INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo RANAMP 250 Injection
RANAMP 500 Injection
RANAMP 1 g Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RANAMP 250 Injection
RANAMP 500 Injection
RANAMP 1 g Injection

COMPOSITION:
RANAMP 250 Injection
Each vial contains:
Ampicillin sodium BP equivalent to Ampicillin anhydrous 250 mg

RANAMP 500 Injection
Each vial contains:
Ampicillin sodium BP equivalent to Ampicillin anhydrous 500 mg

RANAMP 1 g Injection
Each vial contains:
Ampicillin sodium BP equivalent to Ampicillin anhydrous 1 g

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
A semi-synthetic aminopenicillin with an in vitro bactericidal action against a broad spectrum of non penicillinase producing gram-positive and gram-negative pathogens. Being acid stable it is well absorbed when given orally.
The in vitro antibacterial spectrum is as follows: (Sensitivity tests must be performed when marked*)
Gram-Positive organisms:
Particularly active against: Streptococcus pneumoniae*, Streptococcus faecalis * Streptococcus agalactiae (group B), Listeria monocytogenes.
Also active against Staphylococcus aureus *, Streptococcus pyogenes, Streptococcus viridans * Streptococcus bovis, Bacillus anthracis *, Corynebacterium species, Clostridium species *.
Gram-Negative organisms: (these organisms may produce beta-lactamase)
Activity against Escherichia coli *, Haemophilus influenzae * (except meningitis-causing beta-strain), Salmonella * and Shigella * species, penicillin sensitive Neisseria gonorrhoeae, Neisseria meningitidis (except the carrier state).
May be active against Bacteroides fragilis *, Proteus mirabilis * and Nocardia *
IN VITRO SENSITIVITY DOES NOT NECESSARILY IMPLY IN VIVO ACTIVITY.
The following organisms are resistant to ampicillin: Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.

INDICATIONS:
RANAMP (ampicillin) is indicated in the treatment of infections caused by susceptible strains of the following microorganisms:
Infections of the genitourinary tract caused by E coli, P. mirabilis and enterococci.
Respiratory tract and ENT infections e.g. pharynigitis, tonsillitis, sinusitis, laryngitis, otitis media, bronchitis, pneumonia caused by various bacteria including non-penicillinase-producing H. influenzae, staphylococci, and streptococci including Streptococcus pneumoniae.
Infections of the gastro-intestinal tract caused by Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
Gonorrhoea –N. gonorrhoeae (non penicillinase producing)
Meningitis –N. meningitidis (after confirmation by sensitiviity testing)
Miscellaneous infections e.g. Septicaemia, endocarditis and biliary tract infections. Skin and soft tissue infections, bacteremia and as an adjunct in the treatment of sepsis caused by Gram-negative bacteria.

CONTRA-INDICATIONS:
RANAMP is contra-indicated in individuals with a history of a previous hypersensitivity reaction to any of the pencillins. Patients allergic to cephalosporins or cephamycins may be allergic to penicillins also. Ampicillin is also contra-indicated in infectious mononucleosis.
It is contra-indicated in babies born of hypersensitive mothers in the neonatal period.

WARNINGS:
When administered to a patient with penicillin sensitivity, anaphylactic shock may occur. Adrenaline corticosteroids and antihistamines should be used to treat anaphylaxis. Use with caution in patients with known history of allergy.

DOSAGE AND DIRECTIONS FOR USE:
Dosage varies with the type and the severity of the infection, renal function, and age.
Doses for children should not exceed doses recommended for adults.
Parenteral administration is reserved for severe infections that cannot be treated by oral ampicillin.
Children: Up to 400 mg per kg body mass per day, given in divided doses four hourly.
Adults: Up to 12 g daily, given in divided doses 4 hourly.

DIRECTIONS FOR USE OF PARENTERAL RANAMP:
Use only freshly-prepared solutions.
Intramuscular use: Dissolve 250 mg, 500 mg or 1 g in 1 to 2 mL of sterile water for injection and withdraw the entire contents.
Direct intravenous injection: Dissolve 250 mg, 500 mg or 1 g in 5 to 10 mL of sterile water for injection. Administer the dose by slow injection over a period of 3 to 5 minutes.
Intravenous drip: Stability studies on ampicillin sodium at concentration of 2 mg/mL and 30 mg/mL in various intravenous solutions indicate that the medicine will lose less than 10% activity at room temperature (25°C) for the time periods stated below:
Isotonic Sodium chloride : 8 hours
5% Dextrose in water : 4 hours
10% Invert sugar in water : 4 hours
M/6 Sodium lactate solution
(in concentration of 30 mg/mL) : 8 hours

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Skin rashes are most common side effects and are erythematous, pruritic and maculopapular. The rash which usually does not develop within the first week of therapy, may cover the entire body including the sole, palms, and oral mucosa. Other hypersensitivity reactions that have been reported are skin rash, urticaria, erythema multiforme and an occasional case of exfoliative dermatitis. Anaphylaxis is the most serious reaction expierenced.
Gastrointestinal: Nausea, vomiting, pseudomembranous colitis and diarrhoea.
Liver: A moderate elevation in the serum glutamicoxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.
Haematological and Lymphatic Systems: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and granulocytopenia have been reported.
Other adverse reactions that have been reported with the use of ampicillin are laryngeal stridor and high fever. Sore mouth or tongue may occur.
Precautions:
Careful history of sensitivity to allergens, including previous hypersensitivity reactions to penicillins and cephalosporins should be taken before instituting therapy. Ampicillin should be discontinued if any rash occurs.
Care should be taken when treating patients with syphilis, as the Jarisch-Herxheimer reaction may occur shortly after starting treatment. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.
In prolonged therapy, and particularly with high dosage regimens, periodic evaluation of the renal, hepatic and hematopoietic systems is recommended. Care should be taken when high doses are given to patients with renal impairment (becuase of the risk of neurotoxicity) or congestive heart failure.
Interactions
Probenecid may decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.
Ampicillin may decrease the efficacy of oral contraceptives and increased breakthrough bleeding may occur.
Allopurinol increases possibility of skin rash, particularly in hyperuricemic patients, when ampicillin is given concurrently.
Chloramphenicol, erythromycin, sulfonamides, or tetracycline may interfere with the bactericidal effect of penicillins.
After treatment with ampicillin, a false-positive reaction for glucose in the urine may occur with copper sulfate tests but not with enzyme based tests such as Clinistrix.
Usage in pregnancy
Animal reproduction studies have failed to demonstrate a risk to the foetus, and there are no adequate and well controlled studies in pregnant women.
Nursing mother
Ampicillin-class antibiotics are excreted in milk. Ampicillin use by nursing mothers may lead to sensitization, diarrhoea, candidiasis and skin rash of infants. Use with caution when administered to lactating women.
Paediatric use
Pencillins are excreted primarily unchanged by the kidney, therefore, the incompletely developed renal function in neonates and young infants will delay the excretion of penicillin. Administration to neonates and young infants should be limited to the lowest dosage compatible with an effective therapeutic regimen.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage, medication should be discontinued and symptomatic and supportive measures should be instituted as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.

IDENTIFICATION:
RANAMP 250 Injection:
White to off-white crystalline, odourless, hygroscopic powder in a 5 mL clear glass USP type III vial sealed with a grey butyl rubber plug and tear off aluminium seal embossed with 'RANBAXY'.

RANAMP 500 Injection:
White to off-white crystalline, odourless, hygroscopic powder in a 5 mL clear glass USP type III vial sealed with a grey butyl rubber plug tear off aluminium seal embossed with 'RANBAXY 500 mg'

RANAMP 1 g Injection:
White to off-white crystalline, odourless, hygroscopic powder in a 15 mL clear glass USP type III vial sealed with a grey butyl rubber plug and tear off aluminium seal embossed with 'RANBAXY'.
After reconstitution, a clear, colourless to pale yellow solution, free from visible particles is formed.

PRESENTATION:
RANAMP 250 Injection : Carton containing 5 and 50 clear glass USP type III vials
RANAMP 500 Injection : Carton containing 5 and 50 clear glass USP type III vials.
RANAMP 1 g Injection : Carton containing 5 and 50 clear glass USP type III vials.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture. Use the prepared solution immediately.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
RANAMP 250 injection : 30/20.1.2/0247
RANAMP 500 Injection : 30/20.1.2/0248
RANAMP 1 g Injection : 30/20.1.2/0249

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD.
3rd Floor
Outspan House
1006 Lenchen Avenue North
CENTURION

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 June 1996

Updated on this site: June 2005
Source: Pharmaceutical Industry

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