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Limbitrol DS

Generic Name: amitriptyline/chlordiazepoxide (am-ee-TRIP-tih-leen/klor-dye-az-e-POX-ide)
Brand Name: Limbitrol DS

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Limbitrol DS outweigh the risks.

Family and caregivers must closely watch patients who take Limbitrol DS. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Limbitrol DS is not approved for use in children. Talk with the doctor.

Limbitrol DS is used for:

Treating moderate to severe depression with moderate to severe anxiety. It may also be used for other conditions as determined by your doctor.

Limbitrol DS is a combination tricyclic antidepressant and benzodiazepine. How tricyclic antidepressants improve depression symptoms is not fully known. They are thought to increase the activity of certain chemicals in the brain (norepinephrine, serotonin), which help improve mood. The benzodiazepine works in the brain to decrease anxiety.

Do NOT use Limbitrol DS if:

  • you are allergic to any ingredient in Limbitrol DS, to other tricyclic antidepressants (eg, nortriptyline), or to other benzodiazepines (eg, diazepam)
  • you have acute narrow-angle glaucoma, severe liver disease, or severe mental problems (psychosis)
  • you have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) within the last 14 days
  • you are taking cisapride, droperidol, an H1 antagonist (eg, astemizole, terfenadine), a ketolide (eg, telithromycin), a macrolide (eg, erythromycin), mibefradil, pimozide, or sodium oxybate (GHB)
  • you are recovering from a heart attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Limbitrol DS:

Some medical conditions may interact with Limbitrol DS. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mental illness (eg, bipolar disorder, mania, manic-depression), or have considered or attempted suicide
  • if you have a history of alcohol or other substance abuse or dependence, or you regularly drink 3 or more alcohol-containing drinks per day
  • if you have an irregular heartbeat, heart disease, chest pain, liver or kidney problems, prostate problems, thyroid disease, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), muscle problems (eg, myasthenia gravis), glaucoma, or risk factors for glaucoma, or you are unable to urinate (urinary retention)
  • if you have a history of seizures, epilepsy, or blood problems (eg, porphyria)
  • if you are taking a medicine that contains methylene blue

Some MEDICINES MAY INTERACT with Limbitrol DS. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Rifampin because it may decrease Limbitrol DS's effectiveness
  • Linezolid or MAOIs (eg, phenelzine, selegiline) because they can cause serious, sometimes life-threatening, reactions
  • Anticholinergics (eg, scopolamine), azole antifungals (eg, ketoconazole), bupropion, cimetidine, clozapine, disulfiram, fluconazole, nefazodone, omeprazole, phenothiazines (eg, chlorpromazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (eg, duloxetine), sodium oxybate (GHB), terbinafine, or valproic acid because side effects such as blurred vision, difficult urination, drowsiness or sedation, dry mouth, or lightheadedness may occur
  • Antiarrhythmics (eg, quinidine, propafenone), arsenic, cisapride, droperidol, H1 antagonists (eg, astemizole, terfenadine), ketolides (eg, telithromycin), macrolides (eg, erythromycin), mibefradil, pimozide, or streptogramins (eg, quinupristin/dalfopristin) because the risk of serious side effects on the heart (eg, racing heartbeat, dizziness, fainting, life-threatening abnormal heartbeat leading to unconsciousness, lack of heartbeat) may be increased by Limbitrol DS
  • Anticoagulants (eg, warfarin), carbamazepine, hydantoins (eg, phenytoin), thyroid medicines (eg, levothyroxine), or sympathomimetics (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by Limbitrol DS
  • Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Limbitrol DS

This may not be a complete list of all interactions that may occur. Ask your health care provider if Limbitrol DS may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Limbitrol DS:

Use Limbitrol DS as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Limbitrol DS comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Limbitrol DS refilled.
  • Take Limbitrol DS by mouth with or without food.
  • Continue to use Limbitrol DS even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Limbitrol DS. Withdrawal symptoms may occur if you decrease your dose or suddenly stop taking it. Talk with your doctor about any changes to your dose.
  • If you miss a dose of Limbitrol DS, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Limbitrol DS.

Important safety information:

  • Limbitrol DS may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Limbitrol DS with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Limbitrol DS; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Limbitrol DS may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Children, teenagers, and young adults who take Limbitrol DS may be at increased risk for suicidal thoughts or actions. Watch all patients who take Limbitrol DS closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Diabetes patients - Limbitrol DS may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Limbitrol DS may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Limbitrol DS. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can.
  • Tell your doctor or dentist that you take Limbitrol DS before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including blood cell counts and liver function tests, may be performed while you use Limbitrol DS. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, confusion, lightheadedness upon standing, rapid heartbeat, breathing problems, difficult urination, and constipation.
  • Limbitrol DS should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Limbitrol DS has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Limbitrol DS while you are pregnant. Limbitrol DS is found in the breast milk. Do not breast-feed while taking Limbitrol DS.

When used for long periods of time or at high doses, Limbitrol DS may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Limbitrol DS stops working well. Do not take more than prescribed.

Some people who use Limbitrol DS for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Limbitrol DS suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, or sweating.

Possible side effects of Limbitrol DS:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; bloating; blurred vision; constipation; diarrhea; disturbed concentration; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; tiredness; upset stomach; vomiting; weakness; weight gain or loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decreased sexual ability; decreased or increased urination; decreased coordination; delusions; disorientation; fast or irregular heartbeat; fainting; fever, chills, or persistent sore throat; hallucinations; involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs; lightheadedness; mental or mood changes; numbness of an arm or leg; one-sided weakness; pounding in the chest; seizures; severe constipation; speech problems; sudden severe dizziness, headache, stomach pain, or vomiting; tremors; unusual bleeding or bruising; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; enlarged pupils; fast or irregular heartbeat; fever; hallucinations; loss of consciousness; muscle stiffness; seizures; severe or persistent drowsiness or dizziness; slow reflexes; stupor; vomiting.

Proper storage of Limbitrol DS:

Store Limbitrol DS at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Limbitrol DS out of the reach of children and away from pets.

General information:

  • If you have any questions about Limbitrol DS, please talk with your doctor, pharmacist, or other health care provider.
  • Limbitrol DS is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • Do not use Limbitrol DS for other health conditions.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • If your symptoms do not improve after taking Limbitrol DS for 4 weeks, inform your doctor.
  • If using Limbitrol DS for an extended period of time, obtain refills before your supply runs out.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Limbitrol DS or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Limbitrol DS. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Limbitrol DS. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Limbitrol DS.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.