Bioxime P Cefixime Granules

BIOXIME-P®

Cefixime granules 50mg

 

Description

Granules for suspension, of fragrant odour and sweet taste, with cup and spoon for easy-administration.

 

Pharmacology

1. Antibacterial action

Cefixine is a third-generation cephalosporin. It is a broad-spectrum antibiotic with bacterial action. Stable to most β-lactamase producing strains of organisms, as a result, many penicillinase-producing strains and some cephalosporinase-producing strains are susceptible to it. Cefixine’s antibacterial activity against the following bacterial is much stronger than those of other orally administered cephalosporins: Gram-positive bacteria: Streptococcus (except enterococcus), Pneumococcus, and Gram-negative bacteria: Gonococcus, Branhamella, Coliform bacilli, Klebsiella Serratieae, Proteus, Bacillus influenza.

2. Mechanism of action

Cefixine acts by inhibiting synthesis of bacteria cell wall. Its site of action is different with strains, having fairly high affinity to penicillin-binding protein (PBP) 1 (1a, 1b, 1c) and 3.

 

Pharmacokinetics

1. Absorption

Oral administration of a single dose of 200mg cefixine produces a mean peak serum concentration of about 3.0mg/L in about 3-4 hours with an AUC of 25.82mg/L and a half life (t ½) of 3.7-5.1h. Food has little or no effect on the pharmacokinetics of the drug; however, time to reach maximal absorption is increased by approximately 0.8 hours when administered with food.

The half life of the drug is prolonged in children. Patients with renal insufficiency also have longer half life (t ½) and greater renal clearance. Patients with moderate impairement of renal function (20 to 40 ml/min creatinine clearance), the average serum half-life of cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 ml/min creatinine clearance), the half-life increases to an average of 11.5 hours.

2. Distribution

The drug is well distributed in the body after oral administration with high concentrations in sputum, tonsil, secretions of middle ear, gall and prostate, and may penetrate the placenta into fetus’ systemic circulation.

3. Metabolism

Metabolites with activity have not been found in serum and urine.

4. Excretion

It is excreted mainly by the kidney. About 50% of the drug is excreted unchanged in the urine within 24 hours after oral administration of 200mg of the drug on healthy adults without food.

 

Indications

Used for the following infections caused by the bacteria susceptible to cefixime:

* Acute/chronic bronchitis, pneumonia

* Pharyngitis

* Tonsillitis

* Uncomplicated gonorrhea (cervicitis and urethritis)

* Otitis media

* Urinary tract infections

 

Usage and administration

The recommended dosage for adults and children weighing over 50kg or above 12 years is 400mg daily in one or two divided doses. For children over 6 months: 8mg per kg of body weight, in a single or two divided doses. For uncomplicated gonorrhea, a single dosage of 400mg is recommended. In renal insufficiency the dosage should be adjusted accordingly:

Creatinine clearance (ml/min) Dosage
21 – 60 300mg
≤ 20 200mg

 

Adverse reaction

The adverse reactions are transient and mild. The most common are the gastrointestinal tract reactions: diarrhea, increased stool frequency, abdominal pain, nausea, dyspepsia, flatulence and abdominal distention; other are skin rashes, urticaria, drug fever, itch, dizziness, the occurrence rate of which are rare. Eosinophilia and transiently decreased platelet and white cell counts.

Adverse Reactions Occurrence (0.1-5%) Occurrence (< 0.1%)
Allergy Rash, urticaria, erythema Pruritus, fever, edema
Blood Eosinophilia Granulopenia
Liver Increase in GOT, GPT and ALP Jaundice
Kidney Increase in BUN
Digestive system Diarrhea, stomach discomfort Nausea, vomiting, stomachache, chest burning sensation, poor appetite, belly satiety, constipation
Dysbacteriosis Stomatitis, oral candidiasis
Avitaminosis Vitamin K deficiency (Hypoprothrombinemia, hemorrhagic tendency etc), vitamin B deficiency (glossitis, stomatitsi, poor appetite, neuritis etc)
Others Headache, dizziness

 

Contraindications

Cefixine is contraindicated in patients with known hypersensitivity to the drug and also those who have shown hypersensitivity to other cephalosporins.

 

Precaution

* Patients with hypersensitivity to Penicillin.

* Enteritis patients should use with great care.

* For patients with renal insufficiency dosage should be adjusted.

* The treatment course for infection caused by Strptococcus pyrogens should be at least 10 days.

Pregnancy and lactation

Safety in pregnant women has not yet been established, so caution should be taken with these individuals; it is recommended that breats feeding should be suspended while taking cefixime since its secretion in breast milk is not yet certain.

Elderly

There is no need to adjust the dosage. The elderly are prone to adverse reactions and should therefore be subject to close observations.

Use in children under six months

Medication safety in premature infants and neonates is not clear (without any clinical experience). It is therefore not recommended for use in children below six months.

Influence on clinical examination results

(1) Except for test paper reactions, in the examinations of sugar in urine using Benedict reagent, Fehling reagent and Clinitest, the results may be negative, to which attention should be paid.

(2) Direct Coomb’s test may possibly show positive.

 

Drug reactions

* Cefixime is incompatible with Amikacin sulphate, Gentamycin, Kanamycin, Neomycin, Aureomycin hydrochloride, Tetracycline hydrochloride, Oxytetracycline hydrochloride, Calcium chloride, Diphenhydramine hydrochloride and other antihistamine, Lidocaine, Suxamethonium.

* May be incompatible with Penicillins, Phenytoin sodium, Proclorperazine, Vitamin B & C, and protein Carmustine, Streptozocin and amino glycoside antibiotics may increase the renal toxicity.

Clinical symptoms. Measures Mechanism. Risk factor
Warfarin Cefixime may possibly strengthen Warfarin’s activity. However there is no case reported on this product. Intestinal bacterium may induce inhibition on synthesis of vitamin K.

 

Overdose

In case of an overdose, gastric lavage may be used. Haemodialysis or peritoneal dialysis may not effectively eliminate the drug in systemic circulation.

 

Strength

50mg (calculated on the basis of C16H15N5O7S2)

 

Storage

Protect from light and moisture, store in a cool and dry place.

 

Package

50mg/sachet, 12 sachets/individual box, 100 sachets/individual box.

 

Manufactured by

SHENZHEN ZHIJUN PHARMACEUTICAL CO., LTD.

Hi-Tech Zone, Guanian, Baoan Area,

Shenzhen, P.R. China

 

Manufactured for

Biofem

www.biofemgroup.com