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    Carboxymethyl Cellulose Sodium Eye Drops EP 10 ml

    Each ml contains:

     Carboxymethylcellulose Sodium IP....................0.5% w/v 
     Stabilized Oxychloro 
     Complex ....................0.01% w/v 
     (As Presentative)
      Aqueous Buffered Vehicle.................... q.s.
     
    DESCRIPTION:
    Carboxymethylcelluloses Sodium Eye Drops 10 ml are sterile, clear colorless solution for ocular lubrication.

     


PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics: Carboxymethylcellulose Sodium Ophthalmic Solution is an ocular lubricant contributing to an alleviation of subjected symptoms seen in mild to moderate Dry Eye Syndrome. Following are the probable mechanism of action of Carboxymethylcellulose Sodium Eye Drops. *Contribute to correct osmotically and pH distortion generally observed in DES. * Increases humectation of the cornea surface. The sodium CMC ophthalmic solution has the capacity to restore the function of the calciform cells and improve the previous metaplasic states of epithelial cells of the conjunctiva. o The properties of CMC include viscoelasticity which contribute to the lubrication of the eye surface. This increases the stability of the precomeal tear film, which, in turn, protects the eye surface against environmental aggressions. * Similarly, due to its molecular characteristics as polysaccharide, CMC exhibits retentive properties which enhances the permanence of the compound and increases the moistening of the eye surface.

Pharmacokinetics:

Due to the high molecular weight (approx. 250,000-700,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.

 CLINICAL PARTICULARS:

Therapeutic indications Carboxymethylcellulose Sodium Eye Drops are indicated for temporary relief of burning, irritation and discomfort due to dry eye or exposure to wind, dust, sun etc. May be used as protectant against further irritation.

Posology and method of administration:

Posology Paediatric population .

The safety and efficacy of Optava in children and adolescents at the posology recommended in adults has been established by clinical experience of eye drops containing carmellose (carboxymethylcellulose), but no clinical trial data are available. Elderly population No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Method of administration

1 to 2 drops in the affected eye(s) two times a day or as needed.

Contraindications:

Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. 

Special warnings and precautions for use

NOT FOR INJECTION. FOR EXTERNAL USE ONLY

  •  If irritation persists or increases discontinue use and consult physician.
  •  Do not touch the dropper tip or to any surface since this may contaminate solution.
  •  Use the solution within one month after opening the container.
  • Do not use if solution is not clear or have suspended matter.

OVERDOSAGE:

There is no experience of overdose by the ophthalmic route. Overdose is unlikely to occur via the recommended route of administration.

Interaction with other medicinal products and other forms of interaction

 No interaction studies have been performed. 

Undesirable effects

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). 

Eye disorders:

Common:

Conjunctival hyperaemia/ocular hyperaemia, vision blurred, dry eye, instillation site reaction, eye pruritus, eye irritation and eyelid margin crusting, blepharitis, conjunctival oedema, erythema of eyelid, eye pain, eyelid oedema, eyelid ptosis, punctate keratitis.

Nervous system disorders: 

  • Common: Headache
  • Shelf Life: 24 months 

Special precautions for storage: Store in a cool & dry place. 

 Presentation:

Carboxymethyl Cellulose Sodium Eye Drops I.P.

Manufactured for: 10 ml low density polyethylene (LOPE) 10 ml vial.

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