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Azithromycin (ophthalmic): Pediatric drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AzaSite
Therapeutic Category
  • Antibiotic, Ophthalmic
Dosing: Pediatric
Bacterial conjunctivitis

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1 drop in the affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop once daily for 5 days

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Azithromycin (ophthalmic): Drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop into affected eye(s) once daily for the next 5 days

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

1% to 10%: Ophthalmic: Eye irritation (1% to 2%)

<1%, postmarketing, and/or case reports: Blurred vision, contact dermatitis, corneal erosion, decreased visual acuity, dysgeusia, eye pain, facial edema, local ocular hypersensitivity reaction (includes burning sensation of eyes, eye discharge, eye irritation, eye pruritus, stinging of eyes), nasal congestion, punctate keratitis, sinusitis, skin rash, swelling of eye, urticaria, xerophthalmia

Contraindications

Hypersensitivity to azithromycin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and dermatologic reactions, have been reported with systemic use of azithromycin.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Discontinue use and institute alternative therapy if superinfection is suspected.

Special populations:

• Contact lens wearers: Solution contains benzalkonium chloride which may be absorbed by contact lenses; contact lens should not be worn during treatment.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only; do not inject subconjunctivally or introduce directly into the anterior chamber of the eye. Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit-lamp biomicroscopy and, when appropriate, fluorescein staining.

Dosage Forms: US

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

Solution, Ophthalmic:

AzaSite: 1% (2.5 mL) [contains benzalkonium chloride, disodium edta]

Generic Equivalent Available: US

No

Pricing: US

Solution (AzaSite Ophthalmic)

1% (per mL): $106.90

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.

Additional Information

During erythromycin ointment shortage, azithromycin ophthalmic ointment has been used as an alternative treatment for ophthalmia neonatorum; however, as of March 2010 the erythromycin shortage was resolved and the FDA recommends against the use of alternative therapies, including azithromycin (CDC 2010).

Administration: Pediatric

For topical ophthalmic use only; not for injection into the eye. Wash hands before and after instillation. Contact lenses should not be worn during treatment of ophthalmic infections. Avoid touching tip of applicator to eye or other surfaces. Invert closed bottle and shake once before each use. Remove cap with bottle inverted. Tilt head back and gently squeeze inverted bottle to instill drop.

Administration: Adult

For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces. Invert closed bottle and shake once before each use. With bottle inverted, remove cap, tilt head back and gently squeeze bottle to instill drop. Wash hands before and after instillation.

Storage/Stability

Prior to use, store unopened under refrigeration at 2°C to 8°C (36°F to 46°F). After opening, store at 2°C to 25°C (36°F to 77°F) for ≤14 days; discard any remaining solution after 14 days.

Use

Treatment of bacterial conjunctivitis due to susceptible CDC coryneform group G, H. influenzae, S. aureus, S. mitis group, or S. pneumoniae (FDA approved in ages ≥1 year and adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Azithromycin may be confused with azathioprine, erythromycin

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

The amount of azithromycin available systemically following topical application of the ophthalmic drops is estimated to be below quantifiable limits. Systemic absorption would be required in order for azithromycin to cross the placenta and reach the fetus. When administered orally or IV, azithromycin crosses the placenta. Refer to the Azithromycin (Systemic) monograph for details.

Mechanism of Action

Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic absorption estimated to be negligible

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Azitroplos | Tromiatlas | Visag;
  • (BD) Bangladesh: Az | Azicin | Romycin | Zimax | Zita;
  • (CO) Colombia: Azydrop | Dobricon | Meibos;
  • (EG) Egypt: Rame Zithro;
  • (IN) India: Azemo | Azimo | Zetorin;
  • (JP) Japan: Azimycin;
  • (MX) Mexico: Azasite | Dobricon;
  • (PE) Peru: Surgot;
  • (PR) Puerto Rico: Azasite;
  • (PY) Paraguay: Tromiatlas;
  • (RU) Russian Federation: Azidrop
  1. AzaSite (azithromycin) [prescribing information]. Lexington, MA: Thea Pharma Inc; May 2022.
  2. Center for Disease Control and Prevention (CDC). Drug Notices: CDC Guidance on Shortage of Erythromycin (0.5%) Ophthalmic Ointment. 2010. Available at https://www.cdc.gov/std/treatment/drugnotices/erythromycinointmentshortage.htm
Topic 15942 Version 117.0

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