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

Logo LORAMET® 0,5 mg capsule
LORAMET® 1 mg capsule
LORAMET® 2 mg capsule

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

LORAMET® 0,5 mg capsule
LORAMET
® 1 mg capsule
LORAMET
® 2 mg capsule

COMPOSITION:
LORAMET 0,5 mg capsule contains 0,5 mg
lormetazepam
LORAMET 1 mg capsule contains 1 mg lormetazepam
LORAMET 2 mg capsule contains 2 mg lormetazepam

Lormetazepam is a 1,4-benzodiazepine and is chemically known as 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4 benzodiazepine-2-one.
Preservatives per capsule: sodium ethyl-p-hydroxybenzoate 0,08% and sodium propyl-p-hydroxybenzoate 0,04%.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 2.2 Sedative, hypnotic.

PHARMACOLOGICAL ACTION:
LORAMET (lormetazepam) hastens the onset of sleep and increases total sleeping time.
The exact mechanism of action of benzodiazepines has not yet been elucidated; however, benzodiazepines appear to work through several mechanisms. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system either by potentiating the effects of synaptic or presynaptic inhibition mediated by gamma-aminobutyric acid or directly affecting the action potential generating mechanisms.
After oral administration LORAMET (lormetazepam) is rapidly and completely absorbed.
Maximum plasma concentrations from the liquid filled soft gelatin capsules are reached within 60 minutes. The plasma elimination half-life is approximately 10 hours, but may range up to 12 hours. Elimination is mainly via the kidney.
LORAMET (lormetazepam) has essentially a one-step metabolism. It is metabolised principally in the liver where most (94%) of the unchanged drug is directly conjugated to the glucuronide and excreted in this form.
With oral dosing LORAMET (lormetazepam) undergoes approximately 20-30% first-pass metabolism by the liver. Over 85% of LORAMET (lormetazepam) is bound to plasma proteins at therapeutic concentrations.

INDICATIONS:
LORAMET (lormetazepam) is indicated for use as a sedative/hypnotic. Since insomnia is often transient and intermittent, the prolonged administration of LORAMET (lormetazepam) is not recommended.

CONTRA-INDICATIONS:
Lormetazepam is contra-indicated in patients with known hypersensitivity to benzodiazepines.

Use in pregnancy:
The safety of LORAMET (lormetazepam) in pregnancy has not been established.
Benzodiazepines may cause foetal damage when administered to pregnant women. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery, have been reported to have withdrawal symptoms during the postnatal period. The use of benzodiazepines during pregnancy should be avoided.
If lormetazepam is prescribed to a woman of child-bearing potential she should be warned to contact her doctor regarding discontinuation of lormetazepam if she intends to become or suspects that she is pregnant.

Use in labour:
Given during labour or the late phase of pregnancy, benzodiazepines cross the placenta and may cause the floppy infant syndrome, characterised by central respiratory depression, hypothermia and poor sucking.

Use in nursing mothers:
Lormetazepam should not be administered to nursing mothers.

Use in children:
The safety and effectiveness of lormetazepam in children has not been established.

WARNINGS:
As with all central nervous system depressants, patients receiving LORAMET (lormetazepam) should be warned not to operate dangerous machinery or motor vehicles, or climb dangerous heights until it is known that they do not become drowsy or dizzy from lormetazepam therapy. Patients should be advised that their tolerance for alcohol and other central nervous system depressants will be diminished and should either be eliminated or given in reduced dosage in the presence of LORAMET (lormetazepam).
Withdrawal from medication should be gradual. As with other sedative/hypnotics when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after long term daily use of LORAMET (lormetazepam).
It is recommended that the need for continued therapy with LORAMET (lormetazepam) be determined periodically.

DOSAGE AND DIRECTIONS FOR USE:
The dosage of LORAMET (lormetazepam) should be individualised for maximum beneficial effect.
The recommended oral adult dose is 1 mg to 2 mg, and 0,5 mg to 1 mg in elderly patients.
A dose of 2 mg is recommended the night before surgery.
For elderly and debilitated patients, the initial daily dose should generally not exceed 1 mg in order to avoid over-sedation.
The capsules should be taken with water half an hour before retiring.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The adverse effects most commonly encountered with benzodiazepine usage 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 headache, depression of mood and affect, disorientation or confusion, lethargy and ataxia, sleep disturbance, and dermatological or gastro-intestinal symptoms.
Paradoxical reactions with acute hyperexcitable states with rage have been recorded with other benzodiazepines. If these occur with lormetazepam, its use should be discontinued.
Caution should be exercised in patients suffering from insomnia 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.
Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Some patients on benzodiazepines have developed blood dyscrasias, and some have had elevations in liver enzymes.
As with other benzodiazepines, periodic blood counts and liver-function tests are recommended for patients on long-term therapy.
In doses 50 -100 times those recommended clinically, no evidence of toxicity, teratogenicity or embryotoxicity was found in the animal species tested. There was no evidence of cytotoxic, mutagenic or carcinogenic effects.

Interaction with other medicines:
Lormetazepam produces additive central nervous system depressant effects when co-administered with other medications which themselves produce central nervous system depression eg. barbiturates or alcohol.

Abuse:
Benzodiazepines have a potential for abuse.
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.

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 benzodiazepines. 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 LORAMET (lormetazepam) should be terminated gradually to help avoid occurrence of withdrawal symptoms.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
Induced vomiting and/or gastric lavage should be undertaken followed by general supportive care.

IDENTIFICATION:
LORAMET 0,5 mg (lormetazepam) capsules are orange, opaque, oval, 2 minim sized soft gelatin capsules, imprinted "0,5 mg" on one side.
LORAMET 1 mg (lormetazepam) capsules are orange, opaque, oval, 4 minim sized soft gelatin capsules, imprinted “1”on one side.
LORAMET 2 mg (lormetazepam) capsules are orange, opaque, oval, 10 minim sized soft gelatin capsules, imprinted “2”on one side.

PRESENTATION:
LORAMET 0,5 mg, LORAMET 1 mg and LORAMET 2 mg are available in amber glass bottles, in 30's and 100's.

STORAGE DIRECTIONS:
Store in tightly closed containers, protected from light in a cool (below 25°C), dry place.
Keep out of reach of children.

REGISTRATION NUMBERS:
LORAMET 0,5 mg        S/2.2/214
LORAMET 1 mg        S/2.2/215.
LORAMET 2 mg        S/2.2/216

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD
Electron Avenue
Isando
Trademark and product, under licence from
WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT.
25 May 1995
Davbar Dbn.        24540 JZ509

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