What it's for (Indications)
- Relief of productive cough and associated allergic symptoms (e.
- g.
- , rhinitis, sneezing) in respiratory conditions where both mucolysis and antihistaminic/sedative effects are desired.
- This includes conditions like acute and chronic bronchitis, allergic bronchitis, or other respiratory disorders accompanied by excessive, tenacious mucus and allergic manifestations.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Dosage should be individualized based on patient response and tolerability, using the lowest effective dose for the shortest duration necessary. * **General Adult Dosing:** A common adult dosage for similar combinations might be 500mg carbocisteine and 10mg promethazine, 2-3 times daily. * **Pediatric Dosing (2 years and older):** Use with extreme caution. Dosage must be significantly reduced and carefully monitored. Specific product information or clinical guidelines should be consulted for precise age and weight-based dosing. For carbocisteine, typical doses for children >2 years range from 100-250mg 2-3 times daily, and for promethazine, typically 6.25mg to 12.5mg given at bedtime or as a single dose for antihistaminic effect. The combination dosage should reflect this caution and lower dose for promethazine. * **Elderly Patients:** Initiate with lower doses due to increased sensitivity to anticholinergic effects and CNS depression. * **Administration:** Typically taken orally, with or without food. |
Safety & Warnings
Common Side Effects
- Common side effects include drowsiness, sedation, dizziness, dry mouth, blurred vision, gastrointestinal disturbances (nausea, vomiting, diarrhea, indigestion, abdominal discomfort), constipation, urinary retention, headache, and skin rash.
- Less common or more serious effects can include respiratory depression (especially in young children), CNS excitation (paradoxical reaction, particularly in children), photosensitivity, hypotension, extrapyramidal symptoms, and rarely, blood dyscrasias or Neuroleptic Malignant Syndrome (NMS).
Serious Warnings
- Black Box Warning: Promethazine is contraindicated for use in pediatric patients less than 2 years of age due to the potential for fatal respiratory depression. Use with extreme caution in pediatric patients 2 years of age and older.
- 1.
- **Respiratory Depression:** Promethazine carries a significant risk of respiratory depression, which can be fatal, especially in children less than 2 years of age.
- Use with extreme caution in children 2 years and older, the elderly, and patients with compromised respiratory function (e.
- g.
- , asthma, COPD, sleep apnea) or acute respiratory illnesses.
- 2.
- **CNS Depression:** May cause significant drowsiness and impair mental and/or physical abilities required for driving a vehicle or operating machinery.
- Additive CNS depressant effects with alcohol, sedatives, hypnotics, opioids, and other CNS depressants.
- 3.
- **Anticholinergic Effects:** Use with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, urinary retention, pyloroduodenal obstruction, or paralytic ileus.
- 4.
- **Paradoxical Excitation:** Children may experience paradoxical excitation, agitation, nightmares, or seizures.
- 5.
- **Peptic Ulcer Disease:** Carbocisteine should be used with caution in patients with a history of peptic ulcer disease due to theoretical risk of exacerbation.
- 6.
- **Bronchial Secretion Thickening:** While carbocisteine aims to thin mucus, promethazine's anticholinergic effects can lead to thickening of bronchial secretions, potentially making cough more difficult and worsening respiratory status, particularly in patients with asthma or other lower respiratory tract diseases.
- 7.
- **Photosensitivity:** Patients should be advised to avoid prolonged sun exposure.
- 8.
- **Seizure Threshold:** Promethazine may lower the seizure threshold.
- 9.
- **Neuroleptic Malignant Syndrome (NMS):** Rare cases have been reported.
How it Works (Mechanism of Action)
Carbocisteine acts as a mucolytic, reducing the viscosity of bronchial secretions by altering the structure of mucin glycoproteins, thereby facilitating expectoration. Promethazine is a first-generation antihistamine with prominent H1-receptor blocking activity, as well as significant anticholinergic, sedative, and antiemetic properties. It acts on the central nervous system to produce sedation and reduces allergic symptoms.
Commercial Brands (Alternatives)
No other brands found for this formula.