Akular LS (ketorolac) 0.4% 5ml eye drops

Composition 

1 ml eye drops contains:

Active substance

Ketorolac trometamol – 4, 0 mg.

Auxiliary substance

Sodium chloride – 7, 9 mg, disodium edetate – 0, 15 mg octoxynol – 40-0, 03 mg benzalkonium chloride 0, 06 mg, 1 M hydrochloric acid to pH 7, 3-7, 5, 1 M sodium hydroxide solution to pH 7, 3 – 7, 5, purified water to 1 ml. 

In flakone-kapelnyte to 5 ml. In a cardboard box 1 dropper bottle. 

Indications for use

Symptomatic treatment: Pain, foreign body sensation, burning sensation in the eye.

Photophobia.

Watery eyes after refractive surgery on the cornea.

 Pharmacokinetics

Suction

During the installation of a solution of Ketorolac trometamol in the form of eye drops systemic absorption is low.

Distribution

Ketorolac is actively distributed in the tissues of the eye, while the major part is retained in the tissues of the cornea and the sclera. The maximum concentration of drug in the tissue is determined through 0, 5-1 h after application, with the exception of the iris and ciliary body, where the maximum concentration (T max ) is detected 4 hours after application.

Metabolism

With systemic use of Ketorolac is metabolized in the liver. Metabolites of Ketorolac are: R-hydroxyketones, polar metabolites and glucuronide conjugate of Ketorolac and several unknown metabolites.

Breeding

A large part of Ketorolac is excreted in the urine and minor – through the intestines.

Clinical pharmacology

Ketorolac is a nonsteroidal anti-inflammatory agent that possesses analgesic, anti-inflammatory, antipyretic action due to inhibition of prostaglandin synthesis.

Application of pregnancy and breastfeeding

Pregnancy

Controlled studies of Ketorolac in pregnant women have not been conducted. In connection with the known effect of drugs that inhibit prostaglandin synthesis, on the development of the cardiovascular system of the fetus (closure of the ductus arteriosus), avoid use of the drug, Acular LS late-term (third trimester) of pregnancy. In the earlier stages (I and II trimester) of pregnancy to use the drug, Acular drugs should be used with caution, and only if the expected benefit to the mother outweighs the potential risk to the fetus.

Lactation

Due to the low systemic absorption of Ketorolac in the local application, effect of the drug on children who are breastfed, are expected. However, the women in lactation should be used, Acular PM with caution in the absence of data on excretion of the drug in breast milk when applied topically. In systemic and oral administration of Ketorolac passes into breast milk.

Contraindications

Hypersensitivity to the drug.

Pregnancy (III trimester).

Children up to age 3 years.

With caution:

With hypersensitivity to acetylsalicylic acid phenylacetic acid derivatives and other NSAIDs because of possible cross-sensitivity with Ketorolac.

During pregnancy (I and II trimenon).

Lactation.

When the tendency to hemorrhage and with concomitant administration of drugs that increase bleeding time.

Patients with ophthalmological complications in the postoperative period, with the violation of innervation of the cornea, defects of the corneal epithelium, diabetes mellitus, diseases of the mucous membrane of the eye (e.g., the syndrome of “dry eye”), with concomitant rheumatoid arthritis, as well as with small intervals between repeated eye operations because of high risk of development of undesirable reactions of the cornea, which can threaten vision loss.

Side effect

Based on the experience of the drug, Acular BOS as part of a clinical study suggest the development of adverse reactions in accordance with the following frequency:

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On the part of the organ of vision

Often, conjunctival hyperemia, corneal infiltrates, tissue swelling eyes and eye pain.

From the nervous system

Often – headache.

Interaction

Acular, LS can be used in conjunction with other ophthalmic medications: antibiotics, beta-blockers, carbonic anhydrase inhibitors, cycloplegics and mydriatic drugs.

All preparations of NSAIDs, including Ketorolac, can slow down the healing of wounds in the postoperative period. Concomitant use of ocular forms of NSAIDs and corticosteroids may have more to lengthen the healing period.

Overdose

No reported cases of drug overdose, Acular PM.

Method of application and doses

Topically instilled into the conjunctival SAC of the operated eye 1 drop 4 times a day as needed to resolve clinical symptoms within 4 days after the refractive surgery on the cornea.

Precautionary measures

Due to the presence of some NSAID effect on platelet aggregation that may increase the bleeding time, the use of eye forms of NSAIDs after ophthalmic surgery may increase the risk of bleeding in the tissues of the eyes, in particular, to contribute to givemy.

The long local application of NSAIDs may develop keratitis, thinning and destruction of the corneal epithelium, erosions, ulcerative lesions of the cornea or perforation. These phenomena can threaten vision loss. In patients with signs of destruction of the corneal epithelium should immediately stop taking the drug and to carefully monitor the condition of the cornea.

The use of local NSAIDs within 24 hours before surgical operation on the cornea and more than 14 days thereafter may increase the risk of complications in the cornea and their severity.

Acular, LS not recommended for use in individuals who use contact lenses.

Use in children

The safety and efficacy of Ketorolac in children up to 3 years has not been studied.

Use in elderly patients

There were no differences of efficacy and safety of the drug in elderly patients and young patients.

Effects on ability to drive vehicles and management mechanisms

When instillation of the drug, Acular drugs may transient blurred vision, so it is necessary to refrain from driving and performing activities that require high concentration and psychomotor speed reactions, to restore vision. 

Storage conditions

Keep at temperature not exceeding 25 °C.

Expiration date: 1.5 years. After first opening of the dropper bottle is 28 days.

Store in places inaccessible to children.

Do not use after the expiry date.