Caprovel 150mg/12.5mg Sanofi treatment for primary hypertension (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Irbesartan, hydrochlorothiazide
Ingredient High blood pressure

Ingredient

Composition information	Content
Irbesartan	150mg
Hydrochlorothiazide	12.5mg

Uses

Indications

coaprovel is a combination of 2 active ingredients, Irbesartan and hydrochlorothiazid. Irbesartan belongs to the Angiotensin-II receptor antagonist group. Angiotensin-II is a substance produced by the body, when attached to its receptor in the blood vessel, causing blood vessels. The result is hypertension.

Irbesartan prevents the attachment of angiotensin-II to this receptor thus relaxing blood vessels and lowering blood pressure. Hydrochlorothiazid is a drug in the group of thiazide diuretics that increase the amount of urine and thus lower blood pressure.

Two active ingredients in coaprovel mutually lower blood pressure than when using each component separately.

Coaprovel is indicated for patients with hypertension (primary hypertension), when treated individually with Irbesartan or hydrochlorothiazid without controlling blood pressure satisfactorily.

Pharmacokology

Medicine group treatment: Angiotensin II receptor antagonistic, combined ATC Code C09DA04.

Coaprovel is a combination of an angiotensin-II receptor antagonist is Irbesartan, and a thiazide diuretic is hydrochlorothiazide. The combination of these ingredients creates the effect of treating hypertension plus, reducing more blood pressure than when used separately from each component.

Irbesartan is a strong, oral impact, selective antagonist on Angiotensin-II receptor (AT1 subgroup). The drug prevents all the effects of angiotensin-II through the AT1 receptor intermediaries regardless of the origin or synthetic path of Angiotensin-II.

Angiotensin-II receptor selection (AT1) increases plasma renin levels and angiotensin-II levels, reducing plasma Aldosteron levels. Irbesartan has an impact without having to go through metabolism.

hydrochlorothiazid is a thiazid diuretic. Thiazid acts on the mechanism of reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chlorine in approximately each other. The impact of hydrochlorothiazid reduces plasma volume, increases plasma renin activity, increases the secretion of aldosteron, which increases the loss of potassium and bicarbonate, reducing plasma potassium.

Through the effect of Renin - Angiotensin - Aldosteron system of Irbesartan, the simultaneous use of Irbesartan with hydrochlorothiazid tends to remove potassium loss. When using hydrochlorothiazid, diuretic effects are on the 2 hours, and the impact reaches the highest level within 4 hours and prolongs the effect of 6 - 12 hours.

The combination of hydrochlorothiazid and Irbesartan creates a decrease in blood pressure with the additional effect through the amplitude of the drug's treatment dose.

The impact of lowering blood pressure of Irbesartan when combined with hydrochlorothiazid is clearly seen after the first dose and the basic presence after 1-2 weeks, this effect reaches maximum after 6 - 8 weeks.

pharmacokinetics

Simultaneous use of hydrochlorothiazid and irbesartan does not affect the pharmacokinetics of each drug.

Irbesartan and hydrochlorothiazid are oral medications and do not require a biological shift to be active. When using oral coaprovel, absolute bioavailability is 60 - 80% for Irbesartan and 50 - 80% for hydrochlorothiazid. Food does not affect the bioavailability of coaprovel. The plasma peak concentration of the drug after taken is reached for 1.5 - 2 hours with Irbesartan and 1 - 2.5 hours with hydrochlorothiazid.

Irbesartan's cohesion ratio with plasma proteins is about 96%, insignificant cohesion with blood cell components. The distribution of Irbesartan is 53 - 93 liters. Hydrochlorothiazid connects 68% to plasma proteins and the apparent distribution volume is 0.83 - 1.14 l/kg.

The half -life of Irbesartan is 11 - 15 hours. The stable state of plasma concentration is achieved after 3 days after starting the drink once a day. It is not necessary to adjust the dose in the elderly. The average semi -cancellation time in plasma of hydrochlorothiazid varies from 5 -15 hours. Irbesartan is metabolized in the liver via complex and oxidation glucuronide.

There are less than 2% of the dosage excreted in urine is Irbesartan in the form of unchanged. Hydrochlorothiazid is not metabolized but quickly excreted by the kidneys. At least 61% of oral doses are eliminated in a constant form within 24 hours. Hydrochlorothiazid passes through the placenta but does not pass the brain barrier, and is excreted into breast milk.

Renal failure: In patients with kidney failure or patients who are hemorrhage, pharmacokinetic parameters of Irbesartan are not significantly changed. Irbesartan is not excluded. In patients with creatinine clearance

Hepatic failure: In patients with mild to moderate cirrhosis, the pharmacological parameters of Irbesartan are not significantly changed. Studies have not been conducted in patients with severe liver failure.

Before taking Caprovel 150mg/12.5mg Sanofi treatment for primary hypertension (2 blisters x 14 tablets)

How to use

use by oral. The pill should be swallowed with an appropriate amount of liquid (like a glass of water). Coaprovel can be taken during or outside meals. You should take the daily dose at the same time of the day. It is important that you use coaprovel continuously until the doctor decides to use another way.

The maximum lowering efficiency is achieved within 6 - 8 weeks after the beginning of treatment.

Dosage

The usual dose of coaprovel is 1 or 2 capsules a day. Usually coaprovel is prescribed by your doctor when previous hypertension treatments are not enough to lower your blood pressure. The doctor will guide you how to switch from previous treatment to treatment with coaprovel.

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? The overdose manifestation of Irbesartan is common is hypotension and heart rate changes. Overdose due to hydrochlorothiazid is often accompanied by a decrease in serum electrolytes and dehydration due to excessive diuretic. The common symptoms are nausea and drowsiness.

Patients need to be closely monitored, symptomatic treatment and support. The processing depends on the time from taken and the severity of the symptoms. The proposed measures in the overdose treatment include vomiting and/or gastric lavage, and activated carbon.

Must regularly monitor electrolytes and serum creatinine. If hypotension occurs, the patient should be placed in a lying position, quickly rehydration and electrolytes.

What to do when you forget 1 dose? Do not take double the dose to compensate for the forgotten dose.

If you have any more questions about using this medication, ask your doctor or pharmacist.

Side Effects

When using Caprovel 150/12.5, you may experience unwanted effects (ADR).

Like all drugs, coaprovel can cause unwanted effects. Some side effects may be serious and require medical monitoring.

Rare skin allergic reactions (rash, hives), as well as localized swelling on the face, lips and/or tongue in patients with Irbesartan oral patients.

If you have the above symptoms or shortness of breath, stop using coaprovel and see your doctor immediately.

In clinical studies for patients using coaprovel, the following side effects have been reported:

Common, ADR> 1/100

Nausea/vomiting.

abnormal small.

tired.

Stunned (including when standing up from lying or sitting position).

Blood tests showing an increase in the concentration of function measurement of muscle and heart (creatin kinase) or increasing the concentration of kidney function measurements (blood urea, creatinine).

If you encounter any side effects mentioned above, notify your doctor immediately.

Uncommon, 1/1000

diarrhea.

Low blood pressure.

faint.

Heart rate.

blushed.

swelling.

If you encounter any side effects mentioned above, notify the doctor immediately.

Some adverse side effects have been reported since Coaprovel circulated on the market but it is unknown frequency such as: headache , voicing in the ear, cough, taste disorders, indigestion , joint pain and muscles, liver dysfunction and reduced kidney function, hyperpassing blood potassium, and allergic reactions such as rash, or throat. Rarely cases of jaundice (jaundice and/or white iris of the eye).

Like any combination of active ingredients, it is impossible to eliminate the side effects that come with each active ingredient.

Unwanted effect when using Irbesartan mere

In patients with Irbesartan, in addition to the above side effects, chest pain may also be.

Unwanted effects when using hydrochlorothiazids

appetite; stomach stimulation; stomach spasm; constipation ; jaundice and/or yellow eyes; Pancreatitis is characterized by a lot of pain in the epigastric area, often nausea and vomiting; sleep disorders; depression ; blurred vision; leukopenia can lead to or infection; fever; thrombocytopenia (a type of blood cell plays an important role in blood clotting); Reducing red blood cells ( anemia ) manifests such as fatigue, headache, difficulty breathing during exertion, dizziness, and pale mucosa; kidney disease; lung problems include pneumonia or increased secretion in the lungs; skin increases with sunlight; inflammation of blood vessels; Diseases in the skin manifest the peeling of the body, lupus erythematosus manifests the rash on the face, neck and scalp; allergic reactions; muscle weakness and muscle spasm; Change heart rate; posture hypotension; Salivation gland swelling; hyperglycemia; have sugar in urine; increase some types of fat in the blood; Increasing uric acid levels in the blood can lead to gout .

Side effects that come with hydrochlorothiazid may increase at a higher dosage.

If you experience any side effects become serious or have not been listed in the user manual, notify your doctor or pharmacist.

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.

Sexual dysfunction and erection.

Blood test shows low potassium and sodium concentration in blood.

Warnings

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

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If you are allergic to Irbesartan or any ingredients contained in Caprovel.

If you are allergic to hydrochlorothiazide or any drug with sulfonamid derivatives.

If you are more than 3 months pregnant (it is best to avoid using coaprovel from the beginning of pregnancy - see the pregnant woman section).

If you have liver or kidney disease.

If your body encounters obstacles to create urine.

If you have a pathology that increases calcium or reduces the amount of potassium prolonged in the blood.

Do not use coaprovel for children (under 18 years old).

Be cautious when using

let your doctor if you encounter one of the following conditions:

diarrhea or vomiting a lot

Renal problems, or kidney transplantation

Heart problems

Liver problem

Diabetes

lupus erythematosus (also known as scattered erythema luput)

Increased primary aldosteron (the disease is associated with producing more Aldosteron hormones, which is the cause of sodium storage and successive blood pressure).

You also need to notify your doctor if:

You are following a low -salt diet.

You have signs such as abnormal thirst, dry mouth, tiredness, drowsiness, muscle spasms that cause pain, nausea, vomiting or abnormal tachycardia that can indicate an excessive impact of hydrochlorothiazid (contained in coaprovel tablets).

You have been increased skin sensitivity to sunlight with symptoms of sunburn (such as flushing, itching, swelling, blistering) appear faster than usual.

You are about to have surgery or anesthesia.

hydrochlorothiazid contained in this pill can give positive results when testing against doping.

The ability to drive and operate machinery

has not conducted any research on the impact of coaprovel on driving and operating machinery. Coaprovel is not sure if it affects the ability to drive or control machines. However, during the treatment of hypertension, dizziness or fatigue can sometimes occur. If you have these symptoms, you need to consult your doctor before driving or operating machinery.

Pregnancy

Need to notify the doctor if you are pregnant, or may be pregnant. Normally, the doctor will advise you to stop using Caprovel before you get pregnant or as soon as you know you are pregnant and will recommend that you take other medications instead of coaprovel, coaprovel is not recommended in the first months of pregnancy and is not used during pregnancy for more than 3 months, because the drug can be a dangerous cause for the baby if the mother has taken this drug after the first 3 months of pregnancy.

Breastfeeding period

Need to tell the doctor if you are or start breastfeeding.

Do not use coaprovel for women who are breastfeeding, and the doctor will choose another treatment direction for you, especially when your child is born or a short -month.

Drug interaction

Notice to your doctor or pharmacist that the drugs you are using or medium -sized, including non -prescription drugs.

Other medications for hypertension: Coaprovel's hypertension effect can be increased when used simultaneously with other hypertension drugs.

lithium: recommend not to coordinate lithium and coaprovel. If the combination is proved to be necessary, it is recommended to carefully monitor serum lithium concentration.

Medications that affect potassium: The impact of potassium loss of hydrochlorothiazid is weakened due to the potassium retention effect of Irbesartan. Simultaneous use with potassium diuretics, potassium supplements, alternative salts containing potassium or other drugs may increase serum potassium level (such as sodium heparin) can lead to hyperkalemia. Recommended monitoring of serum potassium concentration in patients at risk.

The drugs are affected by serum potassium disorders (such as glycoside digitalis, anti -arrhythmic drugs): Periodic monitoring of blood kail.

Non -steroid anti -inflammatory drugs: Coaprovel's hypertension effect may be reduced.

Additional information about hydrochlorothiazide interaction

Alcohol: There is a possibility of posture hypotension.

Diabetes medications (oral and insulin medications): may have to adjust the dose of diabetes medications.

Colestyramine and Colestipol ion exchange resins: poorly absorbing hydrochlorothiazid.

Corticosteroids, ACTH: increase the loss of electrolytes, especially hypokalemia.

Glycoside digitalis: Thiazide causes hypoglycemic or hypoglycemia, which makes it easy to initiate rhythmic disorder caused by digitalis.

Steroid anti -inflammatory drugs: can reduce diuretic effects, reduce sodium secretion and reduce the impact of hypotension of thiazide diuretics in some patients.

Amines of hypertension (such as noradrenaline): The impact of hypertension can be reduced, but not enough to prevent them from using them.

Non -reducing muscle relaxants (such as tuboCurarine): hydrochlorothiazid increases the impact of non -reducing muscle relaxation.

Gout: Hydrochlorothiazid can increase serum uric acid, increased hypersensitivity reaction rate with allopurinol.

Calcium salts: Thiazide diuretics may increase serum calcium levels due to reducing calcium secretion.

Need a blood test if you use:

Potassium supplements

Alternative salt contains potassium

Potassium drugs or other diuretics

Laxatives

Medications to treat gout

Supplements vitamin D

Heart rate control drug

Diabetes drugs (oral or insulin)

carbamazepine (a epilepsy medication)

Need to notify your doctor if you are taking other antihypertensive drugs, steroids, cancer treatments, painkillers, or arthritis.

Use coaprovel with food and drink

Coaprovel can be taken with or not with food.

by hydrochlorothiazid contained in coaprovel, if you drink alcohol while you are treating this drug, you may feel dizzy in a standing position, especially when standing up from the sitting position.

Storage

Leave the medicine out of the reach and vision of children.

Do not use overdue drugs stated on the box and on the blister.

Store drugs at temperatures below 30 ° C.

Store the drug in the drug box to avoid desiccant.

Do not quit smoking into wastewater or family trash. Ask the pharmacist how to cancel the drug no longer used. These treatments help protect the environment.

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