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Nedocromil: Pediatric drug information

Nedocromil: Pediatric drug information
(For additional information see "Nedocromil: Drug information" and see "Nedocromil: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Alocril
Brand Names: Canada
  • Alocril [DSC]
Therapeutic Category
  • Antiallergic, Ophthalmic
Dosing: Pediatric
Allergic conjunctivitis

Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: 1 to 2 drops in each eye twice daily throughout the period of exposure to allergen

Dosing: Kidney Impairment: Pediatric

All patients: There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

All patients: There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Adult

(For additional information see "Nedocromil: Drug information")

Allergic conjunctivitis

Allergic conjunctivitis: Ophthalmic: 1 to 2 drops in each eye twice daily throughout the period of exposure to allergen.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic, as sodium:

Alocril: 2% (5 mL) [contains benzalkonium chloride, disodium edta]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic, as sodium:

Alocril: 2% ([DSC]) [contains benzalkonium chloride, disodium edta]

Administration: Pediatric

Ophthalmic: Instill drops into conjunctival sac; do not allow tip of container to touch eye, surrounding structures, fingers, or other surfaces to avoid bacterial contamination. Use of contact lenses not recommended during periods of symptomatic allergic conjunctivitis.

Administration: Adult

For ophthalmic use only; do not allow tip of container to touch eye, surrounding structures, fingers, or other surfaces to avoid bacterial contamination. Use of contact lenses not recommended during periods of symptomatic allergic conjunctivitis.

Storage/Stability

Store at 2°C to 25°C (36°F to 77°F).

Use

Treatment of itching associated with allergic conjunctivitis (FDA approved in ages ≥3 years and adults)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (40%)

Gastrointestinal: Unpleasant taste

Ophthalmic: Burning sensation of eyes, eye irritation, stinging of eyes

Respiratory: Nasal congestion

1% to 10%:

Ophthalmic: Conjunctivitis, eye redness, photophobia

Respiratory: Asthma, rhinitis

Contraindications

Hypersensitivity to nedocromil or any component of the formulation

Warnings/Precautions

Dosage form specific issues:

• Ophthalmic solution: Contains benzalkonium chloride, which may be absorbed by contact lenses; users of contact lenses should not wear them during periods of symptomatic allergic conjunctivitis.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Nedocromil has minimal systemic absorption.

Monitoring Parameters

Eye burning, stinging, irritation; photophobia.

Mechanism of Action

Inhibits the activation of and mediator release from a variety of inflammatory cell types associated with hypersensitivity reactions including eosinophils, neutrophils, macrophages, mast cells, monocytes, and platelets; it inhibits the release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis.

Pharmacokinetics (Adult data unless noted)

Absorption: Low (<4%)

Excretion: Urine 70% (as unchanged drug); feces 30% (as unchanged drug)

Pricing: US

Solution (Alocril Ophthalmic)

2% (per mL): $53.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Irtan (DE);
  • Kovilen (IT);
  • Kovinal (IT);
  • Oftacril (PE);
  • Rapitil (GB);
  • Tilad (AT, ES);
  • Tilade (AR, AT, FI, GB, GR, HU, ID, IT, KR, LU, NL, PL, RU, SK);
  • Tilade CFC Free (AU, NZ);
  • Tilade Mint (AE, BH, CY, CZ, IQ, IR, JO, KW, LB, LY, OM, PL, SA, SG, SY, YE);
  • Tilarin (IT);
  • Tilavist (AT, DK, ES, FR, IT, NL, PL, PT, SE)


For country code abbreviations (show table)
  1. Alocril (nedocromil sodium solution/drops) [prescribing information]. Madison, NJ: Allergan Inc; June 2018.
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