What is Moxifloxacino Apotex?
Moxifloxacino Apotex injection is used to treat bacterial infections in many different parts of the body.
Moxifloxacino Apotex belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Moxifloxacino Apotex will not work for colds, flu, or other virus infections.
Moxifloxacino Apotex is to be given only by or under the direct supervision of your doctor.
Moxifloxacino Apotex indications
Acute Bacterial Sinusitis
Moxifloxacino Apotex is indicated in adult patients (18 years of age and older) for the treatment of Acute Bacterial Sinusitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute Bacterial Exacerbation of Chronic Bronchitis
Moxifloxacino Apotex is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Community Acquired Pneumonia
Moxifloxacino Apotex is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]),Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.
MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Uncomplicated Skin and Skin Structure Infections
Moxifloxacino Apotex is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
Complicated Skin and Skin Structure Infections
Moxifloxacino Apotex is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
Complicated Intra-Abdominal Infections
Moxifloxacino Apotex is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.
Avelox is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of Moxifloxacino Apotex could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only .
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacino Apotex and other antibacterial drugs, Moxifloxacino Apotex should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How should I use Moxifloxacino Apotex?
Use Moxifloxacino Apotex drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Moxifloxacino Apotex drops is only for the eye. Do not get it in your nose or mouth.
- To use Moxifloxacino Apotex drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- Do not wear contact lenses while you are using Moxifloxacino Apotex drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
- To clear up your infection completely, use Moxifloxacino Apotex drops for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Moxifloxacino Apotex drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Moxifloxacino Apotex drops.
Uses of Moxifloxacino Apotex in details
Moxifloxacino Apotex is used to treat bacterial infections of the respiratory tract, infections of female upper genital tract, abdominal infections and infections of skin and eye.
Moxifloxacino Apotex description
Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacino Apotex 400 mg. It also contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 4000, titanium dioxide (E171) and ferric oxide (E172) as inactive constituents.
Each 250 mL solution for infusion contain Moxifloxacino Apotex HCl 436.8 mg equivalent to Moxifloxacino Apotex 400 mg. It also contains sodium chloride, 1N hydrochloric acid, 2N sodium hydroxide and water for injection. The solution for infusion (250 mL) contains sodium 34 mmol.
Moxifloxacino Apotex dosage
DOSAGE AND ADMINISTRATION
The dose of Moxifloxacino Apotex is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described below.
For Complicated Intra-Abdominal Infections, therapy should usually be initiated with the intravenous formulation.
When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacino Apotex I.V. may be switched to Moxifloxacino Apotex Tablets when clinically indicated at the discretion of the physician.
Oral doses of Moxifloxacino Apotex should be administered at least 4 hours before or 8 hours after antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution.
Impaired Renal Function
No dosage adjustment is required in renally impaired patients, including those on either hemodialysis or continuous ambulatory peritoneal dialysis.
Impaired Hepatic Function
No dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).
Moxifloxacino Apotex I.V. should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Moxifloxacino Apotex I.V. should be administered by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION MUST BE AVOIDED.
Since only limited data are available on the compatibility of Moxifloxacino Apotex intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacino Apotex I.V. or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of Moxifloxacino Apotex I.V. with an infusion solution compatible with Moxifloxacino Apotex I.V. as well as with other drug(s) administered via this common line.
Preparation for administration of Moxifloxacino Apotex I.V. injection premix in flexible containers:
- Close flow control clamp of administration set.
- Remove cover from port at bottom of container.
- Insert piercing pin from an appropriate transfer set (e.g. one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.
NOTE: Refer to complete directions that have been provided with the administration set.
Moxifloxacino Apotex interactions
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacino Apotex was proven: Atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.
Antacids, Minerals and Multivitamins: Concomitant ingestion of Moxifloxacino Apotex with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacino Apotex after oral administration due to formation of chelate complexes with the multivalent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, antiretroviral drugs (eg, didanosine) and other preparations containing magnesium or aluminium, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral Moxifloxacino Apotex dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacino Apotex. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacino Apotex uptake from the gastrointestinal tract.
Calcium Supplements: When given with high dose calcium supplements, only a slightly reduced rate of absorption was observed, while extent of absorption remained unaffected. The effect of high-dose calcium supplements on the absorption of Moxifloxacino Apotex is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacino Apotex on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacino Apotex does not interfere with the 1A2 subtypes of the CYP450 enzymes.
Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.
Changes in International Normalized Ratio (INR): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacino Apotex. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacino Apotex and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Oral Contraceptives:No interaction has occured following concomitant oral administration of Moxifloxacino Apotex with oral contraceptives.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacino Apotex.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacino Apotex treatment. Pharmacokinetics of Moxifloxacino Apotex were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacino Apotex and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacino Apotex (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacino Apotex increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Parenteral administration of morphine with Moxifloxacino Apotex did not reduce the oral bioavailability of Moxifloxacino Apotex and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacino Apotex. Following single dose administration in healthy subjects, AUC was marginally increased (by approximately 4%) and peak concentrations were decreased by 10%.
Probenecid: No significant effect on apparent total body clearance and renal clearance of Moxifloxacino Apotex was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacino Apotex 400 mg reduced the systemic availability of the drug by >80% by preventing absorption in vivo. The application of activated charcoal in the early absorption phase prevents further increase of systemic exposure in cases of overdose.
After IV drug administration, carbo medicinalis only slightly reduces systemic exposure (approximately 20%).
Food and Dairy Products: Absorption of Moxifloxacino Apotex was not altered by food intake (including dairy products). Moxifloxacino Apotex can be taken independent from food intake.
Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.
Moxifloxacino Apotex side effects
Clinical efficacy trials enrolled over 9,200 Moxifloxacino Apotex orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in Moxifloxacino Apotex trials were described as mild to moderate in severity and required no treatment. Moxifloxacino Apotex was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.
Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of Moxifloxacino Apotex treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).
Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of Moxifloxacino Apotex treated patients were:
BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction
CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged
DIGESTIVE: vomiting, abnormal liver function test (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis
HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia
METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased
MUSCULOSKELETAL: arthralgia, myalgia
NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor
SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria
SPECIAL SENSES: taste perversion
UROGENITAL: vaginal moniliasis, vaginitis
Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of Moxifloxacino Apotex treated patients were:
abnormal dreams, abnormal vision (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia
Post-Marketing Adverse Event Reports:
Additional adverse events have been reported from worldwide post-marketing experience with Moxifloxacino Apotex. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction (see
Moxifloxacino Apotex contraindications
Hypersensitivity to other quinolones, Moxifloxacino Apotex or any of the excipients of Moxifloxacino Apotex.
Use in pregnancy: The safe use of Moxifloxacino Apotex in human pregnancy has not been established. Reversible joint injuries are described in children receiving some quinolones. However, this effect has not been reported as occurring on exposed foetuses. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.
Consequently, the use of Moxifloxacino Apotex during pregnancy is contraindicated.
Use in lactation: As with other quinolones, Moxifloxacino Apotex has been shown to cause lesions in the cartilage of the weight bearing joints of immature animals. Preclinical evidence indicates that small amounts of Moxifloxacino Apotex may be secreted in human milk. There is no data available in lactating or nursing women. Therefore, the use of Moxifloxacino Apotex in nursing mothers is contraindicated.
Use in children: Safety and efficacy of Moxifloxacino Apotex in children and adolescents have not been established.
Active ingredient matches for Moxifloxacino Apotex:
Moxifloxacin in Spain.
List of Moxifloxacino Apotex substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Moxifloxacino Zentiva (Spain)|
|Moxiforce (South Korea)|
|MOXIFORD EYE DROP 1 packet / 5 ML eye drop each (Leeford Healthcare Ltd)||$ 1.05|
|Moxiford 400mg Tablet (Leeford Healthcare Ltd)||$ 0.62|
|Moxifresh NA Eye Drop (Smart Laboratories Pvt Ltd)||$ 0.30|
|MOXIGEN EYE DROP 1 packet / 5 ML eye drop each (Renova Life sciences Pvt Ltd)||$ 1.13|
|Moxigen 0.5% w/v Eye Drop (Renova Life sciences Pvt Ltd)||$ 1.13|
|MOXIGOOD 400 MG TABLET 1 strip / 5 tablets each (Cadila Pharmaceuticals Ltd)||$ 1.75|
|Moxigood 400mg Tablet (Cadila Pharmaceuticals Ltd)||$ 0.35|
|Moxigood 400mg Injection (Cadila Pharmaceuticals Ltd)||$ 0.03|
|Moxigram (Bangladesh, India)|
|Moxigram 0.5% EYE-DPS / 5ml (Micro Vision)||$ 1.16|
|0.5 % x 5ml (Micro Vision)||$ 1.16|
|MOXIGRAM 400 MG TABLET 1 strip / 5 tablets each (Micro Vision)||$ 1.84|
|MOXIGRAM D EYE DROP 1 packet / 10 ML eye drop each (Micro Vision)||$ 1.71|
|MOXIGRAM EYE DROP 1 packet / 5 ML eye drop each (Micro Vision)||$ 1.71|
|MOXIGRAM EYE OINTMENT 1 tube / 5 GM eye ointment each (Micro Vision)||$ 0.78|
|MOXIGRAM INFUSION 1 bottle / 100 ML infusion each (Micro Vision)||$ 1.90|
|MOXIGRAM eye drops 0.5 % x 5ml (Micro Vision)||$ 1.16|
|Moxigram 400mg Tablet (Micro Vision)||$ 0.37|
|Moxigram D Eye Drop (Micro Vision)||$ 1.71|
|Moxigram 0.5% w/v Eye Drop (Micro Vision)||$ 1.87|
|Moxigram 0.5% Eye Ointment (Micro Vision)||$ 0.85|
|Moxigram 400mg Infusion (Micro Vision)||$ 0.02|
|MOXIGRAM TAB (India)|
|MOXIGRAM TAB tab 400 mg x 5's (Micro Labs)||$ 1.57|
|5ml (Micro Labs)|
|Moxigram-DX Moxifloxacin 0.5 %, Dexamethasone 0.1 %. EYE-DPS / 5ml (Micro Labs)|
|Moxigram-DX Moxifloxacin 0.5 %, Dexamethasone 0.1 %. EYE DPS / 5ml (Micro Labs)|
|MOXIGRAM-DX eye drops 5ml (Micro Labs)||$ 1.02|
|Moxigram-DX Moxifloxacin 0.5 %, Dexamethasone 0.1 %. EYE-DPS / 5ml (Micro Labs)|
|Moxigram-DX Moxifloxacin 0.5 %, Dexamethasone 0.1 %. EYE DPS / 5ml (Micro Labs)|
|MOXIJET tab 400 mg x 10's (Astrica)|
|Moxikacin (South Korea)|
|MOXIKED EYE DROPS 1 packet / 5 ML eye drop each (Yash Pharma Laboratories Pvt Ltd)||$ 1.15|
|Moxiked Eye Drop (Yash Pharma Laboratories Pvt Ltd)||$ 1.15|
|400 mg x 3's (R.K Medicare)||$ 3.57|
|Moxilark 400mg TAB / 3 (R.K Medicare)||$ 3.57|
|MOXILARK tab 400 mg x 3's (R.K Medicare)||$ 3.57|
|Moxilark 400mg TAB / 3 (R.K Medicare)||$ 3.57|
|MOXILONE DPS (India)|
|MOXILONE DPS eye drops 0.5 % w/v x 5ml (Invision)||$ 0.73|
|Moximac 400mg TAB / 5 (Macleods (Oxalis))||$ 4.97|
|Moximac 0.5% w/v EYE-DPS / 5ml (Macleods (Oxalis))||$ 0.63|
- PubChem. "moxifloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "moxifloxacin". http://www.drugbank.ca/drugs/DB00218 (accessed September 17, 2018).
- Wikipedia. "moxifloxacin: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Moxifl... (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology