Rotima (Drops) Instructions for Use

Marketing Authorization Holder

Scan Biotech LLC (India)

Manufactured By

Dalkhimpharm, JSC (Russia)

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN WHO registered)

Dosage Form

Rotima

Ophthalmic drops 0.5%: bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Ophthalmic drops in the form of a transparent colorless solution.

Excipients: benzalkonium chloride (as a 50% benzalkonium chloride solution – 0.2 mg) – 0.1 mg, sodium dihydrogen phosphate dihydrate – 0.11 mg, disodium phosphate dodecahydrate – 2.9 mg, disodium edetate dihydrate – 0.02 mg, sodium chloride – 7.1 mg, sodium hydroxide – 0.4 mg, water for injections – up to 1 ml.

5 ml – polymer bottles (1) with dropper caps – cardboard packs.
10 ml – polymer bottles (1) with dropper caps – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Antiglaucoma agent – beta-adrenergic blocking agent

Pharmacological Action

It is a non-selective beta-adrenergic blocker. When applied topically in ophthalmology, it reduces both normal and elevated intraocular pressure by decreasing the production of intraocular fluid and improving its outflow; it does not affect accommodation and pupil size.

It possesses antianginal, hypotensive, and antiarrhythmic effects, which are manifested during systemic use. It reduces sinus node automaticity, decreases heart rate, slows AV conduction, and reduces myocardial contractility and oxygen demand.

Pharmacokinetics

When applied topically, it rapidly penetrates the cornea and enters the systemic circulation in small amounts due to absorption through the conjunctival vessels, nasal mucosa, and lacrimal tract.

Indications

For use in ophthalmology: elevated intraocular pressure, chronic open-angle glaucoma, angle-closure glaucoma (as an additional agent in combination with miotics), secondary glaucoma (including aphakic), congenital glaucoma (when other therapeutic measures are ineffective).

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye(s) twice daily. Administer the drops approximately every 12 hours.

For monotherapy in chronic open-angle glaucoma, the usual dosage is one drop of the 0.5% solution twice daily.

If the therapeutic response is insufficient, consider substitution with another therapeutic class or concomitant therapy with other ophthalmic agents.

For angle-closure glaucoma, use as an adjunctive therapy with a miotic.

If intraocular pressure is controlled with one drop once daily, this regimen may be continued.

Do not administer more than one drop per dose. Wait at least five minutes before instilling any other topical ophthalmic medication.

To minimize systemic absorption, apply gentle pressure to the lacrimal sac at the inner canthus for one to two minutes immediately following instillation. This technique, known as nasolacrimal occlusion, is recommended.

Close the eye gently after administration. Do not blink.

Avoid allowing the dropper tip to contact the eye, eyelids, or any other surface to prevent contamination of the solution.

Adverse Reactions

From the organ of vision: with topical application, irritation and hyperemia of the conjunctiva, eyelid skin, burning and itching in the eyes, lacrimation, photophobia, corneal epithelial edema, punctate superficial keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes are possible. When performing fistulizing antiglaucoma surgeries, the development of retinal detachment in the postoperative period is possible.

With systemic use: heart failure, bradycardia, AV block, arterial hypotension; headache, sleep disorders, nightmares, asthenia, agitation, depression, paresthesia and cold extremities; nausea, vomiting, diarrhea; dyspnea, bronchospasm; muscle weakness; skin allergic reactions, exacerbation of psoriasis, dry conjunctiva are possible.

Contraindications

AV block II and III degree, sinoatrial block, bradycardia, sick sinus syndrome, arterial hypotension, chronic heart failure stage IIB-III, acute heart failure, vasomotor rhinitis, Raynaud’s disease and other obliterative vascular diseases, metabolic acidosis, lactation.

Use in Pregnancy and Lactation

The safety and efficacy of use during pregnancy have not been studied.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

The safety and efficacy of use in children have not been studied.

Special Precautions

Use with caution in patients with impaired liver function, impaired renal function, diabetes mellitus (especially of labile course). With long-term use, it increases the level of triglycerides in blood plasma.

The safety and efficacy of use in children have not been studied.

In ophthalmology, it is used for a long time, therefore, during treatment, the cornea should be examined at least once every 6 months, and lacrimal function and visual field status should be monitored.

Effect on the ability to drive vehicles and mechanisms

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

When used in ophthalmology, immediately after instillation, a decrease in visual acuity and slowing of psychomotor reactions are possible, so for 30 minutes one should refrain from engaging in potentially hazardous activities that require increased attention.

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.