Mibetel Plus Hasan tablets treated with idiopathic hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Telmisartan, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Telmisartan | 40mg |
| Hydrochlorothiazide | 12.5mg |
Uses
indications
Mibetel Plus is indicated in the following cases:
Mibetel Plus is a combination of Telmisartan (Angiotensin II receptor antagonist) and hydrochlorothiazide (thiazid diuretics). This combination has anti -hypertension effects, reduces blood pressure at a higher level than each single component. Mibetel Plus used once a day to reduce blood pressure effectively and mellow in the limit of treatment.
telmisartan
Telmisartan is an Angiotensin II receptor antagonist (AT1 group), which is effective for oral use. Telmisartan occupies Angiotensin II's seat at the cohesion position with the AT1 receptor, which is the position responsible for the known effects of Angiotensin II. Telmisartan does not show any partial impact on the AT1 receptor.
Telmisartan is selected on the AT1 receptor, this cohesion has a prolonged effect. Telmisartan has no affinity with other receptors, including AT2 and other typical AT receptors.
The function of these receptors is not well known, as well as their excessive stimulating effects due to Angiotensin II, which is a substance with increased concentration due to Telmisartan. Plasma aldosteron levels are reduced by telmisartan.
Telmisartan does not inhibit plasma renin or select ion channels. Telmisartan does not inhibit the enzyme Angiotensin (Kinase II), this enzyme also has the effect of breaking Bradykinin, thus not causing side effects through Bradykinin intermediaries.
In humans, the dose of 80 mg Telmisartan inhibits almost completely hypertension of angiotensin II. Inhibition effects (hypotension) are maintained for 24 hours and still measures 48 hours after drinking.
hydrochlorothiazide
hydrochlorothiazid is a thiazid diuretic. The mechanism of anti -hypertension effects of thiazid diuretics has not been fully known. Thiazids affect the reabsorption mechanism of electrolytes in the kidneys, directly increasing sodium and chloride elimination in equal amounts.
The diuretic effect of hydrochlorothiazid is to reduce plasma volume, increase plasma renin activity, increase aldosteron secretion, thereby increasing the secretion of potassium and bicarbonate in urine, and reducing blood potassium. Concomitant use with Telmisartan will reduce the amount of potassium lost due to thiazid diuretics.
After using hydrochlorothiazid, diuretic effects appear after 2 hours, the strongest impact is reached after about 4 hours, maintained for about 6-12 hours.
Dynamic pharmacokinetics
Telmisartan and hydrochlorothiazide does not affect the dynamics of each drug.
telmisartan
absorption
Telmisartan's peak concentration is achieved after 0.5 - 1 hour. The absolute bioavailability of Telmisartan 40mg dose is 42% and the dose of 160mg is 58%.
The presence of food reduces the bioavailability of Telmisartan (the area under the concentration curve over time (AUC) decreases by about 6% when taking 40mg and about 19% for 160mg dose). After 3 hours, the plasma concentration is equivalent to whether Telmisartan is used or not the same food.
A slight decrease in the area under the concentration curve over time (AUC) does not reduce the effectiveness of treatment. Telmisartan accumulates negligible in plasma when taking the drug repeated many times.
Distribution
Telmisartan is strongly connected to plasma proteins, mainly on albumin and α1 glycoprotein. The distribution of about 500 liters shows additional tissue cohesion.
Metabolism
Telmisartan metabolizes through complexes to form acylglucuronic form without pharmacological activity. Telmisartan's glucuronid combinative is the only metabolic product determined in humans.
After taking a dose of 14C Telmisartan, the glucuronid form accounts for about 11% of radioactive activity measured in plasma. The isoenzyme of Cytochrom P450 do not participate in Telmisartan metabolism.
Elimination
After intravenous injection or taken Telmisartan mounted 14C, most dose (97%) are excreted in biliary tract. Only a small amount is found in urine.
Telmisartan's clearance rate in total plasma is> 1500 ml/min. Telmisartan waste sale time is> 20 hours.
hydrochlorothiazid
absorption
After drinking, the peak concentration of hydrochlorothiazid is achieved after 1-3 hours. Due to the excretion through the kidneys, absolute bioavailability reaches about 60%.
Distribution
68% of hydrochlorothiazid is connected to plasma proteins. The distribution volume is 0.83 -1.14 l/kg.
Metabolism
hydrochlorothiazid is not metabolized in the human body.
Elimination
hydrochlorothiazid is excreted almost completely in the form of unchanged urine. About 60% of oral doses are eliminated within 48 hours. The speed of the kidney is about 250-300ml/min. Hydroclorothiazid's exhaust time is 10-15 hours.
Special subjects
Elderly:
There is no difference in pharmacokinetics in the elderly and people under 65 years old.
Sex:
Telmisartan concentration in women's plasma is usually 2-3 times higher than men, but does not see increased significance of response to blood pressure or hypotension standing in women. Therefore, there is no need to adjust the dose. In women, plasma hydrochlorothiazid levels tend to be higher than men. However, this also has no clinical significance.
kidney failure:
The elimination in the kidney does not contribute to the process of eliminating Telmisartan. According to experience, on patients with mild and medium renal failure (the rate of creatinine 30-60 ml/min, about 50 ml/minute), the dose is no need to adjust.
Telmisartan is not excluded when bloody. In patients renal failure , the elimination rate of hydrochlorothiazid is reduced.
In a typical study in patients with an average creatinine clearance rate of 90 ml/min shows that the sale time of hydrochlorothiazid is increased. In patients with severe renal impairment, Telmisartan waste time is about 34 hours.
Hepatic failure:
Studies in patients with hepatic impairment show that Telmisartan's absolute bioavailability increases nearly 100%. Telmisartan's waste sale time does not change in patients with liver failure.
Before taking Mibetel Plus Hasan tablets treated with idiopathic hypertension (3 blisters x 10 tablets)
How to use
Mibetel Plus medicine Used orally.
Can be used with food or not.
There is no special requirement on drug treatment after use.
Dosage
recommended dose: 1 time/day.
Mibetel Plus should be used for patients who do not fully control blood pressure when using Telmisartan alone. Increasing the dose slowly to achieve the desire for each ingredient (telmisartan and hydrochlorothiazid) is recommended before switching to a fixed dosage combination form.
Based on clinical results to consider changing from single therapy to a fixed dose combination therapy. Mibetel Plus should be used 1 time/day.
kidney failure: Need to monitor kidney function periodically.
Hepatic failure: In patients with mild and medium liver failure, the dose of Mibetel Plus should not exceed 40 mg/12.5 mg/day. Mibetel Plus is not indicated for patients with severe liver failure. Thiazid medications should be used with caution in patients with hepatic failure.
Elderly: No dose adjustment.
Children and adolescents: The safety and effectiveness of Mibetel Plus has not been identified in children and young people under 18 years old.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?
Overdose
Information about Telmisartan's overdose in humans is limited. The level of hydrochlorothiazid is removed by unknown hemolysis.
The most prominent manifestation of Telmisartan overdose is low blood pressure, tachycardia. Slow heart rate, vomiting, increased serum creatinine and acute renal failure are also reported.
Overdose of hydrochlorothiazid leads to an electrolyte deficiency (hypokalemia, hemorrhage reduction) and dehydration due to excessive diuretic. The common signs and symptoms when overdose are nausea and drowsiness. Hemoto hypotension can cause muscle spasms and/or worsen the arrhythmia if used simultaneously with Digitalis Glycosid or some anti -arrhyths.
How to deal with overdose
Telmisartan is not excluded from the body by hemolysis. Patients should be closely monitored, symptomatic treatment and support. The management measures depend on the time the patient has taken the drug and the severity of the symptoms.
Proposed measures include vomiting and/or gastric lavage, using activated carbon. Monitor the concentration of electrolytes and creatinin regularly. Excessive treatment of hypotension by letting patients lies on their backs, quickly compensate for salt and fluid for patients.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? If you forget to drink in a day, take a normal dose the next day. Do not take double dose to compensate for the forgotten dose.
Side Effects
When using Mibetel Plus, you may experience unwanted effects (ADR).
The harmful reactions are grouped by frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR Telmisartan in combination with hydrochlorothiazid
CommonLess
Mental: Anxiety.
Reproduction: erectile dysfunction.
Rare
The immune system: The serious or progressive condition of systemic lupus erythematosus.
skin and tissue under the skin (can be fatal): Red rash, itching, rash, increased sweating, urticaria .
Telmisartan
rarely
Urinary kidney: renal failure (including acute renal failure). Rare Blood and lymphatic system: hypernagus, platelets. Nervous system: Drowsy. Skin and subcutaneous tissue: eczema, drug rash, toxic skin rash. Very rare hydrochlorothiazide Unknown frequency Skin and subcutaneous tissue: Lupus erythema syndrome, light sensitive to light, vascular inflammation under the skin, poisoned epidermal syndrome. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Mibetel Plus drug contraindicated in the following cases:
Hypersensitivity to other sulfonamid derivatives (hydrochlorothiazid is a derivative of sulfonamid).
Severe renal failure (Creatinine clearance rate Hypotension, persistent hyperactical hyperacture. pregnancy Do not be treated with Angiotensin II receptor antagonists during pregnancy. Unless the use of Angiotensin II receptor is considered necessary, patients who have a plan to become pregnant should be transferred to hypertension therapy for replacement data with proven safety data. Once pregnant, stop treatment with Angiotensin II receptor drugs immediately and if necessary, use alternative therapy. Hepatic failure Do not use Mibetel Plus for patients with bile stasis, bile congestion or severe liver failure because Telmisartan is mainly eliminated through bile. Telmisartan's liver clearance decreases in these patients. Be cautious when using
Hypertension due to renal artery stenosis
Medications that affect the Renin - Angiotensin - Aldosteron system increases the risk of severe hypotension and renal failure when the patient has narrowed kidney stenosis on both sides or one side.
kidney failure and kidney implant
Mibetel Plus should not be used for patients with severe renal impairment (creatinine clearance
Experience using Mibetel Plus in patients with mild and average renal failure is not much, so it is necessary to regularly monitor the amount of potassium, creatinine and serum uric acid. Increasing blood nitrogen levels due to thiazid diuretics can occur in patients with renal function.
Reducing internal volume
Symptomatic hypotension, especially after the first dose, can occur in patients with volume loss and/or sodium loss due to strong diuretic therapy, strict salt abstain, diarrhea or vomiting. These conditions need to be overcome before using Mibetel Plus.
Dual inhibition of the Renin - Angiotensin - Aldosteron (RAAS) system
There is evidence that the simultaneous use of ACE inhibitors, Angiotensin II or Aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and reduced kidney function (including acute renal failure).
Dual inhibitors of the Renin - Angiotensin - Aldosteron system through combining ACE inhibitors, Angiotensin II or Aliskiren receptor blockers are not recommended.
In some cases, this therapy is needed, it is necessary to closely monitor kidney, electrolyte and blood pressure. Ace ACE inhibitors should not be used simultaneously and Angiotensin II receptor blockers for patients with diabetic kidney disease.
Other conditions that stimulate the Renin - Angiotensin - Aldosteron system
Patients with vascular tone and renal function depend largely on the activity of the Renin - Angiotensin - Aldosteron system (patients with severe congestive heart failure or basic kidney disease, including kidney artery stenosis), the treatment with drugs affects the renin - angiotensin - aldosteron system is associated with acute hypotension, hyperemia, and rarity.
Increasing primary aldosteron
Patients with raw masters increased, often not responding to hypertension drugs through inhibition of the Renin - Angiotensin inhibitors. Therefore, it is not recommended to use Mibetel Plus for these patients.
Aortic valve stenosis and mitral valve, hypertrophic heart muscle disease
As with other vasodilators, special attention should be paid to patients with aortic valve stenosis or mitral valve, or hypertrophic cardiomyopathy.
Impact on metabolism and endocrine
Thiazid therapy may reduce glucose tolerance, while hypoglycemia can occur in diabetes patients treated with insulin or diabetes with Telmisartan. Therefore, in patients with diabetes may need to adjust insulin or hypoglycemic drugs.
The potential diabetes can manifest during thiazid treatment.thiazid diuretics also increase cholesterol and triglycerides, but there are very few or almost no reports at a dose of 12.5mg of hydrochlorothiazid contained in Mibetel Plus. Hyperglycemia can occur or gout may occur in a few patients treated with thiazid.
Electrolyte imbalance
For any patient treated with thiazid, the periodic test of electrolytes in serum must be seriously conducted. Thiazid drugs, including hydrochlorothiazid, can cause water and electrolyte imbalance (hypotension, sodium hypoglycemia and alkaline infection caused by chlorine hypotension).
Warning signs of water - electrolytes include dry mouth, thirst, weakness, indifference, drowsiness, restlessness, muscle pain or crushing, muscle weakness, hypotension, urinary, fast heart rate, and disorders such as nausea or vomiting.
Although hypokalemia may be encountered when using thiazid diuretics, simultaneous treatment with Telmisartan will reduce the ability to lower potassium potassium due to diuretics.
The highest risk of hypokalemia in patients with cirrhosis, patients taking fast diuretics, patients do not compensate for oral electrolytes and on patients treated simultaneously with corticosteroids or ACTH hormones. In contrast, due to the antagonistic mechanism for the Angiotensin II receptors (AT1) of the Telmisartan component in Mibetel Plus, the condition of hyperkalemia may occur.
Although the hyperkalemia has not been clinically significantly recorded with Mibetel Plus, risk factors leading to hyperkalemia include kidney failure and/or heart failure and diabetes. Potassium -saving diuretic, potassium supplements or potassium salts should be carefully coordinated with Mibetel Plus.
There is no evidence that Mibetel Plus reduces or prevents sodium hypoglycemia due to diuretics. Chlorine deficiency is usually mild and no treatment. Thiazids can reduce calcium excretion through the urinary tract and slightly increase the calcium level in serum but no other calcium metabolic disorders.
significant hypercalcemia may be a sign of hidden parathyroid glands, so thiazids should be stopped before conducting adjacent function tests. In addition, the thiazids also increase the elimination of magnesium through the urinary tract, which can lead to lower blood magesi.
Racal difference: Like angiotensin, Telmisartan transfer inhibitors and other Angiotensin receptor antagonists have a significant lowering effect on black people compared to other skin -colored people. Maybe because in the body of black people with high blood pressure has lower re -amount.
Other notes: Like other medications to treat hypertension, excessive hypotension in patients with ischemia or ischemic cardiovascular disease can lead to myocardial infarction or stroke.
Body
Hypersensitivity reactions with hydrochlorothiazid may occur in patients with or without a history of allergies or bronchial asthma, but there is more likely to occur for patients with such a history. The worse or onset of the systemic lupus erythematosus has been reported for the use of thiazid diuretics, including hydrochlorothiazid.
Cases of light -sensitive reactions have also been reported to thiazid diuretics. When this situation is encountered, treatment should be stopped. If treated with diuretics is considered necessary, shielding when exposed to sunlight or artificial UVA rays.
Class myopia and acute closed angle
hydrochlorothiazid, sulfonamid, can cause a specific reaction that leads to acute myopia and acute angle glaucom. Symptoms include an acute onset that reduces vision or eye pain and usually appears within hours to a few weeks after starting the medication.
If left untreated, acute closed angle glauc can lead to permanent vision loss. The first measure is to stop hydrochlorothiazid as soon as possible. Medical or surgical therapies may need to be considered if the glaucoma is uncontrolled. Risk factors for progression of acute angle Glaucom may include a history of allergies to sulfonamid or penicillin.
The ability to drive and operate machinery
When driving or operating machinery, it is necessary to pay attention to dizziness or drowsiness can sometimes occur when using medication to treat hypertension, such as Mibetel Plus.
Pregnancy
There is no adequate document about using Telmisartan for pregnant women. Animal studies show that there is no clear evidence of teratogenic effects, but the toxicity for the fetus has been recorded. Therefore, it is necessary to be cautious, it is best not to use Telmisartan in the first three months of pregnancy.
Unless the use of Angiotensin II receptor is really necessary, women who intend to get pregnant should be replaced by other hypertension drugs that have safe data proven during pregnancy. Once pregnant diagnosis, Telmisartan must be discontinued as soon as possible, if necessary to use other therapy instead.Using Angiotensin II receptor inhibitors in the middle and the last three months of pregnancy can be toxic to the fetus (impaired renal function, amniotic fluid deficiency, skull -retarding) and toxic to babies (kidney failure, low blood pressure, hyperkalemia).
If the Angiotensin II receptor is used from the middle three months of pregnancy, it is recommended that the ultrasound will check the kidney function and the skull. Babies of mothers treated with Angiotensin II receptor antagonists should be closely monitored because of the risk of low blood pressure.
Experience using hydrochlorothiazid during pregnancy is limited, especially in the first three months. Animal studies are incomplete. Hydrochlorothiazid through the placenta. Based on the mechanism of action, the use of hydrochlorothiazid in the middle and the last three months of pregnancy can reduce the perfusion of the placenta, affecting the fetus and infants such as jaundice, electrolyte balance disorders and platelets.
Do not use hydrochlorothiazid to treat edema during pregnancy, pregnancy hypertension or pre -eclampsia due to the risk of reducing plasma volume, reducing placental perfusion and no benefit during treatment. Do not use hydrochlorothiazid to treat primary hypertension in pregnant women unless there is no other replacement therapy.
The period of breastfeeding
There is no information on the use of Mibetel Plus for nursing women. Therefore, Mibetel Plus is not recommended for this object and replacement therapies with full safety data are considered more appropriate, especially for mothers with infant or premature babies.
hydrochlorothiazid is excreted in breast milk in small amounts. High -dose high -dose thiazids can inhibit breast milk. Do not use Mibetel Plus during breastfeeding. If it is necessary to use it during breastfeeding, the lower the dose should be as low as possible.
Interactive drug
Interaction of drugs
Lithium: Increased lithium concentration in serum and recovery can be reported during use simultaneously lithium with ACE inhibitors. Some cases have also been recorded when used with Angiotensin II receptor antagonists, including Misartan. Do not simultaneously use lithium and mibetel plus. If it is necessary to use coordination, closely monitor serum lithium concentration during simultaneous use.
Potassium -causing drugs or hypokalemia (diuretics that excrete potassium excretion, laxative, corticosteroid, acth, amphoticin, carbenoxolon, sodium penicillin g, salicylic acid and derivatives): If these drugs are prescribed in combination with hydrochlorothiaid - Telmisartan, need to monitor Kali level in the blood level. These drugs can increase the effects of hydrochlorothiazid on serum potassium.
Medications that increase potassium concentration or cause hyperkalemia (ACE inhibitors, potassium -saving diocesia, potassium supplements, potassium, cyclosporin or other drugs such as sodium heparin): If these drugs are prescribed in combination with hydrochlorothiazid - telmisartan, need to monitor potassium levels in blood. Based on the experience of using other drugs that inhibit the Renin Angiotensin system, simultaneous use with the above drugs can lead to increased serum potassium and therefore not recommended.
The drugs are affected by serum potassium balance disorders: Periodically monitoring potassium and electrocardiograms (ECG) when using Mibetel Plus with drugs affected by serum potassium balance disorders (Digitalis glycosid, anti -arrhythmic drugs) and products are known to be capable of causing torsion (like some anti -arrhythmia), hypotension is one of which leads to a tip. Some typical drugs such as:
Psychotropic drugs (Thioridazin, Clopromazin, Levomepromazin, TrifluoperaZin, Cyanmemazin, Sulpid, Sultoprid, Amisulprid, Tiaprid, Pimozid, Haloperidol, Droperidol). Some other drugs (Bepridil, Cisaprid, Diphenmanil, Erythromycin IV, Halofantrin, Mizoplastin, Pentamidin, Sparfloxacin, Terfenadin, Vincamin IV). Digitalis glycosides: Thiazid causes potassium and blood magnesium to facilitate the appearance of symptoms of Digitalis arrhythmia. Digoxin: Concentrated with Telmisartan increases the concentration of digoxin in plasma average, the peak concentration increases 49% and the bottom concentration increases by 20%). At the beginning of treatment, adjusting and stopping Telmisartan, and monitoring the concentration of digoxin in the blood to maintain within the scope of treatment. Other medications for hypertension: Telmisartan may increase the effects of other hypertension medications. Clinical test data shows that the double inhibition of the Renin - Angiotensin - Aldosteron (RAAS) system through the combination of ACE inhibitors ACE receptor blockers Angiotensin II or Aliskiren is associated with higher frequency of side effects such as excessive hypotension, hyperkalemia and impaired renal function (including acute renal failure) compared to an impact drug in the system. Diabetes drugs (oral and insulin medications): may need to adjust the dosage of diabetes medications. Metformin: Caution should be used due to the risk of lactic acidic acidosis due to impaired renal function related to hydrochlorothiazid. Cholestyramin and Colestipol: The absorption of hydrochlorothiazid is reduced when the presence of anion exchange resin. Non -steroid anti -inflammatory drugs (NSAIDs): NSAIDs (Acetylsalicylic acid at the dose of anti -inflammatory effects, COX - 2 inhibitors and non -selective NSAIDs) can reduce diuretic effects, stimulate sodium secretion, reduce blood pressure of thiazids and Angiotensin II receptor antagonists. In patients with the risk of renal function (patients dehydrated or elderly patients), simultaneous use of Angiotensin II receptor antagonists and cyclo - oxygenase inhibitors (NSAIDs) can cause further impaired renal function, including acute renal failure, often reversed. Therefore should be careful, especially in the elderly. Patients need to be fully rehydrated and monitor the kidney function when starting combined and periodic treatment. amines that cause hypertension (noradrenalin): The effect of amines that cause hypertension may be reduced. Tutocurarin: The effect of these drugs can be enhanced by hydrochlorothiazid. Gout treatment (Probenecid, sulfyrazon and allopurinol): may need to adjust the dose of uric acid lowering drugs because hydrochlorothiazid can increase serum uric acid. Increase the dose of probenecid or sulfyrazon if necessary. Concomitant use with thiazid may increase the rate of hypersensitivity reactions to allopurinol. Calcium salts: Thiazid diuretics can increase serum calcium concentration due to reduction in excretion. If you have to supplement calcium or use potassium -saving drugs, serum calcium concentration should be monitored and adjusting the dose of calcium accordingly. Beta and diazoxid blockers: Thiazids can enhance the hyperglycemia of Beta and Diazoxid blockers. anti -cholinergic drugs (atropin, biperiden): can increase the bioavailability of thiazid diuretics due to reducing bowel motility and gastric empty speed. Amantadin: Thiazids may increase the risk of unwanted effects of Amantadin. Cyclophosphamide, methotrexate): Thiazids can reduce the excretion of the kidneys of cytotoxic drugs and increase the risk of bone marrow failure of these drugs. Other drugs: Based on pharmacological characteristics, can predict that Baclofen and Amifostin can increase the hypotension effect of drugs for hypertension containing telmisartan. In addition, vertical hypotension can occur more seriously when used with alcohol, barbiturates, sedative drugs - causing sleep or antidepressants. Tyeum of drugs Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Where dry, less than 30 ° C, avoid light.
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