Tolucombi Tablets 80mg/12.5mg Krka Treatment of Definitely Hypertension (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Hydrochlorothiazide, telmisartan

Ingredient

Composition informationContent
Hydrochlorothiazide12.5mg
Telmisartan80mg

Uses

Indications

Tolucombi 80mg/12.5mg indications for treatment in the following cases:

  • Treatment of idiopathic hypertension.

    ATC code: C09DA07

    Tolucombi is a combination of an Angiotensin II, Telmisartan and a diuretics thiazide, hydrochlorothiazide. The combination of these components has an anti -hypertension effect that reduces blood pressure at a larger level than using only single components.

    Tolucombi used once a day, causing blood pressure loss effectively and mellow in the treatment limit.

    telmisartan

    Telmisartan is an Angiotensin II receptor antagonist (AT1 group) specific and effective when used orally. Telmisartan occupies Angiotensin II at the cohesion position with the AT1 receptor is the responsible position for the known activities of Angiotensin II.

    Telmisartan does not show a partial co -operating activity at the AT1 Telmisartan receptor receptor selected on the AT1 receptor receptor. Telmisartan does not show craving with other receptors, including AT2 and less typical AT receptors. The function of these receptors is not clear, as well as excessive stimulation effects may be due to angiotensin II, which is a high concentration when using Telmisartan. Plasma aldosterone levels decreased by Telmisartan. Telmisartan does not inhibit human blood renin or ionic channels. Telmisartan does not inhibit the enzyme transferring angiotensin (Kininase II), this enzyme also has the effect of breaking Bradykinin. Therefore, it is not possible to increase the side effects through Bradykinin intermediaries.

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

    After the first Telmisartan dose, anti -hypertension activity gradually shows within 3 hours. The maximum level of hypotension is usually achieved after 4 weeks of treatment and is maintained throughout the long -term treatment.

    Sustainable anti -hypertension effect continuously for 24 hours after taking the drug, including 4 hours before taking the next dose. This is confirmed by the base/vertex ratio that is always over 80% seen after the dose of 40mg and 80mg Telmisartan in control clinical studies with placebo. In hypertension patients, Telmisartan has the effect of reducing both systolic and diastolic blood pressure without affecting the pulse. Telmisartan's anti -hypertension effect has been compared to other anti -hypertension drugs such as Amlodipine, Atenolone, Enalapril, Hydrochlorothiazide, and Lisinopril.

    If stopped with Telmisartan, the blood pressure will gradually return to the original value before treatment within a few days without the phenomenon of hypertension.

    Through clinical studies directly compare two drugs for hypertension, the rate of dry cough is much less than in patients using Telmisartan compared to patients using angiotensin transferring enamel inhibitors.

    Cardiovascular Protection

    ontarget (Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint 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 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 are monitored on average of 4.5 years. Telmisartan is similar to Ramipril, which reduces the criteria of evaluation as a combination of cardiovascular death, myocardial infarction does not cause death, non -fatal stroke or hospitalized due to congestive heart failure. 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% Cl 0.93 -1,10, P (not inferior) - 0.0019 with 1.13). The mortality rate due to all causes corresponding to 11.6 % and 11.8 % in patients treated with Telmisartan and Ramipril.

    The results show that Telmisartan is effective equivalent to RamIPril in the first secondary criterion, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke [0.99 (97.5% CL 0.90-1.08), P (not inferior) = 0.0004], the main criterion in the Hope Reference Research is the effect of Ramipril SO effect Pharmacy.

    Randomly arranged transcend research patients with ACE I intolerant to other criteria similar to ontarget with telmisartan 80 mg (n = 2954) or placebo (n = 2972). The average time is up to 4 years and 8 months. There is no significant difference of the main coordination criteria (cardiovascular death, non -fatal myocardial infarction, non -fatal stroke, hospitalization due to congestive heart failure) shows [15.7% in the group using telmisartan and 17.0% in the placebo group with a dangerous ratio of 0.92 (95% Cl 0.81 -1,05, P = 0.22)]. There is evidence that the benefits of Telmisartan compared to the placebo in the secondary coordination criteria of cardiovascular death, myocardial infarction does not cause death, and non -fatal stroke [0.87 (95% CL 0.76 -1,00, P = 0.048)]. There is no evidence of benefits on cardiovascular mortality rate (dangerous ratio of 1.03.95 % CL 0.85 -1.24).

    Cough and angioedema are reported less in patients with Telmisartan treatment compared to RamIPril, while hypotension notice more often with Telmisartan.

    Combining Telmisartan with RamIPril is not more beneficial when using each Ramipril or each Telmisartan. Cardiovascular deaths and death due to higher cause in terms of combination. In addition, increasing the rate of blood potassium, renal failure, hypotension and fainting in the combination group. Therefore, combining Telmisartan and Ramipril is not recommended in this population group.

    In the research "Prevention Regimen for Effective Avoiding Seconded" for patients over 50 years old, just undergoing a stroke, increasing the rate of blood infections in patients using Telmisartan compared to placebo, 0.70% compared to 0.49% [RR 1.43 (95% reliable range of 1.00-2,06)]; The proportion of deaths due to blood infections has increased in patients with Telmisartan (0.33 %) compared to patients with placebo (0.16 %) [RR 2.07 (95 %reliable range of 1.14-76)]. Observations that increase the occurrence of hemorrhagic infections associated with the use of Telmisartan may be an opportunity or related to an unknown mechanism.

    Two major random studies controlled ontarget and Va Nephron-D have checked the use of ACE to inhibit ACE and Angiotensin II receptor inhibitors.

    Ontarget research in patients with a history of cardiovascular and stroke, or type 2 diabetes with diabetes complications. VA Nephrond studies in type 2 diabetics and diabetes. These studies have shown that there is no serious effect on the kidneys and/or cardiovascular and mortality, while observing increases the risk of hyperkalemia, acute kidney damage, calculation and/or hypotension. With similar pharmacological properties, the results also indicate that there is a relevance to ACE inhibitors and Angiotensin II receptor inhibitors. ACE inhibitors and Angiotensine II receptor inhibitors should therefore not be used simultaneously in diabetes patients.

    Altitude is a study designed to assess the benefits when taking Aliskiren with ACE inhibitors or Angiotensin II receptor inhibitors in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease or both. This study was ended early because of the increased risk of serious complications. Cardiovascular and stroke complications occur more often in the group using Aliskiren than the placebo group; And serious side effects (hyperkalemia, hypertension and kidney dysfunction) are more often informed in the group using Aliskiren compared to the placebo group.

    Hydrochlorothiazide is a thiazide diuretic. The mechanism of hypotension is not known. Diuretics that affect the electrolyte reabsorption mechanism of electrolytes, directly increasing the excretion of sodium and chloride with equivalent approximation. Hydrochlorothiazide diuretic reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with an increase in potassiumuria and carbonate loss, and decreased serum potassium. Perhaps through the Renin-Anotensin-Aldosterone channel blocker system, Telmisartan's simultaneous indications tend to reverse potassium when combined with diuretics. With hydrochlorothiazide, the starting of the card occurs for 2 hours, and the maximum effect occurs about 4 hours, while the impact lasts approximately 6 to 12 hours.

    Epidemiological studies have shown long -term treatment with hydrochlorothiazide, which reduces the risk of cardiovascular death and disease.

    The effects of the combination of fixed dose of Telmisartan/HCTZ on the rate of death and death on the heart are unknown.

    Dynamic pharmacokinetics

    Simultaneous use of hydrochlorothiazide and telmisartan does not affect the pharmacokinetics of each drug.

    absorption

    Telmisartan: After taking the peak concentrations of Telmisartan achieved after 0.5 - 1.5 hours. The absolute bioavailability of Telmisartan 40 mg is 42% and 160 mg is 58%. Food mitigates Telmisartan's bioavailability with a reduction in the area under the plasma concentration curve over time (AUC) by about 6% for 40 mg tablets and about 19% for 160 mg dose.

    After 3 hours, plasma concentrations are equivalent to whether Telmisartan is used or not food. The area under the concentration-time-decreasing time (AUC) does not reduce the effectiveness of treatment. The pharmacokinetics of Telmisartan are non-linear oral by doses of 20-160 mg, with an increase in plasma concentration ratio (CMAX and AUC) when increasing the dose. Telmisartan accumulates negligible in plasma when taking the drug repeated many times.

    hydrochlorothiazide: After taking tolucombi the top concentrations of hydrochlorothiazide are achieved after 1.0 - 3.0 hours. Due to the excretion through the kidneys, absolute bioavailability is about 60%.

    Distribution

    Telmisartan: Telmisartan is strongly connected to plasma proteins (> 99.5%), mainly albumin and alpha-acid glycoprotein. The distribution of Telmisartan about 500 liters shows additional tissue cohesion.

    Hydrochlorothiazide: Hydrochlorothiazide is connected 68% with plasma proteins and distribution integral is 0.83 - 1.14 l/kg.

    Metabolism

    Telmisartan: Metabolized by the combination of acylglucuronide formation without pharmacological activity. Glucuronide of the original compound is the only metabolic product determined in humans. After a dose of 14C Telmisartan, Glucuronide accounts for about 11% of radioactive activity measured in plasma. Cytochrome P450 Isoenzyme does not participate in Telmisartan metabolism. Hydrochlorothiazide: No metabolism in the human body.

    Elimination

    Telmisartan: After intravenous intravenous injection or drinking Telmisartan mounted 14C, most dose (> 97%) are excreted in biliary tract. Only a small amount found in urine. Telmisartan elimination speed in total plasma after taking the drug is> 1500 ml/min. Telmisartan's ending time is> 20 hours.

    hydrochlorothiazide: is excreted almost completely in the form of unchanged urine. About 60% of oral doses are eliminated in the form of unchanged within 48 hours. The speed of the kidney is about 250-300 ml/min. Hydrochlorothiazide waste time is 10-15 hours.

    Special cases

    Elderly patients

    The pharmacokinetics of Telmisartan are not different between the elderly and the people under 65.

    Gender

    Telmisartan plasma concentrations are usually 2-3 times higher than in women. However, in clinical studies, there is no significant increase in blood pressure response or increasing the rate of hypotension standing in women. No need to adjust the dose. Tend to concentration of plasma hydrochlorothiazide in women than men. This is considered not clinically related.

    Patients with renal failure

    Elimination through the kidney does not contribute to the process of eliminating Telmisartan. According to experience in medium and mild renal impairment patients (the rate of creatinine 30 - 60 ml/min, about 50 ml/minute), the dose adjustments are not needed.

    Telmisartan is not excluded when dialysis. In patients with renal failure, the rate of elimination of hydrochlorothiazide is reduced. In a typical study in patients with an average creatinine clearance rate of 90 ml/min, the sale time of hydrochlorothiazide increases. In patients with kidney function no longer, the selling time cancel about 34 hours.

    Patients with liver failure

    studies in patients with hepatic impairment shows that there is an absolute bioavailability of nearly 100%. The half -life does not change in patients with liver failure.

  • Before taking Tolucombi Tablets 80mg/12.5mg Krka Treatment of Definitely Hypertension (4 blisters x 7 tablets)

    How to use

    Tolucombi tablets for oral tablets, can be taken or not with food.

    Dosage

    tolucombi is indicated in adults that do not fully control blood pressure if only Telmisartan is used. Use single dose for each recommended ingredient before using a fixed dose. When appropriate, change directly to the combination dose may be considered.

    Tolucombi should be used once a day on patients who do not fully control blood pressure when Telmisartan is single.

    Special cases:

    Patients with renal failure: Periodic monitoring of kidney function.

    Patients with hepatic impairment: In patients with medium and mild liver failure, the dosage should not exceed Tolucombi 40/12.5mg/day. Tolucombi is not indicated for patients with severe liver failure. Thiazide drugs should be cautious for patients with liver function.

    Elderly: No dose adjustment.

    Children and adolescents: The safety and effectiveness of tolucombi have not been identified in children and teenagers 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 using overdose?

    Symptoms:

    The most prominent manifestation of Telmisartan overdose is low blood pressure and tachycardia; Slow heart rate, dizziness, vomiting, increased serum creatinine and acute renal failure can also occur.

    Overdose from hydrochlorothiazide is associated with electrolyte reduction (hypokalemia, hypoglycemia) and dehydration due to excessive diuretic. The most common signs and symptoms of overdose are nausea and sleep. Hematuria reduction can cause muscle spasms and/or worsen the arrhythmia associated with simultaneous use with Digitalis Glycosides or some anti -arrhyths.

    Treatment:

    Telmisartan is not eliminated by hemorrhage, patients should be closely monitored, symptomatic treatment and supportive treatment depending on the time from the time of absorption of drugs and the severity of symptoms. Proposed measures include gastric vomiting. Activated carbon can be helpful in treating overdose, should monitor electrolytes and regular creatinin.

    Patients should be closely monitored, symptomatic treatment and support treatment depending on the time from the absorption of drugs and the severity of symptoms. The electrolytes and serum creatinine should be monitored regularly. If low blood pressure occurs, patients should be placed in a lying position, quickly compensate for the volume and salt.

    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? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

    Side Effects

    Safety records

    The most common side effects are dizzy. Serious angioedema rarely (= 1/10,000 to The overall frequency of side effects is reported to Tolucombi compared to telmisartan reports in random trials involving 1471 random patients to receive telmisartan along with hydrochlorothiazide (853) or Telmisartan (636). Side reactions related to the dose are not established and shows that there is no correlation with the sex, age or race of the patient.

    Summary table of side effects of drugs

    Side reactions are reported in clinical trials and occur more often (P = 0.05) with telmisartan combined with hydrochlorothiazide compared to the placebo is displayed below by each organ system.

    Auxiliary reactions are known to occur with single components but have not been seen in clinical trials that can occur when treated with Tolucombi.

    Side reactions are arranged according to the following frequency: Very common (= 1/10); Common (= 1/100 to

    In each group, side effects are arranged in the order of gradually decreasing.

    Infections and parasites:

  • Rare: bronchitis, sore throat, sinusitis.
  • immune system disorders:

  • Rare: Severe or start system lupus erythematosus.
  • Not common: anxiety.
  • Rare: weakness.
  • Common: Dizziness, dizziness.
  • Rare: visual disorders, blurred vision.
  • Not common: Dizziness.
  • Cardiovascular disorders:

  • Not common: fast heartbeat, arrhythmia.
  • Cardiovascular disorders:

  • Not common: hypotension, hypotension.
  • Not common: Difficulty breathing.
  • Rare: respiratory failure (including pneumonia and pulmonary edema).
  • Not common: diarrhea, dry mouth, flatulence.
  • Rare: abdominal pain, constipation, indigestion, vomiting, gastritis.
  • Rare: Abnormal liver function/liver disorders.
  • Skin disorders and subcutaneous tissues:

  • Rare: Evana (also fatal), Red rash, itching, burning, sweating a lot, urticaria.
  • Not common: back pain, muscle spasm, muscle pain.
  • Not common: erectile dysfunction.
  • Common disorders:

  • Not common: chest pain.
  • Non -common: increased blood uric acid.

    telmisartan:

    Side reactions occur similarly to the placebo -frequency and patients treated with Telmisartan. The frequency of side effects is reported to Telmisartan (41.4%) often compared to placebo (43.9%) with controlled tests with placebo. The following side effects are listed synthesized from clinical trials in patients treated with Telmisartan due to high blood pressure or 50 -year -old patients who are at high risk of cardiovascular complications.

    Infections and parasites:

  • Not common: upper respiratory infection, urinary tract infection including cystitis.
  • Not common: Anemia
  • Rare: Hypersensitivity, Anaphylaxis.
  • Non -common: hyperkalemia.
  • Rare: Hypoglycemia (in diabetes patients).
  • Not common: slow heart rate.
  • Nervous system disorders:

  • Rare: Dreaming.
  • Not common: cough.
  • Very rare: interstitial lung disease.
  • Rare: Stomach discomfort.
  • Skin disorders and subcutaneous tissues:

  • Rare: Eczema, drug rash, skin poisoning.
  • Rare: joint pain, ligament pain.
  • Not common: renal failure (including acute renal failure).
  • General disorders:

  • Not common: weakness.
  • Research:

  • Rare: Haemoglobin.
  • Hydrochlorothiazide:

    Hydrochlorothiazide can cause or seriously reduce blood volume that can lead to an electrolyte imbalance. Side effects of unknown frequency of hydrochlorothiazide include:

    Infections and parasites:

  • Unknown: salivary gland inflammation.
  • Unknown: Anemia, hemolytic anemia, bone marrow failure, leukemia, granulocytosis, thrombocytopenia.
  • immune system disorders:

  • Unknown: Anaphylaxis, hypersensitivity.
  • Endocrine disorders:

  • Unknown: adequate control diabetes.
  • Unknown: Anorexia, reducing appetite, electrolyte imbalance, hypercholesterol, hyperglycemia, reducing blood volume.
  • Mental disorders:

  • Unknown: Insomnia.
  • Unknown: dizzy.
  • Eye disorders:

  • Unknown: Vauscers of yellow (xanthopsia), acute myopia, glaucoma of acute angle.
  • Vascular disorders:

  • Unknown: necrotic vasculitis
  • Unknown: Pancreatitis, stomach discomfort.
  • Unknown: jaundice in liver cells, jaundice.
  • Skin disorders and subcutaneous tissues:

  • Unknown: syndrome such as lupus erythematosus, light -sensitive reactions, vasculitis, poisoning epithelium.
  • Unknown: Weak.
  • Kidney and urinary disorders:

  • Unknown: interstitial nephritis, kidney dysfunction, urinary glucose.
  • General disorders:

  • Unknown: Fever.
  • Research:

  • Unknown: Increase triglycerides.
  • Describe selective side effects:

    Abnormal liver disorders/liver function

    Most cases of abnormal liver/liver function disorders due to Telmisartan have occurred in Japanese patients.

    Blood infection

    In Profess research, increasing the rate of blood infections observed in Telmisartan compared to placebo. This may be an accidental finding or related to an unknown mechanism.

    Interstitial lung disease

    Cases of interstitial lung disease have been reported from the use of telmisartan. However, the causal relationship has not been established.

    Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    contraindicated

    Tolucombi 80mg/12.5mg contraindications in the following cases:

  • sensitive to the main active ingredient or with the excipients. Creatinine discharge Caution when using

    pregnancy:

    Do not start treating with Angiotensin II receptor antagonists during pregnancy. Patients who plan to get pregnant should switch to alternative hypertension treatments that have drug safety 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 if necessary, start with an alternative therapy.

    Hepatic failure:

    Do not use tolucombi for patients with bile stasis, bile congestion or severe liver failure because Telmisartan is largely excreted through bile. It can be seen that Telmisartan clearance through the liver decreases in these patients.

    Tolucombi should be used with caution in patients with liver function or liver disease, because only minor changes in water and electrolytes can lead to liver coma. There is no clinical experience for Tolucombi in patients with liver failure.

    Hypertension due to kidney artery:

    Has the ability to increase the risk of severe hypotension and kidney failure when the patient has narrowed kidney stenosis on both sides or the kidney stenosis to the only kidney is still the function of being treated with drugs that affect the Renin - Angiotensin - Aldosterone system.

    kidney failure and kidney transplantation:

    Do not use tolucombi in patients with severe renal impairment (creatinine clearance rate

    Reducing internal volume:

    Symptomatic hypotension, especially after the first dose, can occur in patients with volume loss and/or sodium loss due to excessive diuretic therapy, too strict salt abstinence, diarrhea or vomiting. Such conditions should be overcome before using tolucombi.

    Renin - Angiotesin - Aldosterone:

    There is evidence that simultaneous use with ACE enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors increase the risk of sudden hypotension, hyperkalemia, functional renal failure (including acute renal failure). Therefore, the Dual System of the RAAS system through the use in combination with ACE enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors are not recommended.

    If double closed maple is necessary, it is necessary to have close monitoring and regular function of kidney, electrolyte and blood pressure.

    ACE enzyme inhibitors and Angiotensin II receptor inhibitors are not used in combination with patients with diabetic kidney disease.

    Other conditions that stimulate the renin - angiotensin - Aldosterone system:

    In patients with vascular tone and renal function depends largely on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or basic kidney disease, including kidney artery stenosis), the treatment with other drugs affects the renin-anidensin-aldosterone system related to acute hypotension, increased blood urinary, rarely rarely impaired.

    Increasing primary Aldosterone:

    Patients with raw raw hyperplasia often do not respond to anti-hypertension drugs through inhibiting the Renin-Anotesin system. Therefore, it is not recommended to use Tolucombi.

    Aortic valve stenosis and mitral valve, hypertrophic myocardial disease:

    As well as for other vasodilators, special attention should be paid to patients with aortic valve stenosis or mitral valve, or hypertrophic cardiomyopathy.

    Metabolic and endocrine effects:

    Thiazide therapy may reduce glucose tolerance. In patients with diabetes may need to adjust insulin dose or oral hypoglycemic drugs. Potential diabetes can become an entity during thiazide treatment.

    Increase the concentration of cholesterol and triglyerids related to thiazide diuretic therapy, but very few or almost no such effects are reported at a dose of 12.5 mg contained in tolucombi.

    Hyperglycemia can occur or gout may appear in some patients who are taking Thiazide therapy.

    Electrolyte balance:

    For any patient who uses Thiazide therapy, the periodic test of electrolytes in serum must be performed according to the appropriate time.

    Thiazide drugs, including hydrochlorothiazide, can cause water and electrolyte imbalance (hypotension, sodium hypoglycemia and alkaline infection due to hypoglycemia). The warning signs of electrolyte imbalance are dry mouth, thirst, weakness, sleep, drowsiness, restlessness, muscle pain or cramping, muscle weakness, reducing blood pressure, urinary decrease, tachycardia and gastrointestinal disorders such as nausea or vomiting.

    Although hypokalemia may appear when using thiazide diuretics, simultaneous treatment with Telmisartan can reduce the ability to lower potassium potassium due to diuretics. The risk of hypokalemia will be the highest in patients with cirrhosis, on patients who are taking fast diuretics, in patients who are compensating for enough electrolytes through oral and on patients treated simultaneously with corticosteroids or ACTH. In contrast, due to the antagonistic mechanism of the Angiotensin II receptors (AT1) by Tolucombi's telmisartan component, the condition of hyperkalemia may occur.

    Despite the clinical significant hyperkalemia that has not been recorded with Tolucombi, risk factors leading to hyperkalemia include kidney failure and/or heart failure and diabetes.

    Potassium diuretic, potassium supplements or potassium salts should be used to be used carefully with tolucombi.

    There is no evidence that tolucombi will reduce or prevent sodium hemorrhage due to diuretics. The deficiency of chlorine is usually mild and often does not need treatment.

    Thiazide can reduce the excretion of calcium in the urinary tract and cause slight increase, temporary serum calcium in the condition that no other calcium metabolic disorders. Significant hypercalcemia may be evidence of hidden parathyroid gland. Thiazide should be stopped before performing the adjacent function tests.

    Thiazide has shown to increase the elimination of magnesium through the urinary tract, which can lead to lower blood mages.

    sorbitol and lactose monohydrate:

    The drug contains lactose monohydrate and sorbitol. Patients with rare genetic diseases are intolerant to fructose and/ or rare genetic diseases Glucose-Galactose should not use this drug.

    Like all Angiotensin II receptor antagonists, Telmisartan is less effective for African patients. Because in the body of black high blood pressure has a lower amount of renin.

    Other notes:

    Like any other anti -hypertension, excessive hypotension in patients with ischemia or ischemia can lead to myocardial infarction or stroke.

    Body:

    Hypersensitivity reactions with hydrochlorothiazide 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 serious or activated condition of the system of lupus erythematosus has been reported for the use of thiazide diuretics, including hydrochlorothiazide.

    Cases of reaction to light have been reported to thiazide diuretics. If a reaction to light occurs in treatment, treatment should be discontinued. If treatment is necessary, recommendation from sunlight or artificial UVA.

    Acute myopia and closed angle glaucoma:

    Hydrochlorothiazide is a sulfonamide that can cause a separate reaction, leading to transient myopia and an increase in acute angle. Symptoms include an acute onset of vision or eye pain and typical within a few hours to a few weeks from the beginning of the drug. Increase angle of acute non -treatment angle can lead to permanent vision loss. Stop hydrochlorothiazide as quickly as possible. Medical treatment or surgery immediately can be considered immediately if the urban pressure is still uncontrolled. Risk factors for developing acute narrow -angle glaucoma leading to allergy history Sulfonamide or penicillin.

    The effect of the drug on the ability to drive and operate machinery

    There has been no research on the effect of the drug on the ability to drive and operate machinery. However, when driving or operating machinery, it should be noted that the feeling of dizziness or drowsiness can sometimes occur during anti -hypertension treatment.

    Use drugs for women during pregnancy and lactation

    Pregnancy

    Do not use Angiotensin II receptor inhibitors during pregnancy.

    There is no adequate data on the use of tolucombi in pregnant women, but shows that the effects of toxicity.

    Epidemiological evidence related to the risk of teratogenicity after exposure to Angiotensin II receptor inhibitors during the first quarter of pregnancy is not concluded; However, increasing the risk of not being excluded. While there is no epidemiological data controlled for the risk of Angiotensin II receptor opposites, similar risks can exist in this group of drugs. Women planning to get pregnant should switch to alternative 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 diagnosed with pregnancy, Angiotensin II receptor is immediately diagnosed, and if appropriate, alternative treatment should be started.

    Know how to use Angiotensin II receptor inhibitors for the last three months and the last three months toxic to the fetus (impaired renal function, amniotic fluid, skull slowly) and toxic to babies (kidney failure, low blood pressure, hyperboly). There has been an effect from the middle three months of pregnancy when using Angiotensin II receptor antagonists, recommending ultrasound to test kidney function and skull. Babies of mothers treated with Angiotensin II receptor antagonists should be monitored in a strict low blood pressure.

    Thiazide passes through the placenta and appears in the umbilical cord blood. The drug can cause electrolyte disorders in the fetus and other reactions that have been met in adults. Cases of fetal or fetal or neonatal platelets have been reported for thiazide treatment during pregnancy. Hydrochlorothiazide is limited during pregnancy, especially in the first quarter. Lack of animal studies. Hydrochlorothiazide through the placenta. Based on the pharmacological mechanism of hydrochlorothiazide during the second quarter and the third quarter of pregnancy, it can reduce blood transfusion through the fetus leading to jaundice, electrolyte balance disorders and thrombocytopenia.

    Hydrochlorothiazide should not be used for women during pregnancy, high blood pressure during pregnancy because of the risk of reducing plasma volume and reducing blood transfusion for the fetus, not beneficial for this disease. Hydrochlorothiazide is not used to treat high blood pressure in pregnant women except for rare cases that are not used.

    Breastfeeding period

    There is no relevant information on using tolucombi during breastfeeding, Tolucombi is not recommended and replaced with better treatment for therapy set for nursing patients, especially in newborn or premature babies.

    Hydrochlorothiazide is small in breast milk. High -dose Thiazide has strong diuretic can limit milk secretion. Using tolucombi during breastfeeding is not recommended. If you use tolomombi during breastfeeding, you should lower the dose to the extent possible.

    fertility

    Not yet conducted research on human fertility.

    In preclinical studies, there is no vision of tolucombi's effects on fertility in both men and women.

    Drug interaction

    lithium: Increased lithium and toxic lithium concentration of lithium can be recovered during the process of simultaneous use of lithium with angiotensin enamel inhibitors. In some cases, it has also been reported when used with Angiotensin II receptor antagonists including Telmisartan. Moreover, the lithium's kidney removal rate is reduced by thiazide so the risk of lithium poisoning can increase when using tolucombi. Lithium and tolucombi should only be used simultaneously under medical monitoring and need to monitor serum lithium concentration during simultaneous use.

    Other drugs reduce potassium concentrations and hypokalemia: (For example, diuretics loss potassium, laxative, corticosteroids, acth (Adrenocorticotropic), amphoticin, carbenoxolone, penicillin g sodium, salicylic acid and conduct).

    If these drugs are prescribed with tolucombi, plasma potassium concentration should be monitored. These drugs may increase the effects of hydrochlorothiazide on blood potassium.

    Other drugs increase potassium levels and hyperkalemia: (For example, enzyme inhibitors, potassium -saving diocesia, potassium supplements, replacement salts containing potassium, cyclosporine or other medicinal products such as sodium heparin).

    If these drugs are prescribed with tolucombi, plasma potassium concentration should be monitored. Based on the experience of using other drugs that inhibit the Renin-Anotensin, simultaneous use of the above drugs can lead to increased serum potassium, so it is not recommended.

    Medicines affected by blood potassium disorders: Periodic monitoring of serum potassium is recommended when Tolucombi is used with drugs affected by serum potassium balance disorders (e.g. digitalis glycosides, anti -arrhythmic drugs) and drugs are known to have the ability to cause "Torsades de Pointes" (including anti -arrhythmia) peak.

    La group arrhythmia (eg Quinidine, hydroquinidine, disopyramide).

    Anti -arrhythmia group III (eg amiodarone, sotalol, dofetilide, ibutilide).

    sedative (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiaplyPride, pimozide, haloperidol, droperidol).

    Other (eg Bepridil, Cisapride, Diphemanil, Erythromycin IV, Halofantrin, Mizolastin, Pentamidine, Sparfloxacine, Terfenadine, Vincamine IV).

    glycosidtim: lower potassium and blood magnesium due to thiazide facilitating the appearance of arrhythmia due to digitalis.

    Digoxin: When Telmisartan is simultaneously used with Digoxin, the average increase of the peak concentration is (49%) and the bottom concentration (20%), the monitoring of plasma digoxin should be considered. At the beginning of adjustment, and stop Telmisartan, Digoxin levels should be monitored to maintain the concentration during treatment.

    Other antihypertensive drugs: Telmisartan can be hypotension effect of other lower pressure medications.

    Clinical data shows that the double clutches of the Renin - Angiotesin - Aldosterone (RAAS) system through the use in combination with ACE transferring inhibitors, Angiotensin II or Aliskiren receptor inhibitors, the frequency of increasing the risk of hypotension suddenly, increased blood potassium, functional impairment (including acute renal failure) higher than the use of RAAS system.

    Diabetes (oral and insulin medications): Adjusting the dose of diabetes can be required.

    Metformin: Metformin is used with the recommendation: The risk of lactic acidic acidosis caused by reduced kidney function may be related to hydrochlorothiazide. Cholestyramine and Colestipol: Hydrochlorothiazide absorption may be reduced in the presence of anion exchange resin.

    Non-steroid anti-inflammatory drugs: NSAIDs (for example, acetylsalicylic acid with anti-inflammatory treatment regimen, COX-2 and NSAIDs inhibitors can reduce diuretics, sodium diuretic and hypotension of thiazide diuretics and anti-hypertension effects of Angiotensin II antagonists in some patients with damaged kidney function (such as patients with patients with patients with elderly patients with elderly patients with elderly patients with water patients with elderly water function Kidneys are damaged), combined with Angiotensin II receptor resistance and cyclo-oxygenase inhibitors can lead to further decline in renal function, including acute renal failure, often recovered.

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

    Amine hypertension (eg noradrenaline): The effect of amine causes hypertension may be reduced.

    Non -reducing muscle muscle relaxants (eg tuboCurarine): The effect of these drugs can be enhanced by hydrochlorothiazide.

    Gout treatment (eg Probenecid, sulfinpyrazone and allopurinol): The adjustment of dosage of uric acid lowering drugs may be necessary because hydrochlorothiazide may increase the concentration of seros Uric acid. Simultaneous use with Thiazide may increase the risk of allergic reactions with allopurinol.

    Calcium salts: Thiazide diuretics may increase serum calcium concentration due to reduced excretion. If you have to supplement calcium, serum calcium concentration should be monitored and calcium dose should be adjusted accordingly.

    Beta and diazoxide blockers: The hyperglycemic effect of beta and diazoxide blockers can be increased by thiazide.

    anti -cholinergic drugs (eg atropine, biperiden) can increase the bioavailability of thiazide diuretics by reducing bowel motility and stomach empty speed.

    Amantadine: Thiazide may increase the risk of side effects caused by Amantadine.

    Cycle toxic drugs (eg cyclophosphamide, methotrexate): Thiazide can reduce the excretion of the kidneys of cytotoxic products and affect their marrow inhibitor effects.

    Based on pharmacological characteristics it can be expected that the following drugs can increase the hypotension effect of anti -hypertension drugs including Telmisartan: Baclofen, amifostine.

    Moreover, hypotension can get worse due to alcohol, sedative, sleeping pills or antidepressants.

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