Zipromed - instructions for use, doses, side effects, contraindications

Active substance: ciprofloxacin hydrochloride (in terms of ciprofloxacin) - 3 mg, Excipients: benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, lactic acid 0.0016 ml, sodium chloride 7.0 mg, sodium hydroxide 0, 6 mg, water for injection up to 1 ml.

Description:Transparent solution from colorless to light yellow color.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

Ciprofloxacin is an antimicrobial agent from the group of fluoroquinolones, it has a wide spectrum of antibacterial action, it has a bactericidal effect. The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disrupted. Ciprofloxacin It acts both on multiplying microorganisms, and on those in rest.

The antibacterial spectrum of ciprofloxacin includes Gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp.(indolpositive and indolotricative), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp., Brucella spp., Chlamidia spp.

Gram-positive microorganisms are also sensitive to ciprofloxacin: Staphylococcus spp., Streptococcus pyogenes, St. agalactiae, Corynebacterium diphtheriae, Listeria monocitogenes. The drug is low toxicity.

Pharmacokinetics:

Ciprofloxacin, when applied topically, penetrates well into the tissues of the eye. After a single instillation, its concentration in the moisture of the anterior chamber of the eye after 10 minutes is 0.1 mg / ml. The maximum concentration, determined after 1 hour in the moisture of the anterior chamber, is 0.19 mg / ml.

After 2 hours, the concentration begins to decrease, but its antibacterial effect in the tissues of the cornea persists up to 6 hours, in the moisture of the anterior chamber up to 4 hours. The half-life of serum from the local application is 4-5 hours. The drug is excreted through the kidneys mainly (up to 50%) unchanged and up to 10% in the form of metabolites; about 15% is excreted through the intestine; in breast-feeding mothers - partially excreted in breast milk.

After instillation, systemic absorption of the drug is possible. When treated for 7 days, on average, 4 times a day in both eyes, the average concentration is less than 2 ng / ml.

Indications:

Bacterial inflammatory diseases of the eye and its appendages:

acute and subacute conjunctivitis;
keratitis;
anterior uveitis;
blepharitis and other inflammatory diseases of the eyelids;
dacryocystitis;
prevention and treatment of infectious complications after wounds of the eye and its appendages and in operations on the eyeball.

Contraindications:

Hypersensitivity to the components of the drug or to other quinolones, pregnancy, the period of breastfeeding and children under 1 year.

Dosing and Administration:

Locally. The drug is instilled in 1-2 drops in a conjunctival sac. The frequency of instillations depends on the severity of the inflammatory process.

With acute bacterial conjunctivitis, simple, scaly and ulcerative blepharitis, Cipromed is prescribed 4 to 8 times a day, depending on the severity of the disease. The course of treatment is from 5 to 14 days.

In keratitis, the drug is prescribed 1 drop at least 6 times a day, with a positive effect, the maximum course of treatment, depending on the severity of the lesion of the cornea, is 2-4 weeks.

When the corneal lesion is treated with Pseudomonas aeruginosa tsipromed is prescribed as often as possible - at least 8-12 times a day for 1 drop.The course of treatment depends on the course of the disease and is usually about 2-3 weeks.

With anterior uveitis, the drug is digested 8-12 times a day for 1 drop.

With acute dacryocystitis and canaliculitis, tsipromed is prescribed 6-12 times a day, while chronic - 4-8 times a day, 1 drop.

In case of injuries of the eye and its appendages for the prevention of secondary infection, tsipromed is prescribed for 1 to 2 weeks 1 drop 4-8 times a day.

For the prevention of inflammatory diseases after surgery with perforation of the eyeball, tsipromed is prescribed 4-6 times a day for 1 drop for the entire period of the postoperative period, usually from 5 days to 1 month.

Side effects:

Immediately after instillation, there may be a slight burning sensation within 1-2 minutes, itching, soreness, hyperemia of the mucous membrane of the eye. Perhaps the development of allergic reactions. Edema of the eyelids, photophobia, lacrimation, sensation of foreign body in the eyes, unpleasant aftertaste in the mouth, drop in visual acuity, appearance of white crystalline precipitate in patients with corneal ulcer, keratitis, keratopathy, staining or infiltration of the cornea, development of superinfection.

Overdose:

In case of accidental ingestion of Cipromed inside, no specific symptoms are present.

Possible nausea, vomiting, diarrhea, headache, fainting, a sense of anxiety.

Treatment - the usual measures of emergency care, sufficient supply of fluid into the body, the creation of an acidic urine reaction to prevent crystalluria.

Interaction:

The solution of ciprofloxacin is incompatible with drugs with a pH value of 3-4 that are physically or chemically unstable.

Special instructions:

If the patient wears soft contact lenses, then he should not use Cipromed, since the preservative can be deposited in soft contact lenses and adversely affect the tissues of the eye.

Strict contact lenses should be removed before instillation of the preparation and they should be worn again only after 15 minutes.

When using other ophthalmic drugs, the interval between their administration should be at least 5 minutes.

Effect on the ability to drive transp. cf. and fur:

Immediately after instillation of the drug, it is possible to reduce visual clarity and slow mental reactions, which may reduce the ability to actively participate in street traffic, machine maintenance, or work without support.In an even greater degree, this is the case with the simultaneous use of the drug with alcohol.

Form release / dosage:

Eye drops 0,3%.

Packaging:

5 ml in a plastic bottle-dropper with a screw cap. Each vial-dropper along with the instruction for use is placed in a cardboard box.

5 ml in a bottle of dark glass, closed with a rubber stopper, crimped aluminum cap with a safety plastic cap. One glass bottle with a sterile dropper packed in a plastic bag is placed in a cardboard box along with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:

2 years. Shelf life after bottle opening 1 month.

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

Terms of leave from pharmacies:On prescription

Registration number:П N012981 / 01

Date of registration:20.03.2008

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Zipromed (Cipromed)