Roxim 200

Generic

Cefixime Trihydrate

 

Indications

When caused by sensitive strains of the identified bacteria, cefixime is approved for the treatment of the following infections:

• Urinary tract infections caused by Escherichia coli and Proteus mirabilis that are not difficult.
• Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes cause otitis media.
• Streptococcus pyogenes causes pharyngitis and tonsillitis.
• Streptococcus pneumoniae and Haemophilus influenzae induce acute bronchitis and acute exacerbations of chronic bronchitis.
• Neisseria gonorrhoeae causes uncomplicated gonorrhoea (cervical/urethral).

 

Pharmacology

Cefixime is a semisynthetic third-generation cephalosporin antibiotic for oral use. At easily obtainable plasma concentrations, it is bactericidal against a wide range of gram positive and gram negative bacteria. By interfering with the synthesis of the bacterial cell wall, it kills bacteria. In the presence of the Beta-lactamase enzyme, it is extremely stable. As a result, many organisms resistant to penicillins and some cephalosporins may be sensitive to Cefixime due to the presence of beta-lactamases. It is absorbed about 40% to 50% of the time, whether it is given with or without food.

 

Dosage & Administration

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily

In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

 

Interaction

Ciprofloxacin should not be taken at the same time as magnesium or aluminum-containing antacids, sucralfate, or any calcium, iron, or zinc-containing medications. Ciprofloxacin can be taken two hours after or six hours before these products. Ciprofloxacin should not be taken with milk or other dairy products because the absorption of Ciprofloxacin may be reduced greatly. However, dietary calcium, when consumed as part of a meal, has no effect on Ciprofloxacin absorption.

 

Contraindications

Carbamazepine: Taking these drugs together raises the carbamazepine level. Concurrent use of warfarin and other anticoagulants raises prothrombin time.

 

Side Effects

In general, the medication is well tolerated. Diarrhoea and stool alterations are the most common adverse effects, which are more typically associated with greater doses. Nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache, and dizziness are some of the other side effects. Rashes, pruritus, urticaria, drug fever, and arthralgia have all been described as allergic reactions. When the therapy was stopped, these effects usually decreased.

 

Pregnancy & Lactation

However, no suitable and well-controlled studies in pregnant women have been conducted. Because animal reproduction studies do not always predict human response, this medication should only be used during pregnancy if absolutely necessary. Cefixime is not known to be excreted in human milk. When Cefixime is given to a breastfeeding mother, caution should be observed.

 

Precautions & Warnings

Individuals having a history of gastrointestinal disorders, particularly colitis, should be prescribed with caution. Patients with severe renal impairment, as well as those on continuous ambulatory peritoneal dialysis or hemodialysis, should be given the medicine with caution. Only in severe renal failure (creatinine clearance 20 ml/min) should dosage be adjusted; in that case, a daily dose of 200 mg should not be exceeded.

 

Therapeutic Class

Third generation Cephalosporins

 

Storage Conditions

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.