Alaxen Tablet
Alprazolam
0.5mg
United Chemicals & Pharmaceuticals Ltd.
| Pack size | 100's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 3.00 AED |
Available as:
Indications
Alaxen Tablet is used for:
Anxiety disorders, Panic disorders, Nausea due to chemotherapy
Adult Dose
Oral
Short-term management of anxiety
Adult: 0.25-0.5 mg tid, increased to 3-4 mg daily if necessary.
Elderly: Initially, 0.25 mg bid/tid.
Panic attacks
Adult
Immediate-release
0.5 mg PO q8hr; may increase q3-4Days by <1 mg/day
Average dose: 5-6 mg/day PO
May require up to 10 mg/day PO divided q8hr
Extended-release
0.5-1 mg PO qDay; may increase q3-4Days by <1 mg/day
Average dose: 3-6 mg PO qDay
Anxiety Associated With Depression
1-4 mg/day PO divided q8hr
Child Dose
<18 years old: Not recommended
Renal Dose
Renal impairment: Use caution; not studied
Administration
Administration May be taken with or without food. Side effects eg sleepiness/drowsiness may be reduced if taken immediately after meals.
Contra Indications
Acute narrow-angle glaucoma, preexisting CNS depression or coma, resp depression, acute pulmonary insufficiency or sleep apnoea; severe hepatic impairment; pregnancy, lactation.
Precautions
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
The use of benzodiazepines, including Alprazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing Alprazolam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Abrupt discontinuation or rapid dosage reduction of Alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Alprazolam or reduce the dosage.
Effects on Driving and Operating Machinery: Patients receiving Alprazolam 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.
Neonatal Sedation and Withdrawal Syndrome (NOWS): Use of Alprazolamm during pregnancy can result in neonatal sedation and neonatal withdrawalsyndrome.
Patients with Depression: Exercise caution in patients with signs or symptoms of depression. Prescribe the least number of tablets feasible to
avoid intentional overdosage.
Pregnancy-Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy.
Neonates born to mothers using benzodiazepines during later stages of pregnancy reported to experience symptoms of sedation and neonatal withdrawal; overall available data from published observational studies of pregnant women exposed to drug have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates; monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation, respiratory depression, withdrawal, and feeding problems and manage accordingly
Lactation
Limited data from published literature reports the presence of the drug in human breast milk; there are reports of sedation and withdrawal symptoms in breastfed neonates and infants exposed to alprazolam; effects of alprazolam on lactation are unknown
Because of potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed neonates and infants, advise patients that breastfeeding is not recommended during treatment
Minor tranquilizers should be avoided in first trimester of pregnancy due to increased risk of congenital malformations
Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)
Prenatal benzodiazepine exposure slightly increases oral cleft risk (limited or inconsistent evidence)
Interactions
Use with Opioids: Increase the risk of respiratory depression.
Use with Other CNS Depressants: Produces additive CNS depressant effects.
Use with Digoxin: Increase the risk of digoxin toxicity.
Use with CYP3A Inhibitors (except ritonavir): Increase the risk of adverse reactions of alprazolam.
Use with CYP3A Inducers: Increase the risk of reduced efficacy of alprazolam.
Contraindicated (4)
cobicistat
ketoconazole
levoketoconazole
tipranavir
Serious - Use Alternative (43)
apalutamide
benzhydrocodone/acetaminophen
buprenorphine subdermal implant
buprenorphine transdermal
buprenorphine, long-acting injection
calcium/magnesium/potassium/sodium oxybates
carbamazepine
ceritinib
chloramphenicol
cimetidine
clarithromycin
danazol
erythromycin base
erythromycin ethylsuccinate
erythromycin lactobionate
erythromycin stearate
fentanyl
fentanyl intranasal
fentanyl iontophoretic transdermal system
fentanyl transdermal
fentanyl transmucosal
fexinidazole
hydrocodone
idelalisib
itraconazole
ivosidenib
lonafarnib
lopinavir
methohexital
metoclopramide intranasal
nefazodone
olopatadine intranasal
rifabutin
rifampin
saquinavir
selinexor
sodium oxybate
St John's Wort
sufentanil SL
tovorafenib
valerian
voxelotor
zuranolone
Potentially Fatal: Cimetidine and fluoxetine reduce the clearance of alprazolam. Alprazolam enhances activity of imipramine and desipramine.
Adverse Effects
Side effects of Alprazolam :
>10% (4 mg dose)
Drowsiness (41%),Depression (10-15%),Headache (10-15%),Constipation (10-15%),Diarrhea (10-15%),Dry mouth (10-15%)
>10% (10 mg dose)
Drowsiness (77%),Impaired coordination (40-50%),Increased appetite (30-35%),Fatigue (30-35%),Memory impairment (30-35%),Irritability (30-35%),Decreased salivation (30-35%),Cognitive disorders (20-30%),Insomnia (20-30%),Dcreased appetite (20-30%),Headache (20-30%),Lightheadedness (20-30%),Dysarthria (20-30%),Diarrhea, constipation, and nausea/vomiting (20-30%),Weight change (20-30%),Nasal congestion (15-20%),Decreased or increased libido (10-15%),Menstrual disorder (10-15%),Difficult micturition (10-15%)
1-10% (4 mg dose)
Tachycardia (5-10%),Confusion (5-10%),Insomnia (5-10%),Nausea/vomiting (5-10%),Blurred vision (5-10%),Nasal congestion (5-10%),Hypotension (1-5%),Syncope (1-5%),Akathisia (1-5%),Dizziness (1-5%),Increased salivation (1-5%),Nervousness (1-5%),Tremor (1-5%),Weight change (1-5%)
1-10% (10 mg dose)
Increased salivation (5-10%),Talkativeness (1-5%),Incontinence (1-5%)
Potentially Fatal: Blood dyscrasias.
Mechanism of Action
Alprazolam binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites w/in the CNS, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to Cl ions, which results in hyperpolarisation (a less excitable state) and stabilisation. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors.
Note
Alaxen 0.5mg Tablet manufactured by United Chemicals & Pharmaceuticals Ltd.. Its generic name is Alprazolam. Alaxen is availble in Bangladesh.
Farmaco BD drug index information on Alaxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.