Alrex

Name: Alrex

How supplied

ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:

5 mL (NDC 24208-353-05)
10 mL (NDC 24208-353-10)

DO NOT USE IF NECKBAND IMPRINTED WITH “Protective Seal” AND YELLOW IS NOT INTACT

Storage

Store upright between 15°–25°C (59°–77°F). DO NOT FREEZE.

KEEP OUT OF REACH OF CHILDREN.

Revised: August 2013. Bausch & Lomb Incorporated, Tampa, Florida 33637

How do I store and/or throw out Alrex?

  • Store at room temperature. Do not freeze.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Precautions

General

For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

If this product is used for 10 days or longer, intraocular pressure should be monitored.

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.

Information for Patients

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If redness or itching becomes aggravated, the patient should be advised to consult a physician.

Patients should be advised not to wear a contact lens if their eye is red. Alrex should not be used to treat contact lens related irritation. The preservative in Alrex, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling Alrex before they insert their contact lenses.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (1500 and 750 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender.

Pregnancy

Teratogenic effects

Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased postimplantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (15 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day.

Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.

There are no adequate and well controlled studies in pregnant women. Alrex Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Alrex is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

For Healthcare Professionals

Applies to loteprednol ophthalmic: ophthalmic gel, ophthalmic ointment, ophthalmic suspension

General

The most common reported side effects were anterior chamber inflammation, eye pain, and foreign body sensation.[Ref]

Ocular

Common (1% to 10%): Corneal defect, eye discharge, ocular discomfort, dry eye, epiphora, foreign body sensation in eyes, conjunctival hyperemia, ocular itching, burning on instillation
Uncommon (0.1% to 1%): Abnormal vision, blurring of vision, chemosis, conjunctivitis, conjunctival hyperemia, iritis, eye irritation, eye pain, conjunctival papillae, photophobia, uveitis, keratoconjunctivitis
Frequency not reported: Elevated intraocular pressure, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation[Ref]

Dermatologic

Rare (less than 0.1%): Urticaria, rash, dry skin, eczema[Ref]

Gastrointestinal

Rare (less than 0.1%): Diarrhea, nausea, vomiting[Ref]

Genitourinary

Rare (less than 0.1%): Urinary tract infection, urethritis[Ref]

Metabolic

Rare (less than 0.1%): Weight gain[Ref]

Nervous system

Rare (less than 0.1%): Migraine, taste perversion, dizziness, paresthesia, tinnitus[Ref]

Oncologic

Rare (less than 0.1%): Breast neoplasm[Ref]

Other

Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Chills, fever, pain, face edema
Frequency not reported: Delayed wound healing[Ref]

Psychiatric

Rare (less than 0.1%): Nervousness[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinitis, pharyngitis
Rare (less than 0.1%): Chest pain, cough[Ref]

Some side effects of Alrex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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