Xanax (Aprazolam) | 1mg
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Xanax (Aprazolam) | 1mg

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Xanax (Aprazolam) | 1mg

Xanax (Aprazolam) | 1mg:

Uses

Alprazolam is used to treat anxiety and panic disorders. It belongs to a class of medications called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).

How to use Xanax

Read the Medication Guide provided by your pharmacist before you start taking alprazolam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. Dosage is based on your medical condition, age, and response to treatment. Your dose may be gradually increased until the drug starts working well. Follow your doctor’s instructions closely to reduce the risk of side effects.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

What is Xanax and how is it used?

Xanax is a prescription medicine used to treat the symptoms of anxiety, panic disorder, and anxiety associated with depression. Xanax may be used alone or with other medications.

Xanax belongs to a class of drugs called Antiaxiety Agents, Anxiolytics, Benzodiazepines.

It is not known if Xanax is safe and effective in children younger than 18 years of age.

What are the possible side effects of Xanax?

Xanax may cause serious side effects including:

  • depressed mood
  • thoughts of suicide or hurting yourself
  • racing thoughts
  • increased energy
  • unusual risk-taking behavior
  • confusion
  • agitation
  • hostility
  • hallucinations
  • uncontrolled muscle movements
  • tremor
  • convulsions (seizure), and
  • pounding heartbeats or fluttering in your chest

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Xanax include:

  • drowsiness,
  • feeling tired,
  • slurred speech,
  • lack of balance or coordination,
  • memory problems, and
  • feeling anxious early in the morning

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Xanax. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

DESCRIPTION

XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.

The structural formula is represented to the right:

XANAX® (alprazolam) - Structural Formula Illustration

 

Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.

Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.

XANAX Tablets, 2 mg, are multi-scored and may be divided as shown below:

Inactive Ingredients

Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow and the 1 mg tablet contains FD&C Blue

INDICATIONS

XANAX is indicated for the:

  • acute treatment of generalized anxiety disorder (GAD) in adults.
  • treatment of panic disorder (PD), with or without agoraphobia in adults.

DOSAGE AND ADMINISTRATION

Dosage In Generalized Anxiety Disorder

The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses).

Use the lowest possible effective dose and frequently assess the need for continued treatment

Dosage In Panic Disorder

The recommended starting oral dosage of XANAX for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day. Controlled trials of XANAX in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day.

For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.

The necessary duration of treatment for PD in patients responding to XANAX is unknown. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see DOSAGE AND ADMINISTRATION].

Discontinuation Or Dosage Reduction Of XANAX

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see WARNINGS AND PRECAUTIONSDrug Abuse And Dependence].

Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled postmarketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

Dosage Recommendations In Geriatric Patients

In geriatric patients, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced

Dosage Recommendations In Patients With Hepatic Impairment

In patients with hepatic impairment, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced.

XANAX should be reduced to half of the recommended dosage when a patient is started on ritonavir and XANAX together, or when ritonavir administered to a patient treated with XANAX. Increase the XANAX dosage to the target dose after 10 to 14 days of dosing ritonavir and XANAX together. It is not necessary to reduce XANAX dose in patients who have been taking ritonavir for more than 10 to 14 days.

XANAX is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see CONTRAINDICATIONSWARNINGS AND PRECAUTIONS].

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
  • Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS]
  • Dependence and Withdrawal Reactions [see WARNINGS AND PRECAUTIONS]
  • Effects on Driving and Operating Machinery [see WARNINGS AND PRECAUTIONS]
  • Neonatal Sedation and Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Patients with Depression [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Impaired Respiratory Function [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in:

  • 4-week placebo-controlled clinical studies with XANAX dosages up to 4 mg per day for the acute treatment of generalized anxiety disorder (Table 1)
  • Short-term (up to 10 weeks) placebo-controlled clinical studies with XANAX dosages up to 10 mg per day for panic disorder, with or without agoraphobia (Table 2).

Table 1: Adverse Reactions Occurring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials for Generalized Anxiety

In addition to the adverse reactions (i.e., greater than 1%) enumerated in the table above for patients with generalized anxiety disorder, the following adverse reactions have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

Table 2: Adverse Reactions Occuring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials (Up to 10 Weeks) for Panic Disorder

In addition to the reactions (i.e., greater than 1%) enumerated in the table above for patients with panic disorder, the following adverse reactions have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Adverse Reactions Reported As Reasons For Discontinuation In Treatment Of Panic Disorder In Placebo-Controlled Trials

In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo-treated group are shown in Table 3.

Table 3: Discontinuation-Emergent Symptom Incidence Reported in ≥5% of XANAX-treated Patients and > Placebo-treated Patients

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence].

Paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations, and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of XANAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine disorders: Hyperprolactinemia

General disorders and administration site conditions: Edema peripheral

Hepatobiliary disorders: Hepatitis, hepatic failure

Investigations: Liver enzyme elevations

Psychiatric disorders: Hypomania, mania

Reproductive system and breast disorders: Gynecomastia, galactorrhea

Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome

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