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

Logo RANMOXY SUSPENSION 125 mg/5 mL
RANMOXY SUSPENSION 250 mg/5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RANMOXY SUSPENSION 125 mg/5 mL
RANMOXY SUSPENSION 250 mg/5 mL

COMPOSITION:
Ranmoxy Suspension 125 mg/5 mL
Each 5 mL contains amoxicillin trihydrate
equivalent to
amoxicillin anhydrous 125 mg
Sugar free

Ranmoxy Suspension 250 mg/5 mL
Each 5 mL contains amoxicillin trihydrate
equivalent to amoxicillin anhydrous 250 mg
Sugar free

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION
Ranmoxy is Ranbaxy’s brand of amoxicillin trihydrate, a semisynthetic penicillinase susceptible penicillin, an analogue of ampicillin, with a broad spectrum of in-vitro bactericidal activity against many gram-positive and gram-negative micro-organisms.
In vitro sensitivity does not necessarily imply in-vivo efficacy.
Resistant strains: Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.

PHARMACOKINETICS
Amoxicillin is resistant to inactivation by gastric acid and may be given without regard to meals. It is rapidly and completely absorbed after oral administration. Amoxicillin is not highly protein-bound. Orally administered doses of 250 mg and 500 mg amoxicillin 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 amoxicillin. 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 amoxicillin is 1 to 1,5 hours. Approximately 60 percent of an orally administered dose of amoxicillin 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, nonpenicillinase-producing staphylococci and H. influenzae.
- Infections of the genitourinary 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, nonpenicillinase-producing staphylococci and H. influenzae.
- Gonorrhea, 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 to hypersensitive mothers, and in the neonatal period. Patients with lymphatic leukemia and patients with hyperuricaemia being treated with allopurinol may also be at an increased risk of developing skin rashes.

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

DOSAGE AND DIRECTION FOR USE:
Paediatric dose:
Infants up to 6 kg body weight:        25-50 mg every eight hours
Infants 6 to 8 kg body weight:        50-100 mg every eight hours
Infants and children 8-20 kg body weight:        6,7-13,3 mg per kg body weight every eight hours.
Children 20 kg of body weight and over:        250-500 mg every eight hours

Adults who are not able to take capsules may be given Ranmoxy Suspension.
Usual Adult dose:        250 - 500 mg every eight hours.
Maximum dose upto 4,5 gms a day.

Directions for mixing:
Add 64 mL and 85 mL water for 75 mL and 100 mL pack respectively in two portions to dry mixture in the bottle. Shake well after each addition.

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.
Gastro-intestinal
Nausea, heartburn, vomiting and diarrhoea.
Liver
A moderate rise in serum glutamic oxalacetic transaminase (AST) has been noted, but the significance of this finding is unknown.
Haemic and Lymphatic Systems
Anaemia, 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 also been reported.
Other
A sore mouth or tongue and a black hairy tongue have been reported.
Allergic reactions which may include exfoliative dermatitis, Stevens-Johnson Syndrome and 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 amoxicillin therapy considered.
- Periodic assessment of renal, hepatic and hematopoetic function should be made during prolonged therapy with Ranmoxy.
- Pseudomembranous colitis has been reported.
- 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.
- Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.

INTERACTIONS
Ranmoxy may decrease the efficacy of oral contraceptivesand 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 amoxicillin can be removed by hemodialysis.

IDENTIFICATION:
Ranmoxy Suspension 125 mg/5 mL
White to off-white powder forming an orange suspension on constitution with water. The resulting suspension has a characteristic flavour.
Ranmoxy Suspension 250 mg/5 mL
White to off-white powder forming an orange suspension on constitution with water. The resulting suspension has a characteristic flavour.

PRESENTATION:
Ranmoxy Suspension 125 mg/5 mL White, translucent HDPE bottle for 100 mL pack
  White, translucent HDPE bottle for 75 mL pack
Ranmoxy Suspension 250 mg/5 mL White, translucent HDPE bottle for 100 mL pack

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
After reconstitution the product must be stored at 2-8°C in a refrigerator. The prepared suspension should be consumed within 14 days of preparation.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Ranmoxy Suspension 125 mg/5 mL: 35/20.1.2/0212
Ranmoxy Suspension 250 mg/5 mL: 35/20.1.2/0213

NAME AND BUSINESS ADDRESS OF THE APPLICANT.
RANBAXY (SA) (PTY) LTD
Third Floor, Outspan House,
1006 Lenchen Avenue North,
Centurion

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 2003

New addition to this site: September 2004
Source: Pharmaceutical Industry

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