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INTEGRACE PVT LTD

Dubinor Tablet 10'S

Neuropathic Pain
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    Introduction About DUBINOR TABLET

    DUBINOR TABLET is a combination of Methylcobalamin, Nortriptyline and Pregabalin which belongs to the group of medicines called Vitamins, Antidepressants and Anticonvulsants respectively. It is used to manage diabetic peripheral neuropathic pain with coexistent vitamin B12 deficiency.

    Neuropathic pain is a form of pain where there is a damage or injury to the nerves that transfer information between the brain and spinal cord from the skin, muscles and other parts of the body.

    Patients taking DUBINOR TABLET may have thoughts of harming or killing themselves. If at any time you have these thoughts, immediately consult your physician. Avoid consumption of alcohol during management with DUBINOR TABLET as it may cause dizziness.

    Before taking DUBINOR TABLET, inform your physician if you have liver or kidney problems, diabetes and angioedema. DUBINOR TABLET is not recommended for use in pregnant women unless advised by the doctor and not recommended for breast-feeding women.

    Elderly patients above 65 years of age always should consult the physician before taking it. The most common side effect of DUBINOR TABLET are dry mouth, dizziness, sleepiness, blurred vision and weight gain. Consult your doctor if any of the side effects worsen over the time.     

    Uses Of DUBINOR TABLET

    • Manage diabetic peripheral neuropathic pain with coexistent vitamin B12 deficiency

    How DUBINOR TABLET Works

    DUBINOR TABLET is a combination of methylcobalamin, nortriptyline and pregabalin, where methylcobalamin is a form of vitamin B that helps in the production of myelin (a substance that protects nerve fibers) and regenerates damaged nerve cells. Nortriptyline is a tricyclic antidepressant that increases the chemical messenger levels (serotonin and noradrenaline) that stops the movement of pain signals in the brain. Pregabalin is an anticonvulsant (alpha 2 delta ligand) that decreases pain by altering the calcium channel activity of the nerve cells. Together, methylcobalamin, nortriptyline and pregabalin helps to relieve neuropathic pain (pain from damaged nerves).

    How to use DUBINOR TABLET

    Always take DUBINOR TABLET as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose and duration of DUBINOR TABLET for you depending upon your age, body weight and disease condition. Do not stop taking DUBINOR TABLET without informing your doctor.    

    Side Effects Of DUBINOR TABLET

    Common

    • dizziness, sleepiness
    • trouble concentrating, blurry vision
    • dry mouth
    • weight gain
    • swelling of your hands or feet

    Rare

    Stop taking DUBINOR TABLET and contact your physician immediately if you experience any of the following side effects:

    • hypersensitivity or allergic reactions (symptoms include skin redness, blisters, hives, rash, dyspnoea and wheezing)
    • have feelings of harming or killing themselves

    How To Manage Side Effects

    Dizziness Or Drowsiness

    Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom does not improve.  

    Dry Mouth

    Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    Monitoring required

    DUBINOR TABLET is generally not recommended for use in pregnant women unless considered clearly necessary. Consult your doctor before taking it.

    Breastfeeding

    Contraindicated

    DUBINOR TABLET is generally not recommended for use in breastfeeding women as it may pass through breast milk. Consult your physician before taking it.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate heavy machines if you experience dizziness while taking DUBINOR TABLET. Consult with your physician for advice before taking the medicine.

    Alcohol

    Contraindicated

    Consumption of alcohol is not recommended during management with DUBINOR TABLET as it may cause dizziness.

    Kidney

    Use with Caution

    DUBINOR TABLET should be used with caution in patients with kidney problems. Consult with your doctor for advice before taking DUBINOR TABLET.

    Liver

    Use with Caution

    DUBINOR TABLET should be used with caution in patients with liver problems. Consult with your doctor for advice before taking DUBINOR TABLET.

    Allergy

    Contraindicated

    Do not take DUBINOR TABLET if you are allergic to Methylcobalamin, Nortriptyline, Pregabalin or any other ingredients of this medicine.

    Use In Geriatrics

    Use with Caution

    DUBINOR TABLET should be used with caution in elderly patients above 65 years of age. Consult with your physician for advice before taking DUBINOR TABLET.

    Others

    Before taking DUBINOR TABLET, inform your physician if you have:

    • angioedema
    • diabetes
    • major depressive disorder

    Interactions

    A. Drug-Drug interactions:

    Before taking DUBINOR TABLET inform your physician if you are taking any of the following medicines:

    • medicines used as opioid analgesics such as oxycodone, tramadol (used to manage severe pain)
    • medicine used to manage depression and anxiety (Ex. lorazepam, diazepam, MAO inhibitors like isocarboxazid)
    • medicines used to manage gastroesophageal reflux (Ex. cimetidine, ranitidine)
    • oral contraceptives such as desogestrel and ethinyl estradiol (used to manage pregnancy)
    • medicines used for cancer chemotherapy (Ex. arsenic trioxide)
    • medicines used to manage bacterial infections (Ex. chloramphenicol, azithromycin, clarithromycin and linezolid)
    • reserpine (used to manage high blood pressure)
    • anticholinergic drugs such as dicyclomine (used to manage the symptoms of irritable bowel syndrome)
    • sympathomimetic drugs such as norepinephrine (used to raise blood pressure in emergency condition)

    Overdosage:

    If you or anyone else accidentally takes too much of DUBINOR TABLET, consult your physician immediately or visit the nearby hospital.

    Synopsis

    Drug :   Methylcobalamin, Nortriptyline, Pregabalin
    Pharmacological Category :   Vitamin, Tricyclic antidepressant and Anticonvulsant
    Therapeutic Indication :   Neuropathic Pain
    Dosage Forms :   Capsule, Tablet

    More Information

    • Keep DUBINOR TABLET out of reach to children
    • Store at room temperature

    FAQs About DUBINOR TABLET

    Q: When to seek medical emergency while taking DUBINOR TABLET?

    A: Stop taking DUBINOR TABLET and contact your physician immediately if you experience angioedema (symptoms include swelling of the face, mouth (tongue, lips and gums) and neck (throat and larynx)) and have thoughts of harming or killing themselves.

    Q: What to do If I forget to take a dose of DUBINOR TABLET?

    A: You should take DUBINOR TABLET immediately when you remember. If it is time for the next dose skip the missed dose and follow the regular dose schedule. Do not double the dose to match up the missed dose.

    Q: Does DUBINOR TABLET impair my ability to drive?

    A: Yes, DUBINOR TABLET may cause dizziness, do not drive or operate any machines which require concentration because it can impair your ability to work. Follow appropriate precautions before driving or you may ask someone to drive for you after consulting with your physician.  

    Q: What is the precaution to be followed before taking DUBINOR TABLET?

    A: DUBINOR TABLET is not recommended to use among women who are breast-feeding and pregnant unless advised by the doctor. Before taking DUBINOR TABLET, inform your physician if you have liver or kidney problems, diabetes and angioedema. It should be used with caution in elderly patients.

    Q: Can DUBINOR TABLET be used in patients with liver or kidney problems?

    A: DUBINOR TABLET should be used with caution in patients with kidney or liver problems. Your doctor may monitor your liver and kidney function test to manage the risk of any unusual effects. Consult your doctor before taking it.  

    References

    1. KD. Tripathi. Drugs affecting blood and blood formation. Skeletal Muscle Relaxants. Drugs Used in Mental Illness: Antidepressant and Antianxiety. Antiepileptic Drugs. Drugs Essentials of medical pharmacology. Seventh edition. 2013. Page – 608, 457, 421.

    2. Ram Prabhoo, Atul Panghate, Raj Pavitra Dewda, Balaji More, Tanay Prabhoo, and Rajiv Rana. Efficacy and Tolerability of a Fixed-Dose Combination of Methylcobalamin and Pregabalin in the Management of Painful Neuropathy. North American Journal of Medical Sciences. NIH. National Library of  Medicine, National center for biotechnology information. Pubmed Central. November 2012. [Accessed on 26th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3503385/

    3. Sheena Derry, Philip J Wiffen, Dominic Aldington, R Andrew Moore. Nortriptyline for neuropathic pain in adults. Cochrane Database of Systematic Reviews. NIH. National Library of Medicine, National center for biotechnology information. Pubmed Central.  January 2015 [Accessed on 26th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485407/

    4. Synokem Pharmaceutical Ltd. Pregaba-MNT (Pregabalin, Methylcobalamin and Nortriptyline). Torrent Pharma. [Revised in May 2022] [Accessed on 26th July 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3088.pdf

    5. Leeford Health Care. Pregabanyl-NTM. [Accessed on 26th July 2022] https://www.leeford.in/product/782/pregabanyl-ntm

    6. Leogenic Healthcare. Pregadew Trio [Accessed on 26th July 2022] https://www.leogenic.com/pregadew-trio-nortriptyline-methylcobalamin-pregabalin-tablets/

    7. Akesiss Ltd. Norblend tablet. [Accessed on 26th July 2022] https://akesiss.com/divisions/glyvo-life/norblend/

    8. Krishlar Pharmaceuticals. Kritpre-NP. [Accessed on 26th July 2022] https://www.krishlarpharma.com/product/kritpre-np/

    Author Details

    Written By Dr. R. Dinesh John Rajkumar - Pharm.D
    Reviewed For Accuracy By Dr. Sankara Babu Gorle - MBBS, MD (Pharmacology)
    Last updated on 06 Mar 2023 | 09:05 AM(IST)
    Lab updated