MIO-HOL - instructions for use, dose, side effects, contraindications

Active substanceCarbacholCarbachol

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MIO-HOLE

solution d / eye

VARTAMAN PHARMA, LLC Russia

Dosage form: & nbspsolution for intraocular management

Composition:1 ml of the preparation contains:

active substance: carbachol-0.1 mg;

Excipients: sodium chloride - 9.00 mg, water for injection - up to 1 ml.

Description:Transparent colorless liquid.

Pharmacotherapeutic group:m- and n-cholinomimetic

ATX: & nbsp

S.01.E.B.02 Carbachol

Pharmacodynamics:

M- and n-cholinomimetic, a synthetic derivative of choline. It binds to the m- and n-cholinergic receptors of the postsynaptic membrane of the cholinergic synapses and excites them, simulating the effect of acetylcholine. The action is 100 times stronger than that of acetylcholine, and more prolonged. When topical application causes a narrowing of the pupil, accompanied by a decrease in intraocular pressure. This effect is partly due to the fact that with narrowing of the pupil and flattening of the iris, the fountain spaces (the spaces of the iris-corneal angle) and the helmet canals (the venous sinus of the sclera) expand, which improves the outflow of fluid from the internal media of the eyes.

Causes a spasm of accommodation.

Pharmacokinetics:

Unlike acetylcholine it is not hydrolyzed by cholinesterases and has a more pronounced and prolonged effect. When instilled in the eye, the pupil constriction is observed after 15-20 minutes and lasts 4-8 hours, the decrease in intraocular pressure after 20-30 minutes and reaches a maximum after 2 hours.With intraocular administration, the effect of the drug occurs within 2-5 minutes and lasts for 24 hours.

Metabolised in choline; is excreted by the kidneys.

Indications:Operative interventions in ophthalmology: extraction of cataracts with (without) intraocular lens implantation.

Contraindications:Hypersensitivity to carbachol and other components of the drug, age to 18 years (efficacy and safety not established).

Carefully:

Cicatricial changes in the iris, obliteration of the vessels of the fundus, bronchial asthma, chronic heart failure, hyperthyroidism, urinary tract obstruction, gastric or duodenal ulcer (in the anamnesis), Parkinson's disease, pregnancy, lactation.

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy and during lactation is not present. The use of the drug during pregnancy is possible only if the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

There is no evidence that the drug can be excreted in breast milk, and therefore, breast-feeding for the period of drug use should be discontinued.

Dosing and Administration:The drug Mio-Hol is used for intraocular administration under operating conditions. It is injected once into the anterior chamber of the eye before the operation begins. atraumatic cannula. A single dose is not more than 0.5 ml of the preparation (50 mg carbachol). The duration of action of the drug Mio-Hol up to 24 hours after the administration.

Side effects:Determination of the frequency of adverse reactions: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10000 and <1/1000), very rarely (<1/10000).

From the side of the organ of vision: rarely - retinal detachment, corneal degeneration, inflammation of the choroid of the eyeball, inflammation of the iris, corneal opacity, corneal edema; very rarely - inflammation of the anterior chamber of the eye, hyperemia of the eye, swelling of the eye, blurring of vision.

From the gastrointestinal tract: very rarely - discomfort in the epigastric region, nausea, vomiting.

Overdose:Symptoms: headache, drooling, increased blood pressure, bradycardia, cardiac arrhythmias, nausea, increased intestinal peristalsis, increased sweating, fainting.

Treatment: administration of an antidote (atropine sulfate) subcutaneously or intramuscularly 1-2 mg every 2-4 hours until the symptoms of an overdose disappear. Symptomatic treatment if necessary.

Interaction:The use of carbachol can enhance the effectiveness of depolarizing muscle relaxants; increase the chronotropic effect of cardiac glycosides.

Special instructions:

The drug Mio-Hol is intended for single administration only. Use only a clear, particle-free solution. The use of the drug Mio-Hol can enhance the surgical intervention caused by intraocular inflammation. In the case of hypotension, the risk of an additional decrease in intraocular pressure should be assessed.

Storage and re-use of the solution from the opened bottle is unacceptable.

Effect on the ability to drive transp. cf. and fur:After surgery with the use of the drug Mio-Hol should refrain from managing the transport and employment of other potentially hazardous activities until the full restoration of vision.

Form release / dosage:

Solution for intraocular administration 0.1 mg / ml.

Packaging:1 ml in colorless, transparent bottles made of hydrolytic class 1 glass, sealed with a rubber stopper with an aluminum cap, closed with a protective plastic cover.

For 10 bottles in a cardboard pack of laminated cardboard together with instructions for use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001713

Date of registration:18.05.2012

The owner of the registration certificate:VARTAMAN PHARMA, LLC VARTAMAN PHARMA, LLC Russia

Manufacturer: & nbsp

APPASAMY OCULAR DEVICES (P) LTD. (PHARMA DIVISION) India

Information update date: & nbsp2.10.2013

Illustrated instructions

Instructions

MIO-HOLE (Mio-Chol)