Ampicillin Sodium Powder for Injection

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Ampicillin Sodium Powder for Injection

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Ampicillin Sodium Powder for Injection

Product description

Details:

Ampicillin is a beta-lactam antibiotic that has been used extensively to treat bacterial infections. Ampicillin is effective against Gram-negative organisms such as H. influenzae, coliforms and Proteus SPP. As with other penicillin drugs, ampicillin is relatively non-toxic and adverse effects of a serious nature are encountered only infrequently.
Product Packaging
Ampicillin Sodium Powder for Injection can be packaged as:
7ml, 8ml or 10ml vials,
10 vials / box,
50 vials / box,
or according to the customer's requirements.
  • Antibiotic
  • Ampicillin
  • China
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Product Dosages

    

NameFormDosageCode
Ampicillin Sodium  Powder for Injection 250mg 1000.1954
Ampicillin Sodium Powder for Injection 500mg  1000.2720
Ampicillin Sodium   Powder for Injection  1G  1000.2719
Ampicillin Sodium  Powder for Injection  2G  1000.2207
Additional Information

INTRODUCTION
AMPICILLIN SODIUM is a broad spectrum formulation of ampicillin and penicillinase-stable Cloxacillin. It exhibits bactericidal activity against a wide range of Gram-positive and Gram-negative organisms.

INDICATIONS
 Respiratory Tract Injections
 Ear, Nose and Throat Infections
 Urinary Tract Infections
 Gastro-intestinal Infections
 Skin and Soft Tissue Infections
 Pelvic Infections
 Septicaemia
 Endocarditis
 Orthopaedic Infections

DOSAGE AND ADMINISTRATION
AMPICILLIN SODIUM is effective in a wide range of dosage regimens. The recommendations given here are commonly applied. Further details are available on request.
Adults:
 Oral: 500mg – 1g every 6 hours or more frequently according to the severity of the infection. Administer 1 / 2- 1 hour before meals
 IM injection: 500mg – 1g every 4 – 6 hours, Dissolve 500mg in 1.5 or 1g in 3ml of Water for Injection BP*
 IV injection: 500mg – 1g every 4 – 6 hours or as indicated by the severity of the injection – up to 12g may be administered by IV infusion, Dissolve 500mg in 10ml or 1g in 20ml of Water for Injection BP* and give by slow intravenous injection or add suitably diluted to the ’drip’ tubing. AMPICILLIN SODIUM may be added to the infusion over a period of 30 – 40 minutes.
Children:
 Oral / Injectable: 1 month – 2 years, 1 / 4 adult dose2- 10 years, 1 / 2 adult doses. Dilutions as for adult preparations. 250 mg may be dissolved in 1.0ml Water for Injection BP* for IM administration, or in 5ml for V Injection
 Solutions should be administered immediately after reconstitution.

CONTRA-INDICATIONS
History of hypersensitivity to beta–lactam antibiotics
(penicillin, cephalosporin)
Ocular administration

WARNINGS
 Before initiating therapy with AMPICILLIN SODIUM,
 careful enquiry should be made concerning previous hypersensitivity reactions to beta – lactam.
 AMPICILLIN SODIUM should be avoided if infections mononucleosis and / or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

PRECAUTIONS
Renal Impairment: In cases of renal failure, the dosage should be adapted in accordance with the following:
Creatinine clearance≥ 50 ml/min:
 Normal dose according to indication.
Creatinine clearance 50 – 10 ml/ min:
 Dosage (oral or parenteral administration) initial dose: normal dose (according to indication).
 Dosage (oral or parenteral administration) maintenance dose: the normal unit dose* three times daily.
Creatinine clearance below 10 ml/min:
 Dosage (oral or parenteral administration) initial dose: normal dose (according to indication).
 Dosage (oral or parenterally administration) maintenance dose: the normal unit dose twice or once daily.
 The normal unit dose is: ampicillin/Cloxacillin 500 mg orally, up to 1g intra-muscularly or intravenously.
 In cases of dialysis, an additional normal unit dose is to be administered after the procedure.
 Hepatic Impairment: Reduce frequency of administration depending on the severity of the condition.
 AMPICILLIN SODIUM syrup 250 mg/5 ml contains sodium benzoate and aspartame and should be used with caution in patients with phenylketonuria.

INDICATIONS WITH OTHER MEDICATIONS
 Probenicid may cause increased and prolonged blood levels of AMPICILLIN SODIUM may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
 Sulphonamides and acetylsalicylic acid inhibit serum protein binding of Cloxacillin in vitro. This may result in increased levels of free Cloxacillin in serum in vivo.
Pregnancy and Lactation
Adequate human data on use during pregnancy and lactation are not available.
Side Effects
 As with other penicillins, side erects are usually of a mild and transitory nature. They may include nausea, vomiting, diarrhoea, indigestion, or occasionally skin rash, either urticarial, with suggests penicillin hypersensitivity, or erythematosus. An erythematosus rash may occur in patients with glandular fever or lymphoid leukaemia. In either case it is advisable to discontinue therapy.
 As with other beta-lactam antibiotics, anaphylaxis and other hypersensitivity reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal Necrolysis) have been reported very rarely. Pseudomembraneous colitis and haemorrhagic colitis have been reported.

 As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a transient increase in transaminases has been reported.
As with other beta-lactam, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely.

OVERDOSAGE
Overdosage with oral AMPICILLIN SODIUM is unlikely to cause serious reactions if renal function is normal. Very high dosage of IV administered ampicillin in renal failure may provoke neurotoxic reactions
Gastrointestinal effects such as nausea, vomiting and
diarrhoea should be treated symptomatically.

PHARMACODYNAMIC PROPERTIES
AMPICILLIN SODIUM is a combination of ampicillin and Cloxacillin.
 Cloxacillin is a narrow-spectrum antibiotic of the isoxazolyl penicillin group; it is not inactivated by staphylococcal beta-lactamases.
 Ampicillin is a broad-spectrum antibiotic of the aminopenicillin group; it is not resistant to beta-lactamases.
Absorption:
 Both ampicillin and Cloxacillin are stable in the gastric environment resulting in good parenteral and oral
 absorption. Neither component of the combination
of ampicillin and Cloxacillin interferes with the
absorption or excretion of the other.
 The total quantity absorbed by the oral route represents 50% (Cloxacillin) and 40% (ampicillin) of the quantity administered.
 The presence of food in the stomach may depress oral absorption and AMPICILLIN SODIUM should therefore be taken 0.5-1 h before meals.
Distribution:
 AMPICILLIN SODIUM diffuses well into most tissues and body fluids including, among others, bronchial secretions, sinuses, saliva, cerebrospinal fluid (variable percentage depending on the degree of meningeal inflammation), bile, serous membranes and middle ear.
 Crossing the meningeal barrier: AMPICILLIN SODIUM diffuses in only small proportion into the cerebrospinal fluid of subjects whose meningeal are not inflamed.
 Crossing into breast milk: AMPICILLIN SODIUM is excreted in small quantities in breast milk.
 Plasma half-life for Cloxacillin is 0.5-1 h and 1-1.5 hr for ampicillin.
 AMPICILLIN SODIUM is eliminated mainly through the kidney. Approximately 30% of the dose administered orally and over 60% of the ampicillin dose administered parenterally is eliminated in active form in the urine within 24 hours. The equivalent percentages for Cloxacillin are approximately 20% hours. The equivalent percentages for Cloxacillin are approximately 20% and 30% respectively. A small proportion (10%) of the administered is excreted in bile.


Protein binding:
The serum protein binding rate is approximately 94% for Cloxacillin and 18% for ampicillin.
Stability and Compatibility
 AMPICILLIN SODIUM IV Injection is compatible with commonly used intravenous fluids at 23℃ if infused over a period of six hours. Solution should be changed after one hour if it is administered in fluids containing dextrose or other carbohydrates or within four hours for solutions containing sodium bicarbonate. AMPICILLIN SODIUM should not be mixed with lipid emulsions.

 Syrup: Once dispensed the syrup should be used within 7 days. If necessary dilute with syrup B.P.

STORAGE
 All AMPICILLIN SODIUM containers should be kept tightly closed and stored in a dry place, below 25℃.
Shelf-life
The expiry date is indicated on the packaging.

AVAILABILITY
 For adults:
500mg CAPSULES: Capsules containing 250mg ampicillin1 plus 250mg cloxacillin2 in PVDC coated PVC blister
 For children:
250mg SYRUP: Powder for preparing fruit flavored syrup. When dispensed each 5ml contains 125mg ampicillin1 plus 125mg cloxacillin2

 

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