Prazolex - Alprazolam 0.25 mg

Prazolex - Alprazolam 0.25 mg
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Brand Name:  Alprazolam/ PRAZOLEX 0.25 mg

What is Prazolex? Prazolex is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Prazolex affects chemicals in the brain that may become unbalanced and cause anxiety. Prazolex is used to treat anxiety disorders, panic disorders, and anxiety caused by depression. Action Alprazolam is an anti-anxiety drug. It is a benzodiazepine derivative, chemically and pharmacologically related to other drugs of this class. Presumably, benzodiazepines exert their effects by binding at stereo-specific receptors at several sites within the central nervous system (CNS). Their exact mechanism of action is unknown. All benzodiazepines cause a dose-related CNS depressant activity, varying from mild impairment of task performance to hypnosis.

Indications Prazolex is indicated for the treatments of anxiety and anxiety associated conditions in adults over 18 years old as follows:

1. Anxiety states (anxiety neuroses) Symptoms that occur in such patients include anxiety, tension, fear, insomnia, apprehension, restlessness, concentration difficulties, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints.

 2. Mixed anxiety-depression Symptoms of both anxiety and depression occur concurrently in such patients.

 3. Neurotic or reactive depression such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. Other characteristics include anxiety, appetite disturbances, and changes in weight, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, insomnia, somatic complaints, or thoughts of death or suicide.

 4. Anxiety states, mixed anxiety-depression, or neurotic depression Prazolex is indicated when these conditions are associated with other diseases, such as the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular, or dermatological disorders.


• Hypersensitivity to benzodiazepines or to any component of the product

• Myasthenia gravis

• Chronic obstructive airways disease with incipient respiratory failure.

Adverse Reactions

Side effects are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. In patients treated for anxiety, anxiety associated with depression, the most common side-effects to (Alprazolam) were drowsiness, sedation and ataxia. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses.

Prazolex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as: depressed mood, thoughts of suicide or hurting yourself, unusual risk-taking behavior, decreased inhibitions, no fear of danger; confusion, hyperactivity, agitation, hostility, hallucinations; feeling like you might pass out; urinating less than usual or not at all; chest pain, pounding heartbeats or fluttering in your chest; uncontrolled muscle movements, tremor, seizure (convulsions); or jaundice (yellowing of the skin or eyes). 

Less common side-effects are:

Co-ordination disorders, tremor, lethargy, ataxia, blurred vision, memory impairment/amnesia,

insomnia, nervousness/anxiety, depression, headache, autonomic manifestations, change in mass and various gastrointestinal symptoms. 

The following side-effects have also been reported:

Stimulation, agitation, irritability, concentration difficulties, confusion, hallucinations, other adverse behavioral effects, musculoskeletal weakness, dystonia, fatigue, slurred speech, anorexia, changes in salivation, changes in libido, menstrual irregularities, incontinence, urinary retention, abnormal liver function, jaundice, blood disorders, increased intra-ocular pressure and hypersensitivity reactions. Amnesia and paradoxical excitation may occur. In the case of acute, hyper-excitability states, the medicine should be discontinued. 

Warnings and Precautions

In general, benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks). With the exception of the use of Alprazolam for the treatment of panic disorder, continuous long-term use is not recommended. There is evidence that tolerance develops to the sedative effects of benzodiazepines. After as little as one week therapy with recommended doses, withdrawal symptoms can appear following cessation of treatment, e.g. rebound anxiety following the cessation of an anxiolytic benzodiazepine.

Habituation and emotional or physical dependence may occur with benzodiazepines, including Alprazolam. As with all benzodiazepines, the risk of dependence increases with higher doses and longterm use and is further increased in patients with a history of alcoholism or drug abuse. 

Depression, psychosis and schizophrenia

The use of Alprazolam has not been established in certain types of depression. Thus, it is not recommended as a primary therapy in 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 withdrawal. Suicidal tendencies may be present or uncovered, and protective measures may be required.

Panic-related disorders have been associated with depression, and an increased frequency of suicide amongst untreated patients has been reported. Therefore, the same precaution must be exercised when using the higher doses of Alprazolam in treating patients with panic disorders, as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans.

Administration to severely depressed or suicidal patients should be done with appropriate precautions and appropriate size of the prescription. 

Drug Interactions

 Benzodiazepines, including Alprazolam, produce additive CNS depressant effects when coadministered with drugs such as barbiturates, alcohol, sedatives, tricyclic antidepressants, and non- selective monoamine oxidase inhibitors and other antipsychotics, skeletal muscle relaxants, antihistamines, narcotic analgesics and anesthetics.

Pharmacokinetic interactions can occur when Alprazolam is administered along with drugs that interfere with its metabolism. Compounds that inhibit certain hepatic enzymes (particularly cytochrome P4503A4) may increase the concentration of Alprazolam and enhance its activity. Data from clinical studies with Alprazolam, in vitro studies with Alprazolam, and clinical studies with drugs metabolised similarly to Alprazolam provide evidence for varying degrees of interaction and possible interaction with Alprazolam for a number of drugs. 

Dosage and Administration

The optimum dose should be individualized based upon the severity of the symptoms and individual patient's response. The usual dose will meet the needs of most patients. In patients who require higher doses, dosage should be increased cautiously to avoid adverse effects. In general, patients who have not previously received psychotropic medications will require somewhat lower doses than those previously treated with minor tranquilizers, antidepressants or hypnotics, or those with a history of chronic alcoholism.

It is recommended that the general principle of using the lowest effective dose be followed, particularly in elderly or debilitated patients, to preclude the development of ataxia or over-sedation. In patients who experience early morning anxiety and emergence of anxiety symptoms, it is recommended that the same total daily dose be given as more frequent administration.

Administration Prazolex tablets immediately after meals do not affect the extent of absorption compared to administration on an empty stomach. Food does, however, delay the onset of absorption and decrease the rate of absorption of Prazolex tablets. As a direct consequence, side effects such as somnolence are less pronounced.

Duration of treatment

Data is available to support a usage of up to 6 months for anxiety and anxious patients with some symptoms of depression.

Discontinuation therapy

The dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of Alprazolam be decreased by no more than 0.5 mg every 3 days in order to minimize any possible withdrawal symptoms. Some patients may require an even slower dosage reduction.

Over Dosage Symptoms Symptoms of overdosage with Alprazolam are extensions of its pharmacological actions including central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, slurred speech and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, coma and, very rarely, death. Serious sequelae occur when Alprazolam is taken with other drugs and/or ethanol is concomitantly ingested.

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