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► Azitrox 500 (azithromycin) - Practical Medicine

Azitrox 500 (azithromycin) - coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Azitrox 500 coated tablets; 500 mg; 3 tables Zentiva 19.08 14.53
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:azithromycin

The drug is available on prescription

What is Azitrox ?

An antibacterial drug for general use. Macrolide antibiotic used to treat bacterial infections.

What does Azitrox contain and how does it work?

The active substance is Azithromycin . It is an antibiotic from the group of macrolides, included in the new generation of these antibiotics, a semi-synthetic derivative of Erythromycin . Azithromycin has been developed to avoid some of the disadvantages of erythromycin. The mechanism of its action, common for the whole group of macrolides, consists in inhibiting the synthesis of bacterial proteins. This is done by blocking bacterial ribosomes, cell structures necessary for protein synthesis. This prevents growth and multiplication of bacterial cells. Azithromycin, like other antibiotics from the group of macrolide antibiotics, is classified as a bacteriostatic substance (under certain conditions also acts bactericidal), with a broad spectrum of action. After oral administration, azithromycin is well absorbed and rapidly excreted from serum to tissues. It accumulates in phagocytes that MIG rate to the site of infection, which increases the distribution of the drug to the tissues involved in the inflammatory process. Azithromycin is characterized by a high concentration in infected tissues and a long half-life, which makes it possible to shorten the treatment time to 1-5 days.

When to use Azitrox?

The preparation is indicated for the treatment of the following infections caused by azithromycin-sensitive organisms:
Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis
· Acute otitis media
· Lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, mild to moderately severe lung inflammation, including interstitial pneumonitis
Infection of the skin and soft tissues: rose, impetigo, secondary infected pyoderma; erythema migrans (first symptom of Lyme disease); in addition, 500 mg tablets are indicated for the treatment of moderate acne vulgaris, only in adults
and in addition, a 500 mg tablet or 250 mg capsule formulation is indicated in:
· Treatment of sexually transmitted diseases (uncomplicated chlamydia infections).

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients or other macrolide antibiotics.

Take special care with Azitrox?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The use of macrolide antibiotics (including the preparation) can rarely be associated with severe hypersensitivity reactions, including potentially life threatening reactions such as angioedema and Anaphylactic reactions . Some of these reactions may be recurrent and require longer follow-up and treatment.
Caution should be exercised because treatment with macrolide antibiotics may result in prolongation of the QT interval in ECG and the risk of arrhythmias, includingtorsade de pointes. This action of azithromycin can not be ruled out, especially in patients with risk factors. Do not use the product if there are risk factors such as: prolonged QT interval in ECG, reduced heart rate (bradycardia), severe heart failure , arrhythmia, decreased potassium or Magnesium , or other electrolyte disturbances, and if you are ill use drugs that prolong the QT interval, including antiarrhythmics (class IA and III), cisapride, terfenadine.
Azithromycin is not the drug of choice for the treatment of pharyngitis and tonsillitis caused by some streptococci (Streptococcus pyogenes). Azithromycin is effective in the treatment of streptococcal throat infections, its effectiveness in the prevention of acute rheumatic fever has not been proven (the drug of choice is usually penicillin).
In the case of sexually transmitted diseases, your doctor will normally recommend that you carry out appropriate laboratory tests to confirm or rule out parallel syphilis.
The use of antibiotics may cause excessive development of resistant bacteria and fungi. During the treatment period, it is recommended to observe whether there are symptoms of new infections. If new bacterial or fungal infections (eg yeast infections) appear during the application period, a doctor should be consulted immediately.
If diarrhea occurs during or after treatment, do not treat it yourself, but consult a physician. There is a risk of pseudomembranous colitis, sometimes with a serious, life-threatening course. Its clinical symptoms (such as watery stools with blood and mucus, blunt, spilled or colic stomach ache, fever, periodic pressure on the stool) are caused by the wormClostridium difficile, which can multiply in the conditions of disturbance of the normal bacterial flora in the gut. The use of drugs that inhibit intestinal motility is contraindicated in this case. If necessary, the doctor will apply appropriate pharmacological treatment.
The safety and efficacy of long-term use of azithromycin have not been established. If you have recurrent infections, please consult your doctor, as it may be necessary to change the treatment and use another antibiotic as prescribed by your doctor.
Do not use the preparation in parallel with ergot derivatives (eg ergotamine), due to the risk of poisoning.
If the preparation is used in patients with neurological or mental disorders, care should be taken.
The preparation should not be used to treat infected burn wounds.

Does this preparation affect the ability to drive vehicles?
There are no data on the effect of the preparation on the ability to drive and use machines / machines. The preparation may cause side effects such as dizziness and convulsions that may impair your ability to drive or use machines / machines.

Dosage of Azitrox

The preparation is a granules for oral suspension or coated tablets. If you have any doubts regarding the use of the preparation, consult a physician. The doctor will select the dosage individually depending on the indication, the severity of the infection, the sensitivity of the microorganisms and the patient's condition. In certain special patient groups, additional dosage adjustment is necessary.
Dosage of the preparation in the form of tablets.
Adults and children with a body weight greater than 45 kg:
- respiratory tract infection, otitis media, infection of the skin and soft tissues (with the exception of erythema migrans): 500 mg once daily for 3 days
- erythema migrans: on the first day a single dose of 1 g, then from 2 to 5. 500 mg once daily
- sexually transmitted diseases: 1 g each
- moderate acne, only in adults (this indication only applies to the 500 mg tablet): 500 mg once daily for 3 days, then 500 mg 1 once a week for the next 9 weeks (keeping 7 days intervals) between doses, in the second week, the preparation should be taken 7 days after the first dose).A high dose of azithromycin is used in the above dosing regimen, which is why it is necessary to monitor liver enzymes before and during treatment. The above treatment regimen of moderate acne (3 days + 9 weeks) may be used only once in a given patient because there are no clinical trials whose results would show the safety and efficacy of repeating this treatment regimen.
Elderly patients do not need to adjust their dosage.
Dosage preparation in the form of granules for the preparation of an oral suspension.
Usually 10 mg / kg body weight is used once daily for 3 days; Exception is the dosage in the treatment of erythema migrans (the first symptom of Lyme disease): on the first day 20 mg / kg body weight is used in a single dose, followed by 10 mg / kg body weight once daily for 4 consecutive days (from 2 to 5 day).
In the case of mild to moderate renal dysfunction (creatinine clearance greater than 40 ml / min), no dosage adjustment is necessary. There are no data on the use of the preparation in people with a creatinine clearance less than 40 ml / min, and caution is advised in such cases.
In the case of mild to moderate hepatic impairment, no dosage adjustment is necessary. Do not use in patients with severe hepatic impairment.
Method of administration:
The preparation in the form of tablets and capsules is intended for oral use. The tablets should be swallowed whole (tablets or capsules should not be divided), once a day.
The preparation in the form of granules for preparation of the suspension is intended for oral use. Granules should be mixed with the appropriate amount of water indicated in the package leaflet (shake the bottle) in order to obtain a homogeneous suspension. The prepared suspension should be taken once a day, at least 1 hour before or 2 hours after a meal. Shake before use. The suspension should be administered using the syringe or measuring spoon provided with the package. After administration, the suspension should be drunk with tea or juice so that the medicine does not stay in the mouth.

Can you use Azitrox during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The use of the preparation during pregnancy is only allowed if the doctor deems it absolutely necessary.
Azithromycin is excreted in breast milk. It is recommended that you do not breastfeed during the use of the preparation and for 2 days after its use. Then, consult your doctor and determine if breastfeeding can be continued.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter. In particular, inform your doctor if you use:
· Drugs that may cause QT prolongation in the ECG (including class IA antiarrhythmics eg disopyramide and class III, eg Amiodarone )
· terfenadine
· cisapride
· Antacids
· Ergotamine derivatives (derivatives of ergot)
· Digoxin
· cyclosporine
· nelfinavir
· Anticoagulants (derivatives of coumarin, eg Warfarin )
· theophylline
· rifabutin
· Astemizole, triazolam, midazolam and alfentanil.
Caution is required when azithromycin is used in conjunction with drugs that prolong the QT interval on the ECG, including class IA antiarrhythmics (eg disopyramide) and class III (eg amiodarone), terfenadine and cisapride. QT prolongation, ventricular arrhythmias and dangerous rhythm disturbances may occurtorsades de pointes. Antacids may affect the absorption of azithromycin and should therefore be taken at least one hour before or two hours after taking an antacid. Do not use the preparation in parallel with ergot derivatives (preparations containing ergotamine or its derivatives), due to the risk of poisoning, manifested by peripheral vasospasm and ischemia.The preparation may cause an increase in the blood level of digoxin used in parallel; in patients who use digoxin in parallel, the doctor will usually recommend monitoring its concentration in the blood. Caution is advised in the parallel use of drugs metabolized with the cytochrome P450 3A4 isoenzyme, because it can not be ruled out that azithromycin inhibits the activity of this enzyme. Azithromycin may increase the toxicity of cyclosporin. If it is necessary to use it in parallel, your doctor will probably recommend monitoring blood levels of ciclosporin and adjust the dose accordingly. Nelfinavir may increase the exposure to azithromycin (the risk of increased side effects). Azithromycin enhances the effects of anticoagulants of coumarin derivatives (eg warfarin); During the antibiotic period, your doctor will probably recommend regular monitoring of blood clotting parameters. If necessary, your doctor will adjust the dosage of these medicines. Caution should be exercised when using theophylline in parallel, as other macrolide antibiotics interacted with theophylline, which was accompanied by symptoms of increased plasma concentration. The parallel use of azithromycin and rifabutin may be accompanied by a decrease in neutrophil counts, or neutrophils, although no causation has been confirmed with the use of azithromycin. Caution should be exercised if drugs such as astemizole, triazolam, midazolam and alfentanil are used in parallel, because erythromycin, another macrolide antibiotic, increased their effects.

What side effects can occur?

Like all medicines, Azitrox can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The following side effects may occur: nausea, vomiting, diarrhea, abdominal pain, flatulence, digestive disorders, anorexia, constipation, inflammation of the tongue, pseudomembranous enteritis (manifested by diarrhea), increased liver enzymes or increased bilirubin, rarely liver dysfunction (hepatitis, cholestatic jaundice, hepatic necrosis and hepatic failure, rarely leading to death), pancreatitis (rare), headache and dizziness, drowsiness, insomnia, convulsions, disturbances of taste, smell, hearing, visual disturbances, loss of consciousness, excessive mobility, nervousness, fatigue and weakness (asthenia), tingling and numbness (paresthesia), aggressive behavior, anxiety, anxiety, chest pain, heart palpitations, arrhythmia, risk of QT interval prolongation in ECG and arrhythmiastorsade de pointes, hypotension, very rarely interstitial nephritis, acute renal failure , Arthra lgia, thrombocytopenia, neutropenia (decrease in neutrophil neutrophil count), eosinophilia, superinfection with resistant bacteria and yeast (inflammation of mucous membranes and skin, vaginitis). Possible hypersensitivity reactions (including severe anaphylactic reactions) such as: urticaria, hypersensitivity of the skin to light, angioneurotic edema (possible swelling of the lips, tongue, throat, larynx impeding breathing), hypotension, dyspnoea, increased heart rate (tachycardia), anaphylactic shock as well as severe skin reactions such as erythema multiforme, Stevens and Johnson syndrome, toxic necrotic necrosis. If you experience the first symptoms of any of the above hypersensitivity reactions, please consult your doctor immediately.

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