Consumer medicine information

DBL Hyoscine Injection BP

Hyoscine hydrobromide

BRAND INFORMATION

Brand name

DBL Hyoscine Injection BP

Active ingredient

Hyoscine hydrobromide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Hyoscine Injection BP.

What is in this leaflet

This leaflet answers some common questions about DBL™ Hyoscine Injection BP (hyoscine). It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Hyoscine Injection BP against the benefits this medicine is expected to have for you.

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

Keep this leaflet in a safe place. You may need to read it again.

What DBL™ Hyoscine Injection BP is used for

DBL™ Hyoscine Injection BP is used before surgery to make you drowsy and forgetful, and to reduce the amount of saliva and some fluids you produce in your lungs. It is also used to treat nausea and vomiting from motion sickness.

Hyoscine works by acting directly on your brain, salivary glands and air passages to reduce nerve impulses and slow down the activity of these areas.

Your doctor may have prescribed DBL™ Hyoscine Injection BP for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you are given DBL™ Hyoscine Injection BP

When you must not be given it

DBL™ Hyoscine Injection BP should not be given to you if:

  • you have an allergy to Hyoscine.
    Some of the symptoms of an allergic reaction to hyoscine may include skin rash, itching, difficulty breathing and swelling, especially of the face and throat.
  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.
    If you are given this medicine after the expiry date has passed, it may not work as well.
  • you have, or have ever had, any of the following medical conditions:
    - glaucoma, a disorder where there is a build-up of pressure in the eye.
    - gut problems such as pyloric obstruction, paralytic ileus or inflammatory bowel disease
    - enlarged prostate gland (if you are male)
    - difficulty passing urine
    - increased heart rate due to thyroid problems or heart failure.

Before you are given it

Your doctor must know about all the following before you are given DBL™ Hyoscine Injection BP:

  1. if you have or have ever had any other health problems or medical conditions, including:
  • a fever
  • heart problems
  • liver problems
  • kidney problems
  • thyroid problems
  1. if you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of you being given DBL™ Hyoscine Injection BP during pregnancy.
  2. if you are breast-feeding or plan to breast-feed
    Your doctor will discuss the risks and benefits of you being given DBL™ Hyoscine Injection BP when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Hyoscine Injection BP.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with DBL™ Hyoscine Injection BP. These include:

  • antihistamines; medicines used to treat hayfever or allergy such as promethazine or pheniramine
  • antidepressants; medicines used to treat depression such as, amitryptiline, mianserin or phenelzine
  • Monoamine Oxidase (MAO) inhibitors, medicines used to treat depression
  • medicines used to treat gut problems such as spasm and travel sickness, eg atropine
  • medicines used to treat anxiety or to help you sleep
  • some medicines used to treat mood/thought disorders, such as schizophrenia, eg chlorpromazine, fluphenazine.
  • belladonna, used to treat cramp or spasms
  • cyclopropane
  • procainamide, used to treat some heart conditions

These medicines may be affected by DBL™ Hyoscine Injection BP, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while you are being given Hyoscine Injection BP.

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

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

How it is given

Hyoscine Injection BP can be given in three ways:

  • as an injection into a vein
  • as a deep injection into a large muscle
  • as an injection under the skin.

DBL™ Hyoscine Injection BP must only be given by a doctor, nurse or other trained person.

How much is given

Your doctor will decide what dose of DBL™ Hyoscine Injection BP you will receive and how long you need to receive it for. This depends on your medical condition and other factors, such as your age.

Sometimes only a single dose of DBL™ Hyoscine Injection BP is required.

If you take too much (overdose)

As DBL™ Hyoscine Injection BP is given to you under the supervision of your doctor it is unlikely that you will receive an overdose. However, if you experience severe side effects, tell your doctor immediately, contact the Poisons Information Centre (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at the nearest hospital, You may need urgent medical attention.

Symptoms of a hyoscine overdose include the side effects listed below in the “Side Effects” section, but are usually of a more severe nature.

While you are being given DBL™ Hyoscine Injection BP

Things you must do

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Things to be careful of

Be careful driving or operating machinery until you know how DBL™ Hyoscine Injection BP affects you. Hyoscine may cause dizziness, drowsiness or sleepiness in some people and affect their alertness.

If this occurs, do not drive, operate machinery or do things that could be dangerous if you are not alert.

Children should be careful when riding bicycles or climbing trees

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Hyoscine Injection BP.

DBL™ Hyoscine Injection BP may have unwanted side-effects in a few people. All medicines can 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.

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

Ask your doctor or pharmacist to answer any questions you may have.

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

  • blurred vision or other eye problems, including eye pain
  • mood or mental changes, such as nervousness, anxiety, confusion, paranoia or irritability
  • weakness, drowsiness, restlessness or dizziness
  • unco-ordination or disorientation
  • memory loss
  • hallucinations
  • difficulty urinating
  • dry mouth
  • rashes or skin redness, especially at the site of injection
  • irregular, fast or slow heartbeat
  • difficulty breathing

Some people may get other side effects while being given DBL™ Hyoscine Injection BP.

After being given DBL™ Hyoscine Injection BP

Storage

DBL™ Hyoscine Injection BP should be kept in a cool dry place where the temperature stays below 25°C, and should be protected from light.

Product description

What it looks like

DBL™ Hyoscine Injection BP is a clear, colourless to straw coloured solution.

Ingredients

DBL™ Hyoscine Injection BP contains hyoscine hydrobromide and water for injection.

It does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

DBL™ Hyoscine Injection BP is supplied by:

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

DBL™ Hyoscine Injection BP is available in the following presentation:

  • 400 micrograms /1 mL amp x5 AUST R 16347

This leaflet was prepared in September 1998 and reviewed in October 2019.

Published by MIMS December 2019

BRAND INFORMATION

Brand name

DBL Hyoscine Injection BP

Active ingredient

Hyoscine hydrobromide

Schedule

S4

 

1 Name of Medicine

Hyoscine hydrobromide BP.

2 Qualitative and Quantitative Composition

Each mL contains 0.4 mg of hyoscine hydrobromide trihydrate in Water for Injections. The pH of the solution is between 3.8 and 4.2.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Hyoscine Injection BP is a clear, colourless to straw coloured, sterile solution of hyoscine hydrobromide.3H2O in Water for Injections.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Hyoscine Injection BP is indicated as a preoperative medication to produce sedation and amnesia. It is also used preoperatively to inhibit salivation and excessive secretions of the respiratory tract.
Hyoscine hydrobromide is also indicated for the treatment of selected cases of nausea and vomiting resulting from motion sickness, although oral or transdermal administration is more frequently used for this indication.

4.2 Dose and Method of Administration

Dosage.

Adult dose.

The usual adult dose is 0.3 to 0.6 mg given IM, SC, or IV. This dose may be repeated 3 to 4 times a day. When used as an antiemetic, doses up to 1 mg have been administered. A reduced dosage may be required in elderly or debilitated patients or those with hepatic or renal insufficiency.

Paediatric dose.

The usual paediatric dose is 6 microgram/kg body weight, or 200 microgram/m2 surface area, IM, SC, or IV.

Method of administration.

DBL Hyoscine Injection BP is administered by the intramuscular, subcutaneous or intravenous injection. When given intravenously, the drug should be diluted with sterile water for injection and injected slowly with caution.
When used for preoperative medication, hyoscine hydrobromide should be administered 30 to 60 minutes prior to induction of anaesthesia.

Compatibilities.

For intravenous injection hyoscine hydrobromide should be diluted in sterile water for injection.

4.3 Contraindications

DBL Hyoscine Injection BP is contraindicated in patients hypersensitive to hyoscine hydrobromide.
Hyoscine hydrobromide is also contraindicated in patients with glaucoma or a predisposition to glaucoma, since its effects on the eye can precipitate this condition.
Hyoscine hydrobromide is also contraindicated in patients with pyloric obstruction, paralytic ileus, and in patients with prostatic hypertrophy or urinary bladder neck obstruction, since it may lead to urinary retention in these patients.
Hyoscine hydrobromide is also contraindicated in patients with tachycardia secondary to thyrotoxicosis or cardiac insufficiency, since hyoscine hydrobromide may exacerbate the tachycardia.

4.4 Special Warnings and Precautions for Use

Hyoscine hydrobromide may impair mental alertness, physical co-ordination or visual acuity.
Potentially alarming idiosyncratic reactions may develop following the use of therapeutic doses of hyoscine hydrobromide.
Hyoscine hydrobromide should be administered with caution in patients with fever, since reduction in sweating may inhibit heat loss and lead to hyperpyrexia.
Hyoscine hydrobromide should be administered with caution in patients undergoing cardiac surgery, and in patients with cardiac disease, since the transient increase in heart rate which may be caused by hyoscine hydrobromide may be undesirable in these circumstances.
Hyoscine hydrobromide should also be administered with caution in patients with impaired metabolic, hepatic or renal function, since adverse CNS effects are more likely to occur in these groups.

Use in the elderly.

Hyoscine hydrobromide should also be administered with caution in elderly patients, since CNS effects are more likely to occur.

Paediatric use.

Hyoscine hydrobromide should be administered with caution in children, since children are particularly susceptible to the adverse effects of belladonna alkaloids.
Care should be taken in titrating the dose of hyoscine hydrobromide in children as they are more likely than adults to experience adverse events.

Effects on laboratory tests.

Gastric acid secretion test.

Administration of cholinergics including hyoscine hydrobromide is not recommended in the 24 hours prior to the test since anticholinergics may antagonize the effects of the drugs used in the evaluation of gastric acid secretory function.

Neuroradiological tests.

Mydriasis and cycloplegia may affect the results of neuroradiological tests for intracranial neoplasm, subdural haematoma or aneurysm.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticholinergic agents.

Concurrent use of hyoscine hydrobromide and anticholinergic agents may result in an intensification of the anticholinergic effect.

Antihistamines.

Concurrent use of hyoscine hydrobromide and antihistamines possessing anticholinergic effects may result in an intensification of the anticholinergic effect. Concurrent use of hyoscine hydrobromide and antihistamines possessing CNS depression effects may result in a potentiation of the CNS depression and increased sedation.

Belladonna alkaloids.

Concurrent use of hyoscine hydrobromide and belladonna alkaloids may result in an intensification of the anticholinergic effect.

CNS depression producing medications.

Concurrent administration of hyoscine hydrobromide and drugs producing CNS depression may result in potentiation of the CNS depression, and increased sedation.

Cyclopropane.

Concurrent administration of hyoscine hydrobromide and cyclopropane may result in ventricular arrhythmias.

Monoamine oxidase (MAO) inhibitors.

Concurrent use of hyoscine hydrobromide and MAO inhibitors possessing anticholinergic effects may result in an intensification of the anticholinergic effect. Concurrent use of hyoscine hydrobromide and MAO inhibitors possessing CNS depression effects may result in a potentiation of the CNS depression and increased sedation.

Oral medications.

Since hyoscine hydrobromide decreases gastrointestinal tone and gastric secretions, it may affect the absorption of oral medications.

Phenothiazines.

Concurrent use of hyoscine hydrobromide and phenothiazines possessing anticholinergic effects may result in an intensification of the anticholinergic effect. Concurrent use of hyoscine hydrobromide and phenothiazines possessing CNS depression effects may result in a potentiation of the CNS depression and increased sedation.

Procainamide.

Concurrent use of procainamide and hyoscine hydrobromide may result in additive antivagal effects on AV node conduction.

Tricyclic antidepressants.

Concurrent use of hyoscine hydrobromide and tricyclic antidepressants possessing anticholinergic effects may result in an intensification of the anticholinergic effect. Concurrent use of hyoscine hydrobromide and tricyclic antidepressants possessing CNS depression effects may result in a potentiation of the CNS depression and increased sedation.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
ADEC Category B2 includes drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increased frequency of malformations 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 fetal damage.

Labour.

Parenteral administration of hyoscine hydrobromide before the onset of labour may cause CNS depression in the neonate and may contribute to neonatal haemorrhage due to reduction in vitamin K dependent clotting factors in the neonate.
 Small quantities of hyoscine hydrobromide may be excreted into breast milk. Hyoscine hydrobromide may also inhibit lactation. Therefore hyoscine hydrobromide is not recommended for use during lactation.

4.7 Effects on Ability to Drive and Use Machines

Patients should be warned against activities such as driving a car or operating machinery whilst affected by hyoscine hydrobromide.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular system.

Bradycardia (at low doses), initial tachycardia followed by bradycardia (at higher doses), hypotension, arrhythmia.

Central nervous system.

Sedation, drowsiness, irritability, disorientation, hallucinations, impairment of memory and concentration, dizziness, confusion, tremor, acute toxic psychosis, restlessness, delirium, excitement.
Symptoms of CNS depression predominate at therapeutic doses. Symptoms of CNS stimulation predominate at higher doses, and at therapeutic doses in the presence of pain.

Gastrointestinal.

Dry mouth, constipation, nausea, vomiting.

Genitourinary system.

Difficulty in urinating.

Ocular.

Blurred vision, mydriasis, closed angle glaucoma.

Skin and appendages.

Rashes, erythema, redness or irritation at injection site.

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

Clinical features.

Symptoms associated with overdosage of hyoscine hydrobromide include CNS stimulation (restlessness, confusion, excitement, incoordination, disorientation, memory disturbances, hallucinations, paranoid and psychotic reactions), tachycardia, hyperpyrexia, blurred vision, mydriasis, rapid respiration or respiratory difficulties.
Severe overdosage may cause coma, respiratory depression, cardiac arrhythmia, and may result in death.

Treatment.

Treatment of overdose involves the following measures.
Symptomatic and supportive therapy.
Diazepam or other short acting benzodiazepine or barbiturate may be given to control CNS stimulation.
If hyperthermia occurs, dissipation of heat should be undertaken (i.e. by cold baths).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia), 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Hyoscine is a belladonna alkaloid. Hyoscine hydrobromide is a tertiary amine antimuscarinic agent, which competitively antagonizes acetylcholine. The main pharmacologic actions of hyoscine hydrobromide are a decrease in the production of salivary, bronchial and sweat gland secretions, dilated pupils (mydriasis), paralysis of accommodation (cycloplegia), a decrease in micturition, a decrease in gastrointestinal tone and gastric secretion, and bradycardia, although transient tachycardia may be observed at higher doses.
The effects of hyoscine hydrobromide differ from those of atropine in that hyoscine hydrobromide has a more potent effect on the iris, ciliary body and some secretory glands than atropine, and a less potent effect on the heart, intestine and bronchial muscle. Its effect on the gastrointestinal tract have lead to its use as an antispasmodic in irritable bowel syndrome. Unlike atropine, hyoscine hydrobromide usually produces CNS depression at therapeutic doses, although CNS stimulation occurs at higher doses, and may also occur when hyoscine hydrobromide is used in the presence of pain. Hyoscine hydrobromide does not usually produce the increased respiration rate or blood pressure observed with atropine administration.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Hyoscine hydrobromide is rapidly absorbed after intramuscular or subcutaneous administration. It is reported to cross the placenta, and also crosses the blood brain barrier. After intramuscular administration, the onset of action is approximately 30 minutes and the duration of action is approximately 4 hours. Hyoscine hydrobromide is almost completely metabolized in the liver, and excreted in the urine, although it is reported that small amounts are excreted in the breast milk.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Hyoscine hydrobromide is reported to be incompatible with alkalies, and with methohexitone sodium.

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. Protect from light.

6.5 Nature and Contents of Container

Strength: 0.4 mg/mL. Pack size: 5 x 1 mL. Code: 8251B. ARTG number: AUST R 16347.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The molecular formula of hyoscine hydrobromide is C17H21NO4.HBr.3H2O. Its molecular weight is 438.3.

Chemical structure.


CAS number.

6533-68-2.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes