Carbomer 3 mg/g.
Excipients/Inactive Ingredients: Sorbitol, benzalkonium chloride, sodium hydroxide, purified water to 1 g.
Pharmacotherapeutic group: Artificial tears and other indifferent preparations. ATC code: S01X A 20.
Pharmacology: Pharmacodynamics: CARBOMER (LACRYVISC) Sterile Ophthalmic Gel has no pharmacological activity. The gel forms a protective and wetting film over the cornea and is used as tear substitute. CARBOMER (LACRYVISC) Sterile Ophthalmic Gel has a higher viscosity when compared to aqueous solutions. In spite of this higher viscosity, the gel easily mixes with the tear fluid. After mixing with the tear fluid, the gel forms a wetting transparent film over the surface of the eye without impairing vision. This film is used as a substitute for tear fluid or a qualitatively deficient lachrymal film and thus enables a frictionless movement of the eyelid over the surface of the eye. The eye surface is protected against dryness.
Harmful effects after topical application have not been observed. However, if they should occur, systemic absorption of the small amounts prescribed or even accidental ingestion of the content of a whole tube will not cause toxicological effects.
Pharmacokinetics: In order to assure an effective action CARBOMER (LACRYVISC) Sterile Ophthalmic Gel should remain as long as possible onto the eye surface and should not penetrate the eye. This is guaranteed by its physico chemical properties. Absorption and accumulation of the polymer in the eye tissue is not to be expected because of the high molecular weight. Dependent upon the seriousness of the affection, CARBOMER (LACRYVISC) Sterile Ophthalmic Gel provides relief of the complaints for 3 to 4 hours.
Toxicology: Preclinical safety data: No information provided.
"Dry eye" affections, lachrymal substitute for all affections accompanied by insufficient or defective wetting of the surface of the eye.
Instill 1 drop in the conjunctival sac 4 times daily or as needed. The tube should be held vertically. Contact with the eyes should be avoided. This technique prevents the drop from becoming too big for the contents of the conjunctival sac and eyelashes from sticking together.
In order to prevent infection, the tip of the tube should not come into contact with the eye or eyelids.
No case of overdose has been reported. Overdose is unlikely because of the limited capacity of the conjunctival sac of the eye. An overdose of CARBOMER (LACRYVISC) Sterile Ophthalmic Gel can easily be washed out of the eye with lukewarm tap water. Components of CARBOMER (LACRYVISC) Sterile Ophthalmic Gel are generally regarded as non-toxic materials. Hence toxicity after inadvertent oral ingestion is extremely unlikely.
Hypersensitivity to carbomer or to any of the excipients of this preparation.
For ocular use only. Not for injection or ingestion.
Contact lenses should not be worn during treatment with CARBOMER (LACRYVISC) Sterile Ophthalmic Gel. CARBOMER (LACRYVISC) Sterile Ophthalmic Gel contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided. Patients should be advised to remove their contact lenses prior to the application of CARBOMER (LACRYVISC) Sterile Ophthalmic Gel and wait at least 15 minutes before reinsertion.
If patients experience eye pain, vision changes, irritation of the eyes, persistent redness, or if the condition worsens or persists, discontinue use and consult a doctor.
Effects on ability to drive and use machines: CARBOMER (LACRYVISC) Sterile Ophthalmic Gel has no or negligible influence on the ability to drive or use machines. As with any ophthalmic gel, temporary blurred vision or other visual substances may affect the ability to drive or use machines. Sight may be impaired temporarily until the gel is evenly distributed over the surface of the eye. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Pregnancy: There are no or limited amount of data from the use of CARBOMER (LACRYVISC) Sterile Ophthalmic Gel in pregnant women. However, the component carbomer exert a surface protective effect and is not pharmacologically active. This component is not expected to be absorbed systemically, to demonstrate any systemic toxicity or to have any effect on reproduction or embryofetal development. CARBOMER (LACRYVISC) Sterile Ophthalmic Gel can be used during pregnancy.
Lactation: There are no adequate data on the use of CARBOMER (LACRYVISC) Sterile Ophthalmic Gel during lactation. It is unknown whether carbomer or any of the components are excreted in human milk. Nonetheless, discontinuation of product use during breast-feeding is not considered necessary. CARBOMER (LACRYVISC) Sterile Ophthalmic Gel can be used during breast-feeding.
Summary of the safety profile:
In clinical trials involving 207 patients using Carbomer Ophthalmic Gel 0.3%, the most common adverse drug reactions were blurred vision and eyelid margin crusting occurring in approximately 3% to 4% of patients.
Tabulated summary of adverse reactions:
The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and postmarketing spontaneous reports. (See Table 1.)
Click on icon to see table/diagram/image
Additional adverse reactions identified from post-marketing
surveillance include the following. Frequencies cannot be estimated from the
available data. (See Table 2.)
Click on icon to see table/diagram/image
No interaction studies have been performed.
If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Eye ointments and gels should be administered last.
Incompatibilities: Not applicable.
Store at temperatures not exceeding 25°C.
Shelf life: Discard four weeks after first opening.
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.