Professional Information
Nedocromil (Ophthalmic)
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VA CLASSIFICATION
Primary: OP801
Commonly used brand name(s): Alocril.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Mast cell stabilizer (ophthalmic) —
antiallergic (ophthalmic)—
Indications
Accepted
Conjunctivitis, allergic (treatment)—Nedocromil ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis. {01}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
415.30 {01}
pH
4.0 to 5.5 {01}
Mechanism of action/Effect:
Nedocromil sodium is a mast cell stabilizer and inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have been demonstrated. {01}
Other actions/effects:
In vitro studies showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub-type and β-glucuronide release from macrophages.{01}
Absorption:
Low — less than 4% of the total dose was systemically absorbed following multiple doses of a 2% ophthalmic solution.{01}
Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva.{01}
Biotransformation:
Nedocromil sodium is not metabolized.{01}
Elimination:
Urine — 70%
Feces — 30%
Precautions to Consider
Carcinogenicity/Mutagenicity
A 2 year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential. {01}
Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assay. {01}
Pregnancy/Reproduction
Fertility—
Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose on a mg/kg basis). {01}
Pregnancy—
Reproduction in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. {01}
FDA Pregnancy Category B {01}
Breast-feeding
It is not known whether nedocromil is distributed into human breast milk. {01}
Pediatrics
Safety and effectiveness in children below the age of 3 years have not been established.{01}
Geriatrics
No overall differences in safety or effectiveness have been observed between elderly and younger patients. {01}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problems exist
» Sensitivity to nedocromil
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Headache —40%
nasal congestion (stuffy nose)— 10 to 30%
ocular burning, irritation and stinging — 10 to 30%
unpleasant taste —10 to 30%
asthma (cough; difficulty breathing ; noisy breathing; shortness of breath ; tightness in chest; wheezing)—1 to 10%
conjunctivitis (redness, pain, swelling of eye, eyelid, or inner lining of eyelid; burning, dry or itching eyes; discharge; excessive tearing)—1 to 10%
eye redness — 1 to 10%
photophobia (blurred vision ; change in color vision; difficulty seeing at night; increased sensitivity of eyes to sunlight)—1 to 10%
rhinitis (stuffy nose; runny nose; sneezing)— 1 to 10%
{01}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Nedocromil (Ophthalmic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Proper use of this medication
» Proper dosing
Using as soon as possible; not using if almost time for next scheduled dose; not doubling doses
Proper storage
Precautions while using this medication
Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis {01}
Side/adverse effects
Signs of potential side effects, especially headache, ocular burning, stinging and irritation, unpleasant taste and nasal congestion.
For ophthalmic dosing forms:
Treatment should be continued throughout the period of exposure (i.e. pollen season) or until exposure to the offending allergen is terminated. {01}
Ophthalmic Dosage Forms
NEDOCROMIL SODIUM OPHTHALMIC SOLUTION
Usual Adult Dose
Conjunctivitis, allergic
Topical, to the conjunctiva, 1 or 2 drops in each eye twice daily.{01}
Note: Nedocromil ophthalmic solution should be used at regular intervals. {01}
Usual Pediatric Dose
See Usual adult dose.
Usual Geriatric Dose
See Usual adult dose.
Strength(s) usually available
U.S.—
2% nedocromil sodium (Rx) [Alocril (benzalkonium chloride 0.01%) (edetate disodium 0.05%)]
Packaging and storage:
Store between 2 and 25 °C (36 and 77 °F). Keep tightly closed. {01}
Auxiliary labeling:
• For the eye.
Developed: 03/28/2000
Revised: 08/07/2000
References
- Product Information: Alocril™, nedocromil sodium ophthalmic solution. Allergan, Irvine, CA, (PI revised 1999) reviewed 03/2000.
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