gemifloxacin mesylate


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gemifloxacin mesylate

Factive

Pharmacologic class: Quinolone

Therapeutic class: Broad-spectrum anti-infective

Pregnancy risk category C

Action

Inhibits DNA synthesis by inhibiting DNA gyrase and topoisomerase IV, enzymes needed for bacterial growth

Availability

Tablets: 320 mg

Indications and dosages

Acute exacerbation of chronic bronchitis caused by susceptible organisms

Adults: 320 mg P.O. daily for 5 days

Mild to moderate communityacquired pneumonia caused by susceptible organisms

Adults: 320 mg P.O. daily for 5 days

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug

• History of prolonged QTc interval

Precautions

Use cautiously in:

• epilepsy or history of seizures

• pregnant or breastfeeding patients

• children younger than age 18 (safety not established).

Administration

• Give at same time every day with plenty of fluids, with or without food.

• Make sure patient swallows tablet whole without chewing.

• Don't give iron, multivitamins, didanosine, sucralfate, or antacids containing magnesium or aluminum within 3 hours of gemifloxacin.

Adverse reactions

CNS: fatigue, headache, insomnia, drowsiness, nervousness, dizziness, tremor, vertigo, seizures, loss of consciousness

CV: hypotension, prolonged QTc interval, cardiovascular collapse, shock

EENT: vision abnormality, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, gastritis, gastroenteritis, flatulence, anorexia, dry mouth, pseudomembranous colitis

GU: genital candidiasis, vaginitis, acute renal insufficiency or failure, interstitial nephritis

Hematologic: eosinophilia, anemia, leukopenia, granulocytopenia, thrombocytopenia

Hepatic: jaundice, hepatitis, acute hepatic necrosis, hepatic failure

Metabolic: hyperglycemia

Musculoskeletal: joint, back, or muscle pain; leg cramps; tendinitis; rupture of shoulder, hand, or Achilles tendon

Respiratory: dyspnea, pneumonia

Skin: rash, urticaria, pruritus, eczema, flushing, photosensitivity, angioedema

Other: altered taste, hot flashes, fungal infection, hypersensitivity reaction

Interactions

Drug-drug. Antacids containing aluminum or magnesium, didanosine, iron, multivitamins, sucralfate: reduced gemifloxacin absorption

Antiarrhythmics (class IA, such as quinidine and procainamide, and class III, such as amiodarone and sotalol), antipsychotics, erythromycin, tricyclic antidepressants: increased risk of prolonged QTc interval

Sucralfate: decreased gemifloxacin bioavailability

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, bilirubin: increased levels

Drug-behaviors. Sun exposure: increased risk of photosensitivity

Patient monitoring

• Stay alert for signs and symptoms of hypersensitivity reaction and other serious adverse reactions.

• Monitor ECG in patients at risk for prolonged QTc interval.

Watch for signs and symptoms of tendinitis or tendon rupture.

Patient teaching

• Instruct patient to take drug at same time each day, with or without food.

• Teach patient how to recognize and report signs and symptoms of allergic response.

• Advise patient to take iron, vitamins, antacids, didanosine, or sucralfate 3 hours before or 2 hours after gemifloxacin.

Instruct patient to stop taking drug and immediately report signs or symptoms of hypersensitivity reaction, severe diarrhea, change in urination pattern, easy bruising or bleeding, unusual tiredness, or yellowing of eyes or skin.

Advise patient to stop taking drug and immediately report sudden severe pain in shoulder, hand, or Achilles tendon.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

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References in periodicals archive ?
Gemifloxacin Mesylate standard was obtained from Sigma Pharmaceutical Company (Cairo, Egypt).
The standard stock solution was prepared by dissolving 25 mg of Gemifloxacin Mesylate standard in 25 mL of deionized water, so that the final concentration was 1000 [micro]g/mL.
System suitability was tested by injecting a working solution of 1 [micro]g/mL Gemifloxacin Mesylate under the optimum condition.
This could be explained by the fact that at pH 3.00 it was below the pKa of Gemifloxacin Mesylate (pK[a.sub.1]=5.53, pK[a.sub.2]=9.53).
The optimum wavelength for detecting Gemifloxacin Mesylate was 276 nm using the PDA detector as shown in the spectrum (Figure 2).
To determine the suitability of the method for the determination of Gemifloxacin Mesylate in its pharmaceutical preparations, Quinabiotic[R] 320 mg was purchased from the local market.
Pingle, "Reverse phase-HPLC and HPTLC methods for determination of gemifloxacin mesylate in human plasma," Journal of Chromatography B, vol.
Satyabrata, "Simple and rapid spectrophotometric estimation of gemifloxacin mesylate in bulk and tablet formulations," International Journal of PharmTech Research, vol.
Sankar, "Spectrophotometric determination of gemifloxacin mesylate in pharmaceutical formulations through ion-pair complex formation," E-Journal of Chemistry, vol.
Gouda, "Spectrophotometric methods for the determination of gemifloxacin mesylate in pure form and pharmaceutical formulations," Analytical Chemistry, vol.
Somasekhar, "Direct and derivative spectrophotometric determination of gemifloxacin mesylate in pure form and pharmaceutical preparations using n acceptors," International Journal of Pharma Sciences and Research, vol.
Table-4: Determination of gemifloxacin mesylate using Ag NPs-luminol-potassium ferricyanide SIA-injection CL detection in pure form, dosage forms and biological fluids