Usage
This combination drug is primarily used for symptomatic relief of the common cold and allergies. It addresses multiple symptoms simultaneously, offering a convenient treatment option.
Pharmacological Classifications:
- Analgesic (Paracetamol)
- Antipyretic (Paracetamol)
- Antihistamine (Chlorpheniramine Maleate)
- Decongestant (Phenylephrine)
- Mucolytic (Ambroxol)
Mechanism of Action: This combination targets various pathways to alleviate cold and allergy symptoms. Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis. Chlorpheniramine maleate, an antihistamine, blocks the effects of histamine, relieving allergy symptoms like runny nose and sneezing. Phenylephrine, a decongestant, constricts blood vessels in the nasal mucosa, reducing congestion. Ambroxol acts as a mucolytic, thinning and loosening mucus in the airways, facilitating its expulsion.
Alternate Names
There’s no single international non-proprietary name. It’s marketed under different brand names like Sinarest Ccf, Carecof-Plus, Nosardi Plus.
How It Works
Pharmacodynamics:
- Paracetamol: Exerts analgesic and antipyretic effects centrally by inhibiting prostaglandin synthesis. The exact mechanism of its analgesic action is not fully understood but is thought to involve central COX-3 enzyme inhibition.
- Chlorpheniramine Maleate: A first-generation antihistamine that competitively antagonizes H1 receptors. It reduces vascular permeability, decreases histamine-mediated bronchospasm, and alleviates itching, sneezing, and rhinorrhea.
- Phenylephrine: An alpha-1 adrenergic receptor agonist. It causes vasoconstriction in the nasal mucosa, reducing congestion.
- Ambroxol: Stimulates the serous glands in the respiratory tract, reducing mucus viscosity. It also enhances ciliary activity, aiding in mucus clearance.
Pharmacokinetics:
All components are absorbed orally. Paracetamol is metabolized primarily in the liver, with a small amount undergoing renal excretion. Chlorpheniramine is metabolized in the liver. Phenylephrine is metabolized by monoamine oxidase in the liver and gut. Ambroxol is metabolized in the liver and excreted in the urine.
Elimination Pathways: Primarily renal and hepatic.
Dosage
Dosage recommendations are based on available information and should be individualized based on patient factors. Always consult current product information and guidelines.
Standard Dosage
Adults:
One tablet every 4-6 hours as needed. Maximum daily dose not to exceed the recommended limit for each individual component.
Children:
Dosage varies depending on age and weight. Consult a pediatrician for appropriate dosing and safety considerations. Generally, this combination is not recommended for children under 6.
Special Cases:
- Elderly Patients: Dose adjustment may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Use with caution and adjust dosage based on creatinine clearance.
- Patients with Hepatic Dysfunction: Reduce dosage and monitor liver function.
- Patients with Comorbid Conditions: Caution advised in patients with hypertension, diabetes, glaucoma, hyperthyroidism, cardiovascular disease, and prostatic hypertrophy.
Clinical Use Cases
This combination is not typically used in the specific medical settings of intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its indication is limited to symptomatic relief of common cold and allergy symptoms.
Dosage Adjustments
Dosage adjustments should be made in patients with renal or hepatic impairment.
Side Effects
Common Side Effects:
Drowsiness, nausea, vomiting, headache, dizziness, dry mouth, constipation, blurred vision, insomnia, nervousness.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), tachycardia, palpitations, hypertension, difficulty breathing.
Long-Term Effects:
Long-term use of this combination is generally not recommended due to potential side effects. Chronic use of paracetamol can lead to hepatotoxicity.
Adverse Drug Reactions (ADR):
Severe allergic reactions, hepatotoxicity (with excessive paracetamol use).
Contraindications
Hypersensitivity to any component, severe hypertension, severe liver disease, concurrent use of MAOIs or within two weeks of discontinuation, narrow-angle glaucoma, prostatic hypertrophy.
Drug Interactions
Antihistamines (e.g., diphenhydramine), antidepressants (e.g., tricyclic antidepressants, MAOIs), cough suppressants (e.g., dextromethorphan), alcohol, beta-blockers, methyldopa, reserpine, veratrum alkaloids.
Pregnancy and Breastfeeding
Consult a doctor before use during pregnancy and breastfeeding. Safety not fully established.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: See above.
- Monitoring Parameters: Blood pressure, liver function tests (with prolonged paracetamol use).
Popular Combinations
This combination itself is a commonly used formulation.
Precautions
Assess for pre-existing medical conditions, allergies, and concomitant medications. Caution advised in special populations (elderly, pregnant/breastfeeding women, children). Avoid alcohol and operating machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Chlorpheniramine Maleate + Paracetamol + Phenylephrine?
A: See dosage section above. This varies with the individual product formulation and patient’s age and condition. Always refer to specific product information.
Q2: Can this combination be used in children?
A: Use with caution in children, consult a pediatrician. Specific pediatric formulations may be available. Generally not recommended for children under 6.
Q3: What are the common side effects?
A: Drowsiness, nausea, dry mouth, dizziness are common side effects.
Q4: Can I take this combination if I am pregnant or breastfeeding?
A: Consult a doctor before use during pregnancy or lactation.
Q5: What are the contraindications to using this combination?
A: Contraindications include hypersensitivity, severe hypertension, severe liver disease, and concurrent MAOI use.
Q6: Does this medication interact with other drugs?
A: Yes, it can interact with other medications, including antihistamines, antidepressants, and alcohol. Consult a doctor regarding potential drug interactions.
Q7: Can I drive or operate machinery while taking this medication?
A: Caution advised, as this medication can cause drowsiness. Avoid driving or operating heavy machinery if affected.
Q8: How long can I take this medication?
A: Short-term use is recommended. Consult your doctor about the duration of treatment.
Q9: What should I do if I experience any side effects?
A: Consult your doctor if you experience any persistent or bothersome side effects.
