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

Logo TRANQIPAM-0,5 mg TABLETS
TRANQIPAM-1 mg TABLETS
TRANQIPAM-2,5 mg TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form)

TRANQIPAM-0,5 mg TABLETS
TRANQIPAM-1 mg TABLETS
TRANQIPAM-2,5 mg TABLETS

COMPOSITION:
Each TRANQIPAM-0,5 mg tablet contains 0,5 mg
lorazepam.
Each TRANQIPAM-1 mg tablet contains 1 mg lorazepam.
Each TRANQIPAM-2,5 mg tablet contains 2,5 mg lorazepam.
Lorazepam is a 1,4-benzodiazepine, and is chemically known as a 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepine-2-one.
TRANQIPAM-2,5 mg tablets contain TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
TRANQIPAM (lorazepam) is a benzodiazepine and has anxiolytic properties. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system, by potentiating the effects of synaptic or presynaptic inhibition mediated by gamma-aminobutyric acid.
TRANQIPAM (lorazepam) is readily absorbed when given orally.
Peak plasma concentrations occur approximately 2 hours following administration. The half-life of unconjugated TRANQIPAM (lorazepam) in human plasma is approximately 12 - 16 hours. TRANQIPAM (lorazepam) is about 90% bound to plasma proteins. Conjugation with glucuronic acid to form the inactive glucuronide of TRANQIPAM (lorazepam) is the major metabolic pathway. Seventy to seventy five percent of the dose is excreted as the glucuronide in the urine. Metabolism is only subject to glucoronidation and is not linked to the action of the cytochrome P450 enzyme system.
The plasma levels of TRANQIPAM (lorazepam) are proportional to the dose given.

INDICATIONS:
TRANQIPAM (lorazepam) is indicated for:
1.   Anxiety disturbances or anxiety states:
  a) general anxiety disturbances
  b) panic disturbances
  c) phobic anxiety disturbances
2.   Anxiety associated with and caused by organic disease.
3.   Adjustment disturbances with anxiety or stress reactions.

CONTRA-INDICATIONS:
Known hypersensitivity to benzodiazepines, and in patients with pre-existing central nervous system depression or coma.
The administration of TRANQIPAM is contra-indicated in patients with porphyria.

WARNINGS:
Patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles, or climb dangerous heights until it is established that they do not become drowsy or dizzy or experience psychomotor impairment from lorazepam therapy.
Patients should be advised that their tolerance for alcohol and other central nervous system depressants will be diminished.
Lorazepam treatment should be avoided in general in psychotic patients, and in those suffering from mental depression or suicidal tendencies unless there is a marked component of anxiety in their illness. Care may be needed in epileptic patients in whom the initiation or abrupt withdrawal of benzodiazepine therapy has provoked seizures.
TRANQIPAM-2,5 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 have aspirin-sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Anxiety or tension associated with everyday life does not require treatment with an anxiolytic.
It is recommended that the need for continued therapy with lorazepam be determined periodically.
Dosage for children under 12 years has not been established.
Dosage should be individualized for optimal beneficial effect.
The average dosage for treatment of anxiety is 2 mg to 3 mg daily administered in two to four portions, however this may range between 1 mg and 6 mg daily.
For elderly or debilitated patients an initial dosage of 1 mg or 2 mg per day in two to four portions is recommended, to be adjusted as needed and tolerated.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequent adverse reactions reported are drowsiness and over-sedation followed by dizziness, weakness, unsteadiness, confusion and lethargy. Vertigo, light-headedness, mental depression, slurred speech or dysarthria, changes in libido, ataxia, tremor, urinary retention or incontinence, changes in salivation and jaundice may also occur.
Respiratory depression and hypotension may occur with high doses.
Other adverse reactions reported include nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms, eye-function disturbance.
Transient amnesia or memory impairment has been reported.
Some patients on benzodiazepines have developed blood dyscrasias, and some have had elevations in liver enzymes. Periodic blood counts and liver-function tests are recommended for patients on long-term therapy. Paradoxical reactions such as acute hyperexcitable states with rage may occur.
Particular caution should be exercised with the elderly and debilitated who are at particular risk of over-sedation, respiratory depression, unsteadiness and ataxia. The initial dosage should be reduced in those patients.
Caution should be exercised in patients with pulmonary disease and limited pulmonary reserve, as well as in patients with acute narrow-angle glaucoma.
Caution is required in patients with impaired liver, kidney or respiratory function and in patients receiving other central nervous system depressant medicines in whom central nervous system depression may be potentiated. The pharmacokinetics of lorazepam may change in impaired renal function.
Lorazepam should be used judiciously during pregnancy and preferably avoided. In humans, blood levels obtained from umbilical cord indicate placental transfer of lorazepam and its glucuronide. Neonates appear to conjugate lorazepam slowly, the glucuronide being detectable in the urine for more than seven days. Glucuronidation of lorazepam may competitively inhibit the conjugation of bilirubin, leading to hyperbilirubinaemia in the newborn.
Given during labour lorazepam crosses the placenta and may cause the floppy infant syndrome, characterised by central respiratory depression, hypothermia and poor sucking.
It should not be administered to nursing mothers since there is evidence that lorazepam is excreted in human breast milk.
There is potential for abuse and addiction-prone individuals, such as drug addicts and alcoholics should be under careful surveillance when receiving lorazepam.
The use of lorazepam may lead to dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of lorazepam. 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 lorazepam taken continuously at therapeutic levels. Accordingly, lorazepam should be terminated gradually to help avoid occurrence of withdrawal symptoms.

INTERACTIONS WITH OTHER MEDICINES:
Lorazepam produces additive central nervous system depressant effects when coadministered with other central nervous system depressants e.g. barbiturates or alcohol.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of lorazepam is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma, respiratory and cardiovascular depression. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, hypotension, hypnosis, coma and death.
Treatment is symptomatic and supportive.

IDENTIFICATION:
TRANQIPAM-0,5 mg: tablet is white, round and 5 mm in diameter.
TRANQIPAM-1 mg: White, flat round, bevelled edged tablet, 7 mm diameter, bisected on one side and engraved on the other side with the Lennon logo (mortar and pestle).
TRANQIPAM-2,5 mg: Yellow, flat round, bevelled edged tablet, 8 mm diameter, bisected on one side and engraved on the other side with the Lennon logo (mortar and pestle).
[Ed: NB TRANQIPAM-2,5 mg: colour change to white - Nov 2010 ]

PRESENTATION:
TRANQIPAM-0,5 mg, -1 mg and -2,5 mg tablets in packs of 100 tablets each.

STORAGE INSTRUCTIONS:
Store in a cool (below 25 °C), dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
TRANQIPAM-0,5 mg tablet: X/2.6/83
TRANQIPAM-1 mg tablet: U/2.6/38
TRANQIPAM-2,5 mg tablet: U/2.6/39

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH 6001

Medical Information Hotline on 0800 118 088

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 February 1990

        G402B
        KHOLER C&P P.E.

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