Akyular LS - instructions for use, dose, side effects, contraindications

Excipients: sodium chloride 7.9 mg, disodium edetate 0.15 mg, octoxynol-40 0.03 mg, benzalkonium chloride 0.06 mg, 1 M hydrochloric acid solution to pH 7.3-7.5, 1 M sodium hydroxide solution up to pH 7.3-7.5, water purified to 1 ml.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.B.15 Ketorolac

Pharmacodynamics:Ketorolac is a non-steroidal anti-inflammatory drug, has analgesic, anti-inflammatory, antipyretic effect due to oppression of prostaglandin synthesis.

Pharmacokinetics:

Suction. When instillation of a solution of ketorolac trometamol in the form of eye drops systemic absorption is low.

Distribution. Ketorolac actively distributed in the tissues of the eye, with most of it retained in the tissues of the cornea and sclera. The maximum concentration of the drug in tissues is determined after 0.5-1 h after application, with the exception of the iris and ciliary body, where the maximum concentration (T_m_Oh) is detected 4 hours after application.

Metabolism. With systemic application ketorolac is metabolized in the liver. Metabolites of ketorolac are: p-hydroxyketorolac, polar metabolites, as well as glucuronide conjugate ketorolac and a number of unknown metabolites.

Excretion. Most of ketorolac is excreted in the urine and insignificant through the intestine.

Indications:

Symptomatic treatment of pain, sensation of foreign body, burning in the eye, photophobia, lacrimation after refractive surgery on the cornea.

Contraindications:

- Hypersensitivity to the components of the drug;

- pregnancy (III trimester);

- children under 3 years.

Carefully:

- When hypersensitivity to acetylsalicylic acid, derivatives of phenylacetic acid and other NSAIDs due to possible cross-sensitivity with ketorolac;

- during pregnancy (I and II trimesters) and during lactation;

- with a tendency to bleeding and with the concomitant use of drugs that increase the time of bleeding;

- in patients with ophthalmologic complications in the postoperative period, with violation of the innervation of the cornea, defects in the epithelium of the cornea, diabetes mellitus, diseases of the eye mucosa (eg, dry eye syndrome)with concomitant rheumatoid arthritis, as well as with small intervals between repeated ophthalmic operations due to the high risk of developing unwanted corneal reactions that may threaten vision loss.

Pregnancy and lactation:

Controlled studies of ketorolac in pregnant women have not been conducted.

In connection with the known effect of preparations inhibiting the synthesis of prostaglandins on the development of the fetal cardiovascular system (closure of the arterial duct), the use of the drug Akyular LS on late terms (in the third trimester) of pregnancy should be avoided.

At earlier terms (in the first and second trimesters) of pregnancy, use the drug Akular LS with caution, and only if the expected benefit for the mother exceeds the possible risk to the fetus.

In view of the low systemic absorption of ketorolac in topical application, the effect of the drug on infants who are breastfed is not expected. Nevertheless, in women during breastfeeding should be used Akyular LS with caution, due to the lack of data on the excretion of the drug with breast milk for topical application. With systemic and oral administration ketorolac penetrates into breast milk.

Dosing and Administration:

Locally, they are instilled in the conjunctival sac of the operated eye 1 drop four times a day as needed to eliminate clinical symptoms for no more than 4 days after refractive surgery on the cornea.

Side effects:

Based on the experience of using the drug Akyular LS as part of clinical studies, it is possible to assume the development of unwanted reactions in accordance with the following frequency of occurrence: very often (> 10%), often (> 1%, <10%), infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%), very rarely (<0.01%).

From the side of the organ of vision: hasto - hyperemia of the conjunctiva, corneal infiltrates, edema of the eye tissues and pain in the eyes.

From the nervous system: hasto - headache.

Overdose:

There have been no reports of overdose of the drug Akular LS.

Interaction:

Akular LS can be used simultaneously with other ophthalmic drugs: antibiotics, beta-adrenoblockers, inhibitors of carbonic anhydrase, cycloplegic and mydriatic drugs.

All preparations of the NSAID group, including ketorolac, can slow the healing of wounds in the postoperative period.The concomitant use of ocular forms of NSAIDs and glucocorticosteroids may extend the wound healing period to a greater extent.

Special instructions:

Due to the presence of influence on platelet aggregation in some NSAIDs, which can increase bleeding time, the use of ophthalmic NSAIDs after ophthalmic surgical interventions can increase the risk of bleeding in the eye tissues, including the appearance of a hyphema.

With prolonged local application of NSAIDs, it is possible to develop keratitis, thinning and destruction of the corneal epithelium, erosion, ulcerous lesion of the cornea or its perforation. The listed phenomena can threaten loss of sight. Patients with signs of destruction of the corneal epithelium should immediately stop taking the drug and carefully monitor the condition of the cornea.

The use of local NSAIDs for 24 hours or more before surgery on the cornea and more than 14 days after it can increase the risk of complications from the cornea and their severity.

Akyular LS is not recommended for use in persons who use contact lenses. Shelf life of the drug after the first opening of the bottle-dropper is 28 days.

Use in children

The safety and effectiveness of ketorolac in children under 3 years old has not been studied.

Application in elderly patients

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

Effect on the ability to drive transp. cf. and fur:When instillation of the drug Akular LS, a short-term blurring of vision is possible, therefore, it is necessary to refrain from driving vehicles and performing activities requiring an increased concentration of attention and speed of psychomotor reactions, until vision is restored.

Form release / dosage:

Eye drops 0,4%.

Packaging:For 5 ml in a vial of IVL with a capacity of 10 ml, capped with a shockproof polystyrene cap, which is sealed with a shrinkable polymer film.

1 bottle-dropper along with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

1,5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001529

Date of registration:24.02.2012

The owner of the registration certificate:Allergen, Inc.Allergen, Inc. USA

Manufacturer: & nbsp

ALLERGAN SALES, LLC USA

Representation: & nbspAllergen of CIS SARL. LtdAllergen of CIS SARL. LtdRussia

Information update date: & nbsp24.02.2012

Illustrated instructions

Instructions

Akyular LS (Akyular LS)