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Limbitrol

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Limbitrol

LIMBITROL®
(chlordiazepoxide & amitriptyline HCI) DS (double strength) Tablets

Tranquilizer – Antidepressant

Limbitrol

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of LIMBITROL (chlordiazepoxide amitriptyline ds tablets) Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in the risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. LIMBITROL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

DRUG DESCRIPTION

LIMBITROL (chlordiazepoxide amitriptyline ds tablets) combines for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in DS (double strength) white, film-coated tablets, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in blue, film-coated tablets, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains corn starch, hydroxypropyl cellulose, hyproxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycol, povidone and propylene glycol; LIMBITROL (chlordiazepoxide amitriptyline ds tablets) tablets contain the following colorant system-FD&C Blue No. 1, aluminum lake and titanium dioxide. LIMBITROL (chlordiazepoxide amitriptyline ds tablets) DS tablets contain titanium dioxide.

Chlordiazepoxide is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76.

Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ5γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87.

What are the possible side effects of amitriptyline and chlordiazepoxide (Limbitrol, Limbitrol DS)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such...

Read All Potential Side Effects and See Pictures of Limbitrol »

What are the precautions when taking chlordiazepoxide amitriptyline ds tablets (Limbitrol)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam, alprazolam), or to other tricyclic antidepressants (such as nortriptyline), 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: a certain eye problem (glaucoma), bleeding problems, breathing/lung problems, diabetes, kidney problems, liver problems, heart problems (such as chest pain, irregular heartbeat, recent heart attack), problems urinating (such as due to enlarged prostate),...

Read All Potential Precautions of Limbitrol »

Last reviewed on RxList: 5/11/2009
This monograph has been modified to include the generic and brand name in many instances.

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Limbitrol - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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