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Components:
Nedocromil
Method of action:
Drugs For Obstructive Airway Diseases
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.15

Qualitative and quantitative composition

Nedocromil

Therapeutic indications

The information provided in Therapeutic indications of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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For the prevention, relief and treatment of allergic conjunctivitis, including seasonal allergic conjunctivitis, allergic conjunctivitis and vernal-kerato conjunctivitis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Adults (including the elderly) and children aged 6 years and over:

In seasonal allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily. In seasonal allergic conjunctivitis therapy should be restricted to 12 weeks.

In vernal kerato-conjunctivitis: one drop into each eye four times daily.

Adults (including the elderly):

In perennial allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily.

Kovinal should be used regularly to ensure optimum control of symptoms.

There is only limited clinical trial evidence with Kovinal in children aged below 6 years, therefore use in this age range cannot be recommended.

Contraindications

The information provided in Contraindications of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Kovinal Eye Drops is contraindicated in patients with known hypersensitivity to nedocromil sodium, benzalkonium chloride or other constituents of the formulation.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Patients should be advised not to wear soft contact lenses during treatment with Kovinal Eye Drops. Benzalkonium chloride, a constituent of the formulation, may accumulate in soft contact lenses. This preservative, when slowly released, could possibly irritate the cornea.

In patients who continue to wear hard or gas-permeable contact lenses during Kovinal Eye Drops treatment, the lenses should be taken out of the eye prior to instillation of the drops. They should be inserted again not earlier than 10 minutes after administration, in order to allow an even conjunctival distribution of the solution.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Kovinal Eye Drops has no known effect on the ability to drive or operate machinery.

Additionally, no sedative effects have been reported following the administration of Kovinal Eye Drops.

Undesirable effects

The information provided in Undesirable effects of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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The following frequency rating has been used, when applicable:

Very common (>=1/10); common (>=1/100 to <1/10); uncommon (>=1/1,000 to <1/100); rare (>=1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

In clinical studies conducted in patients treated with nedocromil sodium 2% eye drops, the following adverse events have been reported at the corresponding frequencies:

System organ class

Very common

(> 10 %)

Common

(> 1 % and < 10 % )

Uncommon

(> 0.1 % and < 1 %)

Rare

(> 0.01 % and < 0.1 %)

Very rare

(< 0.01%)

Frequency not known (cannot be estimated from available data)*

Eye disorders

Burning in eye, eye stringing, soreness in eyes

Eye irritation

Nervous system disorder

Dysgeunsia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Animal studies have not shown evidence of significant toxic effects with nedocromil sodium even at high doses, nor have extended human studies with nedocromil sodium revealed any safety hazard with the drug. Overdosage is, therefore, unlikely to cause problems. However, if overdosage is suspected, treatment should be supportive and directed to the control of the relevant symptoms.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Decongestant and other antiallergics

ATC code: S01G X04

Kovinal, the ophthalmic preparation of nedocromil sodium, displays specific anti-allergic and anti-inflammatory properties. Nedocromil sodium has been shown to prevent the release of inflammatory mediators from a range of inflammatory cell types.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Following topical ophthalmic administration, less than 4% of the dose is absorbed following multiple dosing. Absorption occurs primarily through the nasal mucosa as approximately 80% of the ophthalmic dose drains into the nose via the naso-lachrymal duct, although 1-2% of the dose may be absorbed orally.

Nedocromil sodium is reversibly bound to plasma proteins and is not metabolised, but is excreted unchanged in bile and urine. The drug is rapidly cleared from the plasma (plasma clearance 10.2 + 1.3 ml/min/kg - elimination half-life 5.3 + 0.9 min) and accumulation does not occur.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Decongestant and other antiallergics

Preclinical safety data

The information provided in Preclinical safety data of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Animal studies have failed to reveal toxic effects with nedocromil sodium even at high doses.

Incompatibilities

The information provided in Incompatibilities of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Kovinal is based on data of another medicine with exactly the same composition as the Kovinal of the medicine (Nedocromil). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Kovinal directly from the package or from the pharmacist at the pharmacy.
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No special requirements for disposal.

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