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INTRODUCTION
OLMIGHTY AM TABLET is a combination of Amlodipine and Olmesartan which belongs to the group of medicines called Antihypertensive agents. OLMIGHTY AM TABLET is indicated for the treatment of high blood pressure among patients who remain unresponsive to therapy with either olmesartan or amlodipine alone.
High blood pressure (also known as hypertension) is a medical condition in which the force of the blood exerted against the walls of the artery remains very high and as a result it may lead to severe damage to the blood vessels supplying several organs, thus causing heart attack, heart or kidney failure, stroke or even blindness.
During treatment with OLMIGHTY AM TABLET, your doctor might check your kidney function, blood pressure and electrolytes (Ex. potassium) concentration in your blood at regular intervals to avoid the risk of unwanted side effects.
Avoid consumption of grapefruit or grapefruit juice while taking OLMIGHTY AM TABLET as it could lead to an unpredictable decrease in blood pressure. Before taking OLMIGHTY AM TABLET, inform your doctor if you have any liver, kidney or heart disease or if you are pregnant or might be pregnant because this medicine could cause serious harm to the growing baby.
It is not recommended for use in breast-feeding women. OLMIGHTY AM TABLET is not recommended for use in children and adolescents (aged under 18 years) due to lack of safety data. It should be taken with caution in elderly patients (aged 65 years or above).
The most common side effects of taking OLMIGHTY AM TABLET are headache, dizziness, tiredness, edema, sore throat and constipation. Consult your doctor if any of the side effects worsen.
USES OF OLMIGHTY AM TABLET
- Treats high blood pressure (among patients who remain unresponsive to therapy with either olmesartan or amlodipine alone)
HOW OLMIGHTY AM TABLET WORKS
OLMIGHTY AM TABLET effectively reduces elevated blood pressure, where Olmesartan acts by inhibiting the actions of Angiotensin – II (a peptide hormone that causes narrowing of blood vessels and increase in blood pressure) at the angiotensin-II receptors of the kidneys and amlodipine acts by blocking the influx of calcium in the blood vessels by inhibiting the voltage gated calcium channels, thus causing vascular smooth muscle relaxation, vasodilation and a marked decrease in blood pressure.
DIRECTIONS FOR USE
Take OLMIGHTY AM 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 OLMIGHTY AM TABLET for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF OLMIGHTY AM TABLET
COMMON
- dizziness and headache
- swelling of hands, arms, ankles, legs or feet
- tiredness
- bronchitis (inflammation of the bronchus)
- sore throat, runny nose, cough
- nausea, diarrhea, constipation, abdominal pain or indigestion
- joint or bone pain
- back pain
- urinary tract infections or blood in the urine
- chest pain, flu-like symptoms (include fever, chills, cough, runny nose and headache)
- visual disturbance
- difficulty in breathing
UNCOMMON
- dizziness on standing up
- lack of energy
- tingling or numbness of hands or feet
- vertigo (spinning sensation)
- awareness of heartbeat, fast heartbeat, low blood pressure with symptoms such as dizziness, light-headedness and difficult breathing
- cough, vomiting
- dry mouth, upper abdominal pain
- skin rash
- cramps, pain in arms and legs
- feeling more of an urge to pass urine
- sexual inactivity
- inability to get or maintain an erection
- weakness
RARE
- fainting
- allergic reaction
- redness and warm feeling of face
- red and itchy bumps
- swelling of face
Stop taking OLMIGHTY AM TABLET and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reactions (such as skin rash with itching and swelling of the face, mouth and/or larynx)
- signs of hypotension (such as severe dizziness or light-headedness and fainting)
- severe, persistent diarrhea with substantial weight loss
- yellowing of the whites of the eyes, dark urine and itching of the skin
HOW TO MANAGE SIDE EFFECTS
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.
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.
Nausea and vomiting:
Try to take OLMIGHTY AM TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy foods. If the symptom does not improve consult your doctor.
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 did not improve.
Constipation:
Eat fiber rich foods such as fresh fruits, vegetables, cereals and drink plenty of water. Try to exercise more regularly (such as daily walking). Consult your doctor if the symptom did not improve on its own.
Abdominal pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.
WARNING & PRECAUTIONS
PREGNANCY
OLMIGHTY AM TABLET is not recommended for use in early pregnancy and should not be taken when more than 3 months pregnant as it may cause serious harm to your baby. Consult your doctor before taking OLMIGHTY AM TABLET.
BREASTFEEDING
OLMIGHTY AM TABLET may pass into breast milk in small amounts and it is not recommended for use in breastfeeding women. Your doctor may choose another treatment if you wish to breast-feed especially if your baby is newborn or born prematurely. Consult your doctor before taking OLMIGHTY AM TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any tools or machines if you experience dizziness, sleepiness or headache after taking OLMIGHTY AM TABLET.
ALCOHOL
Avoid consumption of alcohol while taking this medicine, as it could aggravate your dizziness and tiredness. Consult your doctor before taking OLMIGHTY AM TABLET.
KIDNEY
OLMIGHTY AM TABLET is not recommended for use in patients with impaired kidney function and should be used with caution in patients with kidney problems or with surgical history of kidney transplant. Consult your doctor before taking OLMIGHTY AM TABLET.
LIVER
OLMIGHTY AM TABLET is not recommended for use in patients with severe liver problems (such as biliary obstruction, gall stones, jaundice) and should be used with caution in patients with liver disease. Consult your doctor before taking OLMIGHTY AM TABLET.
ALLERGY
Talk to your doctor if you are allergic to Olmesartan, Amlodipine or any other calcium channel blockers (Ex. nifedipine, nicardipine, felodipine).
HEART DISEASE
OLMIGHTY AM TABLET is not recommended for use in patients with heart disease (such as aortic stenosis (narrowing of the aorta), cardiogenic shock, circulatory failure or heart attack). Consult your doctor before taking OLMIGHTY AM TABLET.
OTHERS
OLMIGHTY AM TABLET is not recommended for use if you have:
- diabetes-related kidney problems
- severe hypotension (very low blood pressure)
Before taking this medicine, inform your physician if you:
- have severe vomiting and/or diarrhea
- are on a low-sodium diet
- have hyperkalemia (increased levels of potassium in the blood)
- have problems in adrenal glands
Use in pediatrics:
OLMIGHTY AM TABLET is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. Consult your child’s doctor for advice.
Use in geriatrics:
OLMIGHTY AM TABLET should be taken with caution in elderly patients (aged 65 years or above). Proper dose adjustments and careful monitoring of blood pressure and kidney function are required in such patients. Consult your doctor before taking OLMIGHTY AM TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking OLMIGHTY AM TABLET inform to your doctor, if you are taking any of these medicines:
- other blood pressure lowering medicines such as angiotensin-converting enzyme (ACE) inhibitors (Ex. enalapril, lisinopril, ramipril) or aliskiren
- potassium-containing medicines such as potassium supplements, salt substitutes containing potassium (Ex. losartan potassium) and diuretics (Ex. spironolactone)
- non-Steroidal anti-inflammatory drugs (used to relieve pain, swelling and inflammation) Ex. ibuprofen, aspirin, diclofenac
- certain antacids (used to relieve indigestion or heartburn) Ex. aluminium hydroxide or magnesium hydroxide
- medicines used to control blood cholesterol levels (Ex. colesevelam, simvastatin)
- medicines used to treat HIV infection (Ex. ritonavir, nelfinavir or indinavir)
- medicines used to treat fungal infections (Ex. ketoconazole or itraconazole)
- immunosuppressants (used to suppress immune function and prevent graft rejection) Ex. tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporin
- heparin (a medicine used for blood thinning and prevention of blood clots)
- lithium (a medicine used to treat depression or other mental illness)
- diltiazem and verapamil (used to treat abnormal heart rhythm and high blood pressure)
- rifampicin (used to treat tuberculosis)
- erythromycin or clarithromycin (used to treat bacterial infections)
- st. john’s wort (an herbal medicine used to treat depression)
- dantrolene (a medicine used to treat muscle spasm or rigidity)
B. Drug-Food interaction:
Avoid eating grapefruit or consuming grapefruit juice while taking OLMIGHTY AM TABLET as it could lead to an increase in the levels of amlodipine in the blood, which may lead to an unpredictable decrease in blood pressure.
Overdosage:
If you or anyone else accidentally take too much of OLMIGHTY AM TABLET, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of OLMIGHTY AM TABLET includes low blood pressure with dizziness and fast or slow heartbeat.
SYNOPSIS
| Drug | : | Amlodipine, Olmesartan |
| Pharmacological Category | : | Antihypertensive agents |
| Therapeutic Indication | : | High blood pressure |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep OLMIGHTY AM TABLET out of reach of children
- Store OLMIGHTY AM TABLET at room temperature
FAQs ABOUT OLMIGHTY AM TABLET
What are the precautions that I should follow while taking OLMIGHTY AM TABLET?
Before taking OLMIGHTY AM TABLET, inform your doctor if you have diabetes, liver, kidney or heart disease or if you are pregnant or might be pregnant as a precaution. Avoid consumption of grapefruit or grapefruit juice while taking OLMIGHTY AM TABLET as it could lead to an unpredictable decrease in blood pressure.
Can OLMIGHTY AM TABLET be taken during pregnancy?
No, OLMIGHTY AM TABLET is not recommended for use in early pregnancy and should not be taken when more than 3 months pregnant as it may cause serious harm to your baby. Consult your doctor before taking OLMIGHTY AM TABLET. Your doctor may prescribe safest anti-hypertensive medicine which can be taken during pregnancy.
Does OLMIGHTY AM TABLET cause weight gain?
OLMIGHTY AM TABLET does not have any direct impact on your body weight. However, it can cause fluid retention (edema) in your hands, arms, arms, legs and feet which might make you feel heavy. Consult your doctor if the symptom did not improve during or after treatment with OLMIGHTY AM TABLET.
How long should I take OLMIGHTY AM TABLET?
Continue to take OLMIGHTY AM TABLET as long as your doctor tells you to do so. Do not stop taking OLMIGHTY AM TABLET on your own once your blood pressure is controlled without consulting your doctor as it could raise your blood pressure again. Generally, you may be asked to take OLMIGHTY AM TABLET for life-long because it can only control your blood pressure and does not cure it.
Can OLMIGHTY AM TABLET make me feel dizzy?
Yes, OLMIGHTY AM TABLET can make you feel dizzy. 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 during or after treatment with OLMIGHTY AM TABLET.
Is OLMIGHTY AM TABLET safe to use in patients with liver disease?
OLMIGHTY AM TABLET is not recommended for use in patients with severe liver problems (such as biliary obstruction, gall stones, jaundice) and should be taken with caution in patients with liver disease. Your doctor will regularly monitor your liver function tests to assess the risk of liver damage due to OLMIGHTY AM TABLET. Consult your doctor before taking OLMIGHTY AM TABLET.
REFERENCES
1. KD. Tripathi. Antihypertensive Drugs and Drugs Affecting Renin Angiotensin System and Plasma Kinins. Essentials of medical pharmacology. Seventh edition. 2013. Page – 562-563 & 505-508.
2. Randa Hilal-Dandan. Renin and angiotensin. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 738-739.
3. Thomas Michel and Brian B. Hoffman. Treatment of Myocardial ischemia and hypertension. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 755-760.
4. Gerald G. Briggs and Roger K. Freeman. A & O. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 196-198 & 2852-2853.
5. Daiichi Sankyo, Inc. Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in January 2019] [Accessed on 29th October 2022] https://clinicaltrials.gov/ct2/show/NCT00923091
6. Henry Punzi, Joel M Neutel, Dean J Kereiakes, Ali Shojaee, William F Waverczak, Robert Dubiel, Jen-Fue Maa. Efficacy of amlodipine and olmesartan medoxomil in patients with hypertension: the AZOR Trial Evaluating Blood Pressure Reductions and Control (AZTEC) study. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. August 2010. [Accessed on 29th October 2022] https://pubmed.ncbi.nlm.nih.gov/20519261/
7. Henry Punzi, Ali Shojaee, William F Waverczak, Jen-Fue Maa. Efficacy of amlodipine and olmesartan medoxomil in hypertensive patients with diabetes and obesity. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. June 2011. [Accessed on 29th October 2022] https://pubmed.ncbi.nlm.nih.gov/21649842/
8. Daiichi Sankyo Europe GmbH. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 29th October 2022] https://www.medicines.org.uk/emc/files/pil.6527.pdf
9. Torrent Pharmaceuticals Ltd. Olmetor AM. Torrentian.com. [Revised in October 2019]. [Accessed on 29th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1776.pdf
10. Cipla Ltd. Olmecip AM Tablets (Olmesartan medoxomil + Amlodipine). Ciplamed.com. [Revised in February 2020]. [Accessed on 29th October 2022] https://www.ciplamed.com/content/olmecip-am-tablets
11. John lee Pharmaceuticals Pvt Ltd. Omten-40 AM. [Accessed on 29th October 2022] https://johnleeindia.com/product/omten-40-am/
USEFUL DIAGNOSTIC TESTS
- Kidney function test
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 03 Nov 2022 | 04:58 PM(IST)
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