ALEPAM 30 (OXAZEPAM) 30MG X 25 TABLETS

Name of Medicine

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Oxazepam.

6.7 Physicochemical Properties

A white or almost white, crystalline powder, practically insoluble in water, slightly soluble in alcohol and in methylene chloride.
Chemical name: (3RS)-7-chloro-3- hydroxy-5-phenyl-1,3-dihydro-2H- 1,4-benzodiazepin-2-one.
Molecular formula: C₁₅H₁₁ClN₂O₂.
Molecular weight: 286.72.

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

Each Alepam 15 and Alepam 30 tablet contains 15 mg and 30 mg of oxazepam, respectively.

Excipients with known effect.

Lactose, trace quantities of sulfites and galactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Alepam 15: 15 mg tablet: Pale yellow, marked OM/15 on one side, G on reverse.
Alepam 30: 30 mg tablet: Pale orange, marked OM/30 on one side, G on reverse.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Oxazepam is an antianxiety agent which belongs to the benzodiazepine class of drugs.
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 by directly affecting the action potential generating mechanisms. Buy Alepam 30mg online Australia, Alepam 30mg for sale, Buy oxazepam 30mg Australia

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Oxazepam is readily absorbed when given orally. Peak concentrations in plasma occur approximately 2 to 3 hours following administration of 30 mg. The half-life of oxazepam in human plasma ranges from 4 to 15 hours. At clinically relevant concentrations, oxazepam is 95% to 98% bound to plasma protein. 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 oxazepam. Multiple dose therapy leads to no excessive drug accumulation.
There is no indication of induction of drug metabolising enzymes with oxazepam. Oxazepam is not a substrate for N-dealkylating enzymes of the cytochrome P450 system, nor is it hydroxylated to any significant extent.
The pharmacokinetics of oxazepam remain unaltered in older patients, however the elderly generally show increased central nervous system sensitivity to benzodiazepines, and may require a reduced dosage. Hepatic diseases (hepatitis, alcoholic cirrhosis) have a minimal influence on oxazepam kinetics, however these patients have increased cerebral sensitivity to benzodiazepines and dosage reduction may be advisable. As with other benzodiazepines, the pharmacokinetics of oxazepam may change in patients with impaired renal function and the medication should be used with caution. Buy Alepam 30mg online Australia, Alepam 30mg for sale, Buy oxazepam 30mg Australia

5.3 Preclinical Safety Data

Genotoxicity.

In vitro mutagenicity reports on oxazepam are inconclusive. One study reported oxazepam to be mutagenic in a modified Ames Salmonella typhimurium test in the presence, but not in the absence, of metabolic activation. Other investigations (employing the Salmonella/ microsome test, the Ames test, and tests in Aspergillus nidulans, Saccharomyces cerevisiae, isolated rat hepatocytes and a rat liver cell line) have obtained negative results for the mutagenicity of oxazepam.

Carcinogenicity.

In a two year carcinogenicity study in which rats were administered oxazepam in the diet (5, 15, 60 mg/kg/day), no oxazepam related malignant tumours were found. However, there was a significant increase in the incidence of testicular interstitial cell tumours and thyroid cystadenomas (benign tumours) in high dose males. There was also a significant trend for increased incidence of prostatic adenomas. An earlier published study reported that mice fed diets containing 0.05% or 0.15% oxazepam for nine months developed a dose related increase in liver adenomas. In an independent analysis of some of the microscopic slides from this mouse study, several of these tumours were classified as liver carcinomas. Although comprehensive studies have not been performed to examine the possibility of an increased incidence of tumours in humans exposed to oxazepam, at the present time there is no evidence that the clinical use of oxazepam is associated with tumours.  Buy Alepam 30mg online Australia, Alepam 30mg for sale, Buy oxazepam 30mg Australia

4 Clinical Particulars

4.1 Therapeutic Indications

Alepam is indicated for the following.
Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to oxazepam therapy. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient.
Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy. Buy Alepam 30mg online Australia, Alepam 30mg for sale, Buy oxazepam 30mg Australia

4.3 Contraindications

Alepam is contraindicated in:
patients with known hypersensitivity to benzodiazepines;
patients with chronic obstructive airways disease with incipient respiratory failure;
patients with sleep apnoea.