S.T.D. INJECTION - Solution for Injection.

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

S.T.D. INJECTION - Solution for Injection.

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

S.T.D. INJECTION - Solution for Injection.

COMPOSITION:
S.T.D. is a sterile aqueous solution containing 30 mg/mL of sodium tetradecyl sulphate and buffered to pH 7,6. It is preserved with benzyl alcohol 2% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 7.2 –Vasoconstrictors, pressor medicines.

PHARMACOLOGICAL ACTION:
Sodium tetradecyl sulphate is an anionic surface-acting agent which has sclerosing properties when injected intravenously.
The action of sodium tetradecyl sulphate in this technique is considered to be that of irritation to the intima of the vein wall, so that on compression of the vein, fibrosis takes place and the vein is thus permanently occluded by the development of fibrosis in the wall, and across the lumen of the compressed vein.

INDICATIONS:
The solution is designed for intravenous use and is used primarily as a sclerosant in the treatment of varicose veins of the leg by compression sclerotherapy.

CONTRA-INDICATIONS:
The use of S.T.D. injection is not recommended for the treatment of varicose veins by compression sclerotherapy when any of the following factors are present:

a.	Oral Contraceptives Until such time as the exact thromboplastic effect of the oral contraceptive tablet has been established, it is advisable not to use sclerotherapy on patients who are currently taking oral contraceptives.
b.	Inability to walk As the recommended treatment involves daily periods of walking by the patient it is not advisable to embark upon treatment if for any reason the patient cannot walk at least 4½ kilometres each day.
c.	Obese legs It is recommended that patients with obese legs should not receive treatment. In many cases this obesity may be corrected by dieting, after which time treatment may be commenced.
d.	Any known allergy to Sodium tetradecyl sulphate Treatment by injection of S.T.D. should not be continued if an allergic reaction has been experienced after a previous injection of Sodium tetradecyl sulphate.
e.	Acute superficial thrombophlebitis or arterial disease S.T.D. should not be used where there is thrombosis of the deep veins of the leg, acute phlebitis or other affections in the region of the varices.
f.	Local or systemic infection.
g.	Varicosities caused by pelvic or abdominal tumours.
h.	Uncontrolled systemic disease e.g. diabetes mellitus.
i.	Significant valvular incompetence requiring surgical treatment.

WARNING:

1.	Allergy and Anaphylaxis
	a.	History of allergy should be taken from all patients prior to treatment. In particular allergic reactions to previous injections of Sodium tetradecyl sulphate should be noted (see Contra-indications above).
	b.	A higher incidence of allergic reactions is thought to result from repeated treatment involving Sodium tetradecyl sulphate Injection and may involve intervals of several years between courses of injections.
	Equipment for treatment of anaphylaxis
	The treatment of anaphylaxis may require, depending on severity of attack, some or all of the following: Injection of adrenaline, Injection of hydrocortisone, Antihistamine injection, Endotracheal tube, laryngoscope, Mucus extraction pump. The treatment of varicose veins by S.T.D. Injection should not be undertaken if these items are not readily available.
2.	Use in pregnancy and lactation
	Safety for use in pregnancy has not been established. Use only when clearly needed for symptomatic relief and when the potential benefits outweigh the potential hazards to the foetus.
	It is not known whether S.T.D. is excreted in human milk. Caution should be exercised when used in nursing mothers.
3.	Extreme caution in use is required in patients with arterial disease such as severe peripheral atherosclerosis of thromboangiitis obliterans (Buerger's disease).
4.	The in-use period of each multidose vial is a single session of therapy and for use in the treatment of a single patient. Unused vial contents should be discarded immediately after use.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for use in children.
A dose of 0,25 –1 mL is injected intravenously into the lumen of an isolated segment of emptied superficial vein. This is followed by immediate continuous compression. It is never necessary or desirable to inject more than 1 mL at any one site and often half this volume will produce the desired effect. A maximum of four sites (4 mL total) may be injected during one treatment session.
Compression Sclerotherapy
The treatment of varicose veins by Compression sclerotherapy is directed towards the restoration of the efficiency of the synchronised pumping systems within the leg by permanently destroying the leaking points rather than by the eradication of the superficial tortuous veins which may, in many cases, be capable of reverting to normal appearance and function after the restoration of the normal pattern of pressure within the veins of the limb.
Localisation of the perforating veins containing the injured valves is the supremely important object of diagnosis.
Treatment comprises the permanent blocking of the offending leak by producing a short fibrotic segment of vein involving the area of the junction of the perforating and superficial veins. This can be achieved by carrying out the following procedure:

1.	Introducing the sclerosant into this vein after it has been emptied. Extreme care in the needle placement and slow injection of minimal effective volume at each injection site are essential for safe and efficient use.
2.	Maintaining the sclerosant in the empty and isolated segment for 30 seconds.
3.	Applying compression immediately to the site of injection, maintaining it for a period of about 6 weeks, until one is quite sure that, when the patient stands erect, the internal pressure of the blood in the adjacent unobliterated vein cannot reopen the segment.
4.	Applications of compression is most suitable obtained by firm bandaging with a number of strong cotton crepe bandages and by incorporating therein shaped rubber pads over the sites of injection. An elastic stocking applied over the bandages aids compression and the retention of bandages in position.

The use of a small dose, the isolation of the injection within the vein segment and the application of immediate, adequate and lasting compression are of supreme importance in obtaining a good result.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic reactions with S.T.D. may occur. They may present as local or generalised rash, urticaria, nausea and vomiting, asthma or vascular collapse (anaphylaxis).
Extravasation will give rise to pain and may produce necrosis and ulceration (if close to surface). Paraesthesia and anaesthesia may occur if an injection affects a cutaneous nerve. Pigmentation is more likely to occur if blood is extravasated at the injection site (especially when treating smaller veins and compression is not used).
STD should only be administered by practitioners familiar with an acceptable injection technique. Thorough pre-injection assessment for valvular competence and deep vein patency must be carried out.
A history of allergy should be taken from all patients prior to treatment. Where special caution is indicated a test dose of 0,25 to 0,5 mL S.T.D. should be given up to 24 hours before any further therapy.
Special care is required when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk.

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

IDENTIFICATION:
S.T.D. injection is a clear, colourless solution packed in 5 mL rubber-capped vials.

PRESENTATION:
S.T.D. injection is a sterile, aqueous solution of Sodium tetradecyl sulphate, packed in 5 mL multidose vials.

STORAGE INSTRUCTIONS:
Store below 25°C, away from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H621 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

January 1986	12-383/1-95
	Tradepak PE