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Introduction About PRE ALDONIL OD TABLET
PRE ALDONIL OD TABLET is a combination of Epalrestat and Pregabalin which belongs to the group of medicines called Aldose reductase inhibitors and Cyclic GABA analogues respectively. It is used in the management of diabetic neuropathy (nerve pain).
Diabetic neuropathy is a nerve damage occurring over time because of high sugar and fat levels in the blood due to diabetes. Symptoms depend on the type of neuropathy, such as pain and numbness in your feet or problems with the organ functions like that of your heart and bladder.
During management with PRE ALDONIL OD TABLET, your doctor will closely monitor if you have diabetic peripheral neuropathy with irreversible organic changes. Before taking PRE ALDONIL OD TABLET, inform your doctor if you have a history of heart, liver or kidney disease, alcoholism or any drug abuse or dependence.
PRE ALDONIL OD TABLET should not be used in pregnant and breastfeeding women unless considered necessary by your doctor. The safety and effectiveness of PRE ALDONIL OD TABLET have not been established in children and adolescents (under 18 years of age), so consult your doctor before taking it.
The most common side effects of taking PRE ALDONIL OD TABLET are feeling generally unwell, headache, stomach pain, nausea, dizziness, dry mouth and constipation. Contact your doctor if any of the symptoms worsen.
Uses Of PRE ALDONIL OD TABLET
- Manage diabetic nerve pain
How PRE ALDONIL OD TABLET Works
PRE ALDONIL OD TABLET reduces pain where epalrestat inhibits an enzyme (aldose reductase) which converts glucose into sorbitol. In diabetics, there is excess sorbitol production that gets deposited in nerves and other tissues, causing diabetic neuropathy. Thus, epalrestat delays sorbitol accumulation in nerves and other tissues to delay progression of diabetic neuropathy, and pregabalin provides neuroprotection, thus managing neuronal injury or damage.
How to use PRE ALDONIL OD TABLET
Take PRE ALDONIL OD TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of PRE ALDONIL OD TABLET for you according to your age, body weight and disease condition.
Side Effects Of PRE ALDONIL OD TABLET
Common
- feeling generally unwell
- dizziness, drowsiness, headache
- increased appetite
- feeling elated, confused, disorientated, low sexual interest, irritability
- disturbance in attention, clumsiness, memory impairment or loss, shaking, trouble speaking, tingling, numbness, sleepiness, lethargy, sleep problems, tiredness, feeling abnormal
- blurred or double vision
- spinning sensation, problems with balance
- dry mouth, constipation, vomiting, gas, diarrhoea, nausea, swollen abdomen, stomach pain
- difficulties with erection
- swollen body including extremities
- unusual walking style
- weight gain
- muscle cramp, joint, back or limb pain
- sore throat
Uncommon
- loss of appetite, weight loss
- unusual eye movement, changes in eyesight including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, shaking on movement, decreased consciousness, increased sensitivity to noise, feeling unwell
- dryness, swelling, pain, weakness, watering, irritation of eye
- heart rhythm disturbances, increased heart rate, heart failure
- flushing, hot flushes
- trouble breathing, dry nose, nasal congestion
- increased salivation, heartburn, numbness around mouth
- sweating, rash, chills, fever
- muscle twitching, stiffness or pain, joint swelling, neck pain
- breast pain
- trouble or painful urination, retention
- weakness, thirst, chest tightness
- itchiness, hives, runny nose, nosebleed, cough, snoring
- painful periods
- cold hands and feet
Rare
- abnormal sense of smell, swinging vision, changed perception of depth, visual brightness
- dilated pupils, cross eyes
- cold sweat, throat tightness, swollen tongue
- inflammation of the pancreas
- trouble swallowing
- slow or decreased body movement
- trouble writing properly
- raised fluid in the abdomen, fluid in the lungs
- muscle damage
- breast discharge, abnormal breast growth, breast enlargement in males
- interrupted periods
- inappropriate behaviour
- inflammation of the eyes
- jaundice (yellow skin and eyes)
Stop taking PRE ALDONIL OD TABLET and contact your doctor immediately if you experience any of the following side effects:
- swollen face or tongue, skin turning red and starting to blister or peel
- allergic reaction (swollen face, lips, tongue, and throat, diffuse skin rash)
- serious skin rashes like Stevens-Johnson syndrome, toxic epidermal necrolysis (reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, fever and flu-like symptoms)
- loss of vision, other changes in eyesight
- kidney failure, reduced urine volume
- thoughts of harming or killing self
- fits
- difficulty breathing or shallow breaths
How To Manage Side Effects
Nausea:
Take PRE ALDONIL OD TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. If nausea does not improve, contact your doctor.
Vomiting:
Get adequate rest and drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating – you don't have to eat or avoid any specific foods. If vomiting does not improve, contact your doctor.
Headache:
Drink ample amount of water and get adequate rest. Try to be relaxed and stress free. If headache does not improve, contact your doctor.
Dizziness:
Lie down until dizziness is resolved, then get up slowly. Do not hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. If dizziness does not improve, consult your doctor.
Constipation:
Eat plenty of fiber rich foods like fresh fruits, vegetables, cereals and drink plenty of water. Exercise more regularly. If constipation does not improve, contact your doctor.
Diarrhea:
Drink lots of fluids, like water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. If diarrhea does not improve, contact your doctor.
Warning & Precautions
Pregnancy
PRE ALDONIL OD TABLET should not be used in pregnant women unless considered necessary by your doctor. Consult your doctor before taking it.
Breastfeeding
PRE ALDONIL OD TABLET should not be used in breastfeeding women unless considered necessary by your doctor. Consult your doctor before taking it.
Driving and Using Machines
Do not drive or operate any machines if you experience dizziness, sleepiness or decreased concentration after taking PRE ALDONIL OD TABLET.
Alcohol
Avoid consumption of alcohol while taking PRE ALDONIL OD TABLET. It should be used with caution in patients with a history of alcoholism. Consult your doctor before taking it.
Kidney
PRE ALDONIL OD TABLET should be used with caution in patients with kidney disease or impairment. Consult your doctor before taking PRE ALDONIL OD TABLET.
Liver
PRE ALDONIL OD TABLET should be used with caution in patients with liver disease. Consult your doctor before taking PRE ALDONIL OD TABLET.
Allergy
Do not take PRE ALDONIL OD TABLET if you are allergic to Epalrestat, Pregabalin or any other ingredients of this medicine.
Lungs
PRE ALDONIL OD TABLET should be used with caution in patients with respiratory disorders. Consult your doctor before taking PRE ALDONIL OD TABLET.
Heart Disease
PRE ALDONIL OD TABLET should be used with caution in patients with a history of heart disease. Consult your doctor before taking PRE ALDONIL OD TABLET.
Others
Before taking PRE ALDONIL OD TABLET, inform your doctor if you:
- have a history of any drug abuse or dependence
- have nervous system disorders
- have diabetic peripheral neuropathy
Use in pediatrics:
PRE ALDONIL OD TABLET is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety and effectiveness. Consult your child’s doctor for advice.
Use in geriatrics:
PRE ALDONIL OD TABLET should be used with caution in elderly patients (aged 65 years and above) especially with kidney or heart problems. Consult your doctor before taking it.
Interactions
A. Drug - Drug interactions:
Before taking PRE ALDONIL OD TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used to manage severe pain (Ex. morphine, fentanyl)
- oxycodone (used to relieve pain)
- lorazepam (used to manage anxiety)
Overdosage:
If you or anyone else accidentally take too much of PRE ALDONIL OD TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of PRE ALDONIL OD TABLET includes sleepiness, confusion, agitation or restlessness.
Synopsis
| Drug | : | Epalrestat, Pregabalin |
| Pharmacological Category | : | Aldose reductase inhibitor, Cyclic GABA analogue |
| Therapeutic Indication | : | Diabetic neuropathy |
| Dosage Forms | : | Tablet |
More Information
- Keep PRE ALDONIL OD TABLET out of reach of children
- Store PRE ALDONIL OD TABLET at room temperature
FAQs About PRE ALDONIL OD TABLET
Can PRE ALDONIL OD TABLET be used in infants?
PRE ALDONIL OD TABLET is used for adults and its safety and effectiveness in children have not been established. Your doctor will decide the correct dose or select a suitable alternative management for your child.
What if I forget to take a dose of PRE ALDONIL OD TABLET?
If you forget to take a dose of PRE ALDONIL OD TABLET, take it as soon as you remember. However, omit the missed dose if it is almost time for the next dose. Do not take PRE ALDONIL OD TABLET twice to make up for the missed dose.
Can I stop taking PRE ALDONIL OD TABLET on my own?
Continue taking PRE ALDONIL OD TABLET until your doctor tells you to stop, unless you experience any unwanted effects, worsening of your condition or any new symptoms. In such case, contact your doctor right away.
Can PRE ALDONIL OD TABLET cause vomiting?
Vomiting is a common side effect of PRE ALDONIL OD TABLET. In such case, get adequate rest and drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating – you do not need to eat or avoid any specific foods. Tell your doctor if you have continuous vomiting.
What precautions do I need to follow while taking PRE ALDONIL OD TABLET?
Patients taking PRE ALDONIL OD TABLET must inform their doctor about their pre-existing conditions like a history of heart, liver or kidney disease, alcoholism or any drug abuse or dependence. Patients should also inform if they are pregnant, breast-feeding, or having any allergies. Consult your doctor if you experience anything different.
Can PRE ALDONIL OD TABLET make me feel suicidal?
Thoughts of harming or killing self is seen in a small number of patients being managed with PRE ALDONIL OD TABLET. If at any time you have such kind of thoughts, immediately contact your doctor or go to the nearby hospital.
Can PRE ALDONIL OD TABLET be taken during pregnancy?
PRE ALDONIL OD TABLET should not be used in pregnant women unless considered necessary by your doctor. If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before taking it. Inform your doctor immediately if you become pregnant during management with PRE ALDONIL OD TABLET.
Can I take other medicines with PRE ALDONIL OD TABLET?
Before taking PRE ALDONIL OD TABLET, inform your doctor if you are taking, have taken or might take any other medicine, including prescription, non-prescription or any herbal medicine, as these might interact with each other and cause serious side effects.
References
1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Antiepileptic. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 279, 412.
2. Singh, Ravinder, Harbir Kaur Rao, and Thakur Gurjeet Singh. Comparison of safety and efficacy of pregabalin, duloxetine and their combination with epalrestat in diabetic neuropathy: a prospective, double-blind, randomized, controlled Trial. Journal of Applied Pharmaceutical Science. February 2021. [Accessed on 16th July 2022] https://japsonline.com/admin/php/uploads/3307_pdf.pdf
3. Verma, V., Singh, N., & Singh Jaggi, A. Pregabalin in neuropathic pain: Evidences and possible mechanisms. NIH National Library of Medicine, National center for biotechnology information. PubMed central. January 2014 [Accessed on 16th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915349/
4. Laboratorios Lesvi, S.L. Electronic Medicines Compendium (EMC). [Revised in March 2022] [Accessed on 16th July 2022] https://www.medicines.org.uk/emc/files/pil.10770.pdf
5. Micro Labs Ltd. Eparel 50 Tablet (Epalrestat). [Accessed on 16th July 2022] https://www.microlabsltd.com/elibrary/node/1813
Useful Diagnostic Tests
- Filament test
- Sensory test
- Nerve conduction test
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