Moxifloxacin Hydrochloride (Moxifloxacin Hydrochloride)

Trade Name : Moxifloxacin Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 400 mg/1

MOXIFLOXACIN HYDROCHLORIDE Quinolone Antimicrobial [EPC],Quinolones [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Moxifloxacin Hydrochloride (Moxifloxacin Hydrochloride) which is also known as Moxifloxacin Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 400 mg/1 per ml. Read more

Moxifloxacin Hydrochloride (Moxifloxacin Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS
  • See full prescribing information for complete boxed warning.
  • Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together () including:n- Discontinue moxifloxacin hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions ()
  • Arrayn- Array
  • Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis ().
  • Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions ( to ), reserve moxifloxacin hydrochloride for use in patients who have no alternative treatment options for the following indications:
  • Warnings and Precautions, Central Nervous System Effects (5.4)u00a0 u00a0u00a0u00a0u00a0u00a0u00a010/2018 Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019 Warnings and Precautions, Blood Glucose Disturbances (5.12)u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2018
  • Warnings and Precautions, Central Nervous System Effects (5.4)u00a0 u00a0u00a0u00a0u00a0u00a0u00a010/2018 Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019 Warnings and Precautions, Blood Glucose Disturbances (5.12)u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010/2018
  • Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below:
  • Community Acquired Pneumonia ()
  • Skin and Skin Structure Infections: Uncomplicated () and Complicated ()
  • Complicated Intra-Abdominal Infections ()
  • Plague ()
  • Acute Bacterial Sinusitis ()
  • Acute Bacterial Exacerbation of Chronic Bronchitis ()
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ()
  • No data
  • No dosage adjustment in patients with renal or hepatic impairment. (, )
  • Pink, film-coated, unscored, oval-shaped tablets, debossed with u201cTEVAu201d on one side and u201c7387u201d on the other side, containing moxifloxacin hydrochloride, USP (equivalent to 400 mg moxifloxacin).
  • Tablets: Moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) ()
  • Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [].
  • Known hypersensitivity to moxifloxacin tablets or other quinolones (, )
  • No data
  • Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. (, , )
  • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin hydrochloride. Discontinue moxifloxacin hydrochloride at first sign of skin rash, jaundice or any other sign of hypersensitivity. (, )
  • Clostridium difficile
  • The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label:
  • Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • Pregnancy:
  • Geriatrics:
  • Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation. Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.
  • Moxifloxacin hydrochloride, USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(,)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. It is a slightly yellow to yellow crystalline substance. Its chemical structure is as follows:
  • CHFNOu2022HCl M.W. 437.9
  • No data
  • No data
  • No data
  • Moxifloxacin Tablets USP, 400 mg are available as pink, film-coated, unscored, oval-shaped tablets, debossed with u201cTEVAu201d on one side and u201c7387u201d on the other in bottles of 30 (NDC 0093-7387-56).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Avoid high humidity.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Serious Adverse Reactions
  • Advise patients to stop taking moxifloxacin tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
  • Inform patients of the following serious adverse reactions that have been associated with moxifloxacin tablets or other fluoroquinolone use:
  • Antibacterial Resistance
  • Inform patients that antibacterial drugs including moxifloxacin hydrochloride should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When moxifloxacin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by moxifloxacin hydrochloride or other antibacterial drugs in the future.
  • Administration With Food, Fluids, and Drug Products Containing Multivalent Cations
  • Inform patients that moxifloxacin tablets may be taken with or without food. Advise patients drink fluids liberally.
  • Inform patients that moxifloxacin tablets should be taken at least 4 hours before or 8 hours after multivitamins (containing iron or zinc), antacids (containing magnesium or aluminum), sucralfate, or didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.
  • Plague Studies
  • Inform patients given moxifloxacin hydrochloride for plague that efficacy studies could not be conducted in humans for feasibility reasons. Therefore, approval for plague was based on efficacy studies conducted in animals.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. G 12/2019
  • FDA-Approved Medication Guide
  • Moxifloxacin (moxu2033 i floxu2032 a sin) Tablets
  • Read the Medication Guide that comes with moxifloxacin tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What is the most important information I should know about moxifloxacin tablets?
  • Moxifloxacin tablets belong to a class of antibiotics called fluoroquinolones. Moxifloxacinu00a0 tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin tablets.
  • 1. Tendon rupture or swelling of the tendon (tendinitis).
  • 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy).
  • Moxifloxacin tablets may need to be stopped to prevent permanent nerve damage.
  • 3. Central Nervous System (CNS) effects.
  • 4. Worsening of myasthenia gravis (a disease which causes muscle weakness).
  • See the section u201cu201d for more information about side effects.
  • What are moxifloxacin tablets?
  • Moxifloxacin tablets are a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. These bacterial infections include:
  • Moxifloxacin tablets should not be used in patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.
  • Studies of moxifloxacin tablets for use in the treatment of plague were done in animals only, because plague could not be studied in people.
  • It is not known if moxifloxacin tablets are safe and work in people under 18 years of age. Children have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibiotic medicines.
  • Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including moxifloxacin tablets, do not kill viruses.
  • Call your healthcare provider if you think your condition is not getting better while you are taking moxifloxacin tablets.
  • Who should not take moxifloxacin tablets?
  • Do not take moxifloxacin tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in moxifloxacin tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in moxifloxacin tablets at the end of this Medication Guide.
  • What should I tell my healthcare provider before taking moxifloxacin tablets?
  • See u201cu201d
  • Tell your healthcare provider about all your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • Ask your healthcare provider if you are not sure if any of your medicines are listed above.
  • Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take moxifloxacin tablets?
  • What should I avoid while taking moxifloxacin tablets?
  • What are the possible side effects of moxifloxacin tablets?
  • Moxifloxacin tablets can cause side effects that may be serious or even cause death. See u201cu201d
  • Other serious side effects of moxifloxacin tablets include:
  • Serious allergic reactions
  • Aortic aneurysm and dissection
  • Skin rash
  • Serious heart rhythm changes
  • Intestine infection
  • Changes in blood sugar
  • Sensitivity to sunlight (photosensitivity)
  • These are not all the possible side effects of moxifloxacin tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store moxifloxacin tablets?
  • Keep moxifloxacin tablets and all medicines out of the reach of children.
  • General Information about moxifloxacin tablets
  • What are the ingredients in moxifloxacin tablets?
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. D 12/2019
  • NDCu00a0n- -7387-
  • Moxifloxacinu00a0n- Tablets USP
  • 400 mg*
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • Rx only
  • 30 TABLETS
  • TEVA

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