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Eyetaren Eye Drop

Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Email: altinezvisions@gmail.com
Tel: 01-7418609, 08296588658, 0708900917

Brand Name

Eyetaren Eye Drop

Manufacturer

Binex Co. Ltd. 480-2, Jangrim dong Sahu-gu, Busan, Korea.

Therapeutic Class

Nonsteroidal anti-inflammatory drugs (NSAIDs), Eye

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Eye drops (NRN A4-4171): Diclofenac sodium 1 mg per mL.

How to identify the product: Colourless or pale yellow, transparent liquid.

Pack size: 5 mL/ bottle/ box.

eyetaren

Pharmacology

Colorless or pale yellow, transparent liquid.

Diclofenac, a Phenylacetic acid derivative is a non steroidal anti-inflammatory drugs (NSAIDs). It has patent anti-inflammatory, analgesis and antipyretic properties. Diclofenac is a patent inhibitor of cyclooxygenase activity which causes an important reduction in the formation of prostaglandin, prostacyclin and thromboxane products, all of which are of inflammation.

Diclofenac also regulates the lipoxygenase pathway and the platelet aggregation.
Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac causes gastro intestinal tract damage by diminishing prostaglandin synthesis, resulting in inhibition of production of mucin that protects the gastro-intestinal tract. Prostaglandin plays a role in the blood circulation in the kidneys.

NSAIDs inhibit the prostaglandin synthesis, then may cause interstitial nephritis, glomerulonephritis, papilla necrosis and nephritic syndrome, particularly in patients with chronic renal or Cardiac impairment. In these patients, NSAIDs may promote the acute phase of renal or cardiac impairment.

[PHARMACOKINETICS]
Diclofenac is easily absorbed from the digestive tract of taken orally. The absorption is more rapid if the drug is taken on an empty stomach. Diclofenac is extensively bound to plasma proteins, mainly albumin (99%). About 50% of the orally administered dose is metabolized during the first liver passage and the systemic bioavailability is approximately 50% of that of intravenous administration.

The maximum plasma di-clofenac concentrations are reached 4-6 hours after its actions are observed 20-30 minutes after intramuscular injection, 30-60 minutes after rectal administration, 60~120 minutes after ingestion.

The plasma half life about 1-2 hours. The elimination half life from the synovial fluid is 3-6 hours. Approximately 60% of the administered dose is eliminated in the form of partially active metabolites via the kidneys, less than 1% as uncharged drug, the rest of the dose excreted via the bile and feces.

Absorption, metabolism and elimination appear to be independent of age. As long as the recommended dosages and dosage intervals are respected, there is low risk of accumulation in the case of restricted renal or hepatic funtion.

Indications

Prevention of following syndromes in the cataract operation:

  • Treatment of postoperative inflammation in patients who have undergone operation, miosis in patients postoperation, cystoids macular edema associated with intraocular lens implantation and lens extraction.
  • Inflammation treatment for anterior segment of eye chronic conjunctivitis, non-infectious inflammation, inflammation after an external wound.

Contra-indications

Hypersentivity to diclofenac or any of the excipients in the formulation.

Precautions/Warnings

The following patients should not take this drug:

  • Patients who are hypersensitive to any ingredient in this drug; aspirin, phenylacetates derivative, other non-steroidal anti-inflammatory drugs.
  • Asthmatic, itch and acute rhinitis patients after administration of other non-steroidal anti-inflammatory drugs such as Aspirin or cyclo-oxygenase inhibitors.

General cautions:

  • Do not wear soft contact lenses during the time that you are instilled and then wear it after 15 min.Blurred vision may be appeared, avoid driving or operating machines.
  • It may cover the eye infection; discontinue using in the case of infection
  • Diclofenac increases platelet aggregation time so it may affect bleeding time.

[CAUTIONS ON USE]

- Not for injection into the eye.

- Do not touch the applicator tip to any surface including the eye.

- Do not use with other people in order to prevent contamination.

- Be careful not to make the precipitation with metal ion.

- Do not change container to protect mis-use and Preserve potency.

Pregnancy and lactation:

  • Do not use this medicine after the 6th month in pregnancy.
  • This medicine passes into the breast milk, stop breast feeding.

Children: Safety in children has not yet been established.

Interactions

Diclofenac may be precipitated in the case of combination with tropicamide.

To avoid dilution of ingredients in combined administration, take with intervals of 15 min.

Adverse Effects

Delayed wound treatment. Asthma, itch, rhinitis may occur.

Rarely temporary ache, dry feeling, congestion, mydriasis after operation may occur. Sometimes superficial keratitis, corneal erosion, blurred vision, flush, photosensitivity, punctuate keratitis may occur.

Consult with doctor when the above reactions occur after administration.

Dosage & Administration

1. In the case of cataract operation

- Before Operation: 1 drop a time, 5 times for 3 hours.

- After Operation: 1 drop a time, 3 times.

- Maintenance therapy: 1 drop a time, 3-5 times a day. The period should as the symptoms.

2. Inflammation therapy of anterior segment of the eye - 1 drop a time, for 4-5 times a day

- Please take over dose or less-dose according to the symptom.

This drug is prescribed.

Storage/Handling Recommendations

Store in a tight container below 10oC.

[SHELF LIFE] 36 months from manufacturing date.

KEEP OUT OF REACH OF CHILDREN.

Review Date

2016-05-11 04:37:05