Mofloxin

Mofloxin

moxifloxacin

Manufacturer:

Community Pharm PCL

Distributor:

Community Pharm PCL

Marketer:

Community Pharm PCL
Full Prescribing Info
Contents
Moxifloxacin.
Description
Each film-coated tablet contains moxifloxacin hydrochloride equivalent to moxifloxacin 400 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of action: Moxifloxacin is an 8-methoxy fluoroquinolone antibiotic that inhibits topoisomerases II and IV, which control DNA topology and assist in DNA replication, repair and transcription. It has activity against a wide range of aerobic gram-positive and gram-negative microorganisms.
Pharmacokinetics: Moxifloxacin is well absorbed from the GI tract and absolute bioavailability is 86 - 92%. Peak plasma concentrations are attained within 0.5 - 4 hours; steady state is attained after at least 3 days. Moxifloxacin is widely distributed into body tissues and fluids, including saliva, nasal and bronchial secretions, sinus mucosa, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids. The drug is distributed into milk in rats and may be distributed into human milk. Moxifloxacin is 30 - 50% bound to plasma proteins. Approximately 52% of an oral dose of moxifloxacin is metabolized via glucuronide and sulfate conjugation; the metabolites are not microbiologically active. Moxifloxacin is not metabolized by cytochrome P-450 (CYP) isoenzymes. Moxifloxacin is eliminated in urine and by biliary excretion and metabolism. Approximately 45% of an oral dose of drug is excreted unchanged (20% in urine and 25% in feces). A total of 96% of an oral is excreted as unchanged drug or metabolites. Mean half-life of moxifloxacin is 11.5 - 15.6 hours following single or multiple oral doses.
Indications/Uses
Moxifloxacin 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections caused by susceptible strains: Respiratory tract infections: Acute sinusitis; Acute exacerbation of chronic bronchitis; Community-acquired pneumonia.
Uncomplicated skin and skin structure infections.
Complicated skin and skin structure infections (including diabetic foot infections).
Uncomplicated pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
Dosage/Direction for Use
Adult: See table.

Click on icon to see table/diagram/image

Mode of Administration: Moxifloxacin is administered orally without regard to meals. Moxifloxacin should be administered orally at least 4 hours before or 8 hours after antacids containing magnesium or aluminum, metal cation (i.e., iron), sucralfate, multivitamins or dietary supplements containing iron or zinc, or buffered didanosine (pediatric oral solution admixed with antacid). These drugs may substantially interfere with absorption of moxifloxacin, resulting in systemic concentrations considerably lower than desired.
Overdosage
Only limited data on overdose are available. Single doses of up to 1200 mg and multiple doses of 600 mg moxifloxacin over 10 days were administered to healthy subjects without any significant undesirable effects. In the event of overdosage it is recommended that appropriate supportive care including ECG measurements should be instituted as directed by the patient's clinical status.
The use of charcoal early after oral administration may be useful to prevent excessive increase of systemic exposure to moxifloxacin in cases of overdosage.
Contraindications
 Moxifloxacin is contraindicated in patients with a history of hypersensitivity to moxifloxacin or other quinolones.
Special Precautions
Moxifloxacin should be avoided in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.
Moxifloxacin should be avoided in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Moxifloxacin should be avoided in patients who have experienced peripheral neuropathy.
Moxifloxacin should be used in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures or lower seizure threshold only if potential benefits of the drugs outweigh risks.
Moxifloxacin should be avoided in patients with a known history of myasthenia gravis. Patients should be advised to immediately contact a clinician if they have any symptom of muscle weakness, including respiratory difficulties.
Moxifloxacin should be avoided in patients with known prolongation of the QT interval, ventricular arrhythmias (including torsades de points), any ongoing proarrhythmic conditions (including clinically important bradycardia and acute myocardial ischemia), or uncorrected hypokalemia or hypomagnesemia.
Moxifloxacin also should be avoided in patients receiving class IA (e.g., quinidine, procainamide) or III (e.g., amiodarones, sotalol) antiarrhythmic agents or other drugs that prolong the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).
Use In Pregnancy & Lactation
Pregnancy: Category C. There are no adequate and well-controlled studies of moxifloxacin in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Lactation: Moxifloxacin is distributed into milk in rats and may be distributed into human milk. Because of the potential for serious adverse reactions in the infant, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Common: Endocrine metabolic: Hypokalemia (1%).
Gastrointestinal: Abdominal pain (2%), Constipation (2%), Diarrhea (5%), Nausea (7%), Vomiting (2%).
Hepatic: ALT/SGPT level abnormal (1%)
Neurologic: Dizziness (3%), Headache (4%)
Ophthalmic: Dry eyes (Ophthalmic, 1% to 6%), Keratitis (Ophthalmic, 1% to 6%), Pain in eye (Ophthalmic, 1% to 6%), Reduced visual acuity (Ophthalmic, 1% to 6%)
Serious: Cardiovascular: Aortic aneurysm, or dissection, Prolonged QT interval (Oral/IV, 0.1% to less than 1%), Torsades de pointes.
Dermatologic: Rash (Oral/IV, 0.1% to less than 1%), Stevens-Johnson syndrome, Toxic epidermal necrolysis.
Endocrine metabolic: Hyperglycemia (Oral/IV, 0.1% to less than 1%), Hypoglycemia.
Gastrointestinal: Clostridium difficile diarrhea.
Hematologic: Agranulocytosis, Aplastic anemia, Hemolytic anemia, Pancytopenia, Thrombocytopenia (Oral/IV, 0.1% to less than 1%)
Hepatic: Hepatic necrosis, Hepatitis, Liver failure.
Immunologic: Anaphylactoid reaction, Hypersensitivity reaction.
Musculoskeletal: Myasthenia gravis, Exacerbation, Rupture of tendon, Tendinitis.
Neurologic: Guillain-Barre syndrome, Peripheral neuropathy, Pseudotumor cerebri, Raised intracranial pressure, Seizure.
Ophthalmic: Retinal detachment Renal: Renal failure (0.1% to less than 1%).
Respiratory: Extrinsic allergic alveolitis.
Other: Serum sickness due to drug.
Drug Interactions
Concomitant use of moxifloxacin and class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarones, sotalol) antiarrhythmic agents has resulted in prolong QT interval.
Concomitant administration of moxifloxacin with aluminum- or magnesium-containing antacids has resulted in decreased absorption and decreased bioavailability of oral moxifloxacin.
Concomitant use of moxifloxacin and oral antidiabetic agents (e.g., sulfonylurea agents) or insulin has resulted in alterations in blood glucose concentrations, including hypoglycemia and hyperglycemia.
Concomitant use of moxifloxacin and corticosteroids increases the risk of severe tendon disorders (e.g., tendinitis, tendon rupture), especially in geriatric patients older than 60 years of age.
Concomitant use of moxifloxacin and iron preparations or multivitamins or mineral supplements has resulted in decreased absorption and decreased bioavailability of oral moxifloxacin.
Concomitant use of moxifloxacin and anti-inflammatory agents (NSAIAs) may increase the risk of CNS stimulation and seizures.
Storage
Store at temperature below 30°C.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 400 mg (oblong, biconvex, dull red. One side has letter "MFX" and another side has figure "400") x 5's.
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