• Moxifloxacin Apotex 400mg indications
• Uses of Moxifloxacin Apotex 400mg in details
• Moxifloxacin Apotex 400mg description
• Moxifloxacin Apotex 400mg dosage
• Moxifloxacin Apotex 400mg interactions
• Moxifloxacin Apotex 400mg side effects
• Moxifloxacin Apotex 400mg contraindications

What is Moxifloxacin Apotex 400mg?

Moxifloxacin Apotex 400mg injection is used to treat bacterial infections in many different parts of the body.

Moxifloxacin Apotex 400mg belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Moxifloxacin Apotex 400mg will not work for colds, flu, or other virus infections.

Moxifloxacin Apotex 400mg is to be given only by or under the direct supervision of your doctor.

Moxifloxacin Apotex 400mg indications

Community Acquired Pneumonia

Moxifloxacin Apotex 400mg 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 400mg 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 400mg 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 400mg 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.

Plague

Moxifloxacin Apotex 400mg 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 400mg 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 400mg 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 400mg, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacin Apotex 400mg for treatment of ABS in patients who have no alternative treatment options.

Acute Bacterial Exacerbation Of Chronic Bronchitis

Moxifloxacin Apotex 400mg 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 400mg, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacin Apotex 400mg for treatment of ABECB in patients who have no alternative treatment options.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Apotex 400mg and other antibacterial drugs, Moxifloxacin Apotex 400mg 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 400mg?

Use Moxifloxacin Apotex 400mg tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Moxifloxacin Apotex 400mg tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Moxifloxacin Apotex 400mg tablets refilled.
• Take Moxifloxacin Apotex 400mg 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 400mg 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 400mg 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 400mg tablets from a certain food or product.
• Take Moxifloxacin Apotex 400mg tablets on a regular schedule to get the most benefit from it.
• To clear up your infection completely, take Moxifloxacin Apotex 400mg 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 400mg 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 400mg tablets.

Uses of Moxifloxacin Apotex 400mg in details

Use: Labeled Indications

Treatment of mild to moderate community-acquired pneumonia, including multidrug-resistant Streptococcus pneumoniae (MDRSP); acute bacterial exacerbation of chronic bronchitis; acute bacterial rhinosinusitis; complicated and uncomplicated skin and skin structure infections; complicated intra-abdominal infections; prophylaxis and treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve Moxifloxacin Apotex 400mg for use in patients who have no alternative treatment options for acute exacerbation of chronic bronchitis or acute sinusitis.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) Expert Panel Meetings on Prevention and Treatment of Anthrax in Adults, Moxifloxacin Apotex 400mg is as an effective and recommended agent for the treatment of cutaneous anthrax and an alternative agent for postexposure prophylaxis and treatment of systemic anthrax (with or without possible/confirmed meningitis).

Bite wounds (animal/human)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Moxifloxacin Apotex 400mg is an effective and recommended alternative option for treatment of bite wounds, particularly in patients with a human bite wound who are hypersensitive to beta-lactams.

Diabetic foot infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of diabetic foot infections, Moxifloxacin Apotex 400mg is an effective and recommended treatment option for moderate to severe diabetic foot infections.

Meningitis, bacterial

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis and health care-associated ventriculitis and meningitis, Moxifloxacin Apotex 400mg is an effective and recommended alternative agent for the treatment of meningitis caused by penicillin- and cephalosporin-resistant Streptococcus pneumoniae.

Mycoplasma genitalium

Noncontrolled trials support the use of Moxifloxacin Apotex 400mg as alternative treatment in patients with persistent detection of Mycoplasma genitalium who have not responded to or are intolerant of azithromycin. Additional data may be necessary to further define the role of Moxifloxacin Apotex 400mg in this condition.

Pelvic inflammatory disease

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Moxifloxacin Apotex 400mg may be considered as alternative treatment in patients allergic to cephalosporins with pelvic inflammatory disease. The CDC recommends use as an alternative therapy only if standard parenteral cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed.

Surgical prophylaxis

Based on the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society of Healthcare Epidemiology of America (SHEA) guidelines for antimicrobial prophylaxis in surgery, Moxifloxacin Apotex 400mg (systemic) may be administered (in combination with either clindamycin or vancomycin) as an alternative regimen in patients with beta-lactam allergy.

Tuberculosis (second-line therapy)

Based on the American Thoracic Society, Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) Treatment of Tuberculosis guidelines, Moxifloxacin Apotex 400mg (systemic) given for second-line therapy of tuberculosis is effective and recommended in the management of this condition.

Moxifloxacin Apotex 400mg description

Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacin Apotex 400mg 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 400mg HCl 436.8 mg equivalent to Moxifloxacin Apotex 400mg 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 400mg dosage

Moxifloxacin Apotex 400mg Dosage

Generic name: Moxifloxacin Apotex 400mg HYDROCHLORIDE 5mg in 1mL

Dosage form: ophthalmic solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Instill one drop in the affected eye 3 times a day for 7 days.

More about Moxifloxacin Apotex 400mg (Moxifloxacin Apotex 400mg ophthalmic)

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Consumer resources

• Moxifloxacin Apotex 400mg
• Moxifloxacin Apotex 400mg drops
• Moxifloxacin Apotex 400mg (Advanced Reading)

• Other brands: Moxeza

Professional resources

• Moxifloxacin Apotex 400mg eent (AHFS Monograph)
• Moxifloxacin Apotex 400mg (FDA)

Related treatment guides

• Conjunctivitis, Bacterial

• Ophthalmic Surgery

Moxifloxacin Apotex 400mg interactions

See also:
What other drugs will affect Moxifloxacin Apotex 400mg?

Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin Apotex 400mg 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 400mg with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin Apotex 400mg 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 400mg dose.

Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin Apotex 400mg. Absorption parameters (C_max, t_max, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin Apotex 400mg 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 400mg is considered as clinically not relevant.

Theophylline: In accordance with in vitro data, no influence of Moxifloxacin Apotex 400mg on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin Apotex 400mg 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 400mg. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin Apotex 400mg 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 400mg with oral contraceptives.

Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin Apotex 400mg.

Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin Apotex 400mg treatment. Pharmacokinetics of Moxifloxacin Apotex 400mg were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin Apotex 400mg and vice versa.

Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin Apotex 400mg (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin Apotex 400mg increased C_max of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

Morphine:

Parenteral administration of morphine with Moxifloxacin Apotex 400mg did not reduce the oral bioavailability of Moxifloxacin Apotex 400mg and only slighlty decreased C_max (17 %).

Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin Apotex 400mg. 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 400mg was found in a clinical study investigating the impact of probenecid on renal excretion.

Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin Apotex 400mg 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 400mg was not altered by food intake (including dairy products). Moxifloxacin Apotex 400mg can be taken independent from food intake.

Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.

Moxifloxacin Apotex 400mg side effects

See also:
What are the possible side effects of Moxifloxacin Apotex 400mg?

Applies to Moxifloxacin Apotex 400mg ophthalmic: ophthalmic solution

As well as its needed effects, Moxifloxacin Apotex 400mg ophthalmic (the active ingredient contained in Moxifloxacin Apotex 400mg) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Moxifloxacin Apotex 400mg ophthalmic, check with your doctor immediately:

Incidence not known:

• Fainting or loss of consciousness
• fast or irregular breathing
• itching
• skin rash
• swelling of the eyes or eyelids
• tightness in the chest or wheezing
• trouble with breathing

Minor Side Effects

Some Moxifloxacin Apotex 400mg ophthalmic side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• 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
• tearing

Less common:

• Body aches or pain
• congestion
• 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
• rash
• 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 400mg contraindications

See also:
What is the most important information I should know about Moxifloxacin Apotex 400mg?

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacin Apotex 400mg or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Before taking Moxifloxacin Apotex 400mg, 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 400mg. These other medicines can make Moxifloxacin Apotex 400mg much less effective when taken at the same time.

Taking Moxifloxacin Apotex 400mg can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.

Moxifloxacin Apotex 400mg 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 400mg 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 400mg:

Moxifloxacin in Luxembourg.

List of Moxifloxacin Apotex 400mg substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Moxifloxacin-Ratiopharm 400mg (Hungary, Luxembourg)
Moxifloxacina Aurobindo (Portugal)
Moxifloxacina La Santé (Colombia, Costa Rica, Ecuador, Panama)
Moxifloxacina Lafedar (Argentina)
Moxifloxacina MK (Colombia)
Moxifloxacina Rompharm (Romania)
Moxifloxacina Sandoz (Italy, Romania)
Moxifloxacina Teva (Italy)
Moxifloxacina Vesalius (Colombia)
Moxifloxacine Double-E Pharma (Netherlands)
Moxifloxacine EG (Belgium, France)
Moxifloxacine EG 400mg (Luxembourg)
Moxifloxacine Fresenius Kabi (Netherlands)
Moxifloxacine Krka (France)
Moxifloxacine Mylan (Belgium)
Moxifloxacine PCH (Netherlands)
Moxifloxacine Pharmathen (Netherlands)
Moxifloxacine Sandoz (France, Netherlands)
Moxifloxacine Teva (Belgium, Netherlands)
Moxifloxacine VIOSER (Netherlands)
Moxifloxacino Actavis (Spain)
Moxifloxacino Apotex (Spain)
Moxifloxacino Aurobindo (Spain)
Moxifloxacino Bayfarma (Spain)
Moxifloxacino Cinfa (Spain)
Moxifloxacino G.E.S. (Spain)
Moxifloxacino Hetero (Spain)
Moxifloxacino Kabi (Spain)
Moxifloxacino Kern Pharma (Spain)
Moxifloxacino Krka (Spain)
Moxifloxacino MK (Colombia)
Moxifloxacino Mylan (Spain)
Moxifloxacino Pharmathen (Spain)
Moxifloxacino Qualigen (Spain)
Moxifloxacino Ratiopharm (Spain)
Moxifloxacino Sandoz (Spain)
Moxifloxacino Stada (Spain)
Moxifloxacino Tevagen (Spain)
Moxifloxacino Zentiva (Spain)
Moxifloxan (Bulgaria)
See 879 substitutes for Moxifloxacin Apotex 400mg

References

1. PubChem. "moxifloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "moxifloxacin". http://www.drugbank.ca/drugs/DB00218 (accessed September 17, 2018).
3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology