Procipro

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Procipro: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Procipro

ATX code: J01MA02

Active ingredient: ciprofloxacin (Ciprofloxacin)

Manufacturer: Protek Biosystems Pvt. Ltd. (Protech biosystems Pvt. Ltd.) (India)

Description and photo update: 2019-09-07

Procipro is an antimicrobial agent.

Release form and composition

Dosage forms:

solution for infusion: transparent, colorless or light yellow (100 ml in sterile polyethylene bottles, 1 bottle in a cardboard box);
film-coated tablets: round, biconvex, almost white or white, with a line on one side (10 pcs. in blister contour packs, in a cardboard box 1 or 10 packs; for hospitals - 1000 pcs. in plastic bags, in a polymer container 1 package).

Each pack also contains instructions for the use of Procipro.

Composition of 100 ml solution:

active substance: ciprofloxacin lactate - 265 mg, which is equivalent to the content of ciprofloxacin - 200 mg;
auxiliary components: water for injection, sodium chloride.

Composition of 1 film-coated tablet:

active substance: ciprofloxacin hydrochloride - 291.1 mg or 582.2 mg, which is equivalent to the content of ciprofloxacin - 250 or 500 mg, respectively;
auxiliary components: sodium carboxymethyl starch, magnesium stearate, macrogol 6000, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, purified talc, titanium dioxide, starch.

Pharmacological properties

Pharmacodynamics

The active ingredient of Procypro is ciprofloxacin - a synthetic broad-spectrum antimicrobial substance belonging to the group of fluoroquinolones. Its main mechanism of action is the suppression of the bacterial enzyme DNA gyrase, which causes impaired replication of deoxyribonucleic acid and the synthesis of bacterial cellular proteins. The drug has a bactericidal effect on gram-positive microorganisms during division, on gram-negative microorganisms during division and rest.

Sensitivity to ciprofloxacin is shown by:

Gram-negative aerobic bacteria: Enterobacteriaceae Citrobacter spp., Escherichia coli, Enterobacter spp., Edwardsiella tarda, Hafnia alvei, Klebsiella spp., Morganella morganii, Proteus vulgaris, Proteus mirabilis, Providencia spp., Saligella spp., Yersinia spp., Vibrio spp.;
other gram-negative bacteria: Aeromonas spp., Campylobacter jejuni, Haemophilus spp., Moraxella catarrhalis, Neisseria spp., Pasteurella multocida, Pseudomonas aeruginosa, Plesiomonas shigelloides;
some intracellular pathogens: Brucella spp., Chlamydia trachomatis, Legionella pneumophila, Listeria monocytogenes, Mycobacterium kansasii, Mycobacterium tuberculosis, Mycobacterium avium (located intracellularly);
gram-positive aerobic bacteria: Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae), Staphylococcus spp. (Staphylococcus hominis, Staphylococcus haemolyticus, Staphylococcus saprophyticus, Staphylococcus aureus), including most methicillin-resistant staphylococci.

Moderate sensitivity to the drug was found in the bacteria Enterococcus faecalis and Streptococcus pneumoniae. In vitro and in vivo, ciprofloxacin is active against Bacillus anthracis.

Resistance to the drug was noted in the following microorganisms: Bacteroides fragilis, Corynebacterium spp., Clostridium difficile, Nocardia asteroides, Pseudomonas maltophilia, Pseudomonas cepacia, Ureaplasma urealyticum.

The effect of ciprofloxacin against the causative agent of syphilis Treponema pallidum has been insufficiently studied.

Pharmacokinetics

With intravenous (iv) administration of ciprofloxacin at a dose of 200 mg and 400 mg, the serum concentration of the drug 60 minutes after the start of the infusion is, respectively, 2.1 μg / ml and 4.6 μg / ml.

When taken orally, the agent is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50–85%. The maximum serum concentration as a result of taking tablets before meals at a dose of 250, 500, 750 and 1000 mg is 1.2, respectively; 2.4; 4.3 and 5.4 kg / ml, achieved within 1-1.5 hours.

The drug is well distributed in tissues and fluids. The volume of distribution in the body in an equilibrium state is 2–3.5 l / kg. High concentrations are found in the liver, kidneys, gallbladder, bile, lungs, tonsils, prostate tissue, seminal fluid, endometrium, uterus, ovaries and fallopian tubes. In these fluids and tissues of the listed organs, the concentration of ciprofloxacin is higher than in the blood serum. Also, the substance penetrates well into saliva, bronchial secretions, ocular fluid, lymph, pleura, peritoneum, muscles, skin, bones. The cerebrospinal fluid concentration is 6-10% of the serum level. In blood neutrophils, the accumulating concentration of ciprofloxacin is 2–7 times higher than in serum. Plasma protein binding is low. In a small amount, it penetrates the blood-brain barrier.

After intravenous administration, the concentration in urine during the first two hours is almost 100 times higher than in serum.

Ciprofloxacin is excreted mainly by the kidneys - 50–70%. Approximately 15-30% is excreted through the intestines.

The half-life in patients with normal renal function is 3–5 hours. In patients with functional impairment of renal function, this period increases.

In severe renal failure [creatinine clearance (CC) <20 ml / min / 1.73 m ²], the daily dose of the drug should be halved.

Indications for use

Procipro is indicated for the treatment of infectious and inflammatory diseases of the following organs caused by sensitive microorganisms:

ear, throat, nose;
Airways;
digestive system (including teeth, mouth, jaw);
gallbladder and biliary tract;
kidneys and urinary tract;
genitals: gonorrhea, adnexitis, prostatitis, as well as postpartum infections;
musculoskeletal system;
skin, soft tissues and mucous membranes.

Procipro is also used in such cases:

peritonitis and sepsis - treatment;
infections in patients with reduced immunity (with the use of immunosuppressants) - treatment and prevention;
pulmonary anthrax (infection with Bacillus anthracis) - treatment and prevention.

Indications for the use of Procipro tablets in pediatrics:

therapy of complications caused by Pseudomonas aeruginosa in children 5–17 years old with pulmonary cystic fibrosis;
treatment and prevention of pulmonary anthrax.

Contraindications

Absolute:

period of pregnancy and lactation;
age up to 18 years (with the exception of complications caused by Pseudomonas aeruginosa, in children with cystic fibrosis of the lungs 5–17 years old, prevention and treatment of pulmonary anthrax - for Procypro tablets);
simultaneous use of tizanidine (associated with the risk of drowsiness and a pronounced decrease in blood pressure);
hypersensitivity to the components of the drug or other agents from the group of fluoroquinolones.

Relative (antibiotic Procipro is used with caution, after a careful assessment of the benefits / risks):

epilepsy and epileptic syndrome;
violation of cerebral circulation;
pronounced atherosclerosis of the vessels of the brain;
mental illness;
severe hepatic / renal failure;
elderly age.

Procipro, instructions for use: method and dosage

Solution for infusion

Procipro in this dosage form is preferably administered intravenously drip within 30 minutes (if a 200 mg dose is prescribed) or 60 minutes (if a 400 mg dose is prescribed). Jet injection of the solution is possible depending on the circumstances.

The dose is determined by the doctor based on data such as the type of infection, the severity of the disease, the patient's general condition, age, weight and kidney function.

The recommended dosage for intravenous administration is 200 mg 2 times a day. In severe infectious processes, a single dose is increased to 400 mg. In case of recurrent or life-threatening infections caused by Streptococcus pneumoniae, Pseudomonas or staphylococci, the dose may be increased to 400 mg 3 times a day.

In acute gonorrhea, administration of 200 mg of the drug is indicated.

In order to prevent postoperative infections, Procipro is administered at 200 mg 30–60 minutes before surgery.

The duration of therapy is at least 1 week and depends on the type and severity of the disease. With osteomyelitis, the course can reach 2 months.

For patients with impaired renal function, the dose of Procipro is adjusted depending on creatinine clearance: with CC 31-60 ml / min / 1.73 m ² (plasma creatinine concentration - 1.4-1.9 mg / 100 ml) the maximum daily dose may equal 800 mg, with CC ≤ 30 ml / min / 1.73 m ² (plasma creatinine concentration - <2 mg / 100 ml) - 400 mg.

Film-coated tablets

Procipro in tablet form should be taken orally on an empty stomach with sufficient liquid.

The doctor determines the optimal dose individually, depending on the type of infection, the severity of the disease, the general condition of the patient, his age, weight and kidney condition. Adults are usually prescribed 250 mg 2-3 times a day. In severe cases, the dose is increased to 500-750 mg 2 times a day (at 12-hour intervals).

Recommended dosage regimens of Procipro for adults, depending on the indications:

diseases of the urinary tract and kidneys: uncomplicated - 250 mg 2 times a day, complicated - 500 mg 2 times a day;
infections of soft tissues, skin, joints and bones: 500 mg 2 times a day, in severe cases - 750 mg 2 times a day;
diseases of the lower respiratory tract: 250 mg 2 times a day, in severe cases - 500-750 mg 2 times a day;
enteritis and colitis with severe course and high fever, gynecological diseases, prostatitis: 500 mg 2 times a day (in the case of ordinary diarrhea, it is enough to take 250 mg 2 times a day);
gonorrhea, cystitis in women (before menopause): 250-500 mg once;
pulmonary anthrax: 500 mg 2 times a day for 60 days (it is recommended to start using the drug immediately if an infection is suspected).

The duration of taking Procipro depends on the type and severity of the infectious process, but treatment should continue for at least 2 days after the symptoms disappear. In most cases, the duration of therapy is 7-10 days.

Recommended doses of the drug for children:

pulmonary anthrax: 15 mg / kg 2 times a day, but not more than 500 mg per dose and 1000 mg per day, the course of treatment is 60 days, it is recommended to start using Procipro immediately if an infection is suspected;
complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs 5–17 years old: 20 mg / kg 2 times a day, but not more than 1500 mg a day for 10–14 days.

In case of impaired renal function, the dose of Procipro is determined depending on the creatinine clearance:

CC> 50 ml / min - usual dosing regimen;
CC 30-50 ml / min - 250-500 mg every 12 hours;
CC 5-29 ml / min - 250-500 mg every 18 hours;
patients receiving hemodialysis or peritoneal dialysis - 250-500 mg every 24 hours after a dialysis session.

For elderly patients, the dose of the drug is reduced by 30%.

Side effects

laboratory parameters: hyperglycemia, hypoprothrombinemia, increased concentration of urea, bilirubin, lactate dehydrogenase, alkaline phosphatase, creatinine and hepatic transaminase activity;
allergic reactions: the appearance of small nodules that form scabs; blisters with bleeding; urticaria, pruritus, erythema nodosum, punctate hemorrhages on the skin (petechiae), drug fever, vasculitis, dyspnea, edema of the face or larynx, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme (including Stevens-Johnson syndrome);
from the central nervous system: increased intracranial pressure, peripheral paralgesia (anomaly in the perception of pain), anxiety, increased fatigue, headache, insomnia, nightmares, tremors, dizziness, increased sweating, fainting, migraine, cerebral artery thrombosis, confusion, hallucinations, depression, other manifestations of psychotic reactions (occasionally progressing to states in which the patient can harm himself);
on the part of the hematopoietic system: changes in the number of platelets, neutropenia, hemolytic anemia, eosinophilia, leukopenia;
from the digestive system: decreased appetite, abdominal pain, diarrhea, vomiting, nausea, flatulence, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis;
on the part of the cardiovascular system: flushes of blood to the skin of the face, arterial hypotension, heart rhythm disturbances, tachycardia;
on the part of the musculoskeletal system: tendon ruptures, arthritis, arthralgia, myalgia, tendovaginitis;
on the part of the urinary system: crystalluria (mainly with low urine output and alkaline urine), hematuria, urinary retention, polyuria, dysuria, albuminuria, glomerulonephritis, urethral bleeding, decreased renal nitrogen excretion function, interstitial nephritis;
on the part of the senses: tinnitus, hearing loss, visual impairment (diplopia, change in color perception), impairment of taste and smell;
others: superinfections (candidiasis, pseudomembranous colitis), general weakness, photosensitivity.

Overdose

In case of overdose, there is a reversible toxic effect on the kidneys.

Ciprofloxacin has no specific antidote. After taking high doses of the drug inside, it is recommended to wash the stomach. The usual measures of emergency care, careful monitoring of the patient's condition, ensuring an adequate supply of fluid are shown.

The effectiveness of hemo- and peritoneal dialysis is low (up to 10% of the drug can be removed).

special instructions

It is forbidden to exceed the recommended daily doses. It is required to ensure a sufficient flow of fluid into the body, adherence to normal diuresis, and maintain the acidic reaction of urine. Otherwise, crystalluria may develop.

With long-term treatment, it is necessary to monitor the indicators of renal, liver and peripheral blood function.

Patients with a history of seizures, epilepsy, organic lesions and vascular diseases of the brain, Procipro can be prescribed only for health reasons. This is associated with a high risk of developing side effects from the central nervous system.

If, during or after therapy, severe and prolonged diarrhea occurs, it is necessary to exclude pseudomembranous colitis - a serious complication that requires the abolition of Procipro and immediate appropriate treatment.

There are isolated cases of inflammation and tendon ruptures in patients receiving fluoroquinolones, so Procipro should be immediately canceled in case of pain in the tendons or the first signs of tendovaginitis.

In some cases, ciprofloxacin causes phototoxic reactions. In this regard, patients during treatment are advised to avoid exposure to direct sunlight and exposure to artificial ultraviolet radiation. If the first signs of photosensitization appear, Procipro should be canceled.

Fluoroquinolones can cause anaphylactic reactions. When the first signs appear, the drug should be canceled and a doctor should be called urgently. The introduction of adrenaline, glucocorticosteroids is required.

Infusion solution Procipro is photosensitive, therefore, remove the bottle from the box immediately before use.

Influence on the ability to drive vehicles and complex mechanisms

Patients receiving Procipro should be careful when performing potentially hazardous activities that require precision movement, good response and / or increased attention.

Application during pregnancy and lactation

During pregnancy and lactation, the use of Procipro antibiotic is contraindicated.

Pediatric use

In the form of a solution for injection, Procipro is contraindicated under 18 years of age.

Procipro tablets in pediatrics are used only for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs 5–17 years old, as well as for the treatment and prevention of pulmonary anthrax.

With impaired renal function

In severe renal failure, Procipro should be used with caution. Dose adjustment required.

For violations of liver function

With severe hepatic impairment, Procipro should be used with caution. Dose adjustment required.

Use in the elderly

Elderly patients should be treated with caution. Correction of the dosage regimen may be required.

Drug interactions

other antimicrobial agents (aminoglycosides, beta-lactam antibiotics, metronidazole, clindamycin): synergistic action is noted. Ciprofloxacin is successfully used in combination with clindamycin and metronidazole for anaerobic infections, with vancomycin and isoxazolpenicillins - for staphylococcal infections, with azlocillin, mezlocillin and other beta-lactam antibiotics - for streptococcal infections caused by ceftazillin spp.
didanosine: absorption of ciprofloxacin decreases;
non-steroidal anti-inflammatory drugs (with the exception of acetylsalicylic acid): the likelihood of seizures increases;
uricosuric drugs: the excretion of ciprofloxacin slows down (up to 50%), its plasma concentration increases;
metoclopramide: the absorption of ciprofloxacin is accelerated, which reduces the time to reach its maximum concentration in the blood;
warfarin: the risk of bleeding increases;
anticoagulants: bleeding time is lengthened;
cyclosporine: its nephrotoxic effect is enhanced;
tizanidine: its concentration significantly increases (4-21 times) and the area under the concentration-time curve (6-24 times), which increases the risk of a significant decrease in blood pressure and the appearance of drowsiness;
theophylline and other xanthines (for example, caffeine), oral hypoglycemic agents: their concentration increases, the half-life is lengthened, the risk of toxic effects increases;
antacids and preparations containing ions of aluminum, magnesium, zinc or iron: a decrease in the absorption of ciprofloxacin taken by mouth is possible (at least 4-hour intervals should be observed between taking medications).

Procipro solution is pharmaceutically incompatible with solutions and drugs with a pH of 3-4, which are chemically or physically unstable, as well as with solutions with a pH of more than 7.

Analogs

Procipro analogs are Abaktal, Aquamox, Ashlev, Gatispan, Zanocin, Ivacin, Lebel, Levoflox, Leflobact, Maklevo, Moxiflo, Nolitsin, Oflox, Pefloxabol, Remedia, Sparflo, Tarivid, Ultramox, Fleksid, Heinemox, Enemox, Tsifl.

Terms and conditions of storage

Store in a dry, dark place, out of reach of children, at temperatures up to 25 ° C. Avoid freezing the solution.

The shelf life of the solution for infusion is 2 years. Coated tablets can be stored for up to 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Procipro

There are very few reviews of Procipro on specialized medical sites and forums. Patients confirm the high antibacterial efficacy of this drug, but indicate the frequent development of side effects, due to which they even had to interrupt the course of treatment.

Price for Procipro in pharmacies

At the moment, the price of Procypro is unknown due to the lack of the drug in pharmacies. The approximate cost of some popular analogues:

Abaktal - 208–320 rubles. for 10 coated tablets of 400 mg, 527-580 rubles. for 10 ampoules of 5 ml of concentrate for the preparation of a solution for intravenous administration of 400 mg;
Zanocin - 110-169 rubles. for 10 coated tablets of 200 mg;
Tsiprolet - 47-65 rubles. for 10 film-coated tablets of 250 mg, 87-118 rubles. for 10 film-coated tablets of 500 mg, 35-77 rubles. for 1 bottle with a volume of 100 ml solution for infusion 2 mg / ml.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!