Salbutamol/ Ipratropium Bromide
Indications
Registered South African indications:
- Bronchospasm
Cautions
Contraindications
Inhaler
- Hypersensitivity to the active ingredients or any of the excipients in this combination product
- Patients who previously displayed hypersensitivity to soya lecithin or related food products, such as soybean and peanut
- Known hypersensitivity to atropine or its derivatives
- Hypertrophic obstructive cardiomyopathy
- Tachydysrhythmias
- Pregnancy
- Lactation
- Children under 12 years
Solution for inhalation
- Hypersensitivity to the active ingredients or any of the excipients in this combination product
- Known hypersensitivity to atropine or its derivatives
- Hypertrophic obstructive cardiomyopathy
- Tachydysrhythmias
- Children under 12 years
Cautions
- Pregnancy (neb)
- Breastfeeding (neb)
- Diabetes mellitus
- Recent myocardial infarction
- Organic cardiac or vascular disorders
- Hyperthyroidism
- Phaeochromocytoma
- Prostatic hypertrophy
- Bladder outflow obstruction
- Narrow angle glaucoma
- Cystic fibrosis
- Gastrointestinal motility disturbances
- May impair ability to drive and operate machinery
Adult dosage
Forms avail. in SA and covered in this monograph: neb, inh
Relief of bronchospasm associated with chronic obstructive pulmonary disease
Salbutamol/ Ipratropium Bromide
2500/500 (μg/2.5ml)
- Respule (neb): Initial: 1 respule immediately, May be repeated if no relief; Maintenance: 1 respule, 6-8hrly
100/20 (μg)
- Inhaled (inh): 2 inhalations, 6hrly; Max: 12 inhalations/24hrs
Respule: To be used in a nebulizer or intermittent positive pressure ventilator
Paediatric dosage
Paed. forms avail. in SA and covered in this monograph: neb, inh
Relief of bronchospasm associated with chronic obstructive pulmonary disease
Salbutamol/ Ipratropium Bromide
2500/500 (μg/2.5ml)
100/20 (μg)
Younger than 12 years
- Not established for use (see Contraindications)
Older than 12 years
- See adult dosage
Special populations
Pregnancy
Inhaler
- Contraindicated
Solution for inhalation
- Caution
Breastfeeding
Inhaler
- Contraindicated
Solution for inhalation
- Caution
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warnings
Adverse reactions
Central Nervous System Disorders
- Nervousness
- Restlessness
- Memory disorders
- Anxiety
- Depression
- Hyperactivity
- Headache
- Dizziness
- Tremor
Cardiovascular Disorders
- Palpitations
- Tachycardia
- Increased systolic blood pressure
- Arrhythmias
- Reduced diastolic blood pressure
- Peripheral vasodilatation
- Myocardial ischaemia
Respiratory Disorders
- Coughing
- Dysphonia
- Bronchospasm
- Laryngospasm
- Dyspnea
- Paradoxical bronchospasm
Gastrointestinal Disorders
- Dry mouth
- Nausea and vomiting
- Mouth and throat irritation
- Motility disorders
- Dental caries
Genitourinary Disorders
- Urinary retention
Endocrine and Metabolic Disorders
- Hypokalaemia
Musculoskeletal Disorders
- Myalgia
- Muscular cramp
- Muscular weakness
Skin and Subcutaneous Tissue Disorders
- Rash
- Itching
- Urticaria
- Angioedema
Sensory Disorders
- Accommodation disorders
- Pain in the eyes
- Mydriasis
- Increased intraocular pressure
- Closed angle glaucoma
Interactions
- Beta-2 agonists
- Corticosteroids
- Anticholinergics
- Xanthine derivatives
- Beta-blockers
- Monoamine oxidase inhibitors
- Tricyclic antidepressants
- Halogenated hydrocarbons
- Diuretics
- Digoxin
Monitoring
None routine. Specific cases may require
- Serum potassium levels
Mechanism of action
Salbutamol
Salbutamol is a selective beta-2 agonist which acts on the beta-2 adrenoceptors of the bronchial muscle. Stimulation results in relaxation of bronchial smooth muscle in the lungs, resulting in bronchodilation, increased vital capacity, decreased residual volume and reduced airway resistance. Salbutamol has little or no effect on cardiac receptors, but causes uterine smooth muscle relaxation and is thus used to help suppress premature labour.
Ipratropium Bromide
Ipratropium bromide is a quaternary ammonium compound with anticholinergic properties. It inhibits vagally-mediated reflexes by antagonising the action of acetylcholine in bronchial smooth muscle cells, facilitating bronchodilation.
Dosage forms
- Inhaler
- Solution for inhalation
- Unit dose vial for inhalation
Formulation
COMBINATION PREPARATIONS
Salbutamol/Ipratropium Bromide Anhydrous
Inhaler 100μg/20μg
- Duolin HFA (Cipla Medpro)
Nebulising solution U.D.V (per 2.5ml) 2.5mg/0.5mg
- Combivent (Boehringer) originator
- Duolin Respules (Cipla Medpro)
- Sabax Combineb (Adcock)
- Salipra (Medivision)
Nebulising solution U.D.V (per 2.5ml) 3mg/0.5mg
- Co-Iprasal solution (Arrow)
References
1. SAMF_12th Edition_Page 553 2. SmPC: 500 mcg Ipratropium Bromide 3 mg salbutamol sulfate, Boehringer Ingelheim Limited; Last updated on eMC: 29 Jan 2018; Downloaded online 01 Oct 2018 [https://www.medicines.org.uk/emc/product/1423/smpc] 3. SmPC: Salipraneb 0.5mg / 2.5mg per 2.5 ml Nebuliser Solution, Accord-UK Ltd: Last updated on eMC: 24 Aug 2016; Downloaded online 01 Oct 2018 https://www.medicines.org.uk/emc/medicine/32134 (24/08/2016_Actavis_Salipraned_0.5mg/2.5mg per2.5ml_udv) 3.1 PI - Duolin Respules, Cipla medpro - Date of Publication - Oct 2004 [https://drive.google.com/drive/folders/0B0xnChtF7vduVjVoTGE0WmY2c0E?resourcekey=0-1dOqIgJy8zXlmsoKCWBdEA] 4. https://drive.google.com/drive/folders/0B0xnChtF7vduVjVoTGE0WmY2c0E (07/12/2012_Cipla_Duolin_inh) 5. U2D: Ipratropium and albuterol: Drug information, UpToDate; Downloaded online 01 Oct 2018 [https://www.uptodate.com/contents/ipratropium-and-albuterol-drug-information] 6. NAPOS The Drug Database for Acute Porphyria: R03AK04 Salbutamol and other drugs for obstructive airway diseases; Accessed online 01 Oct 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=R03AK04&l=gbr] 7. South African Institute for Drug-Free Sport: Duolin Respules Inhal Solution; Accessed online 01 Oct 2018 [http://www.drugfreesport.org.za/online-medication-check/] 8. Salbutamol monograph; Accessed online 11 Jan 2019 [https://cms.emguidance.com/medicine-edit/60b64482-b284-480d-9e2b-d34fe0ba0c4e] 9. Ipratropium monograph; Accessed online 11 Jan 2019 [https://cms.emguidance.com/medicine-edit/bf1a6563-1588-419e-8561-e957d7d3e9c1] 10. PI - ADCO-COMBINEB, Adcock Ingram Critical Care (Pty) Ltd - Date amended: 19 June 2018 (compliant with regulation 9) - Downloaded online 25 Nov 2024 [https://www.sahpra.org.za/wp-content/uploads/2020/02/Adco-Combineb_PI_Adcock-Ingram_MCC-format-19-June-2018.pdf]
Brands & products
9 products · cached snapshot- Co-Iprasal
- Combivent
- Duolin
- Sabax Combineb
- Salipra
INHInhaler· 2 products
from R139.48| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Combiventdiscontinued | 100 µg;µg | 300 | Ingelheim Pharmaceuticals (Pty) Ltd | R139.48 |
| Duolin HFA Inhaler | 100 µg;µg | 200 | Cipla Medpro (Pty) Ltd | R214.21 |
NEBSolution for inhalation· 6 products
from R399.05| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Co-Iprasal Solution | 3 mg/2.5ml;mg/2.5ml | 2.5 | Teva Pharmaceuticals (Pty) Ltd | R399.05 |
| Sabax Combineb | 3.01 mg/2.5ml;mg/2.5ml | 2.5 | Adcock Ingram Critical Care (Pty) Ltd | R401.08 |
| Iprabut | 2.5 mg/2.5ml;mg/2.5ml | 60 | Pharmacare Limited, Woodmead | R404.71 |
| Salipra | 2.5 mg/2.5ml;mg/2.5ml | 2.5 | Medivision (Pty) Ltd | R427.52 |
| Salipra | 2.5 mg/2.5ml;mg/2.5ml | 2.5 | Medivision (Pty) Ltd | R458.06 |
| Duolin Respules | 2.5 mg/2.5ml;mg/2.5ml | 60 | Cipla Medpro (Pty) Ltd | R587.31 |
UDVUnit dose vial for inhalation· 1 product
from R1167.95| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Combivent U.D.V. | 2.5 mg/2.5ml;mg/2.5ml | 2.5 | Ingelheim Pharmaceuticals (Pty) Ltd | R1167.95 |
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.