Consumer medicine information

Pro-Banthine Tablet

Propantheline bromide

BRAND INFORMATION

Brand name

Pro-Banthine

Active ingredient

Propantheline bromide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pro-Banthine Tablet.

What is in this leaflet

This leaflet answers some common questions about PRO-BANTHINE tablets. It does not contain all the available information about this medicine. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PRO-BANTHINE against the benefits he or she expects it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is PRO-BANTHINE used for

The name of your medicine is PRO-BANTHINE.

The active ingredient is called propantheline bromide.

Propantheline bromide belongs to a group of medicines called the anticholinergics.

Anticholinergics are used to reduce both gastric acid and other secretions in the stomach, and to reduce cramps or spasms in the muscles of your stomach, intestine and urinary tract.

PRO-BANTHINE works by stopping some of the actions of a naturally occurring substance called acetylcholine which then reduces:

  • the amount of acid produced by your stomach
  • cramps or spasms in the muscles of your stomach, intestine and urinary tract
  • the amount of sweat produced by your body

PRO-BANTHINE is used to treat a number of different conditions:

It reduces:

  • ulcers in the stomach (gastric ulcers) and in the first part of the intestine (duodenal ulcers) with the assistance of other medicines
  • urinary problems caused by nerves or muscles that control the bladder
  • excessive sweating

Your doctor may have prescribed this medicine for another condition.

Ask your doctor if you have any questions about why PRO-BANTHINE has been prescribed for you.

PRO-BANTHINE tablets are only available with a doctor’s prescription.

This medicine is not recommended for use in children.

Before you take it

When you must not take it

Do not take PRO-BANTHINE if you are allergic to:

  • propantheline bromide or any other anticholinergic agent
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction to PRO-BANTHINE may include red, itchy skin rashes, difficulty in breathing, swelling of the face or throat or faintness.

Do not take PRO-BANTHINE if you have any of the following medical conditions:

  • Glaucoma, high pressure in the eye
  • heart problems
  • Thyrotoxicosis, a condition of excessive thyroid hormones
  • obstructive gastrointestinal problems
  • prostate problems
  • intestinal problems, including colitis
  • Myasthenia gravis
  • obstructive urinary tract problems
  • hiatus hernia (belching and heartburn)
  • acute bleeding

Do not use this medicine after the expiry date (EXP.) printed on the pack. If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not take it if the packaging is torn, shows signs of tampering or visible signs of deterioration. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

You must tell your doctor if:

  1. you are allergic to any other medicines or any foods, dyes or preservatives
  2. you are pregnant or intend to become pregnant
PRO-BANTHINE is rated in Australia as a Category B2 drug for the use in pregnancy. Your doctor will discuss the risks and benefits of taking PRO-BANTHINE during pregnancy.
  1. you are breast-feeding or intend to breastfeed
Special care is recommended if you are breast-feeding, as no studies have been conducted in breast-feeding mothers. Your doctor will discuss the risks and benefits of taking PRO-BANTHINE during breast-feeding.
Elderly patients are more likely to have less effective kidney or liver function due to age. This may increase the risk of side effects.
You should discuss how much PRO-BANTHINE to take with your doctor or pharmacist.
  1. You have any other medical conditions/ health problems, including:
  • stomach and intestinal problems, including colon inflammation, small bowel not working properly
  • heart diseases
  • lung problems
  • fever or exposure to high environmental temperatures
  • bleeding disorders
  • an overactive thyroid gland
  • high blood pressure
  • liver and/or kidney disease
  • problems with the nervous system
  • down’s syndrome
  • hereditary intolerances such as galactose, lactose, fructose, glucose, sucrase-isomaltose.

If you have not told your doctor about any of the above, tell them before you start to take any PRO-BANTHINE.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

SOME medicines may interact with PRO-BANTHINE.

These include:

  • antacids and anti-diarrhoeals
  • digoxin, a medicine used to treat heart failure
  • medicine used for stomach cramps or spasms
  • painkillers e.g. pethidine, nefopam, and paracetamol
  • anti-parkinson drugs e.g. levodopa
  • anti-arrhythmics, medicines used to treat irregular heart beats e.g. disopyramide, procainamide or quinidine
  • antihistamines, medicines used to prevent or relieve symptoms of allergy
  • antidepressants, medicines used to treat depression
  • metoclopramide and domperidone, medicines used to treat nausea
  • ketoconazole, medicine used to treat fungal infections
  • potassium chloride
  • cisapride, medicine that stimulates stomach muscle contraction
  • medicines used to treat the condition myasthenia gravis
  • urinary alkalinisers
  • medicines used to treat certain mental and emotional conditions
  • corticosteroids, e.g. prednisolone, cortisone
  • other anticholinergics
  • memantine, medicine used to treat Alzheimer’s
  • nitrates
  • other anti-infectives

The above medicines may either reduce the effectiveness of PRO-BANTHINE, reduce its own effectiveness and/or react with PRO-BANTHINE resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking PRO-BANTHINE.

Before you start to take any other medicine, tell your doctor or pharmacist that you are taking PRO-BANTHINE.

How to take it

Follow your doctor's instructions carefully, as they may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

The recommended doses of PRO-BANTHINE are:

For treatment of peptic ulcers

Adults: 1 tablet three times daily and 2 tablets at bedtime.

For treatment of other conditions

Adults: 1 to 2 tablets four times daily.

The safety and efficacy of PRO-BANTHINE in children has not been established.

Different people respond differently to PRO-BANTHINE, so your doctor may tell you to take a different dose.

Do not change your dose of PRO-BANTHINE unless your doctor tells you to do so.

Do NOT take more than 8 tablets in one day.

How to take it

PRO-BANTHINE tablets should be swallowed with a glass of water.

When to take it

Take your PRO-BANTHINE tablets 30 minutes before a meal.

How long to take it

Continue taking PRO-BANTHINE as long as your doctor recommends it.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take your dose as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose):

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much PRO-BANTHINE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much PRO-BANTHINE you may have the following symptoms: Increased severity of the side effects listed; changes in behaviour such as restlessness and excitement; flushing of the skin; a fall in blood pressure; breathing difficulties; and paralysis.

While you are using it

Things you must do

Immediately stop taking PRO-BANTHINE if a skin rash or other allergic reaction occurs.

Use PRO-BANTHINE exactly as directed or as your doctor has prescribed.

Tell any other doctors, dentists or pharmacists who are treating you that you are taking PRO-BANTHINE.

Tell your doctor if you become pregnant while taking PRO-BANTHINE.

Tell your doctor if you feel PRO-BANTHINE is not helping your condition.

Visit you doctor regularly. Your doctor needs to check your progress and see whether you need to stop taking PRO-BANTHINE.

Always discuss with your doctor any problems or difficulties during or after taking PRO-BANTHINE.

Things you must not do

Do not take any other medicines while you are taking PRO-BANTHINE without first telling your doctor.

Do not drive, operate machinery, or participate in dangerous activities where alertness is required, until you know how PRO-BANTHINE affects you. PRO-BANTHINE may cause drowsiness or dizziness in some people and therefore may affect alertness. PRO-BANTHINE can also affect your eyesight by blurring your vision.

Do not give this medicine to anyone else, even if his or her symptoms seem similar to yours.

Things you must be careful of

Be careful when exercising or when the weather is hot. Make sure you keep cool in hot weather and keep warm in cool weather.

PRO-BANTHINE may affect the way your body reacts to temperature changes. It may prevent sweating, even during heatwaves. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Side effects

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PRO-BANTHINE.

PRO-BANTHINE helps most people with the medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Tell you doctor if you notice any of the following and they worry you:

  • thirstiness
  • dry mouth
  • dry skin
  • difficulty in swallowing and talking
  • nervousness
  • drowsiness
  • dizziness
  • weakness
  • confusion
  • headache
  • blurred vision
  • nausea
  • vomiting
  • bloatedness
  • constipation
  • flushing
  • inability to sleep
  • decreased sweating
  • loss of sense of taste
  • impotence
  • reduction in the amount of breast milk

These side effects are usually mild.

Tell your doctor or pharmacist immediately if you notice any of the following:

  • skin rash
  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • unable to pass urine
  • difficulty passing urine
  • fever
  • fast, pounding or irregular heartbeats

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor or pharmacist immediately or go to casualty at your nearest hospital:

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing or trouble breathing

This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.

Some people may get other side effects with PRO-BANTHINE.

Check with your doctor as soon as possible if you have any problems while taking PRO-BANTHINE, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

After using it

Storage

Keep your tablets in the bottle they were provided in until it is time to take them.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the floor is a good place to store medicines.

Keep PRO-BANTHINE in a cool dry place where the temperature stays below 30°C and protect from light.

Do not store it, or any other medicines in a bathroom or near a sink.

Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Do not take PRO-BANTHINE if the tablets do not look quite right.

Disposal

If your doctor tells you to stop taking this medication OR it has passed its expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

PRO-BANTHINE 15 mg tablets are pale orange, film coated tablets in bottles of 100.

Ingredients

Each PRO-BANTHINE tablet contains 15 mg of propantheline bromide as the active ingredient.

The other ingredients in each tablet are:

  • lactose
  • starch-maize
  • magnesium stearate
  • talc-purified
  • Opadry II complete film coating system 85G63218 Orange

PRO-BANTHINE tablets contain soya bean and sugars as lactose, but do NOT contain any gluten.

Sponsor or Supplier

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia

The Australian Registration Number for PRO-BANTHINE 15 mg tablets is AUST R 207283.

This leaflet revised in June 2022.

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Pro-Banthine

Active ingredient

Propantheline bromide

Schedule

S4

 

1 Name of Medicine

Propantheline bromide.

2 Qualitative and Quantitative Composition

Pro-Banthine film-coated tablets contain 15 mg of propantheline bromide.

Excipients with known effect.

Contains soya bean and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pro-Banthine 15 mg, pale orange film-coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Pro-Banthine is indicated as an adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal). Pro-Banthine is also indicated for the neurogenic bladder, urinary incontinence in patients with detrusor hyperactivity, and hyperhidrosis.

4.2 Dose and Method of Administration

Adults.

In peptic ulcer cases, one tablet three times a day, 30 minutes before each meal, and two at bedtime is usual (75 mg daily). There is considerable variation of individual needs and the dosage may be raised until dryness of the mouth occurs. A dose slightly lower than this amount is optimal. The maximum daily dosage should not exceed 120 mg.

For other indications.

The dose is one or two tablets (15 mg to 30 mg) four times daily.

4.3 Contraindications

Propantheline bromide is contraindicated in the following conditions:
Hypersensitivity to propantheline bromide or other anticholinergic drugs, or any of the ingredients in Pro-Banthine tablets (see Section 6.1 List of Excipients).
Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.
Glaucoma, since mydriasis is to be avoided.
Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.).
Obstructive uropathy (prostatism).
Intestinal atony of elderly or debilitated patients.
Toxic megacolon complicating ulcerative colitis.
Hiatal hernia associated with reflux oesophagitis.
Unstable cardiovascular adjustment in acute haemorrhage.
Myasthenia gravis.
Prostatic enlargement.

4.4 Special Warnings and Precautions for Use

Potential risks or benefits should be carefully considered before using the product.
Propantheline bromide should be used with caution in patients with severe cardiac disease in whom even a slight increase in heart rate is undesirable.
Propantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, mitral stenosis or hypertension.
Propantheline bromide should be used with caution in patients with chronic lung disease, as inspissation and formation of bronchial plugs may occur, due to the reduction in bronchial secretion.
In some patients, especially those with ileostomy or colostomy, diarrhoea may be a symptom of incomplete intestinal obstruction. Propantheline bromide therapy should be avoided in such patients.
Caution is also required in patients with known or suspected gastrointestinal infections such as Clostridium difficile-associated diarrhoea and colitis, gastrointestinal reflux disease, acute myocardial infarction, cardiac insufficiency and pyrexia. Gastrointestinal motility may decrease, so continuance of causative toxins and organisms occur, therefore prolonging the infection symptoms.
Caution is required in patients with ulcerative colitis, since in these patients propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus, thus precipitating or aggravating toxic megacolon.
Caution is required for those patients with fever or who may be exposed to elevated environmental temperatures, as there may be an increase in the risk of hyperthermia occurring. Fever and possibly heat stroke may occur due to anhidrosis.
Pro-Banthine should be used with caution in patients with Down's syndrome.
Patients with rare hereditary problems of galactose intolerance or total lactase deficiency should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Use in the elderly.

Caution should also be exercised in elderly patients because of the possibility of inducing urinary retention. Urinary retention may be avoided if these patients are advised to micturate at the time of taking medication. Caution should also be exercised in elderly patients due to the danger of precipitating undiagnosed glaucoma.

Paediatric use.

Safety and efficacy of propantheline bromide in children have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antacids or absorbent antidiarrheals.

May reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide.

Anticholinergics.

May delay absorption of other medication given concomitantly.

Antimyasthenics.

Concurrently used with propantheline bromide may further reduce intestinal motility.
Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Cisapride.

Concurrent use of propantheline bromide with cisapride is likely to counteract gastrointestinal motility normally induced by cisapride.

Digoxin.

Tablets concurrently used with propantheline bromide may assist absorption and lead to elevated serum digoxin levels.

Haloperidol.

Concurrently used with propantheline bromide may decrease the effectiveness of haloperidol as an antipsychotic agent, increased risk of antimuscarinic side effects when antimuscarinics are given with clozapine.

Ketoconazole.

Anticholinergics may decrease gastric acid output and/or increase gastrointestinal pH, possibly resulting in reduction of ketoconazole absorption during concurrent use with anticholinergics. Therefore, take propantheline bromide at least two hours after ketoconazole.

Levodopa.

Concurrent administration of anticholinergics and levodopa may decrease the extent of absorption of levodopa in the small intestine by causing increased metabolism of levodopa in the stomach. If propantheline bromide is discontinued without a concomitant reduction in levodopa dosage, toxicity may result from the increased absorption of levodopa. Increased risk of antimuscarinic side effects when antimuscarinics are given with amantadine.

Metoclopramide.

Concurrently used with propantheline bromide may cause propantheline bromide to antagonise the gastrointestinal motility effects of metoclopramide.

Opioid (narcotic) analgesics.

Concurrently used with propantheline bromide may cause an increase in the risk of severe constipation. This may lead to urinary retention or paralytic ileus occurring.

Analgesics.

Increased risk of antimuscarinic side effects when antimuscarinics are given with nefopam. The absorption of paracetamol has been reported to be reduced and retarded.
Propantheline bromide may also potentiate the sedative effect of phenothiazines.

Potassium chloride, especially wax-matrix preparations.

Concurrent use with propantheline bromide may increase severity of potassium chloride-induced gastrointestinal lesions.

Urinary alkalisers (e.g. antacids, carbonic anhydrase inhibitors and sodium bicarbonate).

May cause a delay in urinary excretion, therefore potentiating propantheline bromide's therapeutic and/or side effects.

Memantine.

Effects of antimuscarinics possibly enhanced by memantine.

Nitrates.

Antimuscarinics possibly reduce effects of sublingual tablets of nitrates (failure to dissolve under tongue owing to dry mouth).

Domperidone.

Antimuscarinics antagonise effects of domperidone on gastrointestinal activity.

Anti-infectives.

The absorption of nitrofurantoin has been reported to be enhanced.

Parasympathomimetics.

Antimuscarinics antagonise effects of parasympathomimetics.
Excessive cholinergic blockage may occur if propantheline bromide is given concomitantly with antihistamines; Type I antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine); synthetic and semisynthetic anticholinergic agents; belladonna alkaloids; narcotic analgesics e.g. pethidine; phenothiazines, tricyclic antidepressants, MAOIs or tricyclics, synthetic and semi-synthetic antimuscarinic agents or other psychoactive drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
The safe use of propantheline bromide in pregnancy has not been established. Therefore, the use of this drug in women of childbearing potential requires that the benefits be weighed against its possible hazards to mother and foetus.
Australian categorisation definition of Category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
Cohort data on parasympatholytics indicate a possible association with minor malformations. In view of this, Pro-Banthine should not be administered in pregnancy unless considered essential.
 Information regarding the secretion of propantheline bromide in breast milk is limited to uncontrolled data derived from marketing experience. Such experience does not suggest that significant quantities of propantheline bromide are secreted in breast milk, since propantheline bromide is incompletely absorbed from the gastrointestinal tract and has poor lipid solubility. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a breastfeeding woman. Suppression of lactation may occur with anticholinergic drugs.

4.7 Effects on Ability to Drive and Use Machines

Propantheline bromide may produce drowsiness or blurred vision. Patients should be cautioned regarding operating machinery or motor vehicles during treatment with this drug.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects of propantheline bromide are usually dose related and are usually reversible when the therapy is discontinued.
The following adverse effects have been reported:

Cardiovascular.

Palpitations, arrhythmias, bradycardia followed by tachycardia.

Neurological.

Insomnia, drowsiness, dizziness, nervousness, headache, mental confusion, weakness.

Dermatological and hypersensitivity reactions.

Anaphylaxis, urticaria, rashes, allergic dermatitis.

Gastrointestinal.

Bloatedness, nausea, vomiting, constipation.

Genitourinary.

Urinary hesitancy and retention, impotence.

Respiratory.

Reduced bronchial secretions.

Ophthalmic.

Blurred vision, mydriasis, cycloplegia, increased ocular tension, dilation of the pupils with loss of accommodation and sensitivity to light.

Other effects.

Xerostomia (dry mouth), decreased salivary secretions, decreased sweating (anhidrosis), heat stroke, flushing, dryness of the skin, dryness of the mouth, thirst, difficulty in swallowing and talking, loss of the sense of taste, suppression of lactation.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), hyperthermia, circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma. With overdosage, a curare-like action may occur i.e. neuromuscular blockade leading to muscular weakness and possible paralysis. Additionally, a rash may appear on the face or the upper trunk of the body. At high doses, propantheline bromide has some ganglion blocking activity therefore postural hypotension and impotence may occur.

Treatment.

Treatment of overdosage of propantheline bromide consists of symptomatic and supportive therapy. An aqueous slurry of activated charcoal may be administered to decrease drug adsorption. For the reversal of severe overdosage symptoms, an intravenous injection of physostigmine 0.5 to 2 mg is administered, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs).
Excitement of a degree which demands attention may be managed with sodium thiopentone 2% solution given slowly intravenously or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. Adequate hydration is also required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Propantheline bromide is an anticholinergic agent which inhibits neural impulses at the effector sites of the parasympathetic nervous system and at the ganglia of the sympathetic and parasympathetic nervous system with peripheral effects similar to atropine. Propantheline bromide does not readily cross the blood-brain barrier thus avoiding the central effects seen with atropine. Propantheline bromide reduces gastric acid secretion and inhibits gastrointestinal motility and has spasmolytic properties. Other secretions including pancreatic juice, sweat and saliva are reduced.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Single oral doses of 15, 30, 45, 60, 75, 90 mg of propantheline bromide tablets were administered to each of 6 subjects and were rapidly absorbed. The absorption half-life of propantheline bromide was 8-30 minutes, and half-life of elimination between 1.3 and 2.1 hours.
After a single 15 mg oral dose of carbon-14 labelled drug given to a healthy man, 390 nanogram/mL peak plasma concentration of total-14C material is attained at 6 hours.

Distribution.

The distribution of propantheline bromide in the body has not been determined. It appears that it does not readily penetrate the CNS and eye, due to complete ionisation and poor lipid solubility.

Metabolism.

After oral administration to man, propantheline bromide is extensively metabolised primarily by hydrolysis to the inactive materials xanthene-9-carboxylic acid and (2-hydroxyethyl)-diisopropylmethylammonium bromide, approximately half of which occurs in the gastrointestinal tract prior to its absorption. Food appears to substantially decrease the extent of absorption following oral administration.
Average peak plasma concentrations of propantheline bromide after the 15, 30, 45, 60, 75 and 90 mg doses were 6, 29, 81, 62, 148 and 146 nanogram/mL respectively, and were attained within 3 hours of oral dosing. Similarly the average amount of unmetabolised propantheline bromide excreted in the urine was 0.70, 1.08, 1.59, 1.85, 2.42 and 3.06 mg respectively.

Excretion.

Unmetabolised drug represents only a small proportion of the total-14C materials. The plasma half-life of the total-14C material is about 9 hours and approximately 70 percent of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of the intact propantheline is about 5 percent after oral administration and about 20 percent after intravenous administration.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Animal studies to determine the carcinogenic or mutagenic potential of propantheline bromide have not been established. There is no information available on the possible effects of propantheline bromide on human fertility.

6 Pharmaceutical Particulars

6.1 List of Excipients

Pro-Banthine tablets contain lactose monohydrate, purified talc, maize starch, magnesium stearate, and Opadry II complete film coating system 85G63218 Orange.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Pro-Banthine tablets are supplied in HDPE bottles (with child-resistant closures) containing 100 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Propantheline bromide is a white or yellowish-white odourless powder with a very bitter taste. It is very soluble in water, alcohol and chloroform, however is insoluble in ether.
Propantheline bromide is a quaternary ammonium compound with a melting point 157° to 162°C. At relative humidities of more than 50% it is hygroscopic and it is deliquescent above about 90%.

Chemical structure.

The chemical name for propantheline bromide is N-methyl-N,N-bis(1-methylethyl)-2-[(9H-xanthen-9-ylcarbonyl)oxy]ethanaminium bromide. Its structural formula is:
C23H30BrNO3. Molecular weight: 448.40.

CAS number.

CAS No: 50-34-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Medicine.

Summary Table of Changes