Svoz

Svoz

moxifloxacin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Moxifloxacin
Indications/Uses
Svoz: Susceptible infections eg, acute sinusitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia (CAP), complicated/uncomplicated skin & skin structure infections, complicated intra-abdominal infections, uncomplicated pelvic inflammatory disease. Svoz Infusion: Susceptible bacterial infections eg, CAP including CAP caused by multidrug-resistant strains, complicated skin & skin structure infections (including diabetic foot infections), complicated intra-abdominal infections including polymicrobial infections (eg, abscesses).
Dosage/Direction for Use
Svoz Acute sinusitis 1 tab once daily for 10 days. Acute exacerbations of chronic bronchitis 1 tab once daily for 5 days. CAP 1 tab once daily for 7-14 days. Uncomplicated skin & skin structure infections 1 tab once daily for 7 days. Complicated skin & skin structure infections 1 tab once daily for 7-21 days (since initiated w/ IV form). Complicated intra-abdominal infection 1 tab once daily for 5-14 days (since initiated w/ IV form). Uncomplicated pelvic inflammatory disease 1 tab once daily for 14 days. Svoz Infusion IV Administer via infusion over 60 min. Adult ≥18 yr 400 mg once daily. Total treatment duration (initially IV followed by oral therapy): CAP 7-14 days, complicated skin & skin structure infections 7-21 days, complicated intra-abdominal infections 5-14 days.
Administration
Tab: May be taken with or without food.
Contraindications
Hypersensitivity to moxifloxacin or other quinolones.
Special Precautions
Phototoxicity reaction or severe skin hypersensitivities including TEN, SJS, erythema multiforme. Discontinue immediately if skin symptoms of phototoxicity; symptoms of rash, lethargy, myalgia & tendonitis; psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, paranoia, depression, self-injurious behavior (eg, attempted or completed suicide), anxiety, agitation, nervousness & delirium; tendinitis & tendon rupture, peripheral neuropathy, & CNS effects; alterations in sensations; skin rash or other sign of hypersensitivity occur. Not recommended for MRSA infections. Development of resistance if skipping dose or stopping medication too early. QT prolongation. Fulminant hepatitis. Fungal or bacterial superinfection including Clostridium difficile-associated diarrhea & colitis or pseudomembranous colitis w/ prolonged use. False -ve results in Mycobacterium spp. culture test. Sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias & weakness. Symptoms of neuropathy eg, pain, burning, tingling or numbness. Patients w/ kidney, heart or lung transplants; RA; known or suspected CNS disorder or w/ factors predisposing to seizures or lower seizure threshold; heart disease especially w/ arrhythmia, HTN & uncorrected hypokalemia; diabetes; psychosis or history of psychiatric disease. Avoid in patients w/ known history of myasthenia gravis; pelvic inflammatory disease as monotherapy; previous peripheral neuropathy; known QT interval prolongation, ventricular arrhythmias, any on-going proarrhythmic conditions, uncorrected hypokalemia or hypomagnesemia. Avoid sunlight exposure during therapy. Manage moderate to severe pseudomembranous colitis w/ fluids, electrolytes, protein supplement & other appropriate antibacterial agents. Monitor ECGs; blood glucose conc; for signs/symptoms of disordered glucose regulation. Concomitant use w/ corticosteroids; warfarin. Avoid concomitant use w/ QT prolonging drugs including class IA (eg, quinidine, procainamide) or class III (eg, amiodarone) antiarrhythmic agents, cisapride, erythromycin, antipsychotics, TCAs. Renal impairment. Mild, moderate or severe hepatic impairment; liver cirrhosis. Pregnancy. Not recommended during lactation. Contraindicated in childn or adolescents <18 yr. Elderly >60 yr. Svoz Infusion: Not to be infused by rapid or bolus IV infusion. Svoz Infusion: Not to be infused by rapid or bolus IV infusion.
Adverse Reactions
Nausea, vomiting, diarrhea, abdominal pain, decreased/increased amylase, anorexia, constipation, xerostomia, flatulence; increased LDH; tremor, confusion, headache, insomnia, anxiety, drowsiness, dizziness; pruritus, rash, urticaria; arthralgia, myalgia, weakness; decreased serum glucose, increased serum ionized Ca; eosinophilia, leucopenia, prolonged prothrombin time, thrombocythemia, increased serum levels of mean corpuscular Hb & neutrophils, decreased serum levels of basophils, Hb, RBC & neutrophils; decreased/increased bilirubin, abnormal LFTs; increased serum albumin. Svoz: Glossitis, dyspepsia; photosensitivity reactions; increased serum Cl; increased INR & WBC, decreased eosinophils; increased γ-glutamyl transpeptidase; vag moniliasis, vaginitis; pharyngitis, pneumonia, rhinitis, sinusitis; allergic reaction, infection, oral moniliasis, diaphoresis. Svoz Infusion: Abdominal discomfort & distension, decreased appetite, dysgeusia, gastritis, gastroenteritis, GERD, increased serum lipase, oral candidiasis; agitation, chills, depression, disorientation, facial & noncardiac chest pain, fatigue, hallucination, hypoesthesia, lethargy, malaise, nervousness, pain, paresthesia, restlessness, vertigo; allergic dermatitis, erythema, hyperhidrosis, night sweats; back, limb & musculoskeletal pain, muscle spasms; dehydration, hyperchloremia, hyperglycemia, hyperlipidemia, hypokalemia, increased γ-glutamyl transferase, serum glucose, triglycerides, & uric acid; anemia, decreased hematocrit & prothrombin time, eosinopenia, leukocytosis, prolonged partial thromboplastin time, thrombocytopenia; increased liver enzymes, serum ALT, AST & transaminases; angina pectoris, atrial fibrillation, bradycardia, cardiac arrest & failure, chest discomfort & pain, edema, HTN, hypotension, increased BP, palpitation, peripheral edema, phlebitis, prolonged QT interval on ECG, syncope, tachycardia; dysuria, fungal vaginosis, vag infection, vulvovag candidiasis & pruritus; hypersensitivity reaction; increased serum globulins; candidiasis, fungal infection (including oral); extravasation; blurred vision; tinnitus; increased BUN & serum creatinine, renal failure; asthma, bronchospasm, dyspnea, hypoxia, wheezing; fever. SJS, TTP, TEN.
Drug Interactions
Increased risk of severe tendon disorders w/ corticosteroids. Enhanced anticoagulant effect of vit K antagonists (eg, warfarin). Svoz: Decreased absorption w/ sucralfate, didanosine, antacid containing Mg, Al or Ca, vit & mineral containing metal cations eg, Fe & Zn. Arrhythmias including torsades de pointes w/ QT-prolonging drugs including amiodarone, astemizole, bepridil, cisapride, disopyramide, erythromycin, pentamidine, chlorpromazine, fluphenazine, methotrimeprazine, perphenazine, prochlorperazine, promazine, thioridazine, trifluoperazine, triflupromazine, procainamide, quinidine, sotalol, terfenadine, amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, trimipramine. Svoz Infusion: Avoid concomitant use w/ class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents. Increased risk of prolonged QT interval w/ QT-prolonging drugs eg, cisapride, erythromycin, antipsychotics, TCA.
MIMS Class
Quinolones
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Svoz: D; Svoz Infusion: S
Presentation/Packing
Form
Svoz FC tab 400 mg
Packing/Price
1 × 5's
Form
Svoz Infusion soln for infusion 400 mg/250 mL
Packing/Price
1's
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