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Introduction About PREGATOR CAPSULE
PREGATOR CAPSULE is a combination of Alpha lipoic acid, Methylcobalamin, Folic acid, Pregabalin, and Pyridoxine, which belongs to the group of medicines called Antioxidants, Cyclic GABA analogues, and Vitamin B complexes, respectively. It is used in adults to manage painful diabetic neuropathy (nerve damage occurring over time because of high sugar and fat levels in the blood due to diabetes).
The symptoms depend on the type of neuropathy, such as pain and numbness in your feet or problems with organ functions like those of your heart and bladder. Avoid consuming alcohol during management with GBNKEYWORD.
PREGATOR CAPSULE is not recommended for use in children and adolescents (younger than 18 years), so consult your doctor before taking it. Before taking PREGATOR CAPSULE, inform your doctor if you have any kidney, liver, heart, respiratory, or nervous system problems; diabetes; or a history of alcoholism or any drug abuse or dependence.
PREGATOR CAPSULE should not be used in pregnant or breastfeeding women unless necessary. The most common side effects of taking PREGATOR CAPSULE are dizziness, drowsiness, headache, increased appetite, blurred vision, weight gain, etc. Contact your doctor if any of the symptoms get worse.
Uses Of PREGATOR CAPSULE
- Manage painful diabetic neuropathy in adults
How PREGATOR CAPSULE Works
PREGATOR CAPSULE relieves nerve pain where alpha-lipoic acid reduces oxidative stress, which is considered a main pathophysiology of diabetic neuropathy development; folic acid (Vitamin B9) is found to improve the functional recovery of nerves, speed of nerve conduction, and cell multiplication; and methylcobalamin takes part in the production of myelin (a compound that covers and protects nerve fibers), thus restoring the damaged nerve cell. Pregabalin binds with high affinity to certain sites in the tissues of the central nervous system and acts as a growth factor for nerve cells, helping to regenerate the damaged nerve tissue, and pyridoxine acts as a coenzyme in a wide range of metabolic functions affecting protein, carbohydrate, and lipid utilization, like the breakdown of glycogen to glucose-1-phosphate and the synthesis of gamma-aminobutyric acid (GABA).
How to use PREGATOR CAPSULE
Take PREGATOR CAPSULE as advised by your physician. Swallow it with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of PREGATOR CAPSULE for you based on your age, body weight, and disease condition. Do not stop taking PREGATOR CAPSULE unless your doctor advises you to stop.
Side Effects Of PREGATOR CAPSULE
Common
- dizziness, drowsiness, headache
- feeling elated, confused, or disorientated
- decreased sexual interest, irritability
- disturbed attention, clumsiness, memory impairment or loss, shaking, trouble speaking, tingling feeling, numbness, sedation, lethargy, lack of sleep, fatigue, feeling weird
- double vision
- spinning sensation, problems with balance, fall
- increased appetite, dry mouth, constipation, vomiting, gas, diarrhea, nausea, swollen abdomen
- difficulties with erection
- swollen body, including extremities
- feeling drunk, abnormal walking style
- weight gain
- muscle cramp, joint, back, or limb pain
- sore throat
Uncommon
- loss of appetite and weight
- low or high blood sugar
- change in self-perception, agitation, mood swings, restlessness, depression, difficulty finding words
- seeing things that are not there, unusual dreams, panic attacks, lack of interest, aggression, elevated mood
- mental impairment, trouble thinking, increased sexual interest, sexual problems including inability to achieve a sexual climax, delayed ejaculation
- changes in eyesight, unusual eye movement, tunnel vision, flashes of light
- jerky movements, reduced reflexes, increased activity, dizziness on standing, skin sensitivity
- taste loss, burning sensation, shaking on movement, low or loss of consciousness, increased noise sensitivity, feeling unwell
- eye swelling, pain, weakness, watering, irritation, or dryness
- heart rhythm changes, increased heart rate, low or high blood pressure, changes in heartbeat, heart failure
- flushing, hot flushes
- nasal dryness or congestion
- increased salivation, heartburn, numbness around the mouth
- sweating, rash, chills, fever
- muscle twitching, swollen joints, stiff muscle, muscle or neck pain
- breast pain
- troubled or painful urination, incontinence
- weakness, thirst, chest tightness
- changes in blood and liver test results (high blood creatinine phosphokinase, alanine aminotransferase, aspartate aminotransferase, blood creatinine, low platelet count, neutrophils, and blood potassium)
- hypersensitivity, swollen face, itchiness, hives, cough, snoring, runny nose, nosebleed
- painful menstrual periods
- cold hands and feet
Rare
- abnormal sense of smell, swinging vision, changed perception of depth, visual brightness, vision loss
- dilated pupils, cross eyes
- cold sweat, throat tightness
- pancreatic inflammation
- trouble swallowing
- slow or decreased body movement
- trouble writing properly
- increased abdominal fluid
- fluid in the lungs
- muscle damage
- breast discharge, unusual breast growth, breast enlargement in men
- interrupted menstrual periods
- decreased white blood cell count
- inappropriate behaviour
- allergic reactions (trouble breathing, eye inflammation, a serious skin reaction characterized by rash, blisters, peeling skin, and pain)
- jaundice (yellow skin and eyes)
Stop taking PREGATOR CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- swollen face
- skin turning red and starting to blister or peel
- allergic reaction (swelling of the face, lips, tongue, and throat, diffuse skin rash)
- blurring or loss of eyesight or other changes in vision
- kidney failure, reduced urine volume
- thoughts of harming or killing oneself
- constipation
- fits
- trouble breathing or shallow breaths
How To Manage Side Effects

Bloating
Eat smaller and more frequent meals. Eat and drink slowly, and exercise regularly. If flatulence does not improve, contact your doctor.

Constipation
Eat plenty of fiber-rich foods like fresh fruits, vegetables, and cereals, and drink plenty of water. Exercise more regularly. If you still feel constipated, contact your doctor.

Diarrhea
Drink lots of fluids, like water or fruit juice, to keep yourself hydrated. Ask your doctor before taking any medicine for diarrhea. If diarrhea does not improve, contact your doctor.

Dizziness Or Drowsiness
Lie down until the 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.

Headache
Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Check with your doctor before taking any medicine for a headache. If your headache does not improve, consult your doctor.

Nausea And Vomiting
Take PREGATOR CAPSULE with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Get adequate rest. Drink lots of fluids, especially water. If nausea and vomiting does not improve, contact your doctor.
Warning & Precautions

Pregnancy
Monitoring requiredPREGATOR CAPSULE is not recommended for use in pregnant women unless considered necessary. Females of childbearing capability must use effective contraception. Consult your doctor before taking it.

Breastfeeding
Monitoring requiredPREGATOR CAPSULE is not recommended for use in breastfeeding women unless considered necessary. Consult your doctor before taking it.

Driving and Using Machines
Use with CautionDo not drive or operate any machines if you experience dizziness, sleepiness, or decreased concentration after taking PREGATOR CAPSULE.

Alcohol
Consult your doctorAvoid consumption of alcohol while taking PREGATOR CAPSULE. Let your doctor know if you have a history of alcoholism.

Kidney
Use with CautionPREGATOR CAPSULE should be taken with caution in patients with kidney disease or impairment. Consult your doctor before taking it.

Liver
Use with CautionPREGATOR CAPSULE should be taken with caution in patients with liver disease. Consult your doctor before taking it.

Allergy
ContraindicatedDo not take PREGATOR CAPSULE if you are allergic to alpha-lipoic acid, methylcobalamin, folic acid, pregabalin, pyridoxine, or any of the other ingredients of PREGATOR CAPSULE.

Lungs
Use with CautionPREGATOR CAPSULE should be taken with caution in patients with respiratory disorders. Consult your doctor before taking it.

Heart Disease
Use with CautionPREGATOR CAPSULE should be taken with caution in patients with a history of heart disease or who received a coronary stent (a tube inserted in the artery that leads to the heart to manage blockages). Consult your doctor before taking it.

Use In Pediatrics
ContraindicatedPREGATOR CAPSULE is not recommended for use in children and adolescents (under 18 years of age). Consult your doctor before taking it.

Use In Geriatrics
Use with CautionPREGATOR CAPSULE should be used with caution in elderly patients (aged above 75 years) with kidney problems and the elderly in general, as it causes dizziness and sleepiness, which could increase the occurrence of accidental injury (fall) in them. Consult your doctor before taking it.
Others
Before taking PREGATOR CAPSULE, inform your doctor if you:
- have diabetes (high blood sugar)
- are prone to constipation
- have a history of any drug abuse or dependence
- have nervous system disorders
- have a folate-dependent tumour
Interactions
A. Drug-Drug interactions:
Before taking PREGATOR CAPSULE, inform your doctor if you are taking any of the following medicines:
- oxycodone (used to manage severe pain)
- Lorazepam (used to manage anxiety)
- medicines containing alcohol
Overdosage:
If you or anyone else accidentally took too much of PREGATOR CAPSULE, contact your doctor immediately. Symptoms of PREGATOR CAPSULE overdose are sleepiness, confusion, agitation, restlessness, or fits.
Synopsis
Drug | : | Alpha Lipoic Acid, Methylcobalamin, Folic Acid, Pyridoxine, and Pregabalin |
Pharmacological Category | : | Antioxidants, Vitamins, and Cyclic GABA Analogues |
Therapeutic Indication | : | Painful diabetic neuropathy |
Dosage Forms | : | Tablet, Capsule |
More Information
Storage
- Keep PREGATOR CAPSULE out of reach of children
- Store PREGATOR CAPSULE below 25°C
FAQs About PREGATOR CAPSULE
Q: Can I take PREGATOR CAPSULE if I have diabetes?
A: Before taking PREGATOR CAPSULE, inform your doctor if you have diabetes and about the medicines you are taking for it, as according to current clinical practice, some diabetic patients who gain weight on PREGATOR CAPSULE management may need to adjust the doses of their anti-diabetic medicines.
Q: Can PREGATOR CAPSULE make me feel suicidal?
A: Thoughts of harming or killing oneself are seen in a small number of patients being managed with PREGATOR CAPSULE. If at any time you have such thoughts, immediately contact your doctor or go to the nearest hospital.
Q: Can PREGATOR CAPSULE be taken during pregnancy?
A: PREGATOR CAPSULE should not be used in pregnant women unless necessary. Females who are of childbearing age must use effective contraception. If you are pregnant, think you may be pregnant, or are planning to get pregnant, consult your doctor before taking PREGATOR CAPSULE. Inform your doctor immediately if you become pregnant during management with PREGATOR CAPSULE.
Q: Can PREGATOR CAPSULE cause constipation?
A: PREGATOR CAPSULE may cause constipation and other gastrointestinal problems like blocked or paralyzed intestines when taken with other medicines (like some types of pain medicines). In such cases, eat plenty of fiber-rich foods, such as fresh fruits, vegetables, and cereals, and drink plenty of water. Inform your doctor if you feel constipated, especially if you are prone to this problem.
Q: Can I drink alcohol during management with PREGATOR CAPSULE?
A: Avoid drinking alcohol during management with PREGATOR CAPSULE and inform your doctor if you have a history of alcoholism.
Q: Can PREGATOR CAPSULE be given to children?
A: No. PREGATOR CAPSULE is used for adults and not recommended for children and adolescents below 18 years of age, as the safety and efficacy of PREGATOR CAPSULE in this age group have not been established. Your doctor will select a suitable alternative management for your child.
Q: Can I take PREGATOR CAPSULE on an empty stomach?
A: Take PREGATOR CAPSULE as advised by your physician. You take it with or without food. However, if you feel nauseous, take PREGATOR CAPSULE with meals or just after meals.
Q: What if I forget to take a dose of PREGATOR CAPSULE?
A: If you forget to take a dose of PREGATOR CAPSULE, take it as soon as you remember. However, omit the missed dose if it is almost time for the next one. Do not take PREGATOR CAPSULE twice to make up for the missed dose.
Q: Can I stop taking PREGATOR CAPSULE on my own?
A: Continue taking PREGATOR CAPSULE until your doctor tells you to stop, unless you experience any unwanted effects, a worsening of your condition, or any new symptoms. In such a case, contact your doctor. Your doctor will advise you to stop taking PREGATOR CAPSULE gradually over a period of at least one week.
Q: Can PREGATOR CAPSULE discontinuation cause withdrawal symptoms?
A: After stopping PREGATOR CAPSULE management, you may experience certain side effects like trouble sleeping, headache, nausea, anxiety, diarrhea, flu-like symptoms, fits, nervousness, depression, pain, sweating, and dizziness. There are more chances of getting these symptoms if you have been taking this medicine for a longer period. If you have any further doubts regarding the use of PREGATOR CAPSULE, ask your doctor.
Q: How should PREGATOR CAPSULE be taken? Can it be crushed?
A: No. Do not break, crush, or chew PREGATOR CAPSULE. Take it as advised by your physician. Swallow it with a glass of water. Your doctor will determine the correct dose and duration for you based on your age, body weight, and disease condition.
Q: What is the use of PREGATOR CAPSULE?
A: PREGATOR CAPSULE is used in adults to manage painful diabetic neuropathy (nerve damage occurring over time because of high sugar and fat levels in the blood due to diabetes).
References
1. KD Tripathi. Antiepileptic Drugs. Drugs Affecting Blood and Blood Formation. Essentials of Medical Pharmacology. Seventh Edition. 2013. Page – 420, 608.
2. Serhiyenko V, Serhiyenko L, Suslik G et al. Alpha-lipoic acid: mechanisms of action and beneficial effects in the prevention and treatment of diabetic complications. MOJ Public Health. MedCrave. July 2018. [Accessed on 14th September 2024] https://medcraveonline.com/MOJPH/alpha-lipoic-acid-mechanisms-of-action-and-beneficial-effects-in-the-prevention-and-treatment-of-diabetic-complications.html
3. Kang WB, Chen YJ, Lu DY, Yan JZ. Folic acid contributes to peripheral nerve injury repair by promoting Schwann cell proliferation, migration and secretion of nerve growth factor. NIH National Library of Medicine, National Centre for Biotechnology Information. PubMed Central. January 2019. [Accessed on 14th September 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6263007/
4. Vasudevan D, Naik MM, Mukaddam QI. Efficacy and safety of methylcobalamin, alpha lipoic acid and pregabalin combination versus pregabalin monotherapy in improving pain and nerve conduction velocity in type 2 diabetes associated impaired peripheral neuropathic condition. [MAINTAIN]: Results of a pilot study. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. January 2014. [Accessed on 14th September 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992764/
5. Innova Captab Ltd. Alpha Lipoic Acid + Methylcobalamin + Folic Acid + Pregabalin + Pyridoxine. [Revised in May 2021] [Accessed on 14th September 2024] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2732.pdf
6. Micro Labs Ltd. Alpha Lipoic Acid + Methylcobalamin + Folic Acid + Pregabalin + Pyridoxine. [Accessed on 14th September 2024] https://www.microlabsltd.com/elibrary/node/1891
Useful Diagnostic Tests
- Nerve conduction testing
- Electromyography
- Complete Blood Count (CBC)/ Hemogram
- Blood Glucose Fasting (FBS)
- Random Blood Sugar (Rbs)
- Post Prandial Blood Sugar (PPBS)
- Vital Diabetes Care
- Extended Diabetes Care
- Advance Diabetes Care
- Diabetic Profile - Basic