Usage
This combination medication is primarily 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 allergies and sinusitis.
Pharmacological Classification:
This combination includes drugs from several classes:
- Aceclofenac: Non-Steroidal Anti-Inflammatory Drug (NSAID)
- Paracetamol: Analgesic and Antipyretic
- Caffeine: Central Nervous System Stimulant
- Cetirizine: Second-generation Antihistamine
- Phenylephrine: Decongestant
Mechanism of Action:
- Aceclofenac: Inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby decreasing inflammation and pain.
- Paracetamol: Inhibits prostaglandin synthesis in the central nervous system, reducing fever and pain.
- Caffeine: Increases the analgesic effects of paracetamol and aceclofenac while reducing drowsiness caused by cetirizine. It constricts cerebral blood vessels, potentially relieving headache.
- Cetirizine: Blocks histamine H1 receptors, alleviating allergic symptoms such as itching, sneezing, and runny nose.
- Phenylephrine: Acts as an alpha-adrenergic agonist, constricting blood vessels in the nasal mucosa, reducing nasal congestion.
Alternate Names
This specific combination doesn’t have a universally recognized international non-proprietary name (INN). It is generally referred to by the names of its constituents.
Brand Names: Several brand names exist for this combination depending on the manufacturer and region, including “DIECOLD PLUS,” “MUCOBREX AC,” “ADDCET COLD,” “ACCECOLD PLUS,” “AFTERCOLD-A” and “Celmol-Plus”.
How It Works
Pharmacodynamics: The combined effect of the individual components targets multiple symptoms simultaneously. Aceclofenac and paracetamol provide pain relief and reduce fever. Cetirizine addresses allergic symptoms, while phenylephrine relieves nasal congestion. Caffeine enhances the analgesic effect and counteracts cetirizine’s sedative properties.
Pharmacokinetics:
- Absorption: All components are absorbed well orally.
- Metabolism: Aceclofenac, paracetamol, and caffeine are primarily metabolized in the liver. Cetirizine undergoes minimal hepatic metabolism. Phenylephrine is metabolized by monoamine oxidase (MAO) in the gastrointestinal tract and liver.
- Elimination: Aceclofenac and paracetamol metabolites are primarily excreted in the urine. Cetirizine is mainly excreted unchanged in the urine. Phenylephrine metabolites are excreted in the urine.
Mode of Action (Cellular/Molecular): Refer to the “Mechanism of Action” section above.
Dosage
Standard Dosage
Children: This combination is generally not recommended for children under 12 years of age. For children older than 12, dosage should be adjusted based on weight and age and determined by a physician.
Special Cases:
- Elderly Patients: Lower doses might be necessary due to age-related decline in renal and hepatic function. Close monitoring is recommended.
- Patients with Renal Impairment: Dose adjustment is required based on the degree of impairment.
- Patients with Hepatic Dysfunction: Dose reduction may be necessary. Close monitoring is required.
- Patients with Comorbid Conditions: Use with caution in patients with hypertension, cardiovascular disease, diabetes, glaucoma, hyperthyroidism, and prostatic hypertrophy.
Clinical Use Cases
This combination is not typically indicated for specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. It is intended for outpatient use in the symptomatic relief of common cold and flu.
Dosage Adjustments
Dosage adjustments are required in patients with renal or hepatic impairment, elderly patients, and those with comorbid conditions. (See “Special Cases” above).
Side Effects
Common Side Effects:
Drowsiness, dizziness, dry mouth, nausea, vomiting, constipation, restlessness, insomnia, headache, and rash.
Rare but Serious Side Effects:
Allergic reactions (anaphylaxis, angioedema), Stevens-Johnson syndrome, liver damage (with excessive paracetamol use), and blood pressure elevation.
Long-Term Effects:
Long-term use, especially of aceclofenac, can increase the risk of gastrointestinal bleeding and renal impairment.
Adverse Drug Reactions (ADR):
Severe allergic reactions, hepatotoxicity (paracetamol), and significant blood pressure elevation.
Contraindications
Hypersensitivity to any component, severe hepatic impairment, severe renal impairment, coronary artery disease, uncontrolled hypertension, MAO inhibitor use within the past 14 days, and during pregnancy and breast feeding.
Drug Interactions
Alcohol, MAO inhibitors, tricyclic antidepressants, other decongestants, antihistamines, blood thinners (warfarin), NSAIDs (aspirin, ibuprofen), and certain antibiotics.
Pregnancy and Breastfeeding
This combination is contraindicated during pregnancy and breastfeeding.
Drug Profile Summary
- Mechanism of Action: Refer to “Mechanism of Action” Section.
- Side Effects: Refer to “Side Effects” Section.
- Contraindications: Refer to “Contraindications” Section.
- Drug Interactions: Refer to “Drug Interactions” Section.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Refer to “Dosage” Section.
- Monitoring Parameters: Blood pressure, liver function tests, and renal function tests in specific populations.
Popular Combinations
This combination is itself a popular formulation targeting various cold and flu symptoms.
Precautions
As outlined in previous sections, caution should be exercised in elderly patients, patients with renal or hepatic impairment, and in those with pre-existing conditions such as hypertension, cardiovascular disease, and diabetes. Alcohol should be avoided, and driving or operating machinery may be impaired due to potential drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Caffeine + Cetirizine + Paracetamol + Phenylephrine?
A: For adults, one tablet every 4-6 hours as needed, not exceeding 4-6 tablets/day. Dosage adjustments needed for children over 12, elderly patients, and those with impaired hepatic or renal function (consult a doctor).
Q2: Can this combination be used in children?
A: Generally not recommended for children under 12. Consult a pediatrician for dosage adjustments in children over 12.
Q3: What are the common side effects?
A: Drowsiness, dizziness, dry mouth, nausea, vomiting, constipation, restlessness, insomnia, headache and rash.
Q4: Are there any serious side effects?
A: Yes, though rare, serious side effects can include allergic reactions, liver damage, and blood pressure elevation.
Q5: Can I take this medication if I am pregnant or breastfeeding?
A: No, it is contraindicated during pregnancy and breastfeeding.
Q6: Can I drink alcohol while taking this medication?
A: No, alcohol should be avoided as it can increase the risk of side effects like drowsiness and gastrointestinal issues.
Q7: Can I operate machinery or drive while taking this combination?
A: Use caution, as drowsiness may occur. Avoid these activities if affected.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is close to the next scheduled dose. Do not double the dose.
Q9: What should I do if I experience an allergic reaction?
A: Seek immediate medical attention.
Q10: Can this be taken with other over-the-counter cold medications?
A: Avoid combining it with other medications containing similar ingredients (e.g., decongestants, antihistamines, analgesics) to prevent overdosing. Consult your doctor.
