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INTRODUCTION
MAXGALIP AT TABLET is a combination of Amitriptyline and Pregabalin which belongs to the group of medicine called Antidepressants and Anti-epileptics respectively. It is used to treat pain caused due to nerve damage. It is indicated in the treatment of peripheral neuropathies (nerve pain in peripheral parts of the body such as hands and legs), diabetic neuropathy (nerve damage caused due to diabetes), trigeminal neuralgia (painful conditions of the face).
Also, it is used to treat post herpetic neuralgia (pain caused due to damage of nerve fibers of skin that occurs after the disappearance of skin rash and blisters (shingles)) and chronic lower back pain or spondylitis (pain and inflammation of spinal bones). It can also be used to treat neuritis (inflammation in the peripheral nerves) and radiculopathy (pain, weakness, tingling, and numbness caused to pinching or damage of nerve roots).
MAXGALIP AT TABLET can be used along with pioglitazone to reduce nerve damage among diabetic patients. During the therapy, your doctor would closely monitor your health condition to avoid the risk of side effects.
MAXGALIP AT TABLET is not recommended for use in patients with liver impairment. It should be used with caution among patients with kidney failure, heart disease, glaucoma or an overactive thyroid.
Before taking MAXGALIP AT TABLET, inform your doctor if you are pregnant or breastfeeding. It should be used with caution among children as it can easily precipitate behavioral changes in them. MAXGALIP AT TABLET may precipitate suicidal thoughts as early as after one week of therapy, therefore consult your doctor immediately if you or anyone else experience such thoughts.
The most common side effects of taking MAXGALIP AT TABLET are dizziness, headache, nausea, vomiting, dry mouth, bloating and altered taste sensation. Consult your doctor if any of the symptoms worsen.
USES OF MAXGALIP AT TABLET
Treats pain in the following conditions such as:
- peripheral neuropathies (nerve pain in hands and legs)
- diabetic neuropathy (nerve pain due to diabetes)
- trigeminal neuralgia (pain in face)
- post herpetic neuralgia (pain due to damaged nerve fibers of skin)
- chronic lower back pain, spondylitis
- neuritis (nerve inflammation)
- radiculopathy (damages in nerve roots arising from spinal cord)
HOW MAXGALIP AT TABLET WORKS
MAXGALIP AT TABLET effectively reduces nerve damage and pain where pregabalin acts by altering the activity of calcium channels of nerve cells and amitriptyline acts by blocking the movement of certain chemical messengers (such as serotonin, noradrenaline, and dopamine) between the nerve cells which are involved in causing pain and inflammation. Together, they stop the transmission of pain signals across the brain and spinal cord and provides relief from pain.
DIRECTIONS FOR USE
Take MAXGALIP AT TABLET as advised by your physician. Swallow MAXGALIP AT TABLET with a glass of water. Do not crush or chew [GBNKRYWORD]. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition. Do not stop taking MAXGALIP AT TABLET abruptly without consulting your doctor as it may lead to withdrawal symptoms such as difficulty in falling asleep, headache, nausea, anxiety, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness.
SIDE EFFECTS OF MAXGALIP AT TABLET
COMMON
- dizziness, drowsiness, headache
- feeling dizzy while standing up (orthostatic hypertension)
- increased hunger or thirst
- feeling high or excited
- feeling shaky, confused, irritated or disoriented
- decreased sexual interest, difficulty in erection, delayed ejaculation
- difficulty in concentration, memory impairment, difficulty in speaking
- clumsiness or abnormal walking
- sense of tingling or numbness
- severe weakness or tiredness
- blurred vision or double vision
- vertigo (spinning sensation)
- problem in balance
- dryness of mouth
- nausea or vomiting
- bloating, diarrhoea
- edema (swelling of body including extremities)
- weight gain
- muscle cramps, joint pain, back pain, pain in limbs
- sore throat
- abnormal heartbeat
- increased sweating
- nose block
- changes in taste
UNCOMMON
- ringing in the ears (tinnitus)
- increased production of breast milk without breast feeding
- increased pressure in eyes which may lead to weak eye or dry eyes
- weight loss
- restlessness, depression, agitation, mood swings, hallucinations, nightmares
- panic attacks
- unusual eye movements, pain and swelling of the eye, watery eyes
- increased sensitivity of skin to light, hot flushes
- difficulty in breathing, dry nose
- increased saliva production
- heartburn or numbness around the mouth and lips
- neck pain, breast pain
- painful menstrual periods
- coldness of hands and feet
RARE
- hair loss
- breast enlargement in men
- changes in the sense of smell
- inflammation of the pancreas (nausea, vomiting, upper stomach pain and tenderness)
- parkinsonism (such as tremor, decreased ability to move, and muscle stiffness)
Stop taking MAXGALIP AT TABLET and contact your doctor immediately if you experience any of the following side effects:
- signs of a severe allergic reaction (skin rash with blisters and peeling, swelling of the eye, throat or tongue which leads to difficulty in breathing)
- sudden attacks of intermittent blurring of vision, rainbow vision with eye pain
- signs of prolonged QT interval (sudden fainting, dizziness, abnormal heart rate)
- signs of intestine paralysis (such as severe constipation, swollen stomach, fever, and vomiting)
- jaundice (yellowing of skin and whites of eyes)
- signs of abnormal blood counts (such as bruising, bleeding, looking pale, or persistent sore throat and fever)
- suicidal thoughts or behavior
- signs of mania (feeling extreme happiness, increased physical activity, profuse and rapidly changing thoughts, and ideas)
- decrease in urine output
- convulsions
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take MAXGALIP AT TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. If you experience severe nausea or vomiting along with severe stomach pain, contact your doctor immediately.
Diarrhea:
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 worsens.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom worsens.
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 worsens.
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
MAXGALIP AT TABLET is generally not recommended for use in pregnant women unless it is considered necessary by the physician. Consult your doctor before taking it.
BREASTFEEDING
MAXGALIP AT TABLET is not generally recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines after taking MAXGALIP AT TABLET as it may cause dizziness and sleepiness.
ALCOHOL
Avoid consumption of alcohol while taking MAXGALIP AT TABLET, as it may enhance the effect of alcohol.
KIDNEY
MAXGALIP AT TABLET is not recommended for use in patients with a history of urinary retention (difficulty in passing urine). It should be used with caution in patients with renal failure. Consult your doctor before taking MAXGALIP AT TABLET.
LIVER
MAXGALIP AT TABLET is not recommended for use in patients who have impaired liver function. It should be used with caution among patients who have any previous history of liver impairment or liver damage. Consult your doctor before taking MAXGALIP AT TABLET.
ALLERGY
Do not take MAXGALIP AT TABLET if you are allergic to Amitriptyline or Pregabalin.
HEART DISEASE
MAXGALIP AT TABLET should be taken with caution in patients with heart diseases (such as myocardial infarction and congestive heart failure). Consult your doctor before taking MAXGALIP AT TABLET.
OTHERS
MAXGALIP AT TABLET is not recommended for use if you:
- have an enlarged prostate (Ex. Benign Prostatic Hypertrophy)
- rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Before taking MAXGALIP AT TABLET, inform your physician if you:
- have a history of seizures (fits)
- have a history of blood dyscrasias (a type of blood disorder)
- have narrow-angle glaucoma (increased pressure in the eye)
- have increased activity of thyroid gland
- are due to have a surgery
Use in pediatrics:
MAXGALIP AT TABLET should be used with caution in children and adolescents (aged below 18 years). Consult your child’s doctor for advice.
Use in geriatrics:
MAXGALIP AT TABLET should be used with caution in elderly patients due to increased risk of adverse reactions. Your doctor may initiate the treatment with the lowest effective dose. Consult your doctor before taking MAXGALIP AT TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking MAXGALIP AT TABLET, inform your doctor if you are taking any of the following medicines:
- monoamine oxidase inhibitors (used to treat depression) Ex. sertraline, isocarboxazid, phenelzine or tranylcypromine
- medicines used to treat overactivity of thyroid gland (Ex. carbimazole)
- guanethidine (used to treat high blood pressure)
- sympathomimetic drugs (medicines which are used to decrease heartbeat, increase in body secretions, and muscle movements) Ex. adrenaline
- local anesthetics (used to cause numbness of a particular region) Ex. lignocaine
- cimetidine (used to treat stomach ulcers)
- ethchlorvynol (a medicine used to induce sleep)
- medicines that can reduce anxiety and induce sleep (Ex. phenobarbital, clonazepam)
- disulfiram (used to treat alcohol addiction)
- neuroleptic drugs (used to treat epilepsy) Ex. phenytoin, carbamazepine, valproic acid
- neomycin (used to treat bacterial infections)
- mesalamine (used to treat irritable bowel syndrome)
- colchicine (used to prevent and treat gout)
Overdosage:
If you or anyone else accidentally take too much of MAXGALIP AT TABLET, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage might include decrease or increase in body temperature, confusion, difficulty in concentration, hallucinations, drowsiness, fast heart rate, heart failure, dilation of pupil, convulsions, eye problems such as cannot move eyes, severe low blood pressure, loss of consciousness, constipation, shaking, muscle tightness, vomiting, weakness, depression and restlessness.
SYNOPSIS
| Drug | : | Amitriptyline, Pregabalin |
| Pharmacological Category | : | Tricyclic Antidepressants, Gamma-aminobutyric acid analogs |
| Therapeutic Indication | : | Nerve pain relief |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep MAXGALIP AT TABLET out of reach of children
- Store at room temperature
FAQs ABOUT MAXGALIP AT TABLET
How long will it take for MAXGALIP AT TABLET to start acting?
MAXGALIP AT TABLET may start to exert its effects from day 2 of administration. An initial benefit of pain relief can be seen in patients after 2-4 weeks of therapy. However, it may take few months to show effects in some individuals.
Can MAXGALIP AT TABLET treat diabetic neuropathy?
Yes, MAXGALIP AT TABLET can be used to treat diabetic neuropathy. It provides symptomatic pain relief in patients who have nerve pain caused due to diabetes. It can also be consumed safely along with pioglitazone among diabetic patients.
What happens if I stop taking MAXGALIP AT TABLET?
Do not stop taking MAXGALIP AT TABLET unless your doctor tells you as it may lead to withdrawal symptoms such as difficulty in falling asleep, headache, nausea, anxiety, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness. Continue to take MAXGALIP AT TABLET as long as instructed by your doctor to achieve better results. Your doctor would closely monitor your condition and may alter the dose steadily by evaluating your response.
Can MAXGALIP AT TABLET reduce nerve damage?
No, MAXGALIP AT TABLET is only used to relieve pain caused due to nerve damage. It can only offer symptomatic pain relief during painful conditions such as neuropathies and trigeminal neuralgia but cannot cure or prevent nerve damage. You may feel better for a while after taking MAXGALIP AT TABLET and may again experience pain once the effect of the medicine subsides. Consult your doctor for advice. You may be prescribed with some other neuroprotective agents by your physician.
Is MAXGALIP AT TABLET addictive?
It is unlikely that MAXGALIP AT TABLET causes addiction or dependence, because they don’t post any pleasant or pleasurable effects during their duration of action. However, prolong use of MAXGALIP AT TABLET can cause withdrawal symptoms (such as difficulty in falling asleep, headache, nausea, anxiety, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness). To avoid this, your doctor will adjust your dose carefully with close monitoring.
Can MAXGALIP AT TABLET be used to treat depression?
MAXGALIP AT TABLET contains amitriptyline which is a tricyclic antidepressant. Although, amitriptyline has antidepressant effects, combination of amitriptyline and pregabalin are predominantly used to treat neuropathic pain. Consult your doctor for advice before taking MAXGALIP AT TABLET if you wish to use this medicine for treating depression.
Does MAXGALIP AT TABLET cause sleepiness or drowsiness?
Yes, MAXGALIP AT TABLET may cause sleepiness or drowsiness in some individuals. Rest and relax while feeling dizzy. Avoid consumption of alcohol while taking MAXGALIP AT TABLET as it can make you feel drowsier. Do not drive or operate any tools or machines while you are feeling sleepy. Consult your doctor if the symptom bothers you.
Can the use of MAXGALIP AT TABLET change my urine color?
Yes, MAXGALIP AT TABLET can change the color of the urine because most of the drug is excreted unchanged in the urine. It can make your urine to turn blue, green or purple in color. This color change in urine is usually not harmful and can be returned to normal once treatment with MAXGALIP AT TABLET has been stopped.
Can I take MAXGALIP AT TABLET along with alcohol?
No, avoid consumption of alcohol while taking MAXGALIP AT TABLET as it may make you feel drowsier. Moreover, MAXGALIP AT TABLET is not recommended for use in patients having alcohol abuse unless considered necessary. Consult your doctor before taking it.
Can I take a higher dose of MAXGALIP AT TABLET to increase pain relieving effects?
No, do not take a higher dose of MAXGALIP AT TABLET than recommended by your doctor. Taking a higher dose of MAXGALIP AT TABLET without consulting a doctor can increase the risk of toxicity and can lead to side effects. If the prescribed dose is not effective for you, consult your doctor for a suitable higher dose. Never consume a higher dose MAXGALIP AT TABLET without proper medical supervision.
What to do if I forgot to take MAXGALIP AT TABLET?
Take MAXGALIP AT TABLET as soon as you remember until it’s time for the next one. If you missed a dose, skip the missed one and take the next dose at the time normally you would take. Do not take a double dose to make up for the missed one, as it may lead to overdosage. If you are not sure, consult your doctor. Your doctor may instruct you about the next steps.
REFERENCES
1. KD. Tripathi. Antiepileptic Drugs & Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 420, 455-460 & 464.
2. Sourav Chakrabarty, Samar Biswas, Tamoghna Maiti, Abhijit Das, Ananya Mandal, and Prasun Banerjee. Pregabalin and Amitriptyline as Monotherapy or as Low-Dose Combination in Patients of Neuropathic Pain: A Randomized, Controlled Trial to Evaluate Efficacy and Safety in an Eastern India Teaching Hospital. NIH National Library of Medicine, National center for biotechnology information. PMC. PubMed Central. October 2019. [Accessed on 25th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6839302/
3. Centaur Pharmaceuticals Pvt Ltd. AmNuring-P Tablets (Amitriptyline + Pregabalin). [Accessed on 25th April 2022] https://www.centaurpharma.com/downloads/neurology/Am-Nuring%20P.pdf
4. Centaur Pharmaceuticals Pvt Ltd. Amnurite-P Tablets (Amitriptyline + Pregabalin). [Accessed on 25th April 2022]. [Accessed on 25th April 2022] https://www.centaurpharma.com/downloads/AmNurite%20P.pdf
5. Mylan Pharmaceuticals Limited. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed on 25th April 2022] https://www.medicines.org.uk/emc/files/pil.9299.pdf
6. Accord. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 25th April 2022] https://www.medicines.org.uk/emc/files/pil.5698.pdf
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