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

Logo RANMOXY 250 CAPSULES
RANMOXY 500 CAPSULES
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RANMOXY 250 CAPSULES
RANMOXY 500 CAPSULES

COMPOSITION:
RANMOXY 250 Capsules
Each capsule contains:
Amoxycillin Trihydrate BP
equivalent to Amoxycillin anhydrous 250 mg
Contains TARTRAZINE

RANMOXY 500 Capsules
Each capsule contains:
Amoxycillin Trihydrate B.P.
equivalent to Amoxycillin anhydrous 500 mg
Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
RANMOXY is Ranbaxy's brand of amoxycillin a semisynthetic penicillinase susceptible penicillin, an analogue of ampicillin, with a broad spectrum ofin-vitro bactericidal activity against many Gram-positive and Gram-negative microorganisms. In vitro sensitivity does not necessarily imply in-vivo efficacy.
Resistant strains: Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.
Pharmacokinetics
Amoxycillin is resistant to inactivation by gastric acid and may be given without regard to meals. It is rapidly and completely absorbed after oral administration. Amoxycillin is not highly protein-bound.
Orally administered doses of 250 mg and 500 mg amoxycillin capsules result in average peak blood levels one to two hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL respectively.
Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxycillin. It diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of amoxycillin is 1 to 1.5 hours. Approximately 60 percent of an orally administered dose of amoxycillin is excreted unchanged in the urine within six to eight hours by glomerular filtration and tubular secretion. RANMOXY is removed by haemodialysis. High concentrations have been reported in bile; some may be excreted in faeces.

INDICATIONS:
RANMOXY is indicated in the treatment of infections due to susceptible non-penicillinase producing strains of the following:
– Infections of the ear, nose and throat due to Streptococci, Pneumococci, non-penicillinase producing Staphylococci and H. influenzae.
– Infections of the genito-urinary tract due to E coli, Proteus mirabilis and Streptococcus faecalis.
– Infections of the skin and soft-tissues due to Streptococci susceptible Staphylococci and E. coli.
– Infections of the lower respiratory tract due to Streptococci, Pneumococci, non-penicillinase producing Staphylococci and H influenzae.
– Gonorrhoea, acute uncomplicated ano-genital and urethral infections due to N. gonorrhoea (males and females).

CONTRA-INDICATIONS:
A history of allergic reaction to any of the penicillins or cephalosporins is a contra-indication. RANMOXY is also contra indicated in infectious mononucleosis. It is also 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.
This product contains F D & C yellow No. 5 (TARTRAZINE) which may cause allergic-type reactions (including Bronchial Asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
E.N.T. Infections, UTI and Skin and Soft-tissue Infections
Adults: 250 mg every 8 hours
Children: 20 mg/kg/day in divided doses every 8 hours.
Children weighing 20 kg or more should be dosed according to the adult recommendations.
In severe infections or those caused by less susceptible organisms: 500 mg every 8 hours for adults and 40 mg/kg/day in divided doses every 8 hours for children may be needed.
Gonorrhoea
Adults: 3 grams as a single oral dose, with probenecid 1 g.
Prepubertal children: 50 mg/kg amoxycillin combined with 25 mg/kg probenecid as a single dose. Since probenecid is contraindicated in children under 2 years, this regimen should not be used in these cases.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The hypersensitivity reactions reported are erythematous maculopapular rashes, urticaria, fever and joint pains. Anaphylactic shock may occur.
Gastrointestinal
Nausea, heartburn, vomiting and diarrhoea
Liver
A moderate rise in serum glutamic oxalacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.
Haemic and Lymphatic Systems
Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia 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 have been reported.
Others
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
– Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If any allergic reaction occurs, appropriate therapy should be instituted and discontinuance of amoxycillin therapy considered.
– Periodic assessment of renal, hepatic and haematopoetic function should be made during prolonged therapy with RANMOXY.
– The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Enterobacter, Pseudomonas or Candida), the medicine should be discontinued and/or appropriate therapy instituted.
– 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.
– Care should be taken when high doses are given to patients with renal impairment (because of the risk of neurotoxicity) or congestive heart failure.
Interactions
RANMOXY may decrease the efficacy of oral contraceptives and may cause increased breakthrough bleeding. Probenecid can delay the excretion of RANMOXY when given concurrently.
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.

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

IDENTIFICATION:
RANMOXY 250 Capsules:
Opaque hard gelatin self-locked capsules of size '1' with yellow cap and yellow body imprinted with 'RANBAXY' on cap and 'RANBAXY' on body in black ink, containing a white to off-white powder/pellet.
RANMOXY 500 Capsules:
Opaque hard gelatin self-locked capsules of size '0' with maroon cap and yellow body imprinted with 'RANBAXY' on cap and 'RANBAXY' on body in white ink, containing a white to off-whitepowder/pellet.

PRESENTATION:
RANMOXY 250 Capsules
– Carton containing 2 x 10 & 15 capsules in blister strips.
  Carton containing 30 x 15 & 100 x 10 capsules in blister strips.
  HDPE bottle containing 15 capsules.
  HDPE bottle containing 100 capsules.
  HDPE bottle containing 500 capsules.
  HDPE bottle containing 1000 capsules.
RANMOXY 500 Capsules
– Carton containing 2 x 10 & 15 capsules in blister strips.
  Carton containing 30 x 15 capsules in blister strips.
  HDPE bottle containing 15 capsules.
  HDPE bottle containing 100 capsules.
  HDPE bottle containing 500 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
RANMOXY 250 Capsules: 30/20.1.2/0196
RANMOXY 500 Capsules: 30/20.1.2/0197

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:
28 February 1996

PLTR382

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