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Composition
ALZOCUM® Alprazolam Tablets, USP
ALZOCUM ® ALPRAZOLAM TABLETS, USP 0.25 mg, 0.5 mg and 1 mg
CIV
Each uncoated tablet contains: Alprazolam USP. 0.25 mg,
Excipients Q.S.
Each uncoated tablet contains: Alprazolam USP. 0. 50 mg,
Excipients Q.S.
Each uncoated tablet contains: Alprazolam USP. 1.00 mg,
Excipients Q.S.
Colors : Erythrosine
Managing an anxiety disorder can be difficult
Support for navigating the challenges of living with this
condition
ALZOCUM (alprazolam) is indicated for the management of anxiety
disorder or the short-term relief of symptoms of anxiety in
adults. ALZOCUM is also indicated for the treatment of panic
disorder in adults, with or without agoraphobia.
IMPORTANT SAFETY INFORMATION ABOUT ALZOCUM
Do not take ALZOCUM if you are allergic to alprazolam or other
benzodiazepines.
Do not take ALZOCUM if you currently take ketoconazole or
itraconazole (antifungal treatments) or if you have acute narrow
angle glaucoma. Before taking ALZOCUM, tell your healthcare
professional about any alcohol consumption and all prescription,
over-the-counter medications and supplements you take, because
some medications can increase the concentration of ALZOCUM in
your bloodstream. Alcohol should generally not be used during
treatment with benzodiazepines such as ALZOCUM.
Tell your healthcare professional if you are pregnant, if you
are nursing, if you are planning to have a child, or if you
become pregnant while you are taking this medication.
Until you see how ALZOCUM affects you, do not drive a car or
operate potentially dangerous machinery.
Do not increase the dose of ALZOCUM, even if you think it isn’t
working, without consulting your physician. Benzodiazepines,
even when used as recommended, may produce emotional and/or
physical dependence.
Do not stop taking this medication abruptly or decrease the dose
without consulting your physician, since withdrawal symptoms can
occur.
INDICATION
ALZOCUM (alprazolam) is indicated for the management of anxiety
disorder or the short-term relief of symptoms of anxiety in
adults. ALZOCUM is also indicated for the treatment of panic
disorder in adults, with or without agoraphobia.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in
profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs 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.
How to use ALZOCUM
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.
This medication may cause withdrawal reactions, especially if it
has been used regularly for a long time or in high doses. In
such cases, withdrawal symptoms (such as seizures) may occur if
you suddenly stop using this medication. To prevent withdrawal
reactions, your doctor may reduce your dose gradually. Report
any withdrawal reactions right away.
Along with its benefits, this medication may rarely cause
abnormal drug-seeking behavior (addiction). This risk may be
increased if you have abused alcohol or drugs in the past. Take
this medication exactly as prescribed to lessen the risk of
addiction.
When this medication is used for a long time, it may not work as
well. Talk with your doctor if this medication stops working
well.
Tell your doctor if your condition persists or worsens.
Side Effects
Drowsiness, dizziness, increased saliva production, or change in
sex drive/ability may occur. If any of these effects persist or
worsen, tell your doctor or pharmacist promptly.
To minimize dizziness and lightheadedness, get up slowly when
rising from a seated or lying position.
Remember that your doctor has prescribed this medication because
he or she has judged that the benefit to you is greater than the
risk of side effects. Many people using this medication do not
have serious side effects.
Tell your doctor right away if any of these unlikely but serious
side effects occur: mental/mood changes (such as hallucinations,
thoughts of suicide), slurred speech or difficulty talking, loss
of coordination, trouble walking, memory problems.Get medical
help right away if these rare but very serious side effects
occur: yellowing eyes or skin, seizures.A very serious allergic
reaction to this drug is rare. However, get medical help right
away if you notice any symptoms of a serious allergic reaction,
including: rash, itching/swelling (especially of the
face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you
notice other effects not listed above, contact your doctor or
pharmacist.
Precautions: Before taking alprazolam, tell your doctor or
pharmacist if you are allergic to it; or to other
benzodiazepines (such as diazepam, lorazepam); or if you have
any other allergies. This product may contain inactive
ingredients, which can cause allergic reactions or other
problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist
your medical history, especially of: severe lung/breathing
problems (such as COPD, sleep apnea), liver disease, kidney
disease, drug or alcohol abuse, glaucoma.
This drug may make you dizzy or drowsy. Do not drive, use
machinery, or do any activity that requires alertness until you
are sure you can perform such activities safely. Avoid alcoholic
beverages.
Before having surgery, tell your doctor or dentist about all the
products you use (including prescription drugs, nonprescription
drugs, and herbal products).
Older adults may be more sensitive to the side effects of this
drug, especially loss of coordination and drowsiness. These side
effects can increase the risk of falling. Alprazolam is not
recommended for use during pregnancy due to the potential for
harm to an unborn baby. Consult your doctor for more details.
This drug passes into breast milk and may have undesirable
effects on a nursing infant. Therefore, breast-feeding while
using this drug is not recommended. Consult your doctor before
breast-feeding.
What should I know regarding pregnancy, nursing and
administering ALZOCUM to children or the elderly?
Interactions : Drug interactions may change how your medications
work or increase your risk for serious side effects. This
document does not contain all possible drug interactions. Keep a
list of all the products you use (including
prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or
change the dosage of any medicines without your doctor's
approval.
Some products that may interact with this drug include: kava,
sodium oxybate.
Other medications can affect the removal of alprazolam from your
body, which may affect how alprazolam works. Examples include
azole antifungals (such as itraconazole, ketoconazole),
cimetidine, certain anti-depressants (such as fluoxetine,
fluvoxamine, nefazodone), drugs to treat HIV (delavirdine,
protease inhibitors such as indinavir), macrolide antibiotics
(such as erythromycin), rifamycins (such as rifabutin), St.
John's wort, drugs used to treat seizures (such as carbamazepine,
phenytoin), among others.
Tell your doctor or pharmacist if you also take drugs that cause
drowsiness such as: certain antihistamines (such as
diphenhydramine), medicine for sleep or anxiety (such as
diazepam, zolpidem), muscle relaxants, narcotic pain relievers
(such as codeine), psychiatric medicines (such as
chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (such as cough-and-cold
products) because they may contain ingredients which cause
drowsiness. Ask your pharmacist about the safe use of those
products.
Cigarette smoking decreases blood levels of this medication.
Tell your doctor if you smoke or if you have recently stopped
smoking.
Does ALZOCUM interact with other medications?
Should I avoid certain foods while taking ALZOCUM?
Notes : Do not share this medication with others. It is against
the law.
Laboratory and/or medical tests (such as liver function tests)
should be performed periodically to monitor your progress or
check for side effects. Consult your doctor for more details.
Missed Dose : If you miss a dose, take it as soon as you
remember. If it is near the time of the next dose, skip the
missed dose and resume your usual dosing schedule. Do not double
the dose to catch up.
STORAGE : Store at room temperature away from light and
moisture. Do not store in the bathroom. Keep all medications
away from children and pets.
DO NOT FLUSH MEDICATIONS DOWN THE TOILET OR POUR THEM INTO A
DRAIN UNLESS INSTRUCTED TO DO SO. PROPERLY DISCARD THIS PRODUCT
WHEN IT IS EXPIRED OR NO LONGER NEEDED. CONSULT YOUR PHARMACIST
OR LOCAL WASTE DISPOSAL COMPANY FOR MORE DETAILS.
Contraindications
Alzocum Tablets are contraindicated in patients with known
sensitivity to this drug or other benzodiazepines. Alzocum may be
used in patients with open angle glaucoma who are receiving
appropriate therapy, but is contraindicated in patients with acute
narrow angle glaucoma.
Alzocum is contraindicated with ketoconazole and itraconazole,
since these medications significantly impair the oxidative
metabolism mediated by cytochrome P450 3A (CYP3A) (see WARNINGS
and PRECAUTIONS-DRUG INTERACTIONS).
Presentation
Alzocum 0.25 Blister pack of 10 tablets
Alzocum 0.50 Blister pack of 10 tablets
Alzocum 1.00 Blister pack of 10
tablets
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Quality
