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INTRODUCTION
PREGALIFT NT TABLET is a combination of Nortriptyline and Pregabalin which belongs to the group of medicines called Tricyclic antidepressants and Anticonvulsants respectively. PREGALIFT NT TABLET is indicated for the treatment of neuropathic pain. Neuropathic pain is a chronic painful nerve condition caused by damage or disease affecting the somatosensory (sense of touch) nervous system.
It can be caused by injury or disease of spinal cord and/or brain, prolonged diabetes mellitus (Ex. diabetic neuropathy), infectious diseases (such as HIV infection or leprosy), chemotherapy, auto-immune disease (Ex. Guillain-Barre syndrome), post-herpetic neuralgia (a long-lasting painful condition that affects the areas around the skin and nerve fibers where shingles were present), fibromyalgia (generalized musculoskeletal pain with fatigue and altered sleep, memory, and mood) or by other metabolic dysfunctions.
Symptoms include shooting, burning or stabbing pain for normal daily activities that are typically not painful, tingling and numbness or spontaneous pain (pain without stimulus).
Continue to take PREGALIFT NT TABLET as long as your doctor tells you to do so because premature discontinuation can cause withdrawal symptoms like insomnia, headache, nausea, anxiety, diarrhea, depression, convulsion and excessive perspiration.
PREGALIFT NT TABLET can increase the risk of suicidal thoughts and behavior in some individuals and therefore patients (or caregivers) should seek immediate medical advice if any such signs emerge.
PREGALIFT NT TABLET is not recommended for use in patients having severe heart or kidney disease. Consult your doctor before taking PREGALIFT NT TABLET. This medicine is not recommended for use in pregnant women unless advised by the doctor and it is not recommended for use in breastfeeding women.
PREGALIFT NT TABLET is strictly not recommended for use in children aged below 6 years and it should be taken with caution in elderly patients (aged 65 years or above).
The most common side effects of taking PREGALIFT NT TABLET are nausea, vomiting, constipation, dizziness, headache, flatulence and dry mouth. Consult your doctor if any of the side effects worsen.
USES OF PREGALIFT NT TABLET
- Treats neuropathic pain
HOW PREGALIFT NT TABLET WORKS
PREGALIFT NT TABLET effectively relieves nerve pain, where nortriptyline acts by inhibiting the movement of pain signals from the brain by blocking the reuptake of certain chemical messengers (norepinephrine and serotonin) at the pre-synapse and pregabalin acts by interfering with influx of calcium and various pain signals travelling through the damaged nerves and the brain, thus leading to a significant pain relief in various neuropathic pain states.
DIRECTIONS FOR USE
Always take PREGALIFT NT 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 PREGALIFT NT TABLET for you depending upon your age, body weight and disease condition. Do not stop taking PREGALIFT NT TABLET without informing your doctor.
SIDE EFFECTS OF PREGALIFT NT TABLET
COMMON
- dizziness, drowsiness, headache
- nausea or vomiting
- dry mouth
- diarrhea, constipation, swollen abdomen, flatulence
- increased appetite, weight gain
- blurred vision
- vertigo (spinning sensation)
- mania, confusion, irritability, disorientation
- insomnia (lack of sleep) or sleepiness
- decreased sex drive, erectile dysfunction
- lack of control over body movements, tremor (shaking)
- memory impairment, attention disturbance
- dysarthria (unable to speak properly)
- numbness or pain in the body
- generalized edema (swelling of the body including extremities)
- muscle cramps
- pain in the joints, back or limbs
- sore throat
UNCOMMON
- loss of appetite and weight loss
- decreased blood glucose level
- low self-esteem, depression, agitation, hallucinations, nightmares, panic attack, apathy
- mental impairment or difficulty with thinking
- increase in sexual interest
- eye problems (problems in vision, dry eyes, eye irritation, swelling or pain)
- skin sensitivity, loss of taste
- weakness or fainting
- increased sensitivity to noise
- heart problems (such as changes in heart rate, changes in blood pressure or heart failure)
- hot flushes
- difficulty in breathing, dry nose, nasal congestion
- increased saliva secretion, heartburn, numbness around the mouth
- skin rash, sweating, chills with fever
- muscle stiffness or twitching, joint swelling, neck pain
- pain in breasts
- difficulty or painful urination, increased urge to urinate
- excessive thirst, chest tightness
- severe allergic reactions (such as swollen face, itching, nasal congestion, nasal bleeds, cough, and snoring)
- painful menstrual periods
- chillness of hands and feet
RARE
- ascites (fluid buildup in abdomen)
- fluid buildup in the lungs
- discharge from the breast or abnormal breast growth
- gynecomastia (breast enlargement in males)
- cold sweat, swollen throat, tightness of throat
- difficulty in swallowing
- abnormal smell sense
- altered vision, vision loss, dilated pupils, cross eyes
- inflammation of the pancreas
- slow or reduced movement of the body
- difficulty in writing
- convulsions
- irregular menstrual cycle
- rhabdomyolysis (muscle damage)
- kidney failure, decreased urine output, difficulty in urination
- allergic reactions (such as difficulty in breathing, inflammation of the eyes and a serious skin reaction characterized by rash, blisters, pain, and skin peeling)
- liver problems (such as jaundice (yellowing of the skin and eyes), liver failure or hepatitis (inflammation of the liver))
Stop taking PREGALIFT NT TABLET and consult your doctor immediately if you experience the following side effects:
- swollen face or tongue
- skin redness with blisters or peeling
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take PREGALIFT NT TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.
Dizziness:
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 did not improve.
Constipation:
Eat fiber rich foods such as fresh fruits, vegetables, cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.
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
PREGALIFT NT TABLET is not recommended for use in pregnant women or women of childbearing age unless considered clearly necessary. Consult your doctor before taking PREGALIFT NT TABLET.
BREASTFEEDING
PREGALIFT NT TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking PREGALIFT NT TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any tools or machines if you experience impairment of mental and physical, dizziness or sleepiness after taking PREGALIFT NT TABLET.
ALCOHOL
Avoid consumption of alcohol while taking PREGALIFT NT TABLET as it could make you feel dizzier or sleepier.
KIDNEY
PREGALIFT NT TABLET should be taken with caution in patients with kidney disease. Consult your doctor before taking PREGALIFT NT TABLET.
LIVER
PREGALIFT NT TABLET is not recommended for use in patients having severe liver disease and should be used with caution in patients with liver disease. Consult your doctor before taking PREGALIFT NT TABLET.
ALLERGY
Do not take PREGALIFT NT TABLET if you are allergic to Pregabalin, Nortriptyline or any other tricyclic antidepressants such as amitriptyline, imipramine.
HEART DISEASE
PREGALIFT NT TABLET is not recommended for use in patients having heart disease (such as recent heart attack, heart block or cardiac arrhythmias). Consult your doctor before taking PREGALIFT NT TABLET.
OTHERS
PREGALIFT NT TABLET is not recommended for use if you:
- have mania (abnormally excited mood)
Before taking PREGALIFT NT TABLET, inform your physician if you:
- have anxiety, hyperactivity or schizophrenia (disorder of thinking)
- have or had a history of alcoholism or substance abuse
- have suicidal ideation or aggressive behavior
- have or had a history of epilepsy
- have thyroid disorder
- are going to have an electroconvulsive therapy
- have diabetes
- have an enlarged prostate
- are going to receive an anesthetic
- have narrow angle glaucoma (an eye condition)
Use in pediatrics:
PREGALIFT NT TABLET is strictly not recommended for use in children aged below 6 years. Consult your child’s doctor for advice.
Use in geriatrics:
PREGALIFT NT TABLET should be taken with caution in elderly patients (aged 65 years or above). Proper dose titration (preferably lower doses) and careful monitoring are required to rule out any unwanted side effects. Consult your doctor for advice before taking PREGALIFT NT TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking PREGALIFT NT TABLET inform to your doctor, if you are taking any of these medicines:
- other antidepressants (used to treat depression) Ex. fluoxetine, sertraline, amitriptyline, imipramine
- antipsychotics (used to treat mental illness) Ex. chlorpromazine, fluphenazine, mesoridazine, perphenazine, prochlorperazine, thioridazine
- sympathomimetic agents (used to treat respiratory or circulatory disorders) Ex. ephedrine, adrenaline, noradrenaline, isoprenaline, phenylephrine and phenylpropanolamine
- medicines used to treat high blood pressure (Ex. guanethidine, betanidine, debrisoquine, clonidine, reserpine)
- medicines used to treat irregular heartbeat (Ex. quinidine, propafenone, flecainide and encainide)
- valproic acid, carbamazepine (used to treat epilepsy)
- medicines used to reduce anxiety such as barbiturates (Ex. phenobarbital, pentobarbital) or lorazepam
- cimetidine (used to treat stomach ulcers)
- oxycodone (used to treat pain)
Overdosage:
If you or anyone else accidentally take too much of PREGALIFT NT TABLET, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of PREGALIFT NT TABLET include somnolence, restlessness, confusion, dizziness, change in body temperature, vomiting, blurred vision, abnormal heart rate, seizures, dry mouth or breathing difficulties.
SYNOPSIS
| Drug | : | Nortriptyline, Pregabalin |
| Pharmacological Category | : | Tricyclic antidepressants, Anticonvulsants |
| Therapeutic Indication | : | Neuropathic pain |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep PREGALIFT NT TABLET out of reach of children
- Store PREGALIFT NT TABLET at room temperature
FAQs ABOUT PREGALIFT NT TABLET
Can I stop taking PREGALIFT NT TABLET once my pain is relieved?
No, do not stop taking PREGALIFT NT TABLET abruptly on your own without consulting your doctor, because premature discontinuation of this medicine can cause withdrawal symptoms like insomnia, headache, nausea, anxiety, diarrhea, depression, convulsion and excessive perspiration in some individuals. If there is a need for stopping PREGALIFT NT TABLET, your doctor will closely monitor your health condition and gradually reduce the dose over time. For more information, consult your doctor.
Can I consume alcohol while taking PREGALIFT NT TABLET?
No, avoid consumption of alcohol while taking PREGALIFT NT TABLET as it could make you feel dizzier or drowsier. PREGALIFT NT TABLET can also increase the risk of depressive side effects like thoughts of self-harming or killing, extreme sadness, agitation or irritability especially in patients with history of emotional disturbances or suicidal ideation.
Can PREGALIFT NT TABLET affect sex drive?
PREGALIFT NT TABLET can affect the sexual life of both men and women. It may cause decreased sex libido, erectile dysfunction or discomfort during intercourse in some individuals. If you experience any of these symptoms while taking PREGALIFT NT TABLET, contact your doctor immediately.
Will PREGALIFT NT TABLET be more effective at doses higher than the recommended dose?
No, always take PREGALIFT NT TABLET as advised by your physician to avoid unwanted side effects. Your doctor will select the correct dose of PREGALIFT NT TABLET and duration of therapy depending upon your age, body weight and health condition. Consuming a higher dose than the recommended dose may lead to toxicity or increased risk of harmful side effects. Consult your doctor if the recommended dosage of PREGALIFT NT TABLET does not completely relieve your pain.
What to do if I forget to take PREGALIFT NT TABLET?
You should take PREGALIFT NT TABLET immediately when you remember. If it is time for your next dose of PREGALIFT NT TABLET skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
Can PREGALIFT NT TABLET cause weight gain?
Yes, PREGALIFT NT TABLET can cause weight gain in some individuals mainly due to its effects on appetite and taste alternation. To manage weight, try to exercise regularly and cut down extra calorie intake. If you are still bothered about weight gain, please consult your doctor.
REFERENCES
1. KD. Tripathi. Antiepileptic Drugs and Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 419-420 & 455-460.
2. Gerald G. Briggs and Roger K. Freeman. P. and N. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3223-3225 & 2822-2824.
3. Shazli Azmi, Kariem T. ElHadd, Andrew Nelson, Adam Chapman, Frank L. Bowling, Anughara Perumbalath, Jonathan Lim, Andrew Marshall, Rayaz A. Malik, and Uazman Alam. Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review. NCBI; PMC US National Library of Medicine, National Institute of Health. [Revised in February 2019]. [Accessed on 27th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6349275/
4. Kanika khajuria, Seema gupta, Dev raj dogra, Dinesh kumar and Vijay Khajuria. Comparison Of Pregabalin And Nortriptyline On Efficacy And Safety In Postherpetic Neuralgia. Asian Journal of Pharmaceutical and Clinical research. July 2021. [Accessed on 27th October 2021] https://innovareacademics.in/journals/index.php/ajpcr/article/view/41872
5. Santosh Bhusal, Sherilyn Diomampo, and Marina N Magrey. Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2016. [Accessed on 27th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4762578/
6. Cory Toth. Pregabalin: latest safety evidence and clinical implications for the management of neuropathic pain. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2014. [Accessed on 27th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110876/
7. Dalim Kumar Baidya, Anil Agarwal, Puneet Khanna, and Mahesh Kumar Arora. Pregabalin in acute and chronic pain. NCBI; PMC US National Library of Medicine, National Institute of Health. July-September 2011. [Accessed on 27th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3161452/
8. Sheena Derry, Philip J Wiffen, Dominic Aldington, R Andrew Moore and Cochrane Pain. Nortriptyline for neuropathic pain in adults. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2015. [Accessed on 27th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485407/
9. Akums Drugs & Pharmaceuticals Ltd. Pregalin NT. Torrentian.com. [Revised in November 2019]. [Accessed on 27th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2774.pdf
10. John lee Pharmaceuticals Pvt. Ltd. Prebel-N. [Accessed on 27th October 2021] https://johnleeindia.com/product/prebel-n/
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