INTRODUCTION

OLMETOP 20 CT is a combination of Chlorthalidone and Olmesartan which belongs to the group of medicines called Thiazide diuretics and Angiotensin-II receptor antagonists respectively. OLMETOP 20 CT is indicated for the treatment of essential hypertension. Essential hypertension (also known as primary 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 walls of blood vessels supplying various important organs. It occurs without any known secondary cause and if remains untreated it can lead to severe problems such as heart attack, heart or kidney failure, stroke, or even blindness.

Olmesartan is an Angiotensin-II receptor antagonist that effectively reduces blood pressure by blocking the actions of Angiotensin – II (a substance that causes narrowing of blood vessels and increase in blood pressure) at the angiotensin type-I receptors and chlorthalidone is a thiazide diuretic that acts by increasing urinary excretion of sodium and water, thus reducing blood volume followed by a marked decrease in blood pressure. Along treatment with OLMETOP 20 CT follow the lifestyle modifications (such as losing weight, quitting smoking or alcohol intake) as advised by your physician along with a healthy balanced diet and a regular physical activity (such as walking or swimming).

During course of the treatment with OLMETOP 20 CT, your doctor might regularly check your blood pressure, kidney function and electrolyte balance to avoid the risk of side effects. Avoid eating grapefruit or consuming grapefruit juice while taking OLMETOP 20 CT as it could potentiate the blood pressure lowering effect of this medicine. Before taking OLMETOP 20 CT, inform your doctor if you have diabetes, liver, kidney, or heart disease as a precaution.

OLMETOP 20 CT is strictly not recommended for use in pregnant or breastfeeding women as it could cause serious harm to the baby. The most common side effects of taking OLMETOP 20 CT are headache, dizziness, tiredness, nausea, stomach pain, lack of appetite or electrolyte imbalance. Consult your doctor if any of the symptoms worsen.

USES OF OLMETOP 20 CT

• Treats essential hypertension

HOW OLMETOP 20 CT WORKS

OLMETOP 20 CT effectively reduce elevated blood pressure where olmesartan acts by blocking the actions of Angiotensin – II (a substance that causes narrowing of blood vessels and increase in blood pressure) at the angiotensin type-I receptors of the vascular smooth muscle and chlorthalidone acts by increasing the urinary excretion of sodium and water by inhibiting sodium-chloride reabsorption in the kidneys, thus leading to a marked decrease in blood pressure.

DIRECTIONS FOR USE

Take OLMETOP 20 CT as advised by your physician. Swallow OLMETOP 20 CT 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 OLMETOP 20 CT

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take OLMETOP 20 CT with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. 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 diarrhea. 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 head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

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.

Constipation: 

Eat fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.

Stomach 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.

Loss of appetite:

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking OLMETOP 20 CT inform to your doctor, if you are taking any of these medicines:

• other medicines used to reduce hypertension and other heart problems such as ACE inhibitors (Ex. captopril, enalapril), angiotensin receptor blockers (Ex. losartan, valsartan), calcium channel blockers (Ex. nifedipine, diltiazem, verapamil), beta-blockers (Ex. atenolol, propranolol), vasodilators (Ex. nitroglycerin, bosentan), digoxin, methyldopa, guanethidine or aliskiren
• lithium (used to treat depression or other mental illness)
• non-steroidal anti-inflammatory drugs (used to treat pain or inflammation) Ex. indomethacin
• simvastatin, colesevelam and cholestyramine (used to control high blood cholesterol levels)
• antacids (used to neutralize stomach acid) Ex. aluminium hydroxide, magnesium hydroxide
• ketoconazole, itraconazole or amphotericin (used to treat fungal infections)
• protease inhibitors (used to treat HIV infections) Ex. ritonavir, indinavir, nelfinavir
• certain antibiotics (used to treat bacterial infections) Ex. rifampicin, erythromycin, clarithromycin
• hypericum perforatum (an herbal medicine used to treat depression)
• dantrolene (used to treat muscle spasticity)
• immunosuppressant (used to suppress immune function and prevent graft rejection) Ex. tacrolimus, sirolimus, temsirolimus, everolimus, or cyclosporine
• adrenocorticotropic hormone (used to treat various endocrine disorders)
• corticosteroids (used to treat allergic or inflammatory diseases and immune reactions) such as prednisolone or betamethasone
• anticholinergics (used to reduce stomach spasms or cramps) such as atropine, biperiden or hyoscine butyl bromide
• cyclophosphamide or methotrexate (used to treat certain forms of cancer)
• salbutamol or formoterol (used to treat asthma)
• amantadine (a medicine used to treat viral infections or Parkinson’s disease)
• allopurinol (a medicine used to treat gout)
• carbenoxolone (a medicine used to treat stomach ulcers)
• calcium salts or vitamin D (used as a supplement)
• medicines used to treat diabetes (Ex. insulin, chlorpropamide or glibenclamide)
• diazoxide (used to manage low blood glucose levels)
• medicines that can alter blood potassium levels such as potassium-sparing diuretics (Ex. spironolactone, acetazolamide), salt substitutes containing potassium (Ex. losartan potassium) and heparin sodium

B. Drug-Food interaction:

OLMETOP 20 CT can be taken with or without food. Avoid consumption of grapefruit or grapefruit juice while taking OLMETOP 20 CT as it could cause severe decrease in blood pressure.

Overdosage:

If you or anyone else accidentally take too much of OLMETOP 20 CT, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of OLMETOP 20 CT might include dizziness, excess sleepiness, nausea, hypovolemia, low blood pressure, and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.

SYNOPSIS

MORE INFORMATION

• Keep OLMETOP 20 CT out of reach of children
• Store OLMETOP 20 CT at room temperature

FAQs ABOUT OLMETOP 20 CT

Can OLMETOP 20 CT be taken during pregnancy?

No. OLMETOP 20 CT is strictly not recommended for use in pregnant women because it can cause serious harm to the developing fetus. If you are planning for pregnancy, consult your doctor before taking OLMETOP 20 CT.

Can I consume alcohol while taking OLMETOP 20 CT?

No. Avoid consumption of alcohol while taking OLMETOP 20 CT, as it could aggravate your existing disease condition and increase the risk of serious complications such as heart attack, stroke, or kidney problems.

Can OLMETOP 20 CT be used in chronic kidney disease?

No. OLMETOP 20 CT is not recommended for use in patients with severe kidney disease such as chronic kidney disease. Kindly consult your doctor before taking OLMETOP 20 CT.

Can OLMETOP 20 CT cause gout?

Yes. OLMETOP 20 CT can increase the levels of uric acid in blood in some individuals, and so caution should be exercised among patients with kidney disease or a previous history of gout. Kindly consult your doctor before taking OLMETOP 20 CT.

Can OLMETOP 20 CT cause leg swelling?

Yes. OLMETOP 20 CT can cause swollen ankles, feet, legs, hands, or arms, although not everybody gets them and so caution should be exercised among patients with kidney or heart disease. Kindly consult your doctor before taking OLMETOP 20 CT.

What to do If I forget to take OLMETOP 20 CT?

You should take OLMETOP 20 CT immediately when you remember. If it is time for your next dose of OLMETOP 20 CT skip the dose and follow your regular dose schedule. Do not double the dose of to match up your missed dose.

REFERENCES

1. KD. Tripathi. Antihypertensive Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 559 & 561-562.

2. 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 – 767-770 & 778.

3. Gerald G. Briggs and Roger K. Freeman. C. and O. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 760 & 2852.

4. Dr. G. Chitti Pantulu, Dr. Avinash Shende, Dr. Prathmesh Mule and Dr. A. A. Faruqui. Evaluation of efficacy and safety of oral olmesartan and chlorthalidone fixed dose combination in the management of hypertension in Indian Patients. International journal of current research. [Accessed on 23rd October 2021] http://www.journalcra.com/article/evaluation-efficacy-and-safety-oral-olmesartan-and-chlorthalidone-fixed-dose-combination

5. Elena Filipova, Stela Dineva , Katya Uzunova, Velichka Pavlova, Krassimir Kalinov and Toni Vekov. Combining angiotensin receptor blockers with chlorthalidone or hydrochlorothiazide – which is the better alternative? A meta-analysis. Systematic reviews. BMC. 2020. [Accessed on 23rd October 2021] https://d-nb.info/1219505919/34

6. TORRENT PHARMACEUTICALS LTD. OLSAR CH. Torrentian.com. [Revised in February 2021] [Accessed on 23rd October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3004.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney function test