Matador Tablets / Film-coated
Levofloxacin
750mg
Dar Al Dawa Development & Investment Co. Ltd.
| Pack size | 5's Blister |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | BIN SAQR ALMUFID PHARMACEUTICAL EST LLC |
| Retail Price | 58.50 AED |
Indications
Matador Tablets / Film-coated is used for:
Chronic bronchitis, Acute bacterial sinusitis, Anthrax, Community-acquired pneumonia, Skin and skin structure infections, Nosocomial pneumonia, Urinary tract infections, Complicated skin and skin structure infections, Acute pyelonephritis, Chronic bacterial prostatitis
Adult Dose
Community-Acquired Pneumonia
500 mg PO/IV once daily for 7-14 days or 750 mg PO/IV once daily for 5 days
Nosocomial Pneumonia
750 mg PO/IV once daily for 7-14 days
Acute Bacterial Sinusitis
500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg PO/IV once daily for 7 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Inhalational Anthrax
Postexposure therapy
500 mg PO once daily for 60 days, beginning as soon as possible after exposure
Skin/Skin Structure Infections
Uncomplicated: 500 mg PO/IV once daily for 7-10 days
Complicated: 750 mg PO/IV once daily for 7-14 days
Chronic Bacterial Prostatitis
500 mg PO/IV once daily for 28 days
Complicated Urinary Tract Infections & Acute Pyelonephritis
250 mg PO/IV once daily for 10 days or 750 mg PO/IV once daily for 5 days
Uncomplicated Urinary Tract Infections
250 mg PO/IV once daily for 3 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections
Plague
Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older
500 mg PO/IV once daily for 10-14 days
Child Dose
Children
PO, IV 16 mg/kg/day div q12h up to 50 kg body weight, then
500 mg qd for postexposure anthrax prophylaxis q12h
For respiratory infections:
<5 y: 20 mg/kg/day q12h
>5 y: 10 mg/kg/day q24h
Renal Dose
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hr. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hr.
CrCl (ml/min)
20-49 Initially, 500 mg daily, then 250 mg every 24 hr. Alternatively: Initially, 750 mg daily, then 750 mg every 48 hr.
10-19 Initially, 500 mg daily, then 250 mg every 48 hr. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hr.
Administration
Oral soln: Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals. Ensure adequate fluid intake.
Tab: May be taken with or without food. Ensure adequate fluid intake.
IV Preparation
Single-use vials: Dilute in 50-100 mL D5W or NS or D5/NS solution for injection to 5 mg/mL; alternative solutions include sodium lactate, Plasma-Lyte, D5/lactated Ringer, D5/NS and potassium chloride
IV Administration
Give by IV infusion only, not bolus; rapid or bolus administration has been associated with hypotension and must be avoided
Infuse 250-500 mg over 60 minutes or 750 mg over 90 minutes
Contra Indications
Hypersensitivity to levofloxacin or other quinolones. Child <18 yr.
Precautions
Known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures. Avoid unnecessary exposure to sunlight or artificial UV light. History of prolonged QT interval, uncorrected electrolyte disturbances. DM (carefully monitor blood glucose levels). Periodically monitor renal, hepatic and haematopoietic functions during treatment. Pregnancy and lactation. Elderly. May impair ability to drive or operate machinery.
Lactation: Drug excreted in breast milk; not recommended
Pregnancy-Lactation
Pregnancy
Levofloxacin has not been shown to increase risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
Oral administration to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (MRHD), respectively, did not result in teratogenicity; fetal toxicity reported in the rat study, but absent at doses up to 1.2 times maximum recommended human dose
Lactation
Drug is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risks of serious adverse reactions, in breastfed infants, a lactating woman may consider pumping and discarding breast milk during treatment and an additional two days (five half-lives) after last dose
Alternatively, advise a lactating woman that breastfeeding is not recommended during treatment and for an additional two days (five half-lives) after last dose
Interactions
Additive effects on QT interval prolongation w/ class IA (e.g. quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmics, fluoxetine or imipramine. Reduced absorption w/ sucralfate, didanosine, antacids containing Mg or Al, dietary supplements containing Zn, Ca, Mg or Fe. Altered glucose levels w/ antidiabetic agents (e.g. insulin, glibenclamide). Increased risk of severe tendon disorders w/ corticosteroids. Increased risk of CNS stimulation and seizures w/ NSAIDs. Increased prothrombin time w/ warfarin.
Adverse Effects
Side effects of Levofloxacin :
1-10%
Nausea (7%), Headache (6%), Diarrhea (5%), Insomnia (4%), Constipation (3%), Dizziness (3%), Dyspepsia (2%), Rash (2%), Vomiting (2%), Chest pain (1%), Dyspnea (1%), Edema (1%), Fatigue (1%), Injection-site reaction (1%), Moniliasis (1%), Pain (1%), Pruritus (1%), Vaginitis (1%)
<1%
Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, arrhythmia
Nervous system: Tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope
Metabolic: Hypoglycemia, hyperglycemia, hyperkalemia
Blood/lymphatic system: Anemia, thrombocytopenia, granulocytopenia
Musculoskeletal/connective tissue: Arthralgia, tendonitis, myalgia, skeletal pain
Gastrointestinal (GI): Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C difficile colitis
Hepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase
Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreaming
Other: Immune hypersensitivity reaction, acute renal failure, urticaria, phlebitis, epistaxis
Potentially Fatal: Anaphylaxis.
Mechanism of Action
Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.
Note
Matador 750mg Tablets / Film-coated manufactured by Dar Al Dawa Development & Investment Co. Ltd.. Its generic name is Levofloxacin. Matador is availble in United Arab Emirates.
Farmaco UAE drug index information on Matador Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.