Drug Interaction:
Methotrexate- may compete for binding sites with PABA
Sulfa Drugs- PABA interferes with antibacterial action.
Salicylates- therapeutic and toxic effects may be increased with concurrent administration
of PABA
Assay interactions-
Drugs metabolised to primary arylamines may cause assay inteference and falsely
elevate test results. These results include -
Acetoaminophen, benzocaine, chloramphenicol, lidocaine, procaine, procainamide
and thiazide diuretics
PABA containing drugs such as sunscreens or certain multiple vitamins may also elevate
test results. Discontinue any of these drugs 3 days prior to bentiromide administration.
In adults, discontinue oral pancreatic supplements 5 days prior to bentiromide admin.
In cystic fibrotic children, reduce the time interval to 1 day
Indication:
Screening test for pancreatic insufficiency, to monitor the adequacy of supplemental
pancreatic therapy
Adverse Reaction:
Most frequent-
Diarrhea, headache (<2%)
Rare-
Flatulence, nausea, vomitting and weakness (0.6%) are transcient and rarely
require symptomatic therapy
Acute respiratory distress and stridor requiring symptomatic therapy has been reported
in one patient following a second dose of bentiromide, the patient developed coughing
and choking after the first dose
Casual relationship unknown- abdominal pain, drowsiness, lightheadedness, heratburn,
transcient elevation of liver function tests
Contra-Indications:
Hypersensitivity to bentriomide
Warnings-
Hypersensitivity- a single case of bentriomide hypersensitivity has been reported.
The frequency of sensitization is unknown. Following administration, patients should
remain in a medical setting for observation
Have epinephrine 1:1000 immediately avalable
Renal/hepatic function impairment-
May alter test interpretation due to altered handling of PABA
Pregnancy-
Reproduction studies in small animals revealed no evidence of impaired fertility or
fetal harm due to bentriomide doses 50 and 100 times the human dose.
Safety for use has not been established. Use only when clearly needed
Lactation-
Safety for use in the nursing mother has not been established
Children-
Safety and efficacy for usein children < 6 years old are not established
Precautions-
Proper use of bentiromide - requires close attention to the technical details of
drug administration and of urine collection, handling and assay fo arylamine
levels and awareness that - false positive- and -false negative- resullts occur
Schedule repeat - dosing if needed at intevals of 7 days or more to assure
complete metabolism and excretion or prior doses of the drug
Diabetes- Insulin may need adjustment to accomodate the fasting patient
Laboratory tests-It has not been established whether concurrent GI diagnostic
testing interferes with the results of this test, conduct GI testing 24 hours before or
after dosing with bentiromide
Dosages/ Overdosage Etc:
Indication-
Screening test for pancreatic insufficiency, to monitor the adequacy of supplemental
pancreatic therapy
Dosage-
Administer following overnight fast. Urinate prior to drug administration.
Administer a single 500mg dose, follow immediately by 250ml of water.
In patients less than 12 years of age calculate the dose on the basis of
14mg/kg. Drinking water is encouraged to promote diuresis.
Give the patient 250ml of water at post-dosing hours 2 to 6.
Obtain a total urine collection during 0 to 6 hours post dosing
Measure the volume of collection and retain a 10ml sample for analysis.
Break the fast following completion of urine collection.
Should re-testing be necessary separate subsequent administration by at least
7 day interval to avoid interference by prior betriomide dosing.
Analysis of urine- use the Smith modification of the Bratton-Marshall arylamines
A negative betriomide test suggesting pancreatic exocrine insufficiency should
not lead to termination of search for a pancreatic etiology of maldigestion or
other pancreatic disease.
A good response to an oral pancreatic enzyme supplement would be confirmatory
of a positive betriomide test
Overdosage-
The treatment includes supportive measures,
Patient Information:
Bentriomide - Diagnostic
1.Patient package is availble with the product.
2. Fast after midnight before taking betriomide
3. Urinate before taking the drug
4.Notify physician if you are taking drugs that may interfere with the test
( see Drug interactions)
5. Discontinue the pancreatic supplements 5 days before the test.
6. Diarrhea, headache, nausea, vomiting, flatulence and weakness have been
reported
7.If any discomfort or unusual change is eperienced , notifty physician
8.Allergies-
Tell your doctor if you are have ever had any unusual or allergic reaction to
Also tell your healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
9. Diet-
Eating prunes or straberries shortly before the bentriomide test period
starts will affect the test results. Avoid these foods before the test.
9.Pregnancy-
Studies have not been done in pregnant women. . However, in animal studies
bentiromide has not shown to cause birth defects or other problems.
10. Breast-feeding-
It is known whether bentriomide passes into breast milk. However, this medicine
has not reported to cause problems in nursing babies
11.Children-
Studies of thie medicine has been done only in older children and adult patients,
and there is no specific information comparing use of betriomide in children up to
6 years with use in other age groups.
12.Older adults-
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way than they do in younger adults, or if they cause different side effects or problems in older people. There is no specific information comparing use of bentriomide in the elderly with use in other age groups
13. 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 are taking beiromide it is especially important that your doctor know if you
taking or using any of the following -
Acetoaminophen- (eg.Tylenol) or
Choramphenicol (eg.Chloromycetin) or
Local anesthetics (eg.benzocaine and lidocaine) or
Para-aminobenzoic acid (PABA ) containing preparations ( eg. sunscream
and some multivitamins ) or
Procainamide (eg. Pronestyl) or
Sulfonamides (sulfa medicines) or
Thiazide diuretics (water pills) use of these medicines during the test period
will affect the test results
Pancreatic supplements (eg.Pancrelipase) use of pancreatic supplements
may give false results
14. Other medical problems-
The presence of other medical problems may affect the results of the test.
Make sure you tell your doctor if you have any other medical problems
especially-
Disease of the stomach and intestine or
Kidney disease or
Liver disease (severe) these medical problems may cause false test results
Pharmacology/ Pharmacokinetics:
Pharmacology-
Bentiromide is a peptide which carries the marker para-aminobenzoic acid (PABA)
500mg of bentriomide contains 170mg PABA
Pharmacokintics-
Following oral administration of bentriomide, is selectively cleaved by pancreatic
chymotrypsin with liberation of PABA, PABA is readily absorbed through the intestinal
mucosa under normal conditions and is conjugated primarily by the liver and rapidly
excreted in the urine
Under conditions of normal exocrine pancreatic function, gastric emptying and gut
and kidney function, over 50% of the PABA contained in bentriomide appears in the
urine within 6 hours following adminstration.
It is not known whether bentiromide or PABA crosses the placental barrier or the
blood brain barrier.
PABA is detected in the urine using the Smith modification of the Bratton- Marshall
test for arylamines which detects both the conjugated and unconjugated aryamines
Pregnancy and lactation:
Pregnancy
Safety for use has not been established. Usewhen clearly needed
Lactation-
Safety for use in the nursing mother has not been established
Children-
safety and efficacy for usein children < 6 years old are not established
