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The information provided in this commentary is intended for educational and professional reference only. It does not replace medical judgment, official product information, or regulatory guidance. Product availability, indications, and safety recommendations may vary by country and may have changed since the original source document.
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2. Summary
Osipect® Syrup is a fixed-dose combination cough preparation containing an expectorant (guaifenesin), a β₂-adrenergic bronchodilator (terbutaline sulfate), a first-generation antihistamine (diphenhydramine HCl), and potassium citrate. Historically, it was used for symptomatic relief of productive and non-productive cough associated with bronchospasm and respiratory congestion.
From a modern evidence-based perspective, such multi-ingredient cough syrups are generally discouraged, especially in children, due to:
- Limited proof of clinical benefit
- Increased risk of adverse effects
- Availability of safer, targeted alternatives
3. Brand Name
Osipect® Syrup
4. Category
- Cough and Cold Preparations
- Fixed-Dose Combination (Expectorant / Bronchodilator / Antihistamine)
5. Active Ingredients
Each 5 mL (one teaspoonful) contains:
- Glyceryl guaiacolate (Guaifenesin) – 50 mg
- Terbutaline sulfate – 1.5 mg
- Diphenhydramine hydrochloride – 14 mg
- Potassium citrate – 50 mg
6. Pharmaceutical Form & Strength
- Oral syrup
- Bottle size: 120 mL
- Strength expressed per 5 mL as above
7. Manufacturer & Marketing Authorization Holder
Manufacturer: Chemical Industries Development (CID), Giza, Egypt
Marketing Authorization Holder: CID
8. Mechanism of Action
- Guaifenesin: Increases respiratory tract fluid secretion and reduces mucus viscosity, facilitating expectoration.
- Terbutaline sulfate: Selective β₂-adrenergic agonist causing bronchial smooth muscle relaxation and bronchodilation.
- Diphenhydramine HCl: First-generation H₁-antihistamine with anticholinergic and sedative effects; reduces cough reflex sensitivity.
- Potassium citrate: Systemic alkalinizing agent; its expectorant role lacks strong clinical evidence.
9. Spectrum of Activity
Not applicable. Osipect® Syrup has no antimicrobial activity and does not treat infections directly.
10. Pharmacokinetics
Specific pharmacokinetic data for the fixed combination are not available.
Based on individual components:
- Oral absorption is generally good
- Metabolism occurs mainly in the liver
- Excretion is predominantly renal
Exact half-life and bioavailability values vary by ingredient and patient factors.
11. Indications
Historical (per source document):
Productive and non-productive cough associated with:
- Acute and chronic bronchitis
- Asthmatic bronchitis
- Reversible airway obstruction
- Respiratory tract infections with tenacious mucus
- Pulmonary emphysema
Updated Clinical Perspective:
Current international guidelines do not recommend routine use of such combinations, particularly in children, due to an unfavorable risk–benefit profile.
12. Administration
- Oral use
- Dosage historically reported as 5–10 mL, 3–4 times daily
- Actual dosing should only be determined by a qualified healthcare professional
13. Method of Preparation
Ready-to-use syrup. No reconstitution or dilution required.
14. Contraindications
- Hypersensitivity to any component
- Neonates and premature infants
- Severe cardiovascular disease
- Concomitant use with monoamine oxidase inhibitors (MAOIs)
15. Warnings & Precautions
- Cardiovascular risk: Terbutaline may cause tachycardia, palpitations, and arrhythmias
- CNS depression: Diphenhydramine causes sedation and impaired alertness
- Use caution in:
- Hypertension
- Hyperthyroidism
- Diabetes mellitus
- Glaucoma or prostatic hypertrophy
- Elderly patients (increased anticholinergic sensitivity)
- Avoid driving or operating machinery.
16. Drug Interactions
- CNS depressants: additive sedation
- Tricyclic antidepressants: increased cardiovascular effects
- Non-selective beta-blockers: antagonize terbutaline
- Diuretics, corticosteroids, xanthines: increased risk of hypokalemia
- Digoxin: possible reduction in serum levels
17. Side Effects
Common:
- Drowsiness, dizziness
- Dry mouth, gastrointestinal discomfort
- Tremor, nervousness
Less Common:
- Palpitations, tachycardia
- Blurred vision, urinary retention
Rare but Serious:
- Cardiac arrhythmias
- Severe allergic reactions
18. Use in Special Populations
- Pregnancy: Use only if clearly necessary; safer alternatives preferred
- Lactation: Avoid if possible due to infant sedation risk
- Pediatrics: Contraindicated in neonates; generally discouraged in children
- Elderly: Start with lowest possible dose; monitor closely
19. Storage Conditions
- Store below 30°C
- Protect from excessive heat and moisture
- Keep out of reach of children
20. Additional Sections
Regulatory & Clinical Notes
- Similar combination cough syrups are discouraged by FDA, EMA, and WHO guidance
- Not included in the WHO Essential Medicines List
- Single-ingredient, symptom-targeted therapy is preferred
21. Frequently Asked Questions (FAQ)
Is Osipect® an antibiotic? No. It does not treat infections.
Does it cause drowsiness? Yes, due to diphenhydramine.
Is it suitable for children? No. Current guidance discourages its use in pediatric patients.
Are there safer alternatives? Yes. Single-ingredient therapies matched to the specific symptom are safer and more effective.
22. References
- Osipect® Syrup Product Leaflet (CID – outdated source)
- Martindale: The Complete Drug Reference
- AHFS Drug Information
- FDA Guidance on Cough and Cold Products
- EMA Recommendations on Pediatric Cough Medicines
- WHO Model List of Essential Medicines
