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INTRODUCTION
DULOTAG 60MG TABLET contains Duloxetine which belongs to the group of medicines called Antidepressants. It is used in adults to treat major depressive disorders (persistently depressed mood, feeling of sadness and lack of interest) and generalized anxiety disorder (chronic feeling of anxiety or nervousness).
DULOTAG 60MG TABLET can also be used to treat diabetic neuropathic pain (nerve damage due to high blood sugar causing burning, stabbing, stinging, shooting or aching feeling in the affected area) and stress urinary incontinence in women. Stress Urinary Incontinence is a condition in which there is accidental leakage of urine during physical exertion or activities like laughing, sneezing, coughing, lifting or exercise.
DULOTAG 60MG TABLET is not recommended for use in patients having liver or kidney disease. Before taking DULOTAG 60MG TABLET, inform your doctor if you have heart disease, fits, mania, bipolar disorder, glaucoma, low sodium levels or a history of bleeding disorder. Alcohol should be consumed with caution during treatment with DULOTAG 60MG TABLET.
DULOTAG 60MG TABLET should be used in pregnant women only if the potential benefits justify the risks to the baby. DULOTAG 60MG TABLET is not recommended for use breastfeeding women. DULOTAG 60MG TABLET is not recommended for use in children and adolescents (under 18 years of age).
During DULOTAG 60MG TABLET treatment, call your doctor right away if you have thoughts of harming or killing yourself. The most common side effects of taking DULOTAG 60MG TABLET are nausea, dry mouth, extreme tiredness, trouble sleeping, headache, decreased sex drive, blurred eyesight, etc. If any of the symptoms deteriorate, consult your doctor.
USES OF DULOTAG 60MG TABLET
DULOTAG 60MG TABLET is used to treat:
- major depressive disorders
- diabetic neuropathic pain
- generalized anxiety disorder
- stress urinary incontinence in women
HOW DULOTAG 60MG TABLET WORKS
DULOTAG 60MG TABLET works by increasing the amount of serotonin and norepinephrine (natural substances in the brain that help maintain mental balance and stop the movement of pain signals), resulting in relief of anxiety, pain and depression. DULOTAG 60MG TABLET helps in treating stress urinary incontinence by increasing the strength of the muscle responsible for holding back urine when you laugh, sneeze or perform physical activities.
DIRECTIONS FOR USE
Take DULOTAG 60MG TABLET as advised by your physician. Swallow it with water. Do not crush or chew the medicine. You may find it easier to take DULOTAG 60MG TABLET at the same times daily to help you remember to take it.
Your doctor will decide the right dose and duration of DULOTAG 60MG TABLET treatment depending upon your age, body weight and severity of the disease. Do not stop taking DULOTAG 60MG TABLET unless your doctor advises you to stop.
SIDE EFFECTS OF DULOTAG 60MG TABLET
COMMON
- nausea, dry mouth, constipation, loss of appetite, gas
- diarrhea, heartburn, indigestion, stomach pain, vomiting
- trouble sleeping, agitation, decreased sex drive, anxiety, difficulty or failure to gain orgasm, unusual dreams
- headache, dizziness, feeling sluggish, sleepiness, shaking, numbness, pricking or tingling of the skin
- blurred eyesight, spinning sensation
- increased blood pressure, flushing, throbbing sensation
- increased sweating, weakness, shivering
- ringing in ears
- increased yawning, extreme tiredness
- itchy rash
- muscle pain or spasm
- painful or frequent urination
- trouble getting an erection, changes in ejaculation
- falls
- weight loss
UNCOMMON
- throat inflammation causing a hoarse voice
- suicidal ideas, disorientation, lack of motivation, trouble sleeping, grinding or clenching the teeth
- sudden involuntary muscular jerks or twitches, nervousness, trouble concentrating, taste changes
- difficulty controlling movement (Ex. lack of coordination, involuntary muscle movements, restless legs syndrome, poor sleep quality)
- large pupils, problems with eyesight
- spinning sensation, ear pain
- fast or irregular heartbeat
- dizziness or lightheadedness on standing up, cold fingers or toes
- throat tightness, nose bleeds
- vomiting blood or black tarry stools, gastroenteritis, burping, trouble swallowing
- liver inflammation that may cause abdominal pain and yellowing of the skin or eyes
- night sweats, hives, cold sweats, sunlight sensitivity, increased tendency to bruise
- muscle tightness or twitching
- trouble or inability to pass urine, difficulty to start urinating, needing to urinate during the night, decreased urine flow
- unusual vaginal bleeding, heavy, painful, irregular or prolonged periods, unusually light or missed periods, painful testicles or scrotum
- chest pain, feeling hot or cold, thirst, shivering, abnormal gait
- weight gain
- increased levels of liver enzymes, blood potassium, creatine phosphokinase, sugar or cholesterol
RARE
- serious allergic reaction (trouble breathing, dizziness with swollen tongue or lips)
- dehydration, low blood sodium levels (dizziness, weakness, confusion, sleepiness, tiredness, nausea, vomiting) syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
- mania (over activity, racing thoughts and reduced need for sleep), perceiving things that are not present, aggression, anger
- serotonin syndrome (feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or rigid muscles), fits
- glaucoma (increased eye pressure)
- coughing, wheezing, breathlessness which may be accompanied by a high temperature
- inflammation of the mouth or large intestine, passing bright red blood in your stools, bad breath, diarrhea
- liver failure (yellow skin or whites of the eyes)
- Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction (swollen face or throat)
- contraction of the jaw muscle
- unusual urine odour
- menopausal symptoms, unusual production of breast milk in men or women
- postpartum haemorrhage (excessive vaginal bleeding just after birth)
Stop taking DULOTAG 60MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- sensing restlessness or unable to sit or stand still
- thoughts of harming or killing self
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take DULOTAG 60MG TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – you don't have to eat or avoid any specific foods. If symptom persists, contact your doctor.
Diarrhea:
Drink plenty of liquids like water or fruit juice for hydration. If symptom persists, contact your doctor.
Constipation:
Consume a lot of fiber rich foods like fresh fruits, vegetables, cereals and drink ample amount of water. Exercise more regularly. If symptom persists, contact your doctor.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol as they can make your mouth dry, use the one that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. If symptom persists, contact your doctor.
Loss of appetite:
Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a protein-rich or other healthy snack such as dried fruit and nuts. If symptom persists, contact your doctor.
Indigestion:
Keep your head and shoulders raised up while sleeping so that stomach acid won’t come up. Avoid eating and having tea, coffee, cola or alcohol 3 to 4 hours before going to sleep. If symptom persists, contact your doctor.
Headache:
Drink plenty of water and get adequate rest. Try to be relaxed and stress free. If headache persists, consult your doctor.
Dizziness:
Lie down until you no longer feel dizzy, then get up slowly. Don’t hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. If symptom persists, consult your doctor.
Skin rash:
Avoid showering with hot water as it can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If symptom persists, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
DULOTAG 60MG TABLET should be used in pregnant women only after discussing the potential benefits and risks to your unborn child with your doctor. Consult your doctor before taking it.
BREASTFEEDING
DULOTAG 60MG TABLET is not recommended for use in breastfeeding mothers. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or use machineries if you feel dizzy or sleepy after taking DULOTAG 60MG TABLET.
ALCOHOL
Alcohol should be consumed with caution while taking DULOTAG 60MG TABLET. Consult your doctor for advice.
KIDNEY
DULOTAG 60MG TABLET is not recommended for use in patients with severe kidney disease. DULOTAG 60MG TABLET should be used with caution in other kidney diseases. Consult your doctor before taking it.
LIVER
DULOTAG 60MG TABLET is not recommended for use in patients with liver disease. Consult your doctor before taking it.
ALLERGY
Do not take DULOTAG 60MG TABLET if you are allergic to Duloxetine or any of the other ingredients of this medicine.
HEART DISEASE
DULOTAG 60MG TABLET should be used with caution in patients with high blood pressure or other heart diseases. Consult your doctor before taking it.
OTHERS
Before taking DULOTAG 60MG TABLET, inform your doctor if you:
- had fits
- had mania
- have bipolar disorder
- have eye problems (Ex. glaucoma)
- had any bleeding disorders in the past (tendency to develop bruises)
- are at risk of low sodium levels (Ex. if you are taking water tablets or are elderly)
Use in pediatrics:
DULOTAG 60MG TABLET is generally not recommended for use in children (below 18 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
DULOTAG 60MG TABLET should be used with caution in elderly patients as they are more prone to certain side effects. Consult your doctor before taking it.
INTERACTIONS
A. Drug - Drug interactions:
Before taking DULOTAG 60MG TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used as antidepressants (Ex. moclobemide, paroxetine, fluoxetine, venlafaxine, clomipramine, amitriptyline, pethidine, St John’s Wort)
- linezolid (used to treat bacterial infections)
- medicines used to treat anxiety (Ex. alprazolam, clonazepam)
- medicines used to treat severe pain (Ex. tramadol, buprenorphine)
- medicines used to treat psychotic disorders (Ex. olanzapine, quetiapine, phenobarbital)
- medicines used to treat allergic conditions (Ex. loratadine, cetirizine)
- medicines used to treat migraine (Ex. sumatriptan, naratriptan)
- tryptophan (used for protein synthesis in the body)
- medicines used to prevent blood clots (Ex. warfarin, rivaroxaban)
Overdosage:
If you or anyone else accidentally take too much of DULOTAG 60MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of DULOTAG 60MG TABLET overdosage are sleepiness, serotonin syndrome (a rare reaction causing feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, rigid muscles), fits, vomiting and fast heartrate.
SYNOPSIS
| Drug | : | Duloxetine |
| Pharmacological Category | : | Selective serotonin and norepinephrine reuptake inhibitors |
| Therapeutic Indication | : | Depression, Generalized anxiety disorder, Diabetic neuropathic pain, Stress Urinary Incontinence (in women) |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep DULOTAG 60MG TABLET out of reach of children
- Store DULOTAG 60MG TABLET at 25°C
FAQs ABOUT DULOTAG 60MG TABLET
What if I miss a dose of DULOTAG 60MG TABLET?
If you forget a dose of DULOTAG 60MG TABLET, take it as soon as you remember. However, if it is time for your next dose, skip the forgotten one and take only a single dose as usual. Leave out the missed dose if it's almost time for the next one. Do not take more than the daily amount of DULOTAG 60MG TABLET that has been prescribed for you in a day.
Can I stop taking DULOTAG 60MG TABLET on my own?
No. Do not stop taking DULOTAG 60MG TABLET without your doctor’s advice even if you feel better. Your doctor may gradually reduce the dose before stopping treatment altogether. If you stop taking DULOTAG 60MG TABLET suddenly, you may have symptoms such as dizziness, tingling feelings or electric shock-like feelings, sleep disturbances, extreme tiredness, sleepiness, restlessness, agitation, anxiety, nausea, vomiting, shaking, headaches, muscle pain, irritability, diarrhoea, excessive sweating or spinning sensation. If any of these bother you, ask your doctor for advice.
How soon can I see the effects of DULOTAG 60MG TABLET?
DULOTAG 60MG TABLET starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Your doctor may continue to give you DULOTAG 60MG TABLET when you are feeling better to prevent your depression or anxiety from returning. In people with diabetic neuropathic pain, it can take a few weeks before you feel better. Tell your doctor if you do not start to feel better after this duration.
Can DULOTAG 60MG TABLET be given to children?
No. DULOTAG 60MG TABLET is used for adults and generally not recommended for children and adolescents below 18 years of age. Your doctor may prescribe DULOTAG 60MG TABLET for patients under 18 if decided that this is in their best interests. If your doctor has prescribed DULOTAG 60MG TABLET for your child and you want to discuss this, please go back to your doctor. Inform your doctor if you see your child experiencing any symptoms like suicide attempt or ideas, aggression, oppositional behaviour and anger.
Can DULOTAG 60MG TABLET make me have suicidal thoughts?
During initial treatment with DULOTAG 60MG TABLET, you might have suicidal thoughts. In such case, call your doctor or go to a hospital straight away. You may find it helpful to confront a relative or close friend and ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.
Can I take DULOTAG 60MG TABLET on an empty stomach?
Take DULOTAG 60MG TABLET as advised by your doctor. You can take DULOTAG 60MG TABLET with or without food. Try taking DULOTAG 60MG TABLET at same time each day which will help you in remembering your dose. Consult your doctor for further queries.
REFERENCES
1. KD Tripathi. Drugs Used in Mental Illness. Essentials of Medical Pharmacology. Eighth Edition. 2019. Page – 490.
2. David J Goldstein. Duloxetine in the treatment of major depressive disorder. NIH National Library of Medicine. National center for biotechnology information. Pubmed.gov. April 2007. [Accessed on 6th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2654630/
3. Trevor R Norman, James S Olver. Duloxetine in the treatment of generalized anxiety disorder. NIH National Library of Medicine. National center for biotechnology information. Pubmed Central. December 2009. [Accessed on 6th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2840566/
4. Wolfgang Jost, Parvaneh Marsalek. Duloxetine: mechanism of action at the lower urinary tract and Onuf's nucleus. NIH National Library of Medicine. National center for biotechnology information. Pubmed.gov. August 2004. [Accessed on 6th June 2022] https://pubmed.ncbi.nlm.nih.gov/15316838/
5. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed on 6th June 2022] https://www.medicines.org.uk/emc/files/pil.6966.pdf
6. Pharmadox Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 6th June 2022] https://www.medicines.org.uk/emc/files/pil.10515.pdf
7. Icon Lifesciences. Dulotin (Duloxetin 10mg). [Accessed on 6th June 2022] https://www.iconlifesciences.in/products.php
AUTHOR DETAILS
Written By Dr. Jeenal Rajani, Pharm.D.
Last updated on 28 Oct 2022 | 02:49 PM(IST)
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