Friday, October 9, 2009

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Alzocum ® Tablets (Alprazolam)



Composition
Alzocum-0.25 Tablets
Each tablet contains Alprazolam 0.25 mg
Alzocum-1 Tablets
Each tablet contains Alprazolam 1 mg

Indications
Alzocum are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual 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.

Dosage and Administration

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.

Panic Disorder
In controlled trials conducted to establish the efficacy of Alzocum in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily.
ALZOCUM TABLETS

Contraindications
Alzocum Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alzocum may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.

Alzocum is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see WARNINGS and PRECAUTIONS-DRUG INTERACTIONS).

Presentation
Alzocum-0.25 Blister pack of 10 tablets
Alzocum-1 Blister pack of 10 tablets


Alprazolam, also known under the trade names Xanax (not to be confused with Zantac), Xanor, and Niravam, is a short-acting drug of the benzodiazepine class used to treat moderate to severe anxiety disorders and panic attacks, and is used as an adjunctive treatment for anxiety associated with moderate depression. It is also available in an extended-release form, Xanax XR, both of which are now available in generic form. Alprazolam possesses anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant properties,


Alprazolam is FDA-approved for the short-term treatment (up to 8 weeks) of panic disorder, with or without agoraphobia. Alprazolam is very effective in treating moderate to severe anxiety, essential tremor, and panic attacks. Physicians that elect to prescribe alprazolam for longer than 8 weeks should be aware that continued efficacy has not been systematically demonstrated beyond 8 weeks' use, as tolerance to alprazolam's effects may occur after 8 weeks and necessitate discontinuation or physician-directed dose escalation. 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.

Alprazolam is 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. Alprazolam is recommended for the short-term treatment (2–4 weeks) of severe acute anxiety. Alprazolam should only very rarely be used for longer periods of time – the body becomes rapidly tolerant to the drug's effects, which may translate to decreased efficacy.


Alprazolam is sometimes prescribed for anxiety with associated depression. There is some evidence for antidepressant treatment of clinical depression in outpatient settings; evidence for inpatients is lacking. The antidepressant effects of alprazolam may be due to its effects on beta-adrenergic receptors.Other benzodiazepines are not known to have antidepressant activity. Studies show that any antidepressant action of alprazolam is questionable and generally weak in comparison to those of antidepressant medications. In contrast, while alprazolam in acute or short-term treatment may have some antidepressant properties, there is evidence that up to a third of long-term users of alprazolam may develop depression.


Alprazolam, like other benzodiazepines, binds to specific sites on the GABAA gamma-amino-butyric acid receptor. When bound to these sites, which are referred to as benzodiazepine receptors, it modulates the effect of GABA A receptors and, thus, GABAnergic neurons. Long-term use causes adaptive changes in the benzodiazepine receptors, making them less sensitive to stimulation and less powerful in their effects.


Not all withdrawal effects are evidence of true dependence or withdrawal. Recurrence of symptoms such as anxiety may simply indicate that the drug was having its expected anti-anxiety effect and that, in the absence of the drug, the symptom has returned to pretreatment levels. If the symptoms are more severe or frequent, the patient may be experiencing a rebound effect due to the removal of the drug. Either of these can occur without the patient's actually being drug-dependent.

Alprazolam and other benzodiazepines may also cause the development of physical dependence, tolerance, and benzodiazepine withdrawal symptoms during rapid dose reduction or cessation of therapy after long-term treatment. There is a higher chance of withdrawal reactions if the drug is administered in a higher dosage than recommended, or if a patient stops taking the medication altogether without slowly allowing the body to adjust to a lower-dosage regimen.


In 1992, Romach and colleagues reported that dose escalation is not a characteristic of long-term alprazolam users, and the majority of patients indicated that alprazolam continued to be effective, suggesting that tolerance to the anti-anxiety effect is limited.


If a patient feels the need to end treatment with alprazolam, he/she should consult his/her physician before discontinuing the medication. Some common symptoms of alprazolam discontinuation include tachycardia, dysphoria, dry mouth, loss of appetite, insomnia, anxiety, dizziness, tremors, nausea, cramps, vomiting, diarrhea, panic attacks, mood swings, heart palpitations, memory loss. Less common and more severe reactions can occur, including hallucinations, seizures or fever.


Patients taking a dosing regimen larger than 4 mg per day have an increased potential for dependence. This medication may cause withdrawal symptoms upon abrupt withdrawal or rapid tapering, which in some cases have been known to cause seizures. The discontinuation of this medication may also cause a reaction called rebound anxiety. Other withdrawal effects reported from discontinuing alprazolam therapy include homicidal ideation (very rare), rage reactions, hyperalertness, vivid dreams, and intrusive thoughts. Grand mal seizures have occurred after abrupt withdrawal after only short-term use. Therefore, even short-term users of alprazolam should taper off of their medication slowly to avoid serious withdrawal reactions including seizures.


Alprazolam should never be abruptly stopped if taken regularly for any length of time because severe withdrawal symptoms may occur. Severe psychosis and seizures have been reported in the medical literature from abrupt alprazolam discontinuation, and one death occurred from withdrawal-related seizures after gradual dose reduction.


In a 1983 study of patients that had taken long-acting benzodiazepines, e.g., clorazepate, for extended periods, the medications were stopped abruptly under double-blind conditions (that is, patients were receiving either placebo or the same drug they had been taking). Only 5% of patients that had been taking the drug for less than 8 months demonstrated withdrawal symptoms, but 43% of those that had been taking them for more than 8 months did, whereas, with alprazolam - a short-acting benzodiazepine - taken for 8 weeks, 35% of patients experienced significant rebound anxiety. To some degree, these older benzodiazepines are self-tapering.


The benzodiazepines diazepam (Valium) and oxazepam (Serepax) have been found to produce fewer withdrawal reactions than alprazolam (Xanax) or lorazepam (Temesta/Ativan). Factors that determine the risk of psychological dependence or physical dependence and the severity of the benzodiazepine withdrawal symptoms experienced during dose reduction of alprazolam include: dosage used, length of use, frequency of dosing, personality characteristics of the individual, previous use of cross-dependent/cross-tolerant drugs (alcohol or other sedative-hypnotic drugs), current use of cross-dependent/cross-tolerant drugs (alcohol or other sedative-hypnotic drugs), use of other short-acting, high-potency benzodiazepines and method of discontinuation.

Availability


Alprazolam IR is available in 0.25 mg, 0.5 mg, 1 mg and 2 mg strength oral, orally disintegrating tablets. Alprazolam Extended Release is available in 0.5 mg, 1 mg and 2 mg 3 mg strength oral

Alprazolam is available in English-speaking countries under the following brand names

* Alganax

* Alzolam

* Alprax

* Alprox

* Alzam

* Anxirid

* Apo-Alpraz

* Alzolam

* Azor

* Calmax

* Gerax

* Helex

* Kalma

* Nervin

* Niravam

* Novo-Alprazol

* Nu-Alpraz

* Tafil

* Texidep

* Xanax

* Xanor

* Zopax


Important information about alprazolam

Do not use this medication if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax). This medication can cause birth defects in an unborn baby. Do not use alprazolam if you are pregnant.


Before taking alprazolam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking alprazolam. This medication can increase the effects of alcohol.

This medication may be habit-forming and should be used only by the person it was prescribed for. Alprazolam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.


It is dangerous to try and purchase alprazolam on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy.


How should I take alprazolam?

Take alprazolam exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Alprazolam may be habit-forming and should be used only by the person it was prescribed for. Alprazolam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.


Measure the liquid form of alprazolam with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take alprazolam orally disintegrating tablets (Niravam)

Using dry hands, remove a tablet from the bottle and place the tablet on your tongue. It will begin to dissolve right away.


Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Swallow several times as the tablet dissolves. If desired, you may drink liquid after the tablet has completely dissolved.


Contact your doctor if this medicine seems to stop working as well in treating your panic or anxiety symptoms.


Your symptoms may return when you stop using alprazolam after using it over a long period of time. You may also have seizures or withdrawal symptoms when you stop using alprazolam. Withdrawal symptoms may include blurred vision, trouble concentrating, loss of appetite, diarrhea, muscle twitching, numbness or tingling, or increased sensations.


Do not stop using alprazolam suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.


To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.


Store alprazolam at room temperature away from moisture, heat, and light. Remove any cotton from the bottle of disintegrating tablets, and keep the bottle tightly closed.


Keep track of how many pills have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What should I avoid while taking alprazolam?

Do not drink alcohol while taking alprazolam. This medication can increase the effects of alcohol. Alprazolam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can increase some of the side effects of alprazolam.

Grapefruit and grapefruit juice may interact with alprazolam and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Prescribing Information

To view the alprazolam (Xanax) prescribing information as an Adobe Portable Document Format , you will need Adobe Acrobat Reader 2.1 or higher.

Internet Mental Health :

* If you do not have Adobe Acrobat Reader installed on your system, click here.

* Physician prescribing information - manufacturer.

* Patient information - American Society of Health-System Pharmacists.


XANAX
(CIV alprazolam) Tablets

Side Effects :

Side effects to XANAX 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, 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 XANAX (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 XANAX 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.

  • drowsiness
  • light-headedness
  • tiredness
  • dizziness
  • irritability
  • talkativeness
  • dry mouth
  • increased salivation
  • changes in sex drive or ability
  • changes in appetite
  • weight changes
  • difficulty urinating

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

  • seizures
  • seeing things or hearing voices that do not exist (hallucinating)
  • severe skin rash
  • yellowing of the skin or eyes
  • memory problems
  • confusion
  • problems with coordination

Alprazolam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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Alprazolam is used to treat anxiety disorders and panic attacks. Alprazolam is in a class of medications called benzodiazepines. It works by decreasing abnormal excitement in the brain.

What special precautions should I follow?

Before taking alprazolam,

  • tell your doctor and pharmacist if you are allergic to alprazolam, chlordiazepoxide (Librium, Librax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), estazolam (ProSom), flurazepam (Dalmane), halazepam (Paxipam), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), quazepam (Doral), temazepam (Restoril), triazolam (Halcion), or any other medications.
  • do not take alprazolam if you are taking itraconazole (Sporanox) or ketoconazole (Nizoral).
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antidepressants ('mood elevators') such as desipramine (Norpramin), imipramine (Tofranil), and nefazodone (Serzone); antifungals such as fluconazole (Diflucan); antihistamines; cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diltiazem (Cardizem, Dilacor, Tiazac); ergotamine (Cafatine, Cafergot, Wigraine, others); erythromycin (E.E.S., E-Mycin, Erythrocin); isoniazid (INH, Nydrazid); medications for mental illness and seizures; nicardipine (Cardene); nifedipine (Adalat, Procardia); oral contraceptives (birth control pills); propoxyphene (Darvon); selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had glaucoma; depression; or lung, kidney, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking alprazolam, call your doctor immediately.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking alprazolam.
  • you should know that alprazolam may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.




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