QUPEN FORTE

ATX code: S01BC05

INSTRUCTIONS FOR USE

CUPEN FORTE

KYUPEN FORTE 

 

Trade name of the drug : Kupin Forte

Active ingredient (INN) : ketorolac tromethamine

Dosage form : eye drops 0.4% and 0.5%

Composition

Each ml of solution contains:

active substance : ketorolac tromethamine – 4 mg and 5 mg;

excipients : benzalkonium chloride, sodium chloride, sodium EDTA, polysorbate, hypromellulose, water for injection.

Description : colorless or slightly yellowish transparent liquid.

Pharmacotherapeutic group : non-steroidal anti-inflammatory drug.

Code ATH : S01BC05

 

Pharmacological properties

It has a pronounced analgesic and moderate anti-inflammatory effect due to inhibition of the activity of cyclooxygenase, the main enzyme in the metabolism of arachidonic acid. This leads to a decrease in the level of prostaglandins in the aqueous humor of the anterior chamber of the eye, which play a major role in the pathogenesis of inflammation and pain. The drug does not affect intraocular pressure. When instilled into the eye, systemic absorption of the drug is very low.

 

Pharmacokinetics

When ketorolac tromethamine solution is instilled in the form of eye drops, systemic absorption is low. Ketorolac is actively distributed in the tissues of the eye, with most of it retained in the tissues of the cornea and sclera. C max  in tissues is determined 0.5-1 hour after application, with the exception of the iris and ciliary body, where C max  is detected 4 hours after application.

 

Indications for use

Reducing pain and preventing inflammation in the postoperative period after cataract removal and other surgical interventions on the anterior segment of the eye.

Inflammatory pain syndrome in diseases of the anterior part of the eye of a non-infectious nature (including chronic non-infectious conjunctivitis). Relieving tingling in the eyes with seasonal allergic conjunctivitis.

Suppression of miosis during cataract extraction surgery.

 

Directions for use and doses

The drug is used by adults and children over 12 years of age by instillation into the conjunctival sac.

Before surgery: 1 drop 5 times within 3 hours before surgery.

In the postoperative period: 1 drop 3 times a day immediately after surgery; then 1 drop 4 times a day for the time required for treatment (7-10 days).

In the treatment of inflammatory pain syndrome, to relieve tingling in the eyes with seasonal allergic conjunctivitis: 1 drop 4 times a day until clinical cure, but not more than 10 days.

 

Side effects

Transient burning and tingling after instillation, allergic reactions, corneal edema, superficial keratitis.

When used for more than 14 days, damage to the integrity of the cornea is possible: thinning, erosion, ulceration and perforation; dry eye syndrome, associated eye infection.

With prolonged uncontrolled use, some patients may experience systemic side effects – headache, dizziness, drowsiness, increased blood pressure.

 

Contraindications

  • hypersensitivity to ketorolac and other non-steroidal anti-inflammatory drugs.
  • cerebral hemorrhages.
  • pregnancy and lactation period.
  • The drug is not recommended for use in children under 12 years of age.

 

Drug interactions

If necessary, the drug can be combined with eye drops containing antibiotics, beta blockers, carbonic anhydrase inhibitors and mydriatics; the break between instillations should be at least 5 minutes. When combined with steroids, the wound healing process is prolonged.

When used simultaneously with other non-steroidal anti-inflammatory drugs, pentoxifylline, anticoagulants, the risk of postoperative bleeding may increase.

 

special instructions

Use with caution in patients with a history of reduced blood clotting.

When wearing soft contact lenses, remove the lenses five minutes before instillation and put them on 15 minutes after taking the medication.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

Effect on the ability to drive and use cars

Use with caution in patients who temporarily lose clarity of vision after application; It is not recommended to drive a car or work with complex machinery, machines or any complex equipment that requires clear vision immediately after instillation.

The drug should be stored out of the reach of children and not used after the expiration date.

 

Overdose

If the method of administration is followed, an overdose is impossible. If your condition worsens or allergic reactions occur, you should stop taking the drug and consult a doctor.

 

Release form

5.0 ml in PVC bottles with a dropper cap, which, together with instructions for use, are placed in a cardboard package.

 

Food conditions

At a temperature not exceeding 25 0 C in a dry, dark place

 

Best before date

2 years.

After opening, use the contents of the bottle within a month.