Instructions for use Moxin film-coated tablets 400 mg blister No. 5
Composition
active ingredient: moxifloxacin;
1 tablet contains 436.8 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin;
excipients: corn starch, microcrystalline cellulose, talc, colloidal anhydrous silicon dioxide, magnesium stearate, sodium starch glycolate (type A), "Opaglass", "Opadry Pink".
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, pink, biconvex, oblong (caplet-like) with a score on one side.
Pharmacotherapeutic group
Antimicrobial agents for systemic use. Antibacterial agents of the quinolone group.
PBX code J01M A14.
Pharmacological properties
Pharmacodynamics.
Mechanism of action
Moxifloxacin is an 8-methoxyfluoroquinolone with a broad spectrum of bactericidal activity. In vitro, moxifloxacin is effective against many gram-positive and gram-negative microorganisms, anaerobes, acid-fast bacteria, bacteria resistant to β-lactam and macrolide drugs, as well as atypical bacteria (e.g., Mycoplasma spp., Chlamidia spp., Legionella spp.).
The bactericidal action is based on the interaction with topoisomerases II and III, which are important enzymes that control DNA topology and promote its replication, repair, and transcription.
Resistance
Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not affect the antibacterial efficacy of moxifloxacin. No cross-resistance between moxifloxacin and these antibiotics has been observed. Plasmid-mediated resistance has not been observed to date.
Cross-resistance has been observed among quinolones. However, some gram-positive and anaerobic microorganisms resistant to other quinolones are susceptible to moxifloxacin.
In vitro studies have shown that resistance to moxifloxacin develops slowly due to multiple mutations.
Impact on intestinal flora in humans
After oral administration of moxifloxacin, the following changes in the intestinal flora were observed. The number of E. coli, Bacillus spp., Bacteroides vulgatus, Enterococci and Klebsiella spp. decreased, as did the anaerobes Bifidobacterium, Eubacterium and Peptostreptococcus. Their numbers returned to normal within two weeks. Clostridium difficile toxin was not detected.
In vitro susceptibility data
Moxifloxacin is active against most strains of the following microorganisms:
Gram-positive bacteria
Streptococcus pneumoniae (including strains with multiple antibiotic resistance, including strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (with minimum inhibitory activity > 2 mg/ml), second-generation cephalosporins (cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole);
Streptococcus pyogenes (group A)*, Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae*, Streptococcus dysgalactiae, Streptococcus anginosus*, Streptococcus constellatus*, Staphylococcus aureus (including methicillin-susceptible strains)*, Staphylococcus aureus (methicillin/ofloxacin-resistant strains) (intermediate susceptibility)**, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-susceptible strains); Staphylococcus epidermidis (methicillin/ofloxacin-resistant strains) (intermediate susceptibility)**, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus
simulans, Corynebacterium diphtheria, Enterococcus faecalis (only strains susceptible to vancomycin and gentamicin). *
Gram-negative bacteria
Gardnerella vaginalis, Haemophilus influenzae (including ß-lactamase-negative and positive strains)*, Haemophilus parainfluenzae*, Moraxella catarrhalis (including ß-lactamase-negative and positive strains)*, Bordetella pertussis, Escherichia coli*, Klebsiella pneumoniae*, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae*, Enterobacter intermedius, Enterobacter sakazaki, Pseudomonas aeruginosa (moderate sensitivity), Pseudomonas fluorescens (moderate sensitivity), Burkholderia cepacia (moderate sensitivity), Stenotrophomonas maltophilia (moderate sensitivity), Proteus mirabilis* (moderate sensitivity), Proteus vulgaris, Morganella morganii, Neisseria gonorrhoeae (moderate sensitivity), Providencia rettgeri, Providencia stuartii.
Anaerobes
Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis*, Bacteroides ovatus, Bacteroides thetaiotaomicron*, Bacteroides uniformis, Fusobacterium spp., Peptostreptococcus spp*, Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Propionibacterium spp., Clostridium perfringens,* Clostridium ramosum.
Atypical
Chlamydia pneumoniae*, Chlamydia trachomatis*, Mycoplasma pneumoniae*, Mycoplasma hominis, Mycoplasma genitalum, Legionella pneumophila*, Sohiella burnettii.
* /** Clinical efficacy confirmed for strains within approved indications.
Toxic effect on reproductive function.
The toxic effect on reproductive function in humans has not been studied.
When studying the effect of moxifloxacin on the reproductive function of animals, it was proven that the drug penetrates the placenta, cases of decreased fetal weight, increased incidence of miscarriages, and a slight increase in the duration of the pregnancy period were recorded.
Pharmacokinetics.
Absorption and bioavailability
In the dose range of 50-1200 mg in a single dose and in doses of 600 mg per day for 10 days, the pharmacokinetics are linear. Steady state is reached within three days. After taking an oral dose of 400 mg, the maximum concentration in the blood is reached within 0.5-4 hours and is 3.1 mg/l. The maximum and minimum plasma concentrations at steady state (400 mg once daily) are 3.2 and 0.6 mg/l, respectively.
When moxifloxacin is taken with food, there is a slight increase in the time to reach maximum concentration (by 2 hours) and a slight decrease in maximum concentration (by approximately 16%), while the duration of absorption does not change. Since these data are not clinically significant, moxifloxacin can be taken regardless of food intake.
Distribution
Moxifloxacin is rapidly distributed in tissues and organs. The exposure of the drug, determined by AUC (AUCnorm = 6 kg/h/l), is high with a volume of distribution at steady state of 2 l/kg. In saliva, higher maximum concentrations can be achieved than in blood plasma. As established in in vitro and ex vivo experiments, in the range from 0.02 to 2 mg/l, binding to blood proteins (mainly albumin) is approximately 45% and is independent of drug concentration. Given this small value, a high maximum concentration of free substance (> 10 x MIC) is observed.
Moxifloxacin reaches high concentrations in tissues, such as the lungs (epithelial fluid, alveolar macrophages), sinuses (maxillary and ethmoid sinuses), nasal polyps and in inflammatory foci, where total concentrations exceed those achieved in plasma. In interstitial fluid (saliva, intramuscular, subcutaneous), the drug is determined in a free, non-protein-bound form, in high concentrations. In addition, high concentrations of the drug are determined in abdominal tissues and fluids and the reproductive system in women.
The maximum concentration and the ratio of concentration at the injection site to plasma concentration for different target tissues give comparable results for both routes of administration of the drug after a single dose of 400 mg moxifloxacin.
Metabolism
Moxifloxacin undergoes phase II biotransformation and is excreted from the body by the kidneys and with feces/bile both in an unchanged form and in the form of inactive sulfo compounds (M1) and glucuronides (M2). During in vitro studies and Phase I clinical trials, no metabolic pharmacokinetic interactions with other drugs involved in phase I biotransformation involving cytochrome P450 enzymes were observed.
Regardless of the route of administration, the metabolites M1 and M2 are found in plasma at concentrations lower than the parent compound. Preclinical studies have included both metabolites equally, thus excluding potential effects on safety and tolerability.
Excretion from the body
The elimination half-life of the drug is approximately 12 hours. The mean total clearance after administration of 400 mg is from 179 to 246 ml/min. Renal clearance is approximately 24-53 ml/min and indicates partial tubular reabsorption of the drug from the kidneys. Concomitant administration of ranitidine and probenecid does not change the renal clearance of the drug.
Pharmacokinetics in different patient groups.
Renal impairment: No significant changes in the pharmacokinetics of moxifloxacin were observed in patients with renal impairment (including those with creatinine clearance < 30 ml/min/1.73 m2) and in those on continuous hemodialysis and long-term ambulatory peritoneal dialysis.
Hepatic impairment: In patients with mild, moderate and severe hepatic impairment, there were no clinically significant differences in moxifloxacin plasma concentrations compared to healthy volunteers or patients with normal hepatic function, respectively.
Elderly patients: Age does not affect the pharmacokinetic parameters of moxifloxacin.
Indication
Treatment of the following bacterial infections caused by susceptible microorganisms (see sections "Special instructions", "Adverse reactions", "Pharmacological properties") in adult patients. Moxifloxacin should be prescribed only when the use of antibacterial agents that are usually recommended for the initial treatment of the following infections is inappropriate or when the indicated treatment has been ineffective.
Acute bacterial sinusitis (diagnosed with a high degree of probability).
Exacerbation of chronic bronchitis (diagnosed with a high degree of probability).
Mild to moderate pelvic inflammatory disease (including upper genital tract infections in women, including salpingitis and endometritis), not associated with tubo-ovarian abscess or pelvic abscesses. The tablet form of the drug Moxin is not recommended for use as monotherapy for mild to moderate pelvic inflammatory disease, but it can be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) due to the increasing resistance of Neisseria gonorrhoeae to moxifloxacin (with the exception of moxifloxacin-resistant strains of N. gonorrhoeae) (see sections "Special instructions", "Pharmacological properties").
The tablet form of the drug is not recommended for initial treatment of any infections of the skin and subcutaneous structures or in case of severe community-acquired pneumonia.
Attention should be paid to official instructions on the proper use of antibacterial agents.
Contraindication
Known hypersensitivity to moxifloxacin or to other quinolones or to any of the excipients of the drug.
Age up to 18 years.
Pregnancy or breastfeeding.
Patients with a history of tendon diseases associated with quinolone treatment.
In preclinical and clinical studies, changes in cardiac electrophysiology in the form of QT prolongation were observed after the use of moxifloxacin. Therefore, for safety reasons, the drug is contraindicated in patients with:
congenital or diagnosed acquired QT prolongation;
electrolyte imbalance, particularly uncorrected hypokalemia;
clinically significant bradycardia;
clinically significant heart failure with reduced left ventricular ejection fraction;
history of symptomatic arrhythmias.
The drug should not be used concomitantly with other drugs that prolong the QT interval (see section "Interaction with other medicinal products and other types of interactions").
Due to limited clinical data, the use of the drug is also contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with elevated transaminase levels (5 times the upper limit of normal).
Interaction with other medicinal products and other types of interactions
An additive effect of moxifloxacin and other medicinal products that can prolong the QT interval cannot be excluded. This interaction may lead to an increased risk of ventricular arrhythmias, including torsade de pointes. For this reason, the use of moxifloxacin in combination with any of the following medicinal products is contraindicated (see also section "Contraindications"):
Class IA antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide);
class III antiarrhythmic drugs (e.g. amiodarone, sotalol, dofetilide, ibutilide);
antipsychotic drugs (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride);
tricyclic antidepressants;
certain antimicrobials (saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, including halofantrine);
some antihistamines (terfenadine, astemizole, mizolastine);
others (cisapride, vincamine IV, bepridil, diphemanil).
Moxifloxacin should be administered with caution to patients taking drugs that may lower potassium levels (e.g. loop and thiazide diuretics, enemas and laxatives (in high doses), corticosteroids, amphotericin B), or drugs whose effects are associated with clinically significant bradycardia.
An interval of about 6 hours is required between taking drugs containing divalent or trivalent cations (such as antacids containing magnesium or aluminum, didanosine tablets, sucralfate, and drugs containing iron or zinc) and moxifloxacin.
When used in combination with warfarin, pharmacokinetic parameters, prothrombin time and other blood clotting parameters do not change.
The pharmacokinetics of digoxin are not significantly altered by moxifloxacin (after multiple doses of moxifloxacin, an increase in Cmax of digoxin by approximately 30% was observed at steady state without any effect on AUC (area under the concentration-time curve). Therefore, there is no need for precautions when taking digoxin concomitantly.
In studies in diabetic volunteers, concomitant oral administration of moxifloxacin and glibenclamide resulted in a decrease in peak glibenclamide concentrations of approximately 21%. The combination of glibenclamide with moxifloxacin could theoretically lead to a slight transient hyperglycemia. However, the observed changes in pharmacokinetics did not result in changes in pharmacodynamic parameters (blood glucose levels, insulin levels). Thus, no clinically relevant interaction between moxifloxacin and glibenclamide was observed.
When activated charcoal is administered simultaneously with oral moxifloxacin at a dose of 400 mg, the systemic bioavailability of the drug is reduced by more than 80% due to inhibition of its absorption. Therefore, the simultaneous use of these two drugs is not recommended (except in cases of overdose, see also the section "Overdose").
Substances for which no clinically significant interaction with moxifloxacin has been demonstrated: ranitidine, calcium supplements, theophylline, oral contraceptives, cyclosporine, itraconazole, parenteral morphine, probenecid. In vitro studies of cytochrome P450 enzymes in humans have confirmed the above. In view of the above results, metabolic interaction via cytochrome P450 enzymes is unlikely.
The absorption of moxifloxacin is independent of food intake (including dairy products), therefore moxifloxacin can be used regardless of food intake.
Application features
Hypersensitivity and allergic reactions to fluoroquinolones, including moxifloxacin, have been reported after initial administration. Anaphylactic reactions may progress to life-threatening anaphylactic shock, even after initial administration. In these cases, the drug should be discontinued and appropriate therapy (e.g. anti-shock) initiated.
When using moxifloxacin, some patients may experience an increase in the QT interval on the ECG. Analysis of the ECG results showed that the prolongation of the QTc interval when using moxifloxacin was 6 ms ± 26 ms - 1.4% compared to the initial level.
Because women have a longer QT interval than men, women may be more sensitive to drugs that prolong the QT interval. Elderly patients may also be more susceptible to drug-associated QT effects.
Patients taking moxifloxacin should be cautious when using drugs that may cause potassium levels to decrease.
Moxifloxacin should be administered with caution to patients with ongoing antiarrhythmic conditions (especially women and the elderly), such as acute myocardial ischemia or QT prolongation, as this may lead to an increased risk of ventricular arrhythmias, including torsade de pointes, and cardiac arrest. The extent of QT prolongation may increase with increasing drug concentration. Therefore, the recommended dose should not be exceeded.
The benefits of treatment with moxifloxacin should be weighed against the risks, especially in cases of mild infections (see section 4.4).
If symptoms of arrhythmia occur during treatment with the drug, treatment should be discontinued and an ECG should be performed.
Cases of fulminant hepatitis, potentially leading to hepatic failure (including fatal outcomes), have been reported with moxifloxacin. Patients should be advised to seek medical advice before continuing treatment if signs and symptoms of fulminant hepatitis develop, such as rapidly progressive asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
In cases of symptoms of liver dysfunction, liver function tests/examination should be performed.
Cases of bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported with moxifloxacin. If skin and/or mucosal reactions occur, patients should be advised to seek medical advice immediately before continuing treatment.
Quinolones are known to induce seizures. Moxifloxacin should be used with caution in patients with CNS disorders that may predispose to seizures or lower the seizure threshold. If seizures occur, moxifloxacin should be discontinued and appropriate measures taken.
Cases of sensory or sensorimotor polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias or weakness have been reported in patients receiving quinolones, including moxifloxacin. If symptoms of neuropathy such as pain, burning, tingling, numbness or weakness develop, patients receiving moxifloxacin treatment should inform their doctor before continuing treatment.
Antibiotic-associated diarrhea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been reported with the use of broad-spectrum antibiotics, including moxifloxacin, and range in severity from mild diarrhea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who develop severe diarrhea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, treatment with antibacterial agents, including moxifloxacin, should be discontinued and appropriate therapeutic measures should be taken immediately. In addition, appropriate sanitary and epidemiological measures should be taken to reduce the risk of disease transmission. Antimicrobial agents are contraindicated in patients with severe diarrhea.
Moxifloxacin should be used with caution in patients with myasthenia gravis due to the possibility of exacerbation of symptoms.
Tendonitis and rupture (especially of the Achilles tendon), sometimes bilateral, may occur with quinolones, including moxifloxacin, even within the first 48 hours of treatment. Cases have also been reported several months after discontinuation of treatment. Tendonitis and rupture may occur with quinolones, including moxifloxacin, particularly in the elderly and in patients receiving concomitant corticosteroid therapy.
At the first signs of pain or inflammation, patients should discontinue moxifloxacin treatment, rest the affected limb(s) and seek immediate medical attention for appropriate treatment (e.g. splinting) of the affected tendon.
Moxifloxacin should be used with caution in elderly patients with impaired renal function if they are unable to maintain adequate fluid intake, as dehydration may increase the risk of renal failure.
If visual impairment or other effects on the organs of vision are observed, an ophthalmologist should be consulted immediately.
Photosensitivity reactions have been reported in patients treated with quinolones. However, studies have shown that moxifloxacin has a lower risk of photosensitivity. Despite this, patients should avoid both ultraviolet radiation and prolonged and/or intense sunlight during treatment with moxifloxacin.
Patients with a family or personal history of glucose-6-phosphate dehydrogenase deficiency are more likely to develop hemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in such patients.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Treatment with Moxinta tablets is not recommended in patients with complicated pelvic inflammatory disease (e.g. associated with tubo-ovarian abscess or pelvic abscess) for whom intravenous therapy is considered necessary.
Pelvic inflammatory disease may be caused by Neisseria gonorrhoeae resistant to fluoroquinolones. Therefore, in such cases, empirical use of moxifloxacin should be administered concomitantly with another appropriate antibiotic (e.g. cephalosporin) unless the development of moxifloxacin-resistant Neisseria gonorrhoeae cannot be completely excluded.
If there is no improvement in the clinical condition after 3 days of treatment, therapy should be reviewed.
Moxifloxacin causes cartilage damage in young animals, so the use of the drug in children is contraindicated.
Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In case of suspected or confirmed MRSA infection, treatment with an appropriate antibacterial agent should be initiated.
The clinical efficacy of intravenous moxifloxacin in the treatment of severe infections associated with burns, fasciitis, and diabetic foot accompanied by osteomyelitis has not been established.
Treatment with moxifloxacin may interfere with culture assays for Mycobacterium spp. due to inhibition of microbial growth, which in turn may lead to false-negative results in samples from patients currently taking moxifloxacin.
Animal studies have not shown any impairment of fertility.
Dysglycemia
As with other fluoroquinolones, blood glucose abnormalities, including hypoglycemia and hyperglycemia, have been reported with the use of Moxin. Dysglycemia has occurred in patients treated with Moxin, predominantly in elderly diabetic patients receiving concomitant oral hypoglycemic agents (e.g. sulfonylureas) or insulin. Close monitoring of blood glucose levels is recommended in diabetic patients.
Use during pregnancy or breastfeeding
Pregnancy
The use of moxifloxacin is contraindicated during pregnancy.
The use of Moxifloxacin is contraindicated during breastfeeding. Small amounts of moxifloxacin may pass into breast milk.
The ability to influence the reaction speed when driving or working with other mechanisms
Moxifloxacin, like other fluoroquinolones, may affect the ability to drive or use machines due to the possibility of central nervous system reactions (e.g. dizziness, acute transient loss of vision, see section 4.8) or acute transient loss of consciousness (syncope, see section 4.8). Patients should be advised to observe their reaction to moxifloxacin before driving or operating machinery.
Method of administration and doses
Adults
It is recommended to take 1 tablet (400 mg) of moxifloxacin per day.
The tablets should be taken without chewing, with sufficient water. The drug can be taken regardless of the time of eating.
Duration of therapy
The duration of therapy with the tablet form of the drug Moxin depends on the type of infections and is:
exacerbation of chronic bronchitis – 5-10 days;
community-acquired pneumonia – 10 days;
acute bacterial sinusitis – 7 days;
mild and moderate pelvic inflammatory disease – 14 days.
Exceeding the specified dose (400 mg once daily) and duration of treatment for each indication is not recommended.
Elderly patients/patients with low body weight
No dose adjustment is required for elderly patients/patients with low body weight.
Liver dysfunction
No dose adjustment is required for patients with impaired liver function (see also section "Special warnings and precautions for use").
Kidney failure
For patients with mild to moderate renal impairment (including creatinine clearance < 30 ml/min/1.73 m2), as well as for patients on continuous hemodialysis and long-term ambulatory peritoneal dialysis, no dose adjustment is required (see section "Pharmacological properties").
Children.
Moxifloxacin is contraindicated in children. The efficacy and safety of Moxifloxacin in children have not been established.
Overdose
In case of accidental overdose, no specific measures are recommended. In case of overdose, the clinical picture should be guided and symptomatic supportive therapy and ECG monitoring should be carried out due to the possibility of QT prolongation.
Co-administration of activated charcoal with a 400 mg oral dose of moxifloxacin will result in a reduction in systemic exposure of the drug by more than 80%. In the event of an oral overdose, administration of activated charcoal at the initial stage of absorption may be effective in preventing increased systemic exposure to moxifloxacin.
Side effects
Within each group, adverse reactions are presented in order of decreasing seriousness. The frequency is defined as follows: common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), rare (<1/10000).
Often
Cardiac: QT prolongation in patients with hypokalemia.
On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea.
Hepatobiliary disorders: increased transaminase levels.
From the sensory organs: change in taste sensations.
From the nervous system: dizziness, headache.
Infectious complications: superinfection resulting from bacterial or fungal resistance, such as oral or vaginal candidiasis.
Infrequently
From the side of the blood and lymphatic system: anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, eosinophilia; prolongation of prothrombin time/increase in INR (international normalized ratio).
On the part of the immune system: allergic reactions.
Metabolism and nutrition disorders: hyperlipidemia.
Psychiatric disorders: anxiety reactions, increased psychomotor activity/agitation.
Nervous system disorders: paresthesia/dysesthesia; taste disturbance (including ageusia in extremely rare cases); confusion and disorientation, sleep disorders (mainly insomnia), tremor, vertigo; drowsiness.
Cardiac: palpitations, tachycardia; QT prolongation; vasodilation; atrial fibrillation, angina pectoris.
On the part of the digestive tract: decreased appetite and reduced food intake, constipation, dyspepsia, flatulence, gastritis, increased amylase levels.
From the vascular system: vasodilation.
Hepatobiliary disorders: liver function abnormalities (including increased LDH (lactate dehydrogenase)), increased bilirubin levels, increased GGTP (gamma-glutamyl transpeptidase), increased blood alkaline phosphatase levels.
Skin and subcutaneous tissue disorders: itching, rash, urticaria, dry skin.
Musculoskeletal system: arthralgia, myalgia.
On the part of the organs of vision: visual disturbances, including diplopia and blurred vision (especially during CNS reactions).
Respiratory, thoracic and mediastinal disorders: dyspnea (including asthmatic status).
General disorders: general weakness (mainly asthenia or fatigue), pain (including back pain, chest pain, pain in the extremities, tenderness in the pelvic projections), hyperhidrosis.
Single
Immune system disorders: anaphylaxis, including rare cases of shock (life-threatening), allergic edema/angioedema, including laryngeal edema (potentially life-threatening).
Metabolism and nutrition disorders: hyperglycemia, hyperuricemia.
Psychiatric disorders: mood lability, depression (in rare cases with possible self-harm such as suicidal ideation/thoughts or suicide attempts); hallucinations.
Nervous system: hypoesthesia; olfactory impairment (including loss of smell);
abnormal dreams, coordination disorders (including gait disturbance due to dizziness or vertigo), seizures with various clinical manifestations (including grand mal seizures); attention deficit disorder, speech disorders, amnesia, peripheral neuropathy and polyneuropathy.
From the side of the organs of hearing and vestibular apparatus: tinnitus, hearing impairment, including deafness (usually reversible).
Cardiac: ventricular tachyarrhythmias, syncope (i.e., acute and brief loss of consciousness).
From the vascular system: arterial hypotension, arterial hypertension.
Gastrointestinal: dysphagia, stomatitis; antibiotic-associated colitis (including pseudomembranous colitis, in extremely rare cases associated with life-threatening complications).
Hepatobiliary disorders: jaundice, hepatitis (predominantly cholestatic).
Musculoskeletal system: tendinitis, muscle twitching, muscle cramps, muscle weakness.
Renal and urinary disorders: renal dysfunction (including increased plasma creatinine and urea nitrogen); renal failure.
General disorders: edema.
Rare
From the side of the circulatory and lymphatic system: increased prothrombin level/decreased INR; agranulocytosis.
Metabolism and nutrition disorders: hypoglycemia.
Psychiatric disorders: depersonalization, psychotic reactions (with possible self-harm such as suicidal ideation/thoughts or suicide attempts).
From the nervous system: hyperesthesia.
On the part of the organs of vision: transient loss of vision (especially during reactions from the CNS).
Cardiac: nonspecific arrhythmias; torsade de pointes, cardiac arrest
Hepatobiliary disorders: fulminant hepatitis, which can potentially lead to life-threatening liver failure (including fatalities).
Skin and subcutaneous tissue disorders: bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
Musculoskeletal system: tendon rupture; arthritis, muscle stiffness; exacerbation of myasthenia gravis symptoms.
In rare cases, the following adverse reactions have been reported after treatment with other fluoroquinolones, which could possibly also be observed with moxifloxacin: hypernatremia, hypercalcemia, hemolytic anemia, rhabdomyolysis, photosensitivity reactions (see section "Special warnings and precautions for use").
Expiration date
3 years.
Storage conditions
Store out of the reach of children, protected from light and moisture at a temperature up to 25 °C.
Packaging
5 tablets in a blister, 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Bafna Pharmaceuticals Ltd., India.
Address
147, Madhavaram Red Hills Road, Grantlion, Vadakarai Village Chennai Tamil Nadu IN 600052, India.
