VOLTAREN OPHTHA®
CIBA Vision
Diclofenac Sodium
Anti-inflammatory – Analgesic
Action And Clinical Pharmacology: Diclofenac is a nonsteroidal anti-inflammatory drug with analgesic properties. The mode of action is not fully known, but it does not act through the pituitary-adrenal axis, even when given systemically. Diclofenac inhibits prostaglandin synthesis by interfering with the action of prostaglandin synthetase. Prostaglandins play a critical role in many inflammatory processes of the eye and appear to play a role in the miotic response during ocular surgery. Topically applied diclofenac significantly reduces prostaglandin-synthetase activity in inflamed eyes, but does not appear to suppress the immune system.
In clinical studies diclofenac has been found to inhibit miosis during cataract surgery, to reduce inflammation following surgical interventions, trauma and in other non-infected inflammatory conditions. Diclofenac reduced the frequency and intensity of cystoid macular edema when administered prophylactically to patients undergoing cataract lens extraction with intraocular lens implantation.
Epithelialization was not adversely affected or delayed. A slight and transient elevation in the intraocular pressure (IOP) has been observed in some patients, following surgery, even with the use of diclofenac.
In man, the drug promptly passed into the aqueous humor following the topical application of 3 to 16 drops of 0.1% diclofenac to the eye. Levels of unchanged diclofenac in the aqueous humor were highly variable, ranging from 10 to 505 ng/g. There were no detectable levels of drug in plasma, indicating that no measurable systemic absorption occurs following a single instillation of the ophthalmic drops.
Indications And Clinical Uses: For the following conditions of the eye: pre- and postoperative cover (e.g., for cataract surgery); non-infected chronic conjunctivitis, keratoconjunctivitis; non-infected post-traumatic conditions of the cornea and conjunctiva.
Contra-Indications: Hypersensitivity to diclofenac or any component.
Since there exists the potential for cross-sensitivity, diclofenac should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents.
Manufacturers’ Warnings In Clinical States: 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.
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.
During prolonged use, it is recommended that physicians conduct periodic examinations of the eye, including measurement of intraocular pressure. Soft contact lenses should not be worn during treatment.
A slight and transient elevation in the intraocular pressure (IOP) has been observed in some patients, following surgery, even with the use of diclofenac.
Adverse Reactions: When instilled into the eye, diclofenac has been associated with a mild to moderate burning sensation in 5 to 15% of patients studied. This symptom was transient in nature and almost never necessitated discontinuation of treatment. In addition, there has been one report each of the following symptoms: sensitivity to light, bad taste, feeling of pressure and a stainable cornea. There have also been 2 reports of an allergic reaction. The incidence of these latter 5 symptoms was 0.2 to 0.3% of all patients studied.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: There has been limited experience with diclofenac overdosage, even when given systemically. The risk of an acute toxic response is highly remote as a 5 mL bottle of the ophthalmic drops contains a total of only 5 mg diclofenac, equivalent to just 3% of the normal recommended oral adult dose.
Dosage And Administration: Surgical Cover in Cataract Procedures: Pre-operatively: instill 1 drop in the conjunctival sac up to 5 times during the 3 hours preceding surgery. Post-operatively: instill 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 such as conjunctivitis, keratoconjunctivitis, and corneal ulcers: instill 1 drop in the conjunctival sac 4 to 5 times daily, depending upon the severity of the disease. Eye swab for culture should be taken before inititation of therapy.
Concomitant Therapy: Diclofenac may, if necessary, be safely combined with an ophthalmic corticosteroid. In clinical studies, an antihistamine and an adrenergic vasoconstrictor have been used concomitantly with the product.
In the presence of infection or if there is a risk of infection, appropriate therapy (antibiotics) should be given concurrently with diclofenac ophthalmic drops.
In surgery, diclofenac has been combined with such standard pretreatment measures as mydriatics and topical antibiotics.
Note: To prevent the active substances from being washed out when additional ophthalmic medication is used, leave an interval of at least 5 minutes between each application.
Availability And Storage: Each mL of ophthalmic solution contains: diclofenac sodium 0.1%. Nonmedicinal ingredients: preserved multi-dose bottles: boric acid, cremophor EL, edetate disodium, sorbic acid and tromethamine; single dose units: boric acid, cremophor EL, purified water and tromethamine (TRIS). Dropper bottles (preserved with sorbic acid) of 2.5, 5 and 10 mL. Single dose units (unpreserved) of 0.3 mL.
VOLTAREN OPHTHA® CIBA Vision Diclofenac Sodium Anti-inflammatory – Analgesic
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