Lanpressun^® T (Drops) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Manufactured By

Sun Pharmaceutical Medicare Ltd. (India)

ATC Code

S01ED51 (Timolol in combination with other drugs)

Active Substances

Latanoprost (Rec.INN registered by WHO)

Timolol (Rec.INN registered by WHO)

Dosage Form

Lanpressan® T

Eye drops 0.05 mg+5 mg/1 ml: dropper bottle 2.5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless, viscous liquid.

Excipients: hypromellose (E4M Premium, 2910) – 5 mg, povidone K90 – 20 mg, zinc chloride – 0.025 mg, macrogol 400 – 30 mg, boric acid – 10 mg, trometamol – 1 mg, water for injections – up to 1 ml.

2.5 ml – polyethylene dropper bottles (1) – cardboard packages.

Clinical-Pharmacological Group

Antiglaucoma drug – synthetic prostaglandin F2α analogue + beta-adrenoblocker

Pharmacotherapeutic Group

Combined antiglaucoma agent (synthetic prostaglandin F_2α analogue + beta-adrenergic blocker)

Pharmacological Action

Combined antiglaucoma agent.

Latanoprost is an analogue of prostaglandin F_2α and a selective agonist of FP-receptors.

It reduces intraocular pressure by increasing the outflow of aqueous humor and exerts an antiglaucoma effect.

The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow.

It does not have a reliable effect on the production of aqueous humor and does not affect the blood-ophthalmic barrier.

Timolol is a non-selective β-adrenergic receptor blocker with slight intrinsic sympathomimetic and membrane-stabilizing activity.

When applied topically, it lowers intraocular pressure by reducing the production of aqueous humor and slightly increasing its outflow.

Pharmacokinetics

Latanoprost

C_max in the aqueous humor (approximately 15-30 ng/ml) is reached 2 hours after instillation into the eye.

After application of the eye drops, Latanoprost is distributed primarily in the anterior segment of the eye, the conjunctiva, and the eyelids.

Only a small amount of the drug reaches the posterior segment.

Latanoprost undergoes hydrolysis in the cornea under the action of esterases to form the biologically active acid.

Metabolism of latanoprost acid in the eye tissues practically does not occur.

The main metabolism occurs in the liver.

T_1/2 from plasma is 17 minutes.

The main metabolites, 1,2-dinor- and 1,2,3,4-tetranor-metabolites, have no or weak biological activity and are mainly excreted in the urine.

Timolol

When applied topically, Timolol rapidly penetrates the cornea.

After instillation of the eye drops, C_max of timolol in the aqueous humor of the eye is reached after 1 hour.

T_1/2 from plasma is 6 hours.

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

Excretion of timolol metabolites is carried out mainly by the kidneys.

Indications

Open-angle glaucoma; increased intraocular pressure.

ICD codes

Dosage Regimen

Instill one drop into the affected eye(s) once daily.

Administer the drops in the evening for optimal efficacy.

If a dose is missed, apply the next dose at the regular time; do not double the dose.

When using other topical ophthalmic agents, administer them at least 5 minutes apart.

To prevent contamination, avoid touching the dropper tip to any surface.

Immediately after instillation, apply gentle pressure to the lacrimal sac (at the inner corner of the eye) for one minute to reduce systemic absorption.

This technique minimizes potential systemic side effects.

If more than one type of eye drop is prescribed, use the timolol-containing combination last.

Remove contact lenses before application and reinsert them 15 minutes later.

Discard the bottle 4 weeks after first opening to prevent microbial contamination.

Adverse Reactions

Eye disorders: visual impairment, blepharitis, cataract, conjunctivitis, allergic conjunctival lesions (including follicles, conjunctival papillary reactions, petechiae), corneal lesions (erosions, pigmentation, punctate keratitis), refraction disorders, eye hyperemia, eye irritation, eye pain, increased iris pigmentation, keratitis, photophobia, scotoma.

Infections: sinusitis, upper respiratory tract infections and other infections.

Metabolism and nutrition disorders: diabetes mellitus, hypercholesterolemia.

Psychiatric disorders: depression.

Nervous system disorders: headache.

Cardiac and vascular disorders: increased blood pressure.

Skin and subcutaneous tissue disorders: hypertrichosis, rash and skin changes (irritation, chalazion).

Musculoskeletal and connective tissue disorders: arthritis.

The following are other adverse events that may be observed during therapy with individual components of this combination (in addition to those listed above).

Latanoprost

Eye disorders: eye irritation (burning sensation, gritty feeling, itching, tingling and foreign body sensation); transient punctate epithelial erosions, eyelid edema, corneal edema and erosions; eyelash and vellus hair lengthening, thickening, increased number and pigmentation; iritis/uveitis; macular edema, including cystoid; change in eyelash growth direction, sometimes causing eye irritation; blurred vision.

Skin and subcutaneous tissue disorders: skin rash, darkening of the eyelid skin and local skin reactions on the eyelids.

Nervous system disorders: dizziness.

Respiratory system disorders: bronchospasm (including acute attacks or exacerbation of the disease in patients with a history of bronchial asthma), dyspnea.

Musculoskeletal and connective tissue disorders muscle/joint pain.

General and administration site reactions nonspecific chest pain.

Timolol (in the form of eye drops)

Immune system disorders systemic allergic reactions, including anaphylaxis, angioedema, urticaria, localized and generalized rash.

Metabolism and nutrition disorders anorexia, masking of hypoglycemia symptoms in diabetic patients.

Psychiatric disorders behavioral and mental disorders, including confusion, hallucinations, anxiety, disorientation, nervousness, memory loss, decreased libido, insomnia and nightmares.

Nervous system disorders cerebral ischemia, acute cerebrovascular accidents, dizziness, exacerbation of myasthenia gravis symptoms, paresthesia, drowsiness, syncope.

Eye disorders cystoid macular edema, decreased corneal sensitivity; choroidal detachment after filtration surgery; ptosis, visual disturbances, including refraction changes and diplopia.

Ear and labyrinth disorders tinnitus.

Cardiac and vascular disorders arrhythmia, bradycardia, cardiac arrest, heart failure, intraventricular conduction block, palpitations, progression of angina pectoris, intermittent claudication, cold hands and feet, decreased blood pressure, Raynaud’s syndrome.

Respiratory system disorders bronchospasm (mainly in patients with previous bronchospastic diseases), cough, dyspnea, nasal congestion, pulmonary edema and respiratory failure.

Gastrointestinal disorders diarrhea, dry mouth, dyspepsia, nausea, retroperitoneal fibrosis.

Skin and subcutaneous tissue disorders alopecia, pseudopemphigoid, psoriasis-like rash or exacerbation of psoriasis.

Musculoskeletal and connective tissue disorders systemic lupus erythematosus.

Reproductive system and breast disorders impotence, Peyronie’s disease.

General and administration site reactions asthenia/fatigue, chest pain, edema.

Contraindications

Bronchial asthma or a history of bronchial asthma; COPD; sinus bradycardia; second- or third-degree AV block; decompensated chronic heart failure of class II-III; cardiogenic shock; age under 18 years; lactation (breastfeeding).

With caution

Inflammatory, neovascular, closed-angle or congenital glaucoma, open-angle glaucoma combined with pseudophakia, pigmentary glaucoma, aphakia, pseudophakia with rupture of the posterior lens capsule, presence of risk factors for macular edema (cases of macular edema, including cystoid, have been described during treatment with latanoprost).

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety of the drug use during pregnancy and lactation (breastfeeding) have not been conducted.

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Contraindicated for use during breastfeeding.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

During use, a gradual change in eye color may occur due to an increase in the amount of brown pigment in the iris; periodic observation by the attending physician is recommended.

Effect on ability to drive vehicles and operate machinery

Instillation of eye drops may cause a transient sensation of a “veil before the eyes” for several minutes, which must be taken into account when driving a car and working with moving machinery.

Until this effect disappears, patients should not drive a car or operate complex machinery.

Drug Interactions

With simultaneous use with slow calcium channel blockers, drugs that reduce catecholamine activity, beta-blockers, antiarrhythmic drugs (including amiodarone and quinidine), cardiac glycosides, cholinomimetics, opioid analgesics and MAO inhibitors, an increase in the hypotensive effect and/or the development of pronounced bradycardia is possible.

When timolol was used concomitantly with epinephrine, mydriasis sometimes developed.

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.