DOXEPIN HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)

제공처:

Mylan Pharmaceuticals Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Do not administer doxepin tablets if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment. Doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data) . There are risks of poor neonatal adaptation with

제품 요약:

Doxepin Tablets are available containing 3.39 mg or 6.78 mg of doxepin hydrochloride, USP equivalent to 3 mg or 6 mg of doxepin, respectively. The 3 mg tablets are light blue, round, unscored tablets debossed with M on one side of the tablet and DI3 on the other side. They are available as follows: NDC 0378-5390-93 bottles of 30 tablets NDC 0378-5390-01 bottles of 100 tablets NDC 0378-5390-05 bottles of 500 tablets The 6 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and DI6 on the other side. They are available as follows: NDC 0378-5391-93 bottles of 30 tablets NDC 0378-5391-01 bottles of 100 tablets NDC 0378-5391-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Doxepin Tablets
(dox′ e pin)
What is the most important information I should know about doxepin
tablets?
Doxepin tablets can cause serious side effects including:
After taking doxepin tablets, you may get up out of bed while not
being fully awake and do an activity
that you do not know you are doing. The next morning, you may not
remember that you did anything
during the night. You have a higher chance for doing these activities
if you drink alcohol or take other
medicines that make you sleepy with doxepin tablets. Reported
activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking doxepin tablets and call your healthcare provider right
away if you find out that you have
done any of the above activities after taking doxepin tablets.
Important:
•
Take doxepin tablets exactly as prescribed.
o
Do not take more doxepin tablets than prescribed.
Take doxepin tablets 30 minutes before bedtime. After taking doxepin
tablets, you should only do
activities needed to get ready for bed.
What are doxepin tablets?
Doxepin tablets are a prescription medicine used to treat adults who
have trouble staying asleep.
It is not known if doxepin tablets are safe and effective in children.
Do not take doxepin tablets if you:
•
are allergic to any of the ingredients in doxepin tablets. See the end
of this Medication Guide for a
complete list of ingredients in doxepin tablets.
•
take a monoamine oxidase inhibitor (MAOI) medicine or have taken an
MAOI in the last 14 days
(2 weeks). Ask your healthcare provider if you are not sure if your
medicine is an MAOI.
•
have an eye problem called narrow angle glaucoma that is not being
treated or have trouble
urinating that is severe.
Before taking doxepin tablets, tell your healthcare provider about all
of your medical conditions,
including if you:
•
have a history of depression, mental illness, or suicidal thoughts
•
have severe sleep apn

제품 특성 요약

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXEPIN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DOXEPIN TABLETS.
DOXEPIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1969
INDICATIONS AND USAGE
Doxepin tablets are indicated for the treatment of insomnia
characterized by difficulties with sleep maintenance. (1, 14)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
•
•
Initial dose: 6 mg, once daily for adults (2.1) and 3 mg, once daily
for the elderly. (2.1, 2.2)
Take within 30 minutes of bedtime. Total daily dose should not exceed
6 mg. (2.3)
Should not be taken within 3 hours of a meal. (2.3, 12.3)
3 mg and 6 mg tablets. Tablets not scored. (3)
Hypersensitivity to doxepin hydrochloride, inactive ingredients, or
other dibenzoxepines. (4.1)
Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Do not
administer if patient is taking MAOIs or has
used MAOIs within the past two weeks. (4.2)
Untreated narrow angle glaucoma or severe urinary retention. (4.3)
Need to evaluate for comorbid diagnoses: Reevaluate if insomnia
persists after 7 to 10 days of use. (5.1)
Abnormal thinking, behavioral changes, complex behaviors: May include
“Sleep-driving” and hallucinations.
Immediately evaluate any new onset behavioral changes. (5.2)
Depression: Worsening of depression or suicidal thinking may occur.
Prescribe the least amount feasible to avoid
intentional overdose. (5.3)
CNS-depressant effects: Use can impair alertness and motor
coordination. Avoid engaging in hazardous activities
such as operating a motor vehicle or heavy machinery after taking
drug. (5.4)