Floxguard Uses

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What is Floxguard?

Floxguard is used to treat bronchitis and pneumonia caused by bacterial infections.

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

Floxguard is available only with your doctor's prescription.

Floxguard indications

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Floxguard is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including Floxguard, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Floxguard for treatment of ABECB in patients who have no alternative treatment options.

Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Floxguard and other antibacterial drugs, Floxguard should be used only to treat 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 Floxguard?

Use Floxguard as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Floxguard.

Uses of Floxguard in details

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Use: Labeled Indications

Treatment of acute exacerbation of chronic bronchitis; treatment of community-acquired pneumonia (CAP), including pneumonia caused by multidrug-resistant strains of S. pneumoniae (MDRSP)

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 Floxguard for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

Off Label Uses

Gonococcal, uncomplicated urogenital infections (patients with cephalosporin allergy)

Data from a multicenter, randomized, open-label, noncomparative trial demonstrated that Floxguard in combination with azithromycin was effective for uncomplicated urogenital gonorrhea (cure rate: 99.5% [lower one-sided 95% CI bound = 97.6%]). However, gastrointestinal adverse events were common (~8% of patients vomited within one hour) and may limit routine use.

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Floxguard in combination with azithromycin may be an effective alternative regimen for the treatment of uncomplicated urogenital gonococcal infections in patients with cephalosporin allergy, although limited evidence is available and more studies are needed.

Floxguard description

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Each film-coated tablet also contains the following excipients: Crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

Floxguard is a synthetic broad-spectrum antibacterial agent for oral administration. Floxguard, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, Floxguard is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid.

The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Floxguard is considered freely soluble at neutral pH (350 mcg/mL at 37°C, pH 7). Its empirical formula is C18H2OFN5O4·CH4O3S.

Floxguard dosage

Floxguard Dosage

Generic name: Floxguard MESYLATE 320mg

Dosage form: tablet

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

Floxguard can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of Floxguard is 320 mg daily, according to the following table (Table 4).

Table 4. Recommended Dosage Regimen of Floxguard

The clinical decision regarding the use of a 5 or 7 day regimen should be guided by results of the initial sputum culture.

INDICATION DOSE / DURATION
Acute bacterial exacerbation of chronic bronchitis One 320 mg tablet daily for 5 days
Community-acquired pneumonia (of mild to moderate severity)
due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection One 320 mg tablet daily for 5 days
due to known or suspected MDRSP*, K. pneumoniae, or M. catarrhalis infection One 320 mg tablet daily for 7 days

*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

The recommended dose and duration of Floxguard should not be exceeded.

Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance 40 mL/min. Table 5 provides dosage guidelines for use in patients with renal impairment.

Table 5. Recommended Doses for Patients with Renal Impairment

Creatinine Clearance

(mL/min)

Dose
>40 See Usual Dosage
40 160 mg every 24 hours

Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

Creatinine Clearance Formula

Women: 0.85 x the value calculated for men

Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.

Use in

Elderly: No dosage adjustment is recommended.

More about Floxguard (Floxguard)

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Floxguard interactions

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What other drugs will affect Floxguard?

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Antacid/Divalent and Trivalent Cations: The systemic availability of Floxguard is significantly reduced when an aluminum- and magnesium-containing antacid is concomitantly administered (AUC decreased 85%; Cmax decreased 87%). Administration of an aluminum- and magnesium-containing antacid, or ferrous sulfate 325 mg at 3 hrs before or at 2 hrs after Floxguard did not significantly alter the systemic availability of Floxguard. Therefore, aluminum- and/or magnesium-containing antacids, ferrous sulfate (iron), multivitamin preparations containing zinc or other metal cations, or Videx (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hrs before or 2 hrs after taking Floxguard tablets.

Calcium carbonate 1000 mg given either 2 hrs before or 2 hrs after Floxguard administration showed no notable reduction in Floxguard systemic availability. Calcium carbonate administered simultaneously with Floxguard resulted in a small, not clinically significant, decreased Floxguard exposure [AUC(0-∞) decreased 21% and Cmax decreased].

Sucralfate: When sucralfate 2 g was administered 3 hrs prior to Floxguard, the oral bioavailability of Floxguard was significantly reduced (53% decrease in AUC; 69% decrease in Cmax). When sucralfate 2 g was administered 2 hrs after Floxguard, the oral bioavailability of Floxguard was not significantly affected; therefore, Floxguard should be taken at least 2 hrs before sucralfate.

In vitro Metabolism: Results of in vitro inhibition studies indicate that hepatic cytochrome P-450 (CYP450) enzymes do not play an important role in Floxguard metabolism. Therefore, gemifloxcin should not cause significant in vivo pharmacokinetic interactions with outer drugs that are metabolized by CYP450 enzymes.

Theophylline: Floxguard 320 mg at steady state did not affect the repeat dose pharmacokinetics of theophylline (300-400 mg twice daily to healthy male subjects).

Digoxin: Floxguard 320 mg at steady state did not affect the repeat dose pharmacokinetics of digoxin (0.25 mg once daily to healthy elderly subjects).

Oral Contraceptives: The effect of an oral estrogen/progesterone contraceptive product (once daily for 21 days) on the pharmacokinetics of Floxguard (320 mg once daily for 6 days) in healthy female subjects indicates that concomitant administration caused an average reduction in Floxguard AUC and Cmax of 19% and 12%, respectively. These changes are not considered clinically significant. Floxguard 320 mg at steady state did not affect the repeat dose pharmacokinetics of an ethinylestradiol/levonorgestrol oral contraceptive product (30 mcg/150 mcg daily for 21 days to healthy female subjects).

Cimetidine: Co-administration of a single dose of Floxguard 320 mg with cimetidine 400 mg 4 times daily for 7 days resulted in slight average increases in gemifloxin AUC(0-∞) and Cmax of 10% and 6%, respectively. These increases are not considered clinically significant.

Omeprazole: Co-administration of a single dose of Floxguard 320 mg with omeprazole 40 mg once daily for 4 days resulted in slight average increases in Floxguard AUC(0-∞) and Cmax of 10% and 11%, respectively. These increases are not considered clinically significant.

Warfarin: Administration of repeated doses of Floxguard (320 mg once daily for 7 days) to healthy subjects on stable warfarin therapy had no significant effect on warfarin-induced anticoagulant activity (ie, international normalized ratios for prothrombin time).

Probenecid: Administration of a single dose of 320 mg Floxguard to healthy subjects who also received repeat doses of probenecid (total dose=4.5 g) reduced the mean renal clearance of Floxguard by approximately 50% resulting in a mean increase of 45% in Floxguard AUC(0-∞) and a prolongation of mean half-life by 1.6 hrs. Mean Floxguard Cmax increased 8%.

Floxguard side effects

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What are the possible side effects of Floxguard?

In clinical studies, 8119 patients received daily oral doses of 320 mg Floxguard. In addition, 1797 healthy volunteers and 81 patients with renal or hepatic impairment received single or repeat doses of Floxguard in clinical pharmacology studies. The majority of adverse reactions experienced by patients in clinical trials were considered to be of mild to moderate severity.

Floxguard was discontinued because of an adverse event (determined by the investigator to be possibly or probably related to drug) in 2.0% of patients, primarily due to rash (0.8%), nausea (0.3%), diarrhea (0.3%), urticaria (0.2%) and vomiting (0.2%). Comparator antibiotics were discontinued because of an adverse event at an overall comparable rate of 2.1%, primarily due to diarrhea (0.5%), nausea (0.4%), vomiting (0.3%), rash (0.3%), abdominal pain (0.2%) and vertigo (0.2%).

The most commonly reported adverse events with a frequency of ≥2% for patients receiving 320 mg Floxguard versus comparator drug (beta-lactam antibiotics, macrolides or other fluoroquinolones) are as follows: diarrhea 5.0% vs. 6.2%; rash 3.5% vs. 1.1%; nausea 3.7% vs. 4.5%; headache 4.2% vs. 5.2%; abdominal pain 2.2% vs. 2.2%; vomiting 1.6% vs. 2.0%; and dizziness 1.7% vs. 2.6%.

Adverse Events with a Frequency of Less than 1%

Additional drug-related adverse events (possibly or probably related) in the 8119 patients, with a frequency of >0.1% to ≤1% included: abdominal pain, anorexia, constipation, dermatitis, dizziness, dry mouth, dyspepsia, fatigue, flatulence, fungal infection, gastritis, genital moniliasis, genital pruritus, hyperglycemia, increased alkaline phosphatase, increased ALT, increased AST, increased creatine phosphokinase, insomnia, leukopenia, pruritus, somnolence, taste perversion, thrombocythemia, urticaria, vaginitis, and vomiting.

Other adverse events reported from clinical trials which have potential clinical significance and which were considered to have a suspected relationship to the drug, that occurred in ≤0.1% of patients were: abnormal urine, abnormal vision, anemia, arthralgia, asthenia, back pain, bilirubinemia, dyspnea, eczema, eosinophilia, facial edema, flushing, gastroenteritis, granulocytopenia, hot flashes, increased GGT, increased non-protein nitrogen, leg cramps, moniliasis, myalgia, nervousness, non-specified gastrointestinal disorder, pain, pharyngitis, photosensitivity/phototoxicity reactions, pneumonia, thrombocytopenia, tremor, vertigo.

In clinical trials of acute bacterial exacerbation of chronic bronchitis (ABECB) and community acquired pneumonia (CAP), the incidences of rash were as follows (Table 3):

Table 3. Incidence of Rash by Clinical Indication in Patients Treated with Floxguard

.

Laboratory Changes: The percentages of patients who received multiple doses of Floxguard and had a laboratory abnormality are listed below. It is not known whether these abnormalities were related to Floxguard or an underlying condition.

Clinical Chemistry: increased ALT (1.7%), increased AST (1.3%), increased creatine phosphokinase (0.7%), increased alkaline phosphatase (0.4%), increased total bilirubin (0.4%), increased potassium (0.3%), decreased sodium (0.2%), increased blood urea nitrogen (0.3%), decreased albumin (0.3%), increased serum creatinine (0.2%), decreased calcium (0.1%), decreased total protein (0.1%), decreased potassium (0.1%), increased sodium (0.1%), increased lactate dehydrogenase (<0.1%) and increased calcium (<0.1%).

CPK elevations were noted infrequently: 0.7% in Floxguard patients vs. 0.7% in the comparator patients.

Hematology: increased platelets (1.0%), decreased neutrophils (0.5%), increased neutrophils (0.5%), decreased hematocrit (0.3%), decreased hemoglobin (0.2%), decreased platelets (0.2%), decreased red blood cells (0.1%), increased hematocrit (0.1%), increased hemoglobin (0.1%), and increased red blood cells (0.1%).

In clinical studies, approximately 7% of the Floxguard treated patients had elevated ALT values immediately prior to entry into the study. Of these patients, approximately 15% showed a further elevation of their ALT at the on-therapy visit and 9% showed a further elevation at the end of therapy visit. None of these patients demonstrated evidence of hepatocellular jaundice. For the pooled comparators, approximately 6% of patients had elevated ALT values immediately prior to entry into the study. Of these patients, approximately 7% showed a further elevation of their ALT at the on-therapy visit and 4% showed a further elevation at the end of therapy visit.

In a clinical trial where 638 patients received either a single 640 mg dose of Floxguard or 250 mg BID of ciprofloxacin for 3 days, there was an increased incidence of ALT elevations in the Floxguard arm (3.9%) vs. the comparator arm (1.0%). In this study, two patients experienced ALT elevations of 8 to 10 times the upper limit of normal. These elevations were asymptomatic and reversible.

Post-Marketing Adverse Reactions: The majority of the post-marketing adverse events reported were cutaneous and most of these were rash. Some of these cutaneous adverse events were considered serious. The majority of the rashes occurred in women and in patients under 40 years of age.

The following are additional adverse reactions reported during the post-marketing use of Floxguard. Since these reactions are reported voluntarily from a population of uncertain size, it is impossible to reliably estimate their frequency or establish a causal relationship to Floxguard exposure:

Floxguard contraindications

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What is the most important information I should know about Floxguard?

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

Before taking Floxguard, tell your doctor if you have a heart rhythm disorder, kidney disease, joint problems, muscle weakness or trouble breathing, a history of seizures, a history of head injury of brain tumor, a condition called pseudotumor cerebri, low levels of potassium or magnesium in your blood, a nerve disorder or history of circulation problems, 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 6 hours before or 2 hours after you take Floxguard.

Floxguard 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 Floxguard 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 Floxguard:

Gemifloxacin in Egypt.


List of Floxguard substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
G Cin 320 mg Tablet (Lupin Laboratories Ltd.)$ 0.22
G Floren 320 mg Tablet (Spade (Indoco Remedies Ltd))$ 0.24
G FLOREN 320MG TABLET 1 strip / 5 tablets each (Spade (Indoco Remedies Ltd))$ 1.15
G Floren 320mg Tablet (Spade (Indoco Remedies Ltd))$ 0.23
G-Cin 320mg TAB / 5 (Lupin)$ 1.08
320 mg x 5's (Lupin)$ 1.08
G-CIN 320MG TABLET 1 strip / 5 tablets each (Lupin)$ 1.43
G-CIN tab 320 mg x 5's (Lupin)$ 1.08
G-Cin 320mg Tablet (Lupin)$ 0.31
G-CIN-A TABLET 1 strip / 5 tablets each (Lupin Ltd)$ 1.33
G-Floren 320mg TAB / 5$ 1.20
320 mg x 5's$ 1.20
Gametop 320mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))$ 54.22
320 mg x 100's (Radix (Solitaire Pharmacia Pvt Ltd))$ 54.22
Gametop 320 mg Tablet (Radix (Solitaire Pharmacia Pvt Ltd))$ 0.54
GAMETOP tab 320 mg x 10's (Radix (Solitaire Pharmacia Pvt Ltd))$ 5.42
Gamibit Gemifloxacin TAB / 325mg (Cubit)$ 0.60
325 mg x 5's (Cubit)
GAMIBIT tab 325 mg x 5's (Cubit)
Gamidian 320 mg Tablet (Custodian Pharma Private Limited)$ 0.42
320 mg x 50's (Forgo Pharmaceuticals (P) Ltd.)$ 13.25
Gamiflox 320 mg Tablet (Forgo Pharmaceuticals (P) Ltd.)$ 0.27
Gamiflox 320mg TAB / 50 (Forgo Pharmaceuticals (P) Ltd.)$ 13.25
GAMIFLOX tab 320 mg x 5's (Forgo Pharmaceuticals (P) Ltd.)$ 1.33
Gamiflox 320mg TAB / 50 (Forgo Pharmaceuticals (P) Ltd.)$ 13.25
320 mg x 1's (Ranbaxy Laboratories Ltd.,)
320 mg x 5's (Ranbaxy Laboratories Ltd.,)$ 0.83
Gembax 320mg TAB / 5 (Ranbaxy Laboratories Ltd.,)$ 0.83
Gembax 320mg INJ / 1 (Ranbaxy Laboratories Ltd.,)
Gembax 320 mg Tablet (Ranbaxy Laboratories Ltd.,)$ 0.18
GEMBAX 320 MG TABLET 1 strip / 5 tablets each (Ranbaxy Laboratories Ltd.,)$ 1.07
GEMBAX inj 320 mg x 1's (Ranbaxy Laboratories Ltd.,)
GEMBAX tab 320 mg x 5's (Ranbaxy Laboratories Ltd.,)$ 0.90
Gembax 320mg TAB / 5 (Ranbaxy Laboratories Ltd.,)$ 0.83
Gembax 320mg INJ / 1 (Ranbaxy Laboratories Ltd.,)
320 mg x 5's (Qualitron (Neiss Labs Pvt Ltd))$ 4.34
Gemberg 320 mg Tablet (Qualitron (Neiss Labs Pvt Ltd))$ 0.87
Gemberg 320mg TAB / 5 (Qualitron (Neiss Labs Pvt Ltd))$ 4.34

References

  1. PubChem. "Gemifloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Gemifloxacin". http://www.drugbank.ca/drugs/DB01155 (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Floxguard 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 Floxguard. 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.

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