Limbitrol

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-?5?-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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms 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.

Other serious...

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


Limbitrol Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, dry mouth, blurred vision, constipation, bloating, trouble urinating, and weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and fainting, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, loss of balance, persistent heartburn, mental/mood changes (such as confusion, excitement, memory problems, suicidal thoughts), shaking (tremor), decreased sexual ability/desire, signs of infection (such as fever, persistent sore throat), persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, chest pain, severe dizziness, fainting, fast/irregular heartbeat, seizures, slurred speech, weakness on one side of the body, vision changes, vomit that looks like coffee grounds.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscles.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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), chronic constipation, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that may increase your risk of seizures (such as brain disease/injury/tumor, alcohol withdrawal).

Amitriptyline/chlordiazepoxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using amitriptyline/chlordiazepoxide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using amitriptyline/chlordiazepoxide safely.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this product, especially bleeding, confusion, dizziness, drowsiness, and difficulty urinating. Your doctor may start the medication at a lower dose to prevent side effects.

Caution is advised when using this drug in children. (See also Warning section.)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Since untreated depression can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Limbitrol Patient Information Including Side Effects

Brand Names: Limbitrol, Limbitrol DS

Generic Name: amitriptyline and chlordiazepoxide (Pronunciation: a mi TRIP ti leen and klor dye az e POX ide)

  • What is amitriptyline and chlordiazepoxide (Limbitrol)?
  • What are the possible side effects of amitriptyline and chlordiazepoxide (Limbitrol)?
  • What is the most important information I should know about amitriptyline and chlordiazepoxide (Limbitrol)?
  • What should I discuss with my healthcare provider before taking amitriptyline and chlordiazepoxide (Limbitrol)?
  • How should I take amitriptyline and chlordiazepoxide (Limbitrol)?
  • What happens if I miss a dose (Limbitrol)?
  • What happens if I overdose (Limbitrol)?
  • What should I avoid while taking amitriptyline and chlordiazepoxide (Limbitrol)?
  • What other drugs will affect amitriptyline and chlordiazepoxide (Limbitrol)?
  • Where can I get more information?

What is amitriptyline and chlordiazepoxide (Limbitrol)?

Amitriptyline is in a group of drugs called tricyclic antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Chlordiazepoxide is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide affects chemicals in the brain that may become unbalanced and cause anxiety.

Amitriptyline and chlordiazepoxide is used to treat depression and anxiety.

Amitriptyline and chlordiazepoxide may also be used for purposes not listed in this medication guide.

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

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

Call your doctor at once if you have any new or worsening symptoms 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.

Other serious side effects include:

  • fast, pounding, or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness (especially on one side of the body), headache, confusion, problems with vision, speech, or balance;
  • hallucinations, or seizures (convulsions), feeling light-headed, fainting;
  • easy bruising or bleeding;
  • jaundice (yellowing of your skin or eyes); or
  • urinating less than usual or not at all.

Less serious side effects may be more likely to occur, such as:

  • feeling dizzy, drowsy, or tired;
  • blurred vision, trouble concentrating;
  • dry mouth, unusual or unpleasant taste;
  • loss of appetite, nausea, vomiting, stomach pain, constipation;
  • weight changes;
  • strange dreams or nightmares;
  • breast or testicle swelling in men; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amitriptyline and chlordiazepoxide (Limbitrol)?

Do not use this medication if you are allergic to amitriptyline (Elavil) or chlordiazepoxide (Librium), or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

Do not use amitriptyline and chlordiazepoxide if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

This medication can cause birth defects in an unborn baby. Do not use amitriptyline and chlordiazepoxide if you are pregnant.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

Do not drink alcohol while taking amitriptyline and chlordiazepoxide. Chlordiazepoxide can increase the effects of alcohol.

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