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Logo SURAMIN

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SURAMIN
Injection

COMPOSITION:
Each vial contains 1 g
SURAMIN B.P.C.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Medicines against protozoa

PHARMACOLOGICAL ACTION:
SURAMIN is active against the early stages of trypanosomiasis.

INDICATIONS:
Trypanosomiasis (African Sleeping Sickness) caused by Trypanosoma gambiense or rhodesiense. Onchocerciasis caused by Onchocerca volvulus.

CONTRA-INDICATIONS:
Pathological urinary conditions e.g. granular casts, symptoms indicating organic kidney damage.

DOSAGE AND DIRECTIONS FOR USE:
1. Preparation of the solution:
SURAMIN is a stable, white, loose powder. With vigorous shaking it dissolves in water and physiological sodium chloride solution. The solution for injection must always be freshly prepared. To do this withdraw from an ampoule 10 mL water for injections (using a sterile syringe and needle) and inject into the vial containing 1 g SURAMIN. The solutions are odourless, almost tasteless and show neutral reaction when tested with litmus paper.
2. Administration:
SURAMIN is injected intravenously in 10 % solution. Only if intravenous administration is impossible may it be given by intramuscular injection (local irritation).

3. Dosage 
  a) Trypanosomiasis (Sleeping Sickness)
    Prophylaxis: For individual and mass prophylaxis it is sufficient to give injections of 1-2 g SURAMIN and repeat these every three months as long as there is a possibility of infection, in general prophylactic campaigns every 6 months.
    The best method is to inject 1 g IV and a second dose of 1 g the following day or within three weeks. The dosage for children and adolescents is 0,2-0,75 g according to age, for infants 0,1-0,15 g. Another injection of 1 g (children correspondingly less) after three months again protects for an equal period of time. In general prophylactic schemes, the interval between injections can safely be extended to six months. No diminution of the efficacy of SURAMIN against trypanosomes (resistance) has been observed following its prophylactic administration.
    Therapy: The normal single dose for adults is 1 g. In strong adults the single dose can be increased to 1,5-2 g. The single dose for children is 0,2-0,75 g according to age, for infants 10-15 mg/kg body mass. Patients in poor general condition should be treated with a lower dose (approx. one quarter of the normal dose).
    The total dosage for a full course of treatment for adults is at least 5 g and may be raised, according to clinical findings, to up to 10 g. The first 2-3 injections can be given daily or at intervals of 2-3 days, further injections at intervals of about a week. A second, equal safety course cannot be given less than three months after the first course of treatment.
    For C.S.F. positive cases, combined treatment with SURAMIN and tryparsamide is recommended. Details are given in the medical booklet on SURAMIN.
  b) Onchocerciasis:
    Adults receive a dose of 1 g IV once a week, altogether for 7-10 weeks, children 0,2-0,75 g according to age, infants 0,15-0,2 g. At the start of therapy a test dose of 0,1-0,2 g should be injected.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Albuminuria often occurs after therapeutic dosage. The albuminuria does not indicate kidney damage but is merely an excretion of protein, usually with no other pathological findings. The first injection of SURAMIN is not always followed by albuminuria but it often occurs after the second or third injection. It usually disappears without leaving any damage, during treatment, but in some cases only a long time after termination of the SURAMIN course. This benign form of albuminuria, which does not have any grave consequences is not, therefore, a contra-indication for SURAMIN in patients with previously healthy kidneys.
Nephritis due to the trypanosome infection usually clears with SURAMIN treatment, even though the excretion of protein may be initially increased.
Palmar-plantar hyperaesthesias are occasionally observed and should receive attention as they may be early symptoms of peripheral neuritis.
Pregnancy: The safety of this preparation in pregnant women has not yet been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS SPECIFIC TREATMENT:
In animal experiments, toxic or lethal doses of SURAMIN cause haemolysis and kidney damage. Treatment is symptomatic.

PRESENTATION:
Boxes of 5 vials of 1 g.

IDENTIFICATION:
White, loose powder

STORAGE DIRECTIONS:
To be stored in a cool place, protected from light. KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
GX/20.2.6/207

NAME OF APPLICANT AND BUSINESS ADDRESS:
Bayer (Pty) Ltd
27 Wrench Road        Isando        1600
Reg No 68/11192/07

DATE OF PUBLICATION:
July 1985

Updated on this site: February 2003
Source: Pharmaceutical Industry

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