Cozaar XQ 5/50mg MSD treats high blood pressure (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Amlodipine, Losartan Kali
Ingredient Myocardial infarction, psoriasis, high blood pressure

Ingredient

Composition information	Content
Amlodipine	5mg
Losartan Kali	50mg

Uses

Indications

Cozaar XQ (Losartan Kali/Amlodipine Camsylate) are indicated for use of idiopathic high blood pressure in adults that are not controlled well with Amlodipine or Losartan.

Pharmacokology

Cozaar XQ is effective in lowering blood pressure. Both Losartan and Amlodipine have lowered blood pressure due to reduced peripheral resistance. The closing the calcium line and the reduction of angiotensin II, the reduction of circuit spasms are the basic mechanisms.

losartan

Losartan inhibits systolic and diastolic blood pressure due to Angiotensin II. At its peak, 100mg of Losartan Kali inhibits about 85% of these response; 24 hours after using a single dose or multiple doses, the inhibition is about 26 - 39%.

After using Losartan, the elimination of Angiotensin II's negative effects on the threadin secretion increases the lyin activity in plasma. Increasing lenin activity in plasma leads to increased plasma angiotensin.

During long -term (6 weeks) treatment for hypertension with losartan dose of 100mg/day, angiotensin II in plasma increased by about 2-3 times at the time of the drug reached the peak concentration in plasma.

In some patients, more, especially during short treatment (2 weeks). However, the anti -hypertension effect and inhibiting the plasma aldosteron levels have been seen in 2 and 6 weeks, when the Angiotensin II receptor is effectively blocked.

After stopping Losartan, the active renin in plasma and angiotensin II concentration returns to untreated level within 3 days.

Because Losartan is an Angiotensin II type antagonistic antagonistic drug, ACE inhibitors (Kininase II), an enzyme that causes Bradykinin degeneration.

In a study comparing the effect of Losartan doses 20mg and 100mg with a ACE inhibitor in response to Angiotensin I, Angiotensin II and Bradykinin, Losartan sees the response of Angiotensin I and Angiotensin II without affecting Bradykinin's response. This result is consistent with the specific mechanism of action of Losartan. In contrast, the ACE inhibitors of Angiotensin I's response and enhances Bradykinin's response without changing the response of Angiotensin II. That is the difference in pharmacological force between Losartan and ACE inhibitors.

Losartan concentration and metabolites are also active in plasma and anti -hypertension effects of Losartan increases when the dose increases.

Because Losartan and its active metabolites are Angiotensin II receptor antagonists, both contribute to anti -hypertension effects.

In a normal male study, taking a 100mg of Losartan Kali dose in high salt diet and low salt, does not change the speed of glomerular filtration and flow or plasma filter fraction through the kidneys. Losartan has the effect of sodium, this effect is stronger when eating a diet of less salt and is not related to the inhibition of nodium reabsorption in the nearby tube. Losartan also increases the elimination of urinary uric acid, in patients with hypertension without diabetes but has proteinuria (≥ 2 g/24 hours) treated for 8 weeks, using Losartan Kali 50mg to 100mg has a significant significant of proteinuria of about 42%. The excretion of albumin and IgG also significantly decreased, in these patients, Losartan maintains the speed of glomerular filtration and reduces filtration capacity.

In hypertension women after menopause are treated with Losartan Kali 50mg for 4 weeks, it does not see the effect on prostaglandin content in the kidney or body.

Losartan does not work on automatic reflexes and does not work to maintain norepinephrin in plasma.

Losartan Pot Such losartan doses do not work on blood glucose content.

In general, Losartan reduces uric acid in serum (usually In a 12 -week parallel design study in patients with left ventricular failure (degree II - IV according to the functional classification of the New York Heart Association), most patients who have used diuretics and/or digitalis, now use Losartan Kali on the lane of 2.5 doses; 10; 25 and 50mg compares with Placebo.

Doses of 25mg and 50mg increases hemodynamic effects and nerves; These effects are maintained during the research period. The hemodynamic response is characterized by increasing the heart index and reducing: the pressure of the pulmonary capillary seasoning, the body's pulse resistance, the average body blood pressure and the heart rate. Hemorrhage drops are related to dosage in patients with heart failure. The nerve effect is characterized by reducing the content of aldosteron and norepinephrin in the circulation.

amlodipine

Hemodynamics: After taking the treatment dose for patients with hypertension, amlodipine causes vasodilation, leading to lowering blood pressure on their backs and standing posture. This reduced blood pressure is not accompanied by a significant change in heart rate or catecholamine level in general blood when used for a long time. Although Amlodipine acute intravenous injection reduces arterial blood pressure and increases heart rate in the studies of hemodynamics of patients with chronic myocardial anemia. Amlodipine for long -term use in clinical trials does not change clinical significance of heart rate or blood pressure in patients with myocardial anemia with normal blood pressure. With the way to take the drug once a day lasts for many days, the anti -hypertension effect remains at least 24 hours. The concentration of plasma drugs is associated with the effects of both the elderly. A amlodipine blood pressure amplitude is also associated with hypertension before treatment; For example, moderate hypertension people (diastolic blood pressure 105 - 114 mmHg) have a response of about 50% larger than patients with mild hypertension (diastolic blood pressure 90 - 104 mmHg). Normal blood pressure people do not change clinical blood pressure (+1 to -2 mmHg).

In people with normal hypertension with normal renal function, amlodipine treatment dose do reduces the kidney resistance and increases the speed of glomerular filtration and blood flow effectively through the kidneys without changing filter or proteinuria.

As with other calcium channel blockers, the hemodynamic values of the heart function at the time of rest and during exertion (or pacemaker) in patients have a normal ventricular function using amlodipine, increasing little heart index without meaning to DP/DT, or on blood pressure or left -end volume of left ventricle. In hemodynamic studies, Amlodipine does not have the effect of reducing contractions when used within the dosage treatment for intact animals and humans, even when used with beta blockers for humans. However, similar results are found in patients with normal heart failure or heart failure is good for drugs that reduce the meaning of heart contractions.

Effects on physiological electricity: Amlodipine does not change the function of the atrial node or atrial transmission in intact animals or people, in patients with stable chronic myocardial anemia, 10mg intravenous injection does not change the meaning of A-H transmission (from the atrial to HIS) and H-V (from HIS to the center of ventricular) and the recovery time after transplanting the rhythm of the rhythm machine. Similar results are obtained in patients with amlodipine and beta blockers simultaneously. In clinical studies using amlodipine in combination with beta blockers for patients or hypertension or angina, there is no complications on the electrocardiogram. In clinical trials in patients only suffering from angina, Amlodipine does not change the amount of on the center of the center or causes a higher level of atrial block.

pharmacokinetics

In studies to evaluate the pharmacokinetics of the combined product, monomers and dog studies show no significant difference in Amlodipine pharmacokinetics and metabolites or losartan and metabolites with Exp3174 activity, when using Amlodipine Camsylate and Losartan separately or using combined drugs or using combined drugs. There is no impact on pharmacokinetics when using products combining Amlodipine Camsylate and Losartan in mice and dogs. A study on healthy people also confirmed that there was no interaction between Amlodipine Camsylate and Losartan.

absorption

Losartan: After drinking, Losartan absorbs well and is initially metabolized in the liver, forming a metabolite of carboxylic acid and other active and other metabolites are no longer active. The whole body of Losartan tablets is about 33%. The average peak concentration of Losartan and metabolites is still active in the order of 1 hour and 3-4 hours. There is no clinical effect of Losartan's concentration in plasma when the drug is used with a standard meal.

amlodipine

After taking amlodipine the dose of treatment, the absorption causes peak concentration in the plasma between 6 and 12 hours. Absolute bioavailability is 64 - 90%. Amlodipine's bioavailability does not change when there is food.

distribution

losartan

Both Losartan and metabolites are also associated with plasma proteins ≥99%, mainly with albumin. The distribution of Losartan is 34 liters. The studies in white rats show that Losartan passes through the brain barrier very poorly, if not absolutely not.

amlodipine

EX Vivo studies are only about 93% of drugs during circulation associated with plasma proteins of hypertension.

transformation

losartan

About 14% of the dose of Losartan oral or intravenously converts into an active metabolic substance. After taking or intravenously Losartan Kali marks 14C, radioactive activity in plasma is mainly of Losartan and its active metabolites. The metabolism of Losartan into its active metabolites is only about 1% of the researchers.

Along with the active metabolites, the no longer active metabolites are also formed, including 2 main metabolites due to the hydroxylation of the butyl side circuit, and a metabolic substance in low amount in the form N - 2 tetrazol glucuronid.

amlodipine

Amlodipine is very strongly metabolized (about 90%) into metabolites that are no longer active through the metabolism in the liver. About 10% of the mother and 60% of the metabolites except for urine.

Elimination

losartan

Losartan's plasma clearance and metabolites are also active in the order of about 600 ml/min and 50 ml/minute. The kidney clearance of Losartan and metabolites is also active in the order of about 74 ml/min and 26 ml/min. When taking Losartan, about 4% of the dose is eliminated in the form of unchanged urine, and about 6% of the dosage is eliminated in the urine in the form of metabolites. Pharmacokinetics of Losartan and metabolites are also active in proportion to the oral dosage of Losartan Kali to the dose of 200mg.

After drinking, Losartan's plasma concentrations and its metabolites decrease in the exponential function with half -life except for the last elimination in the order of about 2 hours and 6 - 9 hours. While using a 100mg dose once a day, both Losartan and metabolites and its active active are not meaningful in plasma.

Losartan and its metabolites are excreted both through the bile and through the urine. After taking a losartan dose marked 14C in humans, about 35% of radioactive activity found in urine and 58% in feces. After intravenous injection, a losartan dose marks a person, about 43% of radioactive activity is seen in urine and 50% in feces.

amlodipine

The excretion of serum in two phases with half -life eliminates the last phase about 30-50 hours. Amlodipine concentration in plasma in kinetic balance state is achieved after 7 to 8 days when used continuously once a day.

Patient characteristics

cozaarxq

Cozaar XQ has not been studied in a special patient population, because the nature of Losartan and Amlodipine has been known very well.

Be careful when using Losartan for people with kidney failure and liver failure, and contraindicated for breastfeeding women. The official research has not been conducted in the elderly and children. For amlodipine, caution should be cautious in people with liver failure, and contraindicated in people with unstable cardiovascular disease and pregnant or breastfeeding women.

losartan

Losartan concentration and metabolites are also active in elderly men with hypertension are not different from young men with hypertension.

Losartan concentration in plasma in hypertension women is 2 times higher than men hypertension. The concentration of metabolites is still active, not different between men and women. The difference in pharmacokinetics has been evaluated and found that there is no clinical significance.

After drinking in patients with mild and medium alcoholic cirrhosis, Losartan's plasma concentrations and its metabolic substance in order are 5 times larger and 1.7 times compared to young men.

Losartan concentration in plasma does not change in patients with renal clearance of over 10 ml/min. Compared to patients with normal AUC kidney function of Losartan about 2 times larger than patients with dialysis. The plasma concentration of metabolites is still active in patients with kidney failure or dialysis. Both Losartan and its metabolites are not removed when dialysis.

amlodipine

The pharmacokinetics of Amlodipine are not affected by the kidney failure. Therefore, patients with renal failure may use the starting dose as usual.

Elderly patients and patients with hepatic impairment have decreased amlodipine clearance, so AUC increases by 40-60% and requires a lower starting dose. AUC increases similarly in patients with medium to severe heart failure.

62 patients with hypertension aged 6 to 17 have used the dose of amlodipine from 1.25 to 20mg. If calculating the weight, the clearance and distribution of the distribution are similar to adults.

Preli clinical research

The effect of hypotension of Cozaar XQ has been shown in three controlled studies including 646 patients with idiopathic hypertension. 325 of these were treated with Cozaar XQ for 8 weeks. The main effect of all studies is a change compared to the initial of diastolic blood pressure (DBP) in the sitting position at the end. Auxiliary variables are changes in systolic blood pressure (SBP) in sitting position and the percentage of people responding. Changes in diastolic blood pressure in a clinical sitting position at 8 weeks (main evaluation criteria) have been proven to Cozaar XQ compared to monomers (Losartan or Amlodipine) in studies conducted.

In a double blind study, a total of 320 patients with mild hypertension to the average received treatment with 4 combined forms of Amlodipine and Losartan (5/50, 5/100.10/50 and 10/100 mg) or Amlodipine alone (5.10 mg) or Losartan alone (50, 100 mg). All doses began at random doses, at the 8th week, cozaar XQ 5/50 and 5/100 coordination treatments are statistically significant compared to single -therapeutic components of diastolic reduction in sitting position and systolic blood pressure in the sitting position.

Table 2. The effect of Cozaar XQ for diastolic blood pressure in the sitting position and systolic blood pressure in the sitting position at 8 weeks

losartan

50 mg

losartan

100 mg

amlodipine 5 mg

Amlodipine

10 mg

cozaarxq

5/50 mg

cozaarxq

5/100 mg

cozaarxq

10/50 mg

cozaarxq

10/100 mg

Type in posture

Sitting (compared to the beginning)*

-7.0 ± 8.6

mmhg

-10.5 ± 8.7 mmHg

-11,7+8.2

mmhg

-16.4 ± 17.6mmhg

-15.6 ± 18.3mmhg

-16.1 ± 7.6mmhg

-20.8 ± 6.9mmhg

-18.3 ± 5.0mmHg

The sitting position

(compared to the original)*

-7.0 ± 13.7mmhg

-16.0 ± 16.3mmHg

-15.5 ± 13.9mmhg

-23.6 ± 12.1mmhg

-25.7 ± 15.9mmhg

-24.0 ± 14.7mmhg

-28.7 ± 13, mmhg

-25.9 ± 13.3mmHg

In a double blind study, control with active ingredients, a total of 184 patients with mild to moderate mild hypertension were not fully controlled when using Amlodipine 5mg, which received treatment with Cozaar XQ 5/50mg or Amlodipine 10mg. In week 8, Cozaar XQ 5/50mg shows the effect of reducing blood pressure similar to Amlodipine 10mg.

Table 3. The effect of reducing the blood pressure of Cozaar XQ after 8 weeks in patients is not controlled by amlodipine 5mg

cozaar xq 5/50 mg

Titrate with

amlodipine 10 mg

Average value

(95%trust range)

Trip price

The sitting position

(compared to the beginning)

-8.9 mmHg

-9.4 mmHg

-0.52

(-2.52; 1.48; p = 0.6095

-12.2 mmHg

-13.4mmHg

-1,17

(-4,42; 2,08)

p = 0.4787

(whole)

89.1%

87.9%

88.52%

p = 0.7960

In a double blind study, a control of the active ingredient, a total of 142 patients with mild to moderate hypertension are not fully controlled when using Losartan 100mg is transferred to Cozaar XQ 5/100mg or still treated with Losartan 100mg. In week 8, Cozaar XQ 5/100mg shows the effect of reducing blood pressure than Losartan 100mg.

Table 4. The effect reduces the blood pressure of Cozaar XQ after 8 weeks in patients not controlled by Losartan 100 mg

switches to Cozaar XQ 5/100 mg

still treated with Losartan 100 mg

Average value

(95%trust range)

Value p

The sitting position

(compared to the beginning)

-11.7 mmHg

-3.2 mmHg

8.52

(6,03; 11,01)

The sitting position

(compared to the beginning)

-13.4 mmHg

-3.4 mmHg

9.98

(6,05; 13,90)

(whole)

90.0%

66.7%

78.2%

p = 0.0008

Before taking Cozaar XQ 5/50mg MSD treats high blood pressure (3 blisters x 10 tablets)

How to use

The recommended dose of Cozaar XQ is a tablet.

Cozaar XQ can be used during or outside meals. Cozaar XQ should be taken with water.

Cozaar XQ can be used with other anti -hypertension drugs.

Dosage

Losartan is an effective drug to treat hypertension, the dose once a day 50mg to 100mg, and amlodipine is effective at 5mg to 10mg doses when used for monomers. The maximum dose recommended by Cozaar XQ is 100mg/5mg.

Patients with non -controlled blood pressure with single Losartan or single amlodipine can be transferred to coordinate treatment with Cozaar XQ.

Cozaar XQ 50mg/5mg is used for patients with unprover blood pressure with Losartan 50 mg or Amlodipine 5mg alone.

Patients who are taking both Losartan and Amlodipine may switch to Cozaar XQ (a fixed dosage combination form of each drug) for convenience) for convenience.

Used for patients with renal failure

No dose adjustment in patients with mild renal impairment (creatinine clearance 20 - 50 ml/minute). For patients with medium to severe renal failure (Creatinine clearance

Used for patients with dehydration in the circuit

For patients with dehydration in the vessel (such as patients with high dosage dosage), the starting dose of 25mg of Losartan should be used once a day (see caution). Because there is no 25mg of Losartan in Cozaar XQ drug, this dose is needed with a single therapy losartan.

Used for patients with liver failure

In cases where low -dose Losartan is required (25mg once a day) for patients with a history of liver failure, it is not recommended to use Cozaar XQ.

Used for the elderly

Elderly people have decreased clearance, so the treatment of amlodipine should start at a dose of 2.5mg daily. But there is no 2.5mg of amlodipine in Cozaar XQ, so this dose is needed with a single amlodipine.

Used for minors and children

Because the safety and effectiveness of Cozaar XQ has not been identified in children ≤ 18 years old, it is not recommended to use Cozaar XQ.

What to do when overdose?

There is no data on the overdose of cozaar XQ in humans. Overdose of each component Amlodipine and Losartan is described as follows:

losartan

The existing figures of overdose in people are limited. The most common manifestation is hypotension and tachycardia; Slow heart rate can occur due to sympathetic nerve stimulation (vagus nerve). If symptoms of hypotension occur, supportive treatment.

Both Losartan and metabolites are also active, they cannot be removed by blood decay.

amlodipine

Overdose can cause excessive peripheral vasodilation leading to strong hypotension and can lead to reflected tachycardia. In humans, amlodipine overdose experience is limited.

The only dose of amlodipine maleat is equivalent to 40mg of amlodipine/kg and 100mg of amlodipine/kg causes death in the order in white rats and white rats. The single doses of amlodipine maleat are equivalent to 4mg/kg or more or higher in dogs (11 times or more to the maximum recommended dose for people on the basis of the dose calculated by mg/m2) causing very strong peripheral vasodilation and hypotension.

If overdose occurs, actively monitor the heart and respiration. Regular blood pressure measurement. If there is a drop in blood pressure, cardiovascular support is required, including lifting limbs and using fluid properly. If hypotension remains not responding to these mild measures, hypertension may be used (such as phenylephrin) but should pay attention to the volume of circulation and urinary efficiency. Because Amlodipine is bound to protein, bloody decentralization does not seem useful.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

cozaar xq

The safety of Cozaar XQ has been assessed in 325 patients with Losartan/Amlodipine Camsylate combination therapy among 646 patients with idiopathic hypertension in three clinical trials (studies of 201.31 and 302) for 8 weeks. The adverse reactions have been reported:

Common (≥ 1/100,

Nervous disorders: dizziness, headache.

Less (≥ 1/1000,

Nervous system disorders: Sleep.

Common disorders and localities: weakness, discomfort in the chest, chest pain, fullness, peripheral edema, concave edema.

Gastrointestinal disorders: abdominal discomfort, indigestion, nausea, reflux esophagitis.

Skin and tissue disorders: itching (whole body), urticaria (whole body).

Heart disorders: Brushing chest drums.

circuit disorders: flushing, hypotension.

Respiratory disorders, chest and mediastinum: Difficulty breathing.

Disorders of sensory organs: dizziness.

Kidney and urinary disorders: pee.

Additional information for active ingredients:

The following adverse reactions have been reported to the components of Cozaar XQ:

losartan

Because clinical trials are conducted under very different conditions, the adverse reaction rate observed in the clinical trials of a drug cannot be compared directly in other drug clinical trials and may not reflect the adverse reaction rate observed in practice.

Losartan generally tolerates well in clinical trials that treat high blood pressure with tests, mild and transient side effects, and no need to stop the drug. The general ratio of the side effects of Losartan is equivalent to the placebo.

In clinical trials that have been tested when treating blood pressure, dizziness is the only side effect that occurs with drugs larger than Placebo in more than 1 % of patients using Losartan. In addition, the hypotension effect of standing posture is associated with the dose occurring in less than 1 % of the patient. The skin rare is very rare, even in clinical trials, the ratio of skin rash is less than Placebo.

In double blind clinical trials for treatment of idiopathic hypertension, the following adverse reactions have been reported in the Losartan group ≥ 1% of patients, regardless of whether it is related to drugs:

losartan

(n = 2085)

Placebo

(n = 535)

Abdominal pain

1.7

3.8

3.9

1.1

2.6

1.7

1.9

1.0

0.4

1.0

1.7

Digestive system

diarrhea

1.9

1.5

Nausea

1.8

2.8

skeletal system

1.6

1.1

dizzy

4.1

2.4

headache

14,1

17,2

insomnia

1.1

0.7

Respiratory system

3,1

2.6

1.3

1.1

sore throat

1.5

2.6

Sinus disorders

1.0

1.3

6.5

5.6

The most common side effects related to drugs are: dizziness, weakness/fatigue and dizziness.

Also in the above study, patients who have never had diabetes have a new rate of diabetes due to lowering Losartan than atenolol (in order of 242 compared to 320 with p

Losartan generally tolerates well in a clinical trial tested in patients with type 2 diabetes with proteinuria. The most common side effects related to drugs are weakness/fatigue, dizziness, hypotension and hyperkalemia (see caution, hypotension and imbalance of fluid and electrolytes).

There are more adverse reactions that have been reported during marketing:

Hypersensitivity: Anaphylaxis reactions, angiography including laryngeal swelling and subjects causing respiratory traces and/or swelling of the face, lips, throat and/or tongue have been reported, though rare in patients using Losartan; Some of these patients have had angels in advance due to other drugs including ACE inhibitors. Vascular inflammation, including Henoch-Schoenlein hemorrhage, has a rare report.

Gastrointestinal: Hepatitis (rare), abnormal liver function, vomiting.

Common disorders and localities: Uncomfortable people.

Hematology: Anemia, thrombocytopenia (rare).

skeletal - muscle system: muscle pain, joint pain.

Nervous/ mental system: migraine, disturbance.

Reproductive system and chest disorders: erectile dysfunction/impotence.

Respiratory: cough.

Skin: urticaria, itching, skin rash, increased sensitivity to light.

amlodipine besylat

Amlodipine Besylat has been assessed for safety in 11,000 patients in tests worldwide. In general, amlodipine besylat treatment is well tolerated at daily dose to 10 mg. The most adverse reaction in the treatment with Amlodipine Besylat is only mild or moderate. In clinical trials with direct comparison of Amlodipine Besylat (n = 1,730) at a dose of up to 10 mg with Placebo (n = 1,250), it is necessary to stop treating amlodipine besylate due to a stroke because of only about 1.5 % of patients and not different from Placebo (about 1 %). The most common side effect is headache and edema. The ratio (%) of side effects occurs according to the dose as follows:

2.5 mg

5.0 mg

10.0mg

Placebo

n - 275

n - 296

n - 268

n = 520

1.8

3.0

10,8

0.6

dizzy

1.1

3,4

1.5

0.7

1.4

2.6

0.7

1.4

4.5

0.6

Examinable research with Placebo

Placebo (%)

(n = 1,730)

(n = 1,250)

headache

7.3

7.8

4.5

2.8

Nausea

2.9

1.9

Abdominal pain

1.6

0.3

1.4

0.6

reaction

Disadvantages

Amlodipine Besylat

Placebo

male (%)

female (%)

male (%)

female (%)

(n = 512)

(n = 914)

(n = 336)

5.6

14.6

1.4

5,1

1.5

4.5

0.3

0.9

1.4

3.3

0.9

1.3

1.6

0.8

0.3

They are listed to warn the physician to be relevant:

Cardiovascular system: arrhythmia (including ventricular tachycardia and atrial fibrillation), slow heartbeat, chest pain, hypotension, peripheral anemia, fainting, tachycardia, posture stunning, posture hypotension, vasculitis.

Central and peripheral nervous system: Reduce sensory, peripheral neuropathy, sensory disorder, tremor, dizziness.

Digestive system: anorexia, constipation, indigestion 1, language disorders, diarrhea, bloating, pancreatitis, vomiting, hyperplasia.

Systemic: allergic reactions, weakness, back pain, hot burning, people uncomfortable, pain, cold tremor, weight gain, weight loss.

skeletal - muscle system: joint pain, joint damage, muscle contraction, muscle pain.

Psychiatry: Sexual disorders (men1 and women), insomnia, nervous tension, depression, abnormal dreams, anxiety, personality loss.

Respiratory system: Difficulty breathing, nose bleeding.

Skin and appendages: Evaluation, diverse erythema, itching, skin rash, erythema, lumpy rash.

sensitivity: visual disorders, conjunctivitis, gravity, eye pain, tinnitus.

urinary system: piss many times, urination disorders, urination at night many times.

Automatic nervous system: dry mouth, sweat a lot.

Metabolism and nutrition: increased blood glucose, thirst.

Hematopoietic system: leukopenia, hemorrhage, thrombocytopenia.

These adverse reactions occur below 1% of testing tests with Placebo, while the adverse reaction rate in high -dose drug studies between 1% and 2%.

The following adverse reactions occur in

Other reactions occur irregularly and indistinguishable due to medication or progression of the disease such as myocardial infarction and angina.

The following other adverse reactions have been reported in after -sales experience:

Because these adverse reactions were reported because people discovered their own uncertainty levels, they could not be reliable in frequency or cause and cause correlation when exposed to drugs.

The following adverse reactions through the following marketing process are reported irregularly and the cause of cause and effect is uncertain: the breast enlargement in men. Increasing jaundice and liver enzymes (most with bile stasis or hepatitis), in some severe cases, the hospital needed was reported by the use of amlodipine besylat.

Not recorded serious unwanted effects in patients with chronic obstructive pulmonary disease, congestive heart failure are good, coronary artery disease, peripheral vascular disease, diabetes, and blood lipid disorders use amlodipine besylate.

Test results

cozaar xq

The bradycardia has seen in some patients after 8 weeks of using losartan/amlodipine, but changing the heart rate is not clinically significant.

Hyperglycinine hypertrophy and liver enzyme hyper enzyme have been reported in some patients, but there is no special monitoring test.

losartan

In clinical trials that check the treatment of idiopathic hypertension, important clinical changes in the test parameters are very rare when using Cozaar XQ. Hyperbysical hyperka (Potassium in serum> 5.5 Meq/l) occurs in 1.5% of patients in clinical trials for hypertension. In a clinical study conducted in patients with type 2 diabetes with proteinuria, 9.9% of patients were treated with Cozaar XQ and 3.4% of patients treated with plantboo hyperpassing (see caution, hypotension and imbalance of fluid and electrolytes). Increasing ALT occurs rare and often resolved by stopping drugs.

amlodipine

Amlodipine treatment does not see clinical changes in regular test parameters. There are no clinical changes that are recorded in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL-cholesterol, uric acid, nitrogen urea, or creatinine.

Report immediately to doctors or pharmacists if any of the above symptoms or other abnormalities.

Warnings

cozaar xq

Patients with volume reduced (for example, people treated with diuretics).

Patients with strict salt restrictions.

Patients with average to severe to severe renal impairment (creatinine clearance

Patients with hyperkalemia.

Hemorrhage lag

Patients with a decreased blood vol Reducing blood volume in vessels should be adjusted before using Cozaar XQ, or a low starting dose (see dosage and usage). Because the beginning of the effect gradually, the hypotension often does not occur.

Hepatic failure

Based on the results of pharmacokinetics research, Losartan concentration in plasma is significant in cirrhosis patients, therefore, lower losartan dose for patients with liver failure (see dosage and use and pharmacokinetic properties)

Because amlodipine is strongly metabolized in the liver and half -life eliminates from plasma (T1/2) is 56 hours in patients with liver failure, increasing or decreasing slow doses when taking amlodipine for patients with severe liver failure.

losartan

Toxicity for pregnancy:

The use of drugs on the Renin - Angiotensin system in the middle and the last three months of pregnancy reduces the kidney function of the fetus, increases disease and death in the fetus and babies. The amniotic fluid results may be associated with reduced lung production and skeletal deformation in fetuses. The possible side effects in newborns include reducing skull production, anuria, hypotension, renal failure and death. When detecting pregnancy, it is necessary to stop Cozaar XQ as soon as possible (see used during pregnancy).

Hypersensitivity: Evala (see side effects).

Electrolyte imbalance:

Electrolyte imbalance is common in patients with renal failure, having or without diabetes and should be concerned. In a clinical study conducted in patients with type 2 diabetes with proteinuria, the rate of hyperkalemia in Losartan treatment group is higher than the Placebo group, however, few patients have to stop treatment due to hyperkalemia (see side effects and test results).

kidney failure

As a result of the inhibition of the Renin - Angiotensin system, renal function changes including renal failure have been reported in sensitive individuals; These renal function changes can recover when stopping treatment.

Other drugs that affect the eenin - angiotensin system may increase serum blood and creatinine urea in patients with patients on both sides of the kidney or kidney stenosis of a kidney. The same effect has been reported to Losartan; These changes of kidney function can recover when stopped treatment.

amlodipine

Increased angina or myocardial infarction:

Acute angina and myocardial infarction may develop after the beginning or increase of amlodipine dose, especially in patients with severe coronary artery disease.

Use in children

Because the safety and effectiveness of Cozaar XQ for children ≤ 18 years old has not been determined, it is not recommended to use Cozaar XQ.

Babies have a history of cozmr xq exposure in the uterus:

If the urinary or hypotension occurs, pay directly on blood pressure support and kidney perfusion. It may be necessary to transmit blood or fertilize as a measure to reverse the lower blood pressure and/or instead of the disordered kidney function.

Used in older people

In clinical studies, it is not relevant to the age to effectively or the safety of Losartan.

Because the clearance of amlodipine decreases in the elderly and as a result, AUC increases by 40 - 60%, Amlodipine therapy needs to start with a daily dose of 2.5 mg daily. Because the amlodipine 2.5 mg dose is not found in Cozaar XQ drug, this dose is needed with a single amlodipine.

Contraindicated

Patients already know if there is a history of sensitivity to the active ingredients of the drug or dihydropyridine.

Pregnant or pregnant women or nursing mothers.

Severe liver failure.

Heavy aortic valve stenosis.

Patients with shock.

Precautions when taking drugs

cozaar xq

Patients with volume reduced (for example, people treated with diuretics).

Patients with strict salt restrictions.

Patients with average to severe to severe renal impairment (creatinine clearance

Patients with hyperkalemia.

Hemorrhage lag

Hepatic failure

losartan

Toxicity for pregnancy:

Hypersensitivity: Evala (see side effects).

Electrolyte imbalance:

kidney failure

Other drugs that affect the Renin - Angiotensin system may increase serum blood and creatinine urea in patients with patients on both sides of the kidneys or the kidney stenosis of the human kidney. The same effect has been reported to Losartan; These changes of kidney function can recover when stopped treatment.

amlodipine

Increased angina or myocardial infarction:

Acute angina and myocardial infarction may develop after the beginning or increase of amlodipine dose, especially in patients with severe coronary artery disease.

Use in children

Because the safety and effectiveness of Cozaar XQ for children ≤ 18 years old has not been determined, it is not recommended to use Cozaar XQ.

Babies have a history of cozmr xq exposure in the uterus:

Used in older people

In clinical studies, it is not relevant to the age to effectively or the safety of Losartan.

Pregnancy

Medications directly acting on the Renin - Angiotensin system can cause damage and developing pregnancy. When detecting pregnancy, it is necessary to stop Cozaar XQ as soon as possible.

Although there is no experience in using cozaar XQ for pregnant women, the Losartan Kali studies on animals prove fetus or newborn child is damaged or died, the mechanism is thought to be pharmacological effects on the renin -angiotensin system. In humans, the renal formation process of pregnancy, although depends on the development of the Renin - Angiotensin system, usually starts in the second three months; Therefore, the risk for pregnancy increases, if Cozaar XQ is used in the second or third month of pregnancy.

These harmful results are often associated with the use of these drugs in the middle and the last three months of pregnancy. Most epidemiological studies survey abnormalities in fetuses after exposure to anti -hypertension drugs used in the first three months of pregnancy, regardless of the drugs that affect the Renin - Angiotensin system with other anti -hypertension drugs. The appropriate management of hypertension in the mother during pregnancy is important to optimize the results for both mother and pregnancy.

In special cases, when there is no appropriate replacement treatment for drug treatments that affect the Renin - Angiotensin system for a separate patient, must notify the mother about the risk that may occur for the fetus, need to conduct ultrasound tests to assess the environment in the amniotic fluid. Stop using cozaar XQ if observed with amniotic fluid unless this drug is considered a drug to save life for the mother. The pregnancy test may be suitable based on the week of gestational age. However, doctors and patients should know that amniotic fluid may not show until after the fetus has been injured for a long time, it is necessary to closely monitor babies with a history of cozaar XQ exposure in the uterus on manifestations

There are no appropriate studies and good test amlodipine in pregnant women.

Breastfeeding period

It is not known whether Losartan or Amlodipine can be secreted into breast milk. Because many drugs are given to breast milk and because of the ability to cause damage to breastfeeding, it is necessary to consider whether to stop breastfeeding or stop taking the drug, depending on the importance of the drug for the mother.

Drug interaction

has not conducted research on drug interactions of Cozaar XQ and other drugs, but each losartan and amlodipine have been studied as described below.

losartan

There is no drug -and -pharmacokinetical drug interaction with clinical significance found in studies on interactive with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin is a substance that induces drug metabolism, reducing the concentration of active, human metabolites, and two 3A4 inhibitors have been studied. Ketoconazole does not affect the conversion of Losartan into active metabolites after losartan intravenous injection, and erythromycin have no clinical significance after oral losartan. Fluconazole is a P450 2C9 inhibitor, reducing the concentration of active metabolites. Consequences of simultaneous use of losartan and inhibitors.

P450 2C9 has not been seen. The non -metabolic objects of Losartan into active metabolites have been shown to have specific and rare defects about Cytochrome P450 2C9. But this data shows that the conversion of Losartan into metabolites has the main activity of P450 2C9 intermediaries and not P450 3A4.

As well as other Angiotensin II blockers, simultaneous use of potassium -keeping pills (such as spironolacton, triamteren, amilorid), potassium supplements, or salt -containing substances containing potassium can increase potassium in serum.

As well as other drugs that affect sodium elimination, liti elimination may decrease. Therefore, the lithium content in the serum should be carefully monitored if the lithium salts are used with Angiotensin II receptor antagonistic drugs.

Non-steroid anti-inflammatory drugs (NSAID) including cyclooxygenase-2 inhibitors (COX-2), which can reduce the effects of ureter and other anti-hypertension drugs. Therefore, the anti-hypertension effect of Angiotensin II receptor drugs or ACE inhibitors can be reduced by NSAIDs including selective COX-2 inhibitors.

In some patients with impaired renal function (such as elderly patients or patients with a decreased blood vol These effects often recover. Therefore, the coordination should be very careful in patients with impaired renal function.

amlodipine

In vitro results

In vitro research results show that Amlodipine does not work on the link with people's plasma proteins, phenytoin, warfarin and indomethacin.

cimetidine

Use amlodipine along with cimetidine does not affect the pharmacokinetics of amlodipine.

Squeezing grapefruit juice

Use a combination of 240ml of grapefruit juice with a single dose of Amlodipine 10mg for 20 healthy volunteers, not seeing meaningful effects on amlodipine pharmacokinetics.

anti -acid Magnesi and aluminum hydroxyd

Use combination of anti -acid drugs such as magnesi and aluminum hydroxyd with a single dose of amlodipine does not have a significant effect on pharmacokinetics of amlodipine.

Sildenafil

A single dose of 100mg Sildenafil for people with idiopathic hypertension does not work on amlodipine pharmacokinetics parameters. When Amlodipine and Sildenafil are used in combination, each drug has its own independent hypotension.

Atorvastatin

Use a combination of 10mg of amlodipine with 80mg of Atorvastatin that does not change the dynamic balance of the pharmacokinetics parameters of Atorvastatin.

Simvastatin

Use a combination of many doses of amlodipine 10mg with simvastatin 80mg, resulting in an increase of 77% in contact with simvastatin compared to when using Simvastatin alone. Limit the dose of simvastatin in patients taking amlodipine to 20mg/day.

digoxin

Use amlodipine combination with digoxin does not change the concentration of Digoxin in the serum, nor does it change the kidney clearance of Digoxin in normal volunteers.

Ethanol (alcohol)

single dose or multiple 10mg doses of amlodipine does not have significant effects on pharmacokinetics of ethanol.

warfarin

Use amlodipine combination with warfarin does not change the time to respond to prothrombin of warfarin.

Interaction with test parameters

Unknown.

Storage

Store at temperatures below 30 ° C (86 ° F). Store in the original packaging. Avoid moisture.

Produced by: Hanmi Pharm. Co., Ltd. 214, Muhao, Paltar-Twyoon, Hwaseong-Si, Gyeonggi-Do, Korea (Korea)

Packed by: Merck Sharp & Dohmo BV. Waarderweg 39, NL-2031 BN HAARLEM, The Netherlands (Natural)

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Cozaar XQ 5/50mg MSD treats high blood pressure (3 blisters x 10 tablets)

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Before taking Cozaar XQ 5/50mg MSD treats high blood pressure (3 blisters x 10 tablets)

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