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

Logo SEREPAX® 10 mg tablets
SEREPAX® 15 mg tablets
SEREPAX® FORTE tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

SEREPAX® 10 mg tablets
SEREPAX
® 15 mg tablets
SEREPAX
® FORTE tablets

COMPOSITION:
Oxazepam is chemically known as 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one.
Tablets containing 10 mg, 15 mg or 30 mg
oxazepam.

SEREPAX 15 mg tablets contain TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION
Category A, 2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
SEREPAX (oxazepam) is readily absorbed when given orally. Peak concentrations in plasma occur approximately 2-3 hours following administration of 30 mg. The half-life of SEREPAX (oxazepam) in human plasma ranges from 4 to 15 hours. In clinically relevant concentrations, SEREPAX (oxazepam) is 95% to 98% bound to plasma protein. SEREPAX (oxazepam) is conjugated at its 3-hydroxy substituent to its glucuronide which accounts for at least 95% of the urinary excretion products. There are no active metabolites of SEREPAX (oxazepam). Oxazepam is a benzodiazepine with anxiolytic, anticonvulsant, muscle-relaxant and sedative properties.
The pharmacokinetics of oxazepam may change in patients with impaired renal function.

INDICATIONS:
SEREPAX (oxazepam) is indicated for the management of anxiety disorders, or for the short-term relief of the symptoms of anxiety.
Alcoholics with acute tremulousness, inebriation, or anxiety associated with alcohol withdrawal are responsive to therapy.
No systematic clinical studies for longer than 4 months have been undertaken.

CONTRA-INDICATIONS:
History of previous sensitivity reactions to oxazepam or to other benzodiazepine derivatives.
Safety in pregnant women has not been established.
SEREPAX (oxazepam) is not indicated for the treatment of primary depressive disorders or psychosis.

WARNINGS:
There is a potential for abuse.
Transient amnesia or memory impairment has been reported in association with the use of SEREPAX (oxazepam).
Addiction-prone individuals such as drug addicts and alcoholics, should be under careful surveillance when receiving benzodiazepines because of the predisposition of such patients to habituation and dependence.
The use of benzodiazepines may lead to dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of benzodiazepine drugs. These symptoms can range from mild dysphoria and insomnia to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, vomiting and sweating. These symptoms, especially the more serious ones, are more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels. Accordingly, SEREPAX (oxazepam) should be terminated gradually to help avoid occurrence of withdrawal symptoms.
It is recommended that the need for continued therapy with SEREPAX (oxazepam) be determined periodically.
Patients receiving SEREPAX (oxazepam) should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from SEREPAX (oxazepam) therapy. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and should either be eliminated or given in reduced dosage in the presence of SEREPAX (oxazepam).

TARTRAZINE WARNING
SEREPAX 15 mg Tablets contain F D and C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine-sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
The optimum dosage requirement should be individualized for maximum beneficial effects.
Residual anxiety syndrome in alcoholic withdrawal 15 - 30 mg, 3 or 4 times daily.
Mild to moderate anxiety syndromes 10 to 15 mg, 3 or 4 times daily.
Severe anxiety syndromes 15 to 30 mg, 3 to 4 times daily.
For older patients, the initial dosage is 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily.
Absolute dosage for children under 12 years has not been established, and such use is not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse reactions are usually observed at the beginning of therapy and generally disappear on continued medication or upon decreasing the dose. The most frequent one is drowsiness. Dizziness, vertigo and headache have been reported in a few instances; occasionally, hypotension has occurred. Syncope either alone or together with drowsiness has been infrequent. Blurred vision, disorientation and fever have been observed. Other side-effects occurring infrequently during SEREPAX (oxazepam) therapy include minor diffuse skin rashes (morbilliform, urticarial and maculopapular), nausea, lethargy, oedema, slurred speech, tremor and altered libido. Paradoxical reactions such as acute hyperexcitable states with rage may occur. If these occur, the medicine should be discontinued. Particular caution should be exercised with the elderly and debilitated, who are at particular risk of oversedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients).
Patients with pulmonary disease and limited pulmonary reserve should be treated with caution. Caution should be exercised in treating patients suffering from anxiety accompanied by an underlying depressive disorder.
Caution should be exercised in the treatment of patients with acute narrow-angle glaucoma. The usual precautions for treating patients with impaired renal or hepatic function should be observed. Some patients on SEREPAX (oxazepam) have developed blood dyscrasias, and some have had elevations in liver enzymes. Periodic blood counts and liver function tests are recommended. SEREPAX (oxazepam) should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. This is particularly true in elderly patients.
Use in pregnancy:
Safety in pregnancy has not been established. Benzodiazepines may cause foetal damage when administered to pregnant women. The use, therefore, of benzodiazepines during the first trimester of pregnancy should always be avoided. If oxazepam is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuation of the medicine if she intends to become or suspects that she is pregnant. Given during labour, or during the late phase of pregnancy, SEREPAX (oxazepam) crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Caution should be exercised when SEREPAX (oxazepam) is given to a nursing woman since there is evidence that benzodiazepines are excreted in human milk.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension. Symptomatic treatment is recommended.

IDENTIFICATION:
Round, flat bevelled edge tablets, scored on one side and plain on the other.
SEREPAX 10 mg is white.
SEREPAX 15 mg is yellow.
SEREPAX FORTE is pink.

PRESENTATION:
SEREPAX 10 mg and SEREPAX 15 mg tablets are packed in amber bottles of 100, 250 and 500 tablets.
SEREPAX FORTE is packed in amber bottles of 100 and 500 tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBERS:
SEREPAX 10 mg tablets: B/2.6/1343
SEREPAX 15 mg tablets: B/2.6/1344
SEREPAX FORTE tablets: A/2.6/774

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Santon        2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24 NOVEMBER 1993

TRADEMARK AND PRODUCT UNDER LICENCE FROM WYETH-AYERST, USA.
308455        030719
        Harry's Priers -K00000 G03

Updated on this site: January 2005
Source: Pharmaceutical Industry

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