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The current trend of hypertension treatment is to combine drugs to increase effectiveness and limit side effects. One of the products that combines an angiotensin II receptor blocker and a thiazide diuretic is Zhekof HCT. So what is Zhekof-HCT and how is it indicated for use?
1. What is Zhekof HCT?
Zhekof-HCT 40/12.5 is a product of Dat Vi Phu Pharmaceutical Co., Ltd. It contains two active ingredients: Telmisartan 40mg and Hydrochlorothiazide 12.5mg. The drug product Zhekof-HCT 40/12.5 is indicated in the treatment of primary hypertension.
2. Uses of the drug Zhekof-HCT 40/12.5
Zhekof HCT is used to treat cases of primary hypertension that is not adequately controlled with telmisartan 40 mg ( Zhekof 40 mg ) monotherapy alone
Zhekof HCT is a fixed-dose combination preparation of a group of active ingredients An angiotensin II receptor antagonist is telmisartan and a thiazide diuretic, hydrochlorothiazide. These two active ingredients provide a synergistic effect of treatment and help control blood pressure more effectively than either alone.
3. Pharmacological characteristics of the drug Zhekof-HCT
Telmisartan is an angiotensin II receptor antagonist with a chemical structure of a benzimidazole derivative, a non-peptide. Telmisartan specifically antagonizes the AT1 receptor of angiotensin II in vascular and adrenal smooth muscle. In the renin-angiotensin system, angiotensin II is formed from angiotensin I through the catalysis of angiotensin converting enzyme (ACE). Angiotensin II causes vasoconstriction, stimulates the adrenal cortex to synthesize and release aldosterone, and stimulates the heart. The active ingredient Telmisartan in Zhekof HCT selectively inhibits the binding of Angiotensin II to the AT1 receptor, thereby vasodilating and limiting the effect of aldosterone."
Advantages of Telmisartan compared to non-inhibitory ACE inhibitors. degrades bradykinin, thus does not cause a persistent dry cough (a common effect of ACE inhibitors). of angiotensin II, at the same time Zhekof HCT can maintain its antihypertensive effect for 24 hours and telmisartan blood levels can still be detected after 48 hours of use.
The remaining ingredient in Zhekof HCT is Hydrochlorothiazide, which belongs to Thiazide diuretics: The effect of thiazide diuretics is to stimulate sodium and chloride excretion and water retention through inhibition of distal tubule reabsorption. and extracellular fluid involved in urinary sodium excretion Hydrochlorothiazide is used to help lower blood pressure by reducing peripheral resistance because the blood vessels gradually adapt to the decrease in blood sodium concentration. Therefore, the antihypertensive effect of hydrochlorothiazide usually appears slowly after 1 - 2 weeks. In addition, an important feature is that Hydrochlorothiazide enhances the effects of other antihypertensive agents, including Telmisartan. Therefore, the combination of these two active ingredients in Zhekof-HCT both limits the potassium-lowering effect of hydrochlorothiazide and increases the effectiveness of blood pressure control.
4. Dosage of the drug Zhekof-HCT 40/12.5
Zhekof HCT is formulated for oral use, once a day with water and can be taken before or after meals. Regarding the dosage of Zhekof HCT, patients should note the following issues:
Patients should only take fixed-dose combination tablets such as Zhekof HCT when adequate blood pressure control cannot be achieved with just Telmisartan 40mg (Zhekof 40mg). . It is recommended that the individual dose of Telmisartan and hydrochlorothiazide be titrated according to the patient's response before switching to Zhekof HCT; Usual dose: 1 tablet of Zhekof HCT 40/12.5mg, once daily. Some notes on the use of Zhekof HCT in special subjects:
People with renal failure need to be periodically monitored for renal function when using Zhekof HCT; Hepatic impairment: The maximum dose is 1 tablet of Zhekof HCT 40/12.5 mg orally per day for patients with mild to moderate hepatic impairment. Zhekof-HCT is not indicated for patients with severe liver failure; Elderly: There is no need to adjust the dose of Zhekof HCT in this subject; Children: The safety and effectiveness of Zhekof HCT in children younger than 18 years of age have not been established. Guidelines for the management of Zhekof HCT overdose:
The most common manifestations of telmisartan overdose are excessive hypotension and tachycardia, sometimes with bradycardia, dizziness, vomiting, increased serum creatinine and acute renal failure. ; Hydrochlorothiazide overdose includes hypokalemia or excessive diuretic volume depletion. The most common symptoms of overdose are nausea, somnolence, hypokalemia that may cause muscle spasms and/or arrhythmias (when digitalis glycosides or other antiarrhythmic agents are used concurrently); Treatment: Telmisartan cannot be removed by hemodialysis, therefore patients should be closely monitored with appropriate symptomatic supportive therapy. Management depends on the time since an overdose of Zhekof HCT and the severity of symptoms and may include induction of vomiting and/or gastric lavage, sometimes with the use of activated charcoal. At the same time, patients should be regularly monitored for electrolytes and serum creatinine. Patients with excessive hypotension can be managed by placing the patient in the supine position with prompt rehydration and electrolyte replacement.
5. Side effects of Zhekof HCT
The most commonly reported adverse effects of Zhekof HCT are dizziness and some other uncommon manifestations as follows:
Hypokalemia; Worried; Syncope, paresthesia; Dizzy; Tachycardia or arrhythmia; Excessive hypotension, orthostatic hypotension; Shortness of breath; Diarrhea, dry mouth, flatulence; Back pain, muscle spasms, muscle pain; Erectile dysfunction; Chest pain; Increased blood uric acid. Some rare side effects when using Zhekof HCT :
Bronchitis, pharyngitis, sinusitis; Initiation or exacerbation of systemic lupus erythematosus; Hyponatremia; Depression; Insomnia, sleep disorders; Blurred vision, visual disturbances; Respiratory failure (possibly due to pneumonia and pulmonary edema); Abdominal pain, constipation, indigestion, vomiting, gastritis; Abnormal liver function; Angioedema (possibly fatal), erythema, pruritus, rash, increased sweating, urticaria; Flu-like symptoms; Increased serum creatinine, increased blood creatine phosphokinase, increased liver enzymes. Zhekof HCT may cause other undesirable effects when used. Patients should closely monitor and promptly notify the doctor of any unusual manifestations encountered when using Zhekof-HCT.
6. Contraindications of Zhekof-HCT
Zhekof HCT 40/12.5 is contraindicated for use in the following cases:
People with hypersensitivity to Telmisartan or Hydrochlorothiazide or other ingredients in the drug; Hypersensitivity to sulfonamide derivatives (because hydrochlorothiazide is a sulfonamide derivative); Pregnant women in the second and third trimesters of pregnancy; People with cholestasis or biliary obstruction; Severe liver failure; Severe renal failure (Cl-Cr less than 30 ml/min); Hypokalemia or, persistent hypercalcemia; Concomitant use of Zhekof HCT with preparations containing aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR less than 60 ml/min/1.73 m2 skin).
7. Some Precautions When Using Zhekof HCT
The following subjects need special caution when using Zhekof HCT :
Pregnant women: Hypertension should not be initiated in this population with an angiotensin II receptor antagonist (such as Telmisartan in Zhekof HCT), except when treatment is absolutely necessary. Patients intending to become pregnant should be switched to pregnancy-safe therapy. Women who are taking Zhekof HCT and find out that they are pregnant should stop treatment with Zhekof HCT immediately, and then consider switching to a suitable alternative; Hepatic impairment: Zhekof HCT should not be used in patients with cholestasis, biliary obstruction or severe hepatic impairment because telmisartan is excreted in the bile and leads to a decrease in clearance from the body; Renal artery stenosis: The risk of hypotension and severe renal impairment is increased in patients with bilateral (or unilateral) renal artery stenosis when treated with drugs that affect the renin-angiotensin system. -aldosterone as Zhekof HCT ; Renal failure and kidney transplantation: Zhekof HCT should not be used in patients with severe renal impairment (Cl-Cr less than 30ml/min). There is also no experience with the use of telmisartan hydrochlorothiazide in patients with recent kidney transplantation. There is limited experience with the use of Zhekof HCT in patients with mild to moderate renal impairment, which requires periodic monitoring of serum potassium, creatinine and uric acid; Volume depletion: Symptomatic hypotension, especially after the first dose of Zhekof-HCT, may occur in subjects with hypovolemia and/or hyponatremia due to diuretic use. strong, salt-restricted diet, diarrhea or vomiting; Other RAAS-stimulating conditions: Persons whose vascular tone and renal function depend primarily on RAAS activity (eg, severe congestive heart failure, pre-existing renal disease, renal artery stenosis, valvular stenosis). aortic or mitral valve) when using drugs that affect this system such as Zhekof HCT can lead to acute hypotension, uremia, oliguria or sometimes acute renal failure; Patients with primary hyperaldosteronism usually do not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system, so the use of Zhekof HCT is not effective; Metabolic and Endocrine Effects: The use of thiazide diuretics may reduce glucose tolerance and hypoglycaemia in diabetic patients being treated with insulin or other antidiabetic agents and telmisartan. Therefore, users of Zhekof HCT should consider blood glucose monitoring to adjust the dose of insulin or antidiabetic agents accordingly; Electrolyte disturbances: Similar to the use of other diuretics, users of Zhekof HCT should have their blood electrolytes checked periodically; Hypokalemia: Although hypokalemia may occur with the use of thiazide diuretics, this effect may be reduced by concomitant treatment with telmisartan; Hyperkalemia: Contrary to the angiotensin II receptor antagonism of Telmisartan may lead to hyperkalemia. Although clinical significance has not been observed with the use of Zhekof HCT, risk factors for severe hyperkalemia include renal and/or heart failure and diabetes mellitus; As with other antihypertensive agents, the use of Zhekof HCT may result in a sharp, sudden drop in blood pressure in people with ischemic heart disease or ischemic heart disease, which may lead to heart attack or stroke. Some other warnings and cautions when using Zhekof HCT:
Patients with advanced peptic ulcer or other gastrointestinal disease should use caution when taking this product because the risk of gastrointestinal bleeding will increase. up; Zhekof HCT should be used with caution in patients with a history of angioedema with or without association with ACE inhibitors or angiotensin II receptor blockers; Telmisartan can interfere with porphyrin metabolism, so Zhekof HCT should only be used in the absence of safer alternatives; The antihypertensive effect of Zhekof HCT (due to Hydrochlorothiazide) is enhanced in sympathectomy subjects; People who often drive or operate machinery need to be cautious when taking Zhekof HCT because the side effects of dizziness and drowsiness sometimes occur suddenly; Using Zhekof HCT for women during pregnancy:
It is not recommended to use Zhekof HCT 40/12.5 in the first 3 months of pregnancy and is absolutely contraindicated in the second and third trimesters of pregnancy; There are no adequate data on the use of Zhekof HCT in pregnant women, however animal studies have shown reproductive toxicity; Use of angiotensin II antagonists (such as Telmisartan in Zhekof HCT) during the second and third trimesters of pregnancy can cause toxicity, such as decreased renal function, oligohydramnios, delayed cranial bone ossification, and toxicity in the neonate. neonatal (eg, renal failure, hypotension, hyperkalemia); There is limited experience with the use of hydrochlorothiazide during pregnancy, especially in the first trimester. Animal studies are incomplete. Hydrochlorothiazide active ingredient can cross the placenta, based on the mechanism of action, it can be seen that the use of Hydrochlorothiazide in the first and third trimesters of pregnancy will cause decreased perfusion to the embryo and cause effects on the fetus and fetus. neonates such as jaundice, electrolyte imbalance and thrombocytopenia.
8. Drug interactions of Zhekof-HCT 40/12.5
Lithium: There have been reports of increased exposure and toxicity of Lithium (reversible) when co-administered with angiotensin II receptor antagonists (including telmisartan). Therefore, the combination of lithium and Zhekof HCT is not recommended.
Preparations that cause hypokalemia (e.g. other potassium-sparing diuretics, laxatives, corticosteroids, ACTH, Amphotericin, Carbenoxolone, Penicillin G, Salicylic Acid): If used concomitantly with Zhekof HCT, plasma potassium concentration should be monitored. frequently because they may enhance the hypokalaemic effect of Hydrochlorothiazide.
Preparations that increase blood potassium (such as ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, Cyclosporin): If used concomitantly with Zhekof HCT, the concentration should be monitored. plasma potassium. The combination of drugs that reduce the activity of the renin-angiotensin system with the above preparations may lead to hyperkalemia, so their use is not recommended.
Drugs Affected by Dyskalemia: Periodic monitoring of serum potassium and electrocardiogram (ECG) is recommended when Zhekof HCT is administered with drugs that may be affected by serum potassium disturbances (eg, digitalis, drugs, etc.). antiarrhythmic) and drugs with the risk of torsades de pointes, including:
Class Ia antiarrhythmic drugs such as Quinidine, Hydroquinidin, Disopyramide; Class III antiarrhythmic drugs such as Amiodarone, Sotalol, Dofetilide, Ibutilide; Antipsychotics such as Thioridazine, Clopromazine, Methotrimeprazine, Trifluoperazine, Cyamemazine, Sulpirid, Sultoprid, Amisulpride, Tiaprid, Pimozide, Haloperidol, Droperidol; Other drugs such as Bepridil, Cisaprid, Diphemanil, Intravenous Erythromycin, Halofantrin, Mizolastine, Pentamidine, Sparfloxacin, Terfenadin, Intravenous Vincamine; Digitalis glycosides; Digoxin: Increased peak and trough plasma concentrations of digoxin have been reported when co-administered with telmisartan. Therefore, when starting, it is necessary to adjust the dose of telmisartan, and it is recommended to monitor blood levels of digoxin to maintain drug concentrations within the therapeutic range.
Other antihypertensive agents: Zhekof HCT may enhance the antihypertensive effect of other antihypertensive agents.
Antidiabetic agents (oral and insulin): It may be necessary to adjust the dose of antidiabetic agents when combined with Zhekof HCT.
Metformin: Caution is advised when metformin is used concomitantly with Zhekof HCT due to the risk of lactic acidosis due to hydrochlorothiazide-induced renal impairment.
Cholestyramine and colestipol resin may reduce the absorption of hydrochlorothiazide in Zhekof HCT.
Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce the diuretic, sodium excretion and antihypertensive effects of Zhekof-HCT drugs
Hypertension amines (such as norepinephrine): The effect of hypertensive amines Pressure can be reduced when combined with Zhekof HCT.
Nonpolar motor muscle relaxants (eg, Tubocurarine) are potentiated when combined with Hydrochlorothiazide.
Cytotoxic drugs (eg, Cyclophosphamide, Methotrexate): Thiazides may decrease renal clearance of cytotoxic drugs and increase their bone marrow suppression effects.
In addition, alcohol, barbiturates, narcotics or antidepressants may aggravate the orthostatic hypotensive effects of Zhekof HCT.
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