Ciprobay 500mg Bayer Treatment for infection (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Ciprofloxacin
Ingredient Otitis media, urinary tract infections, trachoma, eyelash infections, pinkeye, pyelonephritis, blood infections, chronic bronchitis, pneumonia

Ingredient

Composition information	Content
Ciprofloxacin	500mg

Uses

Indications

Ciprobay 500mg drug is indicated in the following cases:

Infectious infections and no complications due to ciprofloxacin sensitive agents.

Respiratory infections: Ciprofloxacin can be used in the treatment of pneumonia caused by Klebsiella, Entobacter, Proteus, E.coli, Pseudomonas, Haemophilus, Branhamella, Legionella spp. and Staphylococcus.

Middle ear infection (middle ear infection) and sinuses around the nose (sinusitis), especially the cause of gram -negative bacteria, including pseudomonas aeruginosa or staphylococci.

Eye infections.

Kidney or urinary tract infections.

Genital infection, including appendages, gonorrhea and prostatitis.

Abdominal infections (such as gastrointestinal infections or biliary tract, peritonitis).

Skin and soft tissue infections.

Bone and joint infections.

Infections.

Infections or a risk of infection (prophylaxis) in patients with impaired immune system (e.g. patients are taking immunocenable or leukopenia).

Selective intestinal disinfection in immunodeficiency.

Preventive cases of invasive infections caused by Neisseria Meningitidis.

Children

Ciprofloxacin can be used for children for the second or third choice treatment in complicated urinary tract infections and nephritis - pyelonephritis caused by Escherichia Coli (age is applied in clinical trials: 1 - 17 years old) and for severe treatment for pneumonia caused by cystic fibrosis. Clinical solution: 5 - 17 years old).

Treatment should only start after careful evaluation between benefits/risks because drugs may have unwanted effects related to joints and/or surrounding tissues.

Children's clinical trials have been performed in the above indications. For other indications, clinical experience is limited.

Inhalation coal disease (after exposure) in adults and children

Reduce the frequency of new disease or reduce the progression of the disease when exposed to bacillus anthracis coal bacilli in the air.

Pharmacokology

Mechanism of action

Ciprofloxacin has in vitro activity against the broad spectrum of both gram -negative and gram -positive bacteria. The bactericidal effect of ciprofloxacin is caused by inhibiting the Topoisomerase Type II enzymes of bacteria and Topoisomerase IV is an essential enzyme for the process of copying, code, repair and recombination DNA.

pharmacokinetic

absorption

After taking the single -tablet doses of 250mg, 500mg and 750mg Ciprobay is absorbed quickly and completely, mainly in the small intestine and reach the maximum concentration in the blood after 1-2 hours.

Absolute bioavailability reaches about 70 - 80%. The maximum concentration in plasma (CMAX) and the total area under the curve (AUC) increased corresponding to the dose.

Distribution

The ability to bind to Ciprofloxacin's protein is low (20 - 30%), and the drug present in plasma is mostly ionized. Ciprofloxacin can diffuse freely outside the wall. The drug distribution vol

Metabolism

Determined a small amount of 4 metabolites including: Desethyleneciprofloxacin (M1), sulphociprofloxacin (m2), oxociprofloxacin (M3) and formylciprofloxacin (M4). On Vitro, metabolites from M1 to M3 have similar antibacterial activity or lower than the antibacterial activity of nalidixic acid. M4, present with the smallest, antibacterial activity on in vitro equivalent to Norfloxacin.

Elimination

ciprofloxacin is metabolized mainly in the form of non -metabolized through the kidneys and a small amount outside the kidney.

Before taking Ciprobay 500mg Bayer Treatment for infection (1 blister x 10 tablets)

How to use

oral drugs. Take the pills with some water. The drug is taken regardless of the meal time.

If you take the medicine when you are hungry, the active ingredient can be absorbed faster. Ciprobay should not be used simultaneously with dairy products or mineral supplements (such as fresh milk, yogurt, orange juice supplementing with calcium) (see the item "interact with other drugs and other types of interactions").

If the patient cannot take the tablet due to the severity of the disease or other causes, the beginning of treatment is recommended by ciprofloxacin injected fluid that can continue with oral ciprofloxacin.

Dosage

Unless the drug is prescribed in another way, the following daily dose is recommended:

Adults

Table 1: The daily dose of oral ciprobay on adult patients.

Indications

daily dose of ciprofloxacin (calculated by mg) for ciprobay film tablets

Respiratory infections (depending on mild level and bacteria that cause severe severity and bacteria disease). Time. spp., Shigella spp., Vibero spp. Fibrosis).
Bone and joint infections. 2 times.

Table 2: Ciprobay's recommended dose for patients who are children and teenagers

Indications for Ciprofloxacin's daily daily dose (calculated by Mg) for Ciprobay film tablets infections in fibrosis. Every day (maximum 750mg/dose). Special patients

Children and teenagers

Dosage recommended to see table 2.

Elderly (over 65 years old)

Older patients should take the lower doses as possible depending on the severity of the disease and the creatinine purification (see the "patient with liver failure, kidney failure").

Patients with renal failure

Table 3: Recommended dose for patients with renal failure.

Creatinin clearance (ml/min/1.73m2) Creatinin serum (µmol/l) Ciprofloxcin's daily oral daily dose of ciprofloxcin 167.98 Maximum 1000mg.

For patients with creatinine clearance between 30 - 60ml/minute/1.73m2 (moderate kidney failure) or serum creatinine levels from 123.76 to 167.98µmol/l, daily dose of ciprofloxacin orally daily is 800mg.

For patients with creatinine clearance less than 30ml/min/1.73m2 (severe renal failure) or serum creatinine greater than or equal to 176.80µmol/l, daily dose of ciprofloxacin oral oral daily is 400mg when the cup is separated, the days after the separation.

Patients with renal impairment are continuously separating output (Continuous Ambulatory Peritoneal Dialysis (CAPD)

Dosage Ciprofloxacin oral daily is 500mg (500mg each time, 1 time or 250mg each time, 2 times a day).

Patients with liver failure

In patients with impaired liver function, no dose adjustment.

Patients with liver and kidney failure

For patients with creatinine clearance between 30 - 60ml/minute/1.73m2 (moderate renal failure) or serum creatinine levels from 123.76 to 167.98µmol/l, daily dose of ciprofloxacin oral daily is 1000mg.

Children

There is no study of dosage in children with impaired kidney function or liver function impairment.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Patients should be fully rehydrated. Only a small amount (

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Ciprobay 500mg, you may experience unwanted effects (ADR).

The most common side effects (ADRS) are based on all clinical studies on Ciprofloxacin (oral, infusion) classified by CIOMS classification of frequency (all n = 51621 patients).

The frequency of unwanted effects reported when using Ciprobay is summarized in the table below. In each group, the unwanted effect is presented according to the degree of severity decreasing. The frequency is described as follows:

Common (≥ 1/100 and ≤ 1/10).

Not common (≥ 1/1000 and ≤ 1/100). The use does not estimate the frequency, listed in the "unknown" section. Agency system

Common Not common rare

Clearly

infection and parasitic infection. Allergic reaction, allergic/angioior. Blood. public), hallucinations. taste. Epilepsy (including epilepsy), dizziness. force. Heart. circuit. melting. Increasing bilirubin. jute. joint pain. Kidney. foul). K).

The following adverse effects are more common in the group of patients using infusion or continuous use (from injection to oral form):

Common. Hearing, fast heartbeat, vasodilation, hypotension, transient liver damage, jaundice, kidney failure, edema. ribs.

New frequency of joint diseases mentioned above is collected from data in adult studies. Reports on joint disease are quite common in children (see "Special and cautious warnings when used").

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Ciprobay medicine 500mg contraindicated in the following cases:

Too satisfied with ciprofloxacin or other quinolone or any excipients (see the "List of excipients").

Simultaneous use of ciprofloxacin with tizanidine (see "interact with other drugs and other types of interactions").

Caution when used

Severe infections and infections caused by gram -positive bacteria and anaerobic bacteria: In the treatment of severe cases of staph infections, staphylococci (staphylococci) and anaerobic infection, Ciprobay must be used in combination with appropriate antibacterial drugs.

Streptococcus pneumoniae infection

It is not recommended to use Ciprobay in the treatment of pneumococcal infections due to the effectiveness of the treatment of streptococcus pneumoniae.

Genital tract infection

Genital tract infection may be caused by the Fluoroquinolon drug. In the case of genital tract infection or suspicion of gonorrhea (Neisseria gonorrheaa), it is important to collect information about the frequency of Ciprofloxacin resistance frequency in the locality and determine the sensitivity to the drug based on tests.

cardiovascular disorders

Ciprobay is related to cases that extend the QT segment (see the "unwanted effect" section). Because women tend to have a longer QT range than men, these patients may be more sensitive to drugs with dual effects about QT. Elderly patients may also be sensitive to the effects of drugs on QT intervals.

Be cautious when using Ciprobay along with drugs that can extend the QT range (such as IA or type III anti -arrhyths, three -round antidepressants, macrolid antibiotics, anti -psychotic drugs) (see the item "Interact with other drugs and other types of interactions"), or in patients with risk factors for extension of QT, such as the QT, such as the interval of the interval, such as the interval of QT, such as the intervals Electrolyte imbalance has not been adjusted such as hypokalemia or hypoglycemia and heart disease such as heart failure, myocardial infarction or slow heart rate).

Children and teenagers

Similar to other drugs in the same group, Ciprofloxacin can cause joint pain in large joints with gravity on adult animals. Analysis of existing safety data on the use of ciprofloxacin in patients under 18 years old, of which most cases are cystic disease, have not given any evidence of cartilage lesions and joints related to drugs.In addition to the use of drugs to treat severe acute pneumonia caused by cystic fibroids caused by Pseudomonas Aeruginosa infection (children aged 5-17), complicated urinary tract infections and renal and renal infections caused by Escherichia coli (children from 1 to 17 years old), and coal disease (after exposure), no research on the use of Ciprobay for other indicators. Clinical experience for drug use in other indications is limited.

Hypersensitivity

In some cases, hypersensitivity and allergic reactions may occur immediately the first dose (see the unwanted effect section ”) and should notify the doctor immediately.

Anaphylaxis/anaphylactic reaction in very rare cases can progress to life -threatening shock, in some cases occurring after first use (see the section "Unwanted effect"). In these cases, Ciprobay must be discontinued, need to conduct medical treatment (for example, shock treatment).

digestive system

In case of severe or prolonged diarrhea during or after treatment, it is necessary to consult a doctor because this symptom can hide a serious gastrointestinal pathology (fake colitis threatens life that can be fatal) that should be treated immediately (see "Unwanted effect"). In this case, Ciprobay must be discontinued and conducted appropriate treatment (for example, vancomycin, taking 250mg x 4 times/day). Contraindicated to use intestinal iron inhibitors in this case.

Bile liver system

Cases of liver necrosis and liver failure threatened to be reported to Ciprobay. Among the events there are any signs and symptoms of liver disease (such as anorexia, jaundice, dark urine, itching or bloating), it is necessary to stop the drug (see the item "unwanted effect").

There may be temporary increase in transaminase, alkaline or jaundice phosphatase, especially in patients with previous liver damage, ciprobay treatment people, (see the item "unwanted effect").

Muscle system

Caution should be used with Ciprobay cautiously in patients with myasthenia gravis, because symptoms may be more serious. Tendonitis and tendons (mainly on Achilles), sometimes on both sides, occur with Ciprobay, even within the first 48 hours of treatment, inflammation and tendons can occur for a few months after stopping treatment with ciprobay. The risk of tendon pathology may increase in the elderly or on patients treated simultaneously with corticosteroids.

If there is any sign of tendonitis (for example, swelling, inflammation) should stop using ciprofloxacin and refer to the doctor. It is advisable to keep the damage to rest and avoid inappropriate movements (due to the risk of muscle tendon breakage).

Be cautious when using Ciprobay in patients with a history of tendon disorders related to treatment with quinolon.

Nervous system

ciprobay, like other ellues, can start coi or lower the seizure threshold. In patients with epilepsy and previous central neuropathy (for example, low epilepsy threshold, a history of epilepsy, reduced blood flow, brain structure is damaged or stroke), only using ciprobay when considering the benefits between the improvement effect of the drug and the risk because these patients may be dangerous because of unwanted effects on the central nervous system. There have been reports on cases of continuous epilepsy (see the "unwanted effect" section). If convulsions occur, stop using Ciprobay.

Mental reactions may occur even after the first dose of fluoroquinolon antibiotics, including Ciprobay. In some rare cases, depression or psychotic reactions can progress to the appearance of suicide ideas/thoughts and self -dangerous behaviors for themselves, such as cases of trying to commit suicide or suicide successfully (see the item "Unwanted effect"). In events that patients have any such reactions, Ciprobay should be stopped immediately and apply appropriate treatments.

There have been reports on cases of multi -nerve pathology or sensory sensation that leads to abnormalities, reduced sensation, sensory or muscle weakness in patients using fluoroquinolon, including Ciprobay. Ciprobay patients should be recommended to report to doctors before continuing treatment if symptoms of neuropathy such as pain, burning sensation, throbbing, numbness or muscle weakness (see "unwanted effects").

Skin and related parts

Ciprofloxacin can cause light -sensitive reactions. Patients who are taking Ciprobay should avoid direct contact with sunlight or ultraviolet rays too much. Treatment should be discontinued if there is light sensitivity (for example, skin reactions like burns) (see the "unwanted effect" section).

cytochrome p450

ciprofloxacin causes moderate inhibition inhibitor CYP 450 1A2. Caution should be carefully used with simultaneous use, other drugs metabolized through the enzyme system (such as Tizanidine, Theophyline, Methylxantines, Caffeine, Ropinirole, Duloxetine, Clozapine, Olanzapine). The concentration of these drugs in serum and unwanted effects of the drug may increase due to the inhibition of metabolic and elimination of ciprofloxacin (see the item "interact with other drugs and other forms of interactions").

Interaction with tests

In In vitro studies, the effect of ciprofloxacin can affect the tuberculosis mycobacterium tuberculosis due to the development of mycobacterium, producing false negative results in patients with Ciprobi patients.

The ability to drive and operate machinery

fluoroquinolone, including ciprofloxacin, can affect the ability to drive and operate machinery due to the effect on the central nervous system (CNS) (see the item "unwanted effect"). Especially when drinking alcohol.

Pregnancy

Existing data on the use of ciprofloxacin on pregnant women shows that there is no toxicity that causes deformities as well as toxicity on pregnancy/infant. Animal studies do not show reproductive toxicity. Based on animal studies, it is not possible to eliminate drugs that can cause fetal cartilage damage so it is not recommended to use Ciprobay during pregnancy.

Animal studies do not show any evidence of teratogenic effect (deformities).

breastfeeding period

ciprofloxacin is excreted through breast milk. It is not recommended to use ciprobay for mothers during breastfeeding due to the risk of joint damage. Should stop breastfeeding when using ciprofloxacin.

Drug interaction

ciprobay 500mg interact with the following drugs:

The drugs that extend the QT. Milk.

Probenecid. different.

nsAID.

Storage

Store at temperatures below 30 ° C (below 86OF).

Other drugs

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