Xanax/Xanax XR/Xanax SL

Xanax/Xanax XR/Xanax SL

alprazolam

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Alprazolam
Indications/Uses
Anxiety including anxiety neurosis, disorders & symptoms. Combination of anxiety & depression including anxiety associated w/ depression. Panic disorders w/ or w/o agoraphobia.
Dosage/Direction for Use
Individualized dosage. Xanax/Xanax SL Anxiety Initially 0.75-1.5 mg daily in divided doses. Usual dose range: 0.5-4 mg daily in divided doses. Panic disorders Initially 0.5-1 mg at bedtime or 0.5 mg 3 times daily. Usual dose range: Adjusted to patient's response. Dose increments should not exceed 1 mg at intervals of 3-4 days. Additional doses can be added until a 3 times or 4 times daily schedule is achieved. Max: 10 mg daily. Geriatric patients Initial & usual dose range: 0.5-0.75 mg daily in divided doses. May be gradually increased if needed & tolerated. Xanax XR 0.5-1 mg once daily preferably in the morning. May be increased at 3- to 4-days interval in increments of no >1 mg/day. Total daily dose: 3-6 mg/day. Elderly, advanced liver disease, debilitating disease Initially 0.5 mg once daily. May be gradually increased if needed & tolerated.
Administration
May be taken with or without food: Side effects eg, sleepiness/drowsiness may be reduced if taken immediately after meals. Xanax XR: Take preferably in the morning. Swallow whole, do not chew/crush/break. Xanax SL: Place under the tongue for at least 2 min. Allow to completely disintegrate under the tongue before swallowing. Do not divide, chew, or swallow.
Contraindications
Hypersensitivity to benzodiazepines & alprazolam. Acute narrow-angle glaucoma. Xanax XR Ketoconazole & itraconazole.
Special Precautions
Episodes of hypomania & mania. Dosage must be gradually tapered to preclude sequelae of rapid w/drawal. Caution against engaging in hazardous occupations or activities requiring complete mental alertness eg, operating machinery or driving a motor vehicle. Impaired renal or hepatic function. Increased risk of congenital abnormalities when administered to pregnant woman during the 1st trimester. Not recommended for use in pregnancy. Nursing should not be undertaken while using benzodiazepines. Childn <18 yr. Elderly or debilitated patients. Xanax Patients w/ panic-related disorders. Xanax XR Dependence & w/drawal reactions, including seizures. Interdose symptoms. Suicide. Impaired pulmonary function. Decreased systemic alprazolam elimination rate in both alcoholic liver disease & obese patients. Alcohol should not be used during treatment. May produce emotional &/or physical dependence. Periodic blood counts, urinalysis & blood chemistry analyses are advisable in keeping w/ good medical practice. Xanax/Xanax XR Concomitant use of benzodiazepines & opioids may result in profound sedation, resp depression, coma & death. Xanax/Xanax SL Depression w/ psychosis features, bipolar disorders or “endogenous” depression (eg, severely depressed in-patients). Patients who are prone to abuse drugs (eg, alcoholics & drug addicts). Not recommended in patients whose primary diagnosis is schizophrenia.
Adverse Reactions
Depression; sedation, somnolence, ataxia, memory impairment, dysarthria, headache, dizziness; dry mouth, constipation; fatigue, irritability. Decreased appetite; confusional state, disorientation, decreased/increased libido, anxiety, insomnia, nervousness; balance disorder/impairment, coordination abnormal, disturbance in attention, hypersomnia, lethargy, tremor; blurred vision; nausea; sexual dysfunction; decreased/increased wt. Xanax/Xanax SL Dermatitis. Xanax XR Paresthesia, dyskinesia, hypoesthesia; fatigue; influenza, upper resp tract infections; depressed mood; increased appetite, anorexia; pharyngolaryngeal pain; road traffic accident; dysmenorrhea, premenstrual syndrome; arthralgia, myalgia, pain in limb; hot flushes; dyspnea, allergic rhinitis; pruritis. Palpitation; vertigo; diarrhea, vomiting, dyspepsia, abdominal pain; malaise, weakness, chest pains; back pain, muscle cramps & twitching; derealization, restlessness, agitation, depersonalization, nightmare; difficulty in micturition; nasal congestion, hyperventilation; increased sweating.
Drug Interactions
Benzodiazepines produce additive CNS depressant effects when co-administered w/ opioids, other psychotropic medications, anticonvulsants, antihistaminics, ethanol & other dugs which produce CNS depression. Co-administration w/ erythromycin. Dose adjustment or discontinuation of alprazolam when co-administered w/ HIV protease inhibitors (eg, ritonavir). Increased digoxin conc especially in elderly (>65 yr). Xanax/Xanax SL Co-administration w/ ketoconazole, itraconazole, or other azole type antifungals is not recommended. Dose reduction is recommended when co-administered w/ nefazodone, fluvoxamine & cimetidine. Co-administration w/ fluoxetine, propoxyphene, OCs, diltiazem, or macrolide antibiotics eg, troleandomycin. Xanax XR Drugs which inhibit CYP3A metabolic pathway may have a profound effect on the clearance of alprazolam. Increased Cmax w/ fluoxetine, OCs. Decreased Cmax w/ propoxyphene. Co-administration w/ diltiazem, INH, macrolide antibiotics eg, clarithromycin & grapefruit juice; sertraline & paroxetine; ergotamine, cyclosporine, amiodarone, nicardipine & nifedipine. Carbamazepine can increase alprazolam metabolism.
MIMS Class
ATC Classification
N05BA12 - alprazolam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Presentation/Packing
Form
Xanax SL tab 0.5 mg
Packing/Price
2 × 15's
Form
Xanax XR ER tab 1 mg
Packing/Price
3 × 10's (Rp364,537/boks)
Form
Xanax caplet 0.5 mg
Packing/Price
10 × 10's (Rp568,100/pak)
Form
Xanax SL tab 1 mg
Packing/Price
2 × 15's
Form
Xanax caplet 0.25 mg
Packing/Price
10 × 10's (Rp398,165/pak)
Form
Xanax XR ER tab 0.5 mg
Packing/Price
3 × 10's (Rp227,841/boks)
Form
Xanax caplet 1 mg
Packing/Price
10 × 10's (Rp933,299/pak)
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