GPO Diclox

GPO Diclox

dicloxacillin

Manufacturer:

GPO

Distributor:

GPO
Full Prescribing Info
Contents
Dicloxacillin Na.
Description
Each capsule contains Dicloxacillin Sodium equivalent to Dicloxacillin 250 and 500 mg.
Action
Pharmacology: Dicloxacillin is a semisynthetic penicillinase-resistant penicillin. The drug is active against most gram-positive cocci including beta-hemolytic streptococci, pneumococci and staphylococci especially penicillinase-producing strains of Staphylococcus aureus and S. epidermidis that are resistant to other penicillins.
Dicloxacillin is resistant to inactivation by gastric secretions and is rapidly but incompletely absorbed from the GI tract. Food generally decreases the rate and extent of absorption. Dicloxacillin is distributed into bone, bile, pleural fluid, and synovial fluid. The drug can cross the placenta and is distributed into milk. Approx. 95-99% of the drug is bound to plasma proteins. The serum half-life in adults is 0.6-0.8 hour and in children 2-16 years of age is 1.9 hours. The half-life is slightly prolonged in patients with impaired renal function.
Dicloxacillin is partially metabolized to active and inactive metabolites. 31-65% of the dose is excreted in urine as unchanged drug and active metabolites within 6-8 hours, approx, 10-20% of this is the active metabolites.
Indications/Uses
Treatment of infections caused by susceptible microorganisms particularly penicillinase-producing strains e.g., mild to moderate respiratory tract infections, skin and soft tissue infections.
Dosage/Direction for Use
The dosage should be taken at least 1 hour before meals or 2 hours after meals.
Adults and Children over 40 kg of body weight: Oral, 125-250 mg every six hours.
Infants and Children up to 40 kg of body weight: Oral, 3.125-8.25 mg/kg every six hours.
Note: Higher dosage may be necessary depending on the severity of the infections.
For most staphylococcal infections, therapy should be continued for at least 14 days.
For group A beta-hemolytic streptococcal infections, therapy should be continued for at least 10 days to decrease the risk of rheumatic fever and glomerulonephritis.
Warnings
(based on the Ministry of Public Health Announcement): It is contraindicated in patients with known hypersensitivity to penicillins.
It may cause hypersensitivity reactions including anaphylactic reactions.
Discontinue the drug and consult the physician if there is skin rashes, itching, or edema.
Special Precautions
Use in Pregnancy & Lactation: Should be used with caution in nursing women.
Safe use during pregnancy has not been established. The drug should be used during pregnancy only when clearly needed.
Use in Children: Should be used with caution in neonates.
Use In Pregnancy & Lactation
Should be used with caution in nursing women.
Safe use during pregnancy has not been established. The drug should be used during pregnancy only when clearly needed.
Adverse Reactions
Gastrointestinal disturbances, such as nausea, vomiting, diarrhea, epigastric discomfort, flatulence, have been reported. As like other penicillins, pruritus, urticaria, skin rashes, and allergic symptoms may also occur.
Storage
In well-closed container, below 25°C.
MIMS Class
ATC Classification
J01CF01 - dicloxacillin ; Belongs to the class of beta-lactamase resistant penicillins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 250 mg x 50 x 10's. 500 mg x 50 x 10's.
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