INTRODUCTION

ZILZOX CH is a fixed-dose combination of Azilsartan and Chlorthalidone which belongs to the group of medicines called Antihypertensive agents. It is used in adults to manage hypertension. Hypertension (also known as high blood pressure) 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, like heart, kidney, or brain.

Azilsartan is an angiotensin II receptor blocker. It acts by relaxing the blood vessels supplying the vital organs. Chlorthalidone is a thiazide-diuretic. It acts by increasing the removal of water and certain electrolytes (sodium and chloride) from the body in the form of urine which eventually reduces blood volume. Collectively, they improve blood flow through the blood vessels and reduces the elevated blood pressure.

While undergoing therapy with ZILZOX CH your doctor will regularly monitor your blood pressure, kidney function, blood sugar, cholesterol or uric acid levels and electrolyte profile (sodium, potassium, and magnesium levels) to avoid the risk of unwanted side effects.

Before taking ZILZOX CH inform your doctor if you have any heart, kidney, or liver problems. You must also inform your doctor if you have diabetes related kidney problems, gout, or are severely dehydrated (due to vomiting or diarrhea).

ZILZOX CH is strictly not recommended for use in pregnant or breastfeeding women. Women taking ZILZOX CH must inform their doctor immediately if they become pregnant while undergoing therapy with ZILZOX CH.

ZILZOX CH may make you feel dizzy or faint. Therefore, be cautious while you drive or operate any tools that requires proper attention. Other common side effects of ZILZOX CH are low blood potassium levels, tiredness, or muscle spasms. Consult your doctor if any of these side effect worsens.

USES OF ZILZOX CH

• Manages hypertension in adults

HOW ZILZOX CH WORKS

ZILZOX CH effectively controls blood pressure. It contains azilsartan and chlorthalidone. Azilsartan blocks the actions of a peptide hormone called angiotensin-II that increases blood pressure. This makes the blood vessels to relax and improves blood flow within them. Chlorthalidone increases the excretion of water and electrolytes (sodium and chloride) from the body in the form of urine. This reduces blood volume which makes the blood to be pumped easier by the heart with less pressure. Collectively they reduces blood pressure.

DIRECTIONS FOR USE

Take ZILZOX CH as directed by the physician. Swallow ZILZOX CH with a glass of water. Do not crush or chew the medicine. ZILZOX CH can be taken with or without meals.

Your doctor will decide the correct dose and for how long ZILZOX CH must be taken depending upon your age, body weight and disease condition. Do not stop taking ZILZOX CH without consulting your doctor.

SIDE EFFECTS OF ZILZOX CH

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Nausea and Vomiting:

Take ZILZOX CH with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before taking ZILZOX CH, inform your doctor if you are taking any of the following medicines such as:

• other medicines that can control blood pressure (such as captopril, enalapril, lisinopril, ramipril, valsartan, telmisartan, irbesartan or aliskiren)
• lithium (a medicine used to manage mental illnesses)
• non-steroidal anti-inflammatory drugs (used for pain relief) such as ibuprofen, diclofenac, celecoxib, or aspirin
• medicines used to increase potassium levels in the blood such as potassium supplements, or potassium-sparing medicines (such as spironolactone, aldosterone)
• medicines that can reduce blood potassium levels such as amphotericin, carbenoxolone, prednisone, or ACTH
• heparin (a medicine used for blood thinning)
• medicines used to manage diabetes (such as metformin, glimepiride)
• medicines used to manage gout (Ex. allopurinol, probenecid)
• medicines used to manage asthma (Ex. salbutamol, budesonide, formoterol)
• digitalis (a medicine used to correct abnormal heart rhythm)
• anticholinergics (used to reduce muscle spasms and to increase heart functions) such as atropine
• amantadine (a medicine used to manage viral infections or Parkinson´s disease)
• cholestyramine (a medicine used to reduce blood cholesterol levels)
• ciclosporin (a medicine used to suppress immune functions or to prevent graft rejection)
• medicines used to manage cancer (Ex. cyclophosphamide or methotrexate)
• Vitamin D and calcium supplements

Overdosage:

If you or anyone else accidentally took more ZILZOX CH, consult your doctor immediately. Symptoms of overdosage might include feeling dizzy or faint.

SYNOPSIS

MORE INFORMATION

• Keep ZILZOX CH out of reach to children
• Store ZILZOX CH at room temperature

FAQs ABOUT ZILZOX CH

What are the uses of ZILZOX CH?

ZILZOX CH is used in adults to manage hypertension. It effectively controls blood pressure, where azilsartan acts by relaxing the blood vessels and chlorthalidone acts by increasing the excretion of sodium and water from the body in the form of urine. Collectively, they relax blood vessels, improves blood flow and reduces blood pressure.

What type of a drug is ZILZOX CH?

ZILZOX CH is an antihypertensive medicine used to reduce elevated blood pressure. It contains a combination of two medicines called azilsartan and chlorthalidone. Azilsartan is an angiotensin II receptor blocker and chlorthalidone is a thiazide-diuretic. They both acts together in reducing blood pressure.

What are the side effects of ZILZOX CH?

ZILZOX CH may make you feel dizzy or faint. Therefore, be cautious while you drive or operate any tools that requires proper attention. Other common side effects of ZILZOX CH are low blood potassium levels, tiredness, or muscle spasms. Consult your doctor if any of these side effect worsens.

Can the use of ZILZOX CH cause kidney problems?

Yes. The use of ZILZOX CH may affect your kidney functions. It is strictly not recommended for use in patients with severe kidney problems. It should be used with caution in patients with other kidney problems (such as dialysis or any recent kidney transplant). Therefore, consult your doctor before taking ZILZOX CH as a precaution.

Can ZILZOX CH reduce blood pressure?

Yes. ZILZOX CH effectively controls blood pressure in patients with hypertension.

What happens when I stop taking ZILZOX CH?

Do not stop taking ZILZOX CH without consulting your doctor as your blood pressure may raise once again. Make sure to take ZILZOX CH for the stipulated duration recommended by your doctor to achieve maximum results.

What is the best time to take ZILZOX CH?

ZILZOX CH can be taken with or without meals. Your doctor will decide the best time for you to take ZILZOX CH based on your age, body weight and disease condition.

How long will it take for ZILZOX CH to show the results?

You might be able to notice a reduction in your blood pressure within 1-2 weeks of starting therapy with ZILZOX CH. However, it may take around 4 weeks for you to notice the maximum benefits. Therefore, continue to take ZILZOX CH as advised by your doctor.

What to do if I forgot to take a dose of ZILZOX CH?

If you have missed a dose of ZILZOX CH, take it as soon as you remember. However, if it is time for the next dose of ZILZOX CH, skip the missed dose and take the next one regularly. Do not take a double dose of ZILZOX CH to compensate the missed ones.

REFERENCES

1. K.D. Tripathi. Diuretics. Antihypertensives. Essential of Medical Pharmacology. 7th Edition. 2013. Page: 583-586 and 561.

2. David J. Collier MD, PhD, Attila Juhasz MD, PhD, Enrico Agabiti-Rosei MD, PhD, Eric Lloyd MS, Michie Hisada MD, MPH, ScD, Lin Zhao PhD, Stuart Kupfer MD, Mark J. Caulfield MD. Efficacy and safety of azilsartan medoxomil/chlortalidone fixed-dose combination in hypertensive patients uncontrolled on azilsartan medoxomil alone: A randomized trial. Wiley Online Library. October 2018. [Accessed on 23rd June 2022] https://onlinelibrary.wiley.com/doi/10.1111/jch.13376

3. Ipca Laboratories. Optimising TRIUMPH with 6·25 mg chlorthalidone. The Lancet.com. February 2020. [Accessed on 23rd June 2022] https://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(19)30535-2.pdf

4. Takeda Ireland Limited. Health Products Regulatory Authority (HPRA). [Revised in December 2021] [Accessed on 23rd June 2022] https://www.hpra.ie/img/uploaded/swedocuments/cf80a3a8-cab0-4606-85da-ef6eb00fe5ee.pdf

5. Takeda Pharmaceuticals America, Inc. U.S. Food & Drug Administration. [Revised in December 2011] [Accessed on 23rd June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202331lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney Function Tests