1. Disclaimer
The information provided in this report is intended solely for educational and professional reference purposes and is not a substitute for medical advice, diagnosis, or treatment. Clinical decisions must always be based on the official prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
⚠️ Critical Contextual Note:
The primary source document for BRONCHOPHANE® Syrup (EIPICO leaflet, revision June 2011) is significantly outdated and reflects older polypharmacy practices that are no longer aligned with modern international guidelines, particularly due to the inclusion of ephedrine. This commentary integrates historical data with current pharmacological understanding for educational purposes only.
2. Summary
BRONCHOPHANE® Syrup is a multi-ingredient cough and cold combination containing an expectorant, antitussive, first-generation antihistamine, and a sympathomimetic bronchodilator/decongestant. It was historically used for the symptomatic relief of cough associated with bronchitis and upper respiratory tract infections.
From a modern clinical perspective, this formulation represents an outdated approach to cough management. The inclusion of ephedrine, in particular, raises significant safety concerns, and the overall risk–benefit profile is unfavorable compared with current single-agent or non-pharmacological alternatives.
3. Brand Name
BRONCHOPHANE® Syrup
Availability and current marketing status should be verified with the manufacturer or the Egyptian Drug Authority (EDA).
4. Category
- Therapeutic Class: Cough and Cold Preparations
- Pharmacological Class:
- Antitussive
- Expectorant
- First-generation Antihistamine
- Sympathomimetic Bronchodilator/Decongestant
- Modern Classification: Obsolete combination cough/cold product
5. Active Ingredients
Each 5 mL of syrup contains:
- Guaifenesin – 50 mg
- Ephedrine Hydrochloride – 7.5 mg
- Diphenhydramine Hydrochloride – 5 mg
- Dextromethorphan Hydrobromide – 4.58 mg
6. Pharmaceutical Form & Strength
- Dosage Form: Oral syrup
- Strength: Fixed-dose combination (as above, per 5 mL)
- Pack Size: 125 mL bottle
- Excipients (not exhaustive): Sucrose, sorbitol, propylene glycol, sodium benzoate, flavoring agents, purified water
Clinical Note: Contains sugars and alcohol-related excipients, relevant for diabetic, pediatric, and hepatic-risk patients
7. Manufacturer & Marketing Authorization Holder
Egyptian International Pharmaceutical Industries Co. (EIPICO)
Tenth of Ramadan City, Industrial Area – Egypt
Leaflet revision date: June 2011
Current authorization status should be confirmed with official regulatory sources.
8. Mechanism of Action
- Guaifenesin: Increases hydration of bronchial secretions, reduces mucus viscosity, and facilitates expectoration.
- Ephedrine: Non-selective α- and β-adrenergic agonist producing bronchodilation and nasal vasoconstriction, with systemic cardiovascular and CNS stimulation.
- Diphenhydramine: H1-receptor antagonist with anticholinergic, sedative, and mild antitussive effects.
- Dextromethorphan: Centrally acting antitussive that suppresses the medullary cough center.
Modern View: Combining these agents offers no proven superiority over targeted therapy and significantly increases adverse-effect risk.
9. Spectrum of Activity
Symptomatic relief of cough, congestion, bronchospasm, and allergic symptoms
❌ No antibacterial, antiviral, or anti-inflammatory disease-modifying activity
10. Pharmacokinetics
- Absorption: All components are well absorbed orally
- Distribution: Diphenhydramine and dextromethorphan cross the blood–brain barrier
- Metabolism: Predominantly hepatic; CYP2D6 plays a key role (dextromethorphan)
- Elimination: Mainly renal (unchanged drug and metabolites)
- Onset of Action: Approximately 30–60 minutes
11. Indications
Historical indications (per 2011 leaflet):
- Acute and chronic bronchitis
- Asthmatic bronchitis
- Cough associated with the common cold
Current clinical interpretation:
These indications are no longer supported for this combination under modern evidence-based guidelines.
12. Administration
Route: Oral use only
Dosage (historical):
- Adults: 5–10 mL, 3–4 times daily
- Children (>6 years): 2.5 mL, 3–4 times daily
- Children 2–6 years: Only under strict medical supervision
⚠️ Modern guidelines discourage routine use of cough/cold combinations in children.
13. Method of Preparation
Ready-to-use oral syrup
Shake well before use
14. Contraindications
- Hypersensitivity to any component
- Concomitant use of MAO inhibitors or within 14 days of discontinuation
- Severe cardiovascular disease or uncontrolled hypertension
- Porphyria
- Narrow-angle glaucoma
- Prostatic hypertrophy with urinary retention
- Children under 2 years of age
- Pregnancy and lactation (relative to absolute, depending on component)
15. Warnings & Precautions
- Ephedrine: Risk of hypertension, arrhythmias, myocardial infarction, stroke, CNS stimulation, and dependence
- Diphenhydramine: Sedation, anticholinergic effects, confusion (especially in elderly)
- Dextromethorphan: Risk of serotonin syndrome and abuse at high doses
- Avoid driving or operating machinery
- Not intended for chronic or persistent cough
16. Drug Interactions
- MAO inhibitors: Severe hypertensive crisis (absolute contraindication)
- SSRIs/SNRIs/TCAs: Serotonin syndrome risk
- Alcohol and CNS depressants: Additive sedation and respiratory depression
- Antihypertensives: Reduced efficacy due to ephedrine
- Other sympathomimetics: Increased cardiovascular toxicity
17. Side Effects
Common:
- Drowsiness, dizziness
- Dry mouth, constipation
- Nausea, headache
Serious:
- Hypertension, palpitations, arrhythmias
- CNS excitation, hallucinations, seizures
- Respiratory depression (especially in overdose or children)
18. Use in Special Populations
- Pregnancy: Avoid; ephedrine poses maternal and fetal risks
- Lactation: Not recommended; risk of infant sedation and toxicity
- Pediatrics: Contraindicated <2 discouraged="" li="" years="">
- Elderly: High risk of sedation, falls, anticholinergic and cardiac effects
19. Storage Conditions
- Store below 30°C
- Protect from light and moisture
- Keep tightly closed and out of reach of children
20. Additional Sections
Regulatory & Clinical Perspective:
Ephedrine-containing cough combinations have been withdrawn or restricted in many countries due to serious safety concerns. This product reflects an older therapeutic philosophy no longer recommended in routine practice.
21. Frequently Asked Questions (FAQ)
Q: Does BRONCHOPHANE® treat infection?
A: No. It provides symptomatic relief only.
Q: Does it cause drowsiness?
A: Yes, mainly due to diphenhydramine.
Q: Is it suitable for children?
A: Modern guidelines advise against its use in young children due to safety concerns.
22. References
- EIPICO. BRONCHOPHANE® Syrup Product Leaflet, Revision June 2011.
- Goodman & Gilman’s The Pharmacological Basis of Therapeutics.
- Martindale: The Complete Drug Reference.
- WHO Model List of Essential Medicines (latest edition).
- American Academy of Pediatrics – Cough and Cold Medication Guidance.
