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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 Azigen?
An antibacterial drug for general use. Macrolide antibiotic used to treat bacterial infections.
What does Azigen 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 Azigen?
The preparation is indicated for the treatment of the following infections caused by azithromycin-sensitive organisms:
· Lower respiratory tract infections: chronic bronchitis, community-acquired pneumonia with a mild to moderate severity
Upper respiratory tract infection: tonsillitis, pharyngitis, sinuses
· Acute otitis media
Infection of the skin and soft tissues of mild or moderate intensity, e.g. inflammation of the hair follicles, cellulitis, rose
· Uncomplicated urethritis and cervicitis caused by chlamydia.
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. The product contains soybean oil, you can not use it if you are allergic to peanut or soya.
When should you exercise extreme caution when using Azigen?
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 preparation is not intended for the treatment of serious infections when it is necessary to achieve high antibiotic concentrations in a short time or to treat burns.
Azithromycin is not the first-line treatment for acute otitis media.
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
) and in the prevention of rheumatic fever. 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.
Additional information about the other ingredients of the preparation:
a granule preparation for oral suspension contains sucrose; people with inherited disorders associated with fructose intolerance, Glucose
-galactose malabsorption or sucrase-isomaltase deficiency should not use the preparation.
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 Azigen
The preparation is in the form of 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.
Adults and children with a body weight greater than 45 kg:
usually 500 mg is administered once daily for 3 days or on the first day a single dose of 500 mg, followed by 250 mg once daily for 4 days; in the treatment of sexually transmitted diseases (uncomplicated urethritis and cervical chlamydia): 1 g.
The preparation is intended for use only in adults and adolescents after 16 years of age.
Elderly patients do not need to adjust their dosage.
In the case of mild to moderate renal dysfunction, there is no need to change the dosage. There are no data on the use of this preparation in people with severe renal impairment and care should be taken in such cases.
In the case of mild to moderate hepatic impairment, no dosage adjustment is necessary. Do not use the preparation in patients with severe hepatic impairment.
Method of administration:
The preparation is intended for oral use. The tablets can be taken with or without food, swallowed whole. Take once a day.
Can Azigen be used 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.
Use during pregnancy is only allowed if the doctor considers it absolutely necessary, only in life-threatening situations.
Azithromycin is excreted in breast milk. Breastfeeding should be discontinued during the use of the preparation and additionally 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
· Ergotamine derivatives (derivatives of ergot)
· Anticoagulants (derivatives of coumarin, eg Warfarin
· Didanosine or rifabutin
· Astemizole, triazolam, midazolam and alfentanil.
Do not co-administer drugs that prolong the QT interval in ECG recording, including class IA antiarrhythmics (eg disopyramide) and class III (eg amiodarone), terfenadine and cisapride, in addition to azithromycin. There may be: QT prolongation, ventricular arrhythmias and dangerous type disorderstorsades 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. 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. Caution should be exercised when using drugs metabolised with the use of cytochrome P450 3A4 isoenzyme (eg quinidine, astemizole, pimozide, cisapride), because it can not be ruled out that azithromycin inhibits the activity of this enzyme. 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, accompanied by symptoms of increased plasma concentration; theophylline concentration in the blood may be indicated.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. Azithromycin may increase the concentration of zidovudine in some peripheral blood cells. 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, Azigen can also cause side effects, although it 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, bloating, digestive disorders, anorexia, constipation, tongue discoloration, 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, disturbances of balance, drowsiness, insomnia, convulsions, disturbances of taste, smell, hearing (hearing impairment, deafness , tinnitus), blurred vision, loss of consciousness, excessive mobility, nervousness, tiredness and weakness (asthenia), tingling and numbness (paresthesia), aggressive behavior, anxiety, anxiety, depersonalization, delirium (in the elderly), pain in the chest, palpitation s erca, cardiac arrhythmias, the risk of QT interval prolongation in ECG and rhythm type disorderstorsade de pointes
, hypotension, rarely interstitial nephritis, acute renal failure
lgia, thrombocytopenia, neutropenia (decrease in neutrophil count or neutrophils), haemolytic anemia, superinfection with resistant bacteria and yeast (inflammation of the mucous membranes and skin, vaginitis). Possible hypersensitivity reactions (including severe anaphylactic reactions) such as rash, pruritus, urticaria, hypersensitivity of the skin to light, angioneurotic edema
(possible swelling of the mouth, tongue, throat, larynx impeding breathing), hypotension, dyspnoea, increased heart rate (tachycardia), anaphylactic shock, and severe skin reactions such as erythema multiforme, Stevens and Johnson syndrome, melanotic toxic necrosis. If you experience the first symptoms of any of the above hypersensitivity reactions, please consult your doctor immediately.
Other preparations on the Polish market containing azithromycin
Azibiot (coated tablets)
Azimycin (coated tablets)
Azithromycin Genoptim (coated tablets)
Azithromycin Krka (coated tablets)
Azitrin (coated tablets)
AzitroLEK (coated tablets)
AzitroLEK (powder for oral suspension)
AzitroLEK 250 (coated tablets)
AzitroLEK 500 (coated tablets)
Azitrox 500 (coated tablets)
Azitrox Z (powder for oral suspension)
Azix (coated tablets)
Azycine (coated tablets)
Azycine (granules for oral suspension)
Azytact (coated tablets)
Azyter (eye drops, solution)
Bactrazole (coated tablets)
Canbiox (coated tablets)
Macromax (coated tablets)
Macromax (orodispersible tablets)
Nobaxin (coated tablets)
Sumamed (coated tablets)
Sumamed (powder for oral suspension)
Sumamed (powder for solution for infusion)
Sumamed (tablet for oral preparation)
Sumamed forte (powder for oral suspension)
Zetamax (prolonged-release granules for oral suspension)