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

SOPENTAL TABLETSSOPENTAL CAPSULES

SCHEDULING STATUS:S6

PROPRIETARY NAME(and dosage form):

SOPENTAL TABLETS

SOPENTAL CAPSULES

COMPOSITION:Tablets or capsules each containing 100 mg Pentobarbitone sodium

PHARMACOLOGICAL CLASSIFICATION:2.3 Barbiturates

PHARMACOLOGICAL ACTION:Pentobarbitone is a short-acting barbiturate with onset of action of about 15 minutes. Effects are noticeable for up to six hours.The barbiturates are sedatives and hypnotics, depending on the dosage, owing to a specific depressant effect on theascending reticular activating system to the cerebral cortex.

INDICATIONS:The chief use of Pentobarbitone is as a hypnotic in insomnia caused by mild anxiety states. The onset of action is sufficientlyshort and there is no marked sedation on the following day. It can also be used in acute anxiety states and as a basalanaesthetic.

CONTRA-INDICATIONS:The administration of Pentobarbitone is contra-indicated in the presence of kidney and liver disease, and where there is a familyhistory of porphyria.

DOSAGE AND DIRECTIONS FOR USE:Adults and children over 12 years:One or two tablets or capsules.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:The concomitant administration of other drugs, such as alcohol, tranquillisers or antihistamines will potentiate the effects ofPentobarbitone and this could lead to dangerous respiratory depression. Continued use of the barbiturates may lead to thedevelopment of tolerance and dependence; this effect is more marked with the shorter-acting barbiturates such asPentobarbitone .

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:Overdosage of Pentobarbitone, as with other barbiturates, will lead to a respiratory depression, peripheral vascular collapse,feeble heart beat, lowered body temperature, suppression of urine, and prolonged coma, with depressed or absent reflexes.Treatment aims at maintaining respiration and eliminating the drug. Artificial respiration should be instituted if necessary andoxygen administered. The stomach should be washed out. Fluid may be given intravenously and urinary output must be

maintained. Respiratory depression may be treated with bemegride, picrotoxin or leptazol.

CONDITIONS OF REGISTRATION:May be advertised to the professions only.

IDENTIFICATION:Tablets: White oval, biconvex tablet.Capsules: Yellow hard gelatine, with white powder.

PRESENTATION:Tablets: 40, 100 and 500.Capsules: 100 and 1 000.

STORAGE INSTRUCTIONS:Store below 25°CProtect from moisture.KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBERS:Tablets: B908 (Act 101/1965)Capsules: B892 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:LENNON LIMITED7 Fairclough RoadPort Elizabeth6001

DISTRIBUTED BY:Continental Ethicals1 Corlett DriveIllovoJohanesburg 2196

DATE OF PUBLICATION OF THIS PACKAGE INSERT:28.11.1969

First presented on this site in September 1996Current: September 2004Source: Pharmaceutical Industry

SAEPI HOME PAGE TRADE NAME INDEX GENERIC NAME INDEX FEEDBACK

Information presented by Malahyde Information Systems © Copyright 1996-2004