Zolium

Zolium0.5 mg

Tablet

Alprazolam

Incepta Pharmaceuticals Ltd.

Product Code : 19003
MRP 3.40
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Medicine overview

Indications of Zolium 0.5 mg

Zolium 0.5 mg is indicated in- Anxiety disorder Short term relief of anxiety Anxiety associated with depression Panic disorder, with or without agoraphobia.

Theropeutic Class

Benzodiazepine sedatives

Pharmacology

Zolium 0.5 mg binds with high affinity to the GABA benzodiazepine receptor complex. Considerable evidence suggests that the central pharmacologic or therapeutic actions of Zolium 0.5 mg are mediated via interaction with this receptor complex.Zolium 0.5 mg, a benzodiazepine, bind nonspecifically to benzodiazepine receptors BNZ1, which mediates sleep, and BNZ2, which affects muscle relaxation, anticonvulsant activity, motor coordination, and memory. As benzodiazepine receptors are thought to be coupled to gamma-aminobutyric acid-A (GABAA) receptors, this enhances the effects of GABA by increasing GABA affinity for the GABA receptor. Binding of the inhibitory neurotransmitter GABA to the site opens the chloride channel, resulting in a hyperpolarized cell membrane that prevents further excitation of the cell.

Dosage & Administration of Zolium 0.5 mg

Must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment.For Adults: Initially 0.25 mg given 2 or 3 times daily. If required, increases may be made in 0.25 mg increments according to the severity of symptoms and patient response.It is recommended that the evening dose should be increased before the daytime doses. Very severe manifestations of anxiety may require larger initial daily doses. The optimal dosage is one that permits symptomatic control of excessive anxiety without impairment of mental and motor function. Exceptionally, it may be necessary to increase dosage to a maximum of 3 mg daily, given in divided doses.For Elderly and Debilitated Patients: The initial dosage is 0.125 mg 2 or 3 times daily. If necessary, this dosage may be increased gradually depending on patient tolerance and response.

Dosage of Zolium 0.5 mg

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.Zolium 0.5 mg 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Zolium 0.5 mg 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Interaction of Zolium 0.5 mg

The CNS-depressant action of Zolium 0.5 mg may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.

Contraindications

Contraindicated in patients with hypersensitivity to Zolium 0.5 mg or other benzodiazepines. Zolium 0.5 mg is also contraindicated in patients with myasthenia gravis, acute narrow angle glaucoma, during pregnancy and also in infants.

Side Effects of Zolium 0.5 mg

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.

Pregnancy & Lactation

Safety in pregnancy has not been established, therefore its use is not recommended. Studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines, such as chlordiazepoxide, diazepam, and also meprobamate, during the first trimester of pregnancy. Since Zolium 0.5 mg is a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential.Studies in rats have indicated that Zolium 0.5 mg and its metabolites are secreted into the milk. Therefore, nursing should not be undertaken while a patient is receiving the drug.

Precautions & Warnings

Because Zolium 0.5 mg may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Zolium 0.5 mg therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Zolium 0.5 mg should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

Overdose Effects of Zolium 0.5 mg

Manifestations of Zolium 0.5 mg overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Use In Special Populations

Use in Children: Safety and efficacy of Zolium 0.5 mg in patients under the age of 18 years has not been established.

Drug Classes

Benzodiazepine sedatives

Mode Of Action

Zolium 0.5 mg is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Zolium 0.5 mg is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.

Pregnancy

Zolium 0.5 mg has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Zolium 0.5 mg is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Zolium 0.5 mg.

Pediatric Uses

The safety and effectiveness of Zolium 0.5 mg in individuals below 18 years of age have not been established.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.