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What is Moxifloxacin Apotex?
Moxifloxacin Apotex is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.
Moxifloxacin Apotex ophthalmic (for use in the eyes) is used to treat bacterial infections of the eyes.
Moxifloxacin Apotex will not treat a viral or fungal infection of the eye. This medicine is for use in treating only bacterial infections.
Moxifloxacin Apotex ophthalmic may also be used for purposes not listed in this medication guide.
Moxifloxacin Apotex indications
Community Acquired Pneumonia
Moxifloxacin 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 pneumonia .
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
Moxifloxacin 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
Moxifloxacin 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
Moxifloxacin 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.
Moxifloxacin Apotex 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 Moxifloxacin 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.
Acute Bacterial Sinusitis
Moxifloxacin Apotex is indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Apotex, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacin Apotex for treatment of ABS in patients who have no alternative treatment options.
Acute Bacterial Exacerbation Of Chronic Bronchitis
Moxifloxacin Apotex is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Apotex, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacin Apotex for treatment of ABECB in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Apotex and other antibacterial drugs, Moxifloxacin 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 Moxifloxacin Apotex?
Use Moxifloxacin Apotex tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Moxifloxacin Apotex tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Moxifloxacin Apotex tablets refilled.
- Take Moxifloxacin Apotex tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Drink plenty of liquids while taking Moxifloxacin Apotex tablets.
- Do not take a product that has magnesium, aluminum, calcium, zinc, iron, or sucralfate in it within 8 hours before or 4 hours after you take Moxifloxacin Apotex tablets. Examples of these products include antacids, multivitamins, chewable/buffered didanosine, didanosine suspension, and quinapril. Check with your doctor or pharmacist if you have a question about whether you should separate Moxifloxacin Apotex tablets from a certain food or product.
- Take Moxifloxacin Apotex tablets on a regular schedule to get the most benefit from it.
- To clear up your infection completely, take Moxifloxacin Apotex tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Moxifloxacin Apotex tablets, take 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 take more than 1 dose in the same day.
Ask your health care provider any questions you may have about how to use Moxifloxacin Apotex tablets.
Uses of Moxifloxacin Apotex in details
Moxifloxacin 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.
Moxifloxacin Apotex description
Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacin 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 Moxifloxacin Apotex HCl 436.8 mg equivalent to Moxifloxacin 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.
Moxifloxacin Apotex dosage
Dosage In Adult Patients
The dose of Moxifloxacin 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 in Table 1.
Table 1: Dosage and Duration of Therapy in Adult Patients
|Type of InfectionDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.|
Oral Dosing In Adults
Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin Apotex Injection may be switched to Moxifloxacin Apotex Tablets when clinically indicated at the discretion of the physician.
Important Administration Instructions
Moxifloxacin Apotex Tablets
With Multivalent Cations
Administer Moxifloxacin Apotex Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.
Moxifloxacin Apotex Tablets can be taken with or without food, drink fluids liberally.
Moxifloxacin Apotex Injection
Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Administer 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. Avoid rapid or bolus intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard any unused portion because the premix flexible containers are for single-use only.
Drug and Diluent Compatibilities
Because only limited data are available on the compatibility of Moxifloxacin Apotex intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin Apotex Injection 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 Moxifloxacin Apotex Injection with an infusion solution compatible with Moxifloxacin Apotex Injection as well as with other drug(s) administered via this common line.
Intravenous Solutions:Moxifloxacin Apotex Injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:
0.9% Sodium Chloride Injection, USP
1 Molar Sodium Chloride Injection
5% Dextrose Injection, USP
Sterile Water for Injection, USP
10% Dextrose for Injection, USP
Moxifloxacin Apotex interactions
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin 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 Moxifloxacin Apotex with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin 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 Moxifloxacin Apotex dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin Apotex. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin 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 Moxifloxacin Apotex is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacin Apotex on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin 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 Moxifloxacin Apotex. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin 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 Moxifloxacin Apotex with oral contraceptives.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin Apotex.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin Apotex treatment. Pharmacokinetics of Moxifloxacin Apotex were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin Apotex and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin Apotex (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin Apotex increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Parenteral administration of morphine with Moxifloxacin Apotex did not reduce the oral bioavailability of Moxifloxacin Apotex and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin 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 Moxifloxacin Apotex was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin 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 Moxifloxacin Apotex was not altered by food intake (including dairy products). Moxifloxacin Apotex can be taken independent from food intake.
Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.
Moxifloxacin Apotex side effects
Applies to Moxifloxacin Apotex ophthalmic: ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Moxifloxacin Apotex ophthalmic (the active ingredient contained in Moxifloxacin Apotex). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Moxifloxacin Apotex ophthalmic:
Incidence not known:
- Fainting or loss of consciousness
- fast or irregular breathing
- skin rash
- swelling of the eyes or eyelids
- tightness in the chest or wheezing
- trouble with breathing
Minor Side Effects
Some of the side effects that can occur with Moxifloxacin Apotex ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
- Burning, dry, or itching eyes
- change in vision
- decreased vision
- dry eye
- excessive tearing
- eye discharge
- itching of the eye
- pain in the eye
- red, sore eyes
- redness of the eye
- swelling of the eye, eyelid, or inner lining of the eyelid
- Body aches or pain
- cough or hoarseness
- decreased hearing
- dryness or soreness of the throat
- fever or chills
- general body discomfort
- lower back or side pain
- painful or difficult urination
- rubbing or pulling of the ears (in children)
- runny nose
- sore throat
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- vomiting and diarrhea (in infants)
Moxifloxacin Apotex contraindications
You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacin Apotex or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.
Before taking Moxifloxacin Apotex, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, a history of seizures, low levels of potassium in your blood (hypokalemia), muscle weakness or trouble breathing, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take Moxifloxacin Apotex. These other medicines can make Moxifloxacin Apotex much less effective when taken at the same time.
Taking Moxifloxacin Apotex can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.
Moxifloxacin Apotex may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Moxifloxacin Apotex and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.
Do not share this medication with another person (especially a child), even if they have the same symptoms you do.
Active ingredient matches for Moxifloxacin Apotex:
Moxifloxacin in Belgium.
List of Moxifloxacin Apotex substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Moxifloxacin-ratiopharm (Germany, Hungary)|
|Moxifloxacina Aurobindo (Portugal)|
|Moxifloxacina La Santé (Colombia, Costa Rica, Ecuador, Panama)|
|Moxifloxacina MK (Colombia)|
|Moxifloxacina Vesalius (Colombia)|
|Moxifloxacine Double-E Pharma (Netherlands)|
|Moxifloxacine EG (Belgium, France)|
|Moxifloxacine Fresenius Kabi (Netherlands)|
|Moxifloxacine Krka (France)|
|Moxifloxacine Mylan (Belgium)|
|Moxifloxacine PCH (Netherlands)|
|Moxifloxacine Sandoz (France, Netherlands)|
|Moxifloxacine Teva (Belgium, Netherlands)|
|Moxifloxacino Actavis (Spain)|
|Moxifloxacino Apotex (Spain)|
|Moxifloxacino Aurobindo (Spain)|
|Moxifloxacino Cinfa (Spain)|
|Moxifloxacino Kern Pharma (Spain)|
|Moxifloxacino Krka (Spain)|
|Moxifloxacino MK (Colombia)|
|Moxifloxacino Mylan (Spain)|
|Moxifloxacino Qualigen (Spain)|
|Moxifloxacino Ratiopharm (Spain)|
|Moxifloxacino Sandoz (Spain)|
|Moxifloxacino Stada (Spain)|
|Moxifloxacino Tevagen (Spain)|
|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|
- 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).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Moxifloxacin Apotex are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Moxifloxacin Apotex. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology