Ocumed^® (Drops) Instructions for Use

Marketing Authorization Holder

Sentiss Pharma, Pvt. Ltd. (India)

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN registered by WHO)

Dosage Forms

	Ocumed®	Eye drops 0.5%: 5 ml bottle with dropper, 5 ml or 10 ml dropper bottle
		Eye drops 0.25%: 5 ml bottle with dropper, 5 ml or 10 ml dropper bottle

Dosage Form, Packaging, and Composition

Eye drops 0.25% as a transparent, colorless solution.

Excipients: benzalkonium chloride (0.1 mg/ml), sodium hydrogen phosphate, sodium dihydrogen phosphate, water for injections.

5 ml – dark glass bottles (1) in a pack with a dropper – cardboard boxes.
5 ml – plastic dropper bottles (1) – cardboard boxes.
10 ml – plastic dropper bottles (1) – cardboard boxes.

Eye drops 0.5% as a transparent, colorless solution.

Excipients: benzalkonium chloride (0.1 mg/ml), sodium hydrogen phosphate, sodium dihydrogen phosphate, water for injections.

5 ml – dark glass bottles (1) in a pack with a dropper – cardboard boxes.
5 ml – plastic dropper bottles (1) – cardboard boxes.
10 ml – plastic dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Drugs used in ophthalmology; antiglaucoma drugs and miotic agents; beta-adrenergic blockers

Pharmacological Action

A non-selective beta-adrenergic blocker for topical use in ophthalmology. It does not possess intrinsic sympathomimetic activity or membrane-stabilizing activity.

The drug reduces both normal and elevated intraocular pressure by decreasing the production of intraocular fluid. It does not affect pupil size or accommodation.

The drug’s effect begins 20 minutes after instillation into the conjunctival sac. The maximum reduction in intraocular pressure develops after 1-2 hours and lasts for 24 hours.

Pharmacokinetics

Absorption

When applied topically, Timolol rapidly penetrates the cornea.

After instillation of the eye drops, the C_max of timolol in the aqueous humor of the anterior chamber of the eye is reached after 1-2 hours.

It enters the systemic circulation in small amounts through absorption via the vessels of the conjunctiva, nasal mucosa, and lacrimal tract.

Elimination

Timolol metabolites are excreted primarily by the kidneys.

Pharmacokinetics in special clinical cases

In newborns and young children, the C_max in blood plasma significantly exceeds that in adults.

Indications

• Elevated intraocular pressure (ocular hypertension);
• Open-angle glaucoma;
• Secondary glaucoma;
• To reduce intraocular pressure in angle-closure glaucoma (as an additional agent in combination with miotics);
• Congenital glaucoma (when other therapeutic measures are insufficient).

ICD codes

Dosage Regimen

Adults and children over 10 years old instill 1 drop (0.25% eye drops) into the conjunctival sac of the affected eye 2 times/day; if the effect is insufficient – 1 drop (0.5% eye drops) 2 times/day. When intraocular pressure normalizes, the maintenance dose is 1 drop (0.25% eye drops) 1 time/day.

Children under 10 years old are prescribed 1 drop (0.25% eye drops) 2 times/day.

The drug is intended for long-term continuous use.

The patient should be warned that only a doctor can change the dose or temporarily discontinue the drug.

Adverse Reactions

From the organ of vision irritation and hyperemia of the conjunctiva, eyelid skin, burning and itching in the eyes, lacrimation or decreased tear secretion, photophobia, corneal epithelial edema, punctate superficial keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes, transient visual acuity impairment, blepharitis, conjunctivitis, keratitis. During surgical interventions for glaucoma, choroidal detachment may develop in the postoperative period.

From the cardiovascular system chest pain, heart failure, bradycardia, bradyarrhythmia, decreased blood pressure, collapse, AV block, cardiac arrest, transient cerebrovascular accidents.

From the respiratory system rhinitis, dyspnea, bronchospasm, pulmonary insufficiency.

From the central and peripheral nervous system headache, dizziness, weakness, depression, paresthesia, myasthenia, drowsiness, hallucinations, tinnitus, slowing of psychomotor reactions.

From the digestive system nausea, vomiting, diarrhea.

Allergic reactions urticaria, eczema.

Other nosebleed, decreased potency, alopecia.

Contraindications

• Bronchial asthma or other severe chronic obstructive respiratory diseases;
• Sinus bradycardia;
• AV block II and III degree;
• Acute heart failure;
• Severe chronic heart failure (NYHA functional class III and IV);
• Cardiogenic shock;
• Allergic reactions with generalized skin rashes;
• Atrophic rhinitis;
• Dystrophic diseases of the cornea;
• Neonatal period;
• Hypersensitivity to the drug components.

Use with caution in patients with pulmonary insufficiency, pulmonary emphysema, severe cerebrovascular insufficiency, heart failure (NYHA functional class I and II), sinoatrial block, arterial hypertension, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia, Reye’s syndrome, when co-administered with other beta-adrenergic blockers, and in children.

Use in Pregnancy and Lactation

There is insufficient experience with the use of the drug during pregnancy and lactation (breastfeeding), so the drug should be prescribed only in cases where the intended therapeutic benefit for the mother outweighs the potential risk to the fetus or child.

It has been established that Timolol penetrates the placental barrier and is excreted in breast milk.

Breastfeeding should be discontinued during treatment.

Special Precautions

The patient should be warned about the need for regular measurement of intraocular pressure and examination of the cornea, as well as the need to discontinue the drug and consult a doctor if side effects occur.

When wearing soft contact lenses, Ocumed^® eye drops should not be used, as the preservative contained in them can accumulate in soft contact lenses and have an adverse effect on eye tissues.

Rigid contact lenses should be removed before instilling the drug and reinserted after 15 minutes.

When switching patients to treatment with Ocumed^®, refraction correction may be required (after the effects of previously used miotics have subsided).

Ocumed^® should be discontinued 48 hours before surgery using general anesthesia.

Ocumed^® should not be used simultaneously with antipsychotic (neuroleptics) and anxiolytic (tranquilizers) drugs.

It is not recommended to consume alcohol during the use of the drug (a sharp decrease in blood pressure is possible).

Use in pediatrics

There is insufficient experience with the use of the drug in children, so the drug should be prescribed only in cases where the intended therapeutic benefit outweighs the potential risk of side effects.

Effect on ability to drive vehicles and machinery

Immediately after application of the drug, a decrease in visual clarity and slowing of psychomotor reactions are possible, which may reduce the ability to engage in potentially hazardous activities requiring increased attention (especially when consuming alcohol simultaneously).

Overdose

Symptoms due to local absorption, systemic effects characteristic of beta-adrenergic blockers may develop (dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting).

Treatment immediately rinse the eyes with water or saline. Symptomatic therapy is carried out.

Drug Interactions

Concomitant use of the drug Ocumed^® with eye drops containing epinephrine may cause pupil dilation.

The reduction of intraocular pressure is enhanced with the simultaneous use of eye drops containing epinephrine and pilocarpine. Two beta-adrenergic blockers should not be instilled into the eyes.

Reduction of blood pressure and slowing of heart rate may be enhanced with the concomitant use of the drug with slow calcium channel blockers, reserpine, and other beta-adrenergic blockers.

Simultaneous use with insulin or oral antidiabetic agents may lead to hypoglycemia.

Timolol enhances the effect of peripheral muscle relaxants (the drug should be discontinued 48 hours before planned surgery using general anesthesia).

Storage Conditions

The drug should be stored out of the reach of children, in a light-protected place at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

The shelf life is 2 years.

After opening, the bottle must be used within 45 days.

Dispensing Status

The drug is dispensed by prescription.

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.