Micardis Plus 40/12.5mg Boehringer tablets treat 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

Micardis medicine is indicated in the following cases:

Treatment of idiopathic hypertension . AT1 of angiotensin II. Telmisartan occupies Angiotensin II's place thanks to the high affinity with the cohesion of this substance at the type AT1 receptor, which is the position that causes the known effects of Angiotensin II. Telmisartan is selected and prolonged with AT1 receptor. Telmisartan does not show partial co -operations at the AT1 receptor.

Telmisartan does not show affinity for other receptors, including AT2 and poor AT receptors. It is unknown the function of these receptors (AT2 and the typical receptors), as well as the effects when they can be stimulated by angiotensin II, when the concentration of this substance rises by Telmisartan. Telmisartan reduces plasma Aldosteron levels. Telmisartan does not inhibit human blood renin or ionic channels. Telmisartan does not inhibit the enzymes of angiotensin, is the enzyme that causes bradykinin (Kininase II). Therefore, the drug is not likely to cause side effects through Bradykinin intermediaries.

On the human body, a dose of 80mg Telmisartan has an almost completely inhibited effect of hypertension due to Angiotensin II. This inhibitory effect is maintained for 24 hours and is still significant until 48 hours.

pharmacokinetics

Telmisartan is quickly absorbed, although the absorption amount changes. Telmisartan's absolute bioavailability is about 50%.

When taken with food, the area under the plasma concentration curve over time (AUC) of Telmisartan may decrease from 6% (at a dose of 40mg) to about 19% (at a dose of 160mg). The plasma concentration of Telmisartan is hungry or with food after 3 hours is similar.

AUC is less reduced, does not reduce the effectiveness of treatment.

Observed the difference in plasma concentrations by gender, CMAX and AUC is about 3 times higher and 2 times and 2 times in women than men, but does not affect the effectiveness.

Telmisartan is heavily connected to plasma proteins (> 99.5%), mainly with albumin and alpha - 1 glycoprotein acid. The average distribution volume is in a stable state of about 500L. Telmisartan metabolizes by a reaction with glucuronide. The metabolites have no pharmacological effects.

Telmisartan has a pharmacokinetic properties decreased according to excess 2 with half -life elimination of the last over 20 hours. The maximum concentration in plasma and smaller levels, the area under the plasma concentration curve over time (AUC) increases without proportional to the dose of treatment. There is no evidence related to the accumulation of telmisartan clinically.

After drinking (and intravenous injection), Telmisartan eliminates almost entirely through feces, mostly in the form of unchanged. Under 2% of the secret dose through the urine. The total clearance in plasma (Cltot) is high (about 900ml/min) compared to the blood flow through the liver (about 1500ml/minute).

Elderly

Telmisartan pharmacokinetics are not different between young and elderly patients.

Patients with renal failure

Lower plasma concentrations in patients with dialysis kidney failure. Telmisartan is highly connected to plasma proteins in patients with renal failure and is not excluded through dialysis. Half lifetime elimination does not change in patients with renal failure.

Patients with liver failure

Mobile pharmacokinetics research in patients with hepatic impairment shows an absolute increase in bioavailability up to nearly 100%. Half -life excretion does not change in patients with liver failure.

Children's groups

Dynamic pharmacokinetics of two levels of Telmisartan are rated as auxiliary criteria in hypertension patients (n = 57) ages 6 to Clinical studies

Treatment of idiopathic hypertension

After the first Telmisartan dose, the hypotension effect gradually appears within 3 hours. In general, the most effective antihypertensive effect is achieved at the 4th week after treatment and maintenance when prolonged treatment.

The anti -hypertension effect is constantly sustainable for 24 hours after taking the drug, including 4 hours before taking the next dose when measuring blood pressure at rest. This is confirmed by the curve of the bottom/peak concentration ratio that is always over 80% seen after the dose of 40mg and 80mg of Telmisartan in clinical studies for control with placebo.

There is a clear tendency for the relationship between the dose and the time for the systolic blood pressure to return to the original level. In this respect, data related to diastolic blood pressure is inconsistent.

In patients with hypertension, Telmisartan works to reduce both systolic and diastolic blood pressure without affecting the heart rate. The lowering effect of Telmisartan is equivalent to drugs for hypertension such as Amlodipine, Atenolol, Enalapril, Hydrochlorothiazide , Losartan, Lisinopril, Ramipril and Valsartan. If stopped with Telmisartan, the blood pressure will gradually return to the original value before treatment for a few days without the phenomenon of hypertension.

In clinical trials, Telmisartan treatment shows a significant reduction in left ventricular muscle mass and left ventricular mass index in hypertension patients and left ventricular hypertrophy.

Through clinical studies with Telmisartan has shown (including comparative drugs such as Losartan, Ramipril and Valsartan) are involved in reducing proteinuria statistics (including microscopic albumin and general albuminin) in hypertension patients and diabetic kidney disease.

Through clinical studies directly compare two drugs to treat hypotension, the rate of dry cough in patients treated with Telmisartan is significantly lower than those who use angiotensin transferring enzyme inhibitors.

Prevention of pathology and cardiovascular death

ontarget (Ongoing Telmisartan Alone and in Combination with RamIPril Global Enfpoint Trial - Multinational research in single -treatment Telmisartan treatment and combined with Ramipril) compares the effective of Telmisartan, Ramipril and combining Telmisartan and Rampril on 25620 patients from 55 years old with a patient with a priority Coronary artery disease, stroke, peripheral vascular disease, or diabetes with target organs (for example, retinopathy, left ventricular hypertrophy, microscopic albumin or general), are typical signs of patients at high cardiovascular risk.

Patients are randomly selected in one of the following three treatment groups: Telmisartan 80mg (n = 8542), Ramipril 10mg (n = 8576), or the group combined Telmisartan 80mg and Ramipril 10mg (N = 8502), and is monitored an average of 4.5 years.

The evaluation criterion is a combination of death due to cardiovascular disease, non -fatal myocardial infarction, non -fatal stroke, or hospitalized due to congestive heart failure.

better compliance with the Telmisartan group compared to the group using Ramipril or the group that combines Telmisartan and Ramipril, although the research population has been screened for tolerance for treatment with enamel inhibitors. Analysis of adultery effects leading to permanent stop treatment and serious adverse effects show that cough and angioedema are reported less in patients treated with Telmisartan than patients treated with Ramipril, on the contrary, low blood pressure is reported more often in the treatment group with Telmisartan.

Telmisartan is similar to RamIPril in reducing the main criteria. The main ratio is equivalent to the Telmisartan group (16.7%), Ramipril (16.5%) and Telmisartan in combination with Ramipril (16.3%). The risk rate in the Telmisartan group compared to the Ramipril group is 1.01 (97.5% CI 0.93 - 1.10, P (not inferior) - 0.0019). The therapeutic effect has been seen for a long time after adjusting the difference in systolic blood pressure at the beginning and the next time. There is no difference in the main criteria of age, gender, race, standard treatment or disease.

Seeing Telmisartan has the same effect as Ramipril in many specific auxiliary criteria, including a complex of cardiovascular death, myocardial infarction is not fatal, and non -fatal stroke, the main criterion in the Hope (The Heart Outcomes Pressvu Telmisartan's risk ratio compared to Ramipril for the main criteria in ontarget is 0.99 (97.5% CI 0.90 - 1.08), P (not inferior) - 0.0004).

Combining Telmisartan with RamIPril is not more effective than using Telmisartan or Ramipril single therapy. In addition, there is a significant higher rate of hyperkalemia, kidney failure, low blood pressure and fainting (fainting) when used in combination. Therefore, it is not recommended to use Telmisartan and Ramipril in this patient group.

Data on children

The low voltage effect of the two levels of Telmisartan has been evaluated in patients with hypertension ages 6 to under 18 years old (n = 76) after using telmisartan 1mg/kg (n = 30 treated) or 2mg/kg (n = 31 is treated) during four weeks of treatment. After adjusting the effects of the age group and initial systolic blood pressure values, it was observed that the change of systolic blood pressure was average compared to the original level (the main goal of the study) of 8.5mmHg in the group using Telmisartan 2mg/kg, and - 3.6mmHg in the group using Telmisartan 1mg/kg.

The change of diastolic blood pressure is adjusted and eliminates the effects of placo compared to the original level of 4.5mmHg and - 4.8mmHg in Telmisartan 1mg/kg and 2mg/kg. This change depends on the dose. Overall safety is considered similar to adults.

Before taking Micardis Plus 40/12.5mg Boehringer tablets treat idiopathic hypertension (3 blisters x 10 tablets)

How to use

Take oral use.

Can take medicine with or not with the same food.

Dosage

Adults

Treatment of idiopathic hypertension

recommended dose is 40mg once a day. It may be effective at a dose of 20mg/day in some patients. Telmisartan can be increased by a maximum dose of 80mg once a day to achieve target blood pressure. Telmisartan can be used in combination with thiazide diuretics such as hydrochlorothiazide and this combination shows Hydrochlorothiazide has the effect of lowering the coordination with Telmisartan. When it is necessary to increase the dose, it is necessary to pay attention to the maximum lowering effect of usually achieved after 4-8 weeks of starting treatment.

For patients with severe hypertension to treat Telmisartan with a dose of up to 160mg for use and use in combination with Hydrochlorothiazide 12.5 - 25mg/day are well -tolerated and effective.

Prevention of pathology and cardiovascular death

The recommended dose is 80mg once a day. It is unknown whether the doses are lower than 80mg of Telmisartan effectively in preventing pathology and cardiovascular death.

Recommended blood pressure monitoring when caught in treatment with Telmisartan to prevent pathology and cardiovascular death, and if necessary, dose adjustments to achieve lower blood pressure.

kidney failure

No dose adjustment in patients with renal failure, including patients with dialysis. Telmisartan is not removed by dialysis.

Hepatic failure

Do not use more than 40mg once a day in patients with mild and medium liver failure.

Elderly

No dose adjustment.

children and teenagers

has not established the safety and effectiveness of micardis for use in children 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? The most outstanding manifestation of Telmisartan overdose is hypotension and tachycardia, slow heart rate can also occur. Supporting treatment should be conducted if there are symptoms of hypotension. Telmisartan is not removed from the body when dialysis.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using micardis , you may experience unwanted effects (ADR).

In general, the adverse effects are reported to Telmisartan (41.4%) is the same as a placebo (43.9%) in controlled clinical studies in hypertension patients. Frequency of adultery is not related to the dose and non -correlation to the gender, age or race of the patient.

Micardis's safety data in patients treated to prevent pathology and cardiovascular death is equivalent in hypertension patients.

The adverse effects listed below are recorded from controlled clinical studies in hypertension patients and after -sales reports. The following list also includes serious adverse effects and adultery effects that lead to a drug stop reported in three long -term clinical studies lasting 6 years on 21642 patients treated with Telmisartan to prevent disease and cardiovascular death.

Infections and parasites: Infections including death, urinary tract infections (including cystitis), upper respiratory tract infections.

Disorders of blood and lymphatic systems: Anemia, eosinophilia, thrombocytopenia.

Immune disorders: Anaphylaxis, hypersensitivity.

Metabolic and nutrient disorders: hyperkalemia, hypoglycemia (in patients with diabetes).

Mental disorders: Anxiety, insomnia, depression .

neurological disorders: fainting.

Eye disorders: vision disorders.

Disorder and vestibular disorders: Dizziness.

heart disorders: slow heart rate, tachycardia.

Vascular disorders: Low blood pressure, hypotension.

Respiratory disorders: Difficulty.

Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, indigestion , flatulence, discomfort in the stomach, vomiting.

Liver disorders: Hepatic dysfunction/liver disorders*

*Most cases of liver function abnormalities/liver dysfunction are seen from after -sales experience with Telmisartan in Japanese patients, which are objects or have these adverse reactions.

Skin and subcutaneous disorders: Evaluation (deadly), eczema, erythema, itching, increased sweating, urticaria, drug rash, toxic rash on the skin, rash.

musculoskeletal disorders: joint pain, back pain, muscle contraction (leg cramps), remote pain (foot pain), muscle pain, tendon pain (symptoms like tendonitis).

Kidney and urinary disorders: renal failure including acute renal failure.

Systemic disorders and medication: chest pain, fake symptoms influenza , weakness (sickness).

Testing: Hemoglobin decrease, hyperuricemia, hyperninery blood, hyper enzyme, increased blood phosphokinase (CPK).

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

Micardis medicine contraindicated in the following cases:

Hypersensitivity to active ingredients or any excipients of the drug.

3 months between and the last 3 months of pregnancy.

breastfeeding.

Pathological congestion.

Severe liver failure.

Contraindicated to use micardis with Aliskiren in patients with diabetes or kidney failure (GFR

Contraindicated in case of patients with rare genetic pathologies that may not be compatible with an excipient component of the drug (please refer to the "Warning and Caution").

Precautions when using

pregnancy

Do not start treatment with Angiotensin II receptor antagonists during pregnancy.

Patients with pregnancy plans should switch to alternative hypertension therapies that have drug safety data proved to be used during pregnancy unless the continued use of Angiotensin II receptor antagonists are thought to be really necessary.

When the patient is diagnosed with pregnancy, immediately stop treatment with Angiotensin II receptor antagonists and if necessary, start with an alternative therapy.

Hypertension caused by kidney disease

Increased the risk of strong hypotension and renal failure when the patient has narrowed kidney narrowing on both sides or artery stenosis to the only kidney and the function is treated with drugs acting on the Renin - Angiotensin - Aldosterone system.

kidney failure and kidney transplant

Periodically monitor potassium and serum creatinine when using micardis in patients with renal function. There is no experience using micardis in new kidney transplant patients.

Intravascular volume loss

Specialized blood pressure after the first dose may appear in patients with reduced intravascular volume or sodium reduction due to strong diuretic treatment, salt, diarrhea or vomiting. Such conditions, especially in reduced internal volume or sodium decrease, should be adjusted before using micardis.

Dual Renin - Angiotensin - Aldosterone System

As a result of inhibiting the Renin - Angiotensin - Aldosterone system, there has been a report on changing renal function (including acute renal failure) in sensitive patients, especially when used in combination with drugs that affect this system. Therefore, it is advisable to limit the double closing of the Renin - Angiotensin - Aldosterone system (for example, a combination of an additional enzyme inhibitor or Aliskiren directly inhibitor with an angiotensin II receptor inhibitors) in some cases specifically determined along with the monitoring of kidney function (see contrary).

Other diseases stimulate the Renin - Angiotensin - Aldosterone system

In patients with renal and vascular functions depend on the operation of the Renin - Angiotensin - Aldosterone system (for example, patients with severe congestive heart failure or renal disease including kidney stenosis), the treatment of drugs that affect the Renin - Angiotensin - Aldosterone system will cause acute blood pressure, hyper nitrogen, rare ureter.

Increasing primary aldosteron

In general, patients with primary hygiene aldosteron will not respond to hypertension medications that act on the inhibition of the renin-anidensin system. Therefore, micardis should not be used in these patients.

Security of mitral valve and aortic valve, hypertrophic heart muscle disease

As other vasodilators, special attention should be paid to patients with aortic valve stenosis or mitral valve or congested heart muscle.

Hemorrhage

When treated with drugs that affect the Renin - Angiotensin - Aldosterone system can cause hyperkalemia, especially in patients with renal failure or heart failure. Recommended monitoring of serum potassium in patients at risk.

Based on the experience of using drugs on the Renin - Angiotensin - Aldosterone system, the use in collaboration with potassium -keeping diuretics, supplements to potassium, replacement salt contains potassium or other drugs that can increase potassium concentration (heparin ...), can increase serum potassium so it should be noted when using these medications with micardis.

Hepatic failure

Telmisartan is excreted mainly through bile. The removal is impaired in patients with biliary obstruction or liver failure. Need to use micardis cautious in these patients.

Sorbitol

This product contains 338mg of sorbitol in each maximum daily recommended daily. Therefore, this drug should not be used in patients with rare genetic pathologies, which are fructose intolerance.

Diabetes treatment

In patients with diabetes, there is an additional cardiovascular risk, for example, patients with diabetes accompanied by coronary artery disease (CAD), the risk of myocardial infarction leading to death and death due to unexpectedly expected disease can increase when treated with drugs that reduce blood pressure such as ARB group and ACE inhibitors. In patients with diabetes, coronary artery disease (CAD) may have no manifestation and therefore the disease is not diagnosed.

Patients with diabetes should be evaluated and diagnosed appropriately, for example screening measures to assess the effect of training on the heart to detect and treat coronary artery disease and before treatment with micardis.

Other notes

Through studies on angiotensin enzyme inhibitors show that Angiotensin receptor inhibitors include clear micardis for poor hypotension effects in black people compared to other black -colored people, maybe due to higher ratio of hypertension with lower renin.

As all anti -hypertension drugs, excessive decrease in blood pressure in patients with heart disease or cardiovascular disease due to ischemia can lead to myocardial infarction or stroke.

The ability to drive and operate machinery

No research on affecting the ability to drive and operate machinery. However, when driving and operating machinery, it should be noted that dizziness or drowsiness may occasionally appear when using medication to treat hypertension.

Pregnancy

do not recommend the use of angiotensin II receptor inhibitors during the first three months of pregnancy and should not start treatment during pregnancy. When diagnosis is pregnant, immediately stop treatment with Angiotensin II receptor antagonists, and if appropriate, should be used for replacement therapy.

Contraindicated use of Angiotensin II receptor inhibitors in the middle and last three months of pregnancy.

Pre -clinical studies using Telmisartan do not indicate teratogenic effects, but shows the toxicity to the fetus.

Knowing the use of Angiotensin II receptor inhibitors in the middle and the last three months of pregnancy toxic to the fetus in humans (impaired renal function, amniotic fluid deficiency, slow chemistry) and toxic to babies (kidney failure, low blood pressure, hyperkalemia).

Women's patients intend to get pregnant should switch to other hypertension therapies that have safe data proved to be used during pregnancy unless the continued use of angiotensin II receptor is considered to be really necessary. When women are diagnosed with pregnancy, immediately stop treating with Angiotensin II receptor antagonists and should start with an appropriate alternative therapy.

If you accidentally use Angiotensin II receptor antagonists from the middle three months of pregnancy, it is recommended that the ultrasound will check the kidney and skull function. Young children of mothers treated with Angiotensin II receptor antagonists should be closely monitored.

Reproductive ability

has not conducted research on fertility in humans.

In preclinical studies, no effects of micardis are on fertility in both men and women.

breastfeeding period

Micardis contraindicated in women who are breastfeeding because it is not clear whether the drug is excreted through breast milk. Animal studies show that there is Telmisartan secretion into mother milk.

Medicinal interaction

micardis may increase the effects of other anti -hypertension drugs. No other clinical interactions are not seen.

There is no clinical significant interaction when using Telmisartan simultaneously with Digoxin, Warfarin, Hydrochlorothiazide, Glibenclamide, Ibuprofen, Paracetamol, Simvastatin and Amlodipine. Digoxin bottom concentration in plasma is found to increase by 20% (in a single case increasing by 39%), it is advisable to consider monitoring digoxin levels in plasma.

In a combination of Telmisartan and Ramipril, which led to increased 2.5 times AUC0 - 24 and CMAX of Ramipril and Ramiprilat. Unknown clinical involvement of this observation.

Increased serum and recovery lithium concentration has been recorded when shared with lithium with angiotensin enamel inhibitors. In some cases, it has also been reported when used with Angiotensin II receptor antagonists including micardis. Therefore, lithium concentration should be monitored in serum when shared with two drugs.

Concentrated with nonsteroidal anti -inflammatory drugs (such as ASA at doses for anti -inflammatory effects, COX -2 inhibitors and non -selective steroid anti -inflammatory drugs) are likely to cause acute kidney failure on patients with dehydration. The drugs acting on the renin-anidensin system like Telmisartan may have a synergistic effect.

Patients who use simultaneously nonsteroidal anti -inflammatory and micardis should be rehydrated and monitor kidney function from the beginning of combined treatment. The anti -hypertension effect of drugs such as Telmisartan has been reduced due to the inhibition of vasodilic prostaglandin that has been reported during treatment in combination with nonsteroidal anti -inflammatory drugs.

Storage

Store the drug in the packaging to avoid moisture. Storage below 300C.

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