Active ingredients: Ciprofloxacin
Ciprofloxacin Accord 250 mg film-coated tablets
Ciprofloxacin Accord 500 mg film-coated tablets
Ciprofloxacin Accord 750 mg film-coated tablets
Why is Ciprofloxacin used - Generic Drug? What is it for?
Ciprofloxacin Accord is an antibiotic belonging to the fluoroquinolone family. The active ingredient is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.
Adults
Ciprofloxacin Accord is used in adults to treat the following bacterial infections:
- respiratory tract infections
- long-lasting or recurrent infections of the ears or sinuses
- urinary tract infections
- testicular infections
- infections of the genital organs in women
- infections of the gastrointestinal tract and intra-abdominal infections
- skin and soft tissue infections
- bone and joint infections
- for the prevention of infections caused by the bacterium Neisseria meningitidis
- exposure to inhalation of anthrax
Ciprofloxacin can be used to manage patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to bacterial infection.
If you have a "severe infection or" infection that is caused by more than one type of bacterium, you are likely to be prescribed additional antibiotic treatment in addition to Ciprofloxacin Accord.
Children and adolescents
Ciprofloxacin Accord is used in children and adolescents under specialist medical supervision to treat the following bacterial infections:
- lung and bronchial infections in children and adolescents with cystic fibrosis
- complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
- exposure to inhalation of anthrax
Ciprofloxacin Accord can also be used to treat other specific serious infections in children and adolescents when your doctor thinks it is necessary.
Contraindications When Ciprofloxacin - Generic Drug should not be used
Do not take Ciprofloxacin Accord if:
- you are allergic (hypersensitive) to the active substance, to other quinolone medicines or to any of the other ingredients of Ciprofloxacin Accord (see section 6).
- take tizanidine (see section 2: Other medicines and Ciprofloxacin Accord)
Precautions for use What you need to know before taking Ciprofloxacin - Generic Drug
Before you take Ciprofloxacin Accord Tell your doctor if:
- have ever had kidney problems, as your treatment probably needs to be adjusted
- suffer from epilepsy or other neurological disorders
- have had tendon problems during previous treatment with antibiotics such as Ciprofloxacin Accord
- are diabetic, as there may be a risk of hypoglycaemia using ciprofloxacin
- have myasthenia gravis (a type of muscle weakness) as the symptoms can get worse
- have had abnormal heart rhythms (arrhythmias)
- you or a family member know that you have glucose-6-phosphate dehydrogenase (G6DP) deficiency as you may be at risk of anemia with ciprofloxacin
- have heart problems
The use of this type of medicine should be done with caution, if you were born with a prolongation of the QT interval or your family history indicates the presence of this problem (seen on the ECG, the recording of the electrical activity of the heart ), if you have an imbalance of salts in the blood (especially a low level of potassium or magnesium in the blood), if you have a very slow heart rhythm (called 'bradycardia'), if you have a weak heart (heart failure), if you have had heart attacks in the past (myocardial infarction), if you are female or if you are elderly, or if you take other medicines that cause abnormal changes in the ECG (see section Other medicines and Ciprofloxacin Accord).
To treat some genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no symptoms of improvement after 3 days of treatment, consult your doctor.
While taking Ciprofloxacin Accord
Tell your doctor immediately, if any of the following occur while taking Ciprofloxacin Accord. Your doctor will decide whether you should stop taking Ciprofloxacin Accord.
- A severe and sudden allergic reaction (anaphylactic reaction / anaphylactic shock, angioedema). Even at the first dose, there is a small chance that you may have a severe allergic reaction with the following symptoms: chest tightness, feeling dizzy, nausea or fainting, or feeling dizzy when standing up. In this case, stop taking Ciprofloxacin Accord and contact your doctor immediately.
- Joint pain or swelling and tendonitis may occur occasionally, particularly if you are elderly and are also receiving corticosteroid treatment. Inflammation and ruptures of the tendons can also occur within 48 hours of starting treatment or up to several months after the end of treatment with ciprofloxacin. At the first sign of pain or inflammation, stop treatment with Ciprofloxacin Accord and rest. "sore area. Avoid any unnecessary exercise, as this can increase the risk of a tendon rupture.
- If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, it may have side effects affecting the central nervous system. In this case, stop taking Ciprofloxacin Accord and contact your doctor immediately.
- You may have psychiatric reactions the first time you take Ciprofloxacin Accord. If you suffer from depression or psychosis, your symptoms may get worse during treatment with Ciprofloxacin Accord. In rare cases, depression or psychosis can develop into thoughts of suicide or suicide or suicide attempts. In this case, stop taking Ciprofloxacin Accord and contact your doctor immediately.
- He may have symptoms of neuropathy, such as pain, burning, tingling, numbness and / or weakness. In this case, stop taking Ciprofloxacin Accord and contact your doctor immediately.
- Hypoglycaemia has been reported very often in diabetic patients, predominantly in the elderly population. If this occurs, contact your doctor immediately.
- Diarrhea can develop while you are taking antibiotics, including Ciprofloxacin Accord, or even several weeks after you stop taking the medicine. If your diarrhea worsens or becomes persistent or if you notice blood or mucus in the stool, stop taking Ciprofloxacin Accord immediately, as this can be life-threatening. Do not take medicines that stop or slow down the bowel movement and contact your doctor.
- Tell your doctor or laboratory staff that you are taking Ciprofloxacin Accord if you need to provide a blood or urine sample for analysis.
- If you have kidney problems tell your doctor as you may need a change in dosage.
- Ciprofloxacin Accord can cause liver damage. If you notice any symptoms, such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or pain in the stomach, stop taking Ciprofloxacin Accord and contact your doctor immediately.
- Ciprofloxacin Accord can cause a reduction in the number of white blood cells and can reduce your resistance to infection. If you have an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of localized infection, such as sore throat / pharynx / mouth pain or urinary problems, see your doctor immediately. a blood test to check for possible reduction in white blood cells (agranulocytosis) It is important to tell your doctor about your medicine.
- Tell your doctor if you or any member of your family have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.
- During treatment with Ciprofloxacin Accord, the skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight or artificial ultraviolet light, eg in sun beds.
Interactions Which drugs or foods can modify the effect of Ciprofloxacin - Generic Drug
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Ciprofloxacin Accord with tizanidine, as it may cause side effects, such as low blood pressure and sleepiness (see section 2: Do not take Ciprofloxacin Accord if)
The interaction of the following medicines with Ciprofloxacin Accord in the body is known. Taking Ciprofloxacin Accord with these medicines may influence the therapeutic effect of these medicines. It can also increase the likelihood of side effects.
Tell your doctor if you are taking:
- Vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
- probenecid (for gout)
- methotrexate (for some cancers, psoriasis, rheumatoid arthritis)
- theophylline (for breathing problems)
- tizanidine (for muscle spasticity in multiple sclerosis)
- olanzapine (an antipsychotic)
- clozapine (an antipsychotic)
- ropinirole (for Parkinson's disease)
- phenytoin (for epilepsy)
- cyclosporine (for skin problems, rheumatoid arthritis and in organ transplants)
- metoclopramide (for nausea or vomiting)
- omeprazole (for peptic ulcer or indigestion)
- glibenclamide (for diabetes)
- other medicines that can alter the heart rhythm: medicines belonging to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolides group), some antipsychotics .
Ciprofloxacin Accord may increase the levels of the following medicines in the blood:
- pentoxifylline (for circulatory disorders)
- caffeine
- duloxetine (for depression, diabetic neuropathy or incontinence)
- lidocaine (for heart problems or for anesthetic use) sildenafil (e.g. for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin Accord. Tell your doctor if you are taking or want to take:
- antacids
- mineral salt supplements
- sucralfate
- a polymeric phosphate chelator (e.g. sevelamer)
- medicines or supplements containing calcium, magnesium, aluminum or iron If these preparations are essential, take Ciprofloxacin Accord approximately two hours before taking them or no earlier than four hours after
Taking Ciprofloxacin Accord with food and drink
Unless you take Ciprofloxacin Accord with a meal, do not eat or drink dairy products (such as milk or yogurt) or calcium-supplemented drinks when taking the tablets, as these can affect the absorption of the active substance.
Warnings It is important to know that:
Pregnancy and breastfeeding
It is preferable to avoid the use of Ciprofloxacin Accord during pregnancy. Tell your doctor if you are planning to become pregnant.
Do not take Ciprofloxacin Accord while breastfeeding, as ciprofloxacin is excreted in breast milk and can be harmful to the baby.
Driving and using machines
Ciprofloxacin Accord can reduce your shine. Some neurological adverse events may occur. Therefore, make sure you know how you react to Ciprofloxacin Accord before driving a vehicle or operating machinery. If you have any further questions, please ask your doctor.
Ciprofloxacin Accord contains lactose monohydrate
Ciprofloxacin Accord contains lactose monohydrate (a type of sugar). If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Ciprofloxacin - Generic Drug: Posology
Your doctor will explain exactly how much Ciprofloxacin Accord to take, how often and for how long. This will depend on the type of infection you are suffering from and its severity.
Tell your doctor if you have kidney problems as your dosage may need to be adjusted.
Treatment usually lasts 5 to 21 days, but can last longer for severe infections. Take the tablets exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Accord.
to. Swallow the tablets with a large amount of liquid. Do not chew the tablets as they have an unpleasant taste.
b. Try to take the tablets at the same time each day.
c. You can take the tablets at mealtimes or between meals. Calcium taken with a meal does not significantly affect absorption. However, do not take Ciprofloxacin Accord with dairy products, such as milk or yogurt, or with added fruit juices (eg calcium-fortified orange juice).
Remember to drink large amounts of fluids while taking Ciprofloxacin Accord
Overdose What to do if you have taken an overdose of Ciprofloxacin - Generic Drug
If you take more Ciprofloxacin Accord than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciprofloxacin Accord
Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Make sure you complete the course of treatment.
If you stop taking Ciprofloxacin Accord
It is important that you complete the course of treatment even if you start feeling better after a few days.If you stop taking this medicine too soon, the infection may not be completely cured and the symptoms of the infection may come back or get worse. It can also develop antibiotic resistance.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Ciprofloxacin - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common side effects (1 to 10 in 100 people may be affected):
- nausea, diarrhea
- joint pain in children
Uncommon side effects (1 to 10 in 1000 people may be affected):
- fungal superinfections
- high concentration of eosinophils, a type of white blood cell
- loss of appetite (anorexia)
- hyperactivity or agitation
- headache, dizziness, sleep problems or taste changes
- vomiting, abdominal pain, digestive problems such as stomach pain (indigestion / heartburn) or wind
- increased amounts of certain substances in the blood (transaminases and / or bilirubin)
- rash, itching or hives
- reduced kidney function
- joint pain in adults
- pain in the muscles and bones, feeling sick (asthenia) or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare side effects (1 to 10 in 10,000 people may be affected):
- inflammation of the intestine (colitis) associated with the use of antibiotics (can be fatal in very rare cases) (see section 2: Warnings and precautions)
- changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in the amount of a blood clotting factor (thrombocytes)
- allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
- confusion, disorientation, anxious reactions, strange dreams, depression (which could develop into thoughts of suicide, suicide attempts or suicide) or hallucinations
- tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, seizures (see section 2: Warnings and precautions) or lightheadedness
- vision problems including double vision
- tinnitus, hearing loss, hearing impairment
- rapid heartbeat (tachycardia)
- dilation of blood vessels (vasodilation), low blood pressure or fainting
- shortness of breath, including asthma symptoms
- liver disorders, jaundice (cholestatic jaundice) or hepatitis
- sensitivity to light (see section 2: Warnings and precautions)
- muscle pain, joint inflammation, increased muscle tone or cramps
- kidney failure, blood or crystals in the urine (see section 2: Warnings and precautions), inflammation of the urinary tract
- water retention or excessive sweating
- increased levels of the enzyme amylase
Very rare side effects (less than 1 in 10,000 people may be affected):
- a special type of reduction in the number of red blood cells (haemolytic anemia); a dangerous decrease in a type of white blood cell (agranulocytosis); a decrease in the number of red blood cells, white blood cells and platelets (pancytopenia), which can be fatal; and bone marrow depression, which can also be fatal (see section 2: Warnings and precautions)
- severe allergic reactions (anaphylactic reaction or anaphylactic shock which can be fatal - serum sickness) (see section 2: Warnings and precautions)
- mental disorders (psychotic reactions which could develop into thoughts of suicide, suicide attempts or suicide) (see section 2: Warnings and precautions)
- migraine, coordination disturbances, unsteady walking (gait disturbance), disturbance of the sense of smell (olfactory disturbances), pressure on the brain (intracranial pressure)
- distortions in the perception of colors
- inflammation of the blood vessel wall (vasculitis)
- pancreatitis
- death of liver cells (hepatic necrosis), which very rarely can lead to life-threatening kidney failure
- small pinpoint bleeding under the skin (petechiae); different types of skin rashes (for example, Stevens-Johnson syndrome or toxic epidermal necrosis, which are potentially fatal)
- muscle weakness, tendon inflammation, tendon rupture - particularly the large tendon located at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions); worsening of symptoms of myasthenia gravis (see section 2: Warnings and Precautions).
Frequency not known (frequency cannot be estimated from the available data)
- problems associated with the nervous system, such as pain, burning, tingling, numbness and / or weakness in the extremities
- abnormal fast heart rhythm, potentially fatal heart rhythm irregularity, altered heart rhythm (called "prolongation of the" QT interval "seen with ECG, which records the electrical activity of the heart)
- postulate rashes
- influence of blood clotting (in patients treated with vitamin K antagonists)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children,
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Ciprofloxacin Accord contains
The active ingredient is ciprofloxacin hydrochloride.
The other ingredients are croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate. The tablet coating consists of hypromellose, lactose monohydrate, macrogol, sodium citrate dihydrate (E331 iii) and the dye titanium dioxide (E171) (see section 2 Ciprofloxacin Accord contains lactose monohydrate).
What Ciprofloxacin Accord looks like and contents of the pack
Ciprofloxacin 250 mg film-coated tablets are white to off-white, round shaped, biconvex film-coated tablets with 'AM' debossed on one side and plain on the other side.
Ciprofloxacin 500 mg film-coated tablets are capsule-shaped, white to off-white, capsule-shaped, biconvex, film-coated tablets with 'CI' debossed on one side and plain on the other side.
Ciprofloxacin 750 mg film-coated tablets are capsule-shaped, white to off-white, capsule-shaped, biconvex, film-coated tablets with 'CJ' debossed on one side and plain on the other side.
Ciprofloxacin Accord is available in PVC / Aluminum blisters.
Pack sizes: 6, 10, 12, 14, 16, 20, 28, 30, 50 and 100 tablets in blister packs.
(Not all pack sizes may be marketed)
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CIPROFLOXACINA ACCORD TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg :
Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 250 mg of ciprofloxacin.
Excipient (s) with known effect:
Contains 2.7 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
500 mg :
Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 500 mg of ciprofloxacin.
Excipient (s) with known effect:
Contains 5.4 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
750 mg :
Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 750 mg of ciprofloxacin.
Excipient (s) with known effect:
Contains 8.2mg of lactose monohydrate
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablet
250 mg: White to off-white, biconvex, round, film-coated tablet with "AM" debossed on one side and plain on the other.
500 mg: White to off-white, biconvex, bevel-edged, capsule-shaped, film-coated tablet, debossed with "CI" on one side and plain on the other.
750 mg: White to off-white, biconvex, bevel-edged, capsule-shaped, film-coated tablet, debossed with "CJ" on one side and plain on the other.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Ciprofloxacin is indicated for the treatment of the infections listed below (see sections 4.4 and 5.1). Prior to initiating therapy, particular attention should be paid to available information on resistance to ciprofloxacin.
Official guidelines on the appropriate use of antibacterial agents should be referenced.
Adults:
Lower respiratory tract infections caused by Gram-negative bacteria
• exacerbations of chronic obstructive pulmonary disease
• bronchopulmonary infections in cystic fibrosis or bronchiectasis
• pneumonia
Chronic suppurative otitis media
Flare-ups of chronic sinusitis, particularly if caused by Gram-negative bacteria
Urinary tract infections
Infections of the genital system:
• Gonococcal urethritis and cervicitis from Neisseria gonorrhoeae sensitive
• Epididymo-orchitis, including cases from Neisseria gonorrhoeae sensitive
• Pelvic inflammatory disease, including cases due to Neisseria gonorrhoeae sensitive
In the genital tract infections mentioned above, if they are sustained by Neisseria gonorrhoeae or deemed as such, it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm its susceptibility through laboratory tests.
• Infections of the gastrointestinal tract (eg traveler's diarrhea). Intra-abdominal infections
• Skin and soft tissue infections caused by Gram-negative bacteria
• Malignant external otitis
• Bone and joint infections
• Prophylaxis of invasive infections from Neisseria meningitidis
• Inhalation anthrax (prophylaxis and curative treatment after exposure)
Ciprofloxacin can be used to manage neutropenic patients with fever suspected to be due to bacterial infection.
Children and adolescents
• Bronchopulmonary infections in cystic fibrosis, caused from Pseudomonas aeruginosa
• Complicated urinary tract infections and pyelonephritis
• Inhalation anthrax (prophylaxis and curative treatment after exposure)
Ciprofloxacin can also be used to treat severe infections in children and adolescents if this is considered necessary.
Treatment should only be initiated by physicians experienced in the treatment of cystic fibrosis and / or severe infections in children and adolescents (see sections 4.4 and 5.1).
04.2 Posology and method of administration
Dosage varies according to the indication, severity and site of the infection, the sensitivity of the pathogen to ciprofloxacin, the patient's renal function and, in children and adolescents, body weight.
The duration of treatment depends on the severity of the disease, as well as on its clinical and bacteriological course.
The treatment of infections caused by certain bacteria (eg . Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and combination with other appropriate antibacterial agents.
Treatment of certain infections (eg pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients, and bone and joint infections) may require association with other appropriate antibacterial agents depending on the pathogens involved.
Adults :
Children and adolescents
Senior citizens :
Elderly patients should be treated with a dose established according to the severity of the infection and the patient's creatinine clearance.
Renal and / or hepatic impairment :
Recommended starting and maintenance doses for patients with impaired renal function:
No dosage adjustment is required in patients with impairment
liver function.
Dosage in children with impaired renal and / or hepatic function was not studied.
Method of administration
The tablets should be swallowed with some liquid, without chewing them, and can be taken independently of meals. If taken on an empty stomach, the absorption of the active ingredient is faster. Ciprofloxacin tablets should not be ingested with dairy products (eg milk, yogurt) or with mineral-enriched fruit juices (eg calcium-supplemented orange juice) (see section 4.5).
In severe cases or if the patient is unable to take the tablets (eg.
patients on enteral feeding), it is recommended that intravenous ciprofloxacin therapy be initiated until it is possible to switch to oral administration.
04.3 Contraindications
Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1)
Concomitant administration of ciprofloxacin and tizanidine (see section 4.5)
04.4 Special warnings and appropriate precautions for use
Severe infections and mixed infections with Gram-positive and anaerobic pathogens
Ciprofloxacin monotherapy is not adequate for the treatment of severe infections and infections that may be caused by Gram-positive or anaerobic pathogens. In these infections, ciprofloxacin must be administered in combination with other appropriate antibacterial agents.
Streptococcal infections (including Streptococcus pneumoniae)
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Infections of the genital system
Gonococcal urethritis, cervicitis, epididymo-orchitis, and pelvic inflammatory disease can be caused by Neisseria gonorrhoeaeisolated resistant to fluoroquinolones.
Therefore, ciprofloxacin should be administered for the treatment of gonococchal urethritis or cervicitis only if theNeisseria gonorrhoeae resistant to fluoroquinolones.
Epididymo-orchitis and pelvic inflammatory disease can be caused by Neisseria gonorrhoeae resistant to fluoroquinolones. Ciprofloxacin should be administered in combination with another appropriate antibacterial agent, unless the presence of Neisseria gonorrhoea resistant to ciprofloxacin. If clinical improvement is not achieved after 3 days of treatment, therapy should be reconsidered.
Urinary tract infections
The resistance of the "Escherichia coli - the most common pathogen involved in
urinary tract infections - varies across the European Union. Prescribers are advised to consider the prevalence of local resistance to urinary tract infections.Escherichia coli to fluoroquinolones. The single dose of ciprofloxacin, which can be used in uncomplicated cystitis, is expected to be associated with lower efficacy than with longer treatment. This is all the more to take into consideration due to the increasing resistance level of Escherichia coli to quinolones.
Intra-abdominal infections
There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Traveler's diarrhea
The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin of relevant pathogens in the countries visited.
Bone and joint infections
Ciprofloxacin should be used in combination with other antimicrobial agents in relation to the results of the microbiological documentation.
Inhalation anthrax
Use in humans is based on sensitivity data in vitro and experimental data in animals, together with limited data in humans. Physicians should refer to national and / or international official documents relating to the treatment of anthrax.
Children and adolescents
Official guidelines should be followed when using ciprofloxacin in children and adolescents. Treatment with ciprofloxacin should only be initiated by physicians experienced in the treatment of cystic fibrosis and / or severe infections in children and adolescents.
Ciprofloxacin has been shown to cause arthropathy in the weight-bearing joints of growing animals. Safety data from a randomized double-blind study on the use of ciprofloxacin in children (ciprofloxacin: n = 335, mean age = 6.3 years ; comparators: n = 349, mean age = 6.2 years; age range = 1 to 17 years) revealed an "incidence of suspected drug-related arthropathy (inferred from clinical signs and joint symptoms) of 7, 2% and 4.6% from day 42. At 1 year, the incidence of drug-related arthropathy was 9.0% and 5.7%, respectively. The increase in suspected cases of drug-related arthropathy over time was not statistically significant between the two groups. Treatment should only be started after a careful risk / benefit assessment, due to the possibility of side effects affecting the joints and / or surrounding tissues.
Broncho-pulmonary infections in cystic fibrosis
Clinical trials were conducted in children and adolescents aged between 5 and 17 years. Experience in treating children aged 1 to 5 years is more limited.
Complicated urinary tract infections and pyelonephritis
Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used and should be based on microbiological testing.
Clinical trials were conducted in children and adolescents aged 1 to 17 years.
Other particular serious infections
Other serious infections in accordance with official guidelines or after careful risk-benefit assessment, when other treatments cannot be used, or after failure of conventional therapy and when microbiological documentation can justify the use of ciprofloxacin.
The use of ciprofloxacin for particular other serious infections, other than those mentioned above, has not been the subject of clinical trials and clinical experience is limited. Consequently, caution is advised when treating patients with these infections.
Hypersensitivity
Allergic and hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, can occur after a single dose (see section 4.8) and can be life threatening. With reactions of this type, the administration of ciprofloxacin should be discontinued and adequate medical treatment is required.
Musculoskeletal system
Ciprofloxacin should not normally be used in patients with a history of tendon disease / disorder related to quinolone treatment. However, in very rare cases, after microbiological documentation of the causative agent and assessment of the risk / benefit ratio, the ciprofloxacin can be prescribed to these patients for the treatment of certain severe infections, particularly in cases of failure of standard therapy or bacterial resistance, where microbiological data can justify the use of ciprofloxacin.
With the use of ciprofloxacin, tendonitis and tendon rupture (especially affecting the Achilles tendon), sometimes bilateral, may occur within the first 48 hours of treatment. Tendon inflammation and ruptures may also occur up to several months after discontinuation of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patients or in those receiving concomitant corticosteroid treatment (see section 4.8).
Upon the appearance of any signs of tendonitis (e.g. painful edema, inflammation) treatment with ciprofloxacin should be discontinued. It is necessary to keep the affected limb at rest.
Ciprofloxacin should be used with caution in patients with myasthenia gravis as symptoms may be aggravated (see section 4.8).
Photosensitivity
Ciprofloxacin can cause photosensitivity reactions. During treatment, patients taking ciprofloxacin should avoid direct exposure to excessive sunlight or ultraviolet light (see section 4.8).
Central nervous system :
Like other quinolones, ciprofloxacin is known to cause seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders who may be predisposed to seizures. If convulsions occur, ciprofloxacin treatment should be discontinued (see section 4.8). Psychiatric reactions may also appear after the first administration of ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal thoughts / thoughts which can culminate in suicide attempt or suicide. In such cases ciprofloxacin treatment should be discontinued.
Cases of polyneuropathy (based on neurological symptoms, such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients treated with ciprofloxacin. Ciprofloxacin should be discontinued in patients with symptoms of neuropathy, including pain, burning, tingling, numbness and / or weakness to prevent the development of an irreversible condition (see section 4.8).
Heart ailments
Caution should be exercised when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for QT interval prolongation, such as, for example:
• congenital long QT interval syndrome
• concomitant use of drugs known to prolong the QT interval (eg class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
• uncompensated electrolyte imbalances (eg hypokalaemia, hypomagnesaemia)
• heart disease (eg heart failure, myocardial infarction, bradycardia)
Elderly patients and women may be more sensitive to QTc-prolonging medications. Consequently, in these populations, caution should be exercised when using fluoroquinolones, including ciprofloxacin.
(See section 4.2 Elderly, and sections 4.5, 4.8 and 4.9).
Hypoglycemia
As with other quinolones, hypoglycaemia has been reported more often in diabetic patients, predominantly in the elderly population. Close monitoring of blood glucose is recommended in all diabetic patients (see section 4.8).
Gastrointestinal system
The onset of severe and persistent diarrhea during or after treatment (even several weeks after treatment) may indicate the presence of antibiotic-induced colitis (life-threatening, possibly fatal), which should be treated immediately (see In such cases, ciprofloxacin treatment should be discontinued immediately and appropriate therapy instituted. In this situation, the use of drugs that inhibit peristalsis is contraindicated.
Renal and urinary system
Crystalluria has been reported in association with the use of ciprofloxacin (see section 4.8). Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided in such patients.
Impaired renal function
Since ciprofloxacin is mainly excreted unchanged by the kidney, dosage adjustment is necessary in patients with impaired renal function, as described in section 4.2, to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.
Hepatobiliary system
Cases of hepatic necrosis and life-threatening liver failure have been reported with the use of ciprofloxacin (see section 4.8). In case of signs and symptoms of liver disease (such as anorexia, jaundice, dark urine, itching or sore abdomen) , treatment should be stopped.
Deficit of glucose-6-phosphate dehydrogenase
Cases of haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, the potential for hemolysis should be monitored.
Resistence
Bacteria showing resistance to ciprofloxacin, with or without clinically apparent superinfection, can be isolated during or after treatment with ciprofloxacin. During extended treatment periods and when treating hospital infections and / or species-caused infections Staphylococcus And Pseudomonas there may be a particular risk of selecting bacteria resistant to ciprofloxacin.
Cytochrome P450
Ciprofloxacin inhibits CYP1A2 thereby causing increased serum concentrations of substances co-administered and metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine and duloxetine). Concomitant administration of ciprofloxacin and tizanidine is contraindicated. Therefore, patients taking these substances concomitantly with ciprofloxacin should be closely monitored for any clinical signs of overdose, and serum concentrations (eg, theophylline) may need to be determined ( see section 4.5).
Methotrexate
The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).
Interaction with tests
The activity in vitro of ciprofloxacin against Mycobacterium tuberculosis it can give rise to false negatives in bacteriological tests performed on samples taken from patients treated with ciprofloxacin.
This medicinal product contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Effects of other medicinal products on ciprofloxacin :
Drugs known to prolong the QT interval Like other fluoroquinolones, ciprofloxacin should be used with caution in patients treated with drugs known to prolong the QT interval (eg class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).
Formation of chelating complexes
Concomitant administration of ciprofloxacin (oral) and drugs containing multivalent cations and mineral supplements (e.g. calcium, magnesium, aluminum, iron), polymeric phosphate chelators (e.g. sevelamer), sucralfate or antacids, and highly buffered formulations ( eg didanosine tablets), containing magnesium, aluminum or calcium, reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered 1-2 hours before or at least 4 hours after taking these preparations. These restrictions of use do not apply to antacids belonging to the H2 antagonist class.
Food and dairy products
Calcium taken with food during meals does not significantly affect absorption. However, fasting concomitant administration of ciprofloxacin with milk and derivatives or drinks enriched with mineral salts (eg milk, yogurt, juice) should be avoided. "orange with added calcium), as the absorption of ciprofloxacin may be reduced.
Probenecid:
Probenecid interferes with renal excretion of ciprofloxacin. Concomitant administration of probenecid and ciprofloxacin results in increased serum concentrations of ciprofloxacin.
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin (oral) leading to a decrease in the time to reach plasma peak. No effects on the bioavailability of ciprofloxacin have been observed.
Omeprazole
Concomitant administration of ciprofloxacin and medicinal products containing omeprazole results in a slight decrease in Cmax and AUC of ciprofloxacin.
Effects of ciprofloxacin on other medicinal products:
Tizanidine
Tizanidine should not be administered together with ciprofloxacin (see section 4.3).In a clinical study in healthy volunteers, an increase in the serum concentration of tizanidine was observed (7-fold increase in Cmax, range 4 to 21-fold; 10-fold increase in AUC, range 6 to 24-fold) administered in concomitant with ciprofloxacin. The increase in serum concentrations of tizanidine is associated with an enhanced hypotensive and sedative effect.
Methotrexate
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, resulting in a potential increase in plasma methotrexate levels and an increased risk of methotrexate-associated toxic reactions. Concomitant use is not recommended (see section 4.4).
Theophylline
Concomitant administration of ciprofloxacin and theophylline may cause an undesirable increase in the plasma concentration of theophylline. This can result in theophylline-induced side effects which, in rare cases, can be life threatening or fatal. During concomitant administration of theophylline, plasma concentrations should be monitored and the dose of theophylline should be adequately reduced (see section 4.4).
Other xanthine derivatives
Following concomitant administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), an increase in the serum concentrations of these xanthine derivatives was observed.
Phenytoin
Concomitant administration of ciprofloxacin and phenytoin may result in an increase or decrease in serum phenytoin levels; it is therefore recommended to monitor serum levels of the medicinal product.
Cyclosporine
A transient increase in plasma creatinine concentration is observed when ciprofloxacin and cyclosporine-containing medicinal products are co-administered. Therefore, plasma creatinine concentrations should be monitored regularly (twice a week) in these patients.
Vitamin K antagonists
Concomitant administration of ciprofloxacin and vitamin K antagonists may enhance their anticoagulant effect. The risk may vary according to the underlying infection, age and general condition of the patient, so that the contribution of ciprofloxacin to the increase in INR (international standardized ratio) is difficult to assess. The INR should be monitored frequently during and immediately after concomitant administration of ciprofloxacin with a vitamin K antagonist (eg warfarin, acenocoumarol, phenprocoumon or fluindione).
Glibenclamide
In special cases, concomitant administration of ciprofloxacin and medicinal products containing glibenclamide may increase the action of glibenclamide (hypoglycaemia).
Duloxetine
In clinical studies, it has been shown that concomitant use of duloxetine with strong inhibitors of the CYP450 isoenzyme 1A2, such as fluvoxamine, may result in an increase in the AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration (see section 4.4).
Ropinirole
In a clinical study, concomitant use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, was shown to increase the Cmax and AUC of ropinirole by 60% and 84%, respectively. It is recommended that ropinirole-induced undesirable effects be monitored and the dosage adjusted accordingly during and immediately after co-administration with ciprofloxacin (see section 4.4).
Lidocaine
In healthy subjects, concomitant use of ciprofloxacin with medicinal products containing lidocaine, a moderate inhibitor of the CYP450 1A2 isoenzyme, has been shown to reduce the clearance of intravenous lidocaine by 22%. Although lidocaine treatment is well tolerated, an interaction with ciprofloxacin associated with undesirable effects may occur after concomitant administration.
Clozapine
Following concomitant administration of 250 mg ciprofloxacin and clozapine for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively, was observed. It is recommended that the patient be monitored and the clozapine dosage adjusted appropriately during and
immediately after co-administration with ciprofloxacin (see section 4.4).
Sildenafil
In healthy subjects, after oral administration of 50 mg concomitantly with 500 mg ciprofloxacin, the Cmax and AUC of sildenafil were increased by approximately double. Therefore, particular caution should be exercised when prescribing ciprofloxacin concomitantly with sildenafil, taking into account the risks and benefits.
04.6 Pregnancy and lactation
Pregnancy
Available data on the administration of ciprofloxacin in non pregnant women
indicate a teratogenic effect or fetal / neonatal toxicity of ciprofloxacin. Animal studies have not shown direct or indirect harmful effects in terms of reproductive toxicity. In animals exposed to quinolones at a young age and in the prenatal period, effects on immature cartilage have been observed, therefore it cannot be excluded that the drug may damage joint cartilage in the undeveloped human organism or the fetus (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Ciprofloxacin Accord during pregnancy.
Feeding time
Ciprofloxacin is excreted in breast milk. Due to the possible risk of joint damage, ciprofloxacin should not be used while breastfeeding.
04.7 Effects on ability to drive and use machines
Due to its neurological effects, ciprofloxacin may influence reaction times in such a way that the ability to drive or use machines is impaired.
04.8 Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhea.
The ADRs reported with ciprofloxacin (oral, intravenous and sequential therapy) in clinical trials and during the post-marketing phase are listed below, classified by frequency. The frequency analysis takes into account data derived from both oral and intravenous administration of ciprofloxacin.
Pediatric patients
The incidence of arthropathy, mentioned above, refers to data collected in adult studies. Arthropathy is common in children (see section 4.4).
04.9 Overdose
An overdose of 12 g has been reported to result in mild symptoms of toxicity. An acute overdose of 16 g was reported to have caused acute renal failure.
Symptoms of overdose consist of dizziness, tremor, headache, fatigue, convulsions, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment, crystalluria and haematuria. Reversible renal toxicity has been reported.
In addition to the usual emergency measures, eg ventricular emptying followed by administration of activated charcoal, it is recommended to monitor renal function, including urinary pH, if necessary, by acidifying the urine to prevent crystalluria. Patients should be kept well Antacids containing calcium or magnesium can theoretically reduce the absorption of ciprofloxacin in the event of an overdose. Only a small amount of ciprofloxacin (hemodialysis or peritoneal dialysis.
In the event of an overdose, symptomatic treatment should be implemented. Due to the possibility of QT interval prolongation, ECG monitoring is necessary.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Fluoroquinolones ATC code: J01MA02
Mechanism of action:
The bactericidal action of ciprofloxacin, as a fluoroquinolone antibacterial agent, is the result of the inhibition of type II topoisomerase (DNA-gyrase) and type IV topoisomerase, necessary for the processes of DNA replication, transcription, repair and recombination bacterial.
Pharmacokinetic / pharmacodynamic relationship :
Efficacy depends primarily on the relationship between maximum serum concentration (Cmax) and minimum inhibitory concentration (MIC) of ciprofloxacin for a pathogenic bacterium and the relationship between area under the curve (AUC) and MIC.
Resistance mechanism :
In vitro resistance to ciprofloxacin can be acquired through a process of successive stages, permutations at the level of the target site, in DNA-gyrase and in topoisomerase IV, resulting in a variable degree of cross-resistance between ciprofloxacin and the other fluoroquinolones. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to most or all of the active substances in the class.
Impermeability and / or resistance mechanisms of the efflux pump to the active ingredient can have a variable effect on the sensitivity to fluoroquinolones, depending on the physico-chemical properties of the different active ingredients of the class and the affinity of the transport systems for each active ingredient. All resistance mechanisms in vitro they are commonly seen in clinical isolates. Resistance mechanisms that inactivate other antibiotics, such as barriers to penetration (common in Pseudomonas aeruginosa) and efflux mechanisms may influence ciprofloxacin sensitivity.
Plasmid-mediated resistance encoded by qnr genes was observed.
Spectrum of antibacterial activity :
Breakpoints separate susceptible strains from those with intermediate susceptibility and the latter from resistant strains:
EUCAST recommendations
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to therapies
high dosage.
* Non-species related breakpoints were determined primarily on the basis of pharmacokinetic / pharmacodynamic data and are independent of MIC distribution for specific species. They should only be used for species for which a species-specific breakpoint has not been assigned and not for species for which susceptibility testing is not recommended.
The prevalence of acquired resistance, for selected species, can vary both geographically and over time and local resistance data should be known, particularly for the treatment of severe infections. As necessary, expert advice should be sought where the local prevalence of resistance is such that the utility of the agent in at least certain types of infections is questionable.
Classifications of relevant species based on susceptibility to ciprofloxacin (for species Streptococcus, see section 4.4)
COMMONLY SENSITIVE SPECIES
Aerobic Gram-positive microorganisms
Bacillus anthracis
Aerobic Gram-negative microorganisms
Aeromonas spp.
Brucella spp.
Citrobacter koseri
Francisella tularensis
Haemophilus ducreyi
Hemophilus influenzae *
Legionella spp.
Moraxella catarrhalis *
Neisseria meningitidis
Pasteurella spp.
Salmonella spp.*
Shigella spp.*
Vibrio spp.
Yersinia pestis
Anaerobic microorganisms
Mobiluncus
Other microorganisms
Chlamydia trachomatis (§)
Chlamydia pneumoniae (§)
Mycoplasma hominis (§)
Mycoplasma pneumoniae (§)
SPECIES FOR WHICH THE ACQUIRED RESISTANCE CAN CONSTITUTE
A PROBLEM
Aerobic Gram-positive microorganisms
Enterococcus faecalis (§)
Staphylococcus spp. *
Gram-negative anaerobic microorganisms
Acinetobacter baumannii +
Burkholderia cepacia + *
Campylobacter spp. + *
Citrobacter freundii *
Enterobacter aerogenes
Enterobacter cloacae *
Escherichia coli *
Klebsiella oxytoca
Klebsiella pneumoniae *
Morganella morganii *
Neisseria gonorrhoeae *
Proteus mirabilis *
Proteus vulgaris *
Providencia spp.
Pseudomonas aeruginosa *
Pseudomonas fluorescens
Serratia marcescens *
Anaerobic microorganisms
Peptostreptococcus spp.
Propionibacterium acnes
RESISTANT ORGANISMS IN ITSELF
Aerobic Gram-positive microorganisms
Actinomyces
Enteroccus faecium
Listeria monocytogenes
Aerobic Gram-negative microorganisms
Stenotrophomonas maltophilia
Anaerobic microorganisms
Except those mentioned above
Other microorganisms
Mycoplasma genitalium
Ureaplasma urealitycum
* Clinical efficacy has been demonstrated for sensitive isolates in the approved clinical indications
+ Resistance rate ≥ 50% in one or more countries of the European Union
(§): Intermediate sensitivity in the absence of acquired resistance mechanisms
: Experimental studies have been conducted in animals infected by inhalation of spores of Bacillus anthracis; these studies show that antibiotics started early after exposure prevent the onset of the disease if the treatment is continued until the number of spores in the organism is reduced below the infectious dose. The use in humans is recommended mainly on sensitivity database in vitro and experimental data in animals, together with some limited data in humans. Two-month treatment with oral ciprofloxacin at a dose of 500 mg twice daily is considered effective in preventing infection in adult humans. The physician should refer to national and / or international official documents on anthrax treatment.
: Lo S. Aureus methicillin-resistant very commonly expresses cross-resistance to fluoroquinolones. The rate of resistance to methicillin is about 20-50% among all staphylococcal species and is generally higher in nosocomial isolates.
05.2 "Pharmacokinetic properties
Absorption
Following single dose oral administration of one ciprofloxacin 250 mg, 500 mg and 750 mg tablet, ciprofloxacin is rapidly and extensively absorbed, especially from the small intestine, and reaching peak serum concentrations after 1-2 hours.
Single doses of 100-750 mg resulted in dose-dependent maximum serum concentrations (Cmax) ranging from 0.56 to 3.7 mg / l. Serum concentrations increase proportionally for doses up to 1000 mg.
The absolute bioavailability is approximately 70-80%.
An oral dose of 500 mg administered every 12 hours produces an "area under the concentration-time curve (AUC) equivalent to that produced by an" intravenous infusion of 400 mg of ciprofloxacin, administered over 60 minutes every 12 hours.
Distribution
Plasma protein binding of ciprofloxacin is low (20-30%). Ciprofloxacin is present in plasma largely in non-ionized form and has a large steady-state volume of distribution of 2-3 l / kg body weight. Ciprofloxacin reaches high concentrations in a variety of tissues such as the lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflammatory lesions (cantharid blister fluid) and the urogenital system (urine, prostate, endometrium), where total concentrations higher than those in plasma are reached.
Metabolism
Low concentrations of four metabolites were found, identified as desethyleneciprofloxacin (M1), sulfociprofloxacin (M2), oxyciprofloxacin (M3) and formylciprofloxacin (M4). The metabolites show antibacterial activity in vitro but lower than that of the parent compound.
Ciprofloxacin is a moderate inhibitor of CYP 450 1A2 isoenzymes.
Elimination
Ciprofloxacin is predominantly excreted unchanged by the kidney and, to a lesser extent, by the faecal route. The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.
Renal clearance is between 180 and 300 ml / kg / h and the total body clearance is between 480 and 600 ml / kg / h. Ciprofloxacin undergoes both glomerular filtration and tubular secretion. Severe renal impairment results in an increase in the half-life of ciprofloxacin, which can reach 12 hours.
Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism. 1% of the dose is excreted via the biliary route. Ciprofloxacin is present in the bile in high concentrations.
Pediatric patients
Pharmacokinetic data in pediatric patients are limited.
In a study in children, Cmax and AUC were not age-dependent (beyond 1 year of age). There was no appreciable increase in Cmax and AUC following multiple dosing (10 mg / kg three times a day).
In 10 children with severe sepsis, Cmax was 6.1 mg / L (range 4.6-8.3 mg / L) after an "one-hour intravenous infusion" of 10 mg / kg in younger children. per year, while in children aged 1 to 5 years it was 7.2 mg / l (range 4.7 - 11.8 mg / l). The AUC values were, in the respective age groups, equal to 17.4 mg * h / l (range 11.8 - 32.0 mg * h / l) and 16.5 mg * h / l (range 11.0 - 23.8 mg * h / l).
These values are within the range found in adults at therapeutic doses. Based on a population pharmacokinetic analysis of pediatric patients with various infections, the expected mean half-life in children is approximately 4-5 hours and the bioavailability of the oral suspension varies. from 50 to 80%.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential or toxicity to reproduction.
Like many other quinolones, ciprofloxacin is phototoxic in animals at exposure levels that have clinical relevance. Photomutagenicity / photocarcinogenicity data show weak photomutagenic or photocarcinogenic effect of ciprofloxacin in vitro and in animal experiments. This effect is comparable to that of other gyrase inhibitors.
Joint tolerability:
As is also known for other gyrase inhibitors, ciprofloxacin causes damage to large weight bearing joints in growing animals. The extent of cartilage damage varies with age, species and dose and can be reduced by relieving the joints. Studies on mature animals (rat, dog) did not show cartilage lesions. In a study in young beagle dogs, ciprofloxacin caused severe joint changes after two weeks of treatment at therapeutic doses, which were still visible after 5 months.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Croscarmellose sodium
Microcrystalline cellulose
Povidone
Magnesium stearate
Hypromellose
Lactose monohydrate
Titanium dioxide (E 171)
Macrogol
Sodium citrate dihydrate (E331 iii)
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Ciprofloxacin 250mg / 500mg / 750mg film-coated tablets are packed in PVC / Aluminum blisters.
Pack sizes: 6, 10, 12, 14, 16, 20, 28, 30, 50 and 100 tablets in blister packs.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow HA1 4HF, Middlesex, United Kingdom
08.0 MARKETING AUTHORIZATION NUMBER
041019011 - 250 mg film-coated tablets, 10 tablets in PVC / Alu blister
041019023 - 250 mg film-coated tablets, 14 tablets in PVC / Alu blister
041019035 - 250 mg film-coated tablets, 20 tablets in PVC / Alu blister
041019047 - 250 mg film-coated tablets, 28 tablets in PVC / Alu blister
041019050 - 250 mg film-coated tablets, 30 tablets in PVC / Alu blister
041019062 - 250 mg film-coated tablets, 50 tablets in PVC / Alu blister
041019074 - 250 mg film-coated tablets, 100 tablets in PVC / Alu blister
041019086 - 500 mg film-coated tablets, 100 tablets in PVC / Alu blister
041019098 - 500 mg film-coated tablets, 50 tablets in PVC / Alu blister
041019100 - 500 mg film-coated tablets, 30 tablets in PVC / Alu blister
041019112 - 500 mg film-coated tablets, 28 tablets in PVC / Alu blister
041019124 - 500 mg film-coated tablets, 20 tablets in PVC / Alu blister
041019136 - 500 mg film-coated tablets, 14 tablets in PVC / Alu blister
041019148 - 500 mg film-coated tablets, 10 tablets in PVC / Alu blister
041019151 - 750 mg film-coated tablets, 10 tablets in PVC / Alu blister
041019163 - 750 mg film-coated tablets, 14 tablets in PVC / Alu blister
041019175 - 750 mg film-coated tablets, 20 tablets in PVC / Alu blister
041019187 - 750 mg film-coated tablets, 28 tablets in PVC / Alu blister
041019199 - 750 mg film-coated tablets, 30 tablets in PVC / Alu blister
041019201 - 750 mg film-coated tablets, 50 tablets in PVC / Alu blister
041019213 - 750 mg film-coated tablets, 100 tablets in PVC / Alu blister
041019225 - 250 mg film-coated tablets, 6 tablets in PVC / Alu blister
041019237 - 500 mg film-coated tablets, 6 tablets in PVC / Alu blister
041019249 - 750 mg film-coated tablets, 6 tablets in PVC / Alu blister
041019252 - 750 mg film-coated tablets, 12 tablets in PVC / Alu blister
041019264 - 500 mg film-coated tablets, 12 tablets in PVC / Alu blister
041019276 - 250 mg film-coated tablets, 12 tablets in PVC / Alu blister
041019288 - 250 mg film-coated tablets, 16 tablets in PVC / Alu blister
041019290 - 500 mg film-coated tablets, 16 tablets in PVC / Alu blister
041019302 - 750 mg film-coated tablets, 16 tablets in PVC / Alu blister
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
4 September 2012
