Summary of Product Characteristics (SmPC) - Ipratropium Steri-neb 250 micrograms/ml nebuliser solution
1 NAME OF THE MEDICINAL PRODUCT
Ipratropium 250 mcg/ml Steri-Neb
Ipratropium 500 mcg/2ml Steri-Neb
Steri-Neb Ipratropium 250 mcg/ml
Ipratropium Unit Dose Nebuliser Solution 250 micrograms /1ml (Ipratropium Steri-Neb) Ipratropium Unit Dose Nebuliser Solution 500 micrograms /2ml (Ipratropium Steri-Neb) Ipratropium Steri-Neb 250 micrograms/ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ipratropium Bromide Ph. Eur. 0.025% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sterile solution for nebulisation
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of reversible airways obstruction.
4.2 Posology and method of administration
Administration is by means of a power-operated nebuliser.
Adults (including the elderly): 0.4-2.0 ml solution (100-500 micrograms) up to four times daily.
Children: 0.4-2.0 ml solution (100-500 micrograms) up to three times daily. If dilution is required sterile sodium chloride 0.9% should be used e.g. Saline Steri-Neb.
Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended.
Only specialists in respiratory medicine should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents.
Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult.
Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed nebulised medication.
4.3 Contraindications
Hypersensitivity to the active substance, atropine or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Use of the nebuliser solution should be subject to close medical supervision during initial dosing. There have been rare reports of paradoxical bronchospasm associated with the administration of nebulised solutions of Ipratropium Bromide. The patient should be advised to seek medical advice should a reduced response become apparent.
Patients must be instructed in the correct administration of the nebuliser solution and be warned not to allow the solution or mist to enter the eyes. Caution is advised in patients with glaucoma. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow angle glaucoma. Should any of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Anticholinergic agents can precipitate acute urinary retention in patients with prostatic hypertrophy should sufficient plasma concentrations be achieved. However, urinary retention has rarely been reported. Nevertheless, caution is advised in patients with prostatic hypertrophy.
Patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ipratropium, as with other anticholinergics, should be used with caution in these patients.
4.5 Interaction with other medicinal products and other forms of interaction
There is evidence that the administration of ipratropium with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
The chronic co-administration of ipratropium with other anticholinergic drugs is not recommended
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see section Special warnings and precautions for use) may be increased when nebulised ipratropium bromide and beta2-agonists are administered simultaneously.
4.6 Fertility, pregnancy and lactation
Animal teratology and reproduction studies have demonstrated no adverse effects. The safety of Ipratropium Bromide in human pregnancy has not been established. As with all medicines, Ipratropium Bromide 250 mcg/ml Steri-Neb should not be used in pregnancy, especially in the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.
Lactation
It is not known to what extent Ipratropium Bromide passes into breast milk. The product should not be administered to nursing mothers unless considered essential by the physician.
Fertility
Clinical data on fertility are not available for ipratropium bromide. Nonclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see section 5.3).
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Anticholinergic side effects are unlikely at therapeutic doses but some patients may complain of a dry mouth. Urinary retention and constipation have rarely been reported. No adverse effect on bronchial secretion has been shown within the therapeutic range.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Ipratropium Bromide.
Summary of the safety profile
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Tabulated summary of adverse reactions
The following adverse reactions have been reported during use of Ipratropium Bromide in clinical trials and during the post-marketing experience.
Frequencies
Very common ≥ 1/10
Common ≥ 1/100 < 1/10
Uncommon ≥ 1/1,000 < 1/100
Rare ≥ 1/10,000 < 1/1,000
Very rare < 1/10,000
MedDRA System Organ Class Adverse reaction | Frequency |
| Immune system disorders | |
| Hypersensitivity | Uncommon |
| Anaphylactic reaction | Uncommon |
| Angioedema of tongue, lips & face | Uncommon |
| Nervous system disorders | |
| Headache | Common |
| Dizziness | Common |
| Eye disorders | |
| Blurred vision | Uncommon |
| Mydriasis (1) | Uncommon |
| Intraocular pressure increased (1) | Uncommon |
| Glaucoma (1) | Uncommon |
| Eye pain (1) | Uncommon |
| Halo vision | Uncommon |
| Conjunctival hyperaemia | Uncommon |
| Corneal oedema | Uncommon |
| Accommodation disorder | Rare |
| Cardiac disorders | |
| Palpitations | Uncommon |
| Supraventricular tachycardia | Uncommon |
| Atrial fibrillation | Rare |
| Heart rate increased | Rare |
| Respiratory, thoracic and mediastinal disorders | |
| Throat irritation | Common |
| Cough | Common |
| Bronchospasm | Uncommon |
| Paradoxical bronchospasm(3) | Uncommon |
| Laryngospasm | Uncommon |
| Pharyngeal oedema | Uncommon |
| Dry throat | Uncommon |
| Gastrointestinal disorders | |
| Dry mouth | Common |
| Nausea | Common |
Gastro-intestinal motility disorder e.g. Diarrhoea Constipation | Common |
| Uncommon Uncommon | |
| Vomiting | Uncommon |
| Stomatitis | Uncommon |
| Skin and subcutaneous tissue disorders | |
| Rash | Uncommon |
| Pruritus | Uncommon |
| Urticaria | Rare |
| Renal and urinary disorders | |
| Urinary retention(2) | Uncommon |
(1) ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes – see section 4.4.
(2) the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.
(3) as with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. Ipratropium Bromide 250 mcg/ml Steri-Neb should be discontinued immediately, the patient assessed and, if necessary, alterative treatment instituted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Inhaler doses of 5 mg produced an increase in heart rate with palpitations but single doses of 2 mg in adults and 1 mg in children did not cause side effects. Single oral doses of Ipratropium Bromide 30 mg caused anticholinergic side effects but these were not severe and did not require treatment.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ipratropium Bromide is a competitive muscarinic acetyl choline receptor antagonist selective for bronchial receptors.
5.2 Pharmacokinetic properties
The plasma half life following in-vivo administration is 3.6 hours. After in- vivo dosing approximately 70% is excreted in the urine.
Ipratropium has a wide therapeutic range and only a small amount of drug is absorbed following inhalation of high therapeutic doses (0.5 mg). Hence, the altered pharmacokinetics which may be present in patients with renal or hepatic impairment, or in elderly patients, is not likely to be clinically significant. Therefore, no special dosage recommendations are required in these populations.
5.3 Preclinical safety data
There were no adverse findings in toxicology or carcinogenicity studies in animals dosed by the inhaled, oral or intravenous routes. The compound does not exhibit any mutagenic potential. There was no evidence of teratogenic or fertility effects in studies in mice, rabbits and rats.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Chloride
IM Hydrochloric acid q.s. to pH 3.4
Water for Injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened container: 24 months.
Diluted solution: not applicable.
Opened container: not applicable.
6.4 Special precautions for storage
Store at a temperature not exceeding 25°C. Protect from light.
6.5 Nature and contents of container
Unit dose, blow moulded, hermetically sealed ampoule made form low density polyethylene. Strips of 5 Steri-Nebs are packed into foil laminate pouches, which in turn are packed into boxes containing 20 and 100 (Steri-Nebs).
Contents: 1 ml or 2 ml solution.
6.6 Special precautions for disposal
(i) Prepared the nebuliser for use.
(ii) Remove a Steri-Neb from the strip by twisting and puffing. (iii) Hold the Steri-Neb upright and twist off the cap, transfer the contents to the reservoir of the nebuliser.
(iv) Use the nebuliser according to the manufacturer’s instructions. (v) After use throw away any remaining solution and clean the nebuliser. Do not allow the solution for nebulisation, or the mist, to enter the eyes.
7 MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK Ridings Point
Whistler Drive
Castleford
West Yorkshire
WF10 5HX
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00530/0694
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st January 2004
10 DATE OF REVISION OF THE TEXT
11/01/2023