Candesartan Stada 16mg Treatment of idiopathic hypertension, heart failure (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Candesartan Culilil
Ingredient High blood pressure
Ingredient
| Composition information | Content |
| Candesartan Culilil | 16mg |
Uses
Indications
Candesartan Stada indicated treatment in the following cases:
Mechanism of action
Angiotensin II is the main vascular hormone of the renin-analioterisin-aldosterone system and plays a role in the mechanism of hypertension, heart failure and other cardiovascular disorders. It also plays a role in the mechanism of hypertrophy and damage to internal organs. The main physiological effects of Angiotensin II, such as vascular contractions, stimulates aldosterone, regulates salt balance and inner water each stimulates cell growth, through the intermediary receptor type 1 (AT1).
Pharmacological effect
Candesartan CilexETIL is a precursor that is quickly converted into active substances Candesartan during the absorption from the gastrointestinal tract by hydrolyzing ester.
Candesartan is an Angiotensin II receptor antagonist, AT1 receptor selection, with tight links and slowly separating from receptors.
Candesartan has no host activity.
Candesartan has no ACE inhibitors, is the catalytic enzyme for the transformation of angiotensin I into angiotensin II and the bradykinin -flawing process. In clinical trials with Candesartan comparison with ACE inhibitors, patients using Candesartan Culilil have lower cough ratio.
Candesartan does not attach or seal other hormone receptors or ion channels that play an important role in the cardiovascular regulation. The antagonism of Angiotensin II receptors (AT1) leads to an increase in plasma renin levels, angiotensin I, angiotensin II concentration and reduced plasma aldosterone levels.
pharmacokinetics
absorption and distribution
After drinking, Candesartan Culilil is converted into active substances Candesartan. The absolute bioavailability of Candesartan is about 40% when using Candesartan Cilexetil in the form of oral solution. The relative bioavailability of the tablet compared to the oral solution is about 34% with very small fluctuations. Therefore, the absolute bioavailability of the tablet is 14%. The average peak concentration in serum is achieved after taking tablets for 3 to 4 hours.
During the therapeutic dose, Candesartan concentration in serum increases linear with the dose. There is no difference in mobility related to gender. The area below the curve of the concentration over time (AUC) of Candesartan is not significantly affected by food.
Candesartan binds to plasma proteins at a very high rate (> 99%). Candesartan's apparent distribution volume is 0.1L/kg.
Birth of Candesartan is not affected by ǎn.
Metabolism and elimination
Candesartan is excreted mainly in the form of unchanged urine and bile, only a small amount is eliminated through the metabolism in the liver (CYP2C9). Existing interactive studies show that there is no influence on CYP2C9 and CYP3A4.
A lot of connection with plasma proteins. Selling time is about 9 hours.
Before taking Candesartan Stada 16mg Treatment of idiopathic hypertension, heart failure (2 blisters x 14 tablets)
How to use
oral tablets.
Candesartan Culilil should be taken once a day, can be used or not with meals.
Birth of Candesartan is not affected by ǎn.
Dosage
Hypertension
The starting dose and the recommended maintenance dose of Candesartan are 8mg/time/day. Most of the hypotension effects achieved within 4 weeks. In some patients who do not control blood pressure, the dose can be increased up to 16mg/day/day and a maximum of 32mg/time/day. Need to adjust the dose according to the patient's response level.
Candesartan can also be coordinated with other hypertension medications. Collaborate with hydrochlorothiazide has been shown to have the effect of lowering blood pressure with different doses of Candesartan.
Elderly
No need to adjust the starting dose in elderly patients.
Patients with intravascular volume reduction
The starting dose is 4mg in patients at risk of hypotension, such as patients with reduced circulatory volume.
kidney failure
The starting dose is 4mg in patients with renal impairment, including patients with hemorrhage. Adjust the dose depending on the patient's response. Experience limited in patients with severe renal impairment or end -stage renal failure (CLCR
Hepatic failure
The starting dose is 4mg/time/day recommended in patients with mild to moderate liver failure. Adjust the dose according to the patient's response.
Candesartan is contraindicated in patients with severe liver failure and/or cholestasis.
Black skin patients
Candesartan's hypotension effect is less pronounced in black skin patients than non -black patients. Therefore, the adjustment of Candesartan and coordinated dose increases is necessary to control blood pressure in this object.
Children
Children and adolescents from 6 to
dose> 32mg has not been studied in children. Most cases, hypotension effects achieved within 4 weeks.
For children may have a decrease in internal volume (for example, patients treated with diuretics, especially children with kidney failure). Candesartan treatment should be started under strict medical supervision and consider the starting dose lower than the normal starting dose.
Candesartan has not been studied in children with glomerular filtration less than 30ml/min/1.73m2.
Black children
Candesartan's hypotension effect is less pronounced in black skin patients than other patients.
Children
Safety and efficiency in children from 1 to 6 years old has not been studied.
Candesartan is contraindicated in children
heart failure
Candesartan's usual starting dose is 4mg/time/day.
Adjust the dose up to the maximum dose of 32mg/time/day or the highest tolerance is made by doubling the dose in a period of at least 2 weeks. Evaluation of patients with heart failure must always include kidney function assessments including monitoring creatinine and serum potassium. Candesartan can be combined with other heart failure treatments, including ACE inhibitors, beta blockers, diuretics and digitalis.
Candesartan can also be combined with ACE inhibitors in patients with symptoms.
It is not recommended to combine ACE inhibitors, potassium -saving diuretic and Candesartan. This combination should only be reminded after careful evaluation of benefits and potential risks.
Special subjects
No need to adjust the starting dose for elderly patients or in patients with intravascular volume, renal failure or mild to moderate liver failure.
Children
The safety and effectiveness of Candesartan in children from birth to 18 years of age has not been studied in the treatment of heart failure. No data available.
monitor after using drugs
When using Candesartan in patients with hypertension with renal failure, periodic monitoring of potassium and creatinine levels should be monitored in serum. Restricted experience in patients with severe kidney failure or at the end (CICR
Evaluation of heart failure patients should include periodic assessments of renal function, especially in elderly patients, aged 75 and older and patients with renal failure. During the adjustment of the Candesartan dose, creatinine and serum potassium should be monitored. Clinical trials in heart failure do not include patients with serum creatinine levels> 265umol/l (> 3mg/dl). Used for children, including kidney failure children. Candesartan has not been studied in children with glomerular filtration
Simultaneous treatment with ACE inhibitors in heart failure
The risk of adverse reactions, especially hypotension, hyperkalemia and impaired renal function (including acute renal failure), can be increased when using Candesartan in combination with ACE inhibitors.
The combination of three drugs - A ACE inhibitors, a mineralocorticoid and Candesartan receptor drugs are also not recommended. Using this combination must be supervised by a doctor and must be monitored regularly for kidney, electrolyte and blood pressure.
Do not use ACE inhibitors and Angiotensin II receptor inhibitors in patients with kidney disease with diabetes.
When using Candesartan in patients with hypertension with renal failure, periodic monitoring of potassium and creatinine levels should be monitored in serum. Restricted experience in patients with severe kidney failure or at the end (CICR
Evaluation of heart failure patients should include periodic assessments of renal function, especially in elderly patients, aged 75 and older and patients with renal failure. During the adjustment of the Candesartan dose, creatinine and serum potassium should be monitored. Clinical trials in heart failure do not include patients with serum creatinine levels> 265umol/l (> 3mg/dl).
Use for children, including children with Candesartan kidney failure has not been studied in children with glomerular filtration
Do not use ACE inhibitors and Angiotensin II receptor inhibitors in patients with kidney disease with diabetes.
Hemorrhage
During dialysis, blood pressure may be particularly sensitive to AT1 receptor inhibition due to reduced plasma volume and activating the Renin - Angiotensin - Aldosterone system. Therefore, the dose of Candesartan should be adjusted and closely monitoring blood pressure in patients with hemolytic.
Renal artery stenosis
Medications that affect the Renin - Angiotensin - Aldosterone system, including Angiotensin II (AIRAS), can increase blood urea and serum creatinine in patients with kidney stenosis on both sides or renal artery stenosis in patients only one side of the kidney.
kidney transplant
Restricting clinical evidence about the use of Candesartan in patients who have undergone kidney transplant.
Hypotension
Hypotension may occur during treatment with Candesartan in patients with heart failure or patients with hypertension with intravascular volume impairment (such as patients with high dosage diuretic). Therefore, it is necessary to closely monitor and treat hypokalemia.
For children may have a decrease in intravascular volume (for example, the patient receives treatment with diuretics, especially children with kidney failure), should start treatment with Candesartan under strict medical supervision and should consider lower starting dose.
Anesthesia and surgery
Hypotension can occur during anesthesia and surgery in patients treated with Angiotensin II antagonistic drugs due to inhibition of the renin-angiotensin system. It is very rare for excessive hypotension, then it is necessary to use intravenous and/ or hypertension solutions.
Aortic valve stenosis and mitral valve (congested heart muscle disease)
It is necessary to be particularly cautious in patients with aortic valve or mitral stenosis, or congestion.
Hemorrhage
Candesartan simultaneous use with potassium -saving submarine, potassium supplements, replacement salts containing potassium or other drug products that can increase potassium concentration (e. Need to monitor the concentration of strong blood potassium.Hyperbysical hyperkalemia may occur in patients with heart failure treated with Candesartan. Need to monitor serum potassium. It is not recommended to combine Ace inhibitors, potassium -saving diuretic (eg spironolactone) and Candesartan, should only be used after careful assessment of benefits and potential risks.
General
In patients with blood vessel tone and renal function depend mainly on the activity of the renin - Angiotensin - Aldosterone system (for example, patients with severe congestive heart failure or kidney disease, including renal artery stenosis), treated with drugs that affect the RAA system that affects acute hypotension, blood urine, urinary or acute (rare), similar to Alilira. As with any other blood pressure treatment, excessive hypotension in patients with ischemia or cerebrovascular disease due to ischemia can lead to myocardial infarction or stroke.
Candesartan's hypotension effects may be enhanced by other drugs with antihypertensive properties despite prescribing with other indications.
What to do when overdose?Symptoms
Based on pharmacological properties, the main manifestation of overdose may be symptomatic and dizziness. In personal reports, overdose up to 672mg Candesartan Cilexetil in adult patients can recover and have no complications.
Treatment
If hypotension has symptoms, symptomatic treatment and monitoring of survival signs. Patients should be placed on their backs, their legs advanced. If necessary, plasma volume should be increased by infusion, for example, isotonic salt solution. If the above measures do not improve symptoms, sympathetic treatment may be used.
Candesartan cannot be removed by hemorrhage.
What to do when you forget 1 dose? Do not use double dose to compensate for the forgotten dose.
Side Effects
In the treatment of hypertension
Common, ADR ≥ 1/100 to
Infections and parasites: Respiratory infections.
Very rare, ADR
Liver disorders: Increased liver enzyme, abnormal liver function or hepatitis. Skin and subcutaneous tissue disorders: angioedema, rash, urticaria, itching. renal and urinary system: renal failure, including sensitive patients. Children Common, ADR ≥ 1/100 to Infections and parasites: Respiratory infections. In the treatment of heart failure Common, ADR ≥ 1/100 to Cardiovascular disorders: Hypotension. renal and urinary system: renal failure, including sensitive patients. Very rare, ADR Liver disorders: Increased liver enzyme, abnormal liver function or hepatitis. Skin and subcutaneous tissue disorders: angioedema, rash, urticaria, itching. 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
Candesartan Stada is contraindicated in the following cases:
Be cautious when using
Dual inhibition of the Renin - Angiotensin - Aldosterone (RAAS).
There is evidence that the simultaneous use of ACE inhibitors, Angiotensin II or Aliskiren receptor inhibitors increases the risk of hypotension, hyperkalemia and reducing kidney function (including acute renal failure). Therefore, it is not recommended to use the dual inhibition of RAA systems through the use of ACE inhibitors, Angiotensin II or Aliskiren receptor inhibitors.
If you need to inhibit the Raa system, you should only take the drug under the supervision of a specialist and must regularly monitor the process of kidney, electrolyte and blood pressure regularly.
Do not use ACE inhibitors and Angiotensin II receptor inhibitors in patients with kidney disease with diabetes.
kidney failure
As well as other agents inhibiting the Renin - Angiotensin - Aldosterone system, Candesartan may affect the kidney function during treatment.
Pregnant women
Allra should not be started during pregnancy. Unless continued treatment with Allra is necessary, patients who have a plan to become pregnant should be changed to hypotension therapy instead of safety records used during pregnancy. During pregnancy, it should be stopped with AIIRA immediately and if necessary, should start the replacement therapy.
In patients with the ability to get pregnant, they should be evaluated regularly and provide appropriate information and/ or action to prevent the risk of exposure during pregnancy.
Lactose excipients
This drug contains lactose monohydrate. Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or malposure - Galactose should not use this drug.
The ability to drive and operate machinery
There is no research on the effect of Candesartan on the ability to drive and use machinery. However, when treated with this drug, it can cause dizziness and fatigue.
Pregnancy
The use of AIIRA is not recommended in the first three months of pregnancy and contraindications in the second and third three months of pregnancy.
There is no evidence of epidemiology related to the risk of teratogenicity after using ACE inhibitors in the first three months of pregnancy; However, it is not possible to eliminate the risks that may occur. Unless the continued treatment of AIIRA is necessary, the patient has a plan to become pregnant, so it is possible to change the treatment method with a document that proves safety for pregnant women. When diagnosed with pregnancy, it should be stopped with AIIRA immediately and replaced the treatment.
Exposure to Alira for 3 months and the third 3 months is shown to be harmful to the fetus (reducing kidney function, amniotic fluid, skull retardation) and babies (kidney failure, hypotension, hyperkalemia).
If exposed to Allra has occurred from the second three months of pregnancy, the ultrasound checks for kidney and skull function.
Need to monitor the strict blood pressure in infants whose mothers have used Aiira.
Breastfeeding period
Because there is no information related to the use of Candesartan while breastfeeding, do not recommend the use of Candesartan and should use alternative treatments with safety records for women to breastfeed.
Drug interaction
Active ingredients have been studied in clinical pharmacokinetic studies including hydrochlorothiazide, warfarin, digoxin, oral contraceptive (ethinyylestradiol/levonorgestrel), glibenclamide, nifedipine and enalapril. There is no clinical pharmacokinetic interaction with these drugs.
Concentrated use of potassium -saving diuretic, potassium supplements, replacement salts containing potassium or other drug products (for example, heparin) may increase potassium levels. Need to monitor blood potassium concentration.
There have been reports on increasing serum and toxic lithium concentration during use simultaneously lithium with ACE inhibitors. The same effect can occur with Alira. Therefore, Candesartan should not be used simultaneously with lithium. If you need to use, you should carefully monitor the lithium concentration in serum.
When concurrent allra is used with nonsteroidal anti-inflammatory drugs (NSAID) (for example, selective inhibitors of COX-2, acetylsalicylic acid (> 3g/day) and NSAID are not selective), can reduce the effect of lowering blood pressure.
Similar to ACE inhibitors, simultaneous use of Aiira and NSAIDs can lead to an increased risk of impaired renal function, including acute renal failure and increased serum potassium, especially in patients with poor kidney function before. Therefore, it is necessary to be cautious when used simultaneously, especially in the elderly.
Patients need to be provided with enough water and monitor the kidney function after the beginning of treatment and periodic treatment.
Clinical test data has shown that the use of a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors increases the frequency of side effects such as hypotension, hyperkalemia and impaired kidney function (including acute renal failure) compared to the use of a RUA system inhibitors.
Storage
Leave a cool dry place, avoid light, temperature below 30 ° C.
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