Usage
This combination medication is primarily used to treat allergic eye reactions (allergic conjunctivitis). Sodium Cromoglycate acts as a mast cell stabilizer, preventing the release of histamine and other inflammatory mediators. Zinc Sulphate Monohydrate serves as an antiseptic and astringent, providing relief from irritation and potentially preventing secondary bacterial infections.
- Pharmacological Classification: Antiallergic, anti-inflammatory, antiseptic.
- Mechanism of Action: Sodium Cromoglycate stabilizes mast cells, inhibiting the degranulation and release of histamine, leukotrienes, and other mediators responsible for allergic symptoms. Zinc Sulphate Monohydrate exerts a mild antiseptic effect and an astringent effect, causing contraction of tissues and reducing inflammation.
Alternate Names
- Cromolyn Sodium + Zinc Sulfate Monohydrate
- Sodium Cromoglicate + Zinc Sulfate Hydrate
- Cromolyn Sodium/Zinc Sulfate Monohydrate Combination
Brand Names:
- Optihist Cromz Eye Drop
- Allercrom Forte Eye Drop (Sodium Cromoglycate only)
How It Works
Pharmacodynamics: Sodium Cromoglycate inhibits mast cell degranulation, preventing the release of inflammatory mediators like histamine and leukotrienes, thereby reducing allergic symptoms. Zinc Sulphate Monohydrate acts as an antiseptic and astringent, further reducing inflammation and the risk of secondary infection.
Pharmacokinetics:
- Sodium Cromoglycate: Poorly absorbed systemically after ophthalmic administration. Primarily excreted unchanged in the bile and urine. Short half-life.
- Zinc Sulphate Monohydrate: Minimally absorbed systemically after topical ocular administration. The elimination pathway for topical zinc is not well-defined.
Mode of Action: Sodium Cromoglycate stabilizes mast cell membranes, preventing calcium influx and subsequent degranulation. It does not directly antagonize histamine receptors or inhibit histamine synthesis. Zinc Sulphate’s astringent effect arises from protein precipitation and tissue contraction. Its antiseptic effect results from the inhibition of bacterial growth.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: Sodium Cromoglycate’s primary mode of action is through the stabilization of mast cell membranes, not through receptor binding, enzyme inhibition, or neurotransmitter modulation. The exact mechanism of zinc’s antiseptic and astringent actions is not fully understood.
Dosage
Standard Dosage
Adults: Instill 1-2 drops in each affected eye four times daily, or as directed by a physician.
Children: Safety and efficacy in children have not been definitively established. For children above 5 years of age, adult dosing guidelines may be followed in some cases. Consult a pediatrician for appropriate dosing recommendations in children under 5 years, referring to specific product guidelines.
Special Cases:
- Elderly Patients: No specific dosage adjustments are typically necessary, but monitoring for adverse effects is recommended.
- Patients with Renal Impairment: No specific dosage adjustments are usually required.
- Patients with Hepatic Dysfunction: No specific dosage adjustments are usually required.
- Patients with Comorbid Conditions: Exercise caution in patients with dry eye syndrome. Adjustments may be necessary based on coexisting conditions; consult a physician.
Clinical Use Cases
The primary clinical use case for this combination is the management of allergic conjunctivitis. It is not typically used in settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dose modification is not usually required for renal/hepatic dysfunction. Adjustments may be needed for patients with dry eye or other comorbid ocular conditions.
Side Effects
Common Side Effects
- Sodium Cromoglycate: Nasal irritation (with nasal formulations), burning sensation in the eye, stinging sensation, sneezing.
- Zinc Sulphate Monohydrate: Abdominal pain, indigestion, nausea, vomiting, diarrhea, gastric irritation, gastritis (primarily with systemic administration).
Rare but Serious Side Effects
Severe allergic reactions (anaphylaxis) are rare but require immediate medical attention. Ocular hypersensitivity reactions may also occur.
Long-Term Effects
No specific long-term adverse effects have been reported with topical ocular use.
Adverse Drug Reactions (ADR)
Clinically significant ADRs are uncommon with topical use but include severe allergic reactions and hypersensitivity.
Contraindications
- Known hypersensitivity to Sodium Cromoglycate or Zinc Sulphate.
Drug Interactions
No significant drug interactions are typically reported with ophthalmic administration. However, advise patients to wait 5-10 minutes between administering different eye drops.
Pregnancy and Breastfeeding
- Pregnancy: Sodium Cromoglycate is generally considered safe to use during pregnancy. Animal studies have shown potential risks with Zinc Sulphate, but human data are limited. Consult a doctor before use during pregnancy.
- Breastfeeding: Limited information is available regarding the safety of this combination during breastfeeding. Consult a doctor before use while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Sodium Cromoglycate: Mast cell stabilization; Zinc Sulphate: Antiseptic and astringent.
- Side Effects: Burning/stinging in the eye, nasal irritation (with nasal formulations).
- Contraindications: Hypersensitivity to either component.
- Drug Interactions: No significant interactions with topical ophthalmic use.
- Pregnancy & Breastfeeding: Consult a physician before using during pregnancy or while breastfeeding.
- Dosage: 1-2 drops in each affected eye four times daily.
- Monitoring Parameters: Resolution of allergic conjunctivitis symptoms, any signs of ocular irritation or hypersensitivity.
Popular Combinations
Sodium Cromoglycate is sometimes combined with other anti-allergic eye drops (e.g., antihistamines) for added benefit in treating allergic conjunctivitis. However, always observe the recommended time interval between administrations.
Precautions
- General Precautions: Screen for allergies to components.
- Specific Populations: Monitor closely in pregnant and breastfeeding women. No dosage adjustments are usually necessary for elderly patients or those with renal/hepatic impairment, but caution is advised. Use cautiously in patients with dry eyes.
- Lifestyle Considerations: No specific lifestyle considerations are associated with topical ophthalmic use, but advise patients against driving immediately after instilling the eye drops if they experience blurred vision.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Sodium Cromoglycate + Zinc Sulphate Monohydrate?
A: The standard dosage is 1-2 drops in each affected eye four times a day.
A: It is generally recommended to avoid wearing soft contact lenses while using eye drops containing benzalkonium chloride (a common preservative) as it can be absorbed by the lenses and cause irritation. Consult your doctor for advice.
Q3: How long does it take for this medication to work?
A: It may take a few days to notice improvement, and up to several weeks for full effectiveness.
Q4: Is this medication safe to use during pregnancy?
A: Sodium Cromoglycate is generally considered safe. Data on Zinc Sulphate in pregnancy is limited, consult your doctor before use.
Q5: Can I use this medication while breastfeeding?
A: Consult your doctor before using this medication while breastfeeding as limited data is available.
Q6: What should I do if I miss a dose?
A: Instill the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule.
Q7: What are the common side effects of this medication?
A: Common side effects include burning or stinging in the eyes, and temporary blurred vision after application.
Q8: Is this medication a steroid?
A: No, neither Sodium Cromoglycate nor Zinc Sulphate Monohydrate are steroids.
Q9: What is the mechanism of action of Sodium Cromoglycate?
A: Sodium Cromoglycate stabilizes mast cells, preventing the release of histamine and other inflammatory mediators that cause allergic symptoms. It is not an antihistamine.
Q10: Can this medication be used for other types of eye infections?
A: This combination is specifically indicated for allergic conjunctivitis. It is not intended for other types of eye infections, such as bacterial or viral conjunctivitis. Consult your doctor for appropriate treatment for other eye conditions.
