Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Contraindications

Children under 12 years
Hypertrophic obstructive cardiomyopathy
Tachyarrhythmia

Precautions and Warnings

Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Cardiac arrhythmias
Cystic fibrosis
Diabetes mellitus
Hyperthyroidism
Hypokalaemia
Hypoxia
Narrow angle glaucoma
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Severe cardiac disorder
Severe vascular disorder

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Do not allow solution or mist to enter eyes
Risk of glaucoma if preparation enters eye
Monitor for development of lactic acidosis
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to report any chest pain
May reduce serum potassium levels
Discontinue if paradoxical bronchospasm occurs
Start treatment at lowest recommended dose
Advise patient on need for adequate dental hygiene & regular dental checks
Advise patient to consult physician if condition worsens / does not improve

Pregnancy and Lactation

Pregnancy

Use salbutamol with ipratropium bromide with caution during pregnancy.

The manufacturer does not recommend the use of salbutamol with ipratropium during pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.

Ipratropium
Available reports indicate no increased risk of teratogenic or developmental effects.
Salbutamol
Inhaled salbutamol is considered a drug of choice for pregnant women (Schaefer 2015).

Salbutamol has not been shown to cause structural abnormalilities but prolonged use of salbutamol during pregnancy has been associated with neurobehavioural toxicity (Briggs, 2015).

Adverse effects seen in both mother and foetus are largely secondary to the drugs cardiovascular and metabolic profile, including tachycardia, hypotension which may lead to foetal distress, cardiac failure, pulmonary oedema and death; hyperglycaemia followed by an increase in serum insulin which is more pronounced in diabetic patients. Other effects reported are: increased growth hormone levels, retinopathy of prematurity and a decreased incidence of neonatal respiratory distress syndrome.

Lactation

Use salbutamol with ipratropium bromide with caution during breastfeeding.

The manufacturer notes that this medication should not be administered to breastfeeding mothers unless the expected benefit is thought to outweigh any possible risk to the neonate.

Ipratropium
The presence of ipratropium in human breast milk is unknown.

Salbutamol
Inhaled salbutamol is likely to be present in human breast milk.

Side Effects

Anaphylactic reaction
Angioedema of tongue, lips and face
Anxiety
Arrhythmias
Asthenia
Atrial fibrillation
Blood pressure changes
Blurred vision (transient)
Bronchospasm (paradoxical)
Conjunctival hyperaemia
Constipation
Corneal oedema
Cough
Depression
Diarrhoea
Disturbances in accommodation
Dizziness
Dry mouth
Dry throat
Dysphonia
Dyspnoea
Fine tremor
Gastro-intestinal motility disturbances
Glaucoma (closed angle)
Headache
Hyperactivity in children
Hyperhidrosis
Hypersensitivity reactions
Hypokalaemia
Increase in dental caries
Increased intra-ocular pressure
Lactic acidosis
Laryngospasm
Loss of mental acuity
Memory disturbances
Mouth irritation
Mouth swelling
Muscle spasm
Myalgia
Mydriasis
Myocardial ischaemia
Nausea
Nervousness
Ocular pain
Palpitations
Peripheral vasodilatation
Pharyngeal oedema
Pruritus
Rash
Restlessness
Skin reactions
Stomatitis
Supraventricular tachycardia
Tachycardia
Throat irritation
Urinary retention
Urticaria
Visual haloes
Vomiting
Weakness

Presentation

Solution for nebulisation containing salbutamol with ipratropium

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Dosage

Adults

Children

Contraindications

Children under 12 years
Hypertrophic obstructive cardiomyopathy
Tachyarrhythmia

Precautions and Warnings

Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Cardiac arrhythmias
Cystic fibrosis
Diabetes mellitus
Hyperthyroidism
Hypokalaemia
Hypoxia
Narrow angle glaucoma
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Severe cardiac disorder
Severe vascular disorder

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Do not allow solution or mist to enter eyes
Risk of glaucoma if preparation enters eye
Monitor for development of lactic acidosis
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to report any chest pain
May reduce serum potassium levels
Discontinue if paradoxical bronchospasm occurs
Start treatment at lowest recommended dose
Advise patient on need for adequate dental hygiene & regular dental checks
Advise patient to consult physician if condition worsens / does not improve

Pregnancy and Lactation

Pregnancy

Use salbutamol with ipratropium bromide with caution during pregnancy.

The manufacturer does not recommend the use of salbutamol with ipratropium during pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.

Ipratropium
Available reports indicate no increased risk of teratogenic or developmental effects.
Salbutamol
Inhaled salbutamol is considered a drug of choice for pregnant women (Schaefer 2015).

Salbutamol has not been shown to cause structural abnormalilities but prolonged use of salbutamol during pregnancy has been associated with neurobehavioural toxicity (Briggs, 2015).

Adverse effects seen in both mother and foetus are largely secondary to the drugs cardiovascular and metabolic profile, including tachycardia, hypotension which may lead to foetal distress, cardiac failure, pulmonary oedema and death; hyperglycaemia followed by an increase in serum insulin which is more pronounced in diabetic patients. Other effects reported are: increased growth hormone levels, retinopathy of prematurity and a decreased incidence of neonatal respiratory distress syndrome.

Lactation

Use salbutamol with ipratropium bromide with caution during breastfeeding.

The manufacturer notes that this medication should not be administered to breastfeeding mothers unless the expected benefit is thought to outweigh any possible risk to the neonate.

Ipratropium
The presence of ipratropium in human breast milk is unknown.

Salbutamol
Inhaled salbutamol is likely to be present in human breast milk.

Side Effects

Anaphylactic reaction
Angioedema of tongue, lips and face
Anxiety
Arrhythmias
Asthenia
Atrial fibrillation
Blood pressure changes
Blurred vision (transient)
Bronchospasm (paradoxical)
Conjunctival hyperaemia
Constipation
Corneal oedema
Cough
Depression
Diarrhoea
Disturbances in accommodation
Dizziness
Dry mouth
Dry throat
Dysphonia
Dyspnoea
Fine tremor
Gastro-intestinal motility disturbances
Glaucoma (closed angle)
Headache
Hyperactivity in children
Hyperhidrosis
Hypersensitivity reactions
Hypokalaemia
Increase in dental caries
Increased intra-ocular pressure
Lactic acidosis
Laryngospasm
Loss of mental acuity
Memory disturbances
Mouth irritation
Mouth swelling
Muscle spasm
Myalgia
Mydriasis
Myocardial ischaemia
Nausea
Nervousness
Ocular pain
Palpitations
Peripheral vasodilatation
Pharyngeal oedema
Pruritus
Rash
Restlessness
Skin reactions
Stomatitis
Supraventricular tachycardia
Tachycardia
Throat irritation
Urinary retention
Urticaria
Visual haloes
Vomiting
Weakness

Effects on Laboratory Tests

Use of salbutamol with ipratropium bromide may cause a positive doping test.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Combiprasal 0.5mg / 2.5mg nebuliser solution. TriOn Pharma Ltd. Revised December 2019.

Summary of Product Characteristics: Combivent UDVs. Boehringer Ingelheim Limited. Revised September 2015.

Summary of Product Characteristics: Ipramol Steri-Neb 0.5 mg / 2.5 mg pre 2.5ml Nebuliser Soluiton. Ivax Pharmaceuticals UK. Revised April 2010.

Summary of Product Characteristics: Salipraneb 0.5mg/2.5mg per 2.5ml Nebuliser Solution. Actavis UK Ltd. Revised March 2016.