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INTRODUCTION

TRYPTOBAL TABLET is a combination of Amitriptyline and Methylcobalamin, which belong to a group of medicines called Tricyclic antidepressants and Vitamins, respectively. It is used in the management of neuropathic pain which is a type of pain caused by 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 which is generally characterized by symptoms such as spontaneous pain which may be of shooting, burning, stabbing or electric shock-like pain, with tingling and numbness feeling.

Avoid taking TRYPTOBAL TABLET if you are allergic to Amitriptyline and Methylcobalamin or have a history of urinary retention due to enlargement of the prostate gland (benign prostatic hypertrophy), myocardial infarction (heart attack), congestive heart failure and/or impaired liver function.

Before taking TRYPTOBAL TABLET, inform your doctor if you have a history of seizures, blood dyscrasias, urinary retention, narrow-angle glaucoma (an eye disorder), increased intraocular (eye) pressure, an overactive thyroid, suicidal thoughts or kidney problems.

TRYPTOBAL TABLET is not recommended for use during pregnancy and in breastfeeding women; it is also not recommended for use in children and adolescents (below 18 years). The most common symptoms of taking TRYPTOBAL TABLET are sleepiness, drowsiness, shakiness of hands or other body parts, dizziness, headache, dry mouth and constipation. Consult your doctor if any of your symptoms get worse.

USES OF TRYPTOBAL TABLET

  • Management of neuropathic pain

HOW TRYPTOBAL TABLET WORKS

TRYPTOBAL TABLET helps to manage neuropathic pain, where amitriptyline increases the levels of certain chemical messengers (serotonin and noradrenaline) that stop the movement of pain signals in the brain and methylcobalamin helps in the production of myelin, a substance that protects the nerve fibres and rejuvenates damaged nerve cells, which together acting with amitriptyline provides relief from neuropathic pain due to damaged nerves.

DIRECTIONS FOR USE

Take TRYPTOBAL TABLET as advised by your physician. Swallow TRYPTOBAL TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF TRYPTOBAL TABLET

COMMON

  • sleepiness
  • drowsiness
  • shakiness of hands or other body parts
  • dizziness
  • headache
  • irregular, hard or rapid heartbeat
  • dizziness due to low blood pressure (orthostatic hypotension)
  • dry mouth
  • constipation
  • nausea
  • excessive sweating
  • weight gain
  • slurred or slow speech
  • aggression
  • problem with the ability of the eye to change its focus from distant to near objects (and vice versa)
  • congested nose
  • confusion
  • sexual disturbances (decreased sex drive, problems with erection)
  • disturbance in attention
  • changes in taste
  • numbness or tingling sensation in the arms or legs
  • disturbed coordination
  • dilated pupils
  • heart block
  • weakness
  • agitation
  • urination disorders such as incontinence, kidney stones and kidney failure
  • feeling thirsty

UNCOMMON

  • excitement, anxiety, difficulty sleeping, nightmares
  • convulsions (fits)
  • tinnitus (ringing or buzzing noise in ears)
  • increased blood pressure
  • diarrhea
  • vomiting
  • skin rash, nettle rash, swelling of the face and tongue
  • difficulties passing urine
  • increased production of breast milk or breast milk outflow without breastfeeding
  • increased pressure in the eyeball
  • collapse conditions
  • worsening of cardiac failure
  • liver function impairment such as cholestatic liver disease

RARE

  • decreased appetite
  • delirium (especially in elderly patients)
  • hallucinations
  • abnormality in the heart's rhythm or heartbeat pattern
  • swelling of the salivary glands
  • hair loss
  • increased sensitivity to sunlight
  • breast enlargement in men
  • fever
  • weight loss

Stop taking TRYPTOBAL TABLET and contact your doctor if you experience any of the following side effects:

  • signs of acute glaucoma (serious eye condition) such as attacks of intermittent blurring of vision, rainbow vision and eye pain
  • signs of prolonged qt interval such as fast, chaotic heartbeats
  • signs of the paralyzed intestine such as bad constipation, a swollen stomach, fever and vomiting
  • signs of jaundice such as yellowing of the skin and the white in the eyes
  • signs of blood or bone marrow effects such as bruising, bleeding, pallor or persistent sore throat and fever
  • suicidal thoughts or behaviour

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest, relax and get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.

Headache:

If TRYPTOBAL TABLET causes a headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Paracetamol is safe to be taken with these medicines. Headaches should usually go away after the first week of taking TRYPTOBAL TABLET. If headaches last more than a week or are severe, inform your doctor.

Nausea and vomiting:

Try to take TRYPTOBAL TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Constipation:

Try to eat more high-fiber foods, such as fresh fruit, vegetables and cereals and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor about receiving alternate treatments for constipation.

Diarrhea:

Drink lots of fluids, such as water, to keep yourself hydrated. Try to avoid taking any medicine to treat diarrhoea. Consult your doctor if the symptom worsens.

WARNING & PRECAUTIONS

PREGNANCY

TRYPTOBAL TABLET is not recommended for use during pregnancy or in women with childbearing potential. Consult your doctor before taking TRYPTOBAL TABLET.

BREASTFEEDING

TRYPTOBAL TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking TRYPTOBAL TABLET.

DRIVING AND USING MACHINES

TRYPTOBAL TABLET might cause dizziness or drowsiness. If you experience these side effects, try to avoid driving or operating heavy machines. Consult your doctor before taking TRYPTOBAL TABLET.

ALCOHOL

Avoid consumption of alcohol while taking TRYPTOBAL TABLET since it increases the sedative effect.

KIDNEY

TRYPTOBAL TABLET should be used with caution in patients with kidney problems such as renal failure. Consult your doctor before taking TRYPTOBAL TABLET.

LIVER

TRYPTOBAL TABLET is not recommended for use in patients with impaired liver function. Consult your doctor before taking TRYPTOBAL TABLET.

ALLERGY

TRYPTOBAL TABLET is not recommended for use if you are allergic to Amitriptyline, Methylcobalamin or any other ingredients of this medicine.

HEART DISEASE

TRYPTOBAL TABLET is not recommended for use if you have heart diseases such as myocardial infarction (heart attack) and congestive heart failure. Consult your doctor before taking TRYPTOBAL TABLET.

OTHERS

TRYPTOBAL TABLET is not recommended for use if you:

  • have a history of urinary retention due to enlargement of the prostate gland (benign prostatic hypertrophy)

Before taking TRYPTOBAL TABLET, inform your doctor if you:                                                                   

  • have a history of seizures
  • have  a history of blood dyscrasias
  • have a history of urinary retention
  • have a history of narrow-angle glaucoma
  • have a history of increased intraocular pressure
  • have hyperthyroidism
  • have suicidal thoughts

Use in Pediatrics:

TRYPTOBAL TABLET should be used with caution in children and adolescents (below 18 years). Consult your doctor before taking TRYPTOBAL TABLET.

Use in Geriatrics:

TRYPTOBAL TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking TRYPTOBAL TABLET.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking TRYPTOBAL TABLET, inform your doctor, if you are taking any of the following medicine:

  • guanethidine (a medicine used to treat hypertension)
  • anticholinergic agents (a medicine used to treat overactive bladder) Ex. atropine, belladonna alkaloids, benztropine mesylate
  • sympathomimetic drugs (medicines used to treat glaucoma, anaphylactic shock, chronic obstructive pulmonary disease) Ex. benzphetamine, ritodrine
  • cimetidine (a medicine used to treat ulcers)
  • ethchlorvynol (a medicine used to treat insomnia)
  • barbiturates (a medicine used to treat seizures)
  • neomycin (a medicine used to prevent or treat bacterial skin infections)
  • aminosalicylic acid (a medicine used for tuberculosis)
  • H2- blockers (a medicine used for gastric ulcers) Ex. famotidine, nizatidine and ranitidine
  • colchicine (a medicine used to treat inflammation and pain)
  • oral contraceptives (a medicine used for birth control) such as sprintec, taytulla
  • parenteral chloramphenicol (a medicine used for superficial eye infections)

Overdosage:

If you or anyone else accidentally takes too much of TRYPTOBAL TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are temporary confusion, disturbed concentration or transient visual hallucinations, hypothermia (a dangerous drop in temperature), drowsiness,  fast heart rate, bundle branch block, congestive heart failure, dilated pupils, disorders of ocular motility (eye movement), convulsions, severe low blood pressure,  stupor (state of unconsciousness), coma, polyradiculoneuropathy (autoimmune disorder); constipation, agitation, muscle rigidity, overactive reflexes, high fever and vomiting.

SYNOPSIS

Drug :   Amitriptyline, Methylcobalamin
Pharmacological Category :   Tricyclic antidepressants and Vitamins
Therapeutic Indication :   Neuropathic pain
Dosage Forms :   Tablet

MORE INFORMATION

  • Keep the medicine out of reach from children
  • Store TRYPTOBAL TABLET at room temperature

FAQs ABOUT TRYPTOBAL TABLET

Q: What is the function of TRYPTOBAL TABLET?

TRYPTOBAL TABLET is used in the management of neuropathic pain, which is a type of pain caused by 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.

Q: Who should avoid taking TRYPTOBAL TABLET?

A: TRYPTOBAL TABLET is not recommended for use in patients who are allergic to Amitriptyline and Methylcobalamin, have a history of urinary retention due to enlargement of the prostate gland (benign prostatic hypertrophy), myocardial infarction (heart attack), congestive heart failure, impaired liver function or are pregnant or breastfeeding women.

Q: What side effects are seen with TRYPTOBAL TABLET?

A: The most common symptoms of taking TRYPTOBAL TABLET are sleepiness, drowsiness, shakiness of hands or other body parts, dizziness, headache, dry mouth and constipation. Consult your doctor if any of these symptoms get worse.

Q: Is it safe to drive after taking TRYPTOBAL TABLET?

A: TRYPTOBAL TABLET might cause dizziness or drowsiness. If you experience these side effects, try to avoid driving or operating heavy machines. Consult your doctor before taking TRYPTOBAL TABLET.

Q: What happens if you take more TRYPTOBAL TABLET than your required dose?

A: If you or anyone else accidentally takes too much TRYPTOBAL TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are temporary confusion, disturbed concentration, visual hallucinations, hypothermia (a dangerous drop in temperature), drowsiness, a fast heart rate, congestive heart failure, dilated pupils, convulsions, severe low blood pressure, stupor (state of unconsciousness), coma, constipation, agitation, muscle rigidity, overactive reflexes, a high fever and vomiting.

REFERENCES

1. KD Tripathi. Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs & Haematinics and Erythropoietin. Essentials of medical pharmacology. Seventh edition. 2013. Page – 464 & 608.

2. EpiCept Corporation.A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in May 2011] [Accessed on 7th June 2022] https://clinicaltrials.gov/ct2/show/NCT00476151

3. Clair Haslam and Turo Nurmikk. Pharmacological treatment of neuropathic pain in older persons. NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. March 2008. [Accessed on 7th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2544357/

4. Brown & Burk UK Ltd. Electronic medicines compendium (EMC). [Revised in January 2022] [Accessed on 7th June 2022] https://www.medicines.org.uk/emc/files/pil.10850.pdf

5. The madras pharmaceuticals. Am Nursing Tablets. [Revised in January 2022] [Accessed on 7th June 2022] https://www.centaurpharma.com/downloads/2022/neurology/Am-Nuring.pdf

USEFUL DIAGNOSTIC TESTS

  • Cryoglobulins
  • Cerebrospinal fluid analysis

AUTHOR DETAILS

Written By Dr. Dhivakaran R, BDS
Last updated on 27 Dec 2022 | 10:02 AM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Shelf Life
    540
    Item Weight
    17.5 g
    Ingredient
    Amitriptyline 10 mg+Methylcobalamin 1500 mcg
    Hsn Code
    30049099
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TRYPTOBAL Tablet 10's
TRYPTOBAL Tablet 10's Mkt: LeeWell Pharmaceutical Pvt Ltd
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