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Logo RIOSTATIN® CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RIOSTATIN® CAPSULES

COMPOSITION:
Each capsule contains:
Tetracycline Hydrochloride 250 mg
Nystatin 250 000 iu
Thiamine Hydrochloride 2,5 mg
Riboflavine 2,5 mg
Nicotinamide 25 mg
Pyridoxine Hydrochloride 0,5 mg
Calcium Pantothenate 5 mg
Ascorbic Acid . 100 mg

PHARMACOLOGICAL CLASSIFICATION:       
A. 20.1.1 Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
Tetracyclines are bacteriostatic antibiotics which inhibit bacterial growth by binding to the 30S ribosomal subunit with consequent misreading of information for protein synthesis. They are effective in vitro against the following organisms (In vitro activity does not necessarily imply in vivo efficacy) :
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae;
Tetracyclines are also effective against the following organisms in vitro :
Haemophilus ducreyi, Actinomyces israelii, Francisella tularensis, Treponema pertenue.
Resistant Pathogens
Many of the following strains are resistant:
Staphylococci
Enterococci
Proteus vulgaris
Fungi and yeasts (except Actinomyces)
Pseudomonas aeruginosa (all strains)
E.coli
Shigella
Streptococcus

INDICATIONS:
Infections caused by susceptible strains of pathogens,
Upper and lower respiratory tract infections:
Sinusitis, pharyngitis, Mycoplasma pneumonia, psittacosis and chronic bronchitis.
Genito-urinary tract infections:
Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections, syphilis and gonorrhoea (in cases of penicillin allergy).
Soft tissue:
Acne.
Ophthalmic:
Trachoma and inclusion conjunctivitis.
Intestinal:
Cholera, Whipple's disease and tropical sprue.
Miscellaneous:
Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, and leptospirosis during the early infective phase.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
Patients with impaired renal function.
Should not be given in pregnancy. Tetracyclines cross the placenta and are deposited in foetal bones and teeth.
Pregnant women are particularly susceptible to severe tetracycline-induced liver damage.
Should not be given to lactating women or to children younger than 12 years of age as permanent discoloration of the child's teeth may occur.
Should not be given to patients with systemic lupus erythematosus.

WARNINGS:
Use with care in patients with liver function impairment.
Frail or elderly patients are susceptible to the hepatotoxic and anti-anabolic effects of tetracyclines.
Do not use concomitantly with hepatotoxic medicines, (including erythromycin, chloramphenicol, isoniazid and sulphonamides).
Symptoms of Myasthenia gravis may be aggravated.
Photosensitivity may occur (see "Side-effects and Special Precautions").
Raised intracranial pressure may occur particularly in infants and especially if Vitamin A or other retinoids are given concomitantly.

DO NOT USE EXPIRED RIOSTATIN® CAPSULES.

Contains tartrazine which may cause allergic type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low, it is however frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
The dosage of RIOSTATIN® capsules should be based on the tetracycline content.
Should be taken either one hour before meals or two hours after meals.
Should be taken with adequate liquid to avoid lodging of capsules in the distal oesophagus as this may result in corrosive irritation and ulceration.
The maximum dose for tetracyclines should not exceed 3 g daily for adults and 50 mg/kg bodymass per day for children.
The usual dose for tetracycline for the commonly occuring infections is 250 to 500 mg (one to two capsules) every six hours, depending on the severity of the infection.
For acne, the adult dosage is 250 mg (one capsule) twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Tetracycline:
Tetracyclines are not indicated for treating commonly occuring infections in children under 12 years of age.
Gastro-intestinal: nausea, vomiting, diarrhoea, glossitis, dysphagia related to oesophagitis, enterocolitis.
Secondary bacterial overgrowth infections may occur: resistant coliform organisms such as Proteus spp. may cause diarrhoea; Pseudomembranous colitis due to Clostridium difficile may occur; super-infection due to resistant staphylococci may cause fulminating enteritis.
Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses.
Blood abnormalities: haemolytic anaemia, eosinophilia, neutropenia, thrombocytopenia.
Allergic (hypersensitivity) reactions: urticaria, maculopapular and erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis, Henoch-Schonlein purpura (anaphylactoid purpura), angioneurotic oedema, anaphylaxis.
Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
The use of expired tetracyclines may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypokalaemia.
In the elderly a negative nitrogen balance may be induced.
Large doses of Riboflavine result in a bright yellow discoloration of the urine.

Nystatin:
May cause diarrhoea, nausea and vomiting.

INTERACTIONS:
Absorption of tetracyclines is diminished by milk, alkalis, aluminium hydroxide and other di- and trivalent cations such as calcium, iron and magnesium if they are given concomitantly.
Doses of anticoagulants may need to be reduced if given concomitantly.
Penicillin should not be given concomitantly with tetracyclines as antagonism in action may occur.
Special precautions should be observed when RIOSTATIN® CAPSULES are co-administered with diuretics, lithium and digoxin.
Tetracyclines may diminish the effectiveness of oral contraceptives.
Methoxyflurane: serious nephrotoxicity may follow concomitant use.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Cream/purple two-colour capsules with RIO imprinted on each half.

PRESENTATION:
Securitainers of 20 and 100 capsules.

STORAGE DIRECTIONS:
Store below 25°C. Protect from light and moisture. Keep out of reach of children.

REFERENCE NUMBER:
A 84 (Act. 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 June 1995

® Registered Trade Mark

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

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