CHARTOREG PLUS 80 / 25 MG

CHARTOREG PLUS

Telmisartan / Hydrochlorothiazide
28 Tablets

Available strengths:

• CHARTOREG PLUS 40 / 12.5 mg — Telmisartan 40 mg + Hydrochlorothiazide 12.5 mg
• CHARTOREG PLUS 80 / 12.5 mg — Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg
• CHARTOREG PLUS 80 / 25 mg — Telmisartan 80 mg + Hydrochlorothiazide 25 mg

Medical Description

CHARTOREG PLUS is a fixed-dose combination of telmisartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide (HCTZ), a thiazide diuretic. It is used for the treatment of arterial hypertension (high blood pressure) when combination therapy is appropriate. By lowering blood pressure, antihypertensive treatment reduces the risk of cardiovascular complications such as stroke and myocardial infarction.

The combination provides complementary antihypertensive actions: telmisartan blocks the effects of angiotensin II at the AT₁ receptor, reducing vasoconstriction and aldosterone-mediated sodium retention, while hydrochlorothiazide increases renal excretion of sodium and water, thereby reducing circulating volume and contributing to blood-pressure reduction.

Indications

CHARTOREG PLUS is indicated for:

• Treatment of hypertension in adults when blood pressure is not adequately controlled with monotherapy or when combination treatment is clinically appropriate.
• Patients requiring an ARB + thiazide diuretic combination for improved blood-pressure control.

WHO hypertension guidance recognizes single-pill combinations of antihypertensive agents from different classes as an important treatment approach for appropriate adults requiring pharmacological therapy.

Strengths & General Clinical Use

The approved fixed-dose strengths include 40/12.5 mg, 80/12.5 mg and 80/25 mg.

Mechanism of Action

Telmisartan:
Telmisartan selectively blocks the binding of angiotensin II to the AT₁ receptor. This inhibits angiotensin-II-mediated vasoconstriction and aldosterone secretion, promoting vasodilation and reducing sodium-retaining effects.

Hydrochlorothiazide:
Hydrochlorothiazide is a thiazide diuretic that increases renal excretion of sodium and water. This reduces extracellular fluid volume and contributes to lower blood pressure. Thiazide diuretics can also produce metabolic/electrolyte changes, which is why monitoring may be necessary during treatment.

Combination effect:
Using the two mechanisms together can provide additive blood-pressure reduction. Clinical trial evidence has demonstrated greater reductions in blood pressure with telmisartan/HCTZ combinations compared with either component alone in patients with mild-to-moderate hypertension.

Dosage & Administration

• Usually taken once daily, preferably at the same time each day.
• The appropriate strength should be selected by the physician according to the patient's blood-pressure response and previous antihypertensive treatment.
• Official prescribing information lists 80/12.5 mg once daily as a usual starting dose for the combination in appropriate patients, with dose adjustment according to response.
• Patients with biliary obstructive disorders or hepatic insufficiency may require initiation with 40/12.5 mg under close medical supervision. The combination is not recommended in severe hepatic impairment.
• Take with or without food, unless otherwise directed by the physician.
• Do not discontinue antihypertensive therapy abruptly without medical advice.

Important Warnings & Precautions

Pregnancy:
Telmisartan can cause serious fetal toxicity. CHARTOREG PLUS should be discontinued as soon as pregnancy is detected and the patient should contact her physician immediately.

Kidney function:
Renal function should be monitored in susceptible patients, particularly those with renal impairment, volume depletion, heart failure, or other conditions that increase the risk of renal dysfunction.

Electrolytes:
Telmisartan may increase serum potassium, whereas hydrochlorothiazide may cause hypokalemia, hyponatremia and hypomagnesemia. Periodic monitoring of electrolytes may therefore be appropriate, particularly in patients at increased risk.

Dehydration / hypotension:
Excessive sweating, vomiting, diarrhea, inadequate fluid intake or other causes of volume depletion may increase the risk of symptomatic hypotension, dizziness or fainting.

Glucose, uric acid and metabolic effects:
Hydrochlorothiazide may affect glucose and uric-acid metabolism and may be clinically relevant in patients with diabetes or gout.

Common & Important Adverse Effects

Possible adverse effects include:

• Dizziness or lightheadedness
• Headache
• Fatigue
• Hypotension
• Increased urination
• Electrolyte disturbances, particularly changes in potassium, sodium or magnesium
• Increased uric acid
• Changes in blood glucose

Less common but potentially serious reactions include angioedema, significant renal impairment, severe electrolyte abnormalities, hypersensitivity reactions and acute myopia/secondary angle-closure glaucoma.

Important Drug Interactions

Patients should inform their physician about all medicines and supplements they use. Important interactions include:

• Aliskiren, particularly in patients with diabetes — concomitant use is contraindicated.
• ACE inhibitors or other ARBs — combined renin-angiotensin-system blockade can increase risks such as hypotension, hyperkalemia and renal impairment.
• Potassium supplements or potassium-containing salt substitutes — may increase potassium levels with telmisartan.
• NSAIDs — may reduce the antihypertensive effect and increase the risk of renal impairment, particularly in susceptible patients.
• Other diuretics, lithium and medicines affecting electrolytes may require additional monitoring.

Monitoring

Depending on the patient's clinical situation, the treating physician may monitor:

• Blood pressure
• Serum creatinine/eGFR and renal function
• Serum potassium
• Sodium and magnesium
• Blood glucose in susceptible patients
• Uric acid in patients at risk of gout

Storage

Store according to the product packaging instructions. Keep the tablets in their original blister/package, protected from moisture, heat and excessive humidity, and keep out of the reach of children.

Medical Disclaimer

CHARTOREG PLUS 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 medical consultation, diagnosis, or individualized treatment. Do not start, stop, or change the dose without consulting your physician. Pregnant women or women planning pregnancy should seek medical advice before using this medicine. Patients with kidney, liver, heart, electrolyte, diabetes, or gout-related conditions should inform their physician before treatment.

References

• U.S. National Library of Medicine — DailyMed: Telmisartan/Hydrochlorothiazide Prescribing Information
• World Health Organization — Guideline for the Pharmacological Treatment of Hypertension in Adults
• World Health Organization — Hypertension Fact Sheet
• PubMed/NIH — Telmisartan plus Hydrochlorothiazide Clinical Trial
• American Society of Hypertension / International Society of Hypertension — Hypertension Guidelines