The coirbeve 150/12.5mg Hasan medicine treats hypertension (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Irbesartan, hydrochlorothiazide
Ingredient Hasan-dermapharm

Ingredient

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Composition information	Content
Irbesartan	150mg
Hydrochlorothiazide	12.5mg

Uses

indications

coirbevel is used to treat hypertension in patients who fail with single treatment regime with Irbesartan or hydrochlorothiazid before. Initial treatment for patients is required to use drug combinations to achieve treatment goals.

Pharmacokinus

Pharmacological classification: Angiotensin II receptor antagonists and diuretics.

ATC code: C09DA04.

Mechanism of action

Anti -blood pressure effects of Irbesartan and thiazid diuretics are combined.

Irbesartan

Irbesartan is a hypertension medicine belonging to the AT1 receptor antagonist group of Angiotensin II. Irbesartan inhibits the physiological effects of Angiotensin II, including aldosteron secretion and vasoconstriction.

Irbesartan is not a precursor and pharmacological effect, regardless of the hydrolysis of the liver, does not inhibit the enzyme metabolism of angiotensin I into angiotensin II, so it does not inhibit the breakdown of Bradykinin and other kinins. Therefore, Irbesartan does not cause persistent dry cough like medications for hypertension in inhibition of enzyme.

Hypotension effect depends on the dose and tend to not lower when taking the dose higher than 300 mg/time/day. The maximum lower blood pressure is about 3-6 hours after drinking. Anti -hypertension effect maintained at least 24 hours. Anti -hypertension effect is manifested within 1-2 weeks, maximum within 4-6 weeks from the beginning of treatment and maintenance of long -term treatment. If the treatment is stopped, the blood pressure gradually returns to the original value but there is no sudden serious illness when stopping the drug.

hydrochlorothiazide

hydrochlorothiazid increases the excretion of sodium chloride and water due to inhibition of the reabsorption of sodium and chloride ions in the distance. Hydroclorothiazid also increases the excretion of potassium, magnesi, bicarbonate ions. Modified diuretic effect.

hydrochlorothiazid has the effect of lowering blood pressure, first due to a decrease in plasma volume and cellular fluid related to sodium excretion, then during the use of drugs, hypotension effect depending on peripheral resistance, through gradual adaptation of blood vessels against the reduction of sodium concentration. Diuretic effects can be seen after a few hours, and the hypotension effect is slow after 1-2 weeks.

Dynamic pharmacokinetics

Irbesartan pharmacokinetics are not changed when combined with hydrochlorothiazid.

Irbesartan

absorption

Irbesartan quickly absorbed through the gastrointestinal tract, biochemical from 60 - 80%. The peak concentration in plasma is about 1-2 hours after drinking. Food does not change the bioavailability of the drug.

Distribution

The concentration of medication in the blood reaches a stable equilibrium after 3 days of medication. Irbesartan binds 96% to plasma protein, the distribution volume is about 53 - 93 liters. Precipable studies show that Irbesartan passes the placenta, distributed into the fetus, through poor brain blood barriers, distributed into mice milk and no data has confirmed whether or not to be distributed into human milk.

Metabolism

Metabolism in the liver by oxidation with CYP2C9 and glucuronic complex into inactive metabolites.

Elimination

Eliminating drugs through feces and urine. After drinking, about 20% of the drug excreted through the urine in the form of metabolism and less than 2% in the form of no metabolism. The sale time is 11 - 15 hours.

hydrochlorothiazid

absorption

After drinking, hydrochlorothiazid is relatively fast, about 65-75% dose.

Distribution

hydrochlorothiazid accumulated in red blood cells, through the placenta, without the bloodstream barrier and distributed into milk.

Metabolism

Hydroclorothiazid is not metabolized.

Elimination

hydrochlorothiazid eliminated mainly through the kidneys in the form of non -metabolic, more than 61% of the drug is excreted within 24 hours. The half -life is about 9.5 - 13 hours but may last in the case of renal failure.

Anti -hypertension effect of hydrochlorothiazid is usually optimized at a dose of 12.5 mg and can only achieve a full effect after 2 weeks.

Pharmacokinetics for some special clinical subjects

Gender

Irbesartan plasma concentrations in women are 11-14% higher than men. However, after using many doses, there is no difference in the accumulation and sale time of the drug. There is no difference in clinical efficiency by gender.

Elderly (65 - 80 years old) with blood pressure, kidney function, normal liver function

AUC and the peak concentration of plasma of Irbesartan are about 20-50% higher than young people (18 - 40 years old).

There is no significant difference in clinical efficiency by age.

AUC survey of hydrochlorothiazid in the elderly after using many doses shows that it is suitable for previous reporting data.

White people and black people have normal blood pressure

AUC and Irbesartan's waste time in black people are about 20-25% higher than white people, the peak concentration of plasma of Irbesartan in two equivalent groups.

Patients with renal failure (regardless of the extent), the patient is hemolysis

Irbesartan pharmacokinetics changed negligible. Irbesartan is not eliminated by the appraisal process. In patients with severe renal failure (creatinine clearance

Patients with impaired liver function due to mild cirrhosis to moderate

Irbesartan's

pharmacokinetics changed negligible.

Before taking The coirbeve 150/12.5mg Hasan medicine treats hypertension (2 blisters x 14 tablets)

How to use

Use the drug once a day, can take the medication during, before or after meals. Should fix the daily use of the drug, do not arbitrarily stop the drug.

Dosage

For patients who fail with a single therapy mode: 1 coirbeve 150/12.5 mg tablet daily, can be increased to 2 capsules/day if needed to control blood pressure.

Initial treatment for patients mandatory to use the combination mode: The starting dose usually 1 tablet of coirbeve 150/12.5 mg daily. The dose may be increased after 1-2 weeks of treatment, the maximum dose is 300 mg of Irbesartan and 25 mg of hydrochlorothiazide (2 tablets).

Note: Do not use the coirbeve 150/12.5 mg initial treatment for patients to receive blood volume.

Special clinical object

Patients with renal failure

coirbevel 150/12.5 mg contains hydrochlorothiazid, should not be used in patients with severe renal impairment (creatinine clearance 30ml/min.

Patients with liver failure

Do not use Couube 150/12.5 patients with severe liver failure, do not need to adjust the dose in case of mild to moderate liver failure.

Elderly

No dose adjustment in the elderly.

Children

It is not recommended to use combination of Irbesartan and hydrochlorothiazide in children due to the safety and effectiveness of the unprocessed.

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?

Irbesartan

The dose of 900 mg/day for 8 weeks in adults is not toxic.

Symptoms: hypotension and arrhythmia.

Management: There is no specific therapy in the treatment of Irbesartan overdose. Patients should be strictly monitored, symptomatic treatment and power. Can cause vomiting, gastric lavage, activated carbon, can not remove Irbesartan by dialysis.

hydrochlorothiazide

Symptoms: Water and electrolyte disorders, which can increase the arrhythmia for patients using digitalis due to hypokalemia.

How to handle: Gastrointestinal lavage when using medication, using activated carbon, using chloride ammonium to prevent blood alkaline (except for patients with liver disease). Quickly compensate for the amount of water and electrolytes lost to adjust the water and electrolyte balance. In the case of hypotension does not respond to the above interventions, use 4 mg/liter norepinephrin 4 mg/liter intravenous injection or dopamine with the initial dose of 5 micrograms/kg/minute.

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

Unwanted effects are grouped by frequency: Very common (ADR> 1/10), common (1/100 ≤ ADR Cardiovascular: Slow heart, arrhythmia, ventricular arrhythmia, abnormal electrocardiogram, flushing, lowering blood pressure, lowering vertical blood pressure, fainting (rarely).

Skin: Itching, discomfort (rarely).

Endocrine metabolism: Sexual dysfunction (common). Diabetes, gout, sudden hot (common).

Digestive: constipation, reducing appetite, bloating, dry mouth, epigastric pain, flatulence, gastroesophageal reflux (rare).

Bone muscle/connective tissue: abnormal reflexes, muscle pain, swelling of the head, weak head (rarely).

Neurological: Coordination disorders, depression, emotional disorders, numbness, abnormalities, sleep disorders, drowsiness, dizziness (rarely).

Respiratory: Dry nose and throat, shortness of breath, wheezing (rarely).

sensitivity: Visual abnormalities, taste disorders, visual disorders (rare).

Other: Feeling cold, excessive sweat, weakness, weakness, weight gain (rarely).

Warnings

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

contraindicated

coirbevel drugs contraindicated in the following cases:

Hypersensitivity to Irbesartan, hydrochlorothiazid or any ingredients of the drug, sensitivity to sulfonamids.

Simultaneous use of 150/12.5 mg coilvel with aliskiren -containing preparations in diabetes patients or patients with renal impairment (CFR

Be cautious when used

There has been reports on hypotension events in hypertension patients, though not accompanied by risk of hypotension when used in combination with Irbesartan and hydrochlorothiazide. Hypotension can also occur in patients with reduced blood volume such as salt loss and water due to strong diuretics, strict salt diet, diarrhea or prolonged vomiting or hemorrhage. Need to reduce blood volume before using the drug.

Increased risk of severe hypotension and impaired renal function in patients with narrowed kidney stenosis on both sides or one -sided kidney stenosis on single kidneys treated with an angiotensin enzyme inhibitor or Angiotensin II receptor antagonist.

Although there is no proof of evidence, a similar risk needs to be measured before using the coirbeve 150/12.5 mg.

Regularly check the concentration of potassium, blood creatinine, blood uric acid in patients with renal impairment. There is no experience using Irbesartan and hydrochlorothiazide in a patient.

Do not use the coirbeve 150/12.5 mg in patients with severe renal impairment (creatinine clearance

However, caution should be used in patients with mild to medium -level renal failure (creatinine clearance ≥ 30 ml/min and

Be cautious and notify your doctor before taking the coirbeve 150/12.5 mg if you have any of the following conditions:

You have excessive vomiting or diarrhea.

You have kidney or kidney disease.

You have heart disease.

You have liver diseases.

You have lupus erythematosus (also known as lupus or sleep).

You have primary Aldosteron (a disease related to the production of hormones of Aldosteron higher than normal, causing sodium, hypertension).

You are taking any of the following hypertension medications: Angiotensin transferred enzyme inhibitors (enalapril, lisinopril, ramipiril), especially if you are suffering from diabetes kidney disease. Your doctor may periodically check the kidney function, blood pressure and electrolyte concentration (potassium) in your blood.

You must notify your doctor if you think you are (or likely) to become pregnant. The coirbeve 150/12.5 mg is not recommended for use in the early period of pregnancy, and is not used if you are 03 months or more pregnant, as it can cause serious harm to the fetus if used in this period.

You should also notify your doctor if:

You are in a restricted diet.

You have symptoms such as abnormal thirst, dry mouth, body fatigue, drowsiness, muscle pain or cramps, nausea, vomiting, or abnormal tachycardia may be a sign of excessive effects of hydrochlorothiazid (an ingredient in the drug).

You have a history of skin sensitive skin sensitivity with symptoms of sunburn (such as red, itching, swelling, blistering) that occurs faster than usual.

You prepare surgery or are about to be anesthetized.

You see changes in vision or pain in one or both eyes while taking the coirbeve 150/12.5 mg. This may be a sign that is developing glaucoma, increasing pressure in one or two eyes. You should stop taking the drug and contact the medical center.

The ingredient of hydrochlorothiazid in the drug can result in positive anti-down test results.

If you do not tolerate some types of sugar (eg lactose), contact your doctor before taking the coirbeve 150/12.5 mg.

Use drugs for women during pregnancy and lactation

Pregnant women

You must notify your doctor if you are (or likely) to become pregnant. The doctor will advise you to stop taking the coirbeve 150/12.5mg before you are pregnant or as soon as you know you are pregnant and advise you to take another medication instead.

coirbeve 150/12.5 mg is not recommended for use in the early period of pregnancy and is not used when you are pregnant for 03 months or more, because it can cause serious harm to the fetus if used after the 3rd month of pregnancy.

breastfeeding women

Notify the doctor if you are breastfeeding or start breastfeeding. The coirbeve 150/12.5 mg is not recommended for breastfeeding mothers, the doctor can choose to replace you if you still want to breastfeed, especially if your baby is an infant or a short -term babies.

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

There are no researches on the effects of the drug on driving and operating machinery. The coirbeve 150/12.5 mg does not affect your ability to drive and operate your machines.

However, sometimes dizziness and fatigue can occur during the treatment of hypertension. If you suffer from the above symptoms, notify your doctor before operating machinery and train.

Drug interaction

Irbesartan

Other anti -hypertension drugs

Increases the hypotension effect of Irbesartan.

Potassium supplements or potassium diuretics

Increases the concentration of potassium when used simultaneously with Irbesartan.

lithium

Increased serum and toxic lithium concentration that can be recovered when used simultaneously with enzyme inhibitors, unpretved and unclear interactions with Irbesartan should still be closely monitored.

digoxin

Digoxin's

pharmacokinetics does not change when used simultaneously with Irbesartan 150 mg in healthy people.

Aliskiren anti -hypertension or enzyme inhibitors

Clinical trials show that the simultaneous coordination of the Renin - Angiotensin dual blocked drugs such as enzyme inhibitors, Angiotensin II or Aliskiren receptor antagonists increases the frequency of unwanted incidents such as hypotension, hyperboly and impaired renal function (including acute renal failure) when compared with the use of lenootensin inhibitors whether.

Non -steroid anti -inflammatory drugs (NSAID)

Concomitance of Angiotensin II and NSAID receptor receptors can reduce the effectiveness of
anti -hypertension.

Other Irbesartan interactions

In clinical trials, pharmacokinetics of Irbesartan are not affected by hydrochlorothiazid. Irbesartan is metabolized by CYP2C9. Therefore, CYP2C9 inhibitors can reduce the metabolism through the liver of Irbesartan. However, there is no pharmacokinetic interaction and pharmacokinetic energy when using Irbesartan in combination with warfarin (a drug that is metabolized mainly through CYP2C9). Effect of enzyme induction drugs CYP2C9 on pharmacokinetics of Irbesartan has not been evaluated. Digoxin's pharmacokinetics are not changed when used simultaneously with Irbesartan.

hydrochlorothiazid

alcohol, barbiturat, addictive sleeping pills

Increase the potential of hypotension.

Oral diabetes and insulin drugs

It should be noted that adjusting the dose due to hydrochlorothiazid has the ability to increase blood glucose.

Other hypotension drugs

The effect of synergies, increasing the potential of hypotension.

corticosteroid, acth

Increases the loss of electrolytes, especially reducing potassium.

Hypertension amines

hydrochlorothiazid may reduce the response to hypertension but not enough to prevent use.

muscle relaxants

hydrochlorothiazid may increase in response to muscle relaxants.

lithium

hydrochlorothiazid reduces lithium clearance and increases the toxicity of this substance.

Steroid anti -inflammatory drugs

Reduce diuretic, sodium and hypotension effect.

quinidine

easily causes torsion, loss of death.

anticoagulant, gout medicine

reduced effects by thiazid.

Anesthesia, glycosid, vitamin D

Increased effects by hydrochlorothiazid.

cholestyramin, colestipol

The absorption of hydrochlorothiazid is reduced in the presence of anion exchange resin. Need to take the medicine at least 1 hour or 4 hours after taking Cholestyramin, Colestipol.

Calcium salt

hydrochlorothiazid may increase serum calcium concentration due to reduced calcium elimination. The use of calcium supplements should be prescribed by a doctor, accompanied by monitoring calcium levels.

Other interactions

The effect of increasing blood glucose of beta and diazoxid blockers may be increased by thiazid diuretics.

Anti -anti -cholinergic drugs (Atropin, Beperiden) may increase the bioavailability of thiazid diuretics by reducing stomach - intestinal motility and gastric empty speed. Thiazid diuretics can increase unwanted effects caused by amantadin; Reducing the renal elimination of cyclophosphamide, methotrexate) and increases the bone marrow inhibition potential of the above drugs.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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