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

Logo RANMOXY 125 DISTAB (Tablets)
RANMOXY 250 DISTAB (Tablets)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

RANMOXY 125 DISTAB (Tablets)
RANMOXY 250 DISTAB (Tablets)

COMPOSITION
Ranmoxy 125 Distab
Each dispersible tablet contains:
Amoxicillin trihydrate
equivalent to amoxicillin anhydrous 125 mg
Ranmoxy 250 Distab
Each dispersible tablet contains:
Amoxicillin trihydrate
equivalent to amoxicillin anhydrous 250 mg

PHARMACOLOGICAL CLASSIFICATION
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION
Mechanism of Action
Amoxicillin belongs to the category of aminopenicillins and is penicillinase susceptible with bactericidal properties. Its mechanism of action is similar to other penicillins. It inhibits bacterial cell wall synthesis and its activity depends on the ability to bind with the penicillin binding proteins (PBPs) located on the cell wall, thus interfering with peptidoglycan synthesis. Peptidoglycan provides the cell wall with mechanical stability. This inhibition results in the weakening of the bacterial cell wall and finally lysis and cell death.
Antibacterial activity
Amoxicillin has an antibacterial spectrum similar to other aminopenicillins. It is active in-vitro against both gram-positive and gram-negative organisms:
(In vitro sensitivity does not necessarily imply in-vivo efficacy)
Gram-positive Organisms: Streptococci (including Streptococcus faecalis), Streptococcus pneumonia and non-penicillinase-producing Staphylococci, Listeria monocytogenes.
Gram-negative Organisms: H. influenzae, E. coli, P. mirabilis, N. gonorrhoeae, Salmonella sp. Shigella sp.
Pharmacokinetics
Amoxicillin is acid stable and is rapidly and completely absorbed from the gastrointestinal tract (75-90%). Peak plasma concentrations of about 5 mcg per mL are achieved 1-2 hours after a 250 mg dose. Presence of food does not affect the total absorption of the medicine. Amoxicillin is widely distributed in body tissues and fluids. It crosses the placenta and appears in breast milk. Distribution into the cerebrospinal fluid is low in subjects with non inflamed meninges. Amoxicillin is about 20% protein bound and has a half-life of 1-1,5  hours.
Amoxicillin is metabolises to a limited extent and about 60% is excreted in urine in six hours by glomerular filtration and tubular secretion.
High concentrations may be reached in bile and some amount may be excreted in faeces.

INDICATIONS
Ranmoxy Distab is indicated in the treatment of the following infections due to susceptible non-penicillinase producing strains:
Genitourinary tract infections caused by Escherichia coli. Proteus mirabilis and Enterococcus faecalis.
Acute uncomplicated anogenital and urethral gonorrhoea in males and females caused by Neisseria gonorrhoeae.
Infections of the nose, ear and throat caused by Streptococci, Pneumococci, non penicillinase producing Staphylococci and Haemophilus influenzae.
Skin and soft tissue infections caused by Streptococci, non-penicillinase producing staphylococci, E. coli and Proteus mirabilis.

CONTRA-INDICATIONS
A history of allergic reaction to any of the penicillins/cephalosporins. A history of antibiotic associated colitis.
Infectious mononucleosis
Babies born of hypersensitive mothers in the neonatal period.

WARNINGS
Before initiating therapy with amoxicillin or any other penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or cephamycins. There is clinical and laboratory evidence of partial cross allergenicity of the penicillins and cephalosporins.
Care should be taken when treating patients with syphilis as the Jarisch-Herxheimer reaction may occur. 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 risk of increased local damage such as optic atrophy.
Patients with a history of gastro-intestinal disease, especially antibiotic associated colitis should be treated with amoxicillin with caution since penicillins may cause pseudomembranous colitis.

DOSAGE AND DIRECTIONS FOR USE
Ranmoxy Distab is used in adults and children who cannot swallow capsules or tablets.
Adults:
Usual adult dose 250 mg every eight hours.
In Gonorrhoea 3 gm of amoxicillin with one gram of probenecid should be given as a single dose.
In severe infections or those caused by less susceptible organisms:
500 mg every 8 hours for adults.
Children:
20 mg/kg/day in divided doses every 8 hours.
In gonorrhoea, 50 mg/kg body weight and 25 mg of probenecid per kg of body weight should be given as a single dose. However, probenecid is not recommended in children under 2 years of age.
Directions for use
Disperse the tablet in a teaspoonful of water before administration.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Gastrointestinal reactions
Diarrhoea, heartburn, nausea or vomiting.
Allergic reactions
Fast or irregular breathing; puffiness or swelling around face; shortness of breath; sudden, severe decrease in blood pressure; skin rash; hives; itching.
Fungal infections
Oral candidiasis and vaginal candidiasis
Liver:
A moderate rise in serum glutamic oxalacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown. Hepatotoxicity, hepatitis.
Haemic and Lymphatic Systems
Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, neutropenia and granulocytopenia have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System
Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and/or dizziness, depression, seizures or hallucinations have been reported.
Other: A sore mouth or tongue and a black hairy tongue have been reported. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis, may occur.

Precautions:
General
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during amoxicillin therapy. If superinfections occur, the medicine should be discontinued and/or appropriate therapy instituted. The efficacy of oestrogen containing contraceptives may be decreased by the concomitant administration of aminopenicillins. Care should be taken when high doses of amoxicillin are given to patients with renal impairment or congestive heart failure. Amoxicillin therapy may produce false positive or falsely elevated test results with copper sulfate urine glucose tests. A false positive result may occur with the Coomb’s test.
Use In Pregnancy and Lactation
Animal reproduction studies have failed to demonstrate a risk to the foetus and there are no adequate and well controlled studies in pregnant women.
Paediatric Use
Renal excretion of penicillins may be delayed in infants and neonates due to their incompletely developed renal function.
Geriatric use
As elderly patients are more likely to have age-related renal function impairment, necessary dosage adjustment may be required in such patients.
Interactions
Probenecid decreases the renal tubular secretion of amoxicillin when co-administered resulting in higher and prolonged blood levels and possible increased risk of toxicity. Amoxicillin may also exhibit a clinically significant interaction with aminoglycosides, ACE inhibitors, potassium containing medications, anticoagulants, methotrexate and NSAIDs.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects. Treatment is symptomatic and supportive. In the event of overdosage, amoxicillin can be removed by haemodialysis.

IDENTIFICATION
Ranmoxy 125 Distab
Peach coloured caplets, scored on one side, with a characteristic flavour.
Ranmoxy 250 Distab
Peach coloured caplets, scored on one side, with a characteristic flavour.

PRESENTATION
Ranmoxy 125 Distab
Carton containing 20, 100 and 500 caplets in aluminium foil strips of 10 caplets each.
Ranmoxy 250 Distab
Cartons containing 20, 100 and 500 caplets in aluminium foil strips of 10 caplets each.

STORAGE INSTRUCTIONS
Store in well closed containers below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
Ranmoxy 125 Distab: 30/20.1.2/0438
Ranmoxy 250 Distab: 30/20.1.2/0439

NAME AND BUSINESS ADDRESS OF THE APPLICANT
RANBAXY (SA) (PTY) LTD
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
Bryanston

DATE OF PUBLICATION OF THIS PACKAGE INSERT
16 January 1997

PLTR097

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