Information: Orbenin 500mg, cloxacillin

Orbenin 500mg,
cloxacillin

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Orbenin 500 mg. Capsulesv
Cloxacillin (O.S.D.)
Oral administration

QUANTITATIVE COMPOSITION
Each capsule contains:
Cloxacillin (O.S.D.) (sodium salt) . . . . . . . . . . . . . . . . . . . 500 mg
Excipients:
Magnesium stearate.

PROPERTIES
Semi-synthetic penicillin with bactericidal action characterized by its stability against penicillinase.
Cloxacillin, like all penicillins, acts by inhibiting the synthesis of the bacterial cell wall. It is bactericidal and active against most Gram-positive bacteria including penicillin-resistant staphylococci in its spectrum of activity.
Cloxacillin is stable in acid media and is well absorbed when administered by the oral route.
It can also be administered intramuscularly or intravenously.
Peak serum levels are obtained following administration and it diffuses rapidly into the whole body, this allows it to reach the source of the infection at therapeutic concentrations.
Cloxacillin is excreted by the renal system in the active form. The percentage of cloxacillin that is recovered in the urine depends on the route of administration, 25% is recovered when administered orally.

INDICACTONS
Cloxacillin is the antibiotic of choice in the treatment of systemic or localized staphylococcal infections, caused by bacteria that are sensitive or resistant to penicillin.

Sepsis
Acute and chronic osteomyelitis
Boils
Mastitis
Infected wounds and burns
Endocarditis
Meningitis
Respiratory tract infections
Urinary tract infection
Skin and soft tissue infections

POSOLOGY
Adults: 1 capsule every 6 hours.
Children: Aged less than 2: quarter of the adult dose.
Aged between 2 and 10: half of the adult dose.
The suspension presentation should be used to administer these doses. (See "Other presentations").

The doses indicated above correspond to average recommended doses however due to the low toxicity of semi-synthetic penicillins these doses may be increased for the treatment of severe infections or in infections that are caused by bacteria that are less sensitive to cloxacillin.
The administration of the capsules should not coincide with meals (capsules should be taken one hour prior to meals or two hours after meals).

CONTRAINDICATIONS
Orbenin is contraindicated in patients with a history of hypersensitivity to penicillins or cephalosporins and should not be administered by sub-conjunctival injection. It should be administered with caution in patients with a previous history of allergy mainly of medicamentosus origin.

INTERACTIONS
The simultaneous administration of Orbenin with bacteriostatic antibiotics (tetracyclines, chloramphenicol) should be avoided because it may lead to antagonism due to its different mechanism of action.

SIDE EFFECTS
Orbenin is well tolerated. Depending on the individual susceptibility to cloxacillin indigestion, unpleasant taste in the mouth or nausea may occur. On rare occasions diarrhoea or vomiting may occur. The adverse effects are limited to sensitivity phenomena (pruritus, skin rash, etc) which sometimes cease without having to interrupt treatment. In very rare cases severe anaphylactic reactions may occur.

OVERDOSE AND ITS TREATMENT
When hypersensitivity reactions occur it is recommended that the administration of the antibiotic be discontinued and specific therapy be instituted (corticosteroids, antihistamines, oxygen therapy, etc.). In the case of an overdose or accidental ingestion, contact your local poison control centre (Servicio de Informacion Toxicologica. Telephone: (91) 562 04 20) immediately.

PRESENTATION
Orbenin, capsules: Pack of 12 capsules, each containing 500 mg. cloxacillin.

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