Simlev Dosage & Drug Information

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Concise Prescribing Info

Contents

Levofloxacin

Indications/Uses

Acute maxillary sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumoniae, complicated UTI, acute pyelonephritis.

Dosage/Direction for Use

FC caplet Acute maxillary sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumoniae, uncomplicated skin & skin structure infection 500 mg once daily. Complicated UTI, acute pyelonephritis 250 mg once daily. Duration of treatment: Acute maxillary sinusitis 10-14 days. Acute exacerbation of chronic bronchitis 7 days. Acute exacerbation of chronic bronchitis 7-14 days. Community acquired pneumoniae 7-14 days. Uncomplicated skin & skin structure infection 7-10 days. Complicated UTI, acute pyelonephritis 10 days. Infusion Acute maxillary sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumoniae, skin & skin structure infection 500 mg daily. Complicated UTI, acute pyelonephritis 250 mg daily. Duration of treatment: Acute maxillary sinusitis 10-14 days. Community acquired pneumoniae 7-14 days. Acute exacerbation of chronic bronchitis 7 days. Uncomplicated skin & skin structure infection 7-10 days. Complicated UTI, acute pyelonephritis 10 days.

Administration

May be taken with or without food: Ensure adequate fluid intake.

Contraindications

Hypersensitivity. Pregnancy & lactation. Childn & adolescents <18 yr.

Special Precautions

Discontinue treatment if shock or hypersensitivity reaction occurs. Ensure adequate fluid intake to avoid high conc of drug in the urine. Avoid excessive sunlight exposure. Alcohol consumption. Patient w/ sensitivity to neurological disorders. Blood glucose level should be monitored in patients receiving oral hypoglycemic or insulin. May impair the ability to drive the vehicle or operate the machinery. Patients w/ kidney dysfunction. Pregnancy & lactation. Childn & adolescents <18 yr. Elderly.

Adverse Reactions

Nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, anorexia, headache, insomnia, drowsiness, sleep disturbances, anxiety, depression, hallucination, psychotic reactions, dyspepsia, tremor, taste perversion, skin rash, itching, urticaria, edema, increased sweating, vaginitis, genital moniliasis, leukorrhea, malaise, fatigue.

View ADR Monitoring Form

Drug Interactions

Al- & Mg-containing antacids, sucralfate, metal cation, multivit, NSAIDs, theophylline, antidiabetics including insulin & glibenclamide.

MIMS Class

Quinolones

ATC Classification

J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Simlev FC caplet 500 mg

Packing/Price

1 × 10's (Rp340,000/boks)

Form

Simlev infusion soln 750 mg

Packing/Price

150 mL x 1's (Rp340,000/boks)

Simlev

levofloxacin

Manufacturer:

Simex