Atropine (Drops) Instructions for Use

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

ATC Code

S01FA01 (Atropine)

Active Substance

Atropine (BAN)

Dosage Form

Atropine

Eye drops 10 mg/1 ml: bottle 5 ml 1 or 5 pcs., dropper bottle 5 ml 1 pcs.

Dosage Form, Packaging, and Composition

Eye drops as a clear, colorless or slightly colored liquid.

Excipients: sodium chloride – 7.8 mg, sodium disulfite (sodium metabisulfite) – 0.1 mg, sodium hydroxide solution 1M or hydrochloric acid solution 1M (for pH adjustment), water for injection – up to 1 ml.

5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.
5 ml – glass bottles (5) – contour cell packs (1) complete with dropper caps (5 pcs.) – cardboard packs.
5 ml – polymer dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

M-Cholinoreceptor blocker for topical use in ophthalmology (mydriatic)

Pharmacotherapeutic Group

Agents used in ophthalmology; mydriatic and cycloplegic agents; anticholinergic agents

Pharmacological Action

m-Cholinoreceptor blocker, is a natural tertiary amine. It is believed that Atropine binds equally to M1-, M2-, and M3- subtypes of muscarinic receptors. It affects both central and peripheral m-cholinoreceptors.

When applied topically in ophthalmology, it dilates the pupil, impedes the outflow of intraocular fluid, increases intraocular pressure, and causes paralysis of accommodation. The pupil, dilated by atropine, practically does not constrict upon instillation of cholinomimetics. Maximum pupil dilation occurs 30-40 minutes after instillation and disappears after 7-10 days.

Pharmacokinetics

Well absorbed through the conjunctiva.

Indications

For pupil dilation and achieving paralysis of accommodation: determination of true eye refraction, examination of the fundus; creating functional rest for inflammatory eye diseases (including iritis, iridocyclitis, chorioretinitis, keratitis), for eye injuries, embolism and spasm of the central retinal artery.

ICD codes

Dosage Regimen

Instill one to two drops into the conjunctival sac of the affected eye(s).

For cycloplegia and mydriasis for diagnostic procedures, apply one to two drops one hour before the examination.

For inflammatory conditions (iritis, iridocyclitis, keratitis), apply one to two drops up to three times daily with an interval of five to six hours.

To minimize systemic absorption, apply light pressure to the lacrimal sac (inner corner of the eye) for one to two minutes immediately after instillation.

Remove soft contact lenses before application and wait at least fifteen minutes before reinsertion.

Avoid allowing the dropper tip to contact the eye or any other surface to prevent contamination.

Do not exceed the prescribed frequency or duration of therapy.

For heavily pigmented irises, a stronger effect or more frequent instillation may be required; follow the ophthalmologist’s specific instructions precisely.

Discontinue use and consult a physician immediately if severe ocular pain, visual disturbance, or signs of systemic reaction (e.g., dry mouth, tachycardia, dizziness) occur.

Adverse Reactions

Local reactions: transient tingling and increased intraocular pressure; with prolonged use – hyperemia of the eyelid skin, hyperemia and edema of the conjunctiva, eyelids and eyeball, photophobia; contact dermatitis.

Systemic reactions: dry mouth, tachycardia, intestinal atony, constipation, urinary retention, xerostomia, bladder atony, headache, dizziness, impaired tactile perception.

Toxic systemic reactions to Atropine in young children and very elderly patients not only cause mydriasis and cycloplegia but can also lead to hyperthermia, dry mouth.

Contraindications

Hypersensitivity to atropine, angle-closure glaucoma (including suspected), keratoconus, anterior and posterior synechiae, children under 7 years of age.

With caution

Arrhythmias, chronic heart failure, coronary artery disease, mitral stenosis, reflux esophagitis, hepatic and/or renal failure, marked urinary retention in prostate hyperplasia, intestinal atony, obstructive intestinal diseases, paralytic ileus, toxic megacolon, ulcerative colitis, hiatal hernia, hyperthermia, arterial hypertension, hyperthyroidism, age over 40 years (risk of undiagnosed glaucoma manifestation), myasthenia gravis.

Use in Pregnancy and Lactation

The use of atropine during pregnancy and breastfeeding is allowed if the expected benefit to the mother outweighs the potential risk to the fetus and child.

It should be borne in mind that with systemic use, Atropine penetrates the placental barrier; it is found in breast milk in trace concentrations.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Atropine is not recommended for use in children with brain damage, cerebral palsy.

Geriatric Use

Pupil dilation can provoke an acute attack of glaucoma in patients with glaucoma, patients over 60 years of age.

When used in patients over 65 years of age, there is a possibility of increased intraocular pressure.

Special Precautions

Before using the medicinal product, remove soft contact lenses.

During instillation of drops into the conjunctival sac, to reduce the risk of systemic side effects, it is recommended to apply light finger pressure to the area of the lacrimal sacs projection, at the inner corner of the eye for 1-2 minutes after instillation to prevent absorption of atropine through the nasal mucosa and enhance the side effect.

When instilling the solution into the eye, press the lower lacrimal point to prevent the solution from entering the nasopharynx.

Heavily pigmented iris is more resistant to dilation; to achieve the effect, it is sometimes necessary to increase the concentration or frequency of administration, so one should beware of overdose of mydriatics.

Pupil dilation can provoke an acute attack of glaucoma in patients with glaucoma, patients over 60 years of age, and people with hyperopia predisposed to glaucoma because they have a shallow anterior chamber.

When used in patients over 65 years of age, there is a possibility of increased intraocular pressure.

Atropine is not recommended for use in case of elevated body temperature (further increase is possible due to suppression of sweat gland activity), in children with brain damage, cerebral palsy, patients with Down syndrome (reaction to m-cholinoblockers increases) and albinism.

Effect on ability to drive vehicles and mechanisms

Patients must be warned that driving vehicles for at least 2 hours after the examination is prohibited.

During use, it is necessary to refrain from driving motor vehicles and engaging in potentially hazardous activities that require increased concentration, speed of psychomotor reactions, and good vision.

Drug Interactions

Antimyasthenic agents, potassium chloride – enhancement of the toxic effects of these drugs due to possible slowing of passage through the gastrointestinal tract.

With simultaneous use with anticholinergic agents and agents with anticholinergic activity, the anticholinergic effect is enhanced.

With simultaneous use with atropine, a slowdown in the absorption of zopiclone, mexiletine, and a decrease in the absorption of nitrofurantoin and its renal excretion is possible. The therapeutic and side effects of nitrofurantoin are likely to be enhanced.

With simultaneous use with phenylephrine, an increase in blood pressure is possible.

Under the influence of guanethidine, a decrease in the hyposecretory action of atropine is possible.

Nitrates increase the likelihood of increased intraocular pressure.

Procainamide enhances the anticholinergic effect of atropine.

Atropine reduces the plasma concentration of levodopa.

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.