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INTRODUCTION
AMICALM 25 TABLET contains Amitriptyline which belongs to the group of medicines called Antidepressants. It is used to treat depression. It is also used to treat neuropathic pain and prevents chronic headache and migraine.
Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest which affects how you feel, think or behave that leads to a variety of emotional and physical problems in the affected person.
Using AMICALM 25 TABLET should not be stopped suddenly, your physician may advise you to reduce dose gradually to overcome withdrawal symptoms.
AMICALM 25 TABLET is not recommended for use in patients suffering from mania and or having heart problems such as heart attack, disturbances in heart rhythm, heart block or coronary artery disease, irregular heartbeat and or congestive heart failure and severe liver disease.
Before taking AMICALM 25 TABLET, inform your doctor if you are suffering from epilepsy (seizures), depression, severe low blood pressure, bipolar disorder, urinary retention and or kidney problems.
AMICALM 25 TABLET is not recommended for use in pregnant women during first and third trimester period and breastfeeding women. It is also not recommended for children and adolescents (below 18 years). Consult your doctor before taking the medicine.
The most common side effects of taking AMICALM 25 TABLET are weight gain, gastrointestinal symptoms like constipation, sleepiness, drowsiness, dizziness, headache, dry mouth, slurred or slow speech. Consult your doctor if any of these above symptoms gets worse.
USES OF AMICALM 25 TABLET
It is used to treat:
- depression
- neuropathic pain
- chronic headache and migraine
HOW AMICALM 25 TABLET WORKS
AMICALM 25 TABLET prevents the reuptake and hence the inactivation of neurotransmitters noradrenaline and serotonin, that are present at the nerve terminals in our brain. Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain. This appears to be associated with the antidepressant activity and helps in regulating the mood. It also stops the transmission of pain signals from nerves to the brain thereby relieving neuropathic pain due to damaged nerves.
DIRECTIONS FOR USE
Take AMICALM 25 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 for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF AMICALM 25 TABLET
COMMON
- sleepiness
- shakiness of hands or other parts of the body
- dizziness
- headache
- irregular, hard or rapid heartbeat
- dry mouth
- constipation
- nausea
- excessive sweating
- weight gain
- slurred or slow speech
- aggression
- problem with ability of the eye to change its focus from distant to near objects (and vice versa)
- congested nose
- confusion
- sexual disturbances (problems with erection, decreased sex-drive)
- changes in taste
- numbness or tingling in the legs or arms
- signs of low sodium concentration in blood such as nausea, vomiting, headache and confusion
- urination disorder
- feeling thirsty
- agitation
- disturbed coordination
- dilated pupils
UNCOMMON
- excitement, anxiety, difficulties sleeping, nightmares
- convulsions
- tinnitus (ringing in ears)
- increased blood pressure
- skin rash, nettle rash (urticaria), swelling of the face and tongue
- difficulties passing urine
- breast milk outflow without breast feeding or increased production of breast milk
- collapse conditions
- liver function impairment such as cholestatic liver disease
RARE
- decreased appetite
- delirium (especially in elderly patients), hallucinations
- swelling of the salivary glands
- hair loss
- increased sensitivity to sunlight
- breast enlargement (men)
- fever
- weight loss
- abnormal results of liver function tests
Stop taking AMICALM 25 TABLET and contact your doctor immediately if you experience any of the following side effects:
- signs of a severe allergic reactions such as difficulty breathing or swelling of your face, lips, throat or tongue
- signs of acute glaucoma (eye disorder) such as attacks of intermittent blurring of vision, rainbow vision and eye pain
- irregular heart rhythm
- signs of paralyzed intestine such as bad constipation, a swollen stomach, fever and vomiting
- yellowing of the skin and the white in the eyes
- signs of blood or bone marrow being affected with symptoms such as bruising, bleeding, pallor or persistent sore throat and fever
- self-harming thoughts
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water abnormal. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom did not improve.
Diarrhea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhoea. Consult your doctor if the symptom did not improve.
Nausea or Vomiting:
Take this medicine with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.
Constipation:
Eat more fiber especially soluble fiber foods like beans, oats, oat bran, rice bran, barley, citrus fruits, apples, strawberries. Keep yourself hydrated. Avoid taking any medicine on your own for treating constipation. Consult your doctor if the symptom did not improve.
Dizziness:
If you feel dizzy, keep your eyes closed sit or lie down. Do not drive or operate machinery. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
AMICALM 25 TABLET is not recommended for use in pregnant women during first and third trimester. Consult your doctor before taking it.
BREASTFEEDING
AMICALM 25 TABLET is not recommended for use in breastfeeding women unless it is clearly necessary. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel drowsiness and dizziness after taking AMICALM 25 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking AMICALM 25 TABLET because it might increase the sedative effects.
KIDNEY
[GNBKEYWORD] should be used with caution in patients with chronic renal failure. Consult your doctor before taking AMICALM 25 TABLET.
LIVER
AMICALM 25 TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with mild to moderate liver diseases. Consult your doctor before taking.
ALLERGY
Do not take AMICALM 25 TABLET if you are allergic to Amitriptyline, other tricyclic antidepressants or to any of the other ingredients of this medicine.
HEART DISEASE
AMICALM 25 TABLET is not recommended for use in patients with heart problems such as heart attack (myocardial infarction), disturbances in heart rhythm, heart block or coronary artery disease, irregular heartbeat and congestive heart failure. Consult your doctor before taking.
OTHERS
AMICALM 25 TABLET is not recommended for use if you:
- are suffering from mania
Before taking AMICALM 25 TABLET, inform your doctor if you have:
- epilepsy
- depression or anxiety
- porphyria (blood disorder)
- pheochromocytoma (tumor of the adrenal gland)
- blood dyscrasias (blood disorder)
- urinary retention
- prostatic hypertrophy (enlarged prostate) such as frequent or urgent need to urinate, increased frequency of urination at night and difficulty while urinating
- increased intra-ocular pressure or narrow angle glaucoma
- signs of hyperthyroidism (overactive thyroid) such as unintentional weight loss, increased appetite, nervousness
- severe low blood pressure
- planned for surgery
- signs of hyponatremia (low sodium level in blood) such as nausea, vomiting, headache., confusion
- difficulty in passing urine
- thyroid disease
- bipolar disorder
- schizophrenia (serious mental disorder)
- narrowing of the gastric outlet (pylorus stenosis) and blocked intestine (paralytic ileus)
- diabetes
Use in pediatrics:
AMICALM 25 TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking the medicine.
Use in geriatrics:
AMICALM 25 TABLET should be used with caution in elderly aged above 65 years. Consult your doctor before taking the medicine.
INTERACTIONS
A. Drug - Drug interactions:
Before taking AMICALM 25 TABLET, inform your doctor if you are taking:
- medicines used to treat depression. Ex. phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion
- selegiline (used to treat Parkinson’s disease)
- adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (used as anesthetics)
- calcium-channel blockers (used to treat high blood pressure) Ex. verapamil and diltiazem
- guanethidine, betanidine, clonidine, reserpine and methyldopa (medicines used in the treatment of high blood pressure)
- anticholinergic drugs (used to treat Parkinson’s disease and gastrointestinal disorders) Ex. atropine, hyoscyamine
- thioridazine (used in the treat schizophrenia)
- nefopam, tramadol and morphine (used to reduce pain)
- medicines to treat fungal infections (Ex. fluconazole, terbinafine, ketoconazole and itraconazole)
- sedatives (used in treatment of pain) such as barbiturates Ex. amobarbital, butabarbital
- buprenorphine / opioids (used for severe pain or opioid drug addiction)
- medicines used to treat diseases associated with heart such as beta blockers (Ex. acebutolol, atenolol) and antiarrhythmics (Ex. disopyramide, flecainide)
- cimetidine (used to treat stomach ulcers)
- alpha2-adrenoceptor stimulants used to treat attention-deficit/hyperactivity disorder Ex. methylphenidate
- ritonavir (used to treat HIV)
- oral contraceptives (used to inhibit pregnancy) Ex. estrogens and progestogens
- rifampicin (to treat bacterial infections)
- phenytoin and carbamazepine (used to treat epilepsy)
- St. john´s wort (herbal medicine used to treat depression)
- thyroid medication (used to abnormal thyroid) Ex. thyroxine
- medicines to treat irregular heartbeats (Ex. quinidine and sotalol)
- astemizole and terfenadine (used to treat allergies and hay fever)
- medicines used to treat mental illnesses Ex. pimozide and sertindole
- cisapride (used to treat certain types of indigestion)
- halofantrine (used to treat malaria)
- methadone (used as detoxicant and to treat pain)
- diuretics (used to treat hypertension) Ex. furosemide
- altretamine (used to treat cancer of the ovaries)
- disulfiram (used to treat chronic alcoholism)
- dopaminergics (used to treat Parkinson’s disease and restless legs syndrome)
- baclofen (used as muscle relaxant)
- nitrate medicine (used to treat angina) Ex. glyceryl trinitrate
- sibutramine (used as an anti-obesity medicine)
Over dosage:
If you or anyone else accidentally takes too much of AMICALM 25 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose include dilated pupils, fast or irregular heartbeats, dry mouth and tongue, fever, agitation, difficulty breathing, blue discoloration of the skin, confusion, hallucinations, disturbed concentration, fast heartrate, uncontrolled movements, difficulties passing water, intestinal blockage, fits, low blood pressure, weak pulse, pallor, decreased heart rate, drowsiness, impaired conduction of heart, hypokalemia, drowsiness, hypothermia, hyperactive reflexes, muscle rigidity and vomiting.
SYNOPSIS
| Drug | : | Amitriptyline |
| Pharmacological Category | : | Anti-depressants |
| Therapeutic Indication | : | Depression, Neuropathic pain, Migraine |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep AMICALM 25 TABLET out of reach of children
- Store below 25°C
FAQs ABOUT AMICALM 25 TABLET
Can AMICALM 25 TABLET make you more depressed after a while or make your condition worse?
Taking AMICALM 25 TABLET can’t make your mood worse. But it may have side effects that can change or alter your mood. Consult your doctor if you get any extreme thoughts, mood swings or unusual changes in behavior in the first weeks after taking AMICALM 25 TABLET.
How much dose of AMICALM 25 TABLET can I take in a day?
Take AMICALM 25 TABLET as advised by your physician. Do not crush or chew the medicine. Swallow the medicine with glass of water. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Is AMICALM 25 TABLET an antibiotic?
No, AMICALM 25 TABLET is not an antibiotic. AMICALM 25 TABLET belongs to group of medicines called antidepressants which is used to treat major depressive episodes of depression and neuropathic pain in adults which is also used to prevent chronic headache and migraine.
Can I consume alcohol after taking AMICALM 25 TABLET?
Sleepiness or drowsiness is the common side effect of AMICALM 25 TABLET. Since alcohol has sedative effect or it induces sleep, alcohol is not recommended for use after taking AMICALM 25 TABLET.
Can AMICALM 25 TABLET be used in pregnancy?
AMICALM 25 TABLET is not recommended for use in pregnancy during first and third trimester. Stop taking this medicine if you become pregnant. Consult your doctor before taking AMICALM 25 TABLET.
REFERENCES
1. K.D. Tripathi. Drugs Used in Mental Illness: Antidepressant and Antianxiety Drugs. Essentials of medical pharmacology. Seventh edition. 2013 Page 455.
2. Amit Thour, Raman Marwaha. Amitriptyline. NIH National Library of Medicine. National Center for Biotechnology Information. StatPearls. [Revised on May 2022] [Accessed on 26th April 2022] https://www.ncbi.nlm.nih.gov/books/NBK537225/
3. M Sandoz, S Vandel, B Vandel, B Bonin, B Hory, Y St Hillier, R Volmat. Metabolism of amitriptyline in patients with chronic renal failure. NIH National Library of Medicine. National Center for Biotechnology Information. PubMed.gov. [Revised on 1984] [Accessed on 26th April 2022] https://pubmed.ncbi.nlm.nih.gov/6723762/
4. DOUGLAS M. MAURER; TYLER J. RAYMOND; and BETHANY N. DAVIS. Depression: Screening and Diagnosis, American Family Physician Organization. [Revised Oct 2018] [Accessed on 26th April 2022] https://www.aafp.org/afp/2018/1015/p508.htm
5. Pharmascience INC. Drug and Health Product Register [Revised Sep 2017] [Accessed on 26th April 2022] https://pdf.hres.ca/dpd_pm/00041275.PDF
6. Sandoz INC. Food and Drugs Administration (FDA) [Revised May 2014] [Accessed on 26th April 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf
7. Brown & Burk UK Ltd. Electronic Medicines Compendium (EMC) [Revised Jan 2022] [Accessed on 26th April 2022] https://www.medicines.org.uk/emc/files/pil.10849.pdf
AUTHOR DETAILS
Written By Dr. Janet.C, Pharm.D
Last updated on 01 Nov 2022 | 06:09 PM(IST)
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