Alprazolam (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Alprazolam Tablets USP

Alprazolam Tablets USP, 1 m g are blue colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘2’ and ‘0’ on either

sides of the breakline and ‘Y’ on the other side.

NDC: 71335-9660-1: 28 Tablets in a BOTTLE

NDC: 71335-9660-2: 20 Tablets in a BOTTLE

NDC: 71335-9660-3: 30 Tablets in a BOTTLE

NDC: 71335-9660-4: 60 Tablets in a BOTTLE

NDC: 71335-9660-5: 90 Tablets in a BOTTLE

NDC: 71335-9660-6: 50 Tablets in a BOTTLE

NDC: 71335-9660-7: 120 Tablets in a BOTTLE

NDC: 71335-9660-8: 100 Tablets in a BOTTLE

NDC: 71335-9660-9: 40 Tablets in a BOTTLE

NDC: 71335-9660-0: 10 Tablets in a BOTTLE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risks from Concomitant Use with Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when alprazolam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1), Drug Interactions (7.1)].

Abuse, Misuse, and Addiction

Inform patients that the use of alprazolam, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2), Drug Abuse and Dependence (9.2)].

Withdrawal Reactions

Inform patients that the continued use of alprazolam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of alprazolam may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of alprazolam may require a slow taper [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].

Effects on Driving and Operating Machinery

Advise patients not to drive a motor vehicle or operate heavy machinery while taking alprazolam due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking alprazolam [see Warnings and Precautions (5.3)].

Patients with Depression

Advise patients, their families, and caregivers to look for signs of suicidality or worsening depression, and to inform the patient’s healthcare provider immediately [see Warnings and Precautions (5.6)].

Concomitant Medications

Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7)].

Pregnancy

Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using alprazolam to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with alprazolam [see Warnings and Precautions (5.4). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to alprazolam during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed during treatment with alprazolam [see Use in Specific Populations (8.2)].

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

MEDICATION GUIDE Alprazolam Tablets, USP C-IV (al pra’ zoe lam)
What is the most important information I should know about alprazolam tablets?
  • Alprazolam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
Get emergency help right away if any of the following happens:
  • shallow or slowed breathing
  • breathing stops (which may lead to the heart stopping)
  • excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking alprazolam tablets with opioids affects you.
  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including alprazolam tablets, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including alprazolam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • You can develop an addiction even if you take alprazolam tablets as prescribed by your healthcare provider.
    • Take alprazolam tablets exactly as your healthcare provider prescribed.
    • Do not share your alprazolam tablets with other people.
    • Keep alprazolam tablets in a safe place and away from children.
  • Physical dependence and withdrawal reactions. Alprazolam tablets can cause physical dependence and withdrawal reactions.
    • Do not suddenly stop taking alprazolam tablets. Stopping alprazolam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
    • Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
    • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not take more alprazolam tablets than prescribed or take alprazolam tablets for longer than prescribed.
What are alprazolam tablets?
  • Alprazolam tablets are a prescription medicine used:
    • to treat anxiety disorders
    • for the short-term relief of the symptoms of anxiety
    • to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
    • Alprazolam tablets are a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep alprazolam tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
    • It is not known if alprazolam tablets are safe and effective in children.
    • Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam tablets.
    • It is not known if alprazolam tablets are safe and effective when used to treat anxiety disorder for longer than 4 months.
    • It is not known if alprazolam tablets are safe and effective when used to treat panic disorder for longer than 10 weeks.
Do not take alprazolam tablets if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in alprazolam tablets. See the end of this Medication Guide for a complete list of ingredients in alprazolam tablets.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take alprazolam tablets, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver or kidney problems
  • have lung disease or breathing problems
  • are pregnant or plan to become pregnant. Alprazolam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take alprazolam tablets while you are pregnant.
  • are breastfeeding or plan to breastfeed. Alprazolam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take alprazolam tablets. You should not breastfeed while taking alprazolam tablets.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking alprazolam tablets with certain other medicines can cause side effects or affect how well alprazolam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take alprazolam tablets?
  • See “What is the most important information I should know about alprazolam tablets?”
  • Take alprazolam tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much alprazolam tablets to take and when to take it.
  • If you take too much alprazolam, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of alprazolam tablets? Alprazolam tablets may cause serious side effects, including:
  • See “What is the most important information I should know about alprazolam tablets?”
  • Seizures. Stopping alprazolam tablets can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. Alprazolam tablets may cause an increase in activity and talking (hypomania and mania) in people who have depression.
    • Alprazolam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how alprazolam tablets affect you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam tablets may make your sleepiness or dizziness much worse.
The most common side effects of alprazolam tablets include:
  • problems with coordination
  • hypotension
  • trouble saying words clearly (dysarthria)
  • changes in sex drive (libido)
These are not all the possible side effects of alprazolam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store alprazolam tablets?
  • Store alprazolam tablets at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep alprazolam tablets and all medicines out of the reach of children.
General information about the safe and effective use of alprazolam tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use alprazolam tablets for a condition for which it was not prescribed.
  • Do not give alprazolam tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about alprazolam tablets that is written for health professionals.
What are the ingredients in alprazolam tablets? Active ingredient: alprazolam Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.Distributed by:Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma Limited Hyderabad-500 032, India

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2022

Alprazolam 1mg (CIV) Tablet

Label
(click image for full-size original)
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-9660(NDC:65862-678)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DOCUSATE SODIUM
SODIUM BENZOATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 2;0;Y
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-9660-1 28 TABLET in 1 BOTTLE None
2 NDC:71335-9660-2 20 TABLET in 1 BOTTLE None
3 NDC:71335-9660-3 30 TABLET in 1 BOTTLE None
4 NDC:71335-9660-4 60 TABLET in 1 BOTTLE None
5 NDC:71335-9660-5 90 TABLET in 1 BOTTLE None
6 NDC:71335-9660-6 50 TABLET in 1 BOTTLE None
7 NDC:71335-9660-7 120 TABLET in 1 BOTTLE None
8 NDC:71335-9660-8 100 TABLET in 1 BOTTLE None
9 NDC:71335-9660-9 40 TABLET in 1 BOTTLE None
10 NDC:71335-9660-0 10 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203346 07/31/2015
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-9660), RELABEL (71335-9660)

Revised: 11/2023 Bryant Ranch Prepack

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