AZIFEX (Azithromycin) 500 mg, 3 tablets

INDICATIONS FOR USE

AZIFEX IS INDICATED FOR THE TREATMENT OF THE FOLLOWING INFECTIONS CAUSED BY MICROORGANISMS SUSCEPTIVE TO AZITHROMYCIN:

- ACUTE BACTERIAL SINUSITIS (PROPERLY DIAGNOSED);

- ACUTE MIDDLE EAR INFLAMMATORY OF BACTERIAL ETIOLOGY (PROPERLY DIAGNOSED);

- PHARYNGITIS/TONSILLITIS (STREPTOCOCcal INFECTIONS);

- EXAMINATION OF CHRONIC BRONCHITIS (PROPERLY DIAGNOSED);

- Community-acquired pneumonia of mild or moderate severity;

- INFECTIONS OF THE SKIN AND SOFT TISSUES OF MILD OR MODERATE SEVERITY, FOR EXAMPLE, FOLLICULITIS, PHEGMON AND erysipelas;

- ERYTHEMA MIGRANT (LYME DISEASE STAGE FIRST) WHEN FIRST AND SECOND LINE ANTIBIOTICS (DOXYCYCLINE, AMOXYCILLIN AND CEFUROXIM AXETIL) ARE CONTRAINDICATED (USE IN ERYTHEMA MIGRANT).

- UNCOMPLICATED URETHRITIS AND CERVICYTIS CAUSED BY CHLAMYDIA TRACHOMATIS.

PRESCRIBING MUST BE IN ACCORDANCE WITH THE OFFICIAL REGULATIONS FOR THE PROPER USE OF ANTIBACTERIAL MEDICINES.

 

LIST OF INFORMATION REQUIRED BEFORE USE

CONTRAINDICATIONS

- HYPERSENSITIVITY TO AZITHROMYCIN, ERYTHROMYCIN, AS WELL AS TO ANY MACROLIDE OR KETOLIDE ANTIBIOTICS, OR TO ANY OF THE AUXILIARY SUBSTANCES

- FIRST TRIMESTER OF PREGNANCY AND LACTATION

 

REQUIRED PRECAUTIONS FOR USE

AS WITH ERYTHROMYCIN AND OTHER MACROLIDES, RARE SERIOUS ALLERGIC REACTIONS, INCLUDING ANGIONEUROTIC EDEMA, ANAPHYLAXIA, STEVENS-JOHNSON SYNDROME, AND TOXIC EPIDERMAL NECROLYSIS, HAVE BEEN REPORTED. IF AN ALLERGIC REACTION OCCURS, THE APPROPRIATE THERAPY SHOULD BE ADMINISTERED. PHYSICIANS SHOULD KNOW THAT RE-APPEARANCE OF ALLERGIC SYMPTOMS MAY OCCUR WHEN SYMPTOMATIC THERAPY IS CLOSED.

 

INTERACTIONS WITH OTHER DRUGS

ANTACIDS (DRUGS REDUCING GASTRIC ACID). THESE DRUGS SHOULD NOT BE TAKEN SIMULTANEOUSLY. AZITHROMYCIN SHOULD BE TAKEN 1 HOUR BEFORE OR 2 HOURS AFTER ANTACIDS.

CETIRIZINE. IN HEALTHY VOLUNTEERS, THE SIMULTANEOUS USE OF A 5-DAY COURSE OF AZITHROMYCIN AND CETIRIZINE 20 MG DOESN'T BE ACCOMPANIED WITH ANY PHARMACOKINETIC INTERACTIONS AND DID NOT CAUSE SIGNIFICANT CHANGES IN THE QT INTERVAL IN THE EQUILIBRIUM STATE.

Didanosine (dideoxyinosine). THE USE OF AZITHROMYCIN 1200 MG/DAY WITH DIDANOSINE 400 MG/DAY DOES NOT INFLUENCE THE PHARMACOKINETICS OF DIDANOSINE.

DIGOXIN (P-GP SUBSTRATES). AS STATED IN THE LITERATURE, THE CONCOMITANT USE OF MACROLIDE ANTIBIOTICS (INCLUDING AZITHROMYCIN) WITH P-GLYCOPROTEIN SUBSTRATE DRUGS (SUCH AS DIGOXIN) LEADS TO INCREASED P-GLYCOPROTEIN SUBSTRATE CONCENTRATION. THEREFORE, WHEN AZITHROMYCIN AND P-GP SUBSTRATES SUCH AS DIGOXIN ARE USED IN PARALLEL, THE POSSIBILITY OF INCREASING THE SERUM CONCENTRATION OF THE RESPECTIVE SUBSTRATE SHOULD BE CONSIDERED.

DIGOXIN AND COLCHICIN (P-GP SUBSTRATES).

SIMULTANEOUS USE OF MACROLIDE ANTIBIOTICS, INCLUDING AZITHROMYCIN, WITH P-GLYCOPROTEIN SUBSTRATES, SUCH AS DIGOXIN AND COLCHICIN, LEADS TO INCREASED SERUM LEVELS OF P-GLYCOPROTEIN SUBSTRATES. THEREFORE, WHEN AZITHROMYCIN AND P-GLYCOPROTEIN SUBSTRATES, SUCH AS DIGOXIN, ARE COMBINED, BE AWARE OF THE POSSIBILITY OF INCREASING SERUM P-GLYCOPROTEIN SUBSTRATES.

ZIDOVUDINE. AZITHROMYCIN IN SINGLE DOSES OF 1000 MG AND IN MULTIPLE DOSES OF 1200 OR 600 MG DOES NOT PROVIDE A PROGRESSIVE INFLUENCE ON THE PHARMACOKINETICS IN THE BLOOD PLASMA OR ON THE URINARY EXCLUSION OF ZIDOVUDINE OR ITS GLUCURONIDE METABOLITE. HOWEVER, AZITHROMYCIN HAS CAUSED INCREASED PHOSPHORYLATED ZIDOVUDINE (CLINICALLY ACTIVE METABOLITE) CONCENTRATIONS IN PERIPHERAL BLOOD MONONUCLEAR CELLS).

AZITHROMYCIN DOES NOT HAVE SIGNIFICANT INTERACTION WITH THE LIVER CYTOCHROME P450 ENZYME SYSTEM. THIS DRUG IS NOT CONSIDERED THAT IS NOT INVOLVED IN THE PHARMACOKINETIC DRUG INTERACTIONS THAT ARE CHARACTERISTIC FOR ERYTHROMYCIN AND OTHER MACROLIDE ANTIBIOTICS. AZITHROMYCIN DOES NOT INDUCTION OR LIVER CYTOCHROME P450 INACTIVATION MEDIATED BY THE CYTOCHROME-METABOLITE COMPLEX.

ERGO ALKALOIDS. IN VIEW OF THE THEORETICAL POSSIBILITY OF ERGOTISM, THE SIMULTANEOUS USE OF AZITHROMYCIN WITH ERGO ALKALOID DERIVATIVES IS NOT RECOMMENDED.

ASTEMIZOL, ALFENTANIL. INTERACTION DATA WITH ASTEMIZOL OR ALFENTANIL ARE NOT AVAILABLE. CAUTION SHOULD BE OBSERVED WHEN THESE DRUGS ARE CONCOMITANTLY USE WITH AZITHROMYCIN, BECAUSE THESE DRUGS ARE KNOWN TO POTENTIFY THE EFFECT OF THESE DRUGS WHEN THEY ARE CONCOMITANTLY USE WITH THE MACROLIDE ANTIBIOTIC ERYTHROMYCIN.

Atorvastatin. CONCOMITANT USE OF ATORVASTATIN (10 MG/DAY) WITH AZITHROMYCIN (500 MG/DAY) DOES NOT INFLUENCE THE PLASMA CONCENTRATION OF ATORVASTATIN (AS EVALUATED BY HMG-COA REDUCTASE INHIBITION ASSAY). HOWEVER, IT SHOULD BE TAKEN INTO ACCOUNT THAT IN THE POST-REGISTRATION PERIOD, CASES OF RHABDOMYOLISIS HAVE BEEN REPORTED IN PATIENTS WHO RECEIVED AZITHROMYCIN IN COMBINATION WITH STATINS.

CARBAMAZEPINE. NO SIGNIFICANT EFFECTS ON THE PLASMA CONCENTRATION OF CARBAMAZEPINE OR ITS ACTIVE METABOLITE HAVE BEEN OBSERVED IN PATIENTS RECEIVING AZITHROMYCIN IN PARALLEL.

CISAPRID. CISAPRIDE IS METABOLIZED IN THE LIVER BY CYP 3A4. BECAUSE MACROLIDES INHIBITE THIS ENZYME, CONCOMITANT USE OF CISAPRIDE MAY INCREASE THE FREQUENCY OF QT INTERVAL PROLONGATION, VENTRICULAR ARRHYTHMIAS, AND VENTRICULAR TACHICARDIA TURNS.

CIMETIDINE. NO EFFECTS ON THE PHARMACOKINETICS OF AZITHROMYCIN HAVE BEEN OBSERVED WHEN CO-TAMINATED WITH CIMETIDINE.

ORAL ANTICOAGULANTS BY COUMARIN TYPE. AZITHROMYCIN DOES NOT AFFECT THE ANTICOAGULANT EFFECT OF A SINGLE DOSE OF WARFARIN (15 mg) TAKEN IN HEALTHY VOLUNTEERS. IN THE POST-REGISTRATION PERIOD, THERE HAVE BEEN REPORTS OF INCREASED ANTICOAGULANT EFFECT IN THE CONCOMITANT USE OF AZITHROMYCIN WITH ORAL ANTICOAGULANTS OF THE COUMARIN TYPE. ALTHOUGH THE APPROPRIATE CAUSE AND EFFECT RELATIONSHIP HAS NOT BEEN ESTABLISHED, THE NEED TO MONITOR PROTHROMBIN TIME FREQUENTLY WHEN AZITHROMYCIN IS USED IN PATIENTS RECEIVING ORAL CORATYPUNINA SHOULD BE TAKEN INTO ACCOUNT.

cyclosporine. CAUTION SHOULD BE OBSERVED IF THERE IS A POTENTIAL TO INCREASED CYCLOSPORIN CONCENTRATION AND THE CYCLOSPORINE CONCENTRATION INDICATORS SHOULD BE MONITORED AND A PROPER LEGAL CORRECTION BE ESTABLISHED.

EFAVIRENTS. CONCOMITANT USE OF A SINGLE DOSE OF AZITHROMYCIN (600 MG) AND EFAVIRENZ 400 MG DAILY FOR 7 DAYS HAVE NOT BEEN ASSOCIATED WITH ANY CLINICALLY SIGNIFICANT PHARMACOKINETIC INTERACTIONS.

FLUCONAZOL. CONCOMITANT USE OF A SINGLE DOSAGE OF AZITHROMYCIN (1200 MG) HAVE NO EFFECT ON THE PARAMETERS OF THE PHARMACOKINETICS OF A SINGLE DOSE OF FLUCONAZOLE EQUAL TO 800 MG. ON THE BACKGROUND OF THE CONCOMITANT USE OF FLUCONAZOLE, THE INDICATORS OF THE TOTAL EXPOSURE AND HALF-LIFE OF AZITHROMYCIN HAVE NOT CHANGED; HOWEVER, A CLINICALLY SIGNIFICANT REDUCTION IN THE CMAX OF AZITHROMYCIN (BY 18%) WAS OBSERVED.

INDINAVIR. CONCOMITANT USE OF AZITHROMYCIN AT A SINGLE DOSAGE OF 1200 MG DID NOT HAVE A STATISTICALLY SIGNIFICANT EFFECT ON THE PHARMACOKINETICS OF INDINAVIR AT A DOSAGE OF 800 MG THREE TIMES A DAY FOR 5 DAYS.

METHYLPREDNISOLONE. AZITHROMYCIN DOES NOT SIGNIFICANTLY INFLUENCE THE PHARMACOKINETICS OF METHYLPREDNISOONE.

MIDAZOLAM. CONCOMITANT USE OF AZITHROMYCIN 500 mg/day FOR 3 DAYS DID NOT CAUSE CLINICALLY SIGNIFICANT CHANGES IN THE PHARMACOKINETICS AND PHARMACODYNAMICS OF A SINGLE DOSE OF MIDAZOLAM (15 mg) IN HEALTHY VOLUNTEERS.

NELFINAVIR. ON THE BACKGROUND OF THE CONCOMITANT USE OF AZITHROMYCIN (IN A DOSAGE OF 1200 MG) WITH NELFINAVIR IN THE EQUILIBRIUM STATE (750 MG THREE TIMES A DAY), THE CONCENTRATION OF AZITHROMYCIN INCREASED. ANY CLINICALLY SIGNIFICANT ADVERSE EFFECTS WERE NOT OBSERVED; DOSE ADJUSTMENT IS NOT REQUIRED.

RIFABUTIN. PATIENTS RECEIVING CONCOMITANT THERAPY WITH AZITHROMYCIN AND RIFABUTIN HAVE BEEN OBSERVED IN NEUTRPENIA. ALTHOUGH THE USE OF RIFABUTIN HAS BEEN ASSOCIATED WITH NEUTROPENIA, A CAUSAL RELATION BETWEEN THIS EVENT AND THE COMBINATION OF RIFABUTIN WITH AZITHROMYCIN HAS NOT BEEN ESTABLISHED.

SILDENAFIL. IN HEALTHY MALE VOLUNTEERS, THERE IS NO DATA ON THE EFFECT OF AZITHROMYCIN (AT 500 mg DAILY FOR 3 DAYS) ON THE AUC AND CMAX OF SILDENAFIL OR ITS MAIN CIRCULATION METABOLITE.

TERFENADINE. RARE CASES WHERE THE POSSIBILITY OF INTERACTION BETWEEN AZITHROMYCIN AND TERFENADINE CANNOT BE COMPLETELY EXCLUDED WERE REPORTED.

THEOPHYLLIN. SINCE THEOPHYLLINE INTERACTIONS HAVE BEEN REPORTED WITH OTHER MACROLIDE DRUGS, IT IS RECOMMENDED TO CAREFULLY MONITOR FOR POSSIBLE SIGNS INDICATING INCREASED THEOPHYLLINE CONCENTRATION.

TRIAZOLAM. CONCOMITANT USE OF AZITHROMYCIN (AT 500 MG ON DAY 1 AND 250 MG ON DAY 2) WITH TRIAZOLAM (AT 0.125 MG ON DAY 2) DID NOT SIGNIFICANTLY AFFECT ANY OF THE PHARMACOKINETICS OF TRIAZOLAM.

TRIMETHOPRIM/SULFAMETOXAZOLE. The concomitant use of trimethopril / sulfamethoxazole DS (at a dose of 160 mg / 800 mg for 7 days) with azithromycin (at a dose of 1200 mg per day 7) did not have a significant effect on the maximum concentration indicators, total exposure and isolation with urine as trimethopris and SULFAMETHOXAZOLE.

SPECIAL WARNINGS

ALLERGIC REACTIONS

AS IN THE CASE OF ERYTHROMYCIN AND OTHER MACROLIDES, SERIOUS ALLERGIC REACTIONS, INCLUDING ANGIONEUROTIC EDEMA AND ANAPHILAXIA (RARLY LEADING TO FATHES), HAVE BEEN REPORTED. SOME OF THESE REACTIONS TO AZITHROMYCIN HAVE BEEN ACCOMPANIED WITH REPEATED SYMPTOMS THAT REQUIRED LONG-TERM OBSERVATION AND TREATMENT.

LIVER FUNCTION DISTURBANCES

BECAUSE THE LIVER IS THE PRIMARY LIVER OF AZITHROMYCIN, AZITHROMYCIN SHOULD BE USED WITH CAUTION IN PATIENTS WITH SEVERE LIVER DISEASE. CASES OF FULMINANT (FULMINANT) HEPATITIS, POTENTIALLY LEADING TO THE APPEARANCE OF LIVER FAILURE, WHICH PRESENTS A THREAT TO LIFE, HAVE BEEN OBSERVED WITH THE BACKGROUND OF THE USE OF AZITHROMYCIN. SOME PATIENTS MAYBE HAVE PREVIOUS LIVER DISEASES OR HAVE BEEN TAKING OTHER HEPATOTOXIC MEDICINES. IN THE EVENT OF SIGNS OR SYMPTOMS OF LIVER FUNCTION SUCH AS RAPIDLY INCREASING ASTHENIA WITH JAUNDICE, DARK URINE, BLEEDING LIKELY, OR HEPATIC ENCEPHALOPATHY, FUNCTIONS SHOULD BE CARRIED OUT IMMEDIATELY IF LIVER DISTURBANCES APPEAR, AZITHROMYCIN TREATMENT SHOULD BE IMMEDIATELY STOP.

KIDNEY FUNCTION DISTURBANCES

DOSE ADJUSTMENT IS NOT REQUIRED IN PATIENTS WITH MILD TO MODERATE RENAL FUNCTION (GFR 10–80 ml/min). IN PATIENTS WITH SEVERE KIDNEY IMPAIRMENT (GFR <10 ml/min), AZITHROMYCIN SYSTEMIC EXPOSURE IS INCREASED BY 33%.

INTERACTION BETWEEN AZITHROMYCIN AND ERGO ALKALOID DERIVATIVES

IN SOME PATIENTS WHO RECEIVED ERGO ALKALOID DERIVATIVES, CONCOMITANT USE WITH SOME MACROLIDE ANTIBIOTICS PROVIDED ERGOTISM (ERGO POISONING). THERE ARE NO DATA REGARDING THE POSSIBLE INTERACTION BETWEEN ERROGEN ALKALOIDS AND AZITHROMYCIN. HOWEVER, TAKING INTO ACCOUNT THE THEORETICAL POSSIBILITY OF ERGOTISM, COMBINATION OF AZITHROMYCIN AND ERGO ALKALOID MEDICATIONS SHOULD BE AVOIDED.

SUPERINFECTIONS

AS WITH ANY OTHER ANTIBIOTIC DRUG, SUPERINFECTION IS STRONGLY RECOMMENDED TO BE SUPERINFECTED BY ANTI-SUSTAINABLE MICROORGANISMS, INCLUDING FUNGAL INFECTIONS.

DIARRHEA CAUSED BY CLOSTRIDIUM DIFFICILE

WHEN USING ALMOST ALL ANTIBACTERIAL DRUGS, INCLUDING AZITHROMYCIN, DIARRHEA CAUSED BY CLOSTRIDIUM DIFFICILE (CLOSTRIDIUM DIFFICILE ASSOCIATED DIARRHOEA, CDAD); THE SEVERITY OF THIS COMPLICATION VARIES FROM MILD DIARRHEA TO FATAL COLITIS. ANTIBACTERIAL TREATMENT ALTERS THE NORMAL COLON MICROFLORA LEADING TO AN EXCESSIVE C. DIFFICILE POPULATION. C. DIFFICILE MICROORGANISMS PRODUCE TOXINS A AND B WHICH PROMOTE CDAD. HYPERTOXIN-PRODUCING C. DIFFICILE STRAINS INCREASED MORBIDITY AND DEATH RATES BECAUSE THESE INFECTIONS MAY BE RESISTANT TO ANTIBACTERIAL THERAPY; IN SOME CASES, A COLECTOMY (REMOVAL OF THE COLON) MAY BE NEEDED. THE POSSIBILITY OF CDAD SHOULD BE CONSIDERED IN ANY CASES OF DIARRHEA IN PATIENTS FOLLOWING ANTIBIOTICS. A CAREFUL MEDICAL HISTORY SHOULD BE CARRIED OUT AS CDAD, ACCORDING TO THE LITERATURE, CAN OCCUR MORE THAN 2 MONTHS AFTER THE END OF ANTIBACTERIAL THERAPY. IN SUCH CASES, CONSIDERATION OF AZITHROMYCIN THERAPY AND USE OF SPECIFIC TREATMENT FOR C. DIFFICILE SHOULD BE CONSIDERED. IF THE USE OF AZITHROMYCIN PROVOKED PSEDOMEMBRANOUS colitis, THE USE OF DRUGS THAT SUPPRESS THE INTESTINAL PERISTALTIS IS CONTRAINDICATED!

PROLONGATION OF THE QT INTERVAL

ON THE BACKGROUND OF THERAPY WITH OTHER MACROLIDE DRUGS, INCLUDING AZITHROMYCIN, AN INCREASE IN THE DURATION OF HEART REPOLARIZATION AND THE QT INTERVAL WAS OBSERVED, THAT CAUSES THE RISK OF HEART ARRHYTHMIA AND PIRUETTE VENTRICULAR TACHYCARDIA.

Since the disorders below can determine the increased risk of ventricular arrhythmias (including pyruetete ventricular tachycardia, Torsade de Pointes), which can lead to a heart stop, should be used with caution to use azithromycin in patients with predisposition to heart arrhythmias (especially in women and women and IN ELDERLY PERSONS), IN PARTICULAR IN PATIENTS WITH THE FOLLOWING DISORDERS:

- CONGENITAL OR DIAGNOSED QT INTERVAL PROLONGATION;

- CURRENTLY USE OF MEDICATIONS WITH OTHER ACTIVE SUBSTANCES KNOWN TO PROLONG THE QT INTERVAL, SUCH AS CLASS IA (QUINIDINE AND PROCAINAMIDE) AND CLASS III (DOFETILIDE, AMIODARONE AND SOTALOLOL) ANTI-Arrhythmic Drugs NEUROLEPTICS SUCH AS PHENOTHIAZIDES AND PIMOSIDE; ANTIDEPRESSANTS SUCH AS CITALOPRAM AS WELL AS FLUOROQUINOLONS SUCH AS MOXIFLOXACIN AND LEVOFLOXACIN;

- ELECTROLYTE BALANCE DISORDERS, PARTICULARLY - HYPOKALEMIA AND HYPOMAGNEMIA;

- CLINICALLY SIGNIFICANT BRADYCARDIA, CARDIAC ARRYTHMIA OR SEVERE HEART FAILURE.

SEVERE PSEUDOPARALITIC MYASTHENIA

IN PATIENTS WHO RECEIVED AZITHROMYCIN, THERE WERE REPORTING CASES OF EXAMINATION OF THE SYMPTOMS OF SEVERE PSEUDOPARLYTIC MYASTENIA (MYASTHENIA GRAVIS) AND FOR THE FIRST TIME DETECTED MYASTENIC SYNDROME.

streptococcal infection

THE DRUG OF FIRST CHOICE FOR THE TREATMENT OF STREPTOCOCCUS PYOGENES PHARYNGITIS/TONSILLITIS AND FOR THE PREVENTION OF RHEUMATIC ATTACKS IS USUALLY PENICILLIN. AZITHROMYCIN IS GENERALLY EFFECTIVE AGAINST STREPTOCOCCIS OF THE OROPHARYNGEAT. HOWEVER, THERE IS NO DATA THAT WOULD CONFIRM THE EFFECTIVENESS OF AZITHROMYCIN AS A MEANS FOR THE PREVENTION OF RHEUMATIC ATTACKS.

PROLONGED USE

THERE ARE NO DATA ON THE SAFETY AND EFFECTIVENESS OF THE PROLONGED USE OF AZITHROMYCIN FOR THE ABOVE INDICATIONS. FOR RAPIDLY DEVELOPING RECURRENT INFECTIONS, ANOTHER ANTIBIOTIC TREATMENT SHOULD BE CONSIDERED.

SKIN REACTIONS

SERIOUS, LIFE-THREATING SKIN REACTIONS, SUCH AS STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLISIS, HAVE BEEN REPORTED. PATIENTS SHOULD BE WARNED TO BE OBSERVED FOR SKIN REACTIONS, AS WELL AS SIGNS AND SYMPTOMS THAT USUALLY OCCUR IN THE FIRST WEEKS OF TREATMENT. IN THE EVENT OF SYMPTOMS CORRECTING TO A SKIN REACTION (FOR PROGRESSIVE RASH, FREQUENTLY ACCOMPANIED WITH BLISTERS OR OTHER MUCOSALE LESIONS), THE USE OF AZITHROMYCIN SHOULD BE IMMEDIATELY DISCONTINUED. RESUME TREATMENT WITH THIS DRUG IN SUCH CASES IS NOT RECOMMENDED.

AZITHROMYCIN IS NOT SUITABLE FOR THE TREATMENT OF SEVERE INFECTIONS WHEN A HIGH BLOOD ANTIBIOTIC CONCENTRATION IS REQUIRED FOR A SHORT TIME.

IN BACTERIAL PHARYNGITIS, AZITHROMYCIN IS RECOMMENDED ONLY WHEN FIRST-LINE THERAPY (BETA-LACTAM ANTIBIOTICS) IS NOT POSSIBLE.

SKIN AND SOFT TISSUES INFECTIONS

THE MAJOR CAUSE OF SOFT TISSUE INFECTIONS (STAPHYLOCOCCUS AUREUS) IS OFTEN RESISTANT TO AZITHROMYCIN. THEREFORE, ANTIBIOTIC SENSITIVITY STUDY IS A MANDATORY PRECONDITION FOR THE USE OF AZITHROMYCIN FOR THE TREATMENT OF SOFT TISSUE INFECTIONS.

INFECTED BURN WOUNDS

THE USE OF AZITHROMYCIN FOR THE TREATMENT OF INFECTED BURN WOUNDS IS NOT SHOWN.

SEXUALLY TRANSMITTED DISEASES

FOR SEXUALLY TRANSMITTED DISEASES, THE PRESENCE OF T. PALLIDIUM CONCOMITANT INFECTION MUST BE EXCLUDED.

DISEASES OF THE NERVOUS SYSTEM OR MENTAL DISORDERS

CAUTION SHOULD BE OBSERVED WHEN USE OF AZITHROMYCIN IN PATIENTS WITH DISEASES OF THE NERVOUS SYSTEM OR MENTAL DISORDERS.

erythema migrans

CAREFULLY CLINICAL MONITORING OF PATIENTS WITH ERYTHEMA MIGRANT SHOULD BE CAREFULLY BECAUSE TREATMENT WITH AZITHROMYCIN MAY NOT BE EFFECTIVE IN THEM.

ASPARTAM

THIS MEDICINE CONTAINS ASPARTAME. ASPARTAM CONTAINS A SOURCE OF PHENYLALANINE. THE MEDICINE MAY CAUSE HARM IN PERSONS WITH Phenylketonuria.

PREGNANCY

THE USE OF AZIFEX IN THE SECOND AND THIRD TRIMESTERS OF PREGNANCY IS ALLOWED ONLY IF THE EXPECTED BENEFITS OUTWARE THE ASSOCIATED RISK TO THE FETUS.

FEATURES OF THE DRUG INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE OR POTENTIALLY DANGEROUS MECHANISMS

THERE IS NO REASON TO ASSUME THAT AZITHROMYCIN CAN HAVE ANY EFFECT ON A PERSON'S ABILITY TO DRIVE VEHICLES AND OPERATE MECHANISMS

RECOMMENDATIONS FOR USE

DOSING MODE

AZIFEX TABLETS ARE TAKEN ONCE A DAY 1 HOUR BEFORE MEAL OR THROUGH

2 HOURS AFTER MEAL.

CHILDREN AND ADOLESCENTS OVER 45 KG AND ADULTS, INCLUDING THE ELDERLY.

AZIFEX TAKE 500 MG FOR 3 DAYS (500 MG ONCE A DAY)

OR FOR 5 DAYS (500 mg ONCE ON THE FIRST DAY AND THEN 250 mg ONCE A DAY ON THE SUBSEQUENT DAYS).

IN INFECTIONS OF THE UPPER AND LOWER RESPIRATORY TRACTS, INFECTIONS

SKIN AND SOFT TISSUES ARE ASSIGNED AT 500 MG / DAY FOR 3 DAYS

(COURSE DOSE - 1.5 G).

IN UNCOMPLICATED URETHRITIIS AND/OR CERVICITIS ASSIGNED ONCE 1 G

(2 TABLETS OF 500 MG).

IN LYME DISEASE (BORELLIOSIS) FOR THE TREATMENT OF THE INITIAL STAGE (ERYTHEMA

MIGRANS) ASSIGN 1 G (2 TABLETS OF 500 MG) ON THE FIRST DAY AND 500 MG

DAILY FROM THE 2nd TO THE 5TH DAY (COURSE DOSE - 3 G).

FOR DISEASES OF THE STOMACH AND DUODENUM,

ASSOCIATED WITH HELICOBACTER PYLORI, ASIFEX IS PRESCRIBED 1 G (2

500 MG TABLETS) PER DAY FOR 3 DAYS AS PART OF COMBINED

THERAPIES.

ELDERLY PERSONS AND PATIENTS WITH IMPAIRED KIDNEY FUNCTION DO NOT

NEED TO CHANGE THE DOSAGE.

IN PATIENTS WITH MILD AND MODERATE RENAL INSUFFICIENCY, MILD AND

MODERATE HEPATIC INSUFFICIENCY DOSE ADJUSTMENT IS NOT REQUIRED.

BECAUSE AZITHROMYCIN IS METABOLIZED IN THE LIVER AND IS EXCLUDED WITH THE BIL, THIS DRUG SHOULD NOT BE USED IN PATIENTS WITH SEVERE HEPATIC INSUFFICIENCY (There is NO EXPERIENCE WITH AZITHROMYCIN IN SUCH PATIENTS).

MEASURES TO BE TAKEN IN THE EVENT OF OVERDOSE

ADVERSE REACTIONS NOTICED AT HIGH DOSES OF THE DRUG WERE SIMILAR TO REACTIONS FROM RECEIVING REGULAR DOSES.

TREATMENT: IN THE EVENT OF OVERDOSE, TAKE ACTIVATED CHARCOAL AND CARRY OUT SYMPTOMATIC THERAPY TO SUPPORT THE LIFE FUNCTIONS OF THE BODY.

RECOMMENDATIONS FOR SEEKING THE CONSULTATION OF A HEALTHCARE PROFESSIONAL TO EXPLAIN HOW TO USE THE MEDICINE

ALWAYS USE THIS DRUG EXACTLY AS YOUR PHYSICIAN RECOMMENDED. IF IN ANY DOUBT, CONSULT YOUR PHYSICIAN.

DESCRIPTION OF ADVERSE REACTIONS THAT MANIFEST IN THE STANDARD USE OF THE MEDICATION AND MEASURES THAT SHOULD BE TAKEN IN THIS CASE (IF NEEDED)

ADVERSE REACTIONS ARE CLASSIFIED BY FREQUENCY:

VERY OFTEN (≥1/10), OFTEN (≥1/100 TO <1/10), UNCOMMON (≥1/1000 TO <1/100), RARE (≥1/10,000 TO <1/1000), VERY RARE (<1/10,000), UNKNOWN (CAN'T BE DETERMINED FROM THE AVAILABLE DATA).

OFTEN

- DIARRHEA, ABDOMINAL PAIN, NAUSEUS, FLAT

OFTEN

- Dizziness, headache, taste perversion, paresthesia

- VISION IMPAIRMENT

- VOMITING, DYSPEPSIA, ANOREXIA

- ITCH, RASH

- ARTRALGIA, FATIGUE

- DECREASE IN THE NUMBER OF LYMPHOCYTES, INCREASE IN THE NUMBER OF EOSINOPHILES, DECREASE IN THE CONTENT OF BICARBONATE IN THE BLOOD SERUM

INFREQUENTLY

- CANDIDIOSIS (INCLUDING ORAL), VAGINAL INFECTIONS

- Leukopenia, Neutropenia, Eosinophilia

- ANGIONEVROTISM, HYPERSENSITIVITY

- NERVOUSNESS

- HYPESTHESIA, INSOMNIA, Drowsiness

- HEARING IMPAIRMENT, UP TO DEAFNESS, TINNING

- HEART BEAT

- CONSTIPATION, GASTRITIS, GASTROENTERITIS, SALIVARY GLANDS HYPERSECREMENT

- HEPATITIS

- PHOTOSENSITIVITY REACTION, urticaria, STEVENS-JOHNSON SYNDROME

- Edema, asthenia, malaise, chest pain

- INCREASED LEVEL OF ASPARTAMINOTRANSFERASE, ALANINE AMinoTRANSFERASE, INCREASED BILIRUBIN, UREA AND CREATININE IN THE BLOOD, ABNORMAL LEVEL OF POTASSIUM IN THE BLOOD

- OSTEOARTHRITIS, MYALGIA, BACK PAIN, NECK PAIN

- DYSURIA, PAIN IN THE AREA OF THE KIDNEY

- METRORRHAGIA, TESTICULAR IMPAIRMENT

RARELY

- AGITATION

- VERTIGO

- ABNORMAL LIVER FUNCTION

RARELY

- DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS SYNDROME)

UNKNOWN

- PSEUDOMEMBRANOUS COLITIS

- THROMBOCYTOPENIA, HEMOLYTIC ANEMIA

- ANAPHILACTIC REACTION

- AGGRESSION, ANXIETY

- Fainting, convulsions, psychomotor hyperactivity, anosmia, ageusia, parasomnia, myasthenia

- BIDIRECTIONAL (PIRUETTE) TACHYCARDIA, ARRYTHMIA, INCLUDING VENTRICULAR TACHYCARDIA, PROLONGATION OF THE QT INTERVAL ON THE ELECTROCARDIOGRAM

- ARTERIAL HYPOTENSION

- PANCREATITIS, tongue discoloration

- LIVER FAILURE (IN RARE CASES WITH A FATAL OUTCOME), FURNISHING HEPATITIS, LIVER NECROSIS, CHOLESTATIC JAUNDICE

- TOXIC EPIDERMAL NECROLYSIS, ERYTHEMA MULTIFFORM

- ACUTE RENAL FAILURE, INTERSTITIAL NEPHRITIS

ONE TABLET CONTAINS THE ACTIVE SUBSTANCE: AZITHROMYCIN DIHYDRATE 269.88 MG OR 539.75 MG

(EQUIVALENT TO AZITHROMYCIN 250 MG OR 500 MG),

EXCIPIENTS:

CALCIUM HYDROPHOSPHATE ANHYDROUS, SODIUM CARBOXYMETHYLCELLULOSE 150,

MICROCRYSTALLINE CELLULOSE (PH 102), SODIUM LAURYL SULPHATE, MAGNESIUM STEARATE
COMPOSITION OF THE SHELL OPADRAY OY-D-7233 WHITE:
HYDROXYMETHYLPROPYLCELLULOSE 2910 5CP, TITANIUM DIOXIDE (E171), TALC, POLYETHYLENE GLYCOL 400, SODIUM LAURYL SULPHATE