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

Logo HICONCIL-NS Capsules 250 mg
HICONCIL-NS Capsules 500 mg
HICONCIL-NS Suspension 125 mg/5 mL
HICONCIL-NS Suspension 250 mg/5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

HICONCIL-NS Capsules 250 mg
HICONCIL-NS Capsules 500 mg
HICONCIL-NS Suspension 125 mg/5 mL
HICONCIL-NS Suspension 250 mg/5 mL

COMPOSITION:
1. Capsules:
The capsules contain
amoxycillin trihydrate equivalent to 250 mg amoxycillin with 250 000 units nystatin, and 500 mg amoxycillin with 250 000 units nystatin respectively.
2. Powders for oral suspension:
Powders providing amoxycillin trihydrate equivalent to 125 mg and 250 mg amoxycillin with 125 000 units nystatin respectively per 5 mL when reconstituted.
The powder contain 0,1 % m/v sodium benzoate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A20.1 –Antibiotic combinations.

PHARMACOLOGICAL ACTION:
HICONCIL-NS combines amoxycillin trihydrate, a semisynthetic, broad-spectrum penicillin, with nystatin, a polyene antifungal antibiotic. Amoxycillin is bactericidal and is effective against a broad range of both Gram-Positive and Gram-negative bacteria. Nystatin is fungistatic against Candida albicans and other yeast-like fungi.
HICONCIL-NS has been formulated for use in clinical situations where the intestinal overgrowth of fungus may complicate the use of a broad-spectrum antibiotic, such as during prolonged or high-dosage antibiotic therapy, during the administration of corticosteroids or antimetabolites, or in the presence of debilitation or impaired host-defence mechanisms. Amoxycillin is rapidly absorbed after oral administration and provides high blood levels and very high concentrations in the tissues and urine. Amoxycillin does not readily diffuse into the brain and spinal fluid except when the meninges are inflamed.
The ingestion of food does not greatly reduce the absorption of amoxycillin. Amoxycillin does not appear to be metabolized in the body. Urinary excretion is rapid and only unchanged amoxycillin is recovered in the urine. Its excretion can be delayed by concurrent administration of probenecid. Approximately 17 % of amoxicillin is bound by serum proteins. Nystatin is poorly absorbed. The therapeutic effects of nystatin occur within the intestinal lumen and it is excreted almost entirely in the faeces following oral administration. Gram-Positive organisms sensitive to HICONCIL-NS in vitro include haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, non-penicillinase producing staphylococci, Clostridia spp., Bacillus anthracis, Corynebacterium diphtheria and most strains of enterococci and Listeria monocytogenes. Amongst the Gram-negative organisms sensitive to HICONCIL-NS are Haemophilus influenzae. Proteus mirabilis, Neisseria gonorrhoeae, Neisseria meningitidis and many strains of Salmonella, Shigella and Escherichia coli.
In vitro sensitivity does not necessarily imply in vivo efficacy.
Amoxycillin does not resist destruction by penicillinase and is thus not effective against penicillinase-producing bacteria particularly resistant staphylococci. All strains of pseudomonas and most strains of Klebsiella and Enterobacter are resistant. Nystatin is fungistatic in vitro against a variety of fungi including the principal fungi pathogenic in man. Orally, it inhibits the overgrowth of candida albicans and other yeast-like flora in the intestinal tract.

INDICATIONS:
HICONCIL-NS is indicated in the therapy of all infections caused by susceptible non-penicillinase producing microorganisms in those patients in whom candidal (monilial) infections are most likely to complicate therapy.
HICONCIL-NS is especially indicated for use in the treatment of patients receiving high and prolonged dosages of antibiotics, with or without corticosteroid therapy, elderly or debilitated patients, diabetics, patients receiving radiation therapy and antineoplastic drugs and patients with prior or recurrent candidal infections. HICONCIL-NS is also indicated in the treatment of women with infections who are taking oral contraceptives or have histories of recurrent vaginal moniliasis. HICONCIL-NS is indicated in the treatment of the following infections:
RESPIRATORY INFECTIONS: Pneumonia, bronchitis, tonsillitis, pharyngitis, laryngitis, otitis media.
GENITOURINARY INFECTIONS: Cystitis, pyelonephritis, urethritis, gonorrhoea.
SKIN AND SOFT TISSUE INFECTIONS: Skin infections such as pyoderma, erysipelas, lymphangitis, cellulitis. Indicated surgical procedures should be performed.

CONTRA-INDICATIONS:
HICONCIL-NS is contra-indicated in individuals who have shown hypersensitivity to nystatin, penicillin or cephalosporins.

WARNINGS:
HICONCIL-NS may cause a serious and occasionally fatal reactions (anaphylactic) typical of penicillin allergy. In patients with a history of penicillin, cephalosporin or nystatin allergy HICONCIL-NS should not be used. Serious anaphylactoid reactions require immediate emergency treatment with adrenalin, oxygen. intravenous steroids and airway management, including intubation, as indicated.

DOSAGE AND DIRECTIONS FOR USE:
Therapeutic doses of amoxycillin are used to calculate the dosage of HICONCIL-NS.
Adults and children with a mass of more than 40 kg:
250 mg –500 mg three times per day. The latter dosage range for the more severe infections.
Children:
  Age and Mass % of Adult Dose Usual Total Daily
      Dose Range*
  Adults (65 kg) 100 % 750 mg –1,5 g
  12 years (40 kg) 75 % 525 mg –1,125 g
  7 years (23 kg) 50 % 375 mg –750 mg
  1 year (10 kg) 25 % 187 mg –375 mg
* Administered three times per day (t i d)
For in-between ages: in-between percentages are used e.g. at 10 years 66 % and at three years 33 % of the adult dose.
The above percentage method of calculating dosage is based on the formula:
Surface area of childx 100 = Percentage of adult dose
Surface of adult

NOTE:
In the case of severe infections, the dosage should be doubled. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A MINIMUM OF 10 DAYS TREATMENT IS RECOMMENDED FOR ANY INFECTION CAUSED BY GROUP A ß-HAEMOLYTIC STREPTOCOCCI. Chronic urinary tract infections may require prolonged, intensive therapy with continued bacteriological and clinical follow-up.
For the treatment of gonorrhoea: 3 g as a single oral dose.
In the treatment of complications of gonococcal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended.
Patients with gonorrhoea in whom syphilis is suspected should have darkfield examinations before receiving treatment and monthly serologic tests for a minimum of four months.
The dose should be reduced in patients with renal failure.
Reconstitution of powders: Each strength is reconstituted with 60 mL of water to yield 100 mL of suspension.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
HYPERSENSITIVITY REACTIONS:
Amoxycillin:
Allergic reactions which have been observed include skin rash, urticaria and serum sickness reactions. A few cases of exfoliative dermatitis and erythema multiforme, angio-oedema and anaphylaxis have been reported. Stevens-Johnson syndrome has been reported rarely.
HICONCIL-NS may cause reactions typical of penicillin allergy, especially in sensitive patients. See under “Warnings”.
GASTROINTESTINAL REACTIONS: Gastrointestinal disturbances include glossitis, stomatitis, black "hairy" tongue, nausea, vomiting and diarrhoea. Amoxycillin may reduce efficacy of oral contraceptives and patients should be warned accordingly.
Pseudomembranous colitis has also been reported. Should this condition occur, discontinue the treatment and initiate appropriate treatment.
LIVER: A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants but the significance of this finding is unknown.
HAEMIC AND LYMPHATIC SYSTEM: Anaemic, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and is believed to be hypersensitivity phenomena.
Periodic assessment of organ system function, including renal, hepatic and haematopoietic, should be made during prolonged therapy.
While candidal growth is minimized with HICONCIL-NS, superinfection with non-susceptible organisms may be seen. If this occurs, the medicine should be discontinued and appropriate measures taken.
Treatment with HICONCIL-NS may give rise to a maculopapular rash. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis. HICONCIL-NS should be used with caution in patients with infectious mononucleosis, lymphatic leukaemia and patients treated with allopurinol since they are especially susceptible to ampicillin-induced skin rashes.
The Jarisch-Herxheimer reaction may occur in patients with syphilis, treated with HICONCIL-NS.
Nystatin:Nystatin given in large oral doses have occasionally produced diarrhoea and gastrointestinal distress.
USE DURING PREGNANCY: Safety of use in pregnancy has not been established.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
Capsules:
HICONCIL-NS capsules 250 mg
Number 1 hard gelatin capsules with an opaque orange cap and an opaque pink body.
HICONCIL-NS capsules 500 mg
Number 0 hard gelatin capsules with an opaque orange cap and an opaque pink body.

Powders for oral suspension: Off-white granular powders. Reconstitution of each strength with water per label instruction produces a yellow, fruit-flavoured suspension.

PRESENTATION:
Capsules: HICONCIL-NS capsules are available in blister packs of 15.
Powders for oral suspension: Powders in plastic bottles providing 100 mL of each strength when reconstituted.

STORAGE INSTRUCTIONS:
Capsules and powders:
Store in a cool, dry place. Temperature should not exceed 25 °C. Keep out of reach of children.
The potency of reconstituted suspension will be maintained for one week at room temperature (25 °C) and for two weeks under refrigeration (4 °C).

REGISTRATION NUMBERS:
HICONCIL-NS capsules 250 mg –H/20.1/110
HICONCIL-NS capsules 500 mg –J/20.1/413
HICONCIL-NS suspension 125 mg/5 mL –H/20.1/112
HICONCIL-NS suspension 250 mg/5 mL –H/20.1/113

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bristol-Myers Squibb (Pty) Ltd *
AMR Park, 1 Concorde Rd East
Bedfordview 2008

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1993
* Authorised user of the TM HICONCIL-NS

        25C44
11/93

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