Zflox Tablets / Film-coated

Moxifloxacin
400mg
ZEINO PHARMA FZ LLC
Pack size 7's Blister
Dispensing mode POM
Source UAE
AgentNEW MEDICAL CENTRE
Retail Price 50.00 AED

Indications

Zflox Tablets / Film-coated is used for: Community Acquired Pneumonia, Acute Bacterial Exacerbation of Chronic Bronchitis, Acute Bacterial Sinusitis, Complicated Intra-Abdominal Infection, Uncomplicated Skin and Skin Structure Infections, Complicated Skin and Skin Structure Infections, Typhoid Fever.

Adult Dose

Oral The dose of Moxifloxacin is 400 mg once every 24 hours. The duration of therapy depends on the type of infection as described bellow Acute Bacterial Sinusitis 400 mg is given once daily for 10 days. Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg is given once daily for 5 days. Community Acquired Pneumonia 400 mg is given once daily for 7-14 days. Uncomplicated Skin & Skin Structure infections 400 mg is given once daily for 7 days. Complicated Skin & Skin Structure infections 400 mg is given once daily for 7-21 days. Complicated Intra-Abdominal infections 400 mg is given once daily for 5-14 days. Typhoid Fever 400 mg is given once daily for 10-14 days.

Child Dose

<18 years: Safety and efficacy not established

Renal Dose

Administration

May be taken with or without food.

Contra Indications

Known hypersensitivity to moxifloxacin, other quinolones. Patients w/ known prolongation of QT interval, uncorrected hypokalaemia, myasthenia gravis. Concurrent use of class Ia (e.g.quinidine, procainamide, class III (e.g. amiodarone, sotalol) antiarrhythmic drugs or w/ other drugs that prolong QT interval (e.g. erythromycin, TCAs, antipsychotic agents).

Precautions

Maintain adequate fluid intake; Patient w/ previous tendon disorders (e.g. rheumatoid arthritis), significant bradycardia or acute myocardial ischaemia, heart failure w/ reduced LVEF, known history of symptomatic arrhythmias, known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures; diabetes. Kidney, heart or lung transplant recipients. Hepatic impairment. Pregnancy and lactation. Patient Counselling This drug may cause dizziness and lightheadedness, if affected do not drive or operate machinery. Rest and refrain from doing strenuous physical activity as it may increase risk of tendon rupture. Avoid exposure to sunlight or artificial UV light (e.g. tanning beds, UVA/UVB treatment) and use protective measures (e.g. sunscreen, wear loose-fitting clothes) if staying outdoors is necessary during therapy. Monitoring Parameters Monitor WBC and signs of infection.

Pregnancy-Lactation

Pregnancy There are no available human data establishing a drug associated risk; however, when moxifloxacin was administered to rats during pregnancy and throughout lactation at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed Advise pregnant women of potential risk to fetus Lactation Not known if moxifloxacin is present in human milk Based on animal studies in rats, moxifloxacin may be excreted in human milk Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drug or from the underlying maternal condition

Interactions

Additive effect on QT interval prolongation w/ other drugs that prolong QT interval (e.g. erythromycin, TCAs, antipsychotic agents). Decreased absorption and bioavailability w/ Al- or Mg-containing antacids, or Fe or Zn preparations. Concomitant use of corticosteroids increases the risk of severe tendon disorders esp in elderly (>60 yr). Decreased absorption w/ sucralfate or didanosine. Potentially Fatal: Concurrent use of class Ia (e.g. quinidine, procainamide) or III (e.g. amiodarone, sotalol) antiarrhythmic drugs or w/ other drugs that prolong QT interval (e.g. erythromycin, TCAs, antipsychotic agents) may cause additive effect on QT interval prolongation.

Adverse Effects

Side effects of Moxifloxacin : 1-10% Nausea (7%), Diarrhea (6%), Dizziness (3%), Decreased amylase (2%), Decreased basophils, eosinophils, hemoglobin, prothrombin time, red blood cells, neutrophils (2%), Decreased serum glucose (2%), Increased serum chloride (2%), Increased serum ionized calcium (2%), Immune hypersensitivity reaction (0.1-2%), Prolonged QT interval (0.1-2%) <1% Acute renal failure, Agranulocytosis, Anaphylactoid reaction, Aplastic anemia, Extrinsic allergic alveolitis, Hemolytic anemia, Hepatic failure, Hepatic necrosis, Hepatitis, Pancytopenia, Seizure, Serum sickness due to drug, Stevens-Johnson syndrome, Tendon rupture, tendinitis, Thrombocytopenia, Torsades de pointes, Toxic epidermal necrolysis

Mechanism of Action

Moxifloxacin inhibits the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.

Note

Zflox 400mg Tablets / Film-coated manufactured by ZEINO PHARMA FZ LLC. Its generic name is Moxifloxacin. Zflox is availble in United Arab Emirates. Farmaco UAE drug index information on Zflox Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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