Usage
This combination medication is primarily prescribed for the treatment of bacterial eye infections. It is also effective in relieving associated symptoms like redness, itching, and watering of the eyes.
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Pharmacological Classification: This combination includes multiple classes:
- Sulphacetamide: Sulfonamide antibiotic
- Zinc Sulphate Monohydrate & Boric Acid: Antiseptics
- Chlorpheniramine Maleate: Antihistamine (H1 receptor antagonist)
- Sodium Chloride: Electrolyte, used as a vehicle.
- Chlorbutol: Preservative with weak local anesthetic properties.
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Mechanism of Action: Sulphacetamide inhibits bacterial growth by interfering with folic acid synthesis, essential for bacterial DNA replication. Zinc sulfate and boric acid act as antiseptics, further contributing to bacterial control and providing soothing relief. Chlorpheniramine maleate alleviates allergic symptoms by blocking histamine H1 receptors, reducing inflammation and itching. Sodium chloride provides isotonicity, making the solution compatible with ocular tissues. Chlorbutol acts as a preservative.
Alternate Names
There isn’t one single international non-proprietary name (INN) for this combination product, as it’s a fixed-dose combination. However, the components have their respective INNs. The combination is often referred to by the active ingredients. It’s important to note that specific formulations might have slightly different concentrations.
- Brand Names: Phenosulf, Zinbosulf, and potentially others depending on the manufacturer and region.
How It Works
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Pharmacodynamics: Sulphacetamide exerts its bacteriostatic effect by competitively inhibiting dihydropteroate synthase, a bacterial enzyme crucial for folic acid synthesis. This prevents bacterial growth and replication. Zinc sulfate and boric acid exhibit antiseptic properties. Chlorpheniramine maleate antagonizes the effects of histamine at H1 receptors, reducing ocular inflammation, itching, and redness. Sodium Chloride helps maintain the solution’s isotonicity.
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Pharmacokinetics: The combination is administered topically as eye drops. Absorption into systemic circulation is minimal, limiting systemic effects. Sulphacetamide, when absorbed systemically, is metabolized in the liver and excreted primarily in the urine. Chlorpheniramine, if absorbed systemically, is also metabolized in the liver. Zinc and boric acid are primarily eliminated unchanged through the kidneys if absorbed systemically.
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Elimination Pathways: Primarily local elimination through tear drainage. Minimally absorbed components are primarily excreted renally. Hepatic metabolism plays a role in the systemic clearance of sulphacetamide and Chlorpheniramine maleate.
Dosage
Standard Dosage
Adults: 1-2 drops in the affected eye(s) every 2-4 hours, or as directed by the physician. The frequency can be reduced as the infection improves.
Children: Dosage should be determined by a pediatrician, considering the child’s age, weight, and the severity of the infection. Lower concentrations and less frequent administration may be appropriate.
Special Cases:
- Elderly Patients: Generally, the standard adult dosage is applicable, but close monitoring for potential adverse reactions is advised. Dose adjustments might be needed based on comorbidities and organ function.
- Patients with Renal Impairment: Caution is advised, and dosage adjustment might be necessary based on the degree of impairment, as minimal systemic absorption can occur.
- Patients with Hepatic Dysfunction: Similar to renal impairment, caution is recommended due to potential metabolic implications if absorbed systemically.
- Patients with Comorbid Conditions: Consider individual patient factors like diabetes, cardiovascular disease, and other conditions that could influence drug metabolism or response.
Clinical Use Cases
The provided sources focus on the use of this combination for bacterial eye infections and do not provide specific dosage recommendations for settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. For such scenarios, consult specialized resources and guidelines.
Dosage Adjustments
Dosage modifications are determined based on individual patient-specific factors, including age, weight, severity of the infection, renal and hepatic function, and any underlying medical conditions.
Side Effects
Common Side Effects
- Transient local irritation, burning, or stinging upon instillation
- Temporary blurred vision
Rare but Serious Side Effects
- Allergic reactions (e.g., itching, redness, swelling, severe burning or stinging)
- Stevens-Johnson syndrome (rare but serious skin reaction)
Long-Term Effects
Long-term use of topical sulphacetamide can potentially lead to secondary fungal infections. Resistance to sulphonamides can develop with prolonged or repeated use.
Contraindications
- Known hypersensitivity to sulfonamides or any component of the formulation.
- Individuals with severe dry eye (keratoconjunctivitis sicca).
Drug Interactions
- Silver preparations: Incompatibility with silver salts in topical ocular medications.
- Other topical eye medications: Concurrent use of other eye drops should be separated by at least 5-10 minutes.
Pregnancy and Breastfeeding
- Pregnancy: This combination should be used during pregnancy only if clearly needed and under the strict supervision of a physician.
- Breastfeeding: It is unknown whether sulphacetamide is excreted in human milk. Caution should be exercised when administering this drug to nursing mothers. Consider the potential risk to the infant.
Drug Profile Summary
- Mechanism of Action: Bacteriostatic (sulphacetamide), antiseptic (zinc sulfate and boric acid), antihistamine (chlorpheniramine maleate).
- Side Effects: Local irritation, burning, stinging, blurred vision, allergic reactions.
- Contraindications: Sulfonamide hypersensitivity.
- Drug Interactions: Silver preparations, other topical eye medications.
- Pregnancy & Breastfeeding: Use with caution.
- Dosage: See above for detailed dosage instructions.
- Monitoring Parameters: Resolution of infection symptoms, ocular tolerance.
Popular Combinations
The given formulation itself represents a common combination. There is limited clinical data to support the use of this specific combination with other drugs for additive effects. Always follow prescriber instructions.
Precautions
- General Precautions: Assess for allergies and pre-existing ocular conditions.
- Specific Populations: Monitor pregnant/breastfeeding women and children carefully.
- Lifestyle Considerations: No specific lifestyle restrictions are generally associated with topical ocular use, but it is recommended to avoid activities requiring clear vision immediately after application due to potential temporary blurring.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Boric Acid + Chlorbutol + Chlorpheniramine Maleate + Sodium Chloride + Sulphacetamide + Zinc Sulphate Monohydrate?
A: The typical adult dosage is 1-2 drops in the affected eye every 2-4 hours. Pediatric and special population dosages should be determined by a physician.
Q2: What are the most common side effects?
A: Transient burning, stinging, and blurred vision are common.
Q3: Is it safe to use during pregnancy?
A: Use only if clearly needed and under strict medical supervision.
A: It’s generally recommended to avoid wearing contact lenses during treatment for eye infections. Consult your doctor.
Q5: What should I do if I miss a dose?
A: Instill the missed dose as soon as remembered, and then return to the regular dosing schedule. Do not double the dose.
Q6: How long does it take to see improvement?
A: Improvement usually occurs within a few days, but complete the full course of treatment as prescribed, even if symptoms subside.
Q7: Can I use this medication for other eye problems besides bacterial infections?
A: No, this combination is specifically indicated for bacterial eye infections. Do not self-treat other eye conditions.
Q8: What should I do if I experience severe side effects?
A: Discontinue use immediately and seek medical attention.
Q9: Can this medication interact with other medications I’m taking?
A: It can potentially interact with silver preparations and other topical eye medications. Inform your doctor about all other medications you are using.