CEFANK-CV Tablet

For the treatment of the following infections in adults and children:

- Uncomplicated Urinary Tract Infections

- Otitis Media

- Pharyngitis and Tonsillitis

-Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis

- Uncomplicated gonorrhea (cervical/urethral)

Posology and Method of Administration

Adults and Children over 10 years: 1 tablet twice daily. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

The most frequent side effects seen with Celfixime-Clav are diarrhoea and stool changes. Events like nausea/vomiting, transient elevation in liver transaminases, alkaline phosphatase and jaundice can also occur.

Thrombocytosis, thrombocytopenia, leucopenia, hypereosinophilia, neutropenia and agranulocytosis may also occur.

Other adverse events that may occur are abdominal pain, abdominal cramps, flatulence, indigestion, headache, vaginitis, vulvar itch, rash, hives, itch, dysuria, chills, chest pain, shortness of breath, mouth ulcers, swollen tongue, sleepiness, thirst, anorexia.

In controlled clinical trials in patients with essential hypertension, dizziness was the only side effect reported that occurred with an incidence greater than placebo in 1% or more of patients treated with Losartan. Rarely, rash was reported although the

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Cefixime should, therefore, not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Breast-feeding

It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Before therapy with Cefixime-Clav is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.

Cefixime as with other broad-spectrum antibiotics should be prescribed with caution in individuals with a history of colitis.

Increases in prothrombin times may occur and therefore care should be taken in patients receiving anticoagulant therapy.

No adequate and well-controlled studies in pregnant women have been reported so Cefixime-Clav should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Cefixime is a semi-synthetic, oral-third-generation cephalosporin, which has marked in vitro bactericidal activity against a side variety of gram-positive and gram-negative organisms. Bactericidal action of cefixime results from inhibition of cell-wall synthesis.

It is highly stable in the presence of beta-lactamase enzymes.

Clavulanic acid is an irreversible “suicide” inhibitor of intracellular and extracellular beta-lactamases, demonstrating concentration-dependent and competitive inhibition. It has a high affinity for the class A beta-lactamases. The frequency of beta-lactamase mediated resistance has continued to rise over the years, but the majority of clinically significant beta-lactamases are inhibited by clavulanate.