CHARTOREG TRIO 5 / 12.5 / 80 MG ( AMLODIPINE / HYDROCHLOROTHIAZIDE / TELMISARTAN ) 28 FILM-COATED TABLETS

CHARTOREG TRIO 5 / 12.5 / 80 MG

Amlodipine + Hydrochlorothiazide + Telmisartan
28 Film-Coated Tablets

Medical Description

CHARTOREG TRIO 5/12.5/80 mg is a fixed-dose combination of three antihypertensive medicines: amlodipine 5 mg, hydrochlorothiazide 12.5 mg, and telmisartan 80 mg. It is designed to provide complementary blood-pressure-lowering effects through three different pharmacological mechanisms.

The combination of an angiotensin II receptor blocker (ARB), a dihydropyridine calcium-channel blocker (CCB), and a thiazide diuretic is an established approach to treating hypertension when adequate blood-pressure control requires multiple agents. WHO guidelines specifically recognize ARBs, dihydropyridine CCBs, and thiazide/thiazide-like diuretics as the three principal antihypertensive classes used in combination therapy.

Composition

Each film-coated tablet contains:

• Amlodipine 5 mg
• Hydrochlorothiazide 12.5 mg
• Telmisartan 80 mg

Pack size: 28 film-coated tablets.

Indication

CHARTOREG TRIO is intended for the treatment of hypertension (high blood pressure) in adults when treatment with multiple antihypertensive agents is clinically appropriate.

Triple antihypertensive therapy may be used when blood pressure remains above the desired level despite dual therapy, or when a patient already requires three antihypertensive medicines and a fixed-dose combination is appropriate. Evidence from clinical studies of the telmisartan/amlodipine/hydrochlorothiazide combination demonstrates additional blood-pressure reduction compared with telmisartan/hydrochlorothiazide alone in patients whose hypertension was inadequately controlled.

Mechanism of Action

1. Telmisartan 80 mg — Angiotensin II Receptor Blocker (ARB)
Telmisartan selectively blocks the AT₁ receptors for angiotensin II. This inhibits angiotensin-II-mediated vasoconstriction and reduces aldosterone-related sodium and water retention, contributing to a reduction in vascular resistance and blood pressure.

2. Amlodipine 5 mg — Calcium-Channel Blocker (CCB)
Amlodipine inhibits calcium entry into vascular smooth muscle through L-type calcium channels. This produces arteriolar vasodilation, decreases peripheral vascular resistance, and lowers blood pressure.

3. Hydrochlorothiazide 12.5 mg — Thiazide Diuretic
Hydrochlorothiazide increases renal excretion of sodium and water. The resulting reduction in extracellular fluid volume contributes to lower blood pressure. With continued treatment, reduction in peripheral vascular resistance also contributes to the antihypertensive effect.

Combining these three classes provides complementary mechanisms while targeting different physiological pathways involved in hypertension.

Clinical Benefits

When appropriately prescribed, the three-component regimen can:

• Provide multi-mechanism blood-pressure reduction.
• Address hypertension through complementary pathways.
• Help patients who remain inadequately controlled with two antihypertensive agents.
• Provide three prescribed antihypertensive components in one tablet, potentially simplifying the treatment regimen.

Clinical research evaluating telmisartan 80 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg found greater blood-pressure reduction than telmisartan/hydrochlorothiazide alone in patients with inadequately controlled hypertension.

Dosage & Administration

• The dose should be determined by the treating physician according to the patient's blood pressure, previous treatment, renal function, electrolyte status, and response to therapy.
• The fixed-dose combination is generally administered once daily when prescribed.
• The tablet should be swallowed with water and may generally be taken with or without food, according to the specific product prescribing information.
• Take the medicine at approximately the same time each day.
• Do not change the dose or discontinue treatment without medical advice.
• Blood pressure and, where clinically appropriate, renal function and serum electrolytes should be monitored during treatment.

WHO recommends monitoring potassium and kidney function when starting or changing treatment involving an ARB or thiazide/thiazide-like diuretic, when testing is readily available.

Important Warnings & Precautions

Pregnancy
Telmisartan, as an ARB, can cause serious fetal injury or death when administered during pregnancy. The medicine should not be used during pregnancy, and women who become pregnant while receiving telmisartan should contact their healthcare professional promptly.

Low blood pressure / dehydration
Excessive fluid loss from vomiting, diarrhea, excessive sweating, or inadequate fluid intake may increase the risk of symptomatic hypotension, dizziness, or fainting.

Kidney function
Patients with renal impairment, renal artery stenosis, heart failure, or conditions associated with reduced circulating blood volume may require closer monitoring of renal function.

Electrolyte disturbances
Hydrochlorothiazide may cause decreases in potassium, sodium and magnesium, while telmisartan may increase serum potassium. Appropriate patients may therefore require periodic electrolyte monitoring.

Diabetes and glucose metabolism
Hydrochlorothiazide may affect glucose control. Patients with diabetes should follow their physician's recommendations for glucose monitoring.

Gout / elevated uric acid
Hydrochlorothiazide may increase serum uric acid and may aggravate hyperuricemia or gout in susceptible individuals.

Liver impairment
Telmisartan is predominantly eliminated through the hepatobiliary route. Patients with hepatic impairment should inform their physician before treatment.

Possible Adverse Effects

Potential adverse effects may include:

• Dizziness or lightheadedness
• Headache
• Fatigue
• Peripheral edema, particularly related to amlodipine
• Increased urination
• Hypotension
• Electrolyte abnormalities
• Increased uric acid
• Changes in blood glucose

Less common but potentially serious reactions can include:

• Significant hypotension
• Renal impairment
• Significant electrolyte disturbances
• Angioedema
• Severe hypersensitivity reactions
• Amlodipine-associated worsening of angina in susceptible patients, particularly around treatment initiation or dose increases

The overall adverse-effect profile of triple antihypertensive therapy reflects the effects and interactions of all three components and should be assessed individually for each patient. Clinical studies of telmisartan/amlodipine/hydrochlorothiazide have generally reported the combination as well tolerated.

Important Drug Interactions

Tell your physician or pharmacist about all medicines and supplements being taken. Particular attention may be required with:

• ACE inhibitors or other ARBs
• Aliskiren
• Potassium supplements or potassium-containing salt substitutes
• Potassium-sparing diuretics
• NSAIDs, including some commonly used painkillers
• Lithium
• Other medicines that lower blood pressure
• Medicines that can alter potassium or other electrolyte concentrations
• Certain medicines that may increase amlodipine exposure

Combining medicines that affect the renin-angiotensin system or potassium balance may increase the risk of hyperkalemia, hypotension, or renal impairment.

Monitoring

Depending on the patient's medical condition, healthcare professionals may monitor:

• Blood pressure
• Heart rate and symptoms of hypotension
• Serum creatinine/eGFR
• Serum potassium
• Sodium and magnesium
• Blood glucose in patients at risk
• Uric acid in patients susceptible to gout
• Signs of peripheral edema or other calcium-channel-blocker-related effects

Storage

Store CHARTOREG TRIO according to the conditions stated on the original product packaging. Keep the tablets in their original package, protected from excessive heat and moisture, and keep out of the reach of children.

Medical Disclaimer

CHARTOREG TRIO is a prescription antihypertensive medicine and should be used only under the supervision of a qualified healthcare professional. This information is provided for educational purposes and does not replace professional medical advice, diagnosis, or individualized treatment. Do not start, stop, or change the dose without consulting your physician. Inform your healthcare professional if you are pregnant, planning pregnancy, breastfeeding, or have kidney, liver, heart, diabetes, electrolyte, or gout-related conditions.

References

• World Health Organization (WHO) — Guideline for the Pharmacological Treatment of Hypertension in Adults.
• WHO — Evidence and recommendations concerning combination antihypertensive therapy.
• National Institutes of Health / PubMed Central — Clinical study of telmisartan 80 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg.
• PubMed / NIH — Randomized clinical evidence for telmisartan/amlodipine/hydrochlorothiazide triple therapy.
• PubMed / NIH — Review of evidence for triple-combination antihypertensive therapy.

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