TOGETHER FOR HEALTH

GLOXIN 250 Powder for oral suspension and 250/500 Capsule 16/04/2011

Packing: - GLOXIN 250 oral powder: Box of 10 sachets of 2.75 g oral powder. Box of 20 sachets of 2.75 g oral powder. - GLOXIN 250 and GLOXIN 500 capsule: Box of 10 blisters of 10 capsules. Box of 100 blisters of 10 capsules.

Active substances: Cefalexin 250 /500 mg

GLOXIN

Cephalexin

 

NAME OF THE PRODUCT

GLOXIN 250 oral powder.

GLOXIN 250 capsule.

GLOXIN 500 capsule.

COMPOSITION

Each sachet/ capsule contains:

Active ingredient:

- GLOXIN 250 oral powder: cephalexin monohydrate equivalent to 250 mg anhydrous cephalexin.

- GLOXIN 250 capsule: cephalexin monohydrate equivalent to 250 mg anhydrous cephalexin.

- GLOXIN 500 capsule: cephalexin monohydrate equivalent to 500 mg anhydrous cephalexin.

INDICATIONS

For the treatment of susceptible infections in acute and chronic bronchitis, otitis media, sinusitis, tonsillitis, pharyngitis, cystitis and prostatitis, obstetric and gyneacological infections such as gonorrhoea that do not respond to penicillin, skin and soft tissue infections, osteal infections.

For the prophylaxis of recurrent urinary tract infections.

DOSAGE AND ADMINISTRATION

Adults: take 250 - 500 mg every 6 hours up to a maximum of 4 g daily. Chronic, recurrent and complex urinary tract infections: 1g twice daily for 2 weeks.
Children: take 25 - 60 mg/ kg body weight daily in 2-3 divided doses. The maximum dose is 100 mg/ kg body weight
daily.

For more severe infections, larger doses may be needed, as determined by your doctor.

The dose of cephalexin should be reduced in renal impairment.

The therapy should be continued for 7 to 14 days.

May be taken with food to reduce gastrointestinal discomfort.

CONTRAINDICATIONS

Patients with hypersensitivity to cephalosporins, penicillins and any ingredient of this product.

WARNINGS AND PRECAUTIONS

Do not use this product with any other product containing cephalexin.

Prolonged use of cephalexin may result in an overgrowth of bacteria that do not respond to the medication.

Check with your doctor before use if you have any the following: history of hypersensitivity to penicillins, history of GI disease, especially pseudomembranous colitis, renal failure.

Use in pregnant and breast-feeding women: There is no experimental evidence of embryotoxic or teratogenic effects attributable to cephalexin but it should be administered with caution during the early months of pregnancy. Cephalexin is excreted in human milk with small quantities, however caution should be exercised when cephalexin is administered to a nursing mothers.

DRUG INTERACTIONS

The renal excretion of cephalexin is delayed by probenecid.

Cephalexin may decrease the efficacy of oestrogen-containing oral contraceptives.

Large doses of cephalexin with aminoglycoside, furosemide, ethacrynic acid and piretanide may induce bad effects on renal function.

ADVERSE DRUG REACTIONS

The most frequently reported adverse effects include diarrhea, vomiting, nausea.

Other side effects including eosinophilia, hypersensitivity reactions such as skin rash, urticaria, pruritus occur occasionally.

There are rare cases such as headache, dizziness, anaphylaxis, weakness, neutropaenia, thrombocytopaenia,  gastrointestinal disturbances, abdominal pain, pseudomembranous colitis, genital itching, vaginitis, interstitial nephritis.

Stop use and ask a doctor if: your symptoms do not improve or get worse within a few days, anaphylactoid reactions, nephrotoxicity or pseudomembranous colitis occur.

Inform your physician in case of any adverse reaction related to drug use.

PHARMACOLOGY AND PHARMACOKINETICS

Cephalexin is a first-generation cephalosporin antibiotic. It is bactericidal because of their inhibition of cell-wall synthesis. Cephalexin is stable in the presence of penicillinase. As a result, many organisms resistant to penicillins are susceptible to cephalexin.

Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:

-   Aerobic Gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes.

-   Aerobic Gram-negative microorganisms: Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis.

Methicillin-resistant staphylococci and most strains of enterococci (Streptococcus faecalis) are resistant to cephalexin. It is not active against most strains of Enterobacter spp., Morganella morganii, and Proteus vulgaris. It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics.

Cephalexin is given by mouth for the treatment of susceptible infections including those of the respiratory and urinary tracts and of the skin.

Pharmacokinetics

-   Cephalexin is almost completely absorbed from the gastrointestinal tract. Following doses of 250 mg and 500 mg, average peak plasma concentration of approximately 9 and 18 mcg/ml, respectively were obtained at 1 hour. If cephalexin is taken with food, absorption may be delayed, but the total amount absorbed is not appreciably altered.

-   Up to 15% of a dose is bound to plasma proteins. The plasma half-life is about 1 hour; it increases with reduced renal function.

-   Cephalexin is widely distributed in the body but does not enter the CSF in significant quantities. It crosses the placenta and small quantities are found in breast milk.

- Cephalexin is not metabolised. About 80% or more of a dose is excreted unchanged in the urine in the first 6 hours by glomerular filtration and tubular secretion; urinary concentrations greater than 1 mg/ml have been achieved after a dose of 500 mg. Probenecid delays urinary excretion. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route. Cephalexin is removed by haemodialysis and peritoneal dialysis.

http://glomedvn.vn/en/admintc/fckeditor/editor/images/spacer.gifOVERDOSAGE

Symptoms: Symptoms of oral overdose may include nausea, vomiting and diarrhea.

Treatment:

-   In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

-   Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastric lavage should not be necessary.

-   Hemodialysis have not been established as beneficial for an overdose of cephalexin.

-   Protect the patient’s airway and support ventilation and perfusion. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal instead of or in addition to gastric emptying. Safeguard the patient’s airway when employing gastric emptying or charcoal.

PRESENTATION

- GLOXIN 250 oral powder:     Box of 10 sachets of 2.75 g oral powder.

                           Box of 20 sachets of 2.75 g oral powder.

- GLOXIN 250 and GLOXIN 500 capsule:      Box of 10 blisters of 10 capsules.

                                        Box of 100 blisters of 10 capsules.

STORAGE: store at the temperature not more than 30oC, in a dry place, protect from light.

SPECIFICATION: Manufacturer’s.

SHELF-LIFE:       GLOXIN 250 oral powder: 24 months from manufacturing date.

              GLOXIN 250 & GLOXIN 500 capsule: 36 months from manufacturing date

PRESCRIPTION ONLY

KEEP OUT OF REACH OF CHILDREN

READ CAREFULLY THE LEAFLET BEFORE USE

FOR MORE INFORMATION, CONSULT YOUR PHYSICIAN.

Manufactured by: GLOMED PHARMACEUTICAL Co., INC

Address: 35 Tu Do Boulevard, Vietnam – Singapore Industrial Park, Thuan An District, Binh Duong Province.

Tel: (0650)3768824 - (0650)3768825    Fax: (0650)3769095

© 2011 GLOMED PHARMACEUTICAL Co., INC