LEVODHG 250

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LEVODHG 250

COMPOSITION:

Levofloxacin (as levofloxacin hemihydrate) ..................... 250 mg

Excipients q.s...................................................................... 1 tablet

(Lactose monohydrate, hydroxypropyl methylcellulose 615, hydroxypropyl methylcellulose 606, sodium starch glycolate, sodium stearyl fumarate, polyethylene glycol 6000, talc, titanium dioxide, yellow ferric oxide).

DOSAGE FORM: Film coated tablet.

PRESENTATION: Box of 3 blisters x 10 tablets. Box of 6 blisters x 10 tablets.

PHARMACODYNAMICS:

Levofloxacin is a synthetic, broad-spectrum fluoroquinolone antibiotic. The mechanism of action is inhibition of bacterial DNA synthesis. Levofloxacin is active against many Gram-negative and Gram-positive microorganisms including Staphylococci, Streptococci and Streptococcus pneumoniae, intestinal bacteria, Haemophilus influenzae. It particularly acts against Gram-positive and anaerobic microorganisms more effectively than other fluoroquinolones. Cross-resistance does not occur between levofloxacin and other antibiotic classes.

PHARMACOKINETICS:

Levofloxacin is rapidly and almost completely absorbed through the gastrointestinal tract. Absolute bioavailability of oral levofloxacin is approximately 99%. There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangable. Levofloxacin is widely distributed throughout the body, but it has poor penetration into the cerebrospinal fluid. Majority of levofloxacin is not metabolized in the body. It is excreted largely as unchanged drug in the urine. Elimination half-life is from 6 to 8 hrs and prolonged in renal impairment patients.

INDICATIONS:

Infections caused by levofloxacin susceptible microorganisms: Community acquired pneumonia, prostatitis, skin infections.

Uncomplicated urinary tract infections

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see the Warnings and Precautions) and for some patients with uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.

Acute exacerbation of chronic bronchitis

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see the Warnings and Precautions) and for some patients with acute exacerbation of chronic bronchitis is self-limiting, reserve levofloxacin for treatment of acute exacerbation of chronic bronchitis in patients who have no alternative treatment options.

Acute bacterial sinusitis

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see the Warnings and Precautions) and for some patients with acute bacterial sinusitis is self-limiting, reserve levofloxacin for treatment of acute bacterial sinusitis in patients who have no alternative treatment options.

CONTRAINDICATIONS:

Hypersensitivity to levofloxacin and other quinolones or any components of the drug. Epilepsy, G6PD deficiency, a history of tendon disorders. Children aged under 18 years. Pregnant women and breast-feeding mothers.

WARNINGS AND PRECAUTIONS:

Disabling and potentially irreversible serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting levofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Discontinue levofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

The drug should be used with caution in patients with central nervous system diseases such as epilepsy, cerebral sclerosis, etc.

Clostridium difficile-associated pseudomembranous colitis has been reported with use of levofloxacin. Diarrhea state should be accurately diagnosed and appropriate measures should be applied in patients taking antibiotics. Moderate to severe photosensitivity reactions can be associated with the use of fluoroquinolones, including levofloxacin. As with all quinolones, disturbances of blood glucose, including both hyperglycemia and hypoglycemia have been reported with levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended.

Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. Levofloxacin should be used with caution in patients suffered from pre-arrhythmias e.g bradycardia, acute myocardial ischemia.

PREGNANCY AND LACTATION:

Levofloxacin must not be used in pregnant women. Breast-feeding must not be given during levofloxacin therapy.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The effect of levofloxacin on the ability to drive and operate machinery is rarely reported.

INTERACTIONS:

Antacids, sucralfate, metal cations and multivitamins may reduce the absorption of levofloxacin. These agents should be taken at least 2 hours before or 2 hours after levofloxacin administration. Theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered. Levofloxacin enhances the effect of warfarin and the risk of dysglycemia when used in combination with hypoglycemic agents. Concomitant administration of a non-steroidal anti-inflammatory drug with levofloxacin may increase the risk of CNS stimulation and convulsive seizures. 

ADVERSE EFFECTS: 

Common: nausea, diarrhoea, elevated liver enzyme, insomnia, headache, infusion site reaction.

Uncommon: vertigo, stress, excitation, anxiety, abdominal pain, flatulence, dyspepsia, vomiting, constipation, increased blood bilirubin, vaginitis, genital candidiasis, pruritus, skin rash.

Rare: hypertension or hypotension, cardiac arrhythmia, myalgia, arthralgia, dry mouth, pseudomembranous colitis, convulsions, abnormal dreams, depression, mental disorders, anaphylactic shock.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

In the event of overdose, gastric lavage and rehydration should be exercised. ECG monitoring should be undertaken.

DOSAGE & ADMINISTRATION:

Levofloxacin is administered orally.

Respiratory tract infections:

Community acquired pneumonia: 500 mg once or twice daily for 7-14 days.

Acute maxillary sinusitis: 500 mg once for 10-14 days.

Skin and skin structure infections:

Uncomplicated: 500 mg once daily for 7-10 days.

Complicated: 750 mg once daily for 7-14 days.

Urinary tract infections:

Complicated: 250 mg once daily for 10 days.

Acute pyelonephritis: 250 mg once daily for 10 days.

Anthrax: Levofloxacin is indicated for anthrax following exposure to aerosolized Bacillus anthracis: 500 mg once daily for 8 weeks.

Uncomplicated urinary tract infections: 250 mg once daily for 3 days.

Acute exacerbation of chronic bronchitis: 500 mg once daily for 7 days.

Acute bacterial sinusitis: 500 mg once daily for 10-14 days.

Dosage in patients with renal failure:

Complicated urinary tract infection, acute pyelonephritis:

Creatinine clearance ≥ 20 ml/min: first dose: 250 mg, then: 250 mg every 24 hours.

Creatinine clearance 10 - 19 ml/min: first dose: 250 mg, then: 250 mg every 48 hours.

Other indications:

Creatinine clearance 50 - 80 ml/min: No dosage adjustment required.

Creatinine clearance 20 - 49 ml/min: first dose: 500 mg, then: 250 mg every 24 hours.

Creatinine clearance 10 - 19 ml/min: first dose: 500 mg, then: 125 mg every 24 hours.

Hemodialysis or CAPD: first dose: 500 mg, then: 125 mg every 24 hours.

Or as directed by the physician.

Read the directions carefully before use.          

Consult the physician for more information.               

This drug is for prescription only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 300C, protect from light.

Specifications: Manufacturer's.

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