if other
untoward symptoms develop.

Liver and kidney disease- Excercise caution in patients with advanced hepato-renal disease
and in all patients with abnormal liver function tests.

Atropine- observe the warnings and precautions for use of anticholinergic agents,
In children signs of atropism may occur even with recommended doses, particularly
inpatients with Downs syndrome

Drug abuse and dependence - is theoritically possible at high dosage. Therefore do
not exceed the recommended dosage

Pregnancy - use during pregnancy only if the potential benefits justifies the potential
risk to the fetus.

Lactation- decide whetherto discontinue nursing or the drug depending on the importance
of the drug to the mother,

Children- contraindicated for use in children under 2 years of age. Safety and efficacy
in children below the age of 12 years have not been established

Dosages/ Overdosage Etc:

Indication
Acute non specic diarrhea
Acute exacerbation of chronic functional diarrhea

Dosage-
Recommended starting dose - 2 tablets, then 1 tablet after each loose stool.
1 tablet every 3 to 4 hours as needed
The total dosage during 24 hour treatment during any 24 hours period should not
exceed 8 tablets
For diarrhea in which clinical improvement is not observed continued administration is
not recommended
For acute diarrhea and acute excaberation of functional diarrhea treatment beyond
48 hours is usually not necesary

Difenoxin hcl with atropine is not innocuous, strictly adhere to dosage recommendations

Children - studies in children younger than 12 years of age are inadequate to evaluate
safety and efficacy
Contraindicated in children younger than 2 years

Patient Information:

Ref - USP PDI Vol II 17th Edition (1997)

Difenoxin with Atropine

1. Adhere strictly to the recommended dosage schedule

2. Keep the medicines out of children

3. May cause drowsiness , use caution while driving or performing hazardous tasks or

tasks that require alertness, coordination of physical dexterity.

4.Allergies-

Tell your doctor if you are have ever had any unusual or allergic reaction to

Difenoxin or atropine. Also tell your healthcare care professional if you are allergic

to any other substances such as foods. preservatives or dyes.

5.Pregnancy-

Difenoxin and atrpopne combinations have not been done in humans. However,

studies in rats have shown that difenoxin and atropine combination, when given

in doses many times the human dose, increases the delivery time and the chance

of death of the newborn

6. Breast-feeding-

Both defenoxin and atropine pass into breast milk. Although it is not known how

much of these drugs pass into the breast milk, defoxin and atropine combination

could cause serious effects in the nursing baby. Be sure you have discussed

the risks and benefits of this medicine with your doctor.

7.Children-

This medicine should not be used in children, especially very young children

who are very sensitie to the effects of defoxin and atropine. This may increase

the chance of side effects during treatment. Also the fluid loss caused by

diarrhea may result in severe condition.

For this reason it is very important that a sufficient amount of liquids be given

to replace the fluid lost by the body. If younany questions about check with

your doctor.

8.Older adults-

Shortness of breath or difficulty in breathing may be more likely to occur

in elderly patients who are usualy more sensitive than younger adults to

the effects of difenoxin. Also fluid loss caused by diarrhea may result in

severe condition.

For this reason elderly patients should not take this medicine without

first checking with their doctor. It is also important that sufficient amount

of liquids be taken to replace the fluid lost by the body. If you have any

questions about this, check with your doctor.

9. Other medicines-

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 such cases your doctor may want to change the dose, or other precautions

may be necessary.

When you taking this medicine, it is especially important that your doctor know

if you are taking any of the following-

Antibiotics such as cephalosporin, clindamycin, erythromycin, tetracycline- these

medicines may cause diarrhea. Defonoxin and atropine may make the diarrhea

caused by antibiotics worse or make it longer

Central nervous system - depressants- effects such as drowsiness, of CNS

depressants or of difenoxin and atropine may become greater.

MAO inhibitors- taking defoxin and atropine while you taking or within 2 weeks

of taking MAO inhibitors may cause severe side effects

10. Other medical problems-

The presence of other medical problems may affect the use of difenoxin

and atropine

Make sure you tell your doctor if you have any other medical problems

especially-

Alcohol abuse- or

Drug abuse- there is greater chance that this medicine become habit forming

Colitis - a more serious problem of the colon may develop if you use this medicine

Downs syndrome - side effects may become more likely and severe in these patients

Dysentry- this condition may get worse, a different kind of treatment may be needed

Emphesema, asthma, bronchitis, or other chrornic lung disease- there is a greater

chance that this medicine may cause breathing problems in patients who have any

of these conditions.

Enlarged prostrate or

Urinary tract blockage or gallstone - use of this medicine may cause spasms

of the billiary tract and make the condition worse.

Glaucoma - severe pain in the eye may occur with the use of this medicine,

howver, the chhance of happening is very low.

Heart disease- this medicine may have some effects on the heart, which may

the condition worse.

Hiatal hernia- the atropine in this medicine may may the condition worse,

however,the chance of this happening is very low.

High blood pressure- atropine may cause an increase in blood pressure,

however, the chance of this happening is very low.

Intestinal blockage- the medicine may make the condition worse.

Kidney disease- atropine in this medicine may build up in the body,

and cause sidev effects

Liver disease- chance of CNS side effects including coma, may be greater

in patients who have this condition

Myastenia gravis- the medicine may make the condition worse.

Overactive or under active thyroid- unwanted side effects on breathing and

heart rate may occur.

Overflow incontinence- this medicine may make the condition worse

Pregnancy and lactation:

Pregnancy -
Use during pregnancy only if the potential benefits justifies the potential
risk to the fetus.

Lactation-
Decide whetherto discontinue nursing or the drug depending on the importance
of the drug to the mother,

Children-
Contraindicated for use in children under 2 years of age. Safety and efficacy
in children below the age of 12 years have not been established

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