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Piloxal

Quadrant Healthcare Ltd
71, Jebba Street, Ebute-Metta (East), Lagos
Email: quaint998@hotmail.com
Tel: 08066122428, 07028090227, 08026044280

Brand Name

Piloxal

Manufacturer

North China Pharmaceutical Co, Ltd.,
No. 388, Heping East Road, Shijiazhuang, Hebei,

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection(NRN:-): Each vial contains Ampicillin Sodium and Cloxacillin Sodium available as sterile powder for preparing the equivalent of 250 mg ampicillin and 250 mg cloxacillin.

Pack Size: 

Pharmacology

PHARMACOLOGICAL ACTION:

(a) Bacteriology: PILOXAL exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms. In vitro sensitivity does not necessarily imply in vivo activity. 

(b) Absorption: Both ampicillin and cloxacillin are acid stable and well absorbed orally, giving peak serum levels about two hours after dosing. As there is a linear dose/response in peak serum level after oral administration of both components, doubling the dose virtually doubles the peak serum levels.

(c) Excretion: Both components are excreted primarily by the kidneys by glomerular filtration and tubular secretion.
Bile: Bile concentrations of PILOXAL vary from 3 - 48 times the serum concentration, according to the condition of the biliary tract.

(d) Probenecid: Higher PILOXAL serum levels can be achieved in patients with normal renal function by the concurrent administration of a renal blocking agent such as probenecid. In adults, a dose of 500 mg of probenecid q.d.s. will result in 1.5 - 2 fold increase in PILOXAL serum levels.

Indications

Piloxal is indicated for the treatment of infections of the respiratory tract, ear, nose and throat, urinary tract, gastro-intestinal tract, skin and soft-tissues; septicaemia, pelvic infections, endocarditis and orthopaedic infections.

Contra-indications

Known allergy to penicillin or cephalosporins. Cases of cross sensitivity have been reported. Babies born of hypersensitive mother in the neonatal period. The oral dosage forms are not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis, PILOXAL should not be administered by sub-conjunctival injection or used as an eye drop as it contains cloxacillin.

Precautions/Warnings

When administered to a patient with penicillin allergy anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.

Use with caution in patients with a known history of allergy. Because of the variability in intestinal absorption of cloxacillin containing products, oral administration is not a suitable substitute for the parenteral route in treatment of severe infections.

Interactions

Adverse Effects

The most common adverse reactions associated with penicillin therapy are allergic reactions and of this skin rashes occurs most frequently.

Administration of penicillins to a hypersensitive patients may occasionally result in anaphylactic shock with collapse and sometimes death occuring within minutes; Angioedema and or bronchospasm may also occur.

A generalized sensitivity reactions with urticaria, fever, joint pains and oesinophilial can develop within a few hours to several weeks after starting penicillin treatment. Other allergic reactions include exfoliative dermatitis and other skin reactions, interstitial nephritis, and vasculitis.

Dosage & Administration

The average adult dose for PILOXAL is 2 - 4g per day. In severe infections, dosages may be safely increased.

Adults and Children over 10 years: 500 mg - 1g intravenously; or Intramuscularly every 4 - 6 hours or as dictated by the severity of the infection.

Children up to 10 years: 20 to 40 mg/kg per day in two divided doses.

Note: patients with renal insufficiency may require a reduced dosage.

DIRECTIONS FOR USE:

Intramuscular Injection:
500 mg vial - dilute with 2 mL of aqueous dilute and shake vigorously.

Intravenous Injection:
Normally given by slow intravenous injection. 500 mg - dissolve in 10 mL of water for Injections B.P. by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P.

Intravenous Infusion:
Vial contents should be dissolved in a suitable volume of fluid and given as a rapid intravenous infusion over 30 minutes or suitably diluted into the drip tubing. Solutions must be used within 30 minutes of preparation.

Storage/Handling Recommendations

Review Date

2017-02-07 04:14:51