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BACTALL contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.
Adults:
BACTALL is used in adults to treat the following bacterial infections:
□ Respiratory tract infections
□ Long lasting or recurring ear or sinus infections
□ Urinary tract infections
□ Genital tract infections in men and women
□ Gastro-intestinal tract infections and intra-abdominal infections
□ Skin and soft tissue infections
□ Bone and joint infections
□ To prevent infections due to the bacterium Neisseria meningitidis
□ Anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.
If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to BACTALL.
Children and adolescents
BACTALL is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:
□ Lung and bronchial infections in children and adolescents suffering from cystic fibrosis
□ Complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
□ Anthrax inhalation exposure
BACTALL may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.
Do not take BACTALL:
□ If you are allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this medicine (listed in Section 6)
□ If you are taking tizanidine (see Section 2: Taking BACTALL with Other medicines)
Talk to your doctor before taking BACTALL
□ If you have ever had kidney problems because your treatment may need to be adjusted.
□ If you suffer from epilepsy or other neurological conditions.
□ If you have a hisory of tendon problems during previous treatment with antibiotics such as BACTALL.
□ If you are diabetic because you may experience a risk of hypoglycemia with ciprofloxacin.
□ If you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.
□ If you have heart problems. Caution should be taken when using Ciprofloxacin, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), havesalt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and BACTALL).
□ If you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.
□ If you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
□ If you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
□ If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant sell arteritis, Behcet `s disease, high blood pressure, or known atherosclerosis).
□ If you feel sudden, sever pain in your abdomen, chest or back, go immediately to an emergency room.
For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
While taking BACTALL
Tell your doctor immediately, if any of the following occurs while taking BACTALL. Your doctor will decide whether treatment with BACTALL needs to be stopped.
□ Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking BACTALL and contact your doctor immediately.
□ Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of BACTALL therapy. At the first sign of any pain or inflammation stop taking BACTALL, contact your doctor and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
□ If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If seizure happens, stop taking BACTALL and contact your doctor immediately.
□ You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or muscle weakness. If this happens, stop taking BACTALL and contact your doctor immediately.
□ You may experience psychiatric reactions the first time you take BACTALL. If you suffer from depression or psychosis, your symptoms may become worse under treatment with BACTALL. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, contact your doctor immediately.
□ Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.
□ Diarrhea may develop while you are taking antibiotics, including BACTALL, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking BACTALL and contact your doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
□ If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
□ Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking BACTALL. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.
□ Tell the doctor or laboratory staff that you are taking BACTALL if you have to provide a blood or urine sample.
□ If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.
□ BACTALL may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, contact your doctor immediately.
□ BACTALL may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
Taking BACTALL with Other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take BACTALL together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take BACTALL).
The following medicines are known to interact with BACTALL in your body. Taking BACTALL together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.
Tell your doctor if you are taking
□ Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)
□ Probenecid (for gout) □ Methotrexate (for certain types of cancer, 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) □ Metoclopramide (for nausea and vomiting)
□ Cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) □ Other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics □ metoclopramide (for nausea and vomiting)
□ Cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) □ Other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics □ Zolpidem (for sleep disorders)
BACTALL may increase the levels of the following medicines in your blood
□ Pentoxifylline (for circulatory disorders) □ Caffeine □ Duloxetine (for depression, diabetic nerve damage or incontinence)
□ Lidocaine (for heart conditions or anesthetic use) □ Sildenafil (e.g for erectile dysfunction) □ Agomelatine (for depression)
Some medicines reduce the effect of BACTALL. Tell your doctor if you take or wish to take
□ Antacids □ Omeprazole □ Mineral supplements □ Sucralfate □ A polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
□ Medicines or supplements containing calcium, magnesium, aluminium or iron
If these preparations are essential, take BACTALL about two hours before or no sooner than four hours after them.
Taking BACTALL with food and drink
□ Unless you take BACTALL during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.
Pregnancy and breast-feeding
□ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
□ It is preferable to avoid the use of BACTALL during pregnancy.
□ Do not take BACTALL during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Driving and using machines:
□ BACTALL may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to BACTALL before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
□ Your doctor will explain to you exactly how much BACTALL you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.
□ Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
□ The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how many tablets to take and how to take BACTALL.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take BACTALL tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more BACTALL than you should
If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the doctor.
If you forget to take BACTALL
Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking BACTALL
It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following section contains the most serious side effects that you can recognize yourself:
Stop taking BACTALL and contact your doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people)
□ Seizure
Very rare (may affect up to 1 in 10,000 people)
□ Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction/shock) (see Section 2)
□ Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2)
□ A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
□ Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy)
□ A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous Pustulosis).
Other side effects which have been observed during treatment with BACTALL are listed below by how likely they are:
Common (may affect up to 1 in 10 people)
□ Nausea, diarrhea □ Joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
□ Joint pain in adults □ Fungal superinfections □ A high concentration of eosinophils, a type of white blood cell □ Decreased appetite
□ Hyperactivity or agitation □ Headache, dizziness, sleeping problems, or taste disorders □ Vomiting, abdominal pain, digestive problems such
as stomach upset (indigestion/heartburn), or wind □ Increased amounts of certain substances in the blood (transaminases and/or bilirubin)
□ Rash, itching, or hives □ Poor kidney function
□ Pains in your muscles and bones, feeling unwell (asthenia), or fever □ Increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
□ Muscle pain, inflammation of the joints, increased muscle tone and cramping
□ Inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2)
□ Changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) □ Allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) (see Section 2)
□ Increased blood sugar (hyperglycaemia) □ Decreased blood sugar (hypoglycaemia) (see Section 2) □ Confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2), or hallucinations □ Pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, or giddiness □ Eyesight problems incl. double vision □ Tinnitus, loss of hearing, impaired hearing □ Rapid heartbeat (tachycardia) □ Expansion of blood vessels (vasodilation), low blood pressure, or fainting □ Shortness of breath, including asthmatic symptoms □ Liver disorders, jaundice (cholestatic icterus), or hepatitis □ Sensitivity to light (see Section 2) □ Kidney failure, blood or crystals in the urine, urinary tract inflammation □ Fluid retention or excessive sweating □ Increased levels of the enzyme amylase
Very rare (may affect up to 1 in 10,000 people)
□ Aspecial type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis ) (see section 2) ; a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal □ Allergic reaction called serum sickness-like reaction (see Section 2)
□ Mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2)
□ Migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri) □ Visual colour distortions □ Inflammation of the wall of the blood vessels (vasculitis)
□ Pancreatitis □ Death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure (see Section 2) □ Small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes □ Worsening of the symptoms of myasthenia gravis.
Not known (frequency cannot be estimated from the available data)
□ Feeling highly excited (mania) or feeling great optimism and over activity (hypomania)
□ Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
□ Influence on blood clotting (in patients treated with Vitamin K antagonists)
□ Keep out of the reach and sight of children.
□ Do not store above 30°C
□ Do not use BACTALL after the expiry date which is stated on the carton and on the blister after (EXP).Date.
□ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What BACTALL contains:
□ The active substance is Ciprofloxacin. Each BACTALL 250 and 500 tablet contains 250mg, 500mg as Ciprofloxacin Hydrochloride.
□ The other ingredients are: Microcrystalline Cellulose 50 micrometer, Microcrystalline Cellulose 180 micrometer, Sodium starch glycolate, Hydroxypropyl Cellulose, Colloidal Anhydrous Silica, Magnesium stearate, Opadry-OY-21033, White Bees Wax.
What BACTALL looks like and contents of the pack:
The Jordanian pharmaceutical manufacturing co.(P.L.C.|)
يحتوي بكتول على المادة الفعالة سيبروفلوكساسين. سيبروفلوكساسين مضاد حيوي ينتمي إلى عائلة الفلوروكينولون. سيبروفلوكساسين يعمل عن طريق قتل البكتيريا التي تسبب الالتهابات. وهو يعمل فقط على سلالات معينة من البكتيريا.
البالغين:
يستخدم بكتول عند البالغين لعلاج العدوى البكتيرية التالية :
□ التهابات الجهاز التنفسي □ عدوى الأذن أو الجيوب الأنفية الطويلة الأمد أو المتكررة □ التهابات المسالك البولية □ التهابات الجهاز التناسلي لدى الرجال والنساء
□ التهابات الجهاز الهضمي والالتهابات داخل البطن □ التهابات الجلد والأنسجة الرخوة □ عدوى العظام و المفاصل □ منع العدوى الناجمة عن بكتيريا النيسرية السحائية.
□ عدوى الجمرة الخبيثة □ يمكن استخدام سيبروفلوكساسين في علاج المرضى الذين يعانون من انخفاض عدد خلايا الدم البيضاء (قلة العدلات) الذين لديهم حمى يُشتبه في كونها ناتجة عن عدوى بكتيرية. □ إذا كنت مصابًا بعدوى وخيمة أو إصابة ناتجة عن أكثر من نوع واحد من البكتيريا، فقد تحتاج لمضاد حيوي آخر بالإضافة إلى بكتول .
الأطفال و المراهقين :
يجب أن يسخدم بكتول تحت إشراف طبي متخصص لعلاج عدوى البكتيريا التالية عند الأطفال والمراهقين:
□ عدوى الرئة والقصبات عند الأطفال والمراهقين الذين يعانون من التليف الكيسي. □ عدوى المسالك البولية المصحوب بمضاعفات، والتي تشمل العدوى التي تصل إلى الكلية (التهاب الحويضة والكلية). □ عدوى الجمرة الخبيثة.
ويمكن أن يستخدم بكتول لعلاج أنواع أخرى معينة من العدوى الوخيمة التي تحدث لدى الأطفال والمراهقين، عندما يرى الطبيب أنه من الضروري استخدامه.
موانع استعمال بكتول:
□ إذا كنت تعاني من حساسية مفرطة لسبروفلوكساسين أو لأي دواء آخر من مجموعة الكوينولون أو لأي من مكونات أقراص بكتول الأخرى (انظر الى القسم 6).
□ إذا كنت تتناول تيزانيدين (انظر إلى القسم 2: تناول بكتول مع أدوية أخرى).
الاحتياطات عند استعمال بكتول:
تحدث إلى طبيبك قبل تناول بكتول:
□ إذا عانيت في أي وقت مضى من مشاكل بالكلى لأن العلاج قد يحتاج الى تعديل.
□ إذا كنت تعاني من الصرع أو أي مرض عصبي آخر.
□ إذاعانيت من مشاكل في الأوتار العضلية خلال فترة علاج سابقة باستخدام مضادات حيوية مثل بكتول.
□ إذا كنت مصابا بمرض السكر، حيث انك قد تواجه خطر نقص سكر الدم مع سيبروفلوكساسين.
□ إذا كنت تعاني من وهن عضلي وبيل (نوع من أنواع ضعف العضلات) لأن الأعراض من الممكن أن تتفاقم.
□ إذا كان لديك مشاكل في القلب. يجب توخي الحذر عند استخدام سيبروفلوكساسين، إذا ولدت أو كان لديك تاريخ عائلي عن إطالة فترة QT (تظهر في مخطط كهربية القلب)، اذا كنت تعاني من فقد توازن الاملاح بالدم (خصوصاً انخفاض نسبة البوتاسيوم او المغنيزيوم بالدم)، اذا كنت تعاني من بطىء في نظم القلب (بطء القلب) او اذا كنت تعاني من ضعف بالقلب (فشل بالقلب)، اذا عانيت مسبقاً من نوبة قلبية (احتشاء عضلة القلب)، اذا كنت انثى او كبير في السن او اذا كنت تتناول أدوية أخرى تؤدي الى خلل في مخطط كهربية القلب (انظر الى القسم 2: تناول بكتول مع أدوية اخرى).
□ إذا كنت انت او أحد أفراد عائلتك من المعروف أن لديه عوز نازعة هيدروجين الغلوكوز -6- فسفات، لانه من الممكن أن تواجه خطر الاصابة بفقر الدم مع سيبروفلوكساسين.
□ إذا تم تشخيص إصابتك بتضخم أو "انتفاخ" في وعاء دموي كبير (تمدد الأوعية الدموية الأبهري أو تمدد الأوعية الدموية المحيطية الكبيرة).
□ إذا كنت قد عانيت من تسلخ الأبهر سابقاً (تمزق في جدار الأبهر).
□ إذا كان لديك تاريخ عائلي من تمدد الأوعية الدموية الأبهري أو تشريح الأبهر أو عوامل خطر أخرى أو حالات مؤهبة (مثل اضطرابات النسيج الضام مثل متلازمة مارفان أو متلازمة إيلرس- دانلُوس، أو اضطرابات الأوعية الدموية مثل التهاب الشرايين تاكاياشو، التهاب الشريان ذو الخلايا العملاقة ، داء بهجت ، وارتفاع ضغط الدم ، أو تصلب الشرايين المعروفة).
□ اذا شعرت بألم مفاجئ شديد في بطنك أو صدرك أو ظهرك، اذهب على الفور إلى غرفة الطوارئ.
لعلاج بعض التهابات المسالك التناسلية، يستطيع طبيبك أن يصف لك مضاد حيوي اخر بالإضافة إلى سيبروفلوكساسين. إذا لم يكن هناك تحسن بالأعراض بعد 3 أيام،
يرجى استشارة طبيبك.
أثناء تناول بكتول:
أخبر طبيبك على الفور إذا حدث لك أي مما يلي أثناء تناول بكتول سوف يقرر طبيبك ما إذا كان هناك حاجة لوقف العلاج ببكتول:
□ إذا كنت تعاني من حساسية شديدة ومفاجئة (تفاعل تأقي/صدمة، وذمة وعائية). حتى من الجرعة الأولى هنالك احتمال صغير أنه من الممكن أن تعاني من حساسية شديدة مع الأعراض التالية مثل، ضيق الصدر، الشعور بالدوخة أو المرض أو الإغماء أو الشعور بالدوخة عند الوقوف. إذا حصل لك ذلك توقف عن تناول بكتول
و اتصل بطبيبك على الفور .
□ ألم أو التهاب في الأوتار العضلية قد يحدث في بعض الأحيان، خصوصاً اذا كنت كبير في السن أو تتناول أدوية تدعى كورتيكوستيرويد، قد يحدث التهاب و تمزق في الأوتار خلال ال 48ساعة الأولى من العلاج أو قد تصل إلى عدة أشهر بعد التوقف عن العلاج باستخدام بكتول. عند ظهور أول علامة للألم أو الالتهاب توقف عن تناول بكتول و أرح المنطقة المؤلمة □ تجنب أي ممارسة لا داعي لها لأنها من الممكن أن تزيد من خطر تمزق الوتر.
□ إذا كنت تعاني من الصرع أو أي مرض عصبي آخر مثل نقص التروية الدماغية أو السكتة الدماغية، فإنك قد تختبر اثار جانبية مرتبطة بالجهاز العصبي المركزي. إذا حصل لك ذلك توقف عن تناول بكتول و اتصل بطبيبك على الفور.
□ قد تختبر أعراض الاعتلال العصبي مثل الألم، حرق، نخز، اخدرار و/أو ضعف. إذا حصل ذلك لك توقف عن تناول بكتول و اتصل بطبيبك على الفور.
□ من الممكن أن تواجه ردود فعل نفسية عند أخذ بكتول للمرة الأولى. إذا كنت تعاني من الاكتئاب أو الذهان، قد تسوء أعراضك عند العلاج باستخدام بكتول. في حالات نادرة، من الممكن أن يتطور الاكتئاب أو الذهان إلى التفكير بالانتحار، محاولات الانتحار، أو الانتحار الكامل. إذا حصل لك ذلك اتصل بطبيبك على الفور.
□ تم الإبلاغ عن نقص في سكر الدم عند مرضى السكري، في الغالب فئة كبار السن. إذا حصل لك ذلك اتصل بطبيبك على الفور.
□ قد تعاني من الإسهال أثناء تناولك المضادات الحيوية، و يشمل بكتول، أو حتى لعدة أسابيع بعد التوقف عن أخذهم. إذا اصبح الإسهال شديد أو مستمر أو لاحظت أن برازك يحتوي على الدم أو المخاط، توقف عن تناول بكتول على الفور لأنه قد يهدد الحياة.لا تتناول الأدوية التي توقف أو تبطئ حركة الأمعاء.
□ في حالة ضعف بصرك أو إذا كانت عيناك متأثرتين على نحو آخر، استشر طبيب العيون على الفور.
□ إذا أصبح جلدك أكثر حساسية للشمس أو الأشعة فوق البنفسجية أثناء تناول بكتول. تجنب التعرض لأشعة الشمس القوية القوية أوالأشعة فوق البنفسجية مثل أسرةالحمام الشمسي.
□ اخبر الطبيب أو موظف المختبر أنك تتناول بكتول إذا احتجت أن تعطي عينة دم أو بول.
□ إذا كنت تعاني من مشاكل الكلى، أخبر طبيبك لأنك قد تحتاج إلى تعديل جرعتك.
□ قد يسبب بكتول تلف في الكبد. إذا لاحظت أي أعراض مثل فقدان الشهية، يرقان (اصفرار الجلد)، بول داكن اللون أو حكه أو إيلام في المعدة، وأخبر الطبيب على الفور.
□ قد يسبب بكتول نقصان في عدد كريات الدم البيضاء وقد تقل مقاومتك للعدوى. إذا كنت تعاني من أعراض العدوى مثل الحمى، تدهور خطير في حالتك العامة، أو حمى مع أعراض موضعية للعدوى مثل التهاب الحلق/البلعوم/الفم أو مشاكل في المسالك البولية، فإن عليك مراجعة طبيبك في الحال. سيتم إجراء فحص دم لقياس عدد كريات الدم البيضاء (ندرة المحببات) من المهم أن تخبر طبيبك عن دوائك.
تناول بكتول مع الأدوية الأخرى:
□ أخبر طبيبك أو الصيدلاني إذا كنت تأخذ أو أخذت مؤخراً، أو قد تأخذ أي أدوية أخرى .
□ لا تتناول بكتول مع تيزانيدين لأنه يمكن أن يسبب آثار جانبية مثل انخفاض ضغط الدم و النعاس (انظرالى القسم 2: موانع استعمال بكتول).
□ من المعروف أن الأدوية التالية تتفاعل مع بكتول في جسمك، و قد يمكن أن يؤثر تناول بكتول مع هذه الأدوية على التأثير العلاجي لها، كما ويمكن أن يزيد من احتمال الإصابة بالأعراض الجانبية.
أخبر طبيبك إذا كنت تتناول:
□ مضادات فيتامين ك ( مثل وارفرين، أسينوكومارول، فينوبروكومون أوفلونيدون) أو غيرها من مضادات التخثر التي تعطى عن طريق الفم. □ بروبينيسايد (يستخدم لعلاج النقرص).
□ ميثوتركسات (يستخدم لعلاج أنواع معينة من السرطان، صداف، التهاب المفاصل الروماتيدي) □ ثيوفيلين (للمشاكل التنفسية).
□ تيزانيدين (يستخدم لعلاج تشنج العضلات في مرض التصلب المتعدد). □ أولانزبين ( مضاد الذهان ). □ كلوزابين ( مضاد الذهان ).
□ روبينيرول (يستخدم لعلاج مرض باركينسون). □ فينيتون ( لعلاج الصرع ). □ ميتوكلوبرامايد ( يستخدم لعلاج الغثيان والقيء ).
□ سايكلوسبورين ( يستخدم لعلاج الأمراض الجلدية ، التهاب المفاصل الروماتويدي ، و زراعة الأعضاء ). □ الأدوية التي تغير نظم القلب: الأدوية التي تنتمي الى مجموعة تسمى مضادات اضطراب النظم (مثل كوينيدين، هيدروكويندين، ديسوبيراميد، اميودارون، سوتالول، دوفيتيليد، ابيوتيليد) مضادات الاكتئاب ثلاثية الحلقات، مضادات المكروبات (التي تنتمي إلى مجموعة الماكرولايد)، و بعض مضادات الذهان.
□ الزولبيديم ( يستخدم لعلاج اضطرابات النوم).
قد يزيد بكتول مستويات الأدوية التالية بالدم:
□ بينتوكسيفلين ( لمشاكل الدورة الدموية ) □ كفايين □ دلوكستين ( لعلاج الاكتئاب، تلف الأعصاب السكري أو سلس )
□ ليدوكاين ( لأمراض القلب أو مخدر) □ سيلدنافيل ( لضعف الانتصاب) □ اغلوميلاتين (للاكتئاب)
بعض الأدوية تقلل تأثير بكتول، أخبر طبيبك إذا كنت تأخذ أو تريد أخذ:
□ مضادات الحموضة □ أوميبرازول □ المكملات المعدنية □ سوكرالفات
□ ممسك الفوسفات البلمري ( مثل سيفيلامير أو كربونات اللانثانوم )
□ الأدوية و المكملات التي تحتوي على كالسيوم، مغنيزيوم، ألمنيوم أو حديد
إذا كانت هذه المستحضرات ضرورية، تناول بكتول قبل ساعتين أو ليس قبل أربع ساعات بعد تناولها.
تتناول بكتول مع الطعام و الشراب:
إذا كنت تتناول بكتول خلال وجبات الطعام، فلا تتناول أو تشرب أي من منتجات الألبان مثل (الحليب واللبن) أو المشروبات التي تحتوي على الكالسيوم عندما تتناول الأقراص، لأن هذه المنتجات يمكن أن تؤثر على امتصاص المادة الفعالة.
الحمل و الرضاعة:
□ إذا كنت حاملاً أوتعتقدي أنك حامل أو تخططين للإنجاب، اسألي طبيبك أو الصيدلي للحصول على المشورة قبل أخذ هذا الدواء.
□ من الأفضل تجنب تناول بكتول خلال فترة الحمل.
□ لا تأخذي بكتول خلال فترة الإرضاع لأن سبروفلوكساسين يفرز في حليب الثدي ويمكن أن يكون له تأثيراً ضاراً على طفلك .
تأثير المستحضر على القيادة واستخدام الآلات:
قد يجعلك بكتول تشعر أنك في حاله تأهب أقل. بعض الأحداث السلبية العصبية يمكن أن تحدث. لذلك تأكد أنك تعرف تأثير بكتول قبل قيادة السيارة أو تشغيل الآلات. إذا كنت في شك تحدث إلى طبيبك.
□ طبيبك سوف يشرح لك بالضبط كمية بكتول التي سوف تأخذها و كم مرة و حتى متى.هذا يعتمد على نوع العدوى لديك و مدى سوئها.
□ أخبر طبيبك اذا كنت تعاني من مشاكل في الكلى حيث أن جرعتك قد تحتاج إلى تعديل.
□ يستمر العلاج عادة من 5 إلى 21 يوم، لكنها قد تستغرق وقتًا أطول للإصابات الوخيمة. دائما تناول هذا الدواء كما وصف لك طبيبك.يجب مراجعة الطبيب او الصيدلاني اذا لم تكن متأكداً من عدد الاقراص التي يجب ان تأخذها او كيفية اخذ بكتول .
أ. ابتلع الأقراص مع كميات كبيرة من الماء. لا تمضغ الأقراص لأن طعمها غير لطيف
ب. حاول أن تتناول الأقراص في نفس الوقت يومياً
ج . يمكن تناول الأقراص مع الوجبات أو بين الوجبات. تناول الكالسيوم كجزء من الوجبات لايؤثر تأثيرا شديداً على الامتصاص. ومع ذلك، لا تتناول أقراص بكتول مع منتجات الألبان مثل الحليب أو اللبن أو مع عصائر الفواكة المدعمة (مثل عصير البرتقال المدعم بالكالسيوم)
تذكر أن تشرب كميات كبيرة من السوائل أثناء تناول هذا الدواء.
الجرعة الزائدة من بكتول:
إذا تناولت أكثر من الجرعة الموصوفة، يجب أن تحصل على مساعدة طبية على الفور. إذا كان ممكنا خذ أقراص الدواء أو العلبة معك لتريها للطبيب.
نسيان تناول جرعة بكتول
تناول الجرعة الاعتيادية في أقرب وقت عند تذكرها و استمر بباقي الجرعات الموصوفة. إذا كان موعد الجرعة التالية قريبا، فلا تتناول تتناول الجرعة المنسية و تابع جرعاتك كالمعتاد لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية. تأكد من إكمالك مسار العلاج.
التوقف عن تناول بكتول
من المهم إكمال مسار العلاج حتى إذا بدأت تشعر بتحسن بعد بضعة أيام. إذا توقفت عن تناول العلاج في وقت مبكر قد يؤدي ذلك إلى عدم شفاء العدوى تماماً أو قد تعود أعراض العدوى أو تسوء. من الممكن أيضا أن يصبح لديك مقاومة للمضاد الحيوي.
اسأل الطبيب أو الصيدلاني إذا كان لديك أي أسئلة أخرى حول استخدام هذا الدواء.
كغيره من الأدوية، قد يسبب بكتول أعراض جانبية، بالرغم من أنها لا تحدث للجميع.
- يحتوي الجزء التالي على الآثار الجانبية الأكثر خطورة التي يمكنك التعرف عليها بنفسك.
توقف عن تناول بكتول واتصل بالطبيب على الفور للنظر في تغيير لعلاج مضاد حيوي آخر إذا لاحظت أيًا من الأعراض الجانبية الخطيرة التالية:
أعراض جانبية نادرة (قد تؤثر على 1 من كل 1000 شخص)
□ نوبات (انظر الى قسم 2)
اعراض جانبية نادر جدًا (قد يؤثر على شخص واحد من بين كل 10000 شخص)
□ تحسس حاد مفاجئ مع أعراض مثل ضيق في الصدر أو الشعور بالدوار أو المرض أو الإغماء أو الشعور بالدوار عند الوقوف (تفاعل الحساسية / صدمة) (انظر القسم 2) □ ضعف العضلات، التهاب الأوتار التي يمكن أن تؤدي إلى تمزق الوتر، خاصةً التي تؤثر على الوتر الكبير في مؤخرة الكاحل (وتر العرقوب) (انظرالى قسم 2) □ طفح جلدي خطير يهدد الحياة، وعادة ما يكون على شكل بثور أو قروح في الفم والحلق والأنف والعينين والأغشية المخاطية الأخرى مثل الأعضاء التناسلية التي قد تتطور إلى تقرحات على نطاق واسع أو تقشير الجلد (متلازمة ستيفنز جونسون، انحلال البشرة السمي)أعراض جانبية غير معروفة (لا يمكن تقدير تكرارها من البيانات المتاحة)
□ شعور غير عادي بالألم، حرق الوخز، الخدر أو ضعف العضلات في الأطراف (اعتلال الأعصاب) (انظر الى القسم 2)
□ تفاعلات دوائية تسبب الطفح الجلدي والحمى والتهاب الأعضاء الداخلية و تغيرات دموية غير طبيعية ومرض أجهزة الجسم بشكل عام (DRESS: تفاعل الدوائي مع كثرة اليوزينيات والاعراض الجهازية، AGEP: الطفح البثوري الحاد العام )
أعراض جانبية شائعة (قد تؤثر على شخص واحد في 10 اشخاص)
□ غثيان، إسهال □ ألم مفاصل و الالتهاب عند الاطفال
أعراض جانبية غير شائعة (قد تؤثر على شخص واحد في100شخص)
□ ألم المفاصل عند البالغين □ عدوى فطريات اضافية □ ارتفاع تركيز اليوزينية (نوع من كريات الدم البيضاء) □ قلة الشهية □ فرط النشاط، هياج
□ صداع، دوخة، مشاكل في النوم أو اضطرابات الذوق □ قيء، ألم البطن، مشاكل في الجهاز الهضمي مثل اضطراب المعدة (عسر الهضم/الحرقة) أو ريح
□ زيادة كميات بعض المواد في الدم (ناقل الامين و/أو بيليروبن) □ طفح جلدي، حكه، أو شرى □ ضعف وظائف الكلى
□ ألم في العضلات والعظام، الشعور بالإعياء ( وهن ) أو حمى □ زيادة الفسفاتيز القلوية في الدم (مادة معينة بالدم)
أعراض جانبية نادرة (قد تؤثر على شخص واحد في 1000شخص)
□ آلام في العضلات، التهاب المفاصل، وزيادة التوتر العضلي، أو تشنج عضلي □ التهاب بالأمعاء (التهاب القولون) المرتبط بتناول المضاد الحيوي (يمكن أن يكون قاتل في حالات نادرة جداً) (انظر الى القسم 2) □ التغييرات في عدد خلايا الدم (قلة الكريات البيضاء، كثرة الكريات البيضاء، قلة العدلات، فقر دم) زيادة أو نقصان في عامل
□ تخثر الدم (الصفيحات) □ تفاعل تحسسي أو تورم (وذمة) أو تورم سريع في الجلد والأغشية المخاطية (وذمة وعائية (انظر الى القسم 2)
□ زيادة نسبة السكر في الدم (فرط سكر الدم) □ انخفاض نسبة السكر في الدم ( نقص سكر الدم ) (انظر الى القسم 2) □ ارتباك، توهان، قلق، أحلام غريبة، اكتئاب ( مما قد يؤدي إلى التفكير في الانتحار، محاولات الانتحار أو الانتحار الكامل)(انظر الى القسم 2) أو هلوسة
□ الشعور بالوخز، حساسية غير عادية لمنبهات الحواس، انخفاض حساسية الجلد، ارتعاش، نوبات أو دوخة
□ مشاكل في الرؤية و تشمل الرؤية المزدوجة □ طنين الأذن، فقدان السمع، اضطراب في السمع □ سرعة ضربات القلب (تسرع القلب) □ توسع الأوعية الدموية، انخفاض ضغط الدم أو الإغماء □ ضيق النفس، و تشمل أعراض الربو □ اضطرابات الكبد أو اليرقان (يرقان الركودي) أو التهاب الكبد □ الحساسية للضوء (انظر الى القسم 2)
□ الفشل الكلوي، دم أو بلورات مع البول، التهاب المسالك البولية □ احتباس السوائل أو التعرق الشديد □ زيادة مستويات إنزيم الأميليز
أعراض جانبية نادرة جدا (قد تؤثر على شخص واحد في 10000شخص )
□ نوع خاص من انخفاض عدد كريات الدم البيضاء ( فقر الدم الانحلالي )، انخفاض خطير في خلايا الدم البيضاء ( ندرة المحببات) (انظر الى القسم 2)، انخفاض في عدد خلايا الدم الحمراء و البيضاء و الصفائح (قلة الكريات الشاملة ) و التي قد تكون قاتلة، انخفاض نخاع العظم و التي أيضا قد تكون قاتلة
□ تفاعلات حساسية تسمى داء المصل (انظر الى القسم 2)
□ الاضطرابات العقلية (التفاعلات الذهانية مما قد يؤدي إلى التفكير في الانتحار، محاولات الانتحار أو الانتحار الكامل ) (انظر الى القسم 2 )
□ الشقيقة ( الصداع النصفي )، اختلال التناسق، مشي غير مستقر( اضطراب المشية )، اضطراب في حاسة الشم □ (اضطراب شمي )، الضغط على الدماغ
( الضغط داخل القحف و ورم كاذب مخي) □ اضطرابات الألوان البصرية □ التهاب في جدار الأوعية الدموية ( التهاب وعائي) □ التهاب البنكرياس □ موت خلايا الكبد (نخر الكبد) في حالات نادرة يؤدي إلى فشل كلوي يهدد الحياة (انظر الى القسم 2) □ نزيف صغيرة تحت الجلد (حبرات)، تمزق الجلد أو ظهور طفح جلدي □ تفاقم أعراض الوهن العضلي الوبيل.
أعراض جانبية غير المعروفة (لا يمكن تقدير تكرارها من البيانات المتاحة)
□ الشعور بالسعادة الشديدة (الهوس) أو الشعور بتفاؤل كبير وفرط النشاط (هوس خفيف) □ نظم قلب سريع وغير طبيعي، عدم انتظام ضربات القلب المهدد للحياة، تغير نظم القلب(تسمى فترة إطالة ال QT تظهر على مخطط كهربية القلب و النشاط الكهربائي للقلب ) □ يؤثر على تخثر الدم ( في المرضى الذين يتعالجون بمضادات فايتامين ك)
□ يحفظ بعيداً عن متناول الاطفال.
□ لا يحفظ بدرجة الحرارة اعلى من 30 °م.
□ لا ينبغي استعمال بكتول بعد تاريخ انتهاء الصلاحية الموجود على العلبة و على شريط الدواء.
□ لا ينبغي التخلص من الادوية من خلال مياه الصرف الصحي او المنزلي. اسأل الصيدلاني عن كيفية التخلص من الادوية التي لم تعد مطلوبة. سوف تساعد هذه الاجراءات على حماية البيئة.
□ المادة الفعالة هي سيبروفلوكساسين. كل قرص من أقراص بكتول 250 و 500 يحتوي على 250، 500 ملغم سيبروفلوكساسين، على التوالي، على هيئة سيبروفلوكساسين هيدروكلورايد.
□ المكونات الأخرى: سلولوز بلوري مكروي 50، سلولوز بلوري مكروي 180، غليكولات نشا الصوديوم، هيدروكسي بروبيل سيليولوز، سيليكاغروية لامائية، ستيارات المغنيزيوم، اوبادراي OY-2103، شمع العسل الابيض.
□ أقراص بكتول 250 هي أقراص خضراء اللون، مستديرة، مسطحة، ثنائية التحدب، مغلفة، منقوش عليها "BA 250" من جانب واحد و جلبة من الجانب الاخر .
□ أقراص بكتول 500 هي أقراص خضراء اللون، محززة، مستطيلة، مغلفة، منقوش عليها "BA 500" من جانب واحد و جلبة من الجانب الاخر .
□ علب تحتوي على 10 أقرص من أقراص بكتول 250 المحفوظة في أشرطة.
□ علب تحتوي على 10 أقرص من أقراص بكتول 500 المحفوظة في أشرطة.
الشركة الاردنية لانتاج الادوية المساهمة العامة
Ciprofloxacin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults
- Lower respiratory tract infections due to Gram-negative bacteria
- exacerbations of chronic obstructive pulmonary disease
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- pneumonia
- Chronic suppurative otitis media
- Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
- Urinary tract infections
- Genital tract infections
- gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae
- epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
- pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
- Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)
- Intra-abdominal infections
- Infections of the skin and soft tissue caused by Gram-negative bacteria
- Malignant external otitis • Infections of the bones and joints
- Prophylaxis of invasive infections due to Neisseria meningitidis
- Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Children and adolescents
- Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
- Complicated urinary tract infections and pyelonephritis
- Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1)
Posology
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and coadministration with other appropriate antibacterial agents.
Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Adults
Indications | Daily dose in mg | Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) | |
Infections of the lower respiratory tract | 500 mg twice daily to 750 mg twice daily | 7 to 14 days | |
Infections of the upper respiratory tract |
Acute exacerbation of chronic sinusitis | 500 mg twice daily to 750 mg twice daily | 7 to 14 days |
Chronic suppurative otitis media | 500 mg twice daily to 750 mg twice daily | 7 to 14 days | |
Malignant external otitis | 750 mg twice daily | 28 days up to 3 months | |
Urinary tract infections (see section 4.4) | Uncomplicated cystitis | 250 mg twice daily to 500 mg twice daily | 3 days |
In pre-menopausal women, 500 mg single dose may be used | |||
Complicated cystitis, Uncomplicated pyelonephritis | 500 mg twice daily | 7 days | |
Complicated pyelonephritis | 500 mg twice daily to 750 mg twice daily | at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) | |
Prostatitis | 500 mg twice daily to 750 mg twice daily | 2 to 4 weeks (acute) to 4 to 6 weeks (chronic) | |
Genital tract infections | Gonococcal uretritis and cervicitis | 500 mg as a single dose | 1 day (single dose) |
Epididymo-orchitis and pelvic inflammatory diseases | 500 mg twice daily to 750 mg twice daily | at least 14 days | |
Infections of the gastro-intestinal tract and intra-abdominal infections | Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea | 500 mg twice daily | 1 day |
Diarrhoea caused by Shigella dysenteriae type 1 | 500 mg twice daily | 5 days | |
Diarrhoea caused by Vibrio cholerae | 500 mg twice daily | 3 days | |
Typhoid fever | 500 mg twice daily | 7 days | |
Intra-abdominal infections due to Gram-negative bacteria | 500 mg twice daily to 750 mg twice daily | 5 to 14 days | |
Infections of the skin and soft tissue | 500 mg twice daily to 750 mg twice daily | 7 to 14 days | |
Bone and joint infections | 500 mg twice daily to 750 mg twice daily | max. of 3 months | |
Neutropenic patients with fever suspected to be due to a bacterial infection. Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance. | 500 mg twice daily to 750 mg twice daily | Therapy should be continued over the entire period of neutropenia | |
Prophylaxis of invasive infections due to Neisseria meningitidis | 500 mg as a single dose | 1 day (single dose) | |
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. | 500 mg twice daily | 60 days from the confirmation of Bacillus anthracis exposure | |
Paediatric population
Indications | Daily dose in mg | Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) |
Cystic fibrosis | 20 mg/kg body weight twice daily with a maximum of 750 mg per dose | 10 to 14 days |
Complicated urinary tract infections and pyelonephritis | 10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. | 10 to 21 days |
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. | 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose. | 60 days from the confirmation of Bacillus anthracis exposure |
Other severe infections | 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. | According to the type of infections |
Elderly patients:
Elderly patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance.
Patients with renal and hepatic impairment
Recommended starting and maintenance doses for patients with impaired renal function:
Creatinine Clearance [mL/min/1.73 m²] | Serum creatinine [µmol/L] | Oral Dose [mg] |
> 60 | < 124 | See Usual Dosage. |
30 – 60 | 124 – 168 | 250 - 500 mg every 12 h |
<30 | >169 | 250 - 500 mg every 24 h |
Patients on haemodialysis | >169 | 250 - 500 mg every 24 h (after dialysis) |
Patient on peritoneal dialysis | >169 | 250 - 500 mg every 24 h |
In patients with impaired liver function no dose adjustment is required. Dosing in children with impaired renal and/or hepatic function has not been studied.
Method of administration
Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly. Ciprofloxacin tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) (see section 4.5).
In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
Severe infections and mixed infections with Gram-positive and anaerobic pathogens
Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.
Streptococcal Infections (including Streptococcus pneumoniae)
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Genital tract infections
Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.
Therefore, ciprofloxacin should be administered for the treatment of gonococcal uretritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
For epididymo-orchitis and pelvic inflammatory diseases, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent (e.g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Urinary tract infections
Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.
The single dose of ciprofloxacin that may be used in uncomplicated cystitis in premenopausal women is expected to be associated with lower efficacy than the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.
Intra-abdominal infection
There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Travellers' diarrhoea
The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
Infections of the bones and joints
Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Inhalational Anthrax
Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax
Paediatric population
The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Safety data from a randomised double-blind study on ciprofloxacin use 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 (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%. Respectively, an incidence of drug-related arthropathy by 1-year followup was 9.0% and 5.7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue (see section 4.8).
Broncho-pulmonary infections in cystic fibrosis
Clinical trials have included children and adolescents aged 5-17 years. More limited experience is available in treating children between 1 and 5 years of age.
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 the results of the microbiological documentation.
Clinical trials have included children and adolescents aged 1-17 years
Other specific severe infections
Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, caution is advised when treating patients with these infections.
Hypersensitivity
Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose (see section 4.8) and may be life-threatening. If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Musculoskeletal System
Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, even within the first 48 hours of treatment. Inflammation and ruptures of tendon may occur even up to several months after discontinuation of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids (see section 4.8).
At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued. Care should be taken to keep the affected limb at rest.
Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).
Vision disorders
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Photosensitivity
Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).
Central Nervous System
Ciprofloxacin like other quinolones are known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure. If seizures occur ciprofloxacin should be discontinued (see section 4.8). Psychiatric reactions may occur even after first administration of ciprofloxacin. In rare cases depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. In the occurrence of such cases, ciprofloxacin 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 receiving ciprofloxacin. Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
Cardiac disorders
Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:
• congenital long QT syndrome
• concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) • uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
• cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.
(See section 4.2 Elderly patients, section 4.5, section 4.8, section 4.9).
Hypoglycemia
As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).
Gastrointestinal System
The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (lifethreatening with possible fatal outcome), requiring immediate treatment (see section 4.8). In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation
Renal and urinary system
Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8). Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Impaired renal function
Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed 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 hepatic failure have been reported with ciprofloxacin (see section 4.8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
Glucose-6-phosphate dehydrogenase deficiency
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, potential occurrence of haemolysis should be monitored.
Resistance
During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Cytochrome P450
Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5). Co-administration of ciprofloxacin and tizanidine is contra-indicated.
Methotrexate
The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).
Interaction with tests
The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in older population.
Therefore, fluoroquinolones should only be used after careful benefit- risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre existing aortic aneurysm and/ or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers- Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Effects of other products on ciprofloxacin:
Drugs known to prolong QT interval
Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).
Chelation Complex Formation
The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers.
Food and Dairy Products
Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
Probenecid
Probenecid interferes with renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.
Omeprazole
Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin.
Effects of ciprofloxacin on other medicinal products:
Tizanidine
Tizanidine must not be administered together with ciprofloxacin (see section 4.3). In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with ciprofloxacin. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.
Methotrexate
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended (see section 4.4).
Theophylline
Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration. This can lead to theophylline-induced side effects that may rarely be life threatening or fatal. During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).
Other xanthine derivatives
On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Phenytoin
Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Cyclosporin
A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.
Vitamin K antagonists
Simultaneous administration of ciprofloxacin with a vitamin K antagonist may augment its anti-coagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalised ratio) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with a vitamin K antagonist (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione).
Duloxetine
In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of 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
It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after coadministration with ciprofloxacin (see section 4.4).
Lidocaine
It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.
Clozapine
Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised (see section 4.4).
Sildenafil
Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.
Agomelatine
In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration (see 'Cytochrome P450' in section 4.4).
Zolpidem
Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
Pregnancy: The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3). As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy. Breast-feeding Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding. |
Due to its neurological effects, ciprofloxacin may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea
ADRs derived from clinical studies and post-marketing surveillance with Ciproxin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
System Organ Class | Common ≥1/100 to < 1/10 | Uncommon ≥1/1 000 to < 1/100 | Rare ≥1/10 000 to < 1/1 000 | Very Rare < 1/10 000 | Frequency not known (cannot be estimated from available data) |
Infections and Infestations |
| Mycotic superinfections |
|
|
|
Blood and Lymphatic System Disorders |
|
Eosinophilia |
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia |
Haemolytic anaemia Agranulocytosis Pancytopenia (life-threatening) Bone marrow depression (life-threatening) |
|
Immune System Disorders |
|
| Allergic reaction Allergic oedema / angiooedema | Anaphylactic reaction Anaphylactic shock (life-threatening) (see section 4.4) Serum sickness-like reaction |
|
Metabolism and Nutrition Disorders |
| Decreased appetite | Hyperglycaemia Hypoglycaemia (see section 4.4) |
|
|
Psychiatric Disorders |
| Psychomotor hyperactivity / agitation | Confusion and disorientation Anxiety reaction Abnormal dreams Depression (potentially culminating in suicidal ideations/thought or suicide attempts and completed suicide) (see section 4.4) Hallucinations | Psychotic reactions (potentially culminating in suicidal ideations/ thoughts or suicide attempts and completed suicide) (see section 4.4) | Mania, incl. hypomania |
Nervous System Disorders |
| Headache Dizziness Sleep disorders Taste disorders | Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (including status epilepticus see section 4.4) Vertigo | Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension and pseudotumor cerebri | Peripheral neuropathy and polyneuropathy (see section 4.4) |
Eye Disorders |
|
| Visual disturbances (e.g. diplopia) | Visual colour distortions |
|
Ear and Labyrinth Disorders |
|
| Tinnitus Hearing loss / Hearing impaired |
|
|
Cardiac Disorders |
|
| Tachycardia |
| Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9) |
Vascular Disorders |
|
| Vasodilatation Hypotension Syncope | Vasculitis |
|
Respiratory, Thoracic and Mediastinal Disorders |
|
| Dyspnoea (including asthmatic condition) |
|
|
Gastrointestinal Disorders | Nausea Diarrhoea | Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence | Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4) | Pancreatitis |
|
Hepatobiliary Disorders |
| Increase in transaminases Increased bilirubin | Hepatic impairment Cholestatic icterus Hepatitis | Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4) |
|
Skin and Subcutaneous Tissue Disorders |
| Rash Pruritus Urticaria | Photosensitivity reactions (see section 4.4) | Petechiae Erythema multiforme Erythema nodosum Stevens-Johnson syndrome (potentially life-threatening) Toxic epidermal necrolysis (potentially life-threatening) |
|
Musculo-skeletal and Connective Tissue Disorders |
| Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia | Myalgia Arthritis Increased muscle tone and cramping | Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4) |
|
Renal and Urinary Disorders |
| Renal impairment | Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis |
|
|
General Disorders and Administration Site Conditions |
| Asthenia Fever | Oedema Sweating (hyperhidrosis) |
|
|
Investigations |
| Increase in blood alkaline phosphatase | Increased amylase |
| International normalised ratio increased (in patients treated with Vitamin K antagonists) |
Paediatric population
The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).
Saudi Arabia: To report any side effect(s): National Pharmacovigilance and Drug Safety Center (NPC): call NPC at +966-11-2038222, Exts: 2317- 2356- 2340, Fax: +966- 11-205-7662, Reporting hotline: 19999, E-mail: npc.drug@sfda.gov.sa, Website: www.sfda.gov.sa/npc.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.
Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Pharmacotherapeutic group: Fluoroquinolones, ATC code: J01MA02
Mechanism of action:
As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
PK/PD relationship:
Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
Mechanism of resistance:
In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.
Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance. All in-vitro mechanisms of resistance are commonly observed in clinical isolates. Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
Plasmid-mediated resistance encoded by qnr-genes has been reported.
Spectrum of antibacterial activity:
Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:
EUCAST Recommendations
Microorganisms | Susceptible | Resistant |
Enterobacteriaceae | S ≤0.5 mg/L | R > 1 mg/L |
Pseudomonas spp. | S ≤0.5 mg/L | R > 1 mg/L |
Acinetobacter spp. | S ≤1 mg/L | R > 1 mg/L |
Staphylococcus spp.1 | S ≤1 mg/L | R > 1 mg/L |
Haemophilus influenzae and Moraxella catarrhalis | S ≤0.5 mg/L | R > 0.5 mg/L |
Neisseria gonorrhoeae | S ≤0.03 mg/L | R > 0.06 mg/L |
Neisseria meningitidis | S ≤0.03 mg/L | R > 0.06 mg/L |
Non-species-related breakpoints* | S ≤0.5 mg/L | R > 1 mg/L |
1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended. | ||
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4).
COMMONLY SUSCEPTIBLE SPECIES |
Aerobic Gram-positive micro-organisms Bacillus anthracis (1) |
Aerobic Gram-negative micro-organisms Aeromonas spp. Brucella spp. Citrobacter koseri Francisella tularensis Haemophilus ducreyi Haemophilus influenzae* Legionella spp. Moraxella catarrhalis* Neisseria meningitidis Pasteurella spp. Salmonella spp.* Shigella spp.* Vibrio spp. Yersinia pestis |
Anaerobic micro-organisms Mobiluncus |
Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) |
SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM |
Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2) |
Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp.+ * Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp. Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens* |
Anaerobic micro-organisms Peptostreptococcus spp. Propionibacterium acnes |
INHERENTLY RESISTANT ORGANISMS |
Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes |
Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia |
Anaerobic micro-organisms Excepted as listed above |
Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum |
* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥50% in one or more EU countries ($): Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1): Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose. The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data. Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans. The treating physician should refer to national and/or international consensus documents regarding treatment of anthrax. (2): Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones. The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates. |
Absorption
Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/L. Serum concentrations increase proportionately with doses up to 1000 mg.
The absolute bioavailability is approximately 70-80%.
A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.
Distribution
Protein binding of ciprofloxacin is low (20-30%). Ciprofloxacin is present in plasma largely in a non-ionised form and has a large steady state distribution volume of 2-3 L/kg body weight. Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
Biotransformation
Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Elimination
Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally. The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.
| Excretion of ciprofloxacin (% of dose) | ||
| Oral Administration | |
Urine | Faeces | |
Ciprofloxacin Metabolites (M1- M4) | 44.7 11.3 | 25.0 7.5 |
Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h. Ciprofloxacin undergoes both glomerular filtration and tubular secretion. Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.
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.
Paediatric patients
The pharmacokinetic data in paediatric patients are limited
In a study in children Cmax and AUC were not age-dependent (above one year of age). No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.
In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age. The AUC values were 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) in the respective age groups.
These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean halflife in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%
Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.
Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels. Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments. This effect was comparable to that of other gyrase inhibitors.
Articular tolerability:
As reported for other gyrase inhibitors, ciprofloxacin causes damage to the large weightbearing joints in immature animals. The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints. Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions. In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
Microcrystalline Cellulose 50 micrometer
Microcrystalline Cellulose 180 micrometer
Sodium starch glycolate
Hydroxypropyl Cellulose EF
Colloidal Anhydrous Silica
Magnesium stearate
Opadry-OY-21033
White Bees Wax
Not applicable
Do not store above 30ºC.
Bactall 500 mg Film coated Tablets are packed in boxes of 10 Tablets blistered in aluminium foil.
Any unused product or waste material should be disposed of accordance with local requirements.
