Cellufresh

Carboxymethylcellulose sodium.

The lubricating properties of carboxymethylcellulose (CMC), the active ingredient in Cellufresh provides long-lasting relief from the dry, scratchy feeling of dry eye irritation.
In addition, Cellufresh contains electrolytes found in own natural tears. Therefore, Cellufresh not only provides comforting relief from dry eye irritation, it also supplements the natural electrolyte balance of own tears.
Each mL contains carboxymethylcellulose sodium 5 mg.
Excipients/Inactive Ingredients: Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate, hydrochloric acid or sodium hydroxide and purified water.
Preservative Free.

Pharmacology: Pharmacodynamics: No clinical pharmacology studies were performed with Cellufresh.
CMC has no pharmacological receptor-mediated properties. The mode of action of CMC is based on its physical properties which provide a lubricant effect and prolonged residence time in the eye. CMC increases tear viscosity and has pseudo-elastic (i.e. shear thinning) properties. Since CMC is an ionic polymer containing carboxyl and hydroxyl groups, its chemical structure is similar to mucin in the tear film, and thus it has mucoadhesive properties. These properties promote prolonged residence times in the eye which alleviate the symptoms of tear deficiency.
In the U.S., carboxymethylcellulose is described as an ophthalmic demulcent; an agent which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation.
Pharmacokinetics: No ocular pharmacokinetic studies have been performed. Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, it is not expected that patient safety concerns will arise from the topical administration of Cellufresh.

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or due to exposure to wind or sun.
Also may be used as a protectant against irritation caused by eye dryness.

Recommended Dose: Instill 1 or 2 drops in the affected eye(s) as needed.
Mode of Administration: Concomitant ocular medications should be administered at least 5 minutes apart from the instillation of Cellufresh to avoid washout effects.

Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically, systemic intoxication from topical overdose is not expected from ocular administration of Cellufresh. Additionally, no toxic side effects are expected should accidental systemic overdose occur.

Cellufresh is contraindicated in patients with hypersensitivity to any ingredient in this product.

To avoid contamination or possible eye injury, do not touch tip of the vial to any surface and avoid contact with the eye.
Discard the vial immediately after use.
Do not reuse.
Do not use if Cellufresh packaging shows evidence of tampering. Do not use if solution changes color or becomes cloudy.
Discontinue use of Cellufresh and consult a doctor if patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
Effects on Ability to Drive and Use Machines: Cellufresh may cause transient blurring of vision which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.
Use in Children: Safety and effectiveness have not been demonstrated with Cellufresh in pediatric patients.
Use in the Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Pregnancy: There are no specific study data on the use of Cellufresh during pregnancy and lactation in humans; however, nonclinical studies with CMC have not demonstrated any harmful effects in pregnancy.
Lactation: Cellufresh has also not been studied in breast-feeding women; however, CMC is not expected to be systemically absorbed; therefore, it would not be expected to be excreted in human breast milk.

Clinical Study Experience: Allergan has conducted multiple clinical studies with CMC.
The CMC family of products include Cellufresh MD, Cellufresh, Celluvisc MD, and Celluvisc Lubricant Eye Drops. (See table.)

Click on icon to see table/diagram/image

Postmarketing Experience: The following additional adverse reactions have been identified during postmarketing use of Cellufresh in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.
Eye Disorders: Eye discharge, ocular hyperaemia.
Immune System Disorders: Hypersensitivity including eye allergy.
Injury, Poisons and Procedural Complications: Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion.

No known drug interactions.

Store below 30°C.

Ophthalmic Lubricants

S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.

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