Kalanta (Drops) Instructions for Use

Marketing Authorization Holder

Gerta, LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substance

Naphazoline (Rec.INN registered by WHO)

Dosage Form

Kalanta

Eye drops 0.05%: bottle 10 ml

Dosage Form, Packaging, and Composition

Eye drops transparent, colorless or slightly yellowish in color.

Excipients: sodium benzoate – 2 mg, boric acid – 18.7 mg, macrogol 300 – 1.125 mg, sodium hyaluronate – 1 mg, disodium edetate dihydrate – 0.5 mg, 1M sodium hydroxide solution or 0.1M nitric acid solution – to adjust pH to 4.0-7.0, water for injections – up to 1 ml.

10 ml – low-density polyethylene bottles (1) with a dropper.

Clinical-Pharmacological Group

Drug with antiallergic and vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; decongestants and antiallergic agents; sympathomimetics used as decongestants

Pharmacological Action

Alpha-adrenomimetic. When applied to mucous membranes, it has a rapid, pronounced, and prolonged vasoconstrictive effect.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

For intranasal application: acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, laryngeal edema of allergic origin, laryngeal edema due to irradiation, hyperemia of the mucous membrane after operations on the upper respiratory tract, to facilitate rhinoscopy, to stop nosebleeds, to prolong the action of local anesthetics used for superficial anesthesia.

For use in ophthalmology: symptomatic temporary relief of secondary eye hyperemia due to moderate irritant exposure and allergic conjunctivitis.

ICD codes

Dosage Regimen

For ophthalmic use, instill one to two drops into the conjunctival sac of the affected eye(s).

Apply up to three to four times daily as needed for symptomatic relief of conjunctival hyperemia.

The maximum duration of continuous use is 72 hours.

Discontinue use and consult a physician if no improvement is observed within this period or if irritation, hyperemia, pain, or visual disturbances increase.

For intranasal use in adults and children over 12 years, administer one to two drops into each nostril.

Repeat the intranasal application every four to six hours as needed for nasal congestion.

Do not use the intranasal formulation for more than five to seven consecutive days due to the risk of rebound congestion.

Avoid prolonged use of either formulation.

Remove contact lenses prior to instillation of ophthalmic drops; lenses may be reinserted after 15 minutes.

Avoid the dropper tip contacting the eye, eyelids, nasal surfaces, or any other surfaces to prevent contamination.

Adverse Reactions

Local reactions: when used in ophthalmology – burning, itching, pain in the eye area; reactive conjunctival hyperemia, visual disturbance, dryness of the nasal mucosa, mydriasis, increased intraocular pressure; with intranasal application – reactive hyperemia, swelling of the nasal mucosa, irritation of the nasal mucosa, with use for more than 1 week – swelling of the nasal mucosa, atrophic rhinitis.

Systemic reactions are possible, mainly in children and elderly patients – pallor of the skin, tachycardia, pain in the heart area, increased blood pressure, increased sweating, tremor, headache, agitation, nausea, drowsiness, dizziness.

Contraindications

Hypersensitivity to naphazoline, arterial hypertension, severe atherosclerosis, thyrotoxicosis, chronic rhinitis, atrophic rhinitis, severe eye diseases, angle-closure glaucoma, diabetes mellitus, tachycardia, simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; pediatric age – depending on the dosage form.

With caution coronary artery disease, prostatic hyperplasia; pheochromocytoma; pregnancy, breastfeeding period; hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; use of other drugs that increase blood pressure.

Use in Pregnancy and Lactation

The use of naphazoline during pregnancy and lactation (breastfeeding) is possible only for strict indications in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the fetus or child.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the naphazoline drug labels regarding contraindications for the use of specific naphazoline dosage forms in children of different ages. In children, especially young children, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Geriatric Use

In elderly patients, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Special Precautions

Naphazoline may have a resorptive effect.

With long-term intranasal use, the severity of the vasoconstrictive effect of naphazoline gradually decreases (tachyphylaxis phenomenon), in connection with which it is recommended to take a break for several days after 5-7 days of use. Prolonged use of the product should be avoided.

If no improvement is observed within 72 hours of using the eye drops, or if irritation or hyperemia increases, or eye pain or visual disturbances appear, the use of the product should be discontinued and a doctor should be consulted. Direct contact of the product with contact lenses should be avoided. It is recommended to remove contact lenses before using the eye drops.

Drug Interactions

Should not be used simultaneously with MAO inhibitors or within 14 days after their discontinuation.

Naphazoline slows down the absorption of local anesthetics (prolongs their action during superficial anesthesia).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.