Drug Interaction:
Monoamine oxidase inhibitors(MAOI)-
since the chemical structure of diphenoxylate is similar to meperidine,concurrent use may precipitate hypertensive crisis.
Barbiturates,tranquilizers & alcohol- diphenoxylate may potentiate the depressant action.
Closely observe the patient when these medicines are used concomitantly.
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Diphenoxylate Hcl 2.mg + Jul- 1969
Atropine sulphate 0.025mg tablet
Adverse Reaction:
Allergic- Pruritus,swelling of gums,angioneurotic edema, urticaria,anaphylaxis.
CNS-dizziness, drowsiness, sedation, headache, malaise, lethargy, restlessness,euphoria, depression, numbness of extremities, confusion.
GI- anorexia, nausea, vomiting, abdominal discomfort, paralytic ileus, toxic megacolon, pancreatitis.
Atropine effects- dry skin and mucous membranes, flushing, hyperthermia,tachycardia, urinary retension, especially in children.
Contra-Indications:
Children below 2 years of age due to greater variability of response, hypersensitivity to diphenoxylate or atropine,obstructive jaundice,diarrhoea associated with psudomembranous enterocolitis or enterotoxin producing bacteria.
Special precautions:
Diphenoxylate has not produced addiction and is devoid of morphine-like subjective effects.At high doses,it exhibits codeine-like subjective effects.
Therefore addiction to diphenoxylate is possible.
Dosages/ Overdosage Etc:
Indications:
Adjunct therapy in management of diarrhoea.
Dosage:
Individualise dose. Adult- Initial dose 5mg 4 times a day
Children- use liquid form only- 0.3 to 0.4mg/kg/daily in 4 divided doses..
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
DIPHENOXYLATE + ATROPINE
1.Adhere strictly to recommended dosage schedules. Keep out of reach of children since accidental overdose may result in severe,even fatal,respiratory depression.
2.Drowsiness or dizziness may occur.
3 Excercise caution in activities requiring mental alertness, coordination or physical dexterity, eg.,driving or operating dangerous machines.
4. Allergy- Tell your doctor if you ever had any allergic reaction to this medicine or any other food substances or preservatives or dyes.
5. Pregnancy- studies not done on humans. Some studies in rats have shown that this medicine lessens weigt gain of pregnant rat and lessens the chance of conceiving or becoming pregnant when given in doses many times the human dose
6. Breast feeding- though the medicine pass into breast milk this medicine has not shown to cause problems in nursing babies.
7. Children- this medicne should not be used in children, especially very young children since they are very sensitive to the effects of this medicine.
8. Older adults- shortness of breath or difficulty in breathing may be especially likely to occur in elderly patients, who are more sensitive than younger adults. Also fluid loss due to diarrhea may result in severe condition . It is important that sufficient amounts of liquid be taken to replace fluid lost by the body.
9. Other medicines- tell yourdoctor ifyoutaking oher medicines especially- Antibiotics- antibiotics cause diarrhes. Dipenoxylate and atropine may make the diarrhea worse. CNS- depressants -medicines that cause drowsiness- effects o fdrowsiness may become greater
10. Other medical problems- presence of other medical problems may affect the use of diphenoxylate . Make sure you tell yourdoctor especially- Alchol abuse or Drug absuse -greater chance of this medicine will become habit forming Colitis severe - more serious problem of colon may develop if you use this medicine
Downs syndrome- -side effects may be more likely to become severe in these patients Dysentry - this condition may get worse, a different kind of treatment is needed
11. Dosing- take the medicine as directed by the physician Dosing wil be diffeernt for diffeent patients. Follow the doctors instructions or directinon the label.
12. Missed dose- If you are taking the medicine on a regular schedule and you miss a dose,take it as soon as possble. However if it is almost time for the next dose, skip the missed dose and go back to your reguar schedule. Do not double doses
13. Storage- To store this medicine Keep out of reach of children since overdose is especially dangerous in children Store away from heat anddirectlight Do not store the tablet in the bathroom or under the kitchen sink or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated medicines or medicines no longer needed. Make sure that all discarded medicines are kept out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Dipheoxylate,a constipating meperidine congener,laks analgesic activity. High doses(40 to 60mg) cause opoid activity,(eg,euphoria,suppression of morphine abstinence syndrome,physical dependence after chronic use.
Pharmacokinetics:
Bioavailabilty of tabltes vs liquids is ~ 90%.Diphenoxylate is rapidly and extensively metabolised to dipheoxylic acid.
Elimination half-life is ~ 12 to 14 hours.
Interaction with Food:
Not available
Pregnancy and lactation:
Pregnancy:
No adequate and well controlled studies in pregnant woman has been undertake. Use only if required.
Lactation:
Diphenoxylic acid may be excreted in breast milk. Use with caution.