Alprazolam Sandoz

What is alprazolam Sandoz used for?

Alprazolam Sandoz is used:  to treat severe anxiety symptoms which cause distress or disturb normal functioning. It belongs to a group of medicines called benzodiazepines. These agents have an anxiety reducing, sedative and muscle-relaxant effect.

Is alprazolam the same as Xanax?

Alprazolam Sandoz(Xanax) belongs to a group of drugs called benzodiazepines. People use Xanax to treat anxiety and panic disorders. It is the single most prescribed psychiatric medication in the United States.

What is alprazolam used to treat?

Alprazolam Sandoz is used to treat anxiety disorders and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Alprazolam is in a class of medications called benzodiazepines. It works by decreasing abnormal excitement in the brain.

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Anxiety Disorders

Alprazolam  Sandoz tablets were compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. Alprazolam Sandoz was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s Global Impressions and Self-Rating Symptom Scale.
Panic Disorder
Support for the effectiveness of alprazolam sandoz in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.
The average dose of alprazolam sandoz was 5 to 6 mg/day in two of the studies, and the doses of alprazolam sandoz were fixed at 2 and 6 mg/day in the third study. In all three studies, alprazolam sandoz was superior to placebo on a variable defined as “the number of patients with zero panic attacks” (range, 37 to 83% met this criterion), as well as on a global improvement score. In two of the three studies, alprazolam sandoz was superior to placebo on a variable defined as “change from baseline on the number of panic attacks per week” (range, 3.3 to 5.2), and also on a phobia rating scale. A subgroup of patients who were improved on alprazolam sandoz during short-term treatment in one of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.

INDICATIONS AND USAGE
Anxiety Disorders
Alprazolam Sandoz tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to alprazolam sandoz.

Panic Disorder
Alprazolam Sandoz is also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder .
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam sandoz by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.

CONTRAINDICATIONS
Alprazolam Sandoz tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.
Alprazolam Sandoz is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A).

WARNINGS:
Risks From Concomitant Use With Opioids
Concomitant use of benzodiazepines, including alprazolam sandoz, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of alprazolam sandoz than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking alprazolam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.
Dependence and Withdrawal Reactions, Including Seizures
Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam. These include a spectrum of withdrawal symptoms; the most important is seizure. Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4.0 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled post marketing discontinuation study of panic disorder patients, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of alprazolam greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.
The Importance of Dose and the Risks of Alprazolam Sandoz as a Treatment for Panic Disorder
Because the management of panic disorder often requires the use of average daily doses of alprazolam sandoz above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with alprazolam sandoz compared to placebo-treated patients.
Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.
In a controlled clinical trial in which 63 patients were randomized to alprazolam and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal.
In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue medication was measured, 71% to 93% of patients treated with alprazolam tapered completely off therapy compared to 89% to 96% of placebo-treated patients. In a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose.
Seizures attributable to alprazolam were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of alprazolam greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every 3 days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from alprazolam. The risk of seizure seems to be greatest 24 to 72 hours after discontinuation for recommended tapering and discontinuation schedule).

Status Epilepticus and its Treatment
The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of alprazolam. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well.
Interdose Symptoms
Early morning anxiety and emergence of anxiety symptoms between doses of alprazolam have been reported in patients with panic disorder taking prescribed maintenance doses of alprazolam. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval. In these situations, it is recommended that the same total daily dose be given divided as more frequent administrations .

Risk of Dose Reduction
Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital). Therefore, the dosage of alprazolam should be reduced or discontinued gradually .
CNS Depression and Impaired Performance
Because of its CNS depressant effects, patients receiving alprazolam should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with alprazolam.
Risk of Fetal Harm
Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If alprazolam is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, alprazolam is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Alprazolam Interaction With Drugs That Inhibit Metabolism via Cytochrome P450 3A
The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients receiving very potent inhibitors of CYP3A. With drugs inhibiting CYP3A to a lesser but still significant degree, alprazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with alprazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class.

The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP3A.
Potent CYP3A Inhibitors
Azole Antifungal Agents
Ketoconazole and itraconazole are potent CYP3A inhibitors and have been shown in vivo to increase plasma alprazolam concentrations 3.98 fold and 2.70 fold, respectively. The coadministration of alprazolam with these agents is not recommended. Other azole-type antifungal agents should also be considered potent CYP3A inhibitors and the coadministration of alprazolam with them is not recommended .
Drugs demonstrated to be CYP3A inhibitors on the basis of clinical studies involving alprazolam (caution and consideration of appropriate alprazolam dose reduction are recommended during coadministration with the following drugs)
Nefazodone
Coadministration of nefazodone increased alprazolam concentration two-fold.
Fluvoxamine
Coadministration of fluvoxamine approximately doubled the maximum plasma concentration of alprazolam, decreased clearance by 49%, increased half-life by 71%, and decreased measured psychomotor performance.
Cimetidine
Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 86%, decreased clearance by 42%, and increased half-life by 16%.
Other Drugs Possibly Affecting Alprazolam Metabolism
Other drugs possibly affecting alprazolam metabolism by inhibition of CYP3A are discussed in the Precautions section.

PRECAUTIONS
General
Suicide
As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients.
Mania
Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression.
Uricosuric Effect
Alprazolam has a weak uricosuric effect. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with alprazolam.

Use in Patients With Concomitant Illness
It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients . The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed. There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with alprazolam. A decreased systemic alprazolam elimination rate (eg, increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving alprazolam.
Information for Patients

For all Users of Alprazolam Sandoz:
To assure safe and effective use of benzodiazepines, all patients prescribed alprazolam should be provided with the following guidance.

• 1. Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when alprazolam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider.
• 2. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.
• 3. Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines.
• 4. Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication.
• 5. Inform your physician if you are nursing.
• 6. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
• 7. Do not increase the dose even if you think the medication “does not work anymore” without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence.
• 8. Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur.

Additional Advice for Panic Disorder Patients:
The use of alprazolam at doses greater than 4 mg/day, often necessary to treat panic disorder, is accompanied by risks that you need to carefully consider. When used at doses greater than 4 mg/day, which may or may not be required for your treatment, alprazolam sandoz has the potential to cause severe emotional and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment. In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue medication was measured, 7 to 29% of patients treated with alprazolam sandoz did not completely taper off therapy. In a controlled post marketing discontinuation study of panic disorder patients, the patients treated with doses of alprazolam sandoz greater than 4 mg/day had more difficulty tapering to zero dose than patients treated with less than 4 mg/day. In all cases, it is important that your physician help you discontinue this medication in a careful and safe manner to avoid overly extended use of alprazolam.
In addition, the extended use at doses greater than 4 mg/day appears to increase the incidence and severity of withdrawal reactions when alprazolam is discontinued. These are generally minor but seizure can occur, especially if you reduce the dose too rapidly or discontinue the medication abruptly. Seizure can be life-threatening.

Laboratory Tests
Laboratory tests are not ordinarily required in otherwise healthy patients. However, when treatment is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable in keeping with good medical practice.

Drug Interactions
Use With Opioids
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

Use With Other CNS Depressants
If alprazolam sandoz tablets are to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines. The benzodiazepines, including alprazolam, produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression.

Use With Imipramine and Desipramine
The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of alprazolam sandoz tablets in doses up to 4 mg/day. The clinical significance of these changes is unknown.

Drugs That Inhibit Alprazolam Metabolism via Cytochrome P450 3A
The initial step in alprazolam sandoz metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam sandoz.
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)
Fluoxetine
Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance.
Propoxyphene
Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%.
Oral Contraceptives
Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.
Drugs and other substances demonstrated to be CYP3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam)
Available data from clinical studies of benzodiazepines other than alprazolam sandoz suggest a possible drug interaction with alprazolam sandoz for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from in vitro studies of alprazolam sandoz suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an in vivo drug interaction study involving a single dose of alprazolam sandoz 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam sandoz. Data from in vitro studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam sandoz.

Drugs Demonstrated to be Inducers of CYP3A
Carbamazepine can increase alprazolam metabolism and therefore can decrease plasma levels of alprazolam.

Drug/Laboratory Test Interactions
Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.

Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenic potential was observed during 2-year bioassay studies of alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose).
Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay.
Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day.

Pregnancy

Teratogenic Effects
Pregnancy Category D.
Nonteratogenic Effects
It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines.

Labor and Delivery
Alprazolam has no established use in labor or delivery.

Nursing Mothers
Benzodiazepines are known to be excreted in human milk. It should be assumed that alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use alprazolam.

Pediatric Use
Safety and effectiveness of alprazolam in individuals below 18 years of age have not been established.

Geriatric Use
The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of alprazolam Sandoz should be used in the elderly to preclude the development of ataxia and over sedation.

ADVERSE REACTIONS
Side effects to alprazolam Sandoz tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam Sandoz, eg, drowsiness or light-headedness.
The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of alprazolam (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of alprazolam Sandoz in patients with panic disorder, with or without agoraphobia.
These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions.
Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.)
Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event.

Is Alprazolam an antidepressant?

Alprazolam appears to be an effective antidepressant in the treatment of outpatients who have a diagnosis of major depressive disorder.

Talk to your doctor or pharmacist before taking Alprazolam Sandoz: 

 if you notice that the effect of the tablets becomes less after a few weeks of use.

  if you are troubled by symptoms that indicate physical and psychological dependence on alprazolam.

 You notice psychological dependence by not wanting to stop taking the medicine. Physical dependence means that withdrawal symptoms occur when the treatment with this medicine is stopped suddenly (see the section “If you stop taking Alprazolam Sandoz”). The risk of dependence increases with higher dosages and a longer period of treatment. Therefore, the duration of treatment must be as short as possible.  if you have been addicted to alcohol and/or drugs in the past; the danger of dependence on alprazolam is greater.  when you stop the treatment. Disorders which existed before treatment began may temporarily return more intensively. You may experience mood changes, insomnia and restlessness, amongst other things. This risk will increase if your dose is reduced too quickly or, if you suddenly stop the treatment. In this case it does not mean alprazolam treatment should be restarted. Instead, your doctor should reduce your dose over a period of several weeks. See section “How to take Alprazolam Sandoz”.  if you experience memory loss. This mostly occurs a few hours after taking the tablet.  “Possible side effects”.  if you experience conflicting reactions such as – anxiety – irritability – attacks of rage – nightmares – increased insomnia – perceptions of things that do not exist (hallucinations) – severe mental disorders in which control over one’s own behavior and actions is disturbed (psychosis) – inappropriate behavior and other behavioral disturbances These conflicting reactions occur more frequently in children and elderly patients. Tell your doctor if such symptoms occur as the treatment may possibly need to be stopped.  If you suffer from chronic tightness of the chest you should be aware that Alprazolam Sandoz can aggravate this.  if you concomitantly drink alcohol or take tranquilizers, as Alprazolam Sandoz´s sedative effect can be increased.  if you suffer from severe depression. Alprazolam Sandoz can sometimes cause an excessively lively mood (mania) or an increase in suicidal tendencies.  If you have a severe mental disorder which disturbs your behavior, actions and self control (psychosis), then Alprazolam Sandoz is not appropriate.  if you have a certain form of suddenly raised eyeball pressure (narrow-angle glaucoma

ALPRAZOLAM SANDOZ SIDE EFFECTS

They are related to the dose ingested and the individual sensitivity of the patient.

Very common (may affect more than 1 in 10 people)

• depression,
• sedation,
• drowsiness,
• difficulty coordinating certain movements,
• memory problems,
• difficulty speaking,
• dizziness,
• headache,
• constipation,
• tired,
• irritability

Common (may affect 1 to 10 in 100 people)

• decreased appetite,
• confusion,
• decreased or increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• difficulty coordinating certain movements,
• attention disorders,
• excessive sleep,
• tremors,
• blurry vision,
• nausea,
• inflammation of the skin (dermatitis),
• sexual dysfunction,
• weight gain or loss

Uncommon (may affect 1 to 10 in 1000 people)

• hallucinations,
• anger,
• restlessness,
• memory loss,
• muscular weakness,
• urinary incontinence,
• irregular menstrual cycles (periods),
• vomiting,
• excitation

Frequency not known (cannot be estimated from the available data)

• excess prolactin (hormone causing lactation),
• aggressiveness,
• hostile behavior,
• abnormal thinking,
• involuntary muscle contractions (dystonia),
• gastrointestinal disorder,
• hepatitis,
• abnormal liver parameters (changes in certain biological tests related to liver damage),
• jaundice (jaundice),
• severe allergic reactions (angioedema),
• photosensitization (skin reaction during exposure to the sun or UV rays),
• urinary retention,
• peripheral edema,
• increased pressure in the eye

CONTRAINDICATIONS

Do not take ALPRAZOLAM SANDOZ 0.25 mg, scored tablet:

• if you are allergic to alprazolam or any of the other ingredients of this medication mentioned in section 6,
• if you have severe respiratory failure,
• if you have sleep apnea syndrome (pauses in breathing during sleep),
• if you have severe liver failure,
• if you have myasthenia (a disease characterized by an excessive tendency to muscle fatigue)

Medicines that increase Alprazolam Sandoz´s sedative effect: 

• Sleep-inducing and tranquilizing medicines 

• Medicines used to treat severe mental disorder (antipsychotics)  medicines used to treat severe depression and certain strong painkillers such as the opioid morphine. These painkillers can also increase the euphoria and dependence risk.

•  Medicines used to treat epilepsy  medicines that are used for anesthesia  certain medicines used to treat allergies, so called sedative antihistamines

•  Medicines that increase Alprazolam Sandoz´s effect as a result of suppression of the breakdown of alprazolam in the liver:  nefazodone, fluvoxamine, fluoxetine, sertraline, medicines used to treat severe depression  cimetidine, 

• Medicine used to treat gastric disorders  certain medicines used to treat AIDS (known as HIV protease inhibitors, e.g. ritonavir, saquinavir, indinavir)  dextropropoxyphene, a Medicine used to treat pain  the oral contraceptive pill  diltiazem, 
• Medicine used to treat high blood pressure and heart disorders  macrolide antibiotics such as erythromycin, 
• Medicines used to treat infections 

• Medicines used to treat fungal infections, such as ketoconazole and itraconazole

• Medicines that decrease Alprazolam Sandoz´s effect due to the increased alprazolam breakdown in the liver:  carbamazepine or phenytoin, medicines used to treat epilepsy and other conditions.  St John’s wort, a herbal medicine used to treat depression.  Rifampicin,

• Medicine to treat tuberculosis.

• Medicines whose effects may be increased by Alprazolam Sandoz:  digoxin, a medicine used to treat heart failure and heart rhythm disturbances; The risk of digoxin poisoning is particularly increased in elderly patients and, where doses exceeding 4 tablets (1 mg) Alprazolam Sandoz are taken daily.  muscle relaxants, such as pancuronium, atracurium The muscle-relaxant effect may be greater, especially on beginning Alprazolam Sandoz treatment.  Imipramine and desipramine, certain medicines used to treat severe depression

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