Diclosphere Diclofenac Sodium Ophthalmic Solution

DICLOSPHERE EYE DROPS
(DICLOFENAC SODIUM OPHTHALMIC SOLUTION)

 

Composition

Each ml contains:
Diclofenac sodium BP 0.1% w/v
Phenylmercuric Nitrate BP 0.001% w/v (As preservative)

 

Pharmacological classification

Nonsterioodal anti-inflammatory.

 

Pharmacological action

Enzyme inhibition in biosynthesis of prostaglandin and anti- inflammatory and analgesic properties. Penetrates the anterior chamber in human eyes, with a rapid onset of action that lasts several hours. It reduces the inflammatory reactions of the anterior ocular segments caused by mechanical and allergic factors. The miosis induced by surgical trauma is inhibited by diclofenac and as such it is effective as pro-surgical medication e.g. in cataract surgery.

 

Indication

For the alleviation of inflammation of the anterior segment of the eye associated with cataract surgery.

 

Doses and Administration

Surgical Cover in Cataract Procedures:

Pre-operatively: 1 drop in the conjunctival sac up to 5 times during the 3 hours preceding surgery.

Post-operatively: 1 drop in the conjunctival sac 15, 30 and 45 minutes following surgery, then 3 to 5 times daily, for as long as required.

Inflammatory Conditions: conjunctivitis, keratoconjunctivitis, and corneal ulcers: 1 drop in the conjunctival sac 4 to 5 times daily, depending upon the severity of the disease.

 

Contraindications

Hypersensitivity to diclofenac or NSAIDS.

Pregnancy, lactation, young children due to the fact that it has not been studied in these cases.

 

Warnings

Pregnancy and Lactation: The safety of diclofenac in pregnancy and lactation has not been established and its use is therefore not recommended in pregnant or lactating women, unless the potential benefit to the mother outweighs the possible risk to the child.

Children: The safety and dosage ranges of diclofenac have not been established in children under 16 years of age; therefore, it is not recommended for pediatric use.

 

NOT FOR INJECTION

Use within one month after opening the container.

If irritation persists or increases discontinue the use and consult physician.

 

Precautions

The anti-inflammatory and analgesic effects of diclofenac may mask signs of infection and physicians should be alert to the development of infection in patients receiving the drug. Soft contact lenses should not be worn during treatment.
Adverse Effects

Mild to moderate burning sensation.

 

Storage

Store in cool and dark place. Keep out of reach of children.

 

Presentation

10ml Plastic Dropper bottles

 

Manufactured in India by

Ciron Drugs and Pharmaceuticals Pvt. Ltd.

N-118, 119, MIDC, Tarapur, Boisar,

Dist. Thane – 401 506.

www.cironpharma.com

 

Manufactured for

Biosphere Pharmaceuticals Ltd.

23, Ogbatulenyi Drive Federal

Trans-Nkisi GRA 3-3

Onitsha, Anambra State

NIGERIA.

Advertisements

Leave a Reply