Moxifloxacin (Tablets, Solution, Drops) Instructions for Use
ATC Code
J01MA14 (Moxifloxacin)
Active Substance
Moxifloxacin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antibacterial drug of the fluoroquinolone group
Pharmacotherapeutic Group
Systemic antibacterial agents; quinolone derivatives; fluoroquinolones
Pharmacological Action
An antimicrobial agent from the group of fluoroquinolones, it acts bactericidally. It exhibits activity against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria: Mycoplasma spp., Chlamydia spp., Legionella spp. It is effective against bacterial strains resistant to beta-lactams and macrolides. It is active against most strains of microorganisms: gram-positive – Staphylococcus aureus (including strains not susceptible to methicillin), Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A); gram-negative – Haemophilus influenzae (including both beta-lactamase-producing and non-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including both beta-lactamase-producing and non-producing strains), Escherichia coli, Enterobacter cloacae; atypical – Chlamydia pneumoniae, Mycoplasma pneumoniae.
According to in vitro studies, although the microorganisms listed below are sensitive to moxifloxacin, the safety and efficacy of its use in the treatment of infections have not been established. Gram-positive microorganisms: Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including strains susceptible to methicillin), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae. Gram-negative microorganisms: Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii. Anaerobic microorganisms: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides uniformis, Fusobacterium spp., Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Propionibacterium spp., Clostridium perfringens, Clostridium ramosum. Atypical microorganisms: Legionella pneumophila, Coxiella burnetii.
It blocks topoisomerase II and IV, enzymes that control the topological properties of DNA and are involved in DNA replication, repair and transcription. The action of moxifloxacin depends on its concentration in the blood and tissues. The minimum bactericidal concentrations are almost the same as the minimum inhibitory concentrations.
Resistance development mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not affect the antibacterial activity of moxifloxacin. There is no cross-resistance between moxifloxacin and these drugs. A plasmid-mediated resistance development mechanism was not observed. The overall frequency of resistance development is low. In vitro studies have shown that resistance to moxifloxacin develops slowly as a result of a series of sequential mutations. With repeated exposure of microorganisms to moxifloxacin at sub-minimum inhibitory concentrations, the MIC values increase only slightly. Cross-resistance is observed between drugs from the fluoroquinolone group. However, some gram-positive and anaerobic microorganisms resistant to other fluoroquinolones are sensitive to moxifloxacin.
Pharmacokinetics
After oral administration, Moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability is about 91%. The pharmacokinetics of moxifloxacin when taken in doses from 50 to 1200 mg once, as well as 600 mg/day for 10 days, is linear. After a single dose of moxifloxacin 400 mg, Cmax in the blood is reached within 0.5-4 hours and is 3.1 mg/L. After oral administration of moxifloxacin at a dose of 400 mg once/day, Cssmax and Cssmin are 3.2 mg/L and 0.6 mg/L, respectively.
Binding to blood proteins (mainly to albumin) is about 45%. Moxifloxacin is rapidly distributed in organs and tissues. Vd is approximately 2 L/kg. High concentrations of moxifloxacin, exceeding those in plasma, are achieved in lung tissue (including epithelial fluid, alveolar macrophages), in the sinuses (maxillary and ethmoid sinuses), in nasal polyps, and in inflammatory foci (in blister fluid in skin lesions). In interstitial fluid and saliva, Moxifloxacin is determined in a free, non-protein-bound form, at a concentration higher than in plasma. In addition, high concentrations of moxifloxacin are determined in the tissues of the abdominal organs, peritoneal fluid, as well as in the tissues of the female genital organs.
Moxifloxacin undergoes phase II biotransformation and is excreted from the body by the kidneys, as well as through the intestines, both unchanged and in the form of inactive sulfo compounds (M1) and glucuronides (M2). Moxifloxacin is not biotransformed by the microsomal cytochrome P450 system. Metabolites M1 and M2 are present in the blood plasma at concentrations lower than the parent compound. According to the results of preclinical studies, it has been proven that these metabolites do not have a negative impact on the body in terms of safety and tolerability.
T1/2 is approximately 12 hours. The average total clearance after oral administration of moxifloxacin at a dose of 400 mg is 179-246 ml/min. Renal clearance is 24-53 ml/min. This indicates partial tubular reabsorption of moxifloxacin. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% through the intestines.
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: acute sinusitis; exacerbation of chronic bronchitis; community-acquired pneumonia (including that caused by strains of microorganisms with multiple antibiotic resistance); uncomplicated skin and soft tissue infections; complicated skin and subcutaneous structure infections (including infected diabetic foot); complicated intra-abdominal infections, including polymicrobial infections, including intraperitoneal abscesses; uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).
It is necessary to take into account the current official guidelines on the rules for the use of antibacterial agents.
ICD codes
| ICD-10 code | Indication |
| A48.1 | Legionnaires' disease |
| E14.5 | Unspecified diabetes mellitus with peripheral circulatory complications |
| I79.2 | Peripheral angiopathy in diseases classified elsewhere (including diabetic angiopathy) |
| J01 | Acute sinusitis |
| J13 | Pneumonia due to Streptococcus pneumoniae |
| J14 | Pneumonia due to Haemophilus influenzae [Afanasyev-Pfeiffer bacillus] |
| J15.7 | Pneumonia due to Mycoplasma pneumoniae |
| J16.0 | Pneumonia due to chlamydia |
| J18.9 | Pneumonia, unspecified |
| J42 | Unspecified chronic bronchitis |
| K65.0 | Acute peritonitis (including abscess) |
| L01 | Impetigo |
| L08.8 | Other specified local infections of skin and subcutaneous tissue |
| N70 | Salpingitis and oophoritis |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| ICD-11 code | Indication |
| 1B72.0 | Bullous impetigo |
| 1B72.1 | Nonbullous impetigo |
| 1B72.Z | Impetigo, unspecified |
| 1B7Y | Other specified pyogenic bacterial infections of skin or subcutaneous tissue |
| 1C19.Z | Legionellosis, unspecified |
| 1C44 | Non-pyogenic bacterial infections of skin |
| 5A14 | Diabetes mellitus, type unspecified |
| BD53.Y | Other specified secondary involvement of arteries and arterioles |
| CA01 | Acute rhinosinusitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA40.00 | Pneumonia due to Chlamydophila pneumoniae |
| CA40.02 | Pneumonia due to Haemophilus influenzae |
| CA40.04 | Pneumonia due to Mycoplasma pneumoniae |
| CA40.07 | Pneumonia due to Streptococcus pneumoniae |
| CA40.Y | Other specified pneumonia |
| CA40.Z | Pneumonia, microorganism not specified |
| DC50.0 | Primary peritonitis |
| DC50.2 | Peritoneal abscess |
| DC50.Z | Peritonitis, unspecified |
| EA50.3 | Staphylococcal scarlet fever |
| GA07.Z | Salpingitis and oophoritis, unspecified |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
Orally prescribed at a dose of 400 mg once/day.
The duration of treatment is determined by the severity of the infection and the clinical effect and can range from 5 to 21 days.
Solution
Used intravenously at a dose of 400 mg once/day.
Drops
Topically. For adults, 1 drop into the affected eye 3 times/day. Usually, improvement occurs within 5 days and treatment should be continued for the next 2-3 days. If the condition does not improve after 5 days, the correctness of the diagnosis and/or prescribed treatment should be questioned. The duration of treatment depends on the severity of the condition and the clinical and bacteriological course of the disease.
Adverse Reactions
Infectious diseases often – fungal superinfections.
From the hematopoietic system: infrequently – anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prolongation of prothrombin time/increase in INR; rarely – change in thromboplastin concentration; very rarely – increase in prothrombin concentration/decrease in INR.
From the immune system infrequently – allergic reactions, urticaria, itching, rash, eosinophilia; rarely – anaphylactic/anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely – anaphylactic/anaphylactoid shock (including potentially life-threatening).
From metabolism infrequently – hyperlipidemia; rarely – hyperglycemia, hyperuricemia; very rarely – hypoglycemia.
From the psyche infrequently – anxiety, psychomotor hyperactivity, agitation; rarely – emotional lability, depression, hallucinations; very rarely – depersonalization, psychotic reactions (potentially manifesting in behavior with a tendency to self-harm, such as suicidal thoughts or suicide attempts).
From the nervous system: often – dizziness, headache; infrequently – paresthesia, dysesthesia, taste sensitivity disorders (including in very rare cases ageusia), confusion, disorientation, sleep disorders, tremor, vertigo, drowsiness; rarely – hypoesthesia, smell disorders (including anosmia), atypical dreams, coordination disorder (including gait disorders due to dizziness or vertigo, in very rare cases leading to injuries from falls, especially in elderly patients), seizures with various clinical manifestations (including “grand mal” seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy, polyneuropathy; very rarely – hyperesthesia.
From the organ of vision infrequently – visual disturbances (especially with CNS reactions); very rarely – transient loss of vision (especially with CNS reactions).
From the organ of hearing rarely – tinnitus, hearing impairment, including deafness (usually reversible).
From the cardiovascular system: often – QT interval prolongation in patients with concomitant hypokalemia; infrequently – QT interval prolongation, palpitations, tachycardia, vasodilation; rarely – increased blood pressure, decreased blood pressure, fainting, ventricular tachyarrhythmias; very rarely – nonspecific arrhythmias, polymorphic ventricular tachycardia (torsades de pointes type), cardiac arrest (mainly in persons with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).
From the respiratory system infrequently – dyspnea, asthmatic condition.
From the digestive system: often – nausea, vomiting, abdominal pain, diarrhea; infrequently – decreased appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (except erosive gastroenteritis), increased amylase activity; rarely – dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).
From the liver and biliary tract: often – increased activity of liver transaminases; infrequently – liver function disorders (including increased LDH activity), increased bilirubin concentration, increased GGT and ALP activity; rarely – jaundice, hepatitis (predominantly cholestatic); very rarely – fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).
From the skin and subcutaneous tissues very rarely – bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
From the musculoskeletal system: infrequently – arthralgia, myalgia; rarely – tendinitis, increased muscle tone and cramps, muscle weakness; very rarely – arthritis, tendon ruptures, gait disturbance due to damage to the musculoskeletal system, exacerbation of myasthenia gravis symptoms.
From the urinary system infrequently – dehydration (caused by diarrhea or reduced fluid intake); rarely – renal function impairment, renal failure due to dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing renal impairment.
Local reactions often – reactions at the injection/infusion site.
General reactions infrequently – general malaise, nonspecific pain, sweating.
The frequency of the following adverse reactions was higher in the group receiving step-down therapy: often – increased GGT activity; infrequently – ventricular tachyarrhythmias, arterial hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including “grand mal” seizures), hallucinations, renal function impairment, renal failure (due to dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing renal impairment).
Contraindications
Hypersensitivity to moxifloxacin, other quinolones; history of tendon pathology that developed due to treatment with quinolone antibiotics; in preclinical and clinical studies, after administration of moxifloxacin, a change in the electrophysiological parameters of the heart was observed, expressed in prolongation of the QT interval. In this regard, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or documented acquired prolongations of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; history of rhythm disturbances accompanied by clinical symptoms; Moxifloxacin should not be used with other drugs that prolong the QT interval; due to limited clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with transaminase levels more than 5 times the upper limit of normal; pregnancy, breastfeeding; children and adolescents under 18 years of age.
With caution use in diseases of the central nervous system (including diseases suspected of involving the central nervous system) that predispose to the occurrence of seizures and lower the seizure threshold; in patients with a history of psychosis and/or psychiatric diseases; in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and cardiac arrest, especially in women and elderly patients; with myasthenia gravis; with liver cirrhosis; with simultaneous use of drugs that reduce potassium levels; in patients with a genetic predisposition or actual deficiency of glucose-6-phosphate dehydrogenase.
Use in Pregnancy and Lactation
The use of moxifloxacin during pregnancy and breastfeeding is contraindicated.
Use in Hepatic Impairment
The use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with transaminase levels more than 5 times the upper limit of normal. It should be used with caution in liver cirrhosis.
Use in Renal Impairment
No dosage adjustment is required for patients with impaired renal function (including with CrCl <30 ml/min/1.73 m2), as well as for patients on continuous hemodialysis and long-term ambulatory peritoneal dialysis.
Pediatric Use
Contraindicated for use in children and adolescents under 18 years of age.
Geriatric Use
Elderly patients should be prescribed with caution to avoid worsening of concomitant diseases.
Special Precautions
In some cases, hypersensitivity and allergic reactions may develop after the first use of moxifloxacin, which should be reported to the doctor immediately. Very rarely, even after the first use, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be discontinued and the necessary therapeutic measures (including anti-shock) should be started immediately.
It should be used with caution in women and elderly patients. Since women have a longer QT interval compared to men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to the effects of drugs that affect the QT interval.
The degree of QT interval prolongation may increase with rising moxifloxacin concentration; therefore, the recommended dose should not be exceeded. QT interval prolongation is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.
Patients should be informed that in case of symptoms of liver failure, symptoms of skin or mucous membrane lesions, or symptoms of neuropathy (pain, burning, tingling, numbness, or weakness), they must consult a doctor before continuing treatment with moxifloxacin.
The use of broad-spectrum antibacterial drugs, including Moxifloxacin, is associated with the risk of developing pseudomembranous colitis. Drugs that inhibit intestinal peristalsis are contraindicated in the development of severe diarrhea.
During therapy with quinolones, including moxifloxacin, the development of tendinitis and tendon rupture is possible, especially in the elderly and patients receiving corticosteroids. Cases have been described that occurred within several months after treatment completion. At the first symptoms of pain or inflammation at the site of injury, the use of moxifloxacin should be discontinued and the affected limb should be immobilized.
During treatment, exposure to direct sunlight and UV radiation should be avoided.
Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA) strains. In the case of suspected or confirmed infections caused by MRSA, appropriate antibacterial drugs should be prescribed.
The ability of moxifloxacin to suppress the growth of mycobacteria may cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., leading to false-negative results when analyzing samples from patients receiving Moxifloxacin.
Psychiatric reactions may occur even after the first administration of fluoroquinolones, including Moxifloxacin. In very rare cases, depression or psychotic reactions progress to the emergence of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts. If such reactions occur in patients, Moxifloxacin should be discontinued and necessary measures taken. Caution should be exercised when using moxifloxacin in patients with a history of psychosis and/or psychiatric disorders.
Due to the widespread prevalence and growing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, monotherapy with moxifloxacin should not be used for the treatment of patients with pelvic inflammatory disease, except in cases where the presence of fluoroquinolone-resistant N. gonorrhoeae has been ruled out. If it is not possible to rule out the presence of fluoroquinolone-resistant N. gonorrhoeae, the issue of supplementing empirical therapy with moxifloxacin with an appropriate antibiotic active against N. gonorrhoeae (e.g., a cephalosporin) should be considered.
During moxifloxacin therapy, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant therapy with oral hypoglycemic drugs (e.g., sulfonylureas) or insulin. When treating patients with diabetes, careful monitoring of blood glucose levels is recommended.
Effect on the ability to drive vehicles and operate machinery
Fluoroquinolones, including Moxifloxacin, may impair patients’ ability to drive a car and engage in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions due to their effect on the central nervous system and vision impairment.
Drug Interactions
The possible additive effect of QT interval prolongation by moxifloxacin and other drugs that affect QT interval prolongation should be considered. Due to the concomitant use of moxifloxacin and drugs affecting QT interval prolongation, the risk of developing ventricular arrhythmia, including polymorphic ventricular tachycardia of the ‘torsades de pointes’ type, increases. Concomitant use of moxifloxacin with the following drugs affecting QT interval prolongation is contraindicated: class IA antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide); class III antiarrhythmic drugs (including amiodarone, sotalol, dofetilide, ibutilide); antipsychotics (including phenothiazine, pimozide, sertindole, haloperidol, sultopride); tricyclic antidepressants; antimicrobial drugs (sparfloxacin, intravenous erythromycin, pentamidine, antimalarial drugs, especially halofantrine); antihistamines (terfenadine, astemizole, mizolastine); others (cisapride, intravenous vincamine, bepridil, diphemanil).
When taken orally concomitantly with antacids, multivitamins, and minerals, the absorption of moxifloxacin may be impaired due to the formation of chelate complexes with polyvalent cations contained in these drugs. As a result, the plasma concentration of moxifloxacin may be significantly lower than therapeutic. In this regard, antacids, antiretroviral drugs (e.g., didanosine), and other drugs containing magnesium, aluminum, sucralfate, iron, or zinc should be taken at least 4 hours before or 4 hours after oral administration of moxifloxacin.
In patients receiving anticoagulants in combination with antibiotics, including moxifloxacin, cases of increased anticoagulant activity of anticoagulant drugs have been noted. Risk factors include the presence of an infectious disease (and the accompanying inflammatory process), age, and the general condition of the patient. Although no interaction between moxifloxacin and warfarin has been identified, in patients receiving combined treatment with these drugs, INR should be monitored and the dose of indirect anticoagulants should be adjusted if necessary.
Moxifloxacin and digoxin do not have a significant effect on each other’s pharmacokinetic parameters. Upon repeated administration of moxifloxacin, the Cmax of digoxin increased by approximately 30%. However, the AUC and Cmin values of digoxin did not change.
With the simultaneous oral administration of activated charcoal and moxifloxacin at a dose of 400 mg, the systemic bioavailability of moxifloxacin decreases by more than 80% due to slowed absorption. In case of overdose, the use of activated charcoal at the early stage of absorption prevents a further increase in systemic exposure.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 400 mg: 5 or 10 pcs.
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Manufactured By
NPC Scan Biotek, LLC (Russia)
Dosage Form
 |
Moxifloxacin | Film-coated tablets, 400 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oblong, biconvex, with a score on one side; the core in cross-section is from white to light yellowish-greenish in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: corn starch – 159.885 mg, microcrystalline cellulose 102 – 55 mg, sodium starch glycolate – 24 mg, hypromellose – 14.3 mg, magnesium stearate – 14 mg, talc – 7 mg, colloidal silicon dioxide – 4 mg, sodium methylparahydroxybenzoate (E219) – 0.015 mg.
Shell composition film coating WT-19022P pink – 15 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 21.79%, polyethylene glycol 6000 – 13.2%, talc – 12.6%, soy lecithin – 3.4%, iron oxide red dye (E172) – 0.01%).
5 pcs. – aluminum/PVC blisters (1) – cardboard packs.
5 pcs. – aluminum/PVC blisters (2) – cardboard packs.
5 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
Solution for infusion 1.6 mg/ml: 250 ml containers
Marketing Authorization Holder
Avexima Siberia LLC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml containers |
Dosage Form, Packaging, and Composition
Solution for infusion clear, greenish-yellow in color.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.75 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, sodium hydroxide solution 2 M or hydrochloric acid 1 M – to pH 3.6 – 5.1, water for injections – to 1 ml.
Theoretical osmolarity 283 mOsm/l.
250 ml – containers – bags.
Solution for infusion 1.6 mg/1 ml: 250 ml bot. 1 or 15 pcs.
Marketing Authorization Holder
Avis Rus LLC (Russia)
Manufactured By
Mosfarm LLC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/1 ml: 250 ml bot. 1 or 15 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion clear, yellow or yellow with a greenish tint.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, hydrochloric acid solution 1M or sodium hydroxide solution 2M – to pH 4.1-4.6, water for injections – to 1 ml.
Theoretical osmolarity 282 mOsm/l.
250 ml – bottles (1) – cardboard packs (for hospitals).
250 ml – bottles (15) – cardboard boxes (for hospitals).
Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 70, 75, 80, 100, 125, 150, 175, 200, or 250 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 49, 50, 56, 60, 70, 75, 80, 100, 125, 150, 175, 200, or 250 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light yellow with a beige tint, round, biconvex; the tablet core in cross-section is light yellow.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.3 mg |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: microcrystalline cellulose – 97.5 mg, lactose monohydrate – 51.2 mg, croscarmellose sodium – 32.5 mg, povidone K25 – 26 mg, magnesium stearate – 6.5 mg.
Film coating composition: hypromellose – 8.4 mg, titanium dioxide – 4.3 mg, macrogol 4000 – 2.1 mg, iron oxide yellow dye – 0.2 mg.
5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
5 pcs. – contour cell blisters (3) – cardboard packs.
5 pcs. – contour cell blisters (4) – cardboard packs.
5 pcs. – contour cell blisters (5) – cardboard packs.
5 pcs. – contour cell blisters (6) – cardboard packs.
5 pcs. – contour cell blisters (7) – cardboard packs.
5 pcs. – contour cell blisters (8) – cardboard packs.
5 pcs. – contour cell blisters (10) – cardboard packs.
7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (5) – cardboard packs.
7 pcs. – contour cell blisters (6) – cardboard packs.
7 pcs. – contour cell blisters (7) – cardboard packs.
7 pcs. – contour cell blisters (8) – cardboard packs.
7 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
25 pcs. – contour cell blisters (1) – cardboard packs.
25 pcs. – contour cell blisters (2) – cardboard packs.
25 pcs. – contour cell blisters (3) – cardboard packs.
25 pcs. – contour cell blisters (4) – cardboard packs.
25 pcs. – contour cell blisters (5) – cardboard packs.
25 pcs. – contour cell blisters (6) – cardboard packs.
25 pcs. – contour cell blisters (7) – cardboard packs.
25 pcs. – contour cell blisters (8) – cardboard packs.
25 pcs. – contour cell blisters (10) – cardboard packs.
5 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
7 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Film-coated tablets 400 mg: 5, 7, or 10 pcs.
Marketing Authorization Holder
Beryozovsky Pharmaceutical Plant, CJSC (Russia)
Manufactured By
Repliek Farm Ltd. Skopje (Republic of North Macedonia)
Packaging and Quality Control Release
Beryozovsky Pharmaceutical Plant, CJSC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets 400 mg: 5, 7, or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oval, biconvex; in cross-section, two layers are visible: a core from white with a yellowish tint to light yellow and a pink coating.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.9 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: lactose monohydrate – 106.8 mg, microcrystalline cellulose (type 101 and type 12) – 91 mg, magnesium stearate – 9.75 mg, hypromellose – 5.55 mg.
Film coating composition: Opadry pink (talc – 6.37 mg, hypromellose – 5.84 mg, titanium dioxide – 1.56 mg, macrogol – 1.15 mg, iron oxide red dye – 0.08 mg) – 15 mg.
5 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
Solution for infusion 1.6 mg/ml: 250 ml bottles
Marketing Authorization Holder
Vips-Med, LLC (Russia)
Manufactured By
Nesvizh Medical Products Plant OJSC (Republic Of Belarus)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml bottles |
Dosage Form, Packaging, and Composition
Solution for infusion in the form of a clear greenish-yellow liquid.
| 250 ml | |
| Moxifloxacin hydrochloride | 436 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: sodium chloride – 2000 mg, hydrochloric acid solution 1M or sodium hydroxide solution 2M to pH 4.0-4.6, water for injections – to 250 ml.
Theoretical osmolarity 282 mOsm/l.
250 ml – bottles (1) – cardboard packs.
250 ml – bottles (12) – cardboard boxes (for hospitals).
250 ml – bottles (24) – cardboard boxes (for hospitals).
Solution for infusion 1.6 mg/ml: 100 ml, 200 ml, or 250 ml bottles
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 100 ml, 200 ml, or 250 ml bottles |
Dosage Form, Packaging, and Composition
Solution for infusion as a clear yellow or yellow with a greenish tint liquid.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.74 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : sodium chloride – 8 mg, 1M hydrochloric acid solution or 2M sodium hydroxide solution to pH 4.1-4.6, water for injections – to 1 ml.
Theoretical osmolarity 282 mOsm/l.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
Bottles 1-35 pcs. – cardboard boxes (for hospitals).
Vials 1-18 pcs. – cardboard boxes (for hospitals).
Eye drops 0.5%: bottle or dropper bottle 5 ml
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Moxifloxacin | Eye drops 0.5%: bottle or dropper bottle 5 ml |
Dosage Form, Packaging, and Composition
Eye drops as a clear yellow or greenish-yellow solution.
| 1 ml | |
| Moxifloxacin hydrochloride | 5.45 mg, |
| Equivalent to moxifloxacin content | 5 mg |
Excipients : sodium chloride – 6.4 mg, boric acid – 3 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.3-7.3, water for injections – to 1 ml.
5 ml – dropper bottles (1) – cardboard pack.
5 ml – dropper vials (1) – cardboard pack.
Solution for infusion 1.6 mg/ml: 250 ml bottles
Marketing Authorization Holder
IST-Pharm, LLC (Russia)
Manufactured By
IST-Pharm, LLC (Russia)
Or
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml bottles |
Dosage Form, Packaging, and Composition
Solution for infusion from light yellow to greenish-yellow, clear.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : sodium chloride – 8 mg, hydrochloric acid or 1 M sodium hydroxide solution – to pH 3.6-5.1, water for injections to 1 ml.
Theoretical osmolarity 303 mOsmol/l.
250 ml – polyethylene bottles (1) – bags (1) – cardboard packs.
250 ml – polyethylene bottles (1) (1-96 pcs) – bags (1) – cardboard packs (for hospitals).
Solution for infusion 1.6 mg/ml: 250 ml bottles or containers
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml bottles or containers |
Dosage Form, Packaging, and Composition
Solution for infusion greenish-yellow, clear.
| 250 ml | |
| Moxifloxacin hydrochloride | 436 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients : sodium chloride – 2000 mg, 1M hydrochloric acid solution or 2M sodium hydroxide solution – to pH 4.1 – 4.6, water for injections – to 250 ml.
Theoretical osmolarity 282 mOsm/l.
250 ml – glass bottles with a capacity of 450 ml (1) – cardboard packs.
250 ml – glass bottles with a capacity of 450 ml (12) – cardboard boxes (for hospitals).
250 ml – containers (1) – cardboard packs.
250 ml – containers (30) – cardboard boxes (for hospitals).
Solution for infusion 1.6 mg/1 ml: 250 ml bags
Marketing Authorization Holder
Nika-Pharm Development, LLC (Russia)
Manufactured By
Altayvitamins, JSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/1 ml: 250 ml bags |
Dosage Form, Packaging, and Composition
Solution for infusion clear, from yellow to greenish-yellow.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.75 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : sodium chloride – 8 mg, 1M sodium hydroxide solution or 1M hydrochloric acid solution – q.s. to pH 3.6 – 5.1, water for injections – to 1 ml.
Theoretical osmolarity 282 mOsmol/l.
250 ml – bag (1), equipped with two injection ports – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, or 14 pcs.
Marketing Authorization Holder
Novaya Farma, LLC (Russia)
Manufactured By
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets, 400 mg: 5, 7, 10, or 14 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oval, biconvex; on the cross-section from light yellow to yellow, a greenish tint is allowed.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients : microcrystalline cellulose – 136 mg, lactose monohydrate – 68 mg, croscarmellose sodium – 32 mg, magnesium stearate – 6 mg.
Film coating composition Opadry® 03F240015 pink (hypromellose – 12.94 mg, titanium dioxide – 3.96 mg, macrogol – 3.66 mg, iron oxide red dye (E172) – 0.44 mg).
5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
5 pcs. – jars (1) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 30, 42, or 60 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 30, 42, or 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oval, biconvex, with a score; on the cross-section the core is from light yellow to yellow.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients : lactose monohydrate – 198.5 mg, croscarmellose sodium – 21 mg, microcrystalline cellulose – 13.1 mg, povidone – 14 mg, colloidal silicon dioxide – 7 mg, magnesium stearate – 7 mg, talc – 3 mg.
Film coating composition hypromellose – 11.56 mg, titanium dioxide – 1.78 mg, macrogol 6000 – 4.84 mg, polysorbate 80 – 1.78 mg, azorubine dye – 0.04 mg.
5 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (6) – cardboard packs.
7 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
5 pcs. – glass jars (1) – cardboard packs.
7 pcs. – glass jars (1) – cardboard packs.
10 pcs. – glass jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 30, 40, or 42 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 30, 40, or 42 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oval, biconvex, with a score, on the cross-section the core is from light yellow to yellow.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients : lactose monohydrate – 198.5 mg, croscarmellose sodium – 21 mg, microcrystalline cellulose – 13.1 mg, povidone – 14 mg, colloidal silicon dioxide – 7 mg, magnesium stearate – 7 mg, talc – 3 mg.
Film coating composition hypromellose – 11.56 mg, titanium dioxide – 1.78 mg, macrogol 6000 – 4.84 mg, polysorbate 80 – 1.78 mg, azorubine dye – 0.04 mg.
5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (6) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
5 pcs. – jars (1) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
Solution for infusion 1.6 mg/ml: 100 ml, 200 ml or 250 ml bottles
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 100 ml, 200 ml or 250 ml bottles |
Dosage Form, Packaging, and Composition
Solution for infusion yellow or yellow with a greenish tint, clear.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.75 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : sodium chloride – 8 mg, 2M sodium hydroxide solution or 1M hydrochloric acid solution – to pH 3.9-5.0, water for injections – to 1 ml.
Theoretical osmolarity: 282 mOsmol/l.
100 ml – glass blood bottles (1) – cardboard packs.
200 ml – glass blood bottles (1) – cardboard packs.
250 ml – glass blood bottles (1) – cardboard packs.
Solution for infusion 1.6 mg/ml: 250 ml bottle
Marketing Authorization Holder
PFC Alium, LLC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml bottle |
Dosage Form, Packaging, and Composition
Solution for infusion as a clear yellow or yellow with a greenish tint liquid.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : mannitol – 50 g, disodium edetate dihydrate – 0.1 g, sodium hydroxide and/or hydrochloric acid – to pH 4.1 – 4.6, water for injections – to 1 l.
Theoretical osmolarity 290 mOsm/l.
250 ml – bottles (1) – cardboard packs.
250 ml – bottles (1 – 40) – cardboard boxes (for hospitals).
Solution for infusion 1.6 mg/1 ml: 250 ml containers
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/1 ml: 250 ml containers |
Dosage Form, Packaging, and Composition
Solution for infusion clear, greenish-yellow.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients : mannitol – 46 mg, water for injections – to 1 ml.
Theoretical osmolarity value 263 mOsm/l.
250 ml – polymeric polypropylene containers with two ports (1) – polyethylene bags (inner) (1) – black polyethylene bags (outer).
Solution for infusion 1.6 mg/ml: 50 ml bottles 5 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
R-Pharm JSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 50 ml bottles 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion clear, greenish-yellow.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin base content | 1.6 mg |
Excipients : sodium chloride – 8.5 mg, disodium edetate – 0.1 mg, water for injections – to 1 ml, 0.1M hydrochloric acid solution or 0.1M sodium hydroxide solution – q.s (used if necessary to adjust the pH value of the drug solution from 4.1 to 4.6 in the technological process).
50 ml – colorless glass vials (5) – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, 14, or 21 pcs.
Marketing Authorization Holder
Pharmconcept, LLC (Russia)
Manufactured By
Pharmconcept, LLC (Russia)
Dosage Form
|
Moxifloxacin | Film-coated tablets, 400 mg: 5, 7, 10, 14, or 21 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oblong, biconvex, with a score on one side; from light yellow to yellow or greenish-yellow in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: microcrystalline cellulose type 102 – 153 mg, croscarmellose sodium – 35 mg, mannitol – 60 mg, magnesium stearate – 7 mg, hypromellose – 23.5 mg, titanium dioxide – 7.1 mg, macrogol 4000 – 6.6 mg, iron oxide red dye – 0.7 mg.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs (for hospitals).
50 pcs. – polymer jars (1) – cardboard packs (for hospitals).
70 pcs. – polymer jars (1) – cardboard packs (for hospitals).
Solution for infusion 1.6 mg/ml: 250 ml containers, bottles, or fl.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Manufactured By
Medpolymer Firm, JSC (Russia)
Or
NPC Eskom, PJSC (Russia)
Dosage Form
|
Moxifloxacin | Solution for infusion 1.6 mg/ml: 250 ml containers, bottles, or fl. |
Dosage Form, Packaging, and Composition
Solution for infusion as a clear greenish-yellow liquid.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 3.6-5.1, water for injections – to 1 ml.
Theoretical osmolarity 303 mOsm/l.
250 ml – bottles (1) – cardboard packs.
250 ml – vials (1) – cardboard packs.
250 ml – vials (1) – film.
250 ml – containers (1) – film.
Film-coated tablets, 400 mg: 5, 10, 15, 30, or 60 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Moxifloxacin Canon | Film-coated tablets, 400 mg: 5, 10, 15, 30, or 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, oval, biconvex; on the cross-section – light yellow in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.35 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: calcium stearate 7 mg, corn starch 50 mg, croscarmellose sodium 21 mg, mannitol 55 mg, povidone 25 mg, microcrystalline cellulose 106.65 mg.
Film coating composition Opadry II yellow 21 mg, including: polyvinyl alcohol 8.4 mg, macrogol (polyethylene glycol) 4.2 mg, talc 3.15 mg, titanium dioxide 3.5 mg, iron oxide yellow – 1.75 mg.
5 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (6) – cardboard packs.
15 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
15 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
15 pcs. – contour cell blisters (aluminum/PVC) (4) – cardboard packs.
Solution for infusion 1.6 mg/ml: 250 ml bottle.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Manufactured By
NPC Eskom, PJSC (Russia)
Or
FSBI Russian Cardiology Research And Production Complex Of The Ministry Of Health Of Russia – Epmbp (Russia)
Dosage Form
|
Moxifloxacin Canon | Solution for infusion 1.6 mg/ml: 250 ml bottle. |
Dosage Form, Packaging, and Composition
Solution for infusion greenish-yellow, clear.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: mannitol – 50 mg, sodium edetate – 0.1 mg, 2 M sodium hydroxide solution or 1 M hydrochloric acid – to pH 4.0-4.6, water for injections – to 1 ml.
Theoretical osmolarity 282 mOsm/l.
250 ml – vials (1) – cardboard packs.
Solution for infusion 1.6 mg/1 ml: 250 ml bottle 1 pc.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Polisan NTFF, LLC (Russia)
Dosage Form
|
Moxifloxacin Stada | Solution for infusion 1.6 mg/1 ml: 250 ml bottle 1 pc. |
Dosage Form, Packaging, and Composition
Solution for infusion clear, yellow-green in color.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.75 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, sodium hydroxide – q.s. to pH 4.1-4.6, concentrated hydrochloric acid – to pH 4.1-4.6, water for injections – to 1 ml.
Theoretical osmolarity 283 mOsmol/l.
250 ml – glass vials (1) – cardboard packs.
Film-coated tablets, 400 mg: 5 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Hemofarm, A.D. (Serbia)
Dosage Form
|
Moxifloxacin Stada | Film-coated tablets, 400 mg: 5 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, capsule-shaped, biconvex; core – light yellow in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: microcrystalline cellulose – 153.7 mg, povidone (povidone K30) – 20 mg, croscarmellose sodium – 36.3 mg, calcium stearate 7 mg, corn starch 50 mg, mannitol 55 mg, colloidal silicon dioxide – 6.6 mg, magnesium stearate – 6.6 mg.
Film coating composition hypromellose – 10.61 mg, propylene glycol – 2.12 mg, titanium dioxide – 3.4 mg, talc 3.54 mg, iron oxide red dye – 0.33 mg.
5 pcs. – blisters (1) – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 45, 50, 60, 75, or 90 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Manufactured By
RA Chem Pharma, Ltd. (India)
Dosage Form
|
Moxifloxacin Velpharm | Film-coated tablets, 400 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 45, 50, 60, 75, or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light orange, biconvex, capsule-shaped, with a bevel; on the cross-section the core is light yellow in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: microcrystalline cellulose – 166.6 mg, croscarmellose sodium – 42 mg, povidone K29/32 – 28 mg, magnesium stearate – 7 mg.
Film coating composition Opadry II orange 85F23452 – 20 mg, incl. polyvinyl alcohol – 40%, titanium dioxide – 24%, macrogol – 20.2%, talc – 14.8%, sunset yellow FCF aluminum lake (E110) – 0.8%, iron oxide red (E172) – 0.2%.
5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
5 pcs. – contour cell blisters (3) – cardboard packs.
5 pcs. – contour cell blisters (4) – cardboard packs.
5 pcs. – contour cell blisters (5) – cardboard packs.
5 pcs. – contour cell blisters (6) – cardboard packs.
7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (5) – cardboard packs.
7 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (1) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (5) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets, 400 mg: 5, 7, 10, 15, 20, 21, 30, 35, or 50 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Form
|
Moxifloxacin-Alium | Film-coated tablets, 400 mg: 5, 7, 10, 15, 20, 21, 30, 35, or 50 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, biconvex, oblong, with rounded ends, with a score; on the cross-section the core is light yellow in color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: microcrystalline cellulose – 161.2 mg, povidone (K-30) – 18 mg, croscarmellose sodium – 70 mg, colloidal silicon dioxide (aerosil) – 7 mg, magnesium stearate – 7 mg.
Film coating composition opadry II (series 85), incl. polyvinyl alcohol – 8.4 mg, macrogol – 4.242 mg, talc – 3.108 mg, titanium dioxide – 4.916 mg, aluminum lake based on azorubine dye – 0.094 mg, aluminum lake based on sunset yellow FCF dye – 0.118 mg.
5 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (5) – cardboard packs.
7 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
7 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
7 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
7 pcs. – contour cell blisters (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (5) – cardboard packs.
Film-coated tablets, 400 mg: 5 or 10 pcs.
Marketing Authorization Holder
Alvogen Ipco S.a.r.l. (Luxembourg)
Manufactured By
Rivopharm S.A. (Switzerland)
Dosage Form
|
Moxifloxacin-Alvogen | Film-coated tablets, 400 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oblong, biconvex, with engraving “400” on one side; on the cross-section – a yellowish core.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: intragranular croscarmellose sodium – 13.6 mg, copovidone – 20.4 mg, microcrystalline cellulose – 116.8 mg, pregelatinized starch – 35 mg, talc – 6.8 mg, colloidal silicon dioxide – 6.8 mg, magnesium stearate – 6.8 mg; extragranular croscarmellose sodium – 27.2 mg, talc – 3.4 mg, colloidal silicon dioxide – 3.4 mg, magnesium stearate – 3.4 mg.
Film coating composition Opadry II white 85F18422 – 19.72 mg (polyvinyl alcohol (partially hydrolyzed) – 7.89 mg, titanium dioxide – 4.93 mg, macrogol – 3.98 mg, talc – 2.92 mg), iron oxide red dye – 0.28 mg.
5 pcs. – blisters (1) – cardboard packs.
5 pcs. – blisters (2) – cardboard packs.
Solution for infusion 1.6 mg/ml: 250 ml bottle 1, 4 or 12 pcs.
Marketing Authorization Holder
Binergia JSC (Russia)
Manufactured By
Kursk Biopharmaceutical Plant – Firm “Biok”, FKP (Russia)
Dosage Form
|
Moxifloxacin-Binergia | Solution for infusion 1.6 mg/ml: 250 ml bottle 1, 4 or 12 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion from light yellow to greenish-yellow, clear.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, 1M sodium hydroxide solution/1M hydrochloric acid solution – to pH 3.6-5.1, water for injections – to 1 ml.
Theoretical osmolarity 286 mOsm/l.
250 ml – vials (1) – cardboard packs.
250 ml – vials (4) – cardboard packs.
250 ml – vials (12) – cardboard packs.
250 ml – vials (20) – cardboard boxes (for hospitals).
250 ml – vials (24) – cardboard boxes (for hospitals).
250 ml – vials (28) – cardboard boxes (for hospitals).
Film-coated tablets, 400 mg: 5, 7, 10, 14, 20, 50, or 100 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Moxifloxacin-Ferein® | Film-coated tablets, 400 mg: 5, 7, 10, 14, 20, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, round, biconvex, with a score; on the break – a uniform mass of light yellow color.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.35 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: potato starch – 110 mg, low molecular weight povidone – 22 mg, calcium stearate – 7.27 mg, hypromellose – to obtain a core weighing – 727 mg.
Film coating composition hypromellose – 24.88 mg, titanium dioxide – 5.4 mg, macrogol-4000 – 2.68 mg, dye “Red Alluring” – 0.04 mg
or
Ready mixture Opadry II pink – 33 mg, including partially hydrolyzed polyvinyl alcohol – 40%, titanium dioxide – 23.5%, macrogol – 20.2%, talc – 14.8%, Allura Red AC dye or Allura Red AC aluminum lake – 1.5%.
5 pcs. – contour cell blisters made of polyvinyl chloride film (1) – cardboard packs.
5 pcs. – contour cell blisters made of polyvinyl chloride film (2) – cardboard packs.
7 pcs. – contour cell blisters made of polyvinyl chloride film (1) – cardboard packs.
7 pcs. – contour cell blisters made of polyvinyl chloride film (2) – cardboard packs.
10 pcs. – contour cell blisters made of polyvinyl chloride film (1) – cardboard packs.
10 pcs. – contour cell blisters made of polyvinyl chloride film (2) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 5 or 10 pcs.
Marketing Authorization Holder
Key G P Laboratories (UK), Limited (United Kingdom)
Manufactured By
Protech Biosystems, Pvt. Ltd. (India)
Dosage Form
|
Moxifloxacin-KGP | Film-coated tablets, 400 mg: 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, biconvex, oval in shape; cross-sectional view: a homogeneous mass from light yellow to light orange, surrounded by an almost white film coating.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: corn starch – 70 mg, microcrystalline cellulose – 96.16 mg, povidone K-30 – 10 mg, methylparaben – 0.7 mg, propylparaben – 0.14 mg, talc – 6.2 mg, magnesium stearate – 6.4 mg, colloidal silicon dioxide – 6 mg, sodium carboxymethyl starch – 11 mg, croscarmellose sodium – 7 mg.
Film coating composition hypromellose 15cP – 10.14 mg, dibutyl sebacate – 2.86 mg, hypromellose 5cP – 2 mg, colloidal silicon dioxide – 1.2 mg, titanium dioxide (E171) – 3 mg, talc – 0.8 mg.
5 pcs. – Al/PVC blisters (1) – cardboard packs.
10 pcs. – Al/PVC blisters (1) – cardboard packs.
Solution for infusion 1.6 mg/1 ml: 250 ml bottle
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Moxifloxacin-SOLOpharm | Solution for infusion 1.6 mg/1 ml: 250 ml bottle |
Dosage Form, Packaging, and Composition
Solution for infusion clear, yellow-green in color.
| 1 ml | |
| Moxifloxacin hydrochloride | 1.744 mg, |
| Equivalent to moxifloxacin content | 1.6 mg |
Excipients: sodium chloride – 8 mg, 1M sodium hydroxide solution or 1M hydrochloric acid solution – to pH 3.6-5.1, water for injections – up to 1 ml.
Theoretical osmolarity: 286 mOsm/l.
250 ml – polypropylene bottles (1) – cardboard packs.
Film-coated tablets 400 mg: 5, 7, or 10 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
Technology Lekarstv LLC (Russia)
Or
R-Pharm JSC (Russia)
Dosage Form
|
Moxifloxacin-TL | Film-coated tablets 400 mg: 5, 7, or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pinkish-brown, oval, biconvex; cross-section shows two layers; tablet core is light yellow.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.8 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: lactose monohydrate – 280 mg, microcrystalline cellulose – 153.2 mg, croscarmellose sodium – 80 mg, povidone – 40 mg, magnesium stearate – 10 mg.
Film coating composition Opadry II (pink) 85F240084 (polyvinyl alcohol – 40%, titanium dioxide – 21.8%, macrogol – 20.2%, talc – 14.8%, yellow iron oxide – 2%, red iron oxide – 1.2%) – 30 mg.
5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – plastic jars (1) – cardboard packs.
7 pcs. – plastic jars (1) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets 400 mg: 5, 7, or 10 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Moxifloxacin-Vertex | Film-coated tablets 400 mg: 5, 7, or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, round, biconvex; cross-section shows a core from light yellow to yellow.
| 1 tab. | |
| Moxifloxacin hydrochloride | 436.4 mg, |
| Equivalent to moxifloxacin content | 400 mg |
Excipients: lactose monohydrate – 187.5 mg, croscarmellose sodium – 21 mg, povidone (K-30) 14 mg, talc 14 mg, microcrystalline cellulose – 13.1 mg, colloidal silicon dioxide 7 mg, magnesium stearate – 7 mg.
Film coating composition hypromellose – 10.5 mg, hypromellose – 4.074 mg, talc – 4.044 mg, titanium dioxide – 2.283 mg, yellow iron oxide – 0.99 mg
or
Dry mixture for film coating weighing 21 mg, including hypromellose (50%), hypromellose (19.4%), talc (19.26%), titanium dioxide (10.87%), yellow iron oxide (0.47%).
5 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
5 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
7 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
![Moxifloxacin [Tablets, Solution, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Moxifloxacin [Tablets, Solution, Drops] 2")