Levofloxacin (Levofloxacin)

Trade Name : Levofloxacin

Hikma Pharmaceuticals USA Inc.

INJECTION, SOLUTION

Strength 750 mg/150mL

LEVOFLOXACIN

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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 Levofloxacin (Levofloxacin) which is also known as Levofloxacin and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 750 mg/150mL per ml. Read more

Levofloxacin (Levofloxacin) 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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  • See full prescribing information for complete boxed warning.
  • Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions ().
  • Warnings and Precautions (, ) u00a0u00a0u00a0 07/2018
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 03/2019
  • Levofloxacin injection is indicated for the treatment of adults (u2265 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).
  • Levofloxacin is a fluoroquinolone antibacterial indicated in adults (u2265 18 years of age) with infections caused by designated, susceptible bacteria (, ).
  • Usage
  • To reduce the development of drug-resistanct bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ().
  • Pneumonia: nosocomial () and community acquired (, )
  • Skin and skin structure infections: complicated () and uncomplicated ()
  • Chronic bacterial prostatitis ()
  • Inhalational anthrax, post-exposure ()
  • Plague ()
  • Urinary tract infections: complicated (, ) and uncomplicated ()
  • Acute pyelonephritis ()
  • Acute bacterial exacerbation of chronic bronchitis ()
  • Acute bacterial sinusitis ()
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  • u00a0INJECTION (5 mg/mL in 5% Dextrose) Premix in Single Dose Flexible Containers, for intravenous infusion
  • Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see ].
  • Known hypersensitivity to levofloxacin or other quinolones (, )
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  • Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (, )
  • Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ()
  • Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ()
  • Clostridium difficile
  • Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (, )
  • The most common reactions (u2265 3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ().
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticalsu00a0Corp.u00a0at 1-877-233-2001, or theu00a0FDA at 1-800-FDA-1088 or .
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  • Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (, , ). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (, , ). May be more susceptible to prolongation of the QT interval. (, , ).
  • Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals (, , ). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) (, , , ) and plague (, , , )
  • In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.
  • Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.
  • Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.
  • Figure 1: The Chemical Structure of Levofloxacin
  • The empirical formula is CHFNO u2022 u00bd HO and the molecular weight is 370.38. Levofloxacin is a light yellowishu2011white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine.
  • The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100u00a0mg/mL). Levofloxacin is considered in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.
  • Levofloxacin has the potential to form stable coordination compounds with many metal ions. This chelation potential has the following formation order: Al>Cu>Zn>Mg>Ca.
  • Excipients and Description of Dosage Formsn n- Levofloxacin Injectionn
  • Levofloxacin Injection Premix in Single Dose Flexible Containers
  • The flexible container is fabricated fromu00a0polypropylene. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the containeru2019s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
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  • Levofloxacin Injection in 5% Dextrose is supplied as a single dose, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W).
  • Levofloxacin Injection Premix in Flexible Containers should be stored at or below 25u00b0C (77u00b0F); however, brief exposure up to 40u00b0C (104u00b0F) does not adversely affect the product. Avoid excessive heat and protect from freezing and light. Levofloxacin Injection Premix in Flexible Containers is manufactured by Hikma Farmacu00eautica (Portugal), S.A. and distributed by West-Ward Pharmaceutical Corp.
  • Keep out of reach of children.
  • Advise the patient to read the n n
  • Serious Adverse Reactions
  • Advise patients to stop taking levofloxacin 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 levofloxacin or other fluoroquinolone use:
  • Antibacterial Resistance
  • Antibacterial drugs including levofloxacin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When levofloxacin is 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 levofloxacin or other antibacterial drugs in the future.
  • Administration with Food, Fluids, and Concomitant Medications
  • Patients should drink fluids liberally while taking levofloxacin to avoid formation of a highly concentrated urine and crystal formation in the urine.
  • Antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or two hours after oral levofloxacin administration.
  • Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin
  • Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue levofloxacin and consult a physician.
  • Patients should be informed that concurrent administration of warfarin and levofloxacin has been associated with increases of the International Normalized Ratio (INR) or prothrombin time and clinical episodes of bleeding. Patients should notify their physician if they are taking warfarin, be monitored for evidence of bleeding, and also have their anticoagulation tests closely monitored while taking warfarin concomitantly.
  • Plague and Anthrax Studies
  • Patients given levofloxacin for these conditions should be informed that efficacy studies could not be conducted in humans for ethical and feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.
  • Manufactured by:n
  • Distributed by:n
  • Revised: March 2019n
  • PIN287-WES/11
  • u00a0
  • LEVOFLOXACIN INJECTION in 5% Dextrose, Solution for Intravenous Use
  • Read this Medication Guide before you start taking levofloxacin. 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.u00a0
  • What is the most important information I should know about levofloxacin?u00a0n n- Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. n
  • 1.u00a0u00a0u00a0 n- Tendon rupture or swelling of the tendon (tendinitis).
  • 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy).
  • Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including levofloxacin. Stop taking levofloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • The nerve damage may be permanent.
  • 3. Central Nervous System (CNS) effects.
  • Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including levofloxacin. Tell your healthcare provider if you have a history of seizures before you start taking levofloxacin. CNS side effects may happen as soon as after taking the first dose of levofloxacin. Stop taking levofloxacin immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • 4.u00a0u00a0u00a0 n- Worsening of myasthenia gravis (au00a0problem that causes muscle weakness).n
  • What is levofloxacin? n
  • Studies of levofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
  • Levofloxacin should not be used in patients with uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis if there are other treatment options available.
  • Levofloxacin is also used to treat children who are 6 months of age or older and may have breathed in anthrax germs, have plague, or been exposed to plague germs.
  • It is not known if levofloxacin is safe and effective in children under 6 months of age.
  • The safety and effectiveness in children treated with levofloxacin for more than 14 days is not known.
  • Who should not take levofloxacin? Do not take levofloxacin
  • What should I tell my healthcare provider before taking levofloxacin?Before you take levofloxacin, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Levofloxacin and other medicines can affect each other causing side effects. Especially tell your healthcare provider if 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 medicinen
  • How should I take levofloxacin?
  • Taking all of your levofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your levofloxacin doses will help you lower the chance that the bacteria will become resistant to levofloxacin. If your infection does not get better while you take levofloxacin, it may mean that the bacteria causing your infection may be resistant to levofloxacin. If your infection does not get better, call your healthcare provider. If your infection does not get better, levofloxacin and other similar antibiotic medicines may not work for you in the future.
  • What should I avoid while taking levofloxacin?
  • What are the possible side effects of levofloxacin?n n- Levofloxacin can cause serious side effects, including:
  • Skin rash may happen in people taking levofloxacin, even after only one dose. Stop taking levofloxacin at the first sign of a skin rash and immediately call your healthcare provider. Skin rash may be a sign of a more serious reaction to levofloxacin.
  • Stop taking levofloxacin and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to levofloxacin (a liver problem).
  • The most common side effects of levofloxacin include:
  • In children 6 months and older who take levofloxacin to treatu00a0anthrax disease or plague, vomiting is also common.
  • Low blood pressure can happen when levofloxacin is given too fast by IV injection. Tell your healthcare provider if you feel dizzy or faint during a treatment with levofloxacin injection.
  • Levofloxacin may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.
  • These are not all the possible side effects of levofloxacin. 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.
  • Keep levofloxacin and all medicines out of the reach of children.
  • General information about the safe and effective use of Levofloxacinn
  • This Medication Guide summarizes the most important information about levofloxacin. If you would like more information about levofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about levofloxacin that is written for healthcare professionals.
  • What are the ingredients in levofloxacin?
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:n
  • Distributed by:n
  • Revised: March 2019n
  • PIN288-WES/6
  • TO OPEN - TEAR AT NOTCHONE UNITn n n Each 50 mL contains a dilute solution equivalent of 250 mg of Levofloxacin, USP(5 mg/mL) in 5% dextrose. May contain Hydrochloric Acid, NF and/or SodiumHydroxide, NF to adjust pH to 3.8-5.8.n See package insert. Recommended storage: at or below25u00baC (77u00baF); however, brief exposure up to 40u00baC (104u00baF) does not adversely affect theproduct. Protect from light. Avoid excessive heat and protect from freezing.n Additives should not be added or infused throughthe same intravenous line. The overwrap is a moisture barrier. Do not removeunit from overwrap until ready to use. Use unit promptly when pouch is open.After removing the overwrap, check for minute leaks by squeezing containerfirmly. If leaks are found, discard unit as sterility may be impaired. n Rx OnlyNDC 0143-9722-01
  • TO OPEN - TEAR AT NOTCHONE UNITn n n Each 100 mL contains a dilute solution equivalent of 500 mg of Levofloxacin, USP (5 mg/mL) in5% dextrose. May contain Hydrochloric Acid, NF and/or Sodium Hydroxide, NF to adjust pH to3.8-5.8.n See package insert. Recommended storage: at or below 25u00baC (77u00baF);however, brief exposure up to 40u00baC (104u00baF) does not adversely affect the product. Protect fromlight. Avoid excessive heat and protect from freezing.n Additives should not be added or infused through the same intravenousline. The overwrap is a moisture barrier. Do not remove unit from overwrap until ready to use.Use unit promptly when pouch is open. After removing the overwrap, check for minute leaks bysqueezing container firmly. If leaks are found, discard unit as sterility may be impaired. n Rx OnlyNDC 0143-9721-01
  • u00a0n
  • TO OPEN - TEAR AT NOTCHONE UNITn n n Each 150 mL contains a dilute solution equivalent of 750 mg of Levofloxacin, USP (5 mg/mL) in 5% dextrose. May contain Hydrochloric Acid, NF and/or Sodium Hydroxide, NF to adjust pH to 3.8-5.8.n See package insert. Recommended storage: at or below 25u00baC (77u00baF); however, brief exposure up to 40u00baC (104u00baF) does not adversely affect the product. Protect fromlight. Avoid excessive heat and protect from freezing.n Additives should not be added or infused through the same intravenous line. The overwrap is a moisture barrier. Do not remove unit from overwrap until ready to use. Use unit promptly when pouch is open. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. n Rx OnlyNDC 0143-9720-01
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