Composition, form of production and packaging
The eye drops are transparent or slightly opalescent, colorless or slightly colored, viscous.
1 ml
pilocarpine hydrochloride 10 mg
hypromellose 4.3 mg
Excipients: disodium edetate - 0.1 mg, benzalkonium chloride - 2 mg, boric acid - 10 mg, water d / and - up to 1 ml.
5 ml - a bottle-droppers polymer (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antiglaucoma preparation. The composition of the drug includes two active substances: pilocarpine hydrochloride and hypromellose (hydroxypropylmethylcellulose).
Pilocarpine - m-cholinomimetic, has a miotic effect. Causes the contraction of the circular and ciliary muscles, which is accompanied by a narrowing of the pupil and an expansion of the angle of the anterior chamber of the eye. As a result, the outflow of aqueous humor improves and the intraocular pressure decreases. With primary open-angle glaucoma, instillation of 1% solution causes a decrease in intraocular pressure by 17-20% of the initial value. The beginning of the effect of the drug - after 10-30 minutes, reaches a maximum after 1.5-2 hours and lasts for 4-6 hours.
Hypromellose has a lubricating and softening effect on the eye tissue, it reduces the locally irritating effect of pilocarpine. With high viscosity, hypromellose increases the contact time of the pilocarpine solution with the cornea.
PHARMACOKINETICS
Pilocarpine penetrates well into the cornea. TC max in the aqueous humor - 30 min. It is retained in the tissues of the eye, which prolongs its T 1/2 , which is 1.5-2.5 hours. It is excreted with the intraocular fluid and is partially metabolized in the blood plasma.
Hypromellose prolongs T 1/2 pilocarpine from the eye tissues.
INDICATIONS
acute attack of angle-closure glaucoma;
- secondary glaucoma (vascular, post-traumatic, for example, burns);
- primary open-angle glaucoma (as a monotherapy and in combination with beta-adrenoblockers or other drugs that reduce intraocular pressure);
- chronic angle-closure glaucoma;
- if necessary, narrowing of the pupil after instillation of mydriatic (except for people with high degree myopia).
DOSING MODE
Buried in the conjunctival sac 1-2 drops 1-3 times / day. The number of instillations can vary depending on the indications and individual sensitivity of the patient.
To treat an acute attack of closed angle glaucoma during the first hour, pilocarpine solution is instilled 1 drop every 15 minutes, for 2-3 hours every 30 minutes, for 4-6 hours every 60 minutes and then 3-6 times a day before stopping the attack.
It is possible to use a combination with adrenomimetics, beta-adrenoblockers, inhibitors of carbonic anhydrase.
SIDE EFFECT
From the side of the organ of vision: local reactions - pain in the eye area; myopia; decreased vision, especially in the dark (due to the development of persistent miosis and spasm of accommodation); lacrimation, superficial keratitis. With prolonged use, it is possible to develop follicular conjunctivitis, contact eyelid dermatitis. Rarely - nuclear cataract, corneal endothelial edema, keratopathy, retinal detachment.
Systemic reactions: headache (in temporal or periorbital regions), rhinorrhea, bronchospasm, hypersalivation, vomiting, diarrhea, increase or decrease in blood pressure, allergic reactions.
CONTRAINDICATIONS
- irit;
- Cyclite;
- Iridocyclitis;
- keratitis;
- a condition after ophthalmic operations and other eye diseases, in which the narrowing of the pupil is undesirable;
- age up to 18 years;
- hypersensitivity to pilocarpine.
With caution : in patients with retinal detachment in the history and in young patients with high degree of myopia.
PREGNANCY AND LACTATION
Use during pregnancy is contraindicated. If necessary, the appointment of lactation, breastfeeding should be discontinued for the duration of treatment.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 18 years.
SPECIAL INSTRUCTIONS
Treatment should be performed with regular monitoring of intraocular pressure.
To reduce absorption to the systemic blood stream, it is recommended to squeeze the tear ducts after 1-2 minutes, pressing the finger at the inner corner of the eye in the area of ​​the projection of the lacrimal sac.
Impact on the ability to drive vehicles and manage mechanisms
In the presence of an initial cataract, the myotonic effect can cause a transient visual impairment (sensation of nearsightedness), therefore, during the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.
OVERDOSE
In case of accidental ingestion, it is manifested by a significant increase in m-cholinomimetic effects, incl. with the development of severe cardiovascular insufficiency and bronchoconstriction.
Treatment: gastric lavage, the administration of atropine (0.5-1 mg p / c or IV), epinephrine (0.3-1 mg p / c or IM), as well as a sufficient amount of fluid.
DRUG INTERACTION
Pilokarpine antagonists are atropine and other m-cholinoblocking agents.
With simultaneous use with adrenomimetics, antagonism of the effect (effect on the diameter of the pupil) is noted.
Simultaneous use with adrenomimetics (including phenylephrine), beta-adrenoblockers (including timolol), inhibitors of carbonic anhydrase increases the decrease in intraocular pressure.
M-cholinomimetic activity of pilocarpine decreases with combination with tricyclic antidepressants, phenothiazine derivatives, chlorprotixen, clozapine; intensifies - when combined with cholinesterase inhibitors.
Possible development of bradycardia and lowering blood pressure during general anesthesia with halothane.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 15 В° to 25 В° C. Do not freeze. Shelf life - 2 years.
