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Ampilin

(Ampicillin Capsules B.P. 250mg) and (Ampicillin Oral Suspension B.P 125mg/5ml)

(Ampicillin Capsules B.P. 500mg)

 

DESCRIPTION

Capsules : Black and red Hard Gelatin Capsules

With in print AMPILIN 250/500

 

Each capsule contains :

Ampicillin Trihydrate B.P equivalent To Ampicillin B.P 250mg

Ampicillin Trihydrate B.P equivalent To Ampicillin B.P 500mg

 

Suspension :

Unreconstituted : Fine, free flowing, homogenous powder, free from lumps and substantially free from dark specks.

Colour : white to red 

Odour : Characteristic of penicillin

Reconstituted : Free flowing homogenous suspension, fruity odour and pink colour

Each 5ml of reconstituted suspension contains :

Ampicillin Trihydrate B.P 143mg

Equivalent To Ampicillin B.P 125mg

 

ACTIONS AND MODE OF MECHANISMS OF ACTION

Bactericidal for Gram-positive organisms, acts by inhibiting transpeptidase, the enzyme responsible for cross-linking of peptidoglycan during the final stage of synthesis of the bacterial cell wall, thus exerts its effect against actively dividing bacteria.

 

Bacteriostatic for Gram-negative organisms, action resembles those of chloramphenicol and tetracycline ie by inhibition of bacterial protein synthesis.

 

PHARMACOLOGY

Ampicillin is bactericidal in its action against Gram-Positive and bacteriostatic against Gram-Negative organisms. Those Gram positive bacteria sensitive to the therapy of ampicillin in the concentration normally achieved in the body include Streptococcus faecalis, Str. pneumonae and haemolytic streptococci. Haemophilus influenzae, Salmonellae, most strains of Escherichia coli, Neisseria gonorrhoeae, N meningitidis, Bacillus pertussis, Proteus mirabilis and Brucella spp ( Gram-negative ). Ampicillin is also effective against some shigella but strains can acquire resistance rapidly. Ampicillin is inactivated by penicillinase and penicillinase-producing strains of Staphylococcus aureus, Proteus spp., E.coli and Klebsuella spp. are resistant. Resistance factors may occur causing resistance to ampicillin and other antibiotics in Gram negative organisms.

 

Ampicillin is relatively stable in the acid gastric secretion and is well absorbed from the G.I.T after oral administration. Absorption is somewhat delayed in the presence of food. Peak plasma concentrations are obtained in about 2 hours and following a dose of 500mg by mouth, are reported to range from 3 to 5 g/ml. The concentration can be doubled by doubling the dose.

 

Ampicillin is widely distributed throughout the body with therapeutic levels in joints, serosal cavities and very high concentrations in the biliary tree ( without causing obstruction), kidney tissues and urine. A somewhat low concentrations are found in the cerebrospinal fluid, but therapeutic concentration is achieved when the meninges is inflamed. It also crosses the placenta barrier and a significant concentration persists in amniotic fluid. Ampicillin is also excrete in the breast milk .

 

About 30% of an oral dose of ampicillin is excreted in the urine in 6 hours. Renal excretion is restarted by probenacid. Ampicillin is also excreted in the faeces, milk and tears.

 

INDICATIONS

Respiratory Tract Infections : Acute and chronic bronchitis, bronchiectasis, pneumonia, tonsillitis, pharyngitis, laryngitis, sinusitis.

Gastro-Intestinal Tract Infections : Typhoid and paratyphoid baciliary dysentary, salmonellosis, shigellosis, bacterial diarrhea.

Urinary Tract Infection : Urethritis, gonorrhoeae, cystitis pyclonephritis

Soft Tissue Infections : Ampicillin is indicated in the above infections when caused by one or more of the following organisms, Streptococci, pneumococci, penicillin G-sensitive staphylococci, enterococci, Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae, N. meningitidis, Shigella, Salmonella typhosa and other Salmonella species.

 

CONTRA INDICATIONS

Patients known to be hypersenstivie to ampicilin or penicillins should be given an antibiotic of another class. Ampicillin should preferably not be given to patients with infectious mononucleosis since they are especially susceptible to ampicillin induced skin rashes, patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.

 

SIDE EFFECTS / ADVERSE EFFECTS

Hypersensitivity reactions are the most common side effects and are either

a) Urticaria ( typical of penicillin hypersensitivity )

b) Maculopapulor eruptions ( characteristic of ampicillin appears about 5 days after treatment has finished )

 

Rashes are more likely to occur in patients with history of allergy, asthma, hay fever, urticaria, infectious mononucleosis and those who have previously demonstrated hypersensitivity to penicillin. Rashes caused by ampicillin may be toxic rather than allergic origin as caused by benzylpenicillina and not necessarily a contra-indication to future treatment with ampicillin or another penicillin.

 

Gastrointestinal side-effects such as glossitis, stomatitis, black hairy tongue, nausea, vomiting, diarrhoea and puritus can also occur with oral ampicillin therapy.

 

As true with all antibiotics super-infections may occur. This incidence is more associated with oral administration but may also occur with parenteral administration. Rarely disorders of blood may occur and increases in serum transaminase concentrations have occasionally been reported.

 

Serious and occasionally fatal anaphylactoid reactions have been reported in patients receiving penicillin therapy. It is more frequent following parenteral therapy but may also occur with oral therapy.

 

PRECAUTIONS / WARNINGS

Precaution

1. Caution with cross-sensitivity of ampicillin with cephalosporins, griseofluvin, penicillamine, and other types of penicillins

 

2. Cautiously used when the following medical problems exist

i) History of gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis.

ii) Infectious monocucleosis / cytomegalomonouclonais / lymphatic leukemia / lymphosarcoma.

iii) Impaired renal function

     The dosage of ampicillin will need to be reduced in patients with marked renal impairment.

iv) Interstitial Nephritis

     Ampicillin should be avoided in patients who have experienced acute interstitial nephritis as a result of antibiotic therapy.

v) Allergic diathesis

    Extreme caution should be used in the treatment of patients with an allergic diathesis.

vi) Pseudomembranous colitis

The use of ampicillin can lead to the development of severe colitis as a result of colorisation with a toxin-producing organism. The colitis an be fatal and must be treated promptyly.

 

If significant diarrhoea occurs ampicillin should be discontinued. This may be sufficient treatment in the early stages although cholestyramine orally may help by binding the toxin to the colonic lumen. In severe cases oral vancomycin 250mg 6 hourly for 5-10 days has proved effective. Parenteral vancomycin is not effective

 

3. SupraInfection : Suprainfection with other mycotic organisms or bacteria may occur during therapy and if it occurs, discontinued ampicillin and substitute with appropriate treatment.

 

4. Prolonged Therapy : as with any potent agent, periodic assessment of organ function should be made during prolonged therapy.

 

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