Ciprodox - instructions for use, dose, side effects, contraindications

Active ingredient: Ciprofloxacin 250mg, 500mg and 750mg. Excipients: microcrystalline cellulose, starch, magnesium stearate; talc, aerosil, sodium starch glycolate, hydroxypropylmethylcellulose, titanium dioxide, diethyl phthalate, blue diamond varnish, yellow lacquer sunset, carmosein varnish.

Description:

Tablets of 250 mg: Pink, round, biconvex tablets, covered with a film membrane. The color at the break is white or almost white.

Tablets of 500 mg: Orange capsule-shaped tablets, film-coated. The color at the break is white or almost white.

Tablets of 750 mg: Blue capsule-shaped tablets coated with a film membrane. The color at the break is white or almost white.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

Antimicrobial preparation of a broad spectrum of action from the group of fluoroquinolones. It is bactericidal.The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disturbed. Ciprofloxacin It acts both on multiplying microorganisms, and on those in the resting phase. TO Ciprofloxacin sensitive Gram-negative aerobic bacteria: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); some intracellular pathogens: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium intracellulare.

Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: Staphylococcus spp. (S. aureus, S. haemolyticus, S. hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St.agalactiae). The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin.

The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate.

To a drug resistant Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. The effect of the drug against Treponema pallidum has not been adequately studied.

Pharmacokinetics:

When taken orally ciprofloxacin quickly absorbed from the digestive tract. Bioavailability of the drug is 50-85%. The maximum concentration of the drug in the blood serum of healthy volunteers with oral intake (before meals) of 250, 500, 750 and 1000 mg of the drug is achieved after 1-1.5 hours and is 1.2; 2.4; 4.3 and 5.4 μg / ml, respectively.

Orally taken ciprofloxacin distributed in tissues and body fluids. High drug concentrations are observed in bile, lung, kidney, liver, gall bladder, uterus, semen, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of the drug in these tissues is higher than in the serum. Ciprofloxacin also penetrates well into the bones, eye fluid, bronchial secretion, saliva, skin, muscles, pleura, peritoneum, lymph.

The accumulating concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum.

The volume of distribution in the body is 2-3.5 l / kg. In the cerebrospinal fluid the drug penetrates in a small amount, where its concentration is 6-10% of that of serum.

The degree of binding of ciprofloxacin to plasma proteins is 30%.

In patients with unchanged kidney function, the elimination half-life is usually 3-5 hours. If the kidney function is impaired, the elimination half-life increases.

The main way to remove ciprofloxacin from the body is the kidney. With urine, 50-70% is output. From 15 to 30% is excreted.

Patients with severe renal insufficiency (creatinine clearance below 20ml / min / 1.73m2) should be prescribed half the daily dose of the drug.

Indications:

Infections and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:

- respiratory tract;

- Ear, throat and nose;

- kidney and urinary tract;

- genital organs;

- the digestive system (including the mouth, teeth, jaws); gallbladder and bile ducts;

- skin, mucous membranes and soft tissues;

- The musculoskeletal system.

Ciprofloxacin is indicated for the treatment of sepsis and peritonitis, as well as for the prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

Contraindications:

pregnancy;
the period of breastfeeding;
children and adolescents under 18;
increased sensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones.

Dosing and Administration:

The dose of ciprofloxacin depends on the severity of the disease, the type of infection, the condition of the body, the age, weight and function of the kidneys in the patient. Recommended doses are usually:

Ciprofloxacin in a tablet dosage form of 250 mg and 500 mg for oral administration:

- uncomplicated diseases of the kidneys and urinary tracts - 250 mg each, and in complicated cases 500 mg twice a day;

- diseases of the lower respiratory tract of medium severity - 250 mg, and in more severe cases 500 mg, 2 times a day;

- For the treatment of gonorrhea, a single administration of Ciprofloxacin in a dose of 250-500 mg is recommended;

- gynecological diseases, enteritis and colitis with severe and high temperature, prostatitis, osteomyelitis - 500 mg twice a day (for the treatment of banal diarrhea can be used at a dose of 250 mg 2 times a day).

The drug should be taken on an empty stomach, washed down with a sufficient amount of liquid. Patients with severe renal dysfunction should be given a half dose of the drug.

The duration of treatment depends on the severity of the disease, but treatment should always last at least two more days after the disappearance of the symptoms of the disease. Usually the duration of treatment is 7-10 days.

Table of recommended doses of the drug for patients with chronic renal failure:

Creatinine clearance ml / mg	Dose
>50	The usual dosing regimen
30-50	250-500 mg once every 12 hours
5-29	250-500 mg once every 18 hours
Patients on hemolytic or peritoneal dialysis	After dialysis 250-500 mg once every 24 hours

Side effects:

On the part of the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis.

On the part of the nervous system: dizziness, headache, fatigue, anxiety, tremor, insomnia, nightmarish dreams, peripheral paralysis (anomaly of perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, and other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can cause harm to himself), migraine, fainting, thrombosis of the cerebral arteries.

From the senses: a violation of taste and smell, visual impairment (diplopia, change in color perception), noise in the ears, hearing loss.

On the part of the CCC: tachycardia, heart rhythm disturbances, lower blood pressure, flushes of blood to the skin of the face.

From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

From laboratory indicators: hypoprothrombinemia, increased activity of "hepatic" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

On the part of the urinary system: hematuria, crystalluria (especially in alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased renal nitrogen function, interstitial nephritis.

Allergic reactions: skin itching, urticaria, the formation of blisters accompanied by bleeding, and small nodules forming scabs, drug fever, pinpoint hemorrhages (petechiae), edema of the face or larynx, dyspnea, eosinophilia, increased photosensitivity, vasculitis, nodal erythema, exudative erythema multiforme , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

Other: arthralgia, arthritis, tendovaginitis, tendon ruptures, general weakness, myalgia, superinfections (candidiasis, pseudomembranous colitis).

Overdose:

The specific antidote is unknown. It is necessary to carefully monitor the patient's condition, make gastric lavage, carry out usual emergency measures, ensure sufficient fluid intake.With the help of hemo- or peritoneal dialysis, only a small amount (less than 10%) of the drug can be excreted.

Interaction:

With simultaneous use with didanosine ciprofloxacin ciprofloxacin absorption decreases due to formation of complexes with ciprofloxacin didanosine contained in the aluminum and magnesium salts.

Simultaneous reception of ciprofloxacin and theophylline may lead to an increase in the concentration of theophylline in the blood plasma, due to competitive inhibition in the binding sites of cytochrome P₄₅₀, which leads to an increase in the half-life of theophylline and an increased risk of toxic action associated with theophylline.

Simultaneous reception of antacids, as well as preparations containing ions of aluminum, zinc, iron or magnesium, can cause a decrease in absorption of ciprofloxacin, so the interval between the appointment of these drugs should be at least 4 hours.

With simultaneous use of ciprofloxacin and anticoagulants, bleeding time is prolonged.

With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of the latter is enhanced.

Special instructions:

Patients with epilepsy, seizures history of seizures, vascular diseases and organic brain lesions due to the risk of developing adverse reactions CNS Ciprofloxacin should be prescribed only for life indications.

If a severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be ruled out, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

If pain occurs in tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described.

During the treatment with ciprofloxacin it is necessary to provide a sufficient amount of fluid while observing normal diuresis.

During treatment with ciprofloxacin, avoid direct exposure to sunlight.

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

Patients receiving Ciprofloxacin, you should be careful when driving a car and doing other potentially hazardous activities,requiring increased attention and speed of psychomotor reactions (especially with simultaneous use of alcohol).

Form release / dosage:

Tablets, film-coated, 250 mg, 500 mg and 750 mg.

Packaging:10 tablets per blister. 1 blister in a cardboard box, along with instructions for use.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014579 / 01-2002

Date of registration:23.09.2008

The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India

Manufacturer: & nbsp

SHREYA LIFE SCIENCES, Pvt.Ltd. India

Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Citrodox (Ciprodox)