FORMULATION

Each film-coated tablet contains:

Levofloxacin (as hemihydrate) ……………………… 500 mg/750 mg

INDICATIONS

Levofloxacin is used for the treatment of acute sinusitis, exacerbation of chronic bronchitis, pneumonia, complicated and non-complicated urinary tract infections (including pyelonephritis), chronic bacterial prostatitis, infections of skin and soft tissues, septicemia/ bacteremia and intra-abdominal infections.

DOSAGE AND ADMINISTRATION

Levofloxacin tablets are used 1-2 times per day. Dose depends on type and severity of infection. Treatment duration depends on clinical course and it is not more than 14 days. It is recommended to prolong the treatment at least during 48-72 hours after normalization of body temperature or microbiologically proven causative agent elimination. The tablet should be swallowed without chewing with enough water. It can be taken with meal and at any other time.

RECOMMENDED DOSES FOR ADULT PATIENTS WITH NORMAL KIDNEY FUNCTION WITH CREATININE CLEARANCE OF MORE THAN 50 mL/min.

* In combination with antibiotics with an action on anaerobic causative agent.

DOSAGE FOR PATIENTS WITH LIVER FUNCTION DISORDERS

Dosage adjustment is not necessary because Levofloxacin is insignificantly metabolized in the liver.

ADVERSE EFFECTS

In rare case, itch, skin redness; rare-general reactions of hypersensitivity (anaphylactic and anaphylactoid) with such symptoms as urticaria, bronchial spasm and possible severe asphyxia; very rare-skin and mucous membrane edema (for example, edema of the face-skin and pharynx tunica mucosa), sudden blood pressure decrease and shock, QT-interval lengthening, hypersensitivity to sunlight and UV light; in single cases-acute skin and mucous membrane rash with wheals formation such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and erythema multiforme

INTERACTIONS

Levofloxacin absorption is significantly decreased in concurrent usage with antacids, which contains magnesium and aluminum, and with drugs, which contain iron salt. Recommended time period between usages of levofloxacin should not be less than 2 hours after bioavailability of levofloxacin is significantly decreased. Clinical trials reveal that there is no approved interaction of Levofloxacin and theophylline. There is no significant effect on the plasma concentration with the concurrent usage of quinolones with theophylline, non steroidal anti inflammatory drugs and other agents, which reduce spastic threshold. Levofloxacin concentration in the presence of Fenbufen was approximately 13% higher compared to levofloxacin usage alone. Probenecid and cimetidine showed statistically reliable influence on levofloxacin excretion. Kidney clearance of levofloxacin is decreased in the presence of probenecid and cimetidine by 34% and 24% respectively. Thus, both drugs can block tubular excretion of levofloxacin. Half-life period of cyclosporine is increased by 33% with concurrent usage of levofloxacin. Usage with antagonists of K vitamin, for example, warfarin, documented an enhanced hypoprothombotic effect caused by the interaction. In lieu to this, coagulation indexes should be controlled for patients who concurrently take antagonists of Vitamin K. It is not recommended to use levofloxacin with alcohol

Pregnancy and lactation:

PHARMACOKINETICS

In per oral use, Levofloxacin is quickly and nearly fully absorbed with plasma concentration peak, which is observed in 1 hour after intake. Absolute bioavailability is nearly 100%. Levofloxacin is liable to linear pharmacokinetics in range from 50 to 600 mg. Meal has some influence on its absorption. Approximately 30-40% of levofloxacin binds with serum protein. Cumulative effect of levofloxacin in 500 mg dosage once a day does not have clinical meaning and can be neglected. Stable distribution is reached within 3 days. Maximal distribution of levofloxacin in bronchial mucosa and liquid secretion from bronchial epithelium in doses more than 500 mg per dose was 8.3 and 10.8 mg/mL, correspondingly. In lung tissue the maximal concentration of levofloxacin in doses more than 500 mg per dose was11.3 mg/mL and was reached within 4-6 hours after use. Concentration in lungs exceeds those in plasma. Maximal concentration of levofloxacin in bladder fluid and after intake of 500 mg 1-2 times daily was 4 and 6.7 mg/mL correspondingly. Levofloxacin poorly penetrates into cerebrospinal fluid. Levofloxacin is insignificantly metabolised, its metabolites are desmethyl-levofloxacin and N-oxide. These metabolites are less than 5% of the preparation, which is excreted with urine

strong>STORAGE CONDITION Store at temperatures not exceeding 25°C.

AVAILABILITY

750 mg Alu/PVC/ PVDC blister pack of 5 and 10 tablets per box.

500 mg Alu/PVC/ PVDC blister pack of 5 tablets per box.

CAUTION

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

MANUFACTURED BY

KUSUM HEALTHCARE PRIVATE LIMITED

SP-289(A) RIICO Indl. Area Chopanki (Bhiwadi)

Distt- Alwar, Rajasthan, INDIA

IMPORTED AND DISTRIBUTED BY

S.M.H.P. MARKETING & CONSULTANCY

G/F Manor Bldg. 2629 Taft Avenue,

Malate, Manila, PHILIPPINES