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Alprazolam

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Alprazolam Tablets, USP CIV


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ALPRAZOLAM DESCRIPTION







Alprazolam




Alprazolam

CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics


Absorption



Distribution

In vitro

Metabolism/Elimination



Special Populations






Race



Pediatrics



Gender



Cigarette Smoking

Drug-Drug Interactions




in vivo

in vivo1/2

CLINICAL STUDIES


Anxiety Disorders



Panic Disorder



ALPRAZOLAM INDICATIONS AND USAGE


Anxiety Disorders



Motor Tension Autonomic HyperactivityVigilance and Scanning


 
Panic Disorder







ALPRAZOLAM CONTRAINDICATIONS




WARNINGS


Dependence and withdrawal reactions, including seizures:



The importance of dose and the risks of alprazolam tablets as a treatment for panic disorder:











Status epilepticus and its treatment:



Interdose Symptoms:



Risk of dose reduction:



CNS depression and impaired performance


 
Risk of fetal harm



Alprazolam interaction with drugs that inhibit metabolism via cytochrome P450 3A: in vitro


 
Potent CYP 3A inhibitors:

in vivo

Drugs demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving alprazolam (caution and consideration of appropriate alprazolam dose reduction are recommended during coadministration with the following drugs):






 
Other drugs possibly affecting alprazolam metabolism:

PRECAUTIONS

General


Suicide


 
Mania



Uricosuric Effect


 
Use in patients with concomitant illness

Information for Patients


For all users of alprazolam tablets:

  • Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines.
  • Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication.
  • Inform your physician if you are nursing.
  • Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
  • Do not increase the dose even if you think the medication "does not work anymore" 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.
Additional advice for panic disorder patients:



Laboratory Tests


Drug Interactions


Use with other CNS depressants


 
Use with imipramine and desipramine


 
Drugs that inhibit alprazolam metabolism via cytochrome P450 3A
 
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam):






 
Drugs and other substances demonstrated to be CYP3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam): in vitro in vivoin vitro

Drugs demonstrated to be inducers of CYP3A:

Drug/Laboratory Test Interactions


Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro

Pregnancy




Labor and Delivery


Nursing Mothers


Pediatric Use


Geriatric Use


ALPRAZOLAM ADVERSE REACTIONS










Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders
ANXIETY DISORDERS
Treatment-Emergent
Symptom IncidenceEvents reported by 1% or more of alprazolam tablet patients are included.
Incidence of Intervention Because of Symptom
 
 Alprazolam Tablets
Placebo
Alprazolam Tablets
Number of Patients
565
 505
 565
% of Patients Reporting:
Central Nervous System
Drowsiness
41.0
 21.6
 15.1
Light-headedness
 20.8
 19.3
 1.2
Depression
13.9
 18.1
 2.4
Headache
12.9
 19.6
 1.1
Confusion
9.9
 10.0
 0.9
Insomnia
 8.9
 18.4
 1.3
Nervousness
 4.1
 10.3
 1.1
Syncope
 3.1
 4.0
  None reported
Dizziness
 1.8
 0.8
 2.5
Akathisia
 1.6
 1.2
  None reported
Tiredness/Sleepiness
  None reported
 None reported
1.8
Gastrointestinal
Dry Mouth
14.7
 13.3
 0.7
Constipation
10.4
 11.4
 0.9
Diarrhea
 10.1
 10.3
 1.2
Nausea/Vomiting
 9.6
 12.8
 1.7
Increased Salivation
4.2
 2.4
  None reported
Cardiovascular
Tachycardia/Palpitations
 7.7
 15.6
 0.4
Hypotension
4.7
 2.2
  None reported
Sensory
Blurred Vision
6.2
 6.2
 0.4
Musculoskeletal
Rigidity
 4.2
 5.3
  None reported
Tremor
 4.0
 8.8
 0.4
Cutaneous
Dermatitis/Allergy
 3.8
 3.1
 0.6
Other
Nasal Congestion
7.3
 9.3
  None reported
Weight Gain
2.7
 2.7
  None reported
Weight Loss
2.3
 3.0
  None reported

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder
PANIC DISORDER
  Treatment-Emergent Symptom IncidenceEvents reported by 1% or more of alprazolam tablet patients are included.
  Alprazolam Tablets Placebo
Number of Patients 1388 1231
% of Patients Reporting:
Central Nervous System
Drowsiness
Fatigue and Tiredness
Impaired Coordination
Irritability
Memory Impairment
Light-headedness/Dizziness
Insomnia
Headache
Cognitive Disorder
Dysarthria
Anxiety
Abnormal Involuntary Movement
Decreased Libido
Depression
Confusional State
Muscular Twitching
Increased Libido
Change in Libido (Not Specified)
Weakness
Muscle Tone Disorders
Syncope
Akathisia
Agitation
Disinhibition
Paresthesia
Talkativeness
Vasomotor Disturbances
Derealization
Dream Abnormalities
Fear
Feeling Warm		 76.8
48.6
40.1
33.1
33.1
29.8
29.4
29.2
28.8
23.3
16.6
14.8
14.4
13.8
10.4
7.9
7.7
7.1
7.1
6.3
3.8
3.0
2.9
2.7
2.4
2.2
2.0
1.9
1.8
1.4
1.3
 42.7
42.3
17.9
30.1
22.1
36.9
41.8
35.6
20.5
6.3
24.9
21.0
8.0
14.0
8.2
11.8
4.1
5.6
8.4
7.5
4.8
4.3
2.6
1.5
3.2
1.0
2.6
1.2
1.5
1.0
0.5
Gastrointestinal
Decreased Salivation
Constipation
Nausea/Vomiting
Diarrhea
Abdominal Distress
Increased Salivation		 32.8
26.2
22.0
20.6
18.3
5.6
 34.2
15.4
31.8
22.8
21.5
4.4
Cardio-Respiratory
Nasal Congestion
Tachycardia
Chest Pain
Hyperventilation
Upper Respiratory Infection		 17.4
15.4
10.6
9.7
4.3
 16.5
26.8
18.1
14.5
3.7
Sensory
Blurred Vision
Tinnitus		 21.0
6.6
 21.4
10.4
Musculoskeletal
Muscular Cramps
Muscle Stiffness		 2.4
2.2
 2.4
3.3
Cutaneous
Sweating
Rash		 15.1
10.8
 23.5
8.1
Other
Increased Appetite
Decreased Appetite
Weight Gain
Weight Loss
Micturition Difficulties
Menstrual Disorders
Sexual Dysfunction
Edema
Incontinence
Infection		 32.7
27.8
27.2
22.6
12.2
10.4
7.4
4.9
1.5
1.3
 22.8
24.1
17.9
16.5
8.6
8.7
3.7
5.6
0.6
1.7





Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials


DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE
Percentage of 641 Alprazolam Tablets-Treated Panic Disorder Patients Reporting Events
Body System/Event
Neurologic
Gastrointestinal
Insomnia
 29.5
 Nausea/Vomiting
16.5
Light-headedness
 19.3
 Diarrhea
13.6
Abnormal involuntary movement
17.3
 Decreased salivation
10.6
Headache
17.0
 Metabolic-Nutritional
Muscular twitching
6.9
 Weight loss
13.3
Impaired coordination
6.6
 Decreased appetite
12.8
Muscle tone disorders
5.9
  
Weakness
5.8
 Dermatological
Psychiatric
Sweating
 14.4
Anxiety
 19.2
  
Fatigue and Tiredness
18.4
 Cardiovascular
Irritability
 10.5
 Tachycardia
12.2
Cognitive disorder
10.3
  
Memory impairment
5.5
Special Senses
Depression
 5.1
Blurred vision
10.0
Confusional state
5.0
 






Post Introduction Reports:

DRUG ABUSE AND DEPENDENCE


Physical and Psychological Dependence:









Controlled Substance Class:

OVERDOSAGE


Clinical Experience



50



General Treatment of Overdose:

The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

ALPRAZOLAM DOSAGE AND ADMINISTRATION




Anxiety disorders and transient symptoms of anxiety:





Panic Disorder:



Dose Titration:





Dose Maintenance:





Dose Reduction:







Dosing in Special Populations:

HOW SUPPLIED




0.25 mg






 
0.5 mg






 
1 mg







2 mg







ANIMAL STUDIES




Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries





Image of Label

Alprazolam

Alprazolam

Alprazolam TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:35356-752(NDC:47335-605)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Alprazolam Alprazolam 1 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
STARCH, CORN
cellulose, microcrystalline
SILICON DIOXIDE
POVIDONE K30
DOCUSATE SODIUM
SODIUM BENZOATE
MAGNESIUM STEARATE
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
BLUE 9 mm 605 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35356-752-10 10 in 1 BOTTLE
2 NDC:35356-752-30 30 in 1 BOTTLE
3 NDC:35356-752-60 60 in 1 BOTTLE
4 NDC:35356-752-90 90 in 1 BOTTLE
5 NDC:35356-752-00 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090082 2010-06-18


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Be sure to consult your doctor before taking any medication!
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