Carboxymethylcellulose sodium, Glycerin, Polysorbate 80.
Carboxymethylcellulose sodium 0.5%, glycerin 1%, polysorbate 80 0.5%.
Preservative: PURITE (stabilized oxychloro complex).
Excipients/Inactive Ingredients: Boric acid, castor oil, erythritol, evocarnitine, carbomer copolymer type A, sodium hydroxide and purified water.
Pharmacology: Pharmacodynamics: Mechanism of Action: No clinical pharmacology studies were performed with OPTIVE ADVANCED Lubricant Eye Drops. However, modes of action for the three active ingredients are described on the following text.
Carboxymethylcellulose sodium has no pharmacological receptor-mediated properties. The mode of action of carboxymethylcellulose sodium is based on its physical properties which provide a lubricant effect and prolonged residence time in the eye. Carboxymethylcellulose sodium increases tear viscosity and has pseudo-elastic (i.e., shear thinning) properties. Since carboxymethylcellulose sodium 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.
The modes of action of glycerine and polysorbate 80 in eye drops are based on their physical properties. These two substances have no pharmacological receptor-mediated properties. In the U.S., glycerine and polysorbate 80 are 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 pharmacokinetic studies have been performed with OPTIVE ADVANCED Lubricant Eye Drops. Since carboxymethylcellulose sodium is pharmacologically inert and not absorbed systemically it is not expected that safety issues will arise from the topical administration of OPTIVE ADVANCED Lubricant Eye Drops. Glycerin is a small molecule that is found throughout the body as a natural metabolic compound. In the low concentrations present in OPTIVE ADVANCED Lubricant Eye Drops, it will mix with the natural pool of glycerin in the body tissues without significant effect.
Polysorbate 80 is also pharmacologically inert and not absorbed systemically, so it is not expected that systemic safety issues will arise from the topical administration of OPTIVE ADVANCED Lubricant Eye Drops.
OPTIVE ADVANCED Lubricant Eye Drops Lubricant Eye Drops are used for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun, and may be used as a protectant against further irritation, including in patients with reduced meibomian gland function. OPTIVE ADVANCED Lubricant Eye Drops hydrates the surface of the eyes for relief of the symptoms of stinging, grittiness, or foreign body sensation caused by environmental factors. OPTIVE ADVANCED Lubricant Eye Drops also provides relief of eye discomfort and visual symptoms caused by reduced blink frequency due to prolonged television watching or concentrated computer screen work.
Instill 1 or 2 drops in the affected eye(s) as needed. If used for post-operative care (e.g., following LASIK surgery), it is recommended for the patient to follow their eye doctor's instructions.
Administration: OPTIVE ADVANCED Lubricant Eye Drops are intended for use in the eye for relief dry eye symptoms. Concomitant ocular medications should be administered at least 5 minutes apart from the instillation to avoid washout effects.
Since carboxymethylcellulose sodium and polysorbate 80 are pharmacologically inert and not absorbed systemically, the likelihood of systemic intoxication from topical overdose is not expected from the administration of OPTIVE ADVANCED Lubricant Eye Drops. Additionally, no toxic side effects are expected should accidental systemic overdose occur.
OPTIVE ADVANCED Lubricant Eye Drops is contraindicated in patients with hypersensitivity to carboxymethylcellulose, glycerin, polysorbate 80 or any of the excipients.
To avoid contamination or possible eye injury, do not touch tip of the bottle to any surface and avoid contact with the eye.
Replace the cap after using. The bottle should be kept tightly closed when not in use.
Do not use if the packaging shows evidence of tampering. Do not use if solution changes color.
Discontinue use and consult a doctor if the patient experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens.
Effects on the Ability to Drive or Operate Machinery: OPTIVE ADVANCED Lubricant Eye Drops 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. Do not use after the expiration date marked on the container.
Use in Children: Safety and effectiveness have not been demonstrated in pediatric patients.
Use in Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
There are no specific study data on the use of OPTIVE ADVANCED Lubricant Eye Drops during pregnancy and lactation in humans; however, animal studies with carboxymethylcellulose sodium (CMC) have not demonstrated any harmful effects in pregnancy. Animal studies using glycerin have shown no evidence of teratogenicity.
OPTIVE ADVANCED Lubricant Eye Drops has also not been studied in breast-feeding women; however, OPTIVE ADVANCED Lubricant Eye Drops is not expected to have significant systemic absorption; therefore, it would not be excreted in human breast milk.
OPTIVE ADVANCED Lubricant Eye Drops were evaluated for safety in subjects with dry eye symptoms. Table illustrates the incidence of adverse drug reactions reported in subjects receiving OPTIVE ADVANCED Lubricant Eye Drops in three clinical studies. (see Table.)
Click on icon to see table/diagram/image
No known drug interactions.
Store at or below 30°C.
The shelf life is 18 months. (pack size: 15 mL)
Discard unused contents 28 days after opening.
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Eye drops (multi-dose) (white, opaque to slightly translucent, viscous, buffered, sterile ophthalmic emulsion) 15 mL.