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APO-ALPRAZ TS is a brand name for Alprazolam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...................................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................................... 5 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations APO-ALPRAZ and APO-ALPRAZ TS should always be prescribed at the lowest effective dose for the shortest duration possible. APO-ALPRAZ and APO-ALPRAZ TS can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.
(see DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Discontinuation) If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.
Geriatric patients in particular may be more sensitive to benzodiazepines (see WARNINGS AND PRECAUTIONS, Falls and Fractures). Long-term use of APO-ALPRAZ and APO-ALPRAZ TS should be avoided in elderly patients. Enhanced monitoring is recommended, recommended.
Dosage should be individualized for maximal benefit. The risk of dependence may increase with dose and duration of treatment, therefore, the lowest possible effective dose and duration should be used and the need for continued treatment reassessed frequently.
In general, patients who have not previously received psychotropic medication will require somewhat lower doses than those previously treated with minor tranquilizers, antidepressants, or hypnotics. Both APO-ALPRAZ and APO-ALPRAZ TS are immediate-release formulations.
5 mg each. 25 mg given 2 or 3 times daily. 25 mg increments according to the severity of symptoms and patient response. It is recommended that the evening dose be increased before the daytime doses. Very severe manifestations of anxiety may require larger initial daily doses.
The optimal dosage is one that permits symptomatic control of excessive anxiety without impairment of mental and motor function. 0 mg daily, given in divided doses.
Page 21 of 41 Elderly or Debilitated Patients:
APO-ALPRAZ and APO-ALPRAZ TS (alprazolam) are contraindicated in patients with known hypersensitivity to alprazolam or to any component of the product’s formulation, or other benzodiazepines. APO-ALPRAZ and APO-ALPRAZ TS are also contraindicated in patients with myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.
However, APO-ALPRAZ and APO-ALPRAZ TS may be used in patients with open angle glaucoma who are receiving appropriate treatment. Co-administration of APO-ALPRAZ and APO-ALPRAZ TS with ketoconazole and itraconazole are contraindicated because these medications significantly impair the metabolism of alprazolam by CYP3A4 (see DRUG INTERACTIONS, Drug-Drug Interactions).
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including APO-ALPRAZ and APO-ALPRAZ TS, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs. Assess each patient’s risk prior to prescribing APO-ALPRAZ and APO-ALPRAZ TS Monitor all patients regularly for the development of these behaviours or conditions.
APO-ALPRAZ and APO-ALPRAZ TS should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, like APO-ALPRAZ and APO-ALPRAZ TS, can produce severe or life-threatening withdrawal symptoms. Avoid abrupt discontinuation or rapid dose reduction of APO-ALPRAZ and APO-ALPRAZ TS.
Terminate treatment with APO-ALPRAZ and APO-ALPRAZ TS by gradually tapering the dosage schedule under close monitoring. (see WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of APO-ALPRAZ and APO-ALPRAZ TS and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alprazolam in Canada.
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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.
It is recommended that the general principle of using the lowest effective dose be followed, especially in elderly or debilitated patients to preclude the development of ataxia or oversedation. 125 mg given 2 or 3 times daily. If necessary, this dosage may be increased gradually depending on patient tolerance and response.
25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. 5 mg three times daily. The dose should be adjusted until the patient is free of panic attacks. Dosage adjustments should be in increments no greater than 1 mg every three to four days.
Interdose symptoms, presumed to reflect insufficient plasma levels, may be lessened by using the same dose, but a schedule that provides for administration 3 or 4 times per day. In controlled trials conducted to establish the efficacy of alprazolam in Panic Disorders, doses in the range of 1 to 10 mg daily were used.
The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the Panic Disorder development program, about 300 received maximum alprazolam doses of greater than 7 mg per day, including approximately 100 patients who received maximum dosages of greater than 9 mg per day.
Occasional patients required as much as 10 mg per day to receive a successful response. Because the management of Panic Disorder often requires the use of average daily doses of alprazolam above 3 mg, the risk of rebound and withdrawal symptoms may be higher than in patients treated for anxiety.
(See also WARNINGS AND PRECAUTIONS, Withdrawal and Rebound in Treating Panic Disorder) The necessary duration of treatment for Panic Disorder is unknown at this time. After a period of extended freedom from panic attacks, a supervised tapered discontinuation may be attempted.
Discontinuation:
To discontinue treatment in patients taking APO-ALPRAZ and APO-ALPRAZ TS, the dosage should be reduced slowly in keeping with good medical practice. 5 mg every 3 days. Some patients may require an even slower dosage reduction. 5 mg every 2 to 3 weeks is more appropriate when a dose of 6 mg daily or more has been administered even for only a few months.
25 mg per 2 to 3 weeks. The ability of patients to completely discontinue therapy with alprazolam after long-term therapy has not been reliably determined. (see also WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Page 22 of
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Page 6 of 41 General APO-ALPRAZ and APO-ALPRAZ TS (alprazolam) are not effective in patients with Personality Disorders. APO-ALPRAZ and APO-ALPRAZ TS are not recommended for the management of Mood or Psychotic Disorders.
Concomitant use with opioids:
Concomitant use of benzodiazepines, including APO-ALPRAZ and APO-ALPRAZ TS, 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 not possible (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Risks from Concomitant use with Opioids; DRUG INTERACTIONS, Serious Drug Interactions).
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with benzodiazepines.
If a decision is made to prescribe APO-ALPRAZ and APO-ALPRAZ TS concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of APO-ALPRAZ and APO-ALPRAZ TS than indicated, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking APO-ALPRAZ and APO-ALPRAZ TS, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation (see OVERDOSAGE).
Advise both patients and caregivers about the risks of respiratory depression and sedation when APO-ALPRAZ and APO-ALPRAZ TS is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the opioid have been determined.
Dependence/Tolerance Use of benzodiazepines, such as APO-ALPRAZ and APO-ALPRAZ TS, can lead to abuse, misuse, addiction, physical dependence (including tolerance) and withdrawal reactions. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol, or illicit drugs.
The risk of dependence increases with higher doses and longer term use but can occur with short- term use at recommended therapeutic doses. The risk of dependence is greater in patients with a history of psychiatric disorders and/or substance (including alcohol) use disorder.
Page 7 of 41 Discuss the risks of treatment with APO-ALPRAZ and APO-ALPRAZ TS with the patient, considering alternative (including non-drug) treatment options. Carefully evaluate each patient’s risk of abuse, misuse and addiction, considering their medical condition and concomitant drug use, prior to prescribing APO-ALPRAZ and APO- ALPRAZ TS.
In individuals prone to substance use disorder, APO-ALPRAZ and APO- ALPRAZ TS should only be administered if deemed medically necessary, employing extreme caution and close supervision. APO-ALPRAZ and APO-ALPRAZ TS should always be prescribed at the lowest effective dose for the shortest duration possible.
All patients receiving benzodiazepines should be routinely monitored for signs and symptoms of misuse and abuse. If a substance use disorder is suspected, evaluate the patient and refer them for substance abuse treatment, as appropriate.
, seizures) if benzodiazepines are […]