Loading…
Alprazolam XR is a brand name for Alprazolam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )
Verbatim from this product's FDA label. Tap a section to expand.
5 mg to 1 mg once daily (preferably in the morning). Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg daily. 1 ) • Recommended total daily dosage is 3 mg to 6 mg daily.
1 ) • Swallow tablets whole; do not divide, crush, or chew. 5 mg every 3 days. Some patients may require an even slower dosage reduction. 2 ) • See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir.
1 Recommended Dosage Administer alprazolam XR orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or chew. 5 mg to 1 mg once daily. Depending on the response, the dosage may be adjusted at intervals of every 3 to 4 days in increments of no more than 1 mg daily.
The recommended dosage range is 3 mg to 6 mg once daily. Controlled trials of alprazolam XR for the treatment of panic disorder included dosages in the range of 1 mg to 10 mg per day. Most patients showed a response in the dosage range of 3 mg to 6 mg per day.
Occasional patients required as much as 10 mg per day. The longer-term efficacy of alprazolam XR has not been systematically evaluated. If alprazolam XR is used for periods longer than 8 weeks, the healthcare provider should periodically reassess the usefulness of the drug for the individual patient.
2) ] . 2 Discontinuation or Dosage Reduction of Alprazolam XR To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam XR or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.
3) ] . 5 mg every three 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.
5 mg once daily. This may be gradually increased if needed and tolerated. 3) ] . 5 mg once daily. 3) ] . 5 Dosage Modifications for Drug Interactions Alprazolam XR should be reduced to half of the recommended dosage when a patient is started on ritonavir and alprazolam XR together, or when ritonavir is added to a patient treated with alprazolam XR.
9) ] The most common adverse reactions in panic disorder patients treated with alprazolam XR (incidence of ≥ 5% and at least twice that of placebo) include: somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased, constipation, and nausea.
gov/medwatch. 1 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 information included in the section on Adverse Reactions Observed in Short-Term, Placebo-Controlled Trials with Alprazolam XR is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder. Adverse Reactions Observed in Short-Term, Placebo-Controlled Trials of Alprazolam XR Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials Approximately 17% of the 531 patients who received alprazolam XR in placebo-controlled clinical trials for panic disorder had at least 1 adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients.
, leading to discontinuation in at least 1% of the patients treated with alprazolam XR at a rate at least twice that of placebo) are shown in Table 1. 2 Adverse Reactions Occurring at an Incidence of 1% or More Among Patients Treated with Alprazolam XR Table 2 shows the incidence of adverse reactions that occurred during 6- and 8-week placebo-controlled trials in 1% or more of patients treated with alprazolam XR where the incidence in patients treated with alprazolam XR was greater than the incidence in placebo-treated patients.
The most commonly observed adverse reactions in panic disorder patients treated with alprazolam XR (incidence of 5% or greater and at least twice the incidence in placebo patients) were: sedation, somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased.
5 WARNINGS AND PRECAUTIONS • Effects on Driving and Operating Machinery: Patients receiving • alprazolam XR should be cautioned against operating machinery or driving a motor vehicle, as well as avoiding concomitant use of alcohol and other central nervous system (CNS) depressant drugs.
4 ) • Patients with Depression: Exercise caution in patients with signs or symptoms of depression. Prescribe the least number of tablets feasible to avoid intentional overdosage. 6 ) • Neonatal Sedation and Withdrawal Syndrome: Alprazolam XR use during pregnancy can result in neonatal sedation and/or neonatal withdrawal.
1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including alprazolam XR, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs 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 XR 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 XR 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 XR, 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 XR is used with opioids. 1) ] . 2 Abuse, Misuse, and Addiction The use of benzodiazepines, including alprazolam XR, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
4 CONTRAINDICATIONS Alprazolam XR is contraindicated in patients: • with known hypersensitivity to alprazolam or other benzodiazepines. 2) ] . 1) ] . • Known hypersensitivity to alprazolam or other benzodiazepines. ( 4 ) • Concomitant use with strong cytochrome P450 3A (CYP3A) inhibitors, except ritonavir.
1 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alprazolam in United States of America.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Increase alprazolam XR dosage to the target dose after 10 to 14 days of dosing ritonavir and alprazolam XR together. It is not necessary to reduce alprazolam XR dosage in patients who have been taking ritonavir for more than 10 to 14 days.
1) ] . 6 Switching Patients from Alprazolam Tablets to Alprazolam XR Tablets Patients who are currently being treated with divided doses of alprazolam may be switched to alprazolam XR at the same total daily dose taken once daily. If the clinical response after switching is inadequate, titrate the dosage as outlined above.
Table 2:
Adverse Reactions Occurring in ≥ 1% in Alprazolam-Treated Patients and Greater than Placebo-Treated Patients in 6- and 8-Week Placebo-Controlled Trials Panic Disorder Alprazolam XR (n=531) Placebo (n=349) Nervous system disorders Sedation 45% 23% Somnolence 23% 6% Memory impairment 15% 7% Dysarthria 11% 3% Coordination abnormal 9% 1% Mental impairment 7% 6% Ataxia 7% 3% Disturbance in attention 3% 1% Balance impaired 3% 1% Dyskinesia 2% 1% Hypoesthesia 1% <1% Hypersomnia 1% 0% General disorders/administration site conditions Fatigue 14% 9% Lethargy 2% 1% Psychiatric disorders Depression 12% 9% Libido decreased 6% 2% Disorientation 2% 0% Confusion 2% 1% Depressed mood 1% <1% Metabolism and nutrition disorders Appetite increased 7% 6% Anorexia 2% 0% Gastrointestinal disorders Constipation 8% 4% Nausea 6% 3% Investigations Weight increased 5 4 Injury, poisoning, and procedural complications Road traffic accident 2% 0% Reproductive system and breast disorders Dysmenorrhea 4% 3% Sexual dysfunction 2% 1% Musculoskeletal and connective tissue disorder Arthralgia Myalgia Pain in limb 2% 2% 1% 1% 1% 0% Respiratory, thoracic, and mediastinal disorders Dyspnea 2% 0% Other Adverse Reactions Observed During the Premarketing Evaluation of Alprazolam XR Following is a list of other adverse reaction reported by 531 patients with panic disorder treated with alprazolam XR.
Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent); those occurring in less than 1/100 patients but at least 1/1000 patients (infrequent); those occurring in fewer than 1/1000 patients (rare).
Cardiac disorders:
Frequent: palpitation; Infrequent: sinus tachycardia Ear and labyrinth disorders: Frequent: vertigo; Infrequent : tinnitus, ear pain Eye disorders: Frequent: blurred vision; Infrequent: mydriasis, photophobia Gastrointestinal disorders: Frequent: diarrhea, vomiting, dyspepsia, abdominal pain; Infrequent: dysphagia, salivary hypersecretion General disorders and administration site conditions: Frequent: malaise, weakness, chest pains; Infrequent: fall, pyrexia, thirst, feeling hot and cold, edema, feeling jittery, sluggishness, asthenia, feeling drunk, chest tightness, increased energy, feeling of relaxation, hangover, loss of control of legs, rigors Musculoskeletal and connective tissue disorders: Frequent: back pain, muscle cramps, muscle twitching Nervous system disorders: Frequent: headache, dizziness, tremor; Infrequent: amnesia, clumsiness, syncope, hypotonia, seizures, depressed level of consciousness, sleep apnea syndrome, sleep talking, stupor Psychiatric system disorders: Frequent: irritability, insomnia, nervousness, derealization, libido increased, restlessness, agitation, depersonalization, nightmare; Infrequent: abnormal dreams, apathy, aggression, anger, bradyphrenia, euphoric mood, logorrhea, mood swings, dysphonia, hallucination, homicidal ideation, mania, hypomania, impulse control, psychomotor retardation, suicidal ideation Renal and urinary disorders: Frequent: difficulty in micturition; Infrequent: urinary frequency, urinary incontinence Respiratory, thoracic, and mediastinal disorders: Frequent: nasal congestion, hyperventilation; Infrequent: choking sensation, epistaxis, rhinorrhea Skin and subcutaneous tissue disorders: Frequent: sweating increased; Infrequent: clamminess, rash, urticaria Vascular disorders: Infrequent: hypotension Discontinuation-Emergent Adverse Reactions Occurring at an Incidence of 5% or More Among Patients Treated with Alprazolam XR Table 3 shows the incidence of discontinuation-emergent adverse reactions that occurred during short-term, placebo-controlled trials in 5% or more of patients treated with alprazolam XR where the incidence in patients treated with alprazolam XR was 2 times greater than the incidence in placebo-treated patients.
3)] . 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. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of alprazolam and/or alprazolam XR.
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, jaundice Investigations: Liver enzyme elevations Psychiatric disorders: Hypomania, mania Reproductive system and breast disorders: Gynecomastia, galactorrhea, menstruation irregular Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome
2) ] . , using a standardized screening tool). Use of alprazolam XR, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of alprazolam XR along with monitoring for signs and symptoms of abuse, misuse, and addiction.
, opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 3) ] . Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.
Acute Withdrawal Reactions The continued use of benzodiazepines, including alprazolam XR, may lead to clinically significant physical dependence. 3) ] . 3) ] . Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam XR.
3) ] . Even after relatively short-term use at doses of ≤ 4 mg/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 postmarketing discontinuation study of panic disorder patients who received alprazolam, 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. 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. 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.
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.
4 Effects on Driving and Operating Machinery Because of its CNS depressant effects, patients receiving alprazolam XR should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle.
1) ] . 5 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.
Strong CYP3A Inhibitors Alprazolam XR is contraindicated in patients receiving strong inhibitors of CYP3A such as azole antifungal agents [see Contraindications (4) ] . 70 fold, respectively. 1) ]. 3) ] . Use caution and consider dose reduction of alprazolam XR, as appropriate, during co-administration with these drugs.
6 Patients with Depression Benzodiazepines may worsen depression. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. , limiting the total prescription size and increased monitoring for suicidal ideation) should be considered in patients with depression.
1) ] . 1) ] . Monitor neonates exposed to alprazolam XR during pregnancy or labor for signs of sedation and monitor neonates exposed to alprazolam XR during pregnancy for signs of withdrawal; manage these neonates accordingly. 9 Risks in Patients with Impaired Respiratory Function There have been reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with alprazolam.
Closely monitor patients with impaired respiratory function. If signs and symptoms of respiratory depression, hypoventilation, or apnea occur, discontinue alprazolam XR.