Usage
Chlorpheniramine Maleate + Paracetamol + Phenylephrine is prescribed for the symptomatic relief of common cold and flu symptoms, including fever, headache, body aches, nasal congestion, runny nose, sneezing, and watery eyes. It is also used to alleviate symptoms associated with allergic rhinitis and sinusitis.
Pharmacological Classification: This drug is a combination product containing:
- Paracetamol: Analgesic and antipyretic
- Phenylephrine: Nasal decongestant (sympathomimetic)
- Chlorpheniramine: Antihistamine
Mechanism of Action: Paracetamol reduces fever and pain by inhibiting prostaglandin synthesis in the central nervous system. Phenylephrine constricts blood vessels in the nasal passages, reducing congestion. Chlorpheniramine blocks the effects of histamine, relieving allergy symptoms like sneezing and runny nose.
Alternate Names
This combination medication doesn’t have a universally recognized international nonproprietary name (INN). It’s often referred to by its constituent drugs. Some regional or descriptive names may exist.
Brand Names: Brand names vary depending on the manufacturer and region. Examples include:
- COL-COL
- Sinarest Plus
- Restocin
- Cimegripe
- Resfenol
- Febrex Plus
- Panadol Sinus Pain & Congestion Relief
How It Works
Pharmacodynamics:
- Paracetamol: Exerts its analgesic and antipyretic effects centrally, primarily by inhibiting prostaglandin synthesis within the hypothalamus. The exact mechanism of analgesic action is not fully understood.
- Phenylephrine: Acts as an alpha-1 adrenergic receptor agonist, causing vasoconstriction in the nasal mucosa, reducing swelling and congestion.
- Chlorpheniramine: Competitively antagonizes histamine at H1 receptors, reducing the effects of histamine release, such as vasodilation, increased capillary permeability, and smooth muscle contraction.
Pharmacokinetics:
- Paracetamol: Readily absorbed from the gastrointestinal tract. Metabolized primarily in the liver via glucuronidation and sulfation. Excreted mainly in the urine.
- Phenylephrine: Absorbed from the gastrointestinal tract but undergoes significant first-pass metabolism. Metabolized by monoamine oxidase (MAO) in the intestinal wall and liver. Excreted in the urine.
- Chlorpheniramine: Well absorbed orally. Metabolized in the liver. Primarily excreted in the urine, with some biliary excretion.
Elimination Pathways: Paracetamol is eliminated predominantly through renal excretion of its metabolites. Phenylephrine undergoes both hepatic and intestinal metabolism before renal excretion. Chlorpheniramine is eliminated primarily through hepatic metabolism and renal excretion.
Dosage
Dosage recommendations vary depending on the specific formulation and the patient’s age and condition. Consult the specific product information for precise dosing instructions.
Standard Dosage
Adults: Typical dosages for adults might involve one or two tablets every four to six hours, not exceeding a specific maximum daily dose (e.g., six tablets).
Special Cases:
- Elderly Patients: Dose adjustments may be necessary due to age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Careful dose adjustment based on the degree of impairment is crucial.
- Patients with Hepatic Dysfunction: Dose reduction is usually required, as these medications are primarily metabolized by the liver.
- Patients with Comorbid Conditions: Caution is advised in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, and other conditions.
Clinical Use Cases
This combination medication is typically not indicated for specific clinical settings like intubation, surgical procedures, mechanical ventilation, or ICU use. Its use is generally limited to the symptomatic relief of common cold and allergy symptoms.
Dosage Adjustments
Dose adjustments may be needed for patients with renal or hepatic impairment, elderly individuals, and those with certain comorbidities. Specific product labeling should always be consulted for detailed instructions.
Side Effects
Common Side Effects:
- Drowsiness
- Dizziness
- Dry mouth
- Blurred vision
- Constipation
- Nervousness
- Insomnia
- Mild headache
Rare but Serious Side Effects:
- Allergic reactions (rash, itching, swelling, difficulty breathing)
- Liver damage (with paracetamol overdose)
- Hypertension (with phenylephrine)
- Cardiac arrhythmias
- Seizures
Long-Term Effects:
Chronic use of high doses of paracetamol can lead to liver damage. Long-term use of phenylephrine may cause rebound congestion.
Contraindications
- Hypersensitivity to any of the ingredients
- Severe liver disease
- Severe hypertension or coronary artery disease
- Narrow-angle glaucoma
- Pyloroduodenal or bladder neck obstruction
- Concomitant use of MAO inhibitors
Drug Interactions
- MAO inhibitors: May cause a hypertensive crisis.
- Tricyclic antidepressants: May potentiate the pressor effect of phenylephrine.
- Beta-blockers: Effects may be reduced by chlorpheniramine.
- Alcohol: Increases the risk of liver damage with paracetamol and may potentiate drowsiness.
- Other CNS depressants: Additive sedative effects.
Pregnancy and Breastfeeding
This combination is generally not recommended during pregnancy and breastfeeding due to the potential risks associated with each component. The FDA Pregnancy Category may vary based on the specific formulation. Consult a physician regarding safer alternative options.
Drug Profile Summary
- Mechanism of Action: Paracetamol: Analgesic/antipyretic; Phenylephrine: Decongestant; Chlorpheniramine: Antihistamine
- Side Effects: Drowsiness, dizziness, dry mouth, constipation, nervousness, insomnia, headache. Serious effects are rare but possible.
- Contraindications: Hypersensitivity, severe liver disease, severe hypertension, narrow-angle glaucoma, MAOI use.
- Drug Interactions: MAOIs, tricyclic antidepressants, beta-blockers, alcohol, CNS depressants.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Varies by product and patient age/condition. Consult product information.
- Monitoring Parameters: Blood pressure, liver function tests (if indicated).
Popular Combinations
This medication is already a combination of three drugs. Adding other medications for cold and flu symptoms may increase the risk of adverse events. Always assess the need for additional medications carefully.
Precautions
- Assess for allergies, renal/hepatic impairment, and relevant comorbidities.
- Caution in pregnant/breastfeeding women, children, and the elderly.
- Advise against alcohol consumption and driving or operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Paracetamol + Phenylephrine?
A: The dosage varies depending on the specific product and the patient’s age, weight, and medical condition. Always consult the product labeling or a healthcare professional for specific dosing instructions.
Q2: Can I take this medication if I am pregnant or breastfeeding?
A: This medication is generally not recommended during pregnancy or while breastfeeding. Consult your doctor for safer alternatives.
Q3: What are the common side effects?
A: Common side effects include drowsiness, dizziness, dry mouth, blurred vision, constipation, nervousness, and insomnia.
Q4: What are the serious side effects?
A: Rare but serious side effects include allergic reactions, liver damage (with paracetamol overdose), hypertension, and cardiac arrhythmias.
Q5: Can I drink alcohol while taking this medication?
A: No, avoid alcohol as it can increase the risk of liver damage with paracetamol and enhance drowsiness.
Q6: Can I drive or operate machinery while taking this medication?
A: This medication can cause drowsiness. It’s advisable to avoid driving or operating heavy machinery until you know how it affects you.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s almost time for your next dose. Do not double the dose to catch up.
Q8: What should I do if I experience an allergic reaction?
A: Stop taking the medication immediately and seek medical attention. Symptoms of an allergic reaction may include rash, itching, swelling, and difficulty breathing.
Q9: How should I store this medication?
A: Store the medication in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of reach of children.
Q10: Can I take this medication with other cold and flu medications?
A: Consult a doctor or pharmacist before combining this medication with other over-the-counter or prescription drugs, as interactions may occur. Avoid taking other products containing paracetamol.
