Usage
This combination medication is primarily prescribed for the symptomatic relief of the common cold and flu. It addresses symptoms such as fever, headache, body aches, nasal congestion, runny nose, sneezing, and watery eyes.
Pharmacological Classification: This drug is a combination of:
- Analgesic and Antipyretic: Paracetamol
- Decongestant: Phenylephrine
- Antihistamine: Chlorpheniramine
- Topical Analgesic: Menthol (sometimes included for throat soothing)
Mechanism of Action: The combination works through the distinct actions of its components: Paracetamol reduces fever and pain, phenylephrine relieves nasal congestion, chlorpheniramine alleviates allergy symptoms, and menthol provides a cooling sensation to soothe throat irritation.
Alternate Names
There is no single international non-proprietary name (INN) for this combination. It’s typically referred to by its component names. Brand names vary by region. Some examples include:
- Sinarest (often with additional ingredients)
- COL-COL (often with additional ingredients)
How It Works
Pharmacodynamics:
- Paracetamol: Inhibits prostaglandin synthesis in the central nervous system, which reduces fever and pain.
- Phenylephrine: Alpha-1 adrenergic agonist, causing vasoconstriction in the nasal mucosa, which reduces swelling and congestion.
- Chlorpheniramine: H1 receptor antagonist, which blocks the effects of histamine, thereby reducing allergic symptoms.
- Menthol: Activates TRPM8 receptors, producing a cooling sensation.
Pharmacokinetics:
- Paracetamol: Rapidly absorbed orally, metabolized in the liver, and excreted renally.
- Phenylephrine: Well absorbed orally but undergoes extensive first-pass metabolism, reducing bioavailability. Excreted renally.
- Chlorpheniramine: Well absorbed orally, metabolized in the liver, and excreted renally.
- Menthol: Absorbed through the skin and mucous membranes, metabolized in the liver, and excreted in urine and feces.
Receptor Binding/Enzyme Inhibition:
- Paracetamol: Exact mechanism of action is not fully understood but involves inhibition of COX enzymes in the CNS.
- Phenylephrine: Binds to alpha-1 adrenergic receptors.
- Chlorpheniramine: Binds to H1 histamine receptors.
- Menthol: TRPM8 receptor agonist.
Elimination Pathways: Primarily renal excretion for all components, following hepatic metabolism.
Dosage
Standard Dosage
This information should be seen as general guidance. Always consult with a medical professional who can make appropriate treatment decisions.
Adults:
Standard doses for adults often include 500mg paracetamol, 5mg phenylephrine, and 2-4mg chlorpheniramine per dose, typically taken every 4-6 hours as needed. However, the exact dosage and frequency will vary based on the specific product and patient needs. The maximum daily dose of paracetamol should not exceed 4000mg.
Children:
Dosing for children should be based on weight or age, following pediatric guidelines and using age-appropriate formulations. This combination is generally not recommended for children under 2 years of age, and caution is advised for older children due to the risk of paradoxical reactions.
Special Cases:
- Elderly Patients: Reduced doses and closer monitoring are advised due to potential age-related decline in liver and kidney function.
- Patients with Renal Impairment: Dose adjustments are often necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Reduced doses are crucial to avoid paracetamol toxicity.
- Patients with Comorbid Conditions: Careful consideration is required, especially for patients with cardiovascular diseases, diabetes, hyperthyroidism, glaucoma, or prostate enlargement.
Clinical Use Cases
This particular combination is not typically used in specific medical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. In emergency situations, other medications are preferred.
Dosage Adjustments
Dose adjustments based on renal/hepatic impairment, metabolic disorders, and other relevant factors are crucial.
Side Effects
Common Side Effects
- Drowsiness
- Dizziness
- Dry mouth, nose, and throat
- Nausea, vomiting, and constipation
- Restlessness or excitability (especially in children)
- Blurred vision
Rare but Serious Side Effects
- Allergic reactions (skin rash, itching, swelling)
- Liver damage (with paracetamol overdose)
- Cardiac arrhythmias (with phenylephrine)
- Hallucinations, seizures (with chlorpheniramine)
- Hypertension crises
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
Long-Term Effects
Chronic use of paracetamol at high doses can lead to liver damage. Long-term use of phenylephrine can lead to rebound congestion.
Adverse Drug Reactions (ADR)
Serious ADRs require immediate medical intervention. These include severe allergic reactions, signs of liver damage (jaundice, abdominal pain), cardiac complications, and severe neurological effects.
Contraindications
- Hypersensitivity to any component
- Severe hypertension
- Severe coronary artery disease
- Narrow-angle glaucoma
- Monoamine oxidase inhibitor (MAOI) use or within two weeks of discontinuation
- Severe liver or kidney disease
Drug Interactions
- MAOIs
- Tricyclic antidepressants
- Beta-blockers
- Other antihistamines, decongestants, or CNS depressants
- Alcohol
- Warfarin
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been fully established. Consult a physician before use. Chlorpheniramine is generally considered low risk in small, occasional doses. Non-sedating antihistamines may be preferred.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Consult a physician.
- Dosage: See above.
- Monitoring Parameters: Liver function tests, blood pressure, heart rate, respiratory rate.
Popular Combinations
This combination itself is a popular one for addressing cold and flu symptoms. Sometimes, guaifenesin (an expectorant) or dextromethorphan (a cough suppressant) may be added.
Precautions
- Screen for allergies and contraindications.
- Assess liver and kidney function, especially in elderly patients.
- Caution in patients with cardiovascular disease, diabetes, or glaucoma.
- Advise against driving or operating machinery if drowsiness occurs.
- Avoid alcohol.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Menthol + Paracetamol + Phenylephrine?
A: Dosing varies depending on the specific product and patient factors (age, weight, comorbidities). Consult a physician or refer to the product information leaflet for specific dosage instructions.
Q2: Can this combination be given to children?
A: Generally not recommended for children under 2 years of age. Consult a physician for pediatric dosing.
Q3: What are the common side effects?
A: Common side effects include drowsiness, dizziness, dry mouth, and gastrointestinal upset.
Q4: Are there any serious side effects?
A: Serious side effects are rare but can include allergic reactions, liver damage (with paracetamol overdose), and cardiovascular effects (with phenylephrine).
Q5: Can this medication interact with other drugs?
A: Yes, it can interact with MAOIs, tricyclic antidepressants, beta-blockers, and other medications. Avoid alcohol.
Q6: Can pregnant or breastfeeding women take this medication?
A: Consult a physician before use during pregnancy or breastfeeding.
Q7: What precautions should be taken when prescribing this medication?
A: Screen for allergies and contraindications, assess liver and kidney function, and caution in patients with relevant comorbidities.
Q8: How should this medication be stored?
A: Store at room temperature, away from heat, moisture, and direct light.
Q9: What should I do if a patient overdoses on this medication?
A: Seek immediate medical attention.
Q10: Can patients with hypertension use this medication?
A: It should be used with caution in patients with hypertension and is generally contraindicated in those with severe hypertension due to the presence of phenylephrine, a decongestant that can raise blood pressure. A physician should be consulted before use.
