Duloxetine

(doo lox' e teen)

PCaution when used during lactation : Caution when used during pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
WARNING

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 paroxetine 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 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. Duloxetine is not approved for use in pediatric patients.
Indication(s) & Dosage

Indications for DULOXETINE

Depression
Adult: 20-30 mg bid or 60 mg once daily. Max: 60 mg daily.

Diabetic neuropathy
Adult: 60 mg once daily. Max: 120 mg daily. 

Moderate to severe stress urinary incontinence in women
Adult: 40 mg bid. 

Renal impairment: CrCl >30 ml/min: No adjustment needed. Avoid use in severe impairment.
Special Populations: In renal impairment, lower starting dose and consider gradual increase in dose.

Administration Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals.
Overdosage Signs and symptoms include serotonin syndrome, somnolence, vomiting and seizures. Treatment consists of general measures such as maintaining an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended. Gastric lavage with appropriate airway protection, if needed, may be used if performed soon after ingestion or in symptomatic patients.
Contraindications Uncontrolled narrow-angle glaucoma. Concomitant use or within 2 wk of MAOIs. Renal and hepatic impairment.
Special Precautions Avoid alcohol and abrupt cessation. May impair ability to drive or engage in task requiring alertness. Increased risk of suicidal thinking and behaviour when used in children and adolescents. Pregnancy, lactation.
Adverse Drug Reactions Nausea, dry mouth, constipation, decreased appetite, somnolence, fatigue, increased sweating.
Drug Interactions Increased risk of hepatic toxicity in patients with substantial alcohol use. Increased risk of serotonin syndrome when used with 5HT1 receptor agonists, MAOIs, lithium, tramadol or St John's wort. Avoid concurrent use with drugs that inhibit hepatic enzymes CYP1A2 and CYP2D6.
Potentially Fatal: Avoid use with antiarrhythmics (amiodarone, quinidine), antipsychotics (chlorpromazine), TCAs (fluoxetine, fluvoxamine), azole antifungals, quinolones (ciprofloxacin), ciclosporin. Please consult detailed drug interactions before prescribing.
Pregnancy Category (US FDA)
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Pharmacology It is a potent inhibitor of neuronal uptake of serotonin and norepinephrine and also a weak inhibitor of dopamine reuptake.
Absorption: Well absorbed from the GI tract after oral admin.
Distribution: About 96% bound to plasma proteins, mainly albumin and alpha1-acid glycoprotein.
Metabolism: Extensively metabolised by CYP1A2 and CYP2D6.
Excretion: Mainly excreted in the urine; about 20% is excreted in the faeces. Elimination half-life: 8-17 hr.
ATC Classification N06AX21 - duloxetine.

Brand/Product Info


Total Products : 7       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
BUIX The Acme Laboratories Ltd. Duloxetine hydrochloride INN 20mg & 40mg Tablet 10's each: 70.20 & 100.40 MRP
DELOXI DR Eskayef Bangladesh Ltd Duloxetine 20mg Capsule (delayed release) 36's MRP: 252.00
DILINER 30 Square Pharmaceuticals Ltd. Duloxetine 30mg Capsule 3x6's: 181.26 MRP
DILINER 60 Square Pharmaceuticals Ltd. Duloxetine 60mg Capsule 3x6's: 289.98 MRP
Duloxen 20 Incepta Pharmaceuticals Limited Duloxetine 20 mg Tablet Tablet 10x3's:MRP 210 Tk
Duloxen 30 Incepta Pharmaceuticals Limited Duloxetine 30 mg Tablet Tablet 10x3's:MRP 300 Tk
DUZELA 20 Sun Pharmaceutical (Bangladesh) Ltd. Duloxetine hydrochloride INN 20mg Capsule 25's: 352.50 MRP

Gen. MedInfo

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (''mood elevators'') such as duloxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take duloxetine, but in some cases, a doctor may decide that duloxetine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take duloxetine or other antidepressants even if you are an adult over 24 years of age. These changes may occur even if you do not have a mental illness and you are taking duloxetine to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive or hostile behavior; irritability; acting without thinking; severe restlessness; frenzied abnormal excitement; or any other unusual changes in behavior. Be sure that your family or caregiver checks on you daily and knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking duloxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with duloxetine. Read the information carefully and ask your doctor if you have any questions. You also can obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood), depression, or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is Duloxetine prescribed?

Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes) and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Duloxetine is also used to treat ongoing bone or muscle pain such as lower back pain or osteoarthritis (joint pain or stiffness that may worsen over time). Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.

How should Duloxetine be used? 

Duloxetine comes as a delayed-release (long-acting) capsule to take by mouth. When duloxetine is used to treat depression, it is usually taken once or twice a day with or without food. When duloxetine is used to treat generalized anxiety disorder, the pain of diabetic neuropathy, fibromyalgia, or ongoing bone or muscle pain, it is usually taken once a day with or without food. Take duloxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take duloxetine exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. Do not open the capsules and mix the contents with liquids or sprinkle the contents on food.

Your doctor may start you on a low dose of medication and increase your dose after one week.

Duloxetine may help control your symptoms but will not cure your condition. It may take 1 to 4 weeks or longer before you feel the full benefit of duloxetine. Continue to take duloxetine even if you feel well. Do not stop taking duloxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking duloxetine, you may experience withdrawal symptoms such as nausea; vomiting; diarrhea; anxiety; dizziness; tiredness; headache; pain, burning, numbness, or tingling in the hands or feet; irritability; difficulty falling asleep or staying asleep; sweating; and nightmares. inform your doctor if you experience any of these symptoms when your dose of duloxetine is decreased.

Other uses for Duloxetine 

Duloxetine is also sometimes used to treat stress urinary incontinence (leakage of urine during physical activity such as coughing, sneezing, laughing, and exercise) in women. Talk to your doctor about using Duloxetine to treat your condition.

Duloxetine may be prescribed for other uses; ask your doctor for more information.

What special precautions to follow?

Before taking duloxetine,

  • inform your doctor if you are allergic to duloxetine, any other medications, or any of the ingredients in duloxetine capsules. Ask your doctor for a list of the ingredients.
  • inform your doctor if you are taking thioridazine or a monoamine oxidase (MAO) inhibitor, such as isocarboxazid, linezolid; methylene blue; phenelzine, selegiline, and tranylcypromine an MAO inhibitor.
  • inform your doctor what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin;  antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine; antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs  such as ibuprofen  and naproxen; buspirone; cimetidine; diuretics; fentanyl; medications for irregular heartbeat such as amiodarone, flecainide, moricizine, propafenone, and quinidine; medications for anxiety, high blood pressure, mental illness, pain, and nausea; propranolol; medications for migraine headaches such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan; lithium; proton pump inhibitors such as lansoprazole, omeprazole, pantoprazole, and rabeprazole; quinolone antibiotics such as ciprofloxacin  and enoxacin; sedatives; certain selective serotonin reuptake inhibitors  such as fluoxetine, fluvoxamine  and paroxetine; sibutramine; sleeping pills; theophylline; tramadol; and tranquilizers. Many other medications may interact with duloxetine, so be sure to inform your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor what nutritional supplements and herbal products you are taking, especially products containing St. John's wort or tryptophan.
  • inform your doctor if you have or have ever had glaucoma (an eye condition). Your doctor may tell you that you should not take duloxetine.
  • inform your doctor if you drink or have ever drunk large amounts of alcohol or if you use or have ever used street drugs or have ever overused prescription medications. Also inform your doctor if you have or have ever had a heart attack; high blood pressure; seizures; coronary artery disease (blockage or narrowing of the blood vessels that lead to the heart); or heart, liver, or kidney disease. If you have diabetes, be sure to talk to your doctor about how serious your condition is so your doctor can decide if duloxetine is right for you.
  • inform your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking duloxetine, call your doctor. Duloxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking duloxetine.
  • you should know that duloxetine may make you drowsy, dizzy, or may affect your judgment, thinking or coordination. Do not drive a car or operate machinery until you know how Duloxetine affects you.
  • ask your doctor about the safe use of alcoholic beverages while you are taking duloxetine. Alcohol can increase the risk of serious side effects from duloxetine.
  • you should know that duloxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking duloxetine or with an increase in dose. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that duloxetine may cause high blood pressure. You should have your blood pressure checked before starting treatment and regularly while you are taking Duloxetine.

What special dietary instructions to follow? 

Unless your doctor tells you otherwise, continue your normal diet.

What to do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can Duloxetine cause? 

Duloxetine may cause side effects. inform your doctor if any of these symptoms are severe or do not go away: 

  • nausea

  • vomiting

  • constipation

  • diarrhea

  • heartburn

  • stomach pain

  • decreased appetite

  • dry mouth

  • increased urination

  • difficulty urinating

  • sweating or night sweats

  • dizziness

  • headache

  • tiredness

  • weakness

  • drowsiness

  • muscle pain or cramps

  • changes in sexual desire or ability

  • uncontrollable shaking of a part of the body

Some side effects can be serious. If you experience any of the following side effects, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • unusual bruising or bleeding

  • pain in the upper right part of the stomach

  • swelling of the abdomen

  • itching

  • yellowing of the skin or eyes

  • dark colored urine

  • loss of appetite

  • extreme tiredness or weakness

  • confusion

  • flu-like symptoms

  • fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness

  • blurred vision

  • fever

  • blisters or peeling skin

  • rash

  • hives

  • difficulty breathing or swallowing

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

  • hoarseness

Duloxetine may cause other side effects. Call your doctor if you have any unusual problems while taking Duloxetine.

What to know about storage and disposal of Duloxetine? 

Keep Duloxetine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose 

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include the following: 

  • agitation

  • hallucinating (seeing things or hearing voices that do not exist)

  • fast heartbeat

  • fever

  • loss of coordination

  • nausea

  • vomiting

  • diarrhea

  • drowsiness

  • seizures

  • dizziness

  • lightheadedness

  • fainting

  • unresponsiveness

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Duloxetine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.