Cipronex – composition, action, indications, contraindications, dosage and side effects

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Cipronex is a preparation used to treat bacterial infections caused by bacteria sensitive to ciprofloxacin. This drug belongs to the fluoroquinolone group of antibiotics and is dispensed in pharmacies on prescription. What are the indications for the use of Cipronex? In what cases should it not be used? How to take Ciproxin and how to choose the right doses? Is it safe to take other medications while using Ciproxin? Are substitutes for this preparation available in pharmacies?

Cipronex – general characteristics of the drug

Cipronex is an antibiotic from the fluoroquinolone group. The active substance of this preparation is ciprofloxacin, which works by killing the bacteria that cause infections. However, it only works against certain strains of bacteria.

Each 250 mg film-coated tablet contains 250 mg of ciprofloxacin as hydrochloride (equivalent to 291 mg of ciprofloxacin hydrochloride). However, each 500 mg film-coated tablet contains 500 mg of ciprofloxacin as hydrochloride (equivalent to 582 mg of ciprofloxacin hydrochloride).

The 250 mg film-coated tablets are white, round, biconvex. On the other hand, the 500 mg film-coated tablets are white, oblong, biconvex, with a line dividing the drug into smaller doses. The package of Cipronex contains 10 film-coated tablets.

The entity responsible for the production and distribution of Cipronex is POLPHARMA SA Zakłady Farmaceutyczne Polpharma SA is a Polish pharmaceutical company based in Starogard Gdański. This concern mainly produces drugs that are used in cardiology, gastroenterology and neurology. The company was founded in 1935 as the Polish Chemical and Pharmaceutical Factory “Polpharma”. The company has 7 production plants located in Poland, Our Country and Kazakhstan, as well as seven research and development centers.

What should you know about antibiotics and how they work? Read: Antibiotics – types, action, use and side effects [EXPLAIN]

Cipronex – composition and action of the drug

Cipronex is an antibiotic, the basic ingredient of which is bactericidal properties ciprofloxacin.

Ciprofloxacin is an antibacterial drug belonging to the group of fluorinated quinolones. The mechanism of action of this type of drugs is based on inhibiting DNA synthesis in bacterial cells by blocking topoisomerases II (enzymes that cut both DNA strands): DNA gyrase – an enzyme responsible for folding DNA strands and creating spatial isomers of DNA strands, and topoisomerase IV – an enzyme responsible for separating strands DNA after the replication process is complete. The consequence of this action is the death of the bacterial cell.

Ciprofloxacin has a broad spectrum of antibacterial activity, which means that it is active against many species of bacteria. It is worth mentioning, however, that Ciproxin works primarily on gram-negative bacteria.

The bacteria may be resistant to the drug. Resistance to ciprofloxacin often results from mutations in the genes encoding bacterial topoisomerases and usually develops slowly and gradually. There may also be drug resistance mechanisms such as a change in the permeability of the bacterial cell wall or the active removal of the active substance from within the bacterial cell.

After oral administration, ciprofloxacin is well absorbed from the gastrointestinal tract. The highest concentration in the blood is achieved after 1-2 hours after taking the drug. The biological half-life is 3-5 hours. The substance is metabolized in the liver into four pharmacologically active metabolites. Ciprofloxacin is excreted from the body mainly unchanged via the kidneys and to a lesser extent via the faeces.

Ciproxin film-coated tablets also contain excipients, including:

  1. microcrystalline cellulose
  2. sodium carboxymethyl starch;
  3. colloidal anhydrous silica;
  4. magnesium stearate;
  5. hypromelozę;
  6. macrogol 6000;
  7. titanium dioxide;
  8. talk.

What are bacteria and how do they function in our body? Check: Bacteria – role, research, pathogenic bacteria

Cipronex – indications for use

Cipronex is a preparation that is used in cases of bacterial infections. Your doctor may recommend this medication, especially for the treatment of:

  1. lower respiratory tract infections caused by Gram-negative bacteria, e.g. exacerbations of chronic obstructive pulmonary disease, bronchopulmonary infections due to cystic fibrosis or bronchiectasis, community-acquired pneumonia;
  2. chronic purulent otitis media;
  3. exacerbations of chronic sinusitis;
  4. uncomplicated acute bladder inflammations;
  5. acute pyelonephritis;
  6. complicated urinary tract infections;
  7. bacterial prostatitis;
  8. gonococcal urethritis and cervicitis caused by Neisseria gnorrhoeae strains;
  9. inflammations of the testicle and epididymis, including those caused by susceptible strains of Neisseria gnorrhoeae;
  10. pelvic inflammations, including those caused by Neisseria gnorrhoeae;
  11. gastrointestinal infections;
  12. intra-abdominal infections;
  13. skin and soft tissue infections caused by Gram-negative bacteria;
  14. malignant otitis externa;
  15. bone and joint infections;
  16. to prevent invasive infections due to Neisseria meningitidis;
  17. pulmonary form of anthrax.

Cipronex can also be used by children and adolescents who are diagnosed with:

  1. bronchopulmonary infections caused by the bacteria Pseudomonas aeruginosa in people with cystic fibrosis;
  2. complicated urinary tract infections, acute pyelonephritis;
  3. pulmonary form of anthrax.
important

Ciprofloxacin can be used to treat neutropenic patients with a fever that is suspected to be caused by a bacterial infection.

What is and what is the risk of antibiotic resistance? Read on: Antibiotic resistance is a global threat. 2050 million people may die as a result of it in 10

Cipronex – contraindications to use

Cipronex, despite its effectiveness in the treatment of bacterial infections, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Cipronex are:

  1. hypersensitivity to the active substance, quinolone antibiotics or any of the excipients;
  2. simultaneous use of tizanidine;
  3. pregnancy and breastfeeding;
  4. age of the patient – the drug should not be used in children under 6 years of age.

What bacterial diseases are most often diagnosed? Check: The most common bacterial diseases – overview and characteristics

Cipronex – precautions

Before and during the use of Ciproxin, follow the precautions included in the package leaflet.

Particular precautions should be taken in cases of:

  1. if you are diagnosed with widening of a large blood vessel (aneurysm of the aorta or large peripheral artery)
  2. a history of aortic dissection (aortic wall tear);
  3. a patient is diagnosed with insufficient valve closure of the heart;
  4. a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome or vascular form of Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome, or blood vessel disease such as Takayasu’s arteritis, giant cell arteritis, Behcet’s disease, hypertension or established atherosclerosis, rheumatoid arthritis, or endocarditis;
  5. you have kidney problems; 
  6. diagnosed with epilepsy or other neurological disorders; 
  7. you have had problems with your tendons in the past during treatment with antibiotics such as Ciproxin; 
  8. diagnosed with diabetes; 
  9. diagnosed with myasthenia gravis;
  10. you have had abnormal heart rhythms (arrhythmias) in the past;
  11. if you are born with or have a family history of QT prolongation (seen on an EKG, a test of the electrical activity of the heart);
  12. if you are diagnosed with an electrolyte imbalance in the blood (especially low levels of potassium and magnesium in the blood);
  13. a very slow heart rate (bradycardia);
  14. poor heart function (heart failure);
  15. previous myocardial infarction;
  16. the elderly patient;
  17. taking other drugs that may cause changes in the ECG record.

It should also be remembered that Ciproxin should not be used after the expiry date which is stated on the box. The expiry date refers to the last day of that month. The drug should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Cipronex – method of use and dosage

Always use Cipronex exactly as described in the package leaflet or according to the doctor’s or pharmacist’s instructions.

Treatment usually lasts 5 to 21 days, but may be longer in severe infections. Ciproxin tablets should be swallowed with plenty of liquid. The tablets should not be chewed as they have an unpleasant taste. It is best to take the tablets at around the same time each day. The tablets can be taken at mealtimes or between meals. Calcium, which is part of the meal, has no significant influence on absorption. However, do not take Ciproxin only with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-enriched orange juice).

Correct doses of Ciproxin is indicated by the physician prescribing the drug to the patient. However, it is worth noting that the dosage of this drug depends on the condition the patient is struggling with.

Dosage of Ciproxin in adults:

  1. infections of the lower and upper respiratory tract: 500-750 mg twice a day for 2-7 days;
  2. malignant otitis externa: 750 mg twice daily for 2 days;
  3. uncomplicated cystitis: 250-500 mg twice a day for 2 days;
  4. complicated cystitis, uncomplicated pyelonephritis: 500 mg twice a day for 2 days;
  5. complicated pyelonephritis: 500-750 mg 2 times a day for at least 10 days;
  6. prostatitis: 500-750 mg 2 times a day for 2-4 weeks (acute) or 4-6 weeks (chronic);
  7. Gonococcal urethritis or cervicitis: 500 mg as a single dose;
  8. testicular epididymitis and pelvic inflammatory disease: 500-750 mg twice daily for at least 2 days;
  9. diarrhea caused by Shigella spp. and empirical treatment of travelers’ diarrhea: 500 mg twice daily for 2 day;
  10. diarrhea caused by Shigella dysenteriae type 1: 500 mg twice daily for 2 days;
  11. diarrhea caused by Vibrio cholerae: 500 mg twice daily for 2 days;
  12. typhoid fever: 500 mg twice daily for 2 days;
  13. intra-abdominal infections caused by Gram-negative bacteria: 500-750 mg twice daily for 2-5 days;
  14. skin and soft tissue infections: 500-750 mg twice a day for 2-7 days;
  15. bone and joint infections: 500-750 mg twice a day for a maximum of 2 months;
  16. treatment or prevention of infections in patients with neutropenia (ciprofloxacin to be administered in combination with other antibacterial drugs): 500-750 mg twice daily for the entire period of neutropenia;
  17. pulmonary anthrax: 500 mg twice daily for 2 days from the confirmation of Bacillus anthracis contact.

Dosage of Ciproxin for children and adolescents:

  1. cystic fibrosis: 20 mg / kg 2 times a day, a maximum of 750 mg per dose for 10-14 days;
  2. complicated urinary tract infections and pyelonephritis: 10-20 mg / kg 2 times a day, a maximum of 750 mg per dose for 10-21 days;
  3. pulmonary anthrax: 10-15 mg / kg bw. Twice daily with a maximum of 2 mg per dose for 500 days from the confirmation of Bacillus anthracis exposure;
  4. patients with impaired renal function. Recommended starting and maintenance dose: 250-500 mg every 24 hours;

Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance. In contrast, no dosage adjustment is necessary in patients with hepatic impairment.

How to take medication correctly? Check: How to take medications effectively?

Cipronex – side effects

Cipronex, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common side effects of Ciproxin (may affect 1 to 10 in 100 people):

  1. nausea (feeling sick);
  2. diarrhea;
  3. joint pain in children.

Uncommon side effects of Ciproxin (may affect 1 to 10 in 1000 people):

  1. fungal superinfections;
  2. high levels of eosinophils (a type of white blood cell);
  3. loss of appetite (anorexia);
  4. overactivity or agitation;
  5. headache, dizziness, trouble sleeping or taste disturbances;
  6. vomiting, stomach pain, digestive problems such as upset stomach (indigestion, heartburn) or wind;
  7. increased levels of certain substances in the blood (transaminases and bilirubin);
  8. rash, itchy skin or hives;
  9. joint pain in adults;
  10. decreased kidney function;
  11. muscle and bone pain, malaise (weakness) or fever;
  12. increased levels of an enzyme in the blood called alkaline phosphatase.

Rare side effects of Ciproxin (may affect 1 to 10 in 10 people):

  1. inflammation of the intestine (colitis) associated with the use of antibiotics (may very rarely be fatal);
  2. change in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased blood clotting factor (platelets);
  3. an allergic reaction, swelling (swelling) or rapid swelling of the skin and mucous membranes (angioedema);
  4. high blood sugar (hyperglycaemia);
  5. confusion, disorientation, anxiety reactions, abnormal dreams, depression (which may result in suicidal ideation or thoughts, or attempted suicide or suicide) or hallucinations;
  6. stinging sensation, excessive sensitivity to sensation, decreased skin sensitivity, tremors, seizures (including status epilepticus) or dizziness;
  7. vision problems (e.g. double vision);
  8. tinnitus, hearing loss, hearing impairment;
  9. fast heart beat (tachycardia);
  10. vasodilation, low blood pressure, or fainting;
  11. shortness of breath, including symptoms of asthma;
  12. liver problems, jaundice (cholestasis) or hepatitis;
  13. sensitivity to light;
  14. muscle pain, arthritis, increased muscle tone or spasm;
  15. kidney failure, blood or crystals in the urine, inflammation of the urinary system;
  16. fluid retention or excessive sweating;
  17. increased levels of an enzyme called amylase.

Very rare side effects of Ciproxin (may affect up to 1 in 10 people):

  1. a particular type of reduced number of red blood cells (haemolytic anemia); a dangerous decrease in the number of white blood cells (agranulocytosis), a decrease in the number of red and white blood cells and platelets (aplastic anemia), which can be fatal, and bone marrow depression, which can also be fatal;
  2. severe allergic reactions (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness);
  3. mental disturbances (psychotic reactions that may result in suicidal ideation or thoughts, or a suicide attempt or suicide);
  4. migraine, impaired coordination, unstable gait (abnormal gait), impaired sense of smell, pressure on the brain (intracranial pressure);
  5. disturbed color vision;
  6. inflammation of the blood vessel wall (vasculitis);
  7. inflammation of the pancreas;
  8. death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure;
  9. small dark spots visible under the skin (ecchymosis); various skin eruptions or rashes (e.g., potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis);
  10. muscle weakness, inflammation of a tendon, rupture of a tendon – especially the large tendon at the back of the ankle (Achilles tendon).

The frequency of side effects after the use of Ciproxin is not known (cannot be estimated from the available data):

  1. problems related to the nervous system such as pain, burning, tingling, numbness and / or weakness in the limbs;
  2. very fast heartbeat;
  3. life-threatening irregular heartbeat;
  4. disturbance of the heart rhythm (called “QT prolongation”, seen on an ECG test of the electrical activity of the heart), ventricular arrhythmia;
  5. acute generalized pustular eruption (AGEP);
  6. feeling over-excited (mania) or feeling overly optimistic and overactive (hypomania);
  7. hypersensitivity reactions called DRESS (drug rash with eosinophilia and systemic symptoms);
  8. prolongation of blood clotting time in patients receiving vitamin K antagonists.
WARNING

The occurrence of side effects after the use of Cipronex can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.

What causes an antibiotic rash? Read on: Antibiotic rash – is it an allergy symptom?

Cipronex and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking Ciproxin.

It is best to avoid the use of Ciproxin during pregnancy. Also, do not take Ciproxin while breastfeeding as ciprofloxacin passes into breast milk and may be harmful to the baby.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Cipronex – interactions with other drugs

Before starting treatment with Ciproxin, inform the treating physician or pharmacist about all the medications they are taking or have recently taken. You should also inform what medications the patient plans to take in the near future. The active substance of Ciproxin may interact with other drugs or substances contained in medical products.

First of all, you cannot use Ciproxin and tizanidine at the same time. The combination of the two drugs can cause side effects such as low blood pressure and sleepiness.

Patients should inform their doctor if they are taking other medications that may affect the work of the heart:

  1. antiarrhythmic drugs – quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide;
  2. tricyclic antidepressants;
  3. some antibacterial drugs (belonging to the macrolide group);
  4. some antipsychotics

The patient should inform the physician if they are taking the following medications as well:

  1. warfarin or other oral anticoagulants – acenocoumarol, phenprocoumon, fluindione;
  2. probenecid for gout; 
  3. methotrexate used for certain types of cancer, psoriasis, rheumatoid arthritis; 
  4. theophylline for respiratory disorders;
  5. tizanidine, used to reduce muscle spasticity in multiple sclerosis; 
  6. clozapine – an antipsychotic drug;
  7. ropinirole for Parkinson’s disease;
  8. phenytoin for epilepsy; 
  9. metoclopramide to prevent nausea and vomiting; 
  10. omeprazole used to treat heartburn and peptic ulcer disease; 
  11. cyclosporin used after organ transplantation; 
  12. glibenclamide used in diabetes; 
  13. duloxetine for depression, anxiety or diabetic neuropathic pain; 
  14. lidocaine for pain relief and for heart rhythm problems; 
  15. sildenafil used for erectile dysfunction. 

In addition, it is worth remembering that the use of Ciproxin may increase the concentration of the following drugs in the blood:

  1. pentoxifylline used in circulatory disorders;
  2. caffeine;
  3. agomelatyna; 
  4. zolpidem.

Certain drugs may reduce the effect of Ciproxin. You should inform your doctor if you are using them or intend to use them. These are:

  1. antacids;
  2. dydanozyna;
  3. mineral supplements;
  4. sucralfate;
  5. polymeric phosphorus binders – e.g. sevelamer; 
  6. Medicines containing calcium, magnesium, aluminum or iron, or dietary supplements used to supplement these ingredients. 

Which drugs should never be combined with each other? Check: Dangerous interactions

Cipronex – interactions with food

When taking Ciproxin, you should also remember about the consumed foods. First of all, you need to pay attention to the dairy products you consume, i.e. milk and its products. Drinking a medicine, e.g. with kefir, or consuming yogurt together with the medicine, reduces the absorption of the drug (even by 50%), thus the patient may not feel any improvement in his health. To avoid this, take the drug at least one hour before or two hours after a dairy meal.

In addition, while taking Ciproxin, the patient should limit the consumption of products containing a lot of iron, such as: lettuce, spinach or liver, because iron hinders the absorption of this antibiotic from the gastrointestinal tract. Thus, the blood concentration of the drug may be too low to overcome the infection. Therefore, Ciproxin should be taken at least one hour before eating these foods, or two hours after a meal.

The patient should also limit the consumption of caffeine contained, inter alia, in in coffee and energy drinks. Ciprofloxacin causes the accumulation of caffeine in the body, resulting in the intensification of side effects such as excessive agitation, insomnia and palpitations.

What is a healthy diet? Read: Healthy diet

Cipronex — cena

The price of the drug Cipronex may differ depending on the city in which the antibiotic will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the content of the active substance in the tablet:

  1. coated tablets 250 mg, 10 pieces – price approx. PLN 6-7. After reimbursement, about 4-5 zlotys;
  2. coated tablets 500 mg, 10 pieces – price approx. PLN 10-11. After a refund of about 6-7 zlotys.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor

Cipronex – substitutes and similar drugs

Products that have the same international name and exist in the same form do not have to be substitutes, because the use of a given drug is determined by the content of the active substance, i.e. the dose of the drug.

It should be remembered that even when the dose of the active substance is similar, the patient may not always use the substitute, because he may be allergic to any of the other excipients of the drug.

Therefore, before using a substitute for Cipronex, read the package leaflet or consult your doctor or pharmacist.

The preparations that contain the same ingredients as Ciproxin and show similar properties include:

  1. Cetraxal – a drug that is available in the form of a solution in ear drops;
  2. Ciloxan – a drug available in the form of a solution in ear drops and eye ointment;
  3. Ciphin 500 – a drug available in the form of coated tablets;
  4. Ciprinol – a drug available in the form of a concentrate for solution for infusion and in coated tablets;
  5. Ciprofloxacin Kabi 100 mg / 50 ml, 200 mg / 100 ml, 400 mg / 200 ml – as a solution for infusion;
  6. Cipronex 0,3% – in the form of eye drops;
  7. Cipropol – in the form of coated tablets;
  8. Proxacin 250, 500 – in the form of coated tablets;
  9. Proxacin 1% – in the form of a concentrate for solution for infusion.

When is it worth asking the pharmacy about drug substitutes? Check: Swap when you can

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