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

Logo PURATA - 10 TABLETS
PURATA - 15 TABLETS
PURATA - 30 TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PURATA - 10 TABLETS
PURATA - 15 TABLETS
PURATA - 30 TABLETS

COMPOSITION:
Each tablets contains 10 (15, 30) mg of
Oxazepam

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 - Tranquillizers

PHARMACOLOGICAL ACTION:
Oxazepam is a benzodiazepine derivative with sedative properties. It is a N-demethylated 3-hydroxylated metabolic product of diazepam. Some muscle relaxation occurs after administration in high dosage. Oxazepam reaches a peak plasma concentration in 4 hours and is excreted in the urine as the glucuronide conjugate.
Oxazepam is absorbed from the gastro-intestinal tract. Up to 80% of a dose is excreted in the urine over 72 hours, about 10% of a dose or less has been recovered from the faeces as free oxazepam.

INDICATIONS:
Oxazepam is used in the treatment of anxiety and tension and to relieve the acute symptoms of the alcohol withdrawal syndrome. Oxazepam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

CONTRA-INDICATIONS:
Oxazepam should not be given to psychotic patients and in those suffering from mental depression or suicidal tendencies. Caution should be observed when giving oxazepam to elderly or debilitated patients who are specially sensitive to its side-effects, to patients with renal or hepatic dysfunction, and to patients with closed-angle glaucoma. Oxazepam is contra-indicated in infants and in patients with known hypersensitivity to oxazepam and other benzodiazepines. Pre-existing CNS depression or coma is normally a contra-indication. Use of oxazepam in the first trimester of pregnancy has been associated with various congenital malformations in the infant and in the last trimester it has been associated with drowsiness, respiratory depression and intoxication in the newborn infant. For these reasons oxazepam is contra-indicated in pregnancy.
Oxazepam is excreted in breast milk and is contra-indicated in nursing mothers because of the side-effects it can cause in the breastfed infant such as drowsiness, slow heartbeat and breathing problems.
Use with care in porfirics, as safety has not been established.

WARNING:
This medicine may lead to drowsiness or impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive or operate machinery where loss of attention might be hazardous.
KEEP OUT OF THE REACH OF CHILDREN

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be started with the lowest recommended dose:
The maximum dose should not be exceeded.
Treatment of anxiety or for control of symptoms of alcohol withdrawal:
Usual dose is 15 to 30 mg three or four times per day.
For elderly or debilitated patients:
10 mg three times per day.
Treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free.
The overall duration of treatment generally should not be more than 8 -12 weeks, including a tapering off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The adverse effects most commonly encountered are drowsiness and oversedation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses. Less commonly, the benzodiazepines may produce depression of mood, disorientation or confusion, lethargy, and ataxia.
Other side effects frequently encountered are dizziness, slurred speech, vertigo, light-headedness, confusion, mental depression, fatigue, apathy, constipation and irritability. Less frequently depression, gastro-intestinal disturbances such as diarrhoea and indigestion, changes in libido, tremor, blurred vision, urinary retention or incontinence, changes in salivation, jaundice and occasional blood disorders have been reported. The benzodiazepines can cause amnesia. Respiratory depression and hypotension may occasionally occur with high dosage. Large doses may produce syncope.
Paradoxical reactions such as acute hyperexcitable states with rage and hostility have been recorded. If these occur, the medicine should be discontinued.
Tolerance and physical dependence can occur.
Skin rashes, headaches, nausea and frequency of urination have been reported.
The benzodiazepines have a moderate potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation especially in patients receiving large doses for prolonged periods.
Special Precautions
Hypotension has occurred and oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications.
Oxazepam can lead to a decrease in alertness which can influence the patient's ability to perform tasks such as driving of a motor and the operating of machinery.
Oxazepam should be administered with particular care to the following patients:
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; (asthma, emphysema, bronchitis)
patients suffering from impairment of renal or hepatic function, or from hypoalbuminaemia;
patients suffering from anxiety accompanied by an underlying depressive disorder;
patients receiving barbiturates or other central nervous system depressants concomitantly with the benzodiazepines. There is an additive risk of central nervous system depression when these medicines are taken together;
patients should be cautioned regarding the additive effect of alcohol when taken together with the benzodiazepines;
alcohol abuse and drug abuse (or a history thereof)
difficulty in swallowing in children
patients with myasthenia gravis on account of the pre-existing muscle weakness;
patients with organic brain changes particularly arteriosclerosis
Given during labour the benzodiazepines cross the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking.
Epileptic patients, in whom the initiation or abrupt withdrawal of benzodiazepine therapy has occasionally provoked seizures, should exercise particular caution while taking this medicine or other benzodiazepines.
With prolonged treatment, periodic blood counts and liver function tests may be advisable.
Oxazepam is not recommended for the primary treatment of psychotic illness. Oxazepam should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). Oxazepam should be used with extreme caution in patients with a history of alcohol or drug abuse.
Dependence
There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history of alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur:
Derealisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound effects
A transient syndrome whereby the symptoms that led to treatment with oxazepam recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage is decreased gradually.
Duration of treatment
The duration of treatment should be as short as possible (see dosage), but should not exceed eight to twelve weeks in case of anxiety, including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. However it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.
INTERACTIONS WITH OTHER MEDICINES
The effects of oxazepam may be enhanced by alcohol, barbiturates, phenothiazines, monoamine oxidase inhibitors or tricyclic antidepressants, antihistamines, medicines for colds, muscle relaxants etc.

INTERACTIONS
Grapefruit juice has been found to increase the bio-availability of certain drugs (those metabolised by the cytochrome P450 3A4 enzyme), by inhibiting their metabolism in the liver and gut. Because Oxazepam might potentially be affected, patients taking this are advised not to drink grapefruit juice, as potentially serious adverse effects may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sedation, ataxia, dysarthria, hypotension, confusion, respiratory and cardiovascular depression and occasionally sleep and coma have been observed in patients ingesting massive doses with suicidal intent. A few deaths have been reported at doses greater than 700 mg.
The stomach should be emptied by aspiration and lavage. There is no specific treatment and recovery usually follows symptomatic and supportive therapy, with particular attention being paid to the maintenance of cardiovascular, respiratory, and renal functions, and to the maintenance of electrolyte balance.

IDENTIFICATION:
10 mg White, flat bisected bevelled edged tablet engraved with mortar and pestle on one side, and "01" on the other.
15 mg Yellow, flat bisected tablet with bevelled edges and engraved with mortar and pestle on the other side.
30 mg Pink, flat bisected tablet with bevelled edges and engraved with mortar and pestle on the other side.

PRESENTATION:
10 mg:         100 tablets –blisters
        500 tablets –white securitainers
15 mg:         100 tablets –blisters
        500 tablets –securitainers
30 mg         100 tablets –white securitainers
        500 tablets –white securitainers

STORAGE INSTRUCTIONS:
Store below 25°C
Protect from light and moisture
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
10 mg        K/2.6/323
15 mg        K/2.6/324
30 mg        K/2.6/325

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29/6/78
        D812
        A & S PRINTERS

Updated on this site: February 2004
Source: Community Pharmacy

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