Ciprodox (Tablets) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

ATC Code

J01MA02 (Ciprofloxacin)

Active Substance

Ciprofloxacin (Rec.INN registered by WHO)

Dosage Forms

	Ciprodox	Film-coated tablets, 250 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120 or 200 pcs.
		Film-coated tablets, 500 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120 or 200 pcs.
		Film-coated tablets, 750 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120 or 200 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, round, biconvex; on the break – white or almost white.

Excipients: microcrystalline cellulose, starch, magnesium stearate, talc, aerosil, sodium starch glycolate, hypromellose, titanium dioxide, diethyl phthalate, carmoisine lake.

10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets orange in color, capsule-shaped; on the break – white or almost white.

Excipients: microcrystalline cellulose, starch, magnesium stearate, talc, aerosil, sodium starch glycolate, hypromellose, titanium dioxide, diethyl phthalate, dye “Sunset Yellow” lake.

10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets blue in color, capsule-shaped; on the break – white or almost white.

Excipients: microcrystalline cellulose, starch, magnesium stearate, talc, colloidal silicon dioxide (aerosil), sodium starch glycolate, hypromellose, titanium dioxide, diethyl phthalate, dye brilliant blue lake.

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

A broad-spectrum antimicrobial drug from the fluoroquinolone group. It acts bactericidally. The drug inhibits the enzyme DNA gyrase of bacteria, resulting in disruption of DNA replication and synthesis of bacterial cellular proteins. Ciprofloxacin acts on both multiplying microorganisms and those in the resting phase.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: Enterobacteriaceae (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-intraceliulare.

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). Most staphylococci resistant to methicillin are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae and Enterococcus faecalis is moderate.

Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, and Nocardia asteroides are resistant to the drug.

The effect of the drug on Treponema pallidum has not been sufficiently studied.

Pharmacokinetics

When taken orally, Ciprofloxacin is rapidly absorbed from the gastrointestinal tract. The bioavailability of the drug is 50-85%. C_max in the serum of healthy volunteers after oral administration (before meals) of 250, 500, 750 and 1000 mg of the drug is reached after 1-1.5 hours and is 1.2, 2.4, 4.3 and 5.4 mcg/ml, respectively.

Orally taken Ciprofloxacin is distributed in the tissues and fluids of the body. High concentrations of the drug are observed in bile, lungs, kidneys, liver, gallbladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of the drug in these tissues is higher than in serum. Ciprofloxacin also penetrates well into bones, ocular fluid, bronchial secretions, saliva, skin, muscles, pleura, peritoneum, and lymph.

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

V_d in the body is 2-3.5 L/kg. The drug penetrates into the cerebrospinal fluid in small amounts, where its concentration is 6-10% of that in serum.

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

In patients with unchanged renal function, T_1/2 is usually 3-5 hours. In case of impaired renal function, T_1/2 increases.

The main route of elimination of ciprofloxacin from the body is the kidneys. 50-70% is excreted in the urine. From 15 to 30% is excreted in feces.

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

Indications

Infections and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin

• Of the respiratory tract;
• Of the ear, throat and nose;
• Of the kidneys and urinary tract;
• Of the genital organs;
• Of the digestive system (including the mouth, teeth, jaws);
• Of the gallbladder and biliary tract;
• Of the skin, mucous membranes and soft tissues;
• Of 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 (during therapy with immunosuppressants).

ICD codes

Dosage Regimen

The dose of Ciprofloxacin depends on the severity of the disease, the type of infection, the condition of the body, age, body weight and renal function of the patient. The recommended usual doses

• uncomplicated diseases of the kidneys and urinary tract – 250 mg, and in complicated cases – 500 mg 2 times/day;
• moderate diseases of the lower respiratory tract – 250 mg, and in more severe cases – 500 mg 2 times/day;
• For treatment of gonorrhea a single dose of ciprofloxacin 250-500 mg is recommended;
• gynecological diseases, enteritis and colitis with severe course and high fever, prostatitis, osteomyelitis – 500 mg 2 times/day (for the treatment of common diarrhea, it can be used at a dose of 250 mg 2 times/day).

The drug should be taken on an empty stomach with plenty of fluid.

Patients with severe renal impairment should be prescribed half the dose of the drug.

The duration of treatment depends on the severity of the disease, but treatment should always continue for at least two more days after the symptoms of the disease have disappeared.

Usually the duration of treatment is 7-10 days.

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

Adverse Reactions

From the digestive system nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

From the nervous system dizziness, headache, increased fatigue, anxiety, tremor, insomnia, “nightmare” dreams, peripheral paralgesia (abnormality in the perception of pain sensation), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally progressing to states in which the patient may harm themselves), migraine, fainting, cerebral artery thrombosis.

From the senses disturbances of taste and smell, visual impairment (diplopia, change in color perception), tinnitus, hearing loss.

From the cardiovascular system tachycardia, cardiac arrhythmias, decreased blood pressure, flushing of the skin of the face.

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

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

From the urinary system hematuria, crystalluria (primarily with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased nitrogen-excreting function of the kidneys, interstitial nephritis.

Allergic reactions skin itching, urticaria, formation of blisters accompanied by bleeding and small nodules forming scabs, drug fever, petechial hemorrhages (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative multiforme erythema, Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell’s syndrome).

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

Contraindications

• Pregnancy;
• Breastfeeding period;
• Childhood and adolescence under 18 years;
• Hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group.

Use in Renal Impairment

Patients with severe renal impairment should be prescribed half the dose of the drug.

Pediatric Use

Contraindication: childhood and adolescence under 18 years.

Special Precautions

Ciprofloxacin should be prescribed to patients with epilepsy, a history of seizures, vascular diseases and organic brain lesions only for vital indications due to the threat of developing adverse reactions from the central nervous system.

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

If pain in the tendons occurs or at the first signs of tenosynovitis, treatment should be discontinued due to the fact that isolated cases of inflammation and even tendon rupture have been described during treatment with fluoroquinolones.

During treatment with ciprofloxacin, it is necessary to ensure sufficient fluid intake while maintaining normal diuresis.

During treatment with ciprofloxacin, contact with direct sunlight should be avoided.

Effect on ability to drive vehicles and mechanisms

Patients taking Ciprofloxacin should exercise caution when driving and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially when consuming alcohol simultaneously).

Overdose

There is no specific antidote. It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out usual emergency measures, and ensure sufficient fluid intake. Only a small amount (less than 10%) of the drug can be removed by hemodialysis or peritoneal dialysis.

Drug Interactions

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

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

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

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

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

Storage Conditions

Store in a dry place out of reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

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.