Alzapred Forte

Alzapred Forte (Loteprednol) by Alza Sterile Ophthalmic Suspension 5 ml Eye Drops. Loteprednol is a topical ophthalmic corticosteroid. Alzapred Forte contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing.

They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. Corticosteroids are capable of producing a rise in intraocular pressure.

Package Contains: Each Alzapred Forte package contains an eye dropper bottle of 5ml & a leaflet.

Composition:

Each ml Contains:

Loteprednol etabonate 5mg.

(Manufacturer’s Specs.)

Excipients: Edetate disodium, Glycerin, Povidone, Tyloxapol & Benzalkonium Chloride 0.01% as preservative.

Dosage: Use as directed by the Physician or Pharmacist.

Dosage & Administration: As directed by the physician.

Indications & Usage: Alzapred Forte is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.

Loteprednol is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with Loteprednol experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (>10 mmHg) was 1% with Alzapred Forte and 6% with prednisolone acetate 1%. Alzapred Forte should not be used in patients who require a more potent corticosteroid for this indication.

Alzapred Forte is also indicated for the treatment of post-operative inflammation following ocular surgery.

Dosage & Administration: Shake well before using.

Steroid Responsive Disease Treatment: Apply one to two drops of Alzapred Forte into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Post-Operative Inflammation: Apply one to two drops of Alzapred Forte into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Contraindications: Alzapred Forte, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Alzapred Forte is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Information for Patients: This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any inflammation becomes aggravated, the patient should be advised to contact a physician. As with all ophthalmic preparations containing Benzalkonium chloride, patients should be advised not to wear soft contact lenses when using this medicine.

Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

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 this product is used for 10 days or longer, intraocular pressure should be monitored, even though it may be difficult in children and uncooperative patients.

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.

Adverse reactions/ Side Effects: Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

Ocular adverse reactions occurring in 5-15% of patients treated with Loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia.

Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied.

Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis, and pharyngitis.

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, and it did not impair fertility in either gender.

Pregnancy: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic. Loteprednol etabonate was maternally toxic at higher doses, as evidenced by significantly reduced maternal body weight gain. There are no adequate and well-controlled studies in pregnant women. Therefore, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Women: Systematic corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other outward effects. Caution should be exercised when Alzapred Forte is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Precautions/ Instruction:

Protect from heat and light.

Store below 25°C.

Keep out of the reach of children.

Use within one month after opening.

Shake well before use.

Note: For full prescribing information see leaflet in the pack.

Manufacturer & Buy Online:

Alzapred Forte eye drops are manufactured by: Alza Pharmaceuticals.

This is the link to the manufacturer: https://www.rozee.pk

You can buy it online at: https://chemistcart.pk

You can also buy it from a nearby pharmacy.