Bified 30 Menarini treatment for hypertension, myocardial infarction (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Zofenopril
Ingredient A.Menarini Manufacturing Logistics and Services S.R.I
Ingredient
| Composition information | Content |
| Zofenopril | 30mg |
Uses
indications
BileL 30 drugs are indicated in the following cases:
ATC code: C09AA15.
Bifril's treatment effect in patients with hypertension and acute myocardial infarction may be the main result of inhibiting the renin-angiotensin aldosteron system in plasma. The inhibitor of enzyme in the form of angiotensin (ki 0.4 nm on rabbit lungs when using zofenoprilate arginin) reduces the plasma angiotensin II concentration, reduces vascular activity and reduces aldosteron secretion. Despite the low decrease in aldosteron, there may be slight increase in serum potassium concentration, accompanied by fluid loss and sodium. When stopping the negative response of angiotensin II on the process of lenin secretion increases the activity of plasma renin. The activity of angiotensin transition in plasma decreases at a rate of 53.4% and 74.4%, respectively 24 hours after using a single dose of 30 mg and 60 mg of Zofenopril calcium. Angiotensin shifting inhibition increases the activity of the kallikrein-pinin system in place and during circulation, causing peripheral vessels through the activity of the prostaglandin system. This mechanism may also be associated with the hypotension effect of zofenopril calcium and may be the cause of some adverse reactions. In patients with hypertension, using Bified drugs reduces both lying blood pressure and standing posture with the same level, without the phenomenon of increased compensation heart rate. The average resistance level of the vascular wall tends to decrease after using the Bify.
In some patients, it is necessary to treat a few weeks to reach optimal hypotension. The effectiveness of hypertension treatment is maintained during long -term treatment.
Sudden stopping of the drug has no relationship with sudden hypertension. There are no updated data related to the impact of Bify on mortality and the incidence of disease in hypertension patients. Although the lowering effect has been recorded on all races, black people (usually a population of hypertension patients with low renin activity) have a response to lower enzyme inhibitors than other populations. This difference is no more if using the drug simultaneously with diuretics.
Clinical effect when using Bified for patients after infarction may be related to many factors such as reducing the plasma angiotensin II concentration (this way helps limit ventricular restructuring process, a process that can adversely affect the long-term prognosis of infarction patients), and the increase in the concentration of vasodilators in plasma/tissue (Prostaglandin-oilin-oil).
A randomized clinical trial has been performed, comparing Zofenopril with placebo, performed on 1556 patients with a history of myocardial infarction and not treated with fibrinolytic regimen. The regimen is started within 24 hours and lasts for 6 weeks. The occurrence of combined output criteria (severe heart failure and/or death after 6 weeks) decreased on the group of patients treated with Zofenopril (Zofenopril 7.1%, placebo 10.6%). After 1 year, the survival rate is improved in the group of patients treated with Befril.
Dynamic pharmacokinetics
Zofenopril is a medication, because the active drug is a drug without sulfhydryl, zofenoprilat, this substance is made up of thio-anticipated hydropive reaction.
absorption
Zofenopril absorbed quickly, almost completely through oral and metabolized almost completely into zofenoprilat, this drug reached the peak concentration after 1.5 hours after taking Zofenopril. Single -dose kinetics in the dose range from 10 to 80 mg Zofenopril and no accumulation phenomenon after the dose of 15 - 60 mg Zofenopril within 3 weeks. The presence of food in the gastrointestinal tract reduces the speed but does not affect the level of absorption and area under the concentration curve (AUC) of zofenoprilat. Therefore, the pharmacokinetics of the drug are almost similar when drinking at full or hungry.
distribution
After using a dose of radioactive zofenopril, the measurement results under the Ex-Vivo condition show that about 88% of radioactive activity is attached to plasma proteins and the distribution volume in equilibrium is 96 liters.
transformation
After using a dose of radioactive zofenopril, there are eight metabolites, accounting for 76% of radioactive activity found in human urine. The main metabolites are zofenoprilat (22%), the metabolic product of many roads, including glucoronic complex (17%), ring and glucoronic (13%), Cysteine (9%) and methylation at the sulfur position of the Thiol group (8%). The sale time of zofenoprilate is 5.5 hours and the total clearance is 1300ml/minute after taking Zofenopril calcium.
excretion When used in injection, Zofenoprilat has radioactive emissions in urine (76%) and feces (16%), while if using a oral dose of zofenopril with radioactive mounting, 69% and 26% of radioactive activity are recovered in urine and fertilizers. This shows that the drug is eliminated through both roads (liver and kidneys).
Elderly pharmacokinetics
On the elderly, no dose should be adjusted if normal kidney function.
Dynamic pharmacokinetics in patients with renal dysfunction
Based on the comparison of the main dynamic parameters of Zofenoprilat measured after taking oral a dose of radioactive zofenopril, patients with mild kidney failure (Creatinin clearance> 45 and 90 mL/min).
On patients with average to severe renal failure (7 - 44 ml/minute), the elimination level decreased by about 50% compared to normal. Therefore, on this object, it is necessary to start using Bify at a dose of ½ of the usual dose.
On patients with end -stage renal failure with dialysis and peritoneal filtration, the level of excretion decreases to only 25% compared to normal. Therefore, on this object, it is necessary to start using Bified at a dose equal to 1/4 of the usual dose.
pharmacokinetics in patients with liver dysfunction
On patients with mild to moderate liver dysfunction, after giving a single dose of Zofenopril with radioactive material, the value of CMAX and TMAX of Zofenoprilat is similar to the value recorded on normal people. However, the area of the area under the AUC curve in patients with cirrhosis is about 2 times higher than the value obtained on normal people. This shows that when used in patients with mild to moderate liver function impairment, the dose is half the dose is needed compared to the dose on the patient with normal liver function. There is no pharmacokinetic data of zofenopril and zofenoprilat on severe liver failure. Therefore, contraindicated use of zofenopril on this object.
Before taking Bified 30 Menarini treatment for hypertension, myocardial infarction (2 blisters x 14 tablets)
How to use
can take Bified before, during or after meals. Need to gradually adjust the clinical treatment of the patient.
Dosage
Dosage in case of treatment:
Hypertension
The adjustment of the dose should be determined based on the blood pressure index measured right before the next dose mode. The consideration of increasing the dose is done every 4 weeks.
Patients do not lose fluid or salt loss:
Need to start at a dose of 15 mg once a day and increase gradually until the target of the blood pressure is reached optimal.
The usual effect is 30 mg once a day.
The maximum dose is 60 mg/day divided into 1 or 2 times.
In case of not being enough to respond to treatment, one additional medicine can be combined with other hypertension treatment, such as diuretics.
Patients suspected of loss of fluid or salt loss:
On a high -risk patient, there may be hypotension immediately after the first dose (see the special note and cautious when used). When starting treatment with enzyme inhibitors, it is necessary to overcome the loss of epidemic and/or salt loss of the patient, stop the diuretic regimen used earlier for about 2 to 3 days and start at a dose of 15mg/day. If not, need to start at a dose of 7.5 mg/day.
Patients with high risk of acute hypotension should be closely monitored, preferably monitoring at the hospital, within the period corresponding to the time to promote the effect of the first inhibition of enzyme inhibitors, and whenever the dose of enamel inhibitors inhibit enamel inhibitors and/or diuretics. This should also be done with patients with angina or brain vascular disease, because in these patients, rapid hypotension can cause myocardial infarction or stroke.
Dosage in patients with renal failure and separation:
In patients with hypertension with mild renal failure (Creatinine clearance> 45 ml/min) can be used with bifril at the same dose level and 1 -time mode/day similar to patients with normal kidney function. Patients with average to severe to severe renal impairment (Creatinine clearance For patients with hypertension in the process of separation, biformil should start at a dose equal to 1/4 dose used in patients with normal renal function.The latest clinical data has recorded the occurrence of anaphylactic reactions on patients treated with enzyme inhibitors transferred during dialysis with high -line filter or during filtering to eliminate LDL (see section 4.4 «special and cautious note when used).
Dosage on the elderly (over 65 years old):
On the elderly, there is creatinine clearance, do not need to adjust the dose.
On the elderly, the clearing of creatinine (less than 45 ml/min) should be used by 1/2 of the usual dose.
Creatinine clearance may be estimated from serum creatinine levels by the following formula:
Dosage in patients with liver failure:
In patients with hypertension with mild to moderate liver failure, the starting dose of Bify is half the starting dose for patients with normal liver function.
On patients with hypertension with severe liver failure, contraindicated Bifril.
Children (under 18 years old):
Information on the effectiveness and safety of bifril in children has not been fully studied. Therefore, drugs should not be used in children.
acute myocardial infarction Bifril treatment needs to start within 24 hours after symptoms of myocardial infarction and need to be continued for 6 weeks.
The dose is as follows:
In the necessary cases, patients also need to use other standard medications such as nitrate, aspirin or channel blocking B.
Dosage on the elderly: Need to use bifril carefully in patients with myocardial infarction over 75 years old.
Dosage in patients with renal failure and separation:
Biftil's effectiveness and safety in patients with myocardial infarction with kidney failure or patients who are in the process of separation have not been set up. Therefore, it is not used on the patient's object.
Dosage in patients with liver failure:
Bifril's efficiency and safety in patients with myocardial infarction with liver failure has not been set up. Therefore, do not use drugs on this patient object.
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?
After taking overdose, patients need to be closely monitored, preferably in an active treatment unit. Electrolyte concentration and serum creatinine should be closely monitored. Clinical interventions depend on the nature and severity of the symptoms. If the patient is detected as soon as an overdose, it is necessary to take measures to prevent drug absorption such as gastric lavage, which can be used for adsorbent and sodium sulphat. If the condition of hypotension appears, the patient should be treated as in the case of shock, may be used correctly for drugs developing fluid volume and/or angiotensin II treatment. The condition of the heart rate slow or the vagus reaction can be treated by using atropine. Can consider the use of heart rate aids. It is possible to eliminate enzyme inhibitors from circulating by dialysis. High -line polyacrylonitril filter should be avoided.
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 doses to compensate for missed dose.
Side Effects
When using the drug often has unwanted effects (ADR) such as:
Central nervous system disorders:
Gastrointestinal disorders:
Skin and subcutaneous tissue disorders:
Blood disorders and lymphatic systems:
For a few patients, there is a condition of granulocytosis and hemorrhage. There are several reports on hemolytic anemia in patients with glucose-6-phosphate dehydrogenase.
Metabolic and nutrition disorders:
Very rare, hypoglycemia.
Mental disorders:
Rare, depression, mood disorders, sleep disorders, confusion.
Central nervous system disorders:
Sometimes we have an intense condition, taste disorders, balance disorders.
visual disorders:
rare, open.
Disorders of ears and mesmerizing:
Rare, tinnitus.
heart disorders:
Some single reports on heart rate increase, chest drumming, arrhythmia, angina, myocardial infarction when using enzyme inhibitors are related to hypotension.
circuit disorders:
Serious hypotension has appeared after the beginning or increased treatment dose. This condition especially appears on some patients with risk factors (see special and cautious note when used). Combined with hypotension, there are some symptoms such as dizziness, fatigue, vision loss, rarely rarity than consciousness disorders (fainting).
Some rare cases appear blushing.
respiratory disorders, chest and mediastinum:
Rare, there are some reports on shortness of breath, sinusitis, rhinitis, tongue inflammation, bronchitis and bronchospasm. The transferred enzyme inhibitor is reported related to the onset of the nerve angioedema related to the face and pharyngeal tissue on a small group of patients. In some separate cases, the neurotransmitter related to the upper respiratory tract has clogged the respiratory tract at risk of death.
Gastrointestinal disorders:
Some cases of abdominal pain, diarrhea, constipation and dry mouth.
Some single reports on pancreatitis and bowelitis have been described related to enzyme inhibitors.
Very rare, there is a report on intestinal angioedema.
Liver disorders:
Some single cases with jaundice and hepatitis are related to enzyme inhibitors.
Skin and tissue subcutaneous:
Sometimes, allergic reactions and hypersensitivity can appear such as itching, urticaria, erythema, Stevens-Johnson syndrome, poisoned epidermal necrosis, psoriasis, hair loss.
This reaction may be accompanied by symptoms of fever, muscle pain, joint pain, eosinophilia and/or increased results of antibody antibody tests.
rare, sweating.
Musculoskeletal and connective tissue disorders:
Sometimes muscle pain may occur.
kidney disorders and urinary systems:
Renal failure may appear or severe. Acute renal failure has been reported (see special and cautious note when used).
Rarely, urination disorders may appear.
Reproductive disorders and milk excretion:
Rare, erectile dysfunction.
Common disorders and abnormalities at the position of giving the drug:
Very rare, peripheral edema and chest pain.
Testing disorders: Increased urea and blood creatinine levels, which can be recovered after stopping the drug, especially in patients with kidney failure, severe heart failure and hypertension.
On a few patients, there are reports on hemoglobin reduction, haematocrit, platelets and leukocytes. There are also some reports on increased concentration of liver and bilirubin in the blood.
Doubtful reports of unwanted effects:
The suspected report of unwanted effects after the drug is circulated is very important. This allows the evaluation of the benefits/risks of the drug. Health staff must report any doubts of unwanted effects on the national reporting system.
Instructions on how to handle ADR:
Notify the physician with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Bify 30 contraindications in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
Hypotension:
Like other transferred inhibitors, Bified can sharpen blood pressure, especially right after the first dose. However, the condition of hypotension is less recorded in patients with no complications of hypertension. This condition is more common in patients who have reduced the volume of circulatory or electrolyte disorders when taking diuretics, diets that limit salt, juris, go outside, vomit, or in patients with hypertension dependent on the severity of the Renin level (see more the item of drug interaction and unwanted effect).
On patients with heart failure, with or without renal failure, there have been cases of symptomic hypotension. This phenomenon is at risk of appearing more in patients with severe heart failure, manifested by the use of high -dose dosage drugs, hypoglyc sodium or impaired renal function. On patients there are many risks of hypotension, when starting to use medication, it is necessary to monitor strict health, preferably monitoring at the hospital, it is necessary to start low doses and gradually increase the dose carefully.
If possible, diuretics should be temporarily suspended when starting to use Bifril. This should also pay special attention when using drugs for patients with angina or patients with brain vascular disease. Because in these patients, rapid and sudden hypotension can cause myocardial infarction or stroke.
If the hypotension occurs, the patient is on the back, which may be added with the volume of fluid with a conventional intravenous saline solution. Even when the hypotension occurs after the initial dose, it is still possible to gradually increase the dose of each component of the drug after taking measures to control the lower pressure effectively.
On patients with heart failure with normal or low blood pressure, the lower pressure to lower the pressure may occur when using Bified. This effect can be predicted and often not the reason for stopping the drug. If hypotension becomes a regular symptom, need to reduce the dose or stop using Bifril.
Hypotension in patients with myocardial infarction:
Do not start using bifril in patients with acute myocardial infarction if the patient is at risk of severe hemodynamic reduction due to vasodilators. These are cases where patients with systolic blood pressure are
Patients with myocardial infarction with liver failure:
Efficiency and safety of Bifril in patients with myocardial infarction with liver failure has not been set up. Therefore, should not be used for this object.
Elderly:
Need to be carefully used Bifril in patients with myocardial infarction over 75 years old
Patients with kidney hypertension:
In patients with 2 -sided kidney stenosis or one side stenosis and only one kidney left, using transferred enzyme inhibitors can increase the risk of serious hypotension and kidney failure. Treatment with diuretics can be a factor that contributes to this risk. The impaired renal function can be manifested by a slight change of serum creatinine concentration even for patients with kidney stenosis on the one side. If it is really necessary, it is necessary to start biformil treatment at the hospital, accompanied by strict monitoring, starting with low doses and gradually increasing the dose. Temporary diuretics should be temporarily suspended when starting to use Befril and closely monitoring the kidney function during the first few weeks of treatment.
Patients with renal failure:
Bified need to be used carefully in patients with renal failure because this object needs to reduce the dose. During the course of treatment, it is necessary to closely monitor kidney function by appropriate measures. There have been reports on some cases of renal failure related to the use of enzyme inhibitors, especially in patients with severe heart failure or kidney disease, including kidney stenosis. Some patients who do not have the previous kidney disease have appeared to increase urea and creatinine in the blood, especially when using enzyme inhibitors simultaneously with diuretics. In this case, a reduction of enzyme inhibitors should be reduced and/or stop using diuretics. Should monitor tight kidney function in the first weeks of treatment.
Efficiency and safety of bifril in patients with myocardial infarction with kidney failure has not been fully studied. Therefore, biformil should not be used for patients with myocardial infarction with renal failure (serum creatinine concentration ≥ 2.1 mg/dl and proteinuria level of 2500 mg/day).
Patients are separating:
Patients are being separated from using high -line polyacrylonitrile (for example, An 69) and being treated with a conversion inhibitor may experience anaphylactic reaction with manifestations such as swelling of the face, blushing, lowering blood pressure and shortness of breath in the first few minutes after the beginning of dialysis. In this case, another type of filter should be used or another medication for hypertension.
Zofenopril's effectiveness and safety in patients with myocardial infarction is dialysis has not been set up. Therefore, should not be used on this patient object.Patients are using dialysis techniques to remove LDL:
Patients treated with enzyme inhibitors simultaneously use dialysis techniques to eliminate LDL cholesterol using Dextran Sulphat may experience anaphylactic reaction similar to what is recorded in patients with dialysis using high -line membrane (see details above). In this case, the drug should be selected in a group of other hypertension drugs to use for patients.
Anaphylactic reaction during sensitivity or after being burned by insects:
Rarely, in some cases, the patient has used enzyme inhibitors during the treatment of sensitivity (for example, hypersensitivity with venom of winged bugs) or after being burned with insects has encountered life -threatening anaphylactic reactions. On these patients themselves, after stopping the enzyme inhibitors, if accidentally used, it may reappear the anaphylactic reaction. Therefore, it is necessary to be cautious when using enzyme inhibitors transferred to patients who are in the hypersensitive treatment cycle.
Patients with kidney transplantation:
In fact, there are not many cases of using Bified for patients who have just experienced kidney transplant. Therefore, it is not recommended to use drugs on this patient.
primary Aldosteron syndrome:
Patients with primary Aldosteron power syndrome often do not respond to drugs that treat hypertension, which are acting through the renin-angiotensin system. Therefore, zofenopril should not be used in this case.
Tharma:
The phenomenon of veins on the face, limbs, lips, tongue, bars and/or larynx can appear on patients treated with enzyme inhibitors and often appear in the first weeks of treatment. However, in some rare cases, serious angioedema may appear after long -term treatment with enzyme inhibitors. Need to stop the enzyme inhibitors and replace it with another group to treat hypertension.
The phenomenon of angioedema related to the tongue, bar or larynx can be life -threatening. Emergency measures should be taken such as subcutaneous injection immediately 1: 1000 adrenalin solution (0.3 to 0.5 ml) or slow intravenous intravenous 1mg/ml (need to dilute in accordance with the instructions) and closely monitor ECG, blood pressure. Also can take other emergency measures. Patients need to be hospitalized and monitored at least 12 to 24 hours and must not be discharged from the hospital until they completely resolve the symptoms completely.
Even in cases where patients only have tongue edema, no signs of respiratory failure, patients still need to be monitored due to antihistamine and corticosteroid treatments may not be enough to control.
The ratio of angioedema event when using enamel inhibitors in black and black enamel on black people is higher on other populations.
Patients who have a history of angioedema are not related to transferred inhibitors may increase the risk of angioedema when using enzyme inhibitors (see the contraindication section).
ho:
While batingil treatment, dry cough, no pus -free cough, this condition may end after stopping treatment. Coughing due to transferred enzyme inhibitors should be considered a part of the diagnosis distinguished from normal cough.
liver failure:
In some rare cases, the enzyme inhibitors are associated with a symptom of jaundice and the progression of the liver necrosis and (sometimes) can lead to death. This mechanism has not been well known. If the patient uses a yeast inhibitor that appears jaundice or has a significant increase in liver enzymes, it is necessary to stop the medication inhibitors and monitor medical care carefully.
Hematuria:
Hemorrhage hyperkalemia may occur during the treatment of transferred enzyme inhibitors. Patients are at risk of hyperkalemia, including: Patients with renal impairment, diabetes, patients who use simultaneous diuretics to keep potassium, potassium -supplements or salt -containing substances containing potassium, patients using active ingredients that are at risk of hyperkalemia (such as heparin). If using the above -mentioned drugs, it is necessary to monitor the concentration of blood potassium in a regular basis (see more drug interaction).
Use in combination with Rennin-Anotension-Ordosterone inhibitors:
There has been evidence that the sharing of enzyme inhibitors transferred to Angiotensin II or Aliskiren receptor inhibitors increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Therefore, it is not combined to use enzyme inhibitors with Angiotensin II or Aliskiren receptor inhibitors (see more drug interactions and pharmacological properties).
If the combination of rennin-angiotension-aldosterone inhibitors is really necessary, it is necessary to pay special attention and control of the renal function, electrolyte concentration and regular blood pressure for patients.
Do not use in combination with enzyme inhibitors with angiotensin II receptor inhibitors in patients with diabetes -related kidney disease.
surgery/anesthesia:
Transfer inhibitors can cause hypotension or even shock due to hypotension in patients undergoing major surgery or during anesthesia, because these drugs block the formation of the secondary angiotensin II to compensate for the threadin secretion. If it is not possible to stop using enzyme inhibitors, closely monitor plasma volume and intravascular fluid volume.
Aortic valve stenosis or mitral valve/myocardial hypertrophy:
Can use enamel inhibitors carefully in patients with mitral stenosis and clogged flow in the left ventricle.
Neutral leukemia/grain leukemia:
There have been a number of reports on neutropenia/grain leukocytes, thrombocytopenia and anemia in patients using enzyme inhibitors. The risk of neutropenia tends to be related to dosage, drug form and depend on the patient's clinical condition. This condition is rarely found in patients with non -complicated clinical characteristics but may appear in patients with impaired renal function, especially when patients have epidermal diseases such as system lupus, sclerosis and are being treated with immunosuppressive drugs, Allopurinol or processed treatment, or combining the above factors. Some of these patients have appeared severe infections that did not respond to strong antibiotics during the first time.
If using Zofenopril in these patients, the total number of white blood cells should be checked and the number of leukocytes before the regimen, then checks continuously every 2 weeks during the first 3 months of Zofenopril treatment, the months after regular tests. During treatment, it is necessary to guide all patients on reporting as soon as there are any signs of infection (such as sore throat, fever) while the number of leukemia lines is controlled. Zofenopril should be stopped and the same drugs (see drug interaction) if detected or suspected neutropenia symptoms (neutral leukemia less than 1000/mm3).
This situation will recover after stopping using enzyme inhibitors.
psoriasis:
Need to use carefully enamel inhibitors on patients with psoriasis.
proteinuria:
proteinuria may appear, especially in patients with renal failure or patients using high doses of enzyme inhibitors. Patients who have renal disease should be assessed for proteinuria concentration (in the first urine during the day), this test is done before starting treatment and then conducted periodically.
Patients with diabetes:
Blood sugar concentration should be closely monitored in patients with diabetes previously treated with oral diabetes or insulin, during the first month of treatment with enzyme inhibitors (see drug interaction).
lithium:
The combination of lithium and bifril is generally not recommended (see drug interactions).
Race:
Like other enzyme inhibitors, Zofenopril may be less effective in reducing blood pressure on black people compared to other races.
Translual inhibitors can cause angelicular ratio on black people higher than in other races.
Pregnant women:
Do not start treatment with enzyme inhibitors during pregnancy. Unless the use of enzyme inhibitors is considered an urgent, other cases, patients intended to be pregnant should be transferred to another medication for hypertension that has clear data on safety in pregnant women. Once you have been confirmed to be pregnant, it is necessary to stop the medication inhibitors, if necessary, you must start the treatment of other hypertension to replace (see the control item and the pregnant & nursing woman item).
other:
This specialist contains lactose. Patients with genetic problems in galactose tolerance, lapp-lactase enzyme deficiency or poor absorption of glucose-galactose should not use this special medicine.
The effect of the drug on driving and operating machinery
There has been no research on the impact of Bify on the ability to operate machinery and trains. When driving or using machines, it should be noted that symptoms may appear such as sleeping, dizziness or fatigue.
Use drugs for women during pregnancy and lactation
Pregnant women:
Do not recommend the use of enzyme inhibitors in the first 3 months of pregnancy (see caution and special warning). Contraindicated use of enzyme inhibitors in the middle 3 months and the last 3 months of pregnancy (see the item contraindicated and caution and special warning).
Epidemiological evidence related to fetal defects after using enzyme inhibitors in the first 3 months of pregnancy has not been fully concluded. However, it does not exclude the drug that increases the risk of deformities. Unless the use of enzyme inhibitors is considered to be really necessary, pregnant patients need to be transferred to another medication for hypertension that has sufficient data on safety during pregnancy. When a woman is diagnosed with pregnancy, it is necessary to stop the enzyme inhibitors immediately, if necessary, immediately use an alternative regimen.
The use of enzyme inhibitors in the middle and the last 3 months of pregnancy is known as toxicity on human embryos (reducing kidney function, reducing amniotic fluid, slow processing of skull) and toxicity on infants (causing kidney failure, lowering blood pressure, increasing blood potassium) (see section 5.3).
If the enzyme inhibitor has been used in the middle of the 3 months of pregnancy, the ultrasound is required to check the kidney function and check the fetal skull. Babies born from a mother who have used the enzyme inhibitors should be strictly monitored to prevent hypotension (see contraindications and caution and special warnings).
breastfeeding women:
Due to the lack of adequate information related to the use of Befril during breastfeeding, Bified is not recommended for this object. A replacement regimen should be used with safety data on pregnant women who have been fully studied, especially in the period of nurturing newborn or premature babies.
Drug interaction
Interactive is not recommended to use:
Diuretics keep potassium or potassium supplements: Yeast inhibitors reduce the level of potassium loss due to diuretics. Potassium diuretics such as spironolacton, triamteren, or amilorid, potassium supplements, or salt -containing potassium replacements can lead to excessive hyperkalemia. If you have recorded hypokalemia and need to use these drugs simultaneously, you must be used carefully, regularly monitor blood potassium concentration and electrocardiography (see caution and special warning).
Transfer inhibitors, Angiotensin II or Aliskiren receptor inhibitors:
There has been clinical data showing the use of rampen-analotension-aldosterone inhibitors through the use of enzyme inhibitors with Angiotensin II or Aliskiren inhibitors that increase the frequency of unwanted effects such as hypotension, hyperboly and renal function impairment (including acute renal failure) compared to using system inhibitors inhibitors Rennin-Anotension-Aldosterone Unit (See also Contraindications, Precautions and Warning and Pharmacological Characteristics).
Interactive should be cautious:
Diuretics (thiazid or diuretics): The treatment of high -dose high -dose diuretics can lead to loss of fluid loss and the risk of hypotension at the beginning of the treatment regimen with zofenopril (see section 4.4). Hypoglycemic effects can be reduced by stopping diuretics, enhancing fluid, salt compensation or need to start the regimen with low doses of Zofenopril.
Lithi: Increasing lithium recovery in serum and has a toxic report that occurs when indicated simultaneously lithium with enzyme inhibitors. Simultaneous use with thiazid diuretics may increase the risk of toxicity of lithium and worsen the inherent toxic risks due to the use of lithium along with enzyme inhibitors. Therefore, Bified is not recommended to use with Lithi. In the case of really necessary, lithium concentration must be monitored carefully.
Gold: Using enzyme inhibitors has been recorded as an increase in the frequency of nitrite reactions (symptoms of vasodilation including blush, nausea, dizziness and hypotension, this symptom may be very serious) in patients using gold salt by injection (for example, sodium aurothiomalate).
Anesthesia: Yeast inhibitors can enhance the lowering effects of some anesthesia.
Sleeping drugs/antidepressants 3 rounds/anti -psychotic/Barbiturat drugs: can cause hypotension.
Other drugs for hypertension (for example, beta receptor blockers, alpha receptor blockers, calcium channel blockers): may increase the effect or potential for hypotension. Caution should be careful when treated with nitroglycerin and other nitrate compounds, or other vasodilators.
cimetidine: may increase the risk of hypotension.
Cyclosporin: Increased risk of kidney dysfunction when used simultaneously with enzyme inhibitors.
Allopurinol, processAnamid, cytostatic or immunosuppressive drugs: increased the risk of hypersensitivity reactions when used simultaneously with enzyme inhibitors. Data from other enzyme inhibitors shows an increased risk of leukemia when used with these drugs.
Diabetes treatment: In some rare cases, transferred inhibitors can enhance the hypoglycemia of insulin and oral diabetes treatment drugs such as sulphonylure in diabetes patients. In these cases, diabetes treatment may be reduced during the treatment period with enzyme inhibitors.
Dialysis with high current filter: Increases the risk of anaphylactic reaction when used with enzyme inhibitors.
Spelopomy or immunosuppressive drugs, corticosteroids use systemic or processes: simultaneously used with enzyme inhibitors will increase the risk of leukopenia.
Interactive should be noted
Non -steroid anti -inflammatory drugs (including aspirin dose ≥ 3g/day): Using nonsteroidal anti -inflammatory drugs can reduce the effect of lowering the blood pressure of enzyme inhibitors.
In addition, anti -inflammatory drugs and enzyme inhibitors are known to cause cumulative effects in increasing serum potassium concentration while renal function may decline. In principle, these effects can recover and especially appear in patients with impaired renal function. In some rare cases, acute renal failure may appear, especially in patients with kidney function begins to be damaged like the elderly or in patients with dehydration.
antacids: Reducing the bioavailability of enzyme inhibitors.
Similar sympathetic drugs: can reduce the effectiveness of hypertension of the enzyme inhibitors, need to monitor patients carefully to make sure to reach the treatment destination.
Food: may slow down but do not reduce the absorption level of zofenopril calcium.
Additional information: There is no direct clinical data on Zofenopril's interaction with metabolic drugs through the CYP enzyme system. However, Zofenopril's In vitro metabolic studies have shown that the drug does not have a clear interaction with the metabolic drugs through the CYP enzyme system.Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
Other drugs
- Avamys
- BRUFEN SYRUP 100MG/5ML
- PARIET 20MG GASTRO-RESISTANT TABLETS
- RADIAN MASSAGE CREAM
- TERTROXIN TABLETS 20MCG
- ZOPICLONE 7.5MG TABLETS
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions