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Drugs & Medications

Limbitrol DS

GENERIC NAME(S): AMITRIPTYLINE HCL/CHLORDIAZEPOXIDE

WARNINGS:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Who should not take Limbitrol DS?
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Uses

This product contains 2 medicines (amitriptyline, chlordiazepoxide) and is used to treat mental/mood disorders such as depression with symptoms of anxiety. Amitriptyline belongs to a class of medications called tricyclic antidepressants. It may help improve mood and feelings of well-being, relieve anxiety and tension, and help you sleep better. It works by affecting the balance of certain natural chemicals (neurotransmitters such as serotonin) in the brain. Chlordiazepoxide helps to reduce anxiety. It acts on the brain and nerves to produce a calming effect. It belongs to a class of drugs known as benzodiazepines.

How to use Limbitrol DS

Read the Medication Guide available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Take this medication by mouth, usually 1-4 times daily or as directed by your doctor. The larger portion of the total daily dose may be taken at bedtime to help reduce daytime sleepiness. The dosage is based on your medical condition, age, and response to treatment.

To reduce your risk of side effects (such as drowsiness, dry mouth, dizziness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

This medication may not work right away. You may feel some benefit the first week. However, it may take up to 4 weeks before you experience the full effect.

It is important to continue taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as worsening anxiety, headaches, shakiness, seizures, stomach cramps, muscle aches/cramps, vomiting, sweating) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists or worsens (such as nervousness or feelings of sadness get worse, or you have thoughts of suicide).

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.

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 need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using amitriptyline/chlordiazepoxide, tell your doctor or pharmacist of all the drugs you take and 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, constipation, difficulty urinating, and QT prolongation (see above). Your doctor may start the medication at a lower dose to prevent side effects. Confusion, dizziness, drowsiness can increase the risk of falling.

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.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this product include:

anticholinergic drugs (such as benztropine, belladonna alkaloids), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin), certain drugs for high blood pressure (drugs that work in the brain such as clonidine, guanabenz, reserpine), clozapine, levodopa, thyroid supplements.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of amitriptyline and chlordiazepoxide from your body, thereby affecting how amitriptyline/chlordiazepoxide works. These drugs include cimetidine, disulfiram, terbinafine, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide), antidepressants (such as SSRIs like citalopram/fluvoxamine/paroxetine/sertraline). This is not a complete list.

Many drugs besides amitriptyline may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, cisapride, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using amitriptyline/chlordiazepoxide, report all medications you are currently using to your doctor or pharmacist.

Cigarette smoking decreases blood levels of chlordiazepoxide. Tell your doctor if you smoke or if you have recently stopped smoking.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Also report the use of drugs which might increase seizure risk when combined with amitriptyline including isoniazid (INH), phenothiazines (such as thioridazine), theophylline, or tricyclic antidepressants (such as nortriptyline), among others. Consult your doctor or pharmacist for details.

Amitriptyline is very similar to nortriptyline. Do not use medications containing nortriptyline while using amitriptyline.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, inability to wake up (coma).

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver function tests) may be performed from time to time to monitor your progress or check for side effects. Keep all medical appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.

Images

CHLORDIAZEPO-AMITRIPTYL 5-12.5
CHLORDIAZEPO-AMITRIPTYL 5-12.5
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CHLORDIAZEPO-AMITRIPTYL 5-12.5
CHLORDIAZEPO-AMITRIPTYL 5-12.5

Identification

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This medicine is a green, round, film-coated tablet imprinted with "MYLAN" and "211".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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