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Inzolam

DESCRIPTION
An oval, scored tablet blue in colour with markings 'DUO 861' and 'd/d'.

COMPOSITION
Each tablet contains Triazolam 0.25mg

PHARMACODYNAMICS
Triazolam is a potent short-acting benzodiazepines with general properties similar to those of diazepam.

PHARMACOKINETICS
Triazolam is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations being achieved within 2 hours of administration by mouth. Triazolam has a plasma elimination half-life ranging from 1.5 to 5.5 hours. It is reported to be about 89% bound to plasma proteins. Hydroxylation of Triazolam in the liver is mediated by the cytochrome P450 isozyme CYP3A4. Triazolam is excreted in the urine mainly in the form of its conjugated metabolites with only small amounts appearing unchanged.

INDICATIONS
Inzolam is useful in the management of patients with transient and short term insomnia. It is also useful as a short term adjunctive treatment in the management of selected patients with long-term insomnia.

RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION
It is important to individualised dosage of Triazolam in patients within various population groups in order to obtain maximum therapeutic effect while using the smallest effective dose. The recommended dose for most adults is 0.25 mg before retiring. A dose of 0.125 mg may be found sufficient for some patients (e.g. low body weight). A dose of 0.5 mg should be used only for exceptional patients who do not respond adequately to a trial of a lower dose since the risk of several adverse reactions increases with the size of the dose administered. A dose of 0.5 mg should not be exceeded. In geriatric and/or debilitated patients the recommended dosage range is 0.125mg to 0.25 mg. Therapy should be initiated at 0.125 mg in this group and the 0.25 mg dose should be used only for exceptional patients who do not respond to a trial of the lower dose. A total dose of 0.25 mg should not be exceeded in these patients.

CONTRAINDICATIONS
Triazolam is contraindicated with ketoconazole, itraconazole, and nefazodone, medications that significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A), pregnancy, lactation (breast feeding), depressed patients with suicidal tendencies, hypersensitivity to benzodiazepines, Myasthenia gravis, chronic obstructive airways disease with incipient respiratory failure.

PRECAUTIONS / WARNINGS

Warning: May be habit forming on prolonged used

Caution to patients not to take Inzolam in circumstances where a full night's sleep and clearance of the drug from the body are not possible before they would again need to be active and functional, e.g. an overnight flight of less than 7-8 hours, since amnetic episodes have been reported in such situations.


Depression, Psychosis and Schizophrenia: Triazolam is not recommended as primary therapy for patients with depression and psychosis. In such conditions, psychiatric assessment and supervision are necessary if benzodiazepines are indicated. Benzodiazepines may increase depression in some patients and may contribute to deterioration in severely disturbed schizophrenics with confusion and with withdrawal. Suicidal tendencies may be present or uncovered and protective measures may be required.


Paradoxical Reactions: Paradoxical reactions such as acute rage, stimulation or excitement may occur; should such reactions occur, Triazolam should be discontinued.


Geriatric or Debilitated Patients: Such patients may be particularly susceptible to the sedative effects of benzodiazepines and associated giddiness, ataxia and confusion, which may increase the possibility of a fall. For this reason, the dosage should be limited to the smallest effective amount to preclude such effects. The systemic availability of oral Triazolam is increased in geriatric patients probably due to a diminished firstpass hepatic metabolism.


Impaired Renal/Liver Function: Patients with impaired renal or liver function should use benzodiazepine medication with caution and a reduction in dosage, or decision not to prescribe, may be necessary in such patients. In rare instances some patients taking benzodiazepines have developed blood dyscrasias, and some have had elevations of liver enzymes. As with other benzodiazepines, periodic blood counts and liver function tests are recommended. Caution must be used in treating patients with impaired hepatic function, severe pulmonary insufficiency, or sleep apnoea.


Impaired Respiratory Function: Caution in the use of Triazolam is recommended inpatients with respiratory depression. In patients with chronic obstructive pulmonary disease, benzodiazepines can cause increased arterial carbon dioxide tension and decreased oxygen tension. In patients with compromised respiratory function, respiratory depression and apnoea have been reported infrequently.


Hypotension: Although hypotension may occur only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in the elderly patient.


Abuse: Caution must be exercised in administering Triazolam to individuals known to be addiction prone, or those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeat prescriptions without adequate medical supervision.

 

Dependence: The use of benzodiazepines may lead to dependence as defined by the presence of a withdrawal syndrome on discontinuation of the drug Tolerance as defined by a need to increase the dose in order to achieve the same therapeutic effect seldom occurs in patients receiving the recommended dose under medical supervision. Tolerance to sedation may occur with benzodiazepines, especially in those with drug seeking behaviour. Tolerance may develop during 1 to 2 weeks of therapy. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance with benzodiazepines, including Triazolam. These symptoms range from insomnia, anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to light, sound and touch, abnormal body sensations (eg. feelings of motion, metallic taste), depersonalisation, derealisation, delusional beliefs, hyperreflexia and loss of short term memory, to a major syndrome which may include convulsions, seizures, tremor, abdominal and muscle cramps, confusional state, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. Such manifestations of withdrawal, especially the more serious ones are more common in patients who have received excessive doses over a prolonged period. However, withdrawal symptoms have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels. Accordingly, Triazolam should be terminated by tapering the dose to minimise occurrence of withdrawal symptoms. Patients should be advised to consult with their physician before either increasing the dose or abruptly discontinuing the medication. Rebound phenomena have been described in the context of benzodiazepine use Rebound insomnia and anxiety mean an increase in the severity of these symptoms beyond pre-treatment levels following the cessation of benzodiazepines Rebound phenomena in general possible reflect there-emergence of pre-existing symptoms combined with withdrawal symptoms described earlier. Some patients prescribed benzodiazepines with very short half-lives (in the order of 2 to 4 hours) may experience relatively mild rebound symptoms between their regular doses. Withdrawal/rebound symptoms may follow the use of high doses for relatively short periods.


Acute Narrow-Angle Glaucoma: Caution should be used in the treatment of patients with acute-narrow glaucoma (because of atropine-like side effects).

 

Epilepsy: Abrupt withdrawal of benzodiazepines in persons with convulsive disorders may be associated with a temporary increase in the frequency and/or severity of seizures. Patients with convulsive disorder should not be abruptly withdrawn from Triazolam.

 

Use in Paediatrics: Benzodiazepines and other hypnotic drugs may impair mental alertness in children. Triazolam is not recommended as safety and effectiveness in patients under the age of 18 has not been established.

 

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