Colosar-denk 50/12.5 Denk treatment for hypertension (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Losartan, hydrochlorothiazide
Ingredient Denk Pharma GmbH & Co. Kg
Ingredient
| Composition information | Content |
| Losartan | 50mg |
| Hydrochlorothiazide | 12.5mg |
Uses
Indications
Colosar-denk drugs are indicated in the following cases:
The diuretic effect is caused by hydrochlorothiazid that increases the activity of lenin in plasma and the secretion of aldosteron as well as the concentration of angiotensin II, on the contrary, reduces potassium in plasma. Losartan blocks the relevant physiological effects of Angiotensin II and through the inhibition of aldosteron it may tend to reduce the loss of potassium associated with diuretic.
Losartan has proven the effect of the urinary and light uric acid. Hydroclorothiazid causes an increase in AID Uric moderate level. The combination of Losartan and hydrochlorothiazid tends to reduce the hyperuricemia in the blood caused by diuretic.
Anti -blood pressure effect of Losartan/HCT maintains a 24 -hour period.
Losartan/HCT effectively lower blood pressure in men and women, black and non -black, people under 65 years old and equal or over 65 years old and have a effect on hypertension levels.
pharmacokinetic
absorption
losartan
After taking Losartan is well absorbed and initially transformed. Acidic activity metabolites and other inactive metabolites are formed. Birth of the whole body of Losartan films is about 33%.
The peak concentration of Losartan in plasma is achieved after 1 hour and active metabolites are 3-4 hours. There is no significant effect of food on Losartan's concentration in plasma if taken with a standardized meal.
Distribution
losartan
Losartan and its active metabolites bind to plasma proteins> 99%, first of all with albumin. The distribution of Losartan is 34 liters. Rat studies show that Losartan is small if it is not completely unable to penetrate through blood -brain barriers.
hydrochlorothiazide
hydrochlorothiazid passes through the placenta, but does not pass the blood -brain barrier and goes into milk.
Metabolism
losartan
About 14% of Losartan's oral dose is converted into activated metabolites.
After taking Losartan marked by 14C, the concentration of radioactive substances in plasma is first of all of Losartan and its active metabolites. The minimum metabolism of Losartan to activated metabolites is found about 1% of the research objects.
In addition, there are inactive metabolites including two main substances formed by Butyloxylation of Butyl branch circuit and one smaller substance than N-2 Tetrazol Glucuronid.
Excretion
losartan
Leaving plasma clearance is about 600 ml/min and active metabolites are 50 ml/min. Kidney clearance is about 74ml/min (losartan) and 26 ml/min (active metabolites).
If you take Losartan about 4% of the excretory dose in the form of unchanged in the urine and about 6% excreted urine in the form of active metabolites. The pharmacokinetics of Losartan and its active metabolites are linearly losartan doses of potassium to 200 mg.
After drinking, the Losartan concentration is the excess of the last half of the last half of the life and about 2 hours and the active metabolite in plasma is 6 - 9 hours. Both Losartan and active metabolites are not significantly accumulated in plasma when taking one -time dose on 100 mg.
Losartan and metabolites excreted through bile and urine. After taking the losartan dose marked 14C about 35% of radioactive activity found in the urine and 58% in feces.
hydrochlorothiazide
hydrochlorothiazid is an non -metabolic substance, but is eliminated very quickly through the kidney.
When the plasma concentration has been measured at least 24 hours, half -life in the observed hematoma is changed between 5.6 and 14.8 hours. Minimum of 61% of oral dose is not changed within 24 hours.
Special population
losartan hydrochlorothiazide
Losartan concentration in plasma and active metabolites and the absorption of hydrochlorothiazid in elderly people with high blood pressure are not significantly different from young people with high blood pressure.
losartan
After drinking in patients with alcoholic cirrhosis mild and medium, Losartan concentration and active metabolites in plasma are 5 times higher (Losartan) and about 1.7 times (active metabolites) compared to the corresponding concentration in young female patients. Both Losartan and metabolites cannot be excluded by blood vessels.
Before taking Colosar-denk 50/12.5 Denk treatment for hypertension (2 blisters x 14 tablets)
How to use
Colosar-denk 50/12.5 drugs can be used with other anti-blood pressure drugs.
When used, swallow the tablet with a glass of water. Can be used or not food.
Dosage
High blood pressure
Losartan/hydrochlorothiazid is not suitable for use when starting treatment, but used to treat patients when taking Losartan or hydrochlorothiazide separate without controlling blood pressure. It is recommended to identify the dose according to separate components (losartan and hydrochlorothiazid). Wherever is suitable for clinical, it is changed directly from single treatment to fixed coordination for patients with unsatisfactory blood pressure.
The usual maintenance dose is a Colosar-Denk 50/12.5 (50 mg Losartan and 12.5 mg of hydrochlorothiazid), once a day.
For patients who do not respond well, the dose can be raised to 2 tablets/day/day (100 mg of Losartan and 25 mg of hydrochlorothiazide).
In general, the effect of reducing blood pressure is maintained for 3 to 4 weeks after the beginning of treatment.
Used for patients with renal impairment and blood viagers
No need to adjust the initial dose for patients with medium renal impairment (ie creatinine clearance from 30 to 40 ml/minute).
Do not recommend Losartan/HCT tablets for patients who are bloody. Do not use Losartan/HCT tablets for patients with severe renal impairment (meaning creatinine clearance
Used for patients with inner volume reduction
Need to adjust the decrease in volume and/or loss of sodium before taking Losartan/HCT tablets.
Used for patients with liver failure
Losartan/HCT is contraindicated for patients with severe liver failure.
Used for elderly patients
In general, it is not necessary to adjust the dose for elderly patients.
used for children and adolescents (under 18 years old)
There is no experience in children and adolescents. Therefore, do not use Losartan/HCT for children and adolescents.
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? Treatment is only symptomatic treatment and support. Must stop treatment with Colosar-Denk 50/12.5 and closely monitor patients.
The proposed measure includes vomiting and adjusting water and imbalance of electrolytes, treating liver coma and lowering blood pressure according to the built process.
losartan
So far, the data on the overdose of Losartan is limited. Symptoms may be lower blood pressure and tachycardia, slow heart rate that can occur due to sympathetic stimulation (nervous nerves). If symptoms of hypotension occur, support treatment. Both Losartan and active metabolites are not excluded by blood via.
hydrochlorothiazide
The most common signs and symptoms are the symptoms caused by the drop in electrolytes (hypokalemia, hypoglycemia, sodium hemorrhage) and dehydration due to excessive urination.
If used in digitalis, decreased potassium can highlight the arrhythmia. So far, the level of elimination of hydrochlorothiazid with silent blood has not been set.
What to do when forgetting 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 Colosar-denk, you may experience unwanted effects (ADR).
In clinical studies with Losartan Kali and Hydrochlorothiazid does not observe any unwanted reactions of this combination drug.
Unwanted reactions that seem to focus on the previous reactions that have been observed with Losartan Kali and/or hydrochlorothiazide.
In control clinical studies with basic hypertension, only dizziness, dizziness is reported 1% or more in the Losartan/Hydrochlorothiazide group and more than the placebo group.
In addition, the following reactions are reported after the product is put into the market:
Liver disorders
Hematology system
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
Colosar-denk drugs contraindicated in the following cases:
Precautions when using
Caution and note when using with patients with symptoms and/or the following cases:
The ability to drive and operate machinery
There is no research on the ability to drive and operate the machine. However, when driving or operating the machine should be noted that dizziness, dizziness, or fatigue can occur when taking anti -high blood pressure, especially when starting treatment, or when increasing the dose.
Pregnancy
Colosar-denk 50/12.5 is contraindicated during pregnancy.
Breastfeeding period
Because there is no information on the use of combination of Losartan and Hydroclorothiazid during breastfeeding, it is not recommended to use and choose other treatments that have set a safe profile when breastfeeding.
Drug interaction
The following drugs are likely to cause drug interaction (details, please read the instruction manual carefully):
Storage
Store in a cool dry place, temperatures below 30 ° C. Avoid light.
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