Usage
This combination medication is primarily used for symptomatic relief of the common cold, flu, and allergies. It addresses symptoms like fever, headache, body aches, nasal congestion, runny nose, sneezing, and itchy/watery eyes.
Pharmacological Classification:
- Chlorpheniramine Maleate: Antihistamine (H1 receptor antagonist)
- Paracetamol/Acetaminophen: Analgesic and Antipyretic
- Sodium Citrate: Expectorant
Mechanism of Action:
- Chlorpheniramine: Competes with histamine for H1-receptor sites, reducing allergic symptoms.
- Paracetamol: Inhibits prostaglandin synthesis in the central nervous system, reducing fever and pain. The exact mechanism of its analgesic action is not fully understood.
- Sodium Citrate: Increases respiratory tract secretions, thinning mucus and making it easier to cough up.
Alternate Names
This combination doesn’t have a widely recognized single international nonproprietary name (INN) or brand name. It is often referred to by its constituent drug names. Various regional brand names exist depending on the manufacturer and country.
How It Works
Pharmacodynamics:
- Chlorpheniramine: Reduces capillary permeability, decreases histamine-mediated bronchoconstriction, and exerts anticholinergic effects.
- Paracetamol: Produces analgesia by raising the pain threshold, and antipyresis through action on the hypothalamic heat-regulating center.
- Sodium Citrate: Acts as an expectorant, primarily by increasing hydration and decreasing viscosity of respiratory secretions.
Pharmacokinetics:
- Chlorpheniramine: Well-absorbed orally. Metabolized in the liver, primarily by CYP3A4, and excreted in urine.
- Paracetamol: Rapidly absorbed from the gastrointestinal tract. Metabolized primarily in the liver by glucuronidation and sulfation pathways and excreted in urine. Small amounts may be metabolized via CYP2E1 to the toxic metabolite NAPQI.
- Sodium Citrate: Absorbed from the gastrointestinal tract and is primarily eliminated through the kidneys.
Mode of Action:
- Chlorpheniramine: Antagonizes the effects of histamine at H1 receptors.
- Paracetamol: Exact mechanism is not completely understood, but is thought to be mediated through inhibition of central COX enzymes and possibly other mechanisms.
- Sodium Citrate: Acts by altering electrolyte balance to stimulate respiratory gland secretions, loosening phlegm.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Chlorpheniramine: H1 receptor antagonist.
- Paracetamol: Inhibits central cyclooxygenase (COX) enzymes.
- Sodium Citrate: Affects electrolyte balance in airway mucus glands.
Elimination Pathways:
- Chlorpheniramine: Primarily renal excretion.
- Paracetamol: Primarily renal excretion of metabolites.
- Sodium Citrate: Primarily renal excretion.
Dosage
This combination is not available as a single FDA-approved product with a fixed-dose combination. Dosage will vary based on the specific formulation and should be determined based on product packaging instructions.
Standard Dosage
Dosage guidelines for the individual components are provided for informational purposes and are not a substitute for specific product labeling:
Adults:
- Paracetamol: 325-650 mg every 4-6 hours as needed, not to exceed 4000 mg in 24 hours.
- Chlorpheniramine: 2-4 mg every 4-6 hours as needed, not to exceed 24 mg in 24 hours.
- Sodium Citrate: Follow product-specific guidelines.
Children:
Consult a healthcare professional for appropriate pediatric dosing, as it varies based on age and weight.
Special Cases:
- Elderly Patients: Dosage adjustments may be needed.
- Patients with Renal Impairment: Dosage adjustments are likely required.
- Patients with Hepatic Dysfunction: Use with caution; dosage adjustments may be needed.
- Patients with Comorbid Conditions: Consider individual patient factors.
Clinical Use Cases
Dosage recommendations for specific clinical settings (intubation, surgical procedures, ICU use, etc.) are not available for this combination product, as it’s primarily intended for over-the-counter relief of cold and allergy symptoms.
Dosage Adjustments
Consult a healthcare professional for patient-specific dose adjustments.
Side Effects
Common Side Effects
- Drowsiness
- Dry mouth
- Blurred vision
- Constipation
- Nausea
Rare but Serious Side Effects
- Allergic reactions (e.g., skin rash, itching, swelling)
- Hepatotoxicity (with excessive paracetamol intake)
- Cardiac arrhythmias
Long-Term Effects
Chronic complications are not typically expected from short-term use. Long-term, excessive use of paracetamol can cause hepatotoxicity.
Adverse Drug Reactions (ADR)
Any severe or unusual reaction should be reported to a healthcare professional immediately.
Contraindications
- Hypersensitivity to any of the components
- Severe liver disease
- Severe renal impairment
- Use with MAO inhibitors
Drug Interactions
- Alcohol (increases risk of liver damage with paracetamol)
- Other CNS depressants (e.g., sedatives, hypnotics)
- MAO inhibitors
- Tricyclic antidepressants
Pregnancy and Breastfeeding
Consult a healthcare professional before use during pregnancy or breastfeeding. Limited, occasional use of chlorpheniramine may be acceptable during breastfeeding, but larger or prolonged doses may affect the infant or decrease milk supply.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Consult a healthcare professional.
- Dosage: See above.
- Monitoring Parameters: Liver function tests with high doses of paracetamol, especially in patients at risk for hepatic impairment.
Popular Combinations
This particular combination is not often encountered clinically in fixed formulations. Other combinations containing paracetamol or chlorpheniramine may be used more commonly with other decongestants or antitussives.
Precautions
- Avoid exceeding recommended doses.
- Use caution in patients with hepatic or renal dysfunction, glaucoma, cardiovascular disease.
- Avoid alcohol during use.
- May impair driving or operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Paracetamol/Acetaminophen + Sodium Citrate?
A: Dosage varies depending on the specific product. Always follow the instructions provided on the product packaging. General adult dosage information is provided above, however, it is vital to refer to specific drug label information, and/or consult a healthcare provider.
Q2: Can this combination be used in children?
A: Consult a healthcare professional for appropriate pediatric dosing, which varies based on age and weight. Certain formulations may not be suitable for young children.
Q3: What are the potential drug interactions?
A: See the “Drug Interactions” section above. Be sure to inform your doctor about all medications, including OTC products and supplements, that you are taking.
Q4: Can I drink alcohol while taking this medication?
A: It’s best to avoid alcohol while taking this medication due to the increased risk of liver damage associated with paracetamol use, and the increased likelihood of adverse effects like drowsiness and dizziness.
Q5: What should I do if I experience side effects?
A: Most side effects are mild and resolve on their own. Contact a healthcare professional if side effects are bothersome or severe.
Q6: Can I take this medication if I am pregnant or breastfeeding?
A: Consult your doctor before use during pregnancy or breastfeeding.
Q7: Is it safe to drive or operate machinery while taking this medication?
A: This medication can cause drowsiness and impair cognitive function. Use caution when driving or operating machinery.
Q8: Are there any long-term effects of taking this combination?
A: Long-term effects are not typically expected from short-term use as directed. However, long-term use of paracetamol at high doses can result in hepatotoxicity.
Q9: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your regular schedule. Do not double the dose to catch up.
