Azilect (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

AZILECT 0.5 mg Tablets:

White to off-white, round, flat, beveled tablets, debossed with “GIL 0.5” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-142-56).

AZILECT 1 mg Tablets:

White to off-white, round, flat, beveled tablets, debossed with “GIL 1” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-229-56).

Storage:

Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

17 PATIENT COUNSELING INFORMATION

Hypertension

Advise patients that treatment with recommended doses of AZILECT may be associated with elevations of blood pressure. Tell patients who experience elevation of blood pressure while taking AZILECT to contact their healthcare provider.

The risk of using higher than recommended daily doses of AZILECT should be explained, and a brief description of the tyramine associated hypertensive reaction provided.

Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of AZILECT because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Tell patients to inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and over-the-counter cold medications, since there is a potential for interaction with AZILECT. Because patients should not use meperidine or certain other analgesics with AZILECT, they should contact their healthcare provider before taking analgesics [see Contraindications (4) and Warnings and Precautions (5.2)].

Falling Asleep During Activities of Daily Living and Somnolence

Advise and alert patients about the potential for sedating effects associated with AZILECT and other dopaminergic medications, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with AZILECT and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of AZILECT.

Because of possible additive effects, advise patients to exercise caution when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with AZILECT or when taking concomitant medications that increase plasma levels of rasagiline (e.g., ciprofloxacin) [see Warnings and Precautions (5.3)].

Ciprofloxacin or Other CYP1A2 Inhibitors

Inform patients that they should contact their healthcare provider of AZILECT if they take ciprofloxacin or a similar drug that could increase blood levels of rasagiline because of the need to adjust the dose of AZILECT [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)].

Hepatic Impairment

Tell patients who have hepatic problems to contact their healthcare provider regarding possible changes in AZILECT dosing [see Warnings and Precautions (5.5)].

Hypotension / Orthostatic Hypotension

Patients should be advised that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned against standing up rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially, at the initiation of treatment with AZILECT [see Warnings and Precautions (5.6)].

Dyskinesia

Advise patients taking AZILECT as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia [see Warnings and Precautions (5.7)].

Hallucinations / Psychotic-Like Behavior

Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur when taking AZILECT. Advise patients that, if they have a major psychotic disorder, that AZILECT should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of AZILECT [see Warnings and Precautions (5.8)].

Impulse Control/Compulsive Behaviors

Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease (including AZILECT). Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges, or other urges while being treated with AZILECT. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking AZILECT. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking AZILECT [see Warnings and Precautions (5.9)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Tell patients to contact their healthcare provider if they wish to discontinue AZILECT [see Warnings and Precautions (5.10)].

Missing Dose

Instruct patients to take AZILECT as prescribed. If a dose is missed, the patient should not double-up the dose of AZILECT. The next dose should be taken at the usual time on the following day.

Pregnancy

Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant [see Use in Specific Populations (8.1)].

logo
(click image for full-size original)

AZI-004

Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054

©2020 Teva Neuroscience, Inc.

Package/Label Display Panel

NDC 68546-142-56
AZILECT® (rasagiline tablets)
0.5 mg
30 Tablets Rx only

image
(click image for full-size original)

Package/Label Display Panel

NDC 68546-229-56
AZILECT® (rasagiline tablets)
1 mg
30 Tablets Rx only

image
(click image for full-size original)

AZILECT
rasagiline mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASAGILINE MESYLATE (RASAGILINE) RASAGILINE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
SILICON DIOXIDE
STEARIC ACID
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GIL;0;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-142-27 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68546-142-27)
2 NDC:68546-142-56 30 TABLET in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021641 07/10/2006
AZILECT
rasagiline mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-229
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASAGILINE MESYLATE (RASAGILINE) RASAGILINE 1 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
SILICON DIOXIDE
STEARIC ACID
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code GIL;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68546-229-27 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68546-229-27)
2 NDC:68546-229-56 30 TABLET in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021641 07/10/2006
Labeler — Teva Neuroscience, Inc. (009906397)

Revised: 04/2021 Teva Neuroscience, Inc.

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