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Cyclosporine Emulsion 0.4Ml

  • Manufacturer Name : Apotex
  • MFG # : 60505620202
  • NDC : 60505620202
  • Distributor Name : AmeriSource Bergen
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Additional Information

Product NameCyclosporine Emulsion 0.4 mL
ApplicationTreatment of Dry Eye Disease
Active IngredientCyclosporine
Mechanism of ActionCalcineurin inhibitor that reduces inflammation and increases tear production
Dosage FormOphthalmic Emulsion
Strength0.05%
Volume0.4 mL per vial
Preservative-FreeYes
Administration RouteOphthalmic (Eye Drops)
Duration of ActionLong-term management with continued use
Common Side EffectsTemporary burning, stinging, blurred vision, eye redness
Storage RecommendationsStore at room temperature (15-25°C), protect from light
PrecautionsAvoid touching the dropper tip to prevent contamination
PackagingIndividually packaged sterile vials
UsageChronic dry eye treatment, keratoconjunctivitis sicca, autoimmune-related ocular inflammation

Description

Cyclosporine Emulsion 0.4 mL is an ophthalmic immunomodulatory agent used for the treatment of dry eye disease and associated inflammation. It is specifically formulated to increase tear production in patients with keratoconjunctivitis sicca, a condition characterized by chronic ocular dryness and irritation.

The active ingredient, cyclosporine, is a calcineurin inhibitor that suppresses T-cell activation and cytokine release, thereby reducing immune-mediated damage to the lacrimal glands. This mechanism helps restore natural tear production and alleviates symptoms such as burning, redness, and discomfort.

The emulsion is supplied in sterile, preservative-free containers to ensure safety and efficacy. Due to its lipid-based formulation, it enhances drug retention on the ocular surface, providing prolonged therapeutic benefits. Patients are advised to shake the vial gently before administration to ensure uniform distribution of the active ingredient.

Product Properties:

Description I
Description I
DESI Drug Ind -; -
DESI Drug Ind -; -
Drug Category USES: Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.
Drug Category USES: Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.
Drug Type Code COMMON BRAND NAME(S): Cequa, Restasis
Drug Type Code COMMON BRAND NAME(S): Cequa, Restasis
HCPCS 1
HCPCS 1
Medical Coverage -
Medical Coverage -
Termination Date (SYE-kloe-SPOR-in)
Termination Date (SYE-kloe-SPOR-in)
Active Ingredients 3420 cyclosporine 59865133
Active Ingredients 3420 cyclosporine 59865133
AHFS Class 52089200 EENT ANTI-INFLAMMATORY AGENTS, MISC.
AHFS Class 52089200 EENT ANTI-INFLAMMATORY AGENTS, MISC.
DEA Class NC
DEA Class NC
Dose Form DROPPERETTE, SINGLE-USE DROP DISPENSER
Dose Form DROPPERETTE, SINGLE-USE DROP DISPENSER
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 51820 cyclosporine OPHTHALMIC DROPERETTE 0.05 %
Gen Code and Des 51820 cyclosporine OPHTHALMIC DROPERETTE 0.05 %
Inactive Ingredients 2551 polysorbates 9005645
Inactive Ingredients 2551 polysorbates 9005645
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.05%
Strength 0.05%
Common Brand Name -
Common Brand Name -
Drug Interaction -
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 16
Case Quantity 16
Drug Form Pack Size 24
Drug Form Pack Size 24
Form EMULSION
Form EMULSION
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 60X0.4
Unit Size 60X0.4
How to Use -
How to Use -
Missed Dose 24
Missed Dose 24
Notes ML
Notes ML
Overdose AB
Overdose AB
Phonetic Pronunciation -
Phonetic Pronunciation -
Precautions -
Precautions -
Side Effects -
Side Effects -
Storage 12/23/2002
Storage 12/23/2002
Uses -
Uses -

Frequently Asked Questions(FAQs)

The cost of Cyclosporine Emulsion 0.4Ml is available for registerd members only .
Cyclosporine Emulsion 0.4Ml is manufactured by Apotex.
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