Usage
This combination medication is primarily prescribed for the symptomatic relief of the common cold and allergies (allergic rhinitis). It addresses symptoms such as nasal and sinus congestion, sinus pain, headache, fever, runny nose, sneezing, itchy or watery eyes, and sore throat. It’s also used as an adjunct therapy with antibacterial agents in conditions like sinusitis, tonsillitis, and otitis media.
Pharmacological Classification:
This drug is a combination of:
- Analgesic and Antipyretic: Paracetamol
- Decongestant: Phenylephrine
- Antihistamine: Chlorpheniramine maleate
- Mucolytic: Sodium Citrate
Mechanism of Action:
- Paracetamol reduces fever by acting on the hypothalamic heat-regulating center and relieves pain by inhibiting prostaglandin synthesis.
- Phenylephrine is an alpha-adrenergic agonist that constricts blood vessels in the nasal mucosa, reducing congestion.
- Chlorpheniramine is an H1-receptor antagonist that blocks the effects of histamine, relieving allergy symptoms.
- Sodium Citrate helps thin and loosen mucus, facilitating its expulsion.
Alternate Names
This combination doesn’t have a universally recognized International Nonproprietary Name (INN). It is often referred to by the names of its constituents.
Brand Names: Sinarest Plus Suspension, KOLQ Syrup, Maxtra P Oral Drops (some formulations may have additional ingredients like menthol or ammonium chloride).
How It Works
Pharmacodynamics:
The combined effects of the individual components provide comprehensive relief from cold and allergy symptoms. Paracetamol reduces fever and pain, phenylephrine relieves congestion, chlorpheniramine alleviates allergic manifestations, and sodium citrate thins mucus secretions.
Pharmacokinetics:
- Paracetamol: Rapidly absorbed from the GI tract. Metabolized in the liver and excreted in the urine.
- Phenylephrine: Well absorbed orally. Metabolized by monoamine oxidase in the intestine and liver.
- Chlorpheniramine: Well absorbed orally. Metabolized in the liver, with metabolites and unchanged drug excreted in the urine. Half-life varies significantly (2-43 hours).
- Sodium Citrate: Absorbed from the GI tract and primarily excreted unchanged in the urine.
Mode of Action: Paracetamol inhibits COX enzymes centrally. Phenylephrine acts as an alpha-1 adrenergic receptor agonist. Chlorpheniramine is an H1 receptor antagonist. Sodium citrate increases the alkalinity of the respiratory secretions making them less viscous.
Elimination Pathways: Primarily renal excretion for all components.
Dosage
Standard Dosage
Adults:
A common formulation contains Paracetamol 500mg, Phenylephrine 5mg, and Chlorpheniramine 2mg. This can be taken every 4-6 hours as needed, not exceeding the maximum daily dose of paracetamol (4000mg).
Children:
Dosing is weight or age-dependent, and a physician should determine the appropriate dose. For example, children aged 2-4 years (6-16.5 kg) might receive 2.5 ml of a specific formulation three times a day. Pediatric formulations usually have lower strengths of each ingredient.
Special Cases:
- Elderly Patients: Dose adjustments may be needed due to age-related decline in organ function.
- Patients with Renal Impairment: Dosage reduction may be necessary.
- Patients with Hepatic Dysfunction: Dosage reduction is usually recommended.
- Patients with Comorbid Conditions: Careful consideration is required for patients with hypertension, diabetes, glaucoma, hyperthyroidism, cardiovascular disease, or other relevant conditions.
Clinical Use Cases
This specific combination isn’t typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. Its primary use is for outpatient management of common cold and allergy symptoms.
Dosage Adjustments
Adjustments should be based on patient-specific factors such as renal or hepatic function, age, and concomitant medications.
Side Effects
Common Side Effects:
Drowsiness, dizziness, dry mouth, nausea, constipation, blurred vision, nervousness, headache, insomnia.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), liver damage (with paracetamol overdose), hallucinations, difficulty breathing.
Long-Term Effects:
Chronic use of phenylephrine can lead to rebound congestion. Long-term paracetamol use at high doses can cause liver damage.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), hepatotoxicity (paracetamol), cardiac arrhythmias (phenylephrine).
Contraindications
Hypersensitivity to any component, severe hypertension, severe liver disease, concurrent use of MAO inhibitors, narrow-angle glaucoma, uncontrolled hyperthyroidism.
Drug Interactions
MAO inhibitors, tricyclic antidepressants, beta-blockers, digoxin, warfarin, alcohol, other medications containing paracetamol or phenylephrine, OTC cold and allergy medications.
Pregnancy and Breastfeeding
Use with caution during pregnancy and breastfeeding, only if clearly needed and under medical supervision. Phenylephrine and chlorpheniramine can potentially have adverse effects on the fetus or nursing infant.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Use with caution.
- Dosage: See above.
- Monitoring Parameters: Liver function tests (for prolonged use or high doses of paracetamol), blood pressure (for patients with hypertension).
Popular Combinations
This medication already contains four active ingredients. Additional combinations may be considered by a physician based on specific patient needs but are not routinely recommended.
Precautions
Screen for allergies, hepatic and renal impairment, and other relevant medical conditions. Advise patients about potential side effects, drug interactions, and precautions regarding alcohol consumption and operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Paracetamol + Phenylephrine + Sodium Citrate?
A: Dosage varies depending on the formulation and the patient’s age and condition. Refer to the Dosage section above for general guidance. Always consult with a physician for individualized dosing recommendations.
Q2: Can this combination be used in children under 2 years of age?
A: It’s generally not recommended for children under 2 years old. Consult a pediatrician for appropriate alternatives.
Q3: Can pregnant or breastfeeding women take this medication?
A: Use with caution during pregnancy and breastfeeding, only if clearly needed and under strict medical supervision.
Q4: What are the common side effects patients should be aware of?
A: Common side effects include drowsiness, dizziness, dry mouth, nausea, constipation, blurred vision, nervousness, headache, and insomnia.
Q5: Are there any serious drug interactions I should be concerned about?
A: Yes, significant interactions can occur with MAO inhibitors, tricyclic antidepressants, beta-blockers, digoxin, and warfarin. Inform your patients to disclose all medications they are taking, including OTC drugs and supplements.
Q6: Can patients consume alcohol while taking this medication?
A: Alcohol should be avoided, as it can exacerbate drowsiness and increase the risk of liver damage with paracetamol.
Q7: Can this medication be used long-term?
A: Long-term use should be avoided unless specifically directed by a physician. Chronic use of phenylephrine can lead to rebound congestion, and high doses of paracetamol over extended periods can cause liver damage.
Q8: What should I do if a patient experiences an allergic reaction?
A: Discontinue the medication immediately and seek medical attention. Allergic reactions can range from mild skin rashes to severe anaphylaxis.
Q9: What are the signs of paracetamol overdose?
A: Signs of overdose can include nausea, vomiting, abdominal pain, and liver damage. Prompt medical intervention is crucial in cases of suspected overdose.
