WHAT FOZIKARD AND WHAT IT IS USED
Fozikard is a medicinal product of the so-called ACE inhibitors. Its therapeutic action is expressed in decreasing high blood pressure and help treat heart nedostatachnost.Fozikard® be used to treat:
• Hypertension (high blood pressure);
• Complex therapy of cardiac insufficiency.
2. WHAT YOU NEED TO KNOW BEFORE FOZIKARD
Fozikard not apply to:
• Allergy to fosinopril or to any of the excipients;
• Once known angioedema (swelling of the tongue, oral mucosa and / or throat), with previous treatment with ACE inhibitors or in patients with congenital or idiopathic angioedema;
• Pregnancy and lactation;
• Children.
In the application of this product, please note the following:
Allergy / angioneurotic edema: Angioedema (swelling of the face, extremities, lips, tongue, throat and / or vocal cords) were observed in patients treated with ACE inhibitors, including fosinopril .. In these cases, treatment should be discontinued and apply appropriate therapy. In the case of a limited edema of the face and lips, the condition can recover without treatment, but may also be used in anti-allergic agents (eg. antihistamines) to alleviate symptoms. Angioedema, progressive swelling of the throat and vocal cords is a life-threatening complication. When it is accompanied by obstruction (narrowing) of the airways should immediately conduct appropriate therapy, eg. subcutaneous administration of epinephrine (0.3 to 0.5 ml of 1: 1000) and take the necessary measures to release the airways. These patients should be under medical supervision until symptoms disappear completely.
Hipotonsh (low blood pressure): There was a sharp and abrupt decrease in blood pressure during treatment with fosinopril. As a possible reason for this phenomenon is considered salt deficiency or reduced blood volume therapy with potent diuretics, patients on hemodialysis. Very rarely occurs in patients with uncomplicated form of hypertension. Pronounced hypotension was observed in patients with severe congestive heart failure with or without associated renal insufficiency, and could occur with olnguriya (decreased urine production) and / or progressive azotemia (increased content of nitrogen substances in the blood), rarely with acute renal failure including fatal. Due to the risk of a sudden sharp drop in blood pressure in these groups of patients, therapy should be started under medical supervision with a lower dose - 5 mg. These patients should be monitored in the first two weeks of treatment, as well as necessary by increasing the dose of fosinopril and / or diuretika.Podobno behavior is used in patients suffering from ischemic heart disease or cerebrovascular disease, in which sharp drop in blood pressure can lead to myocardial infarction or cerebrovascular accident. In the event of a sharp drop in blood pressure, the patient should be placed in a horizontal position and if necessary to apply a saline infusion. Transient decreases in blood pressure is not a contraindication to continue therapy with fosinopril in suitable doza.Otsenka of renal function prior to initiation of therapy with fosinopril should evaluate renal function of the patient and be checked regularly during treatment. If suspected stenosis of the renal arteries, it is necessary to perform contrast x-ray of renal vessels to assess the degree.
Impaired renal function: Possible changes in renal function in susceptible individuals. There is an increased risk of worsening of renal function in patients with underlying renal insufficiency, congestive heart failure, bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. In. such patients may experience an increase in serum urea and creatinine, which is usually transient and being reversed after discontinuation of therapy. They need to monitor renal function during the first few weeks of lechenieto.Vazmozhno minor and transient increase in nitrogen bodies in blood in hypertensive patients with pre-existing, but latent renal impairment, which occurs more frequently if Staril co-administered with a diuretic . These patients may require a dose adjustment of fosinopril and discontinuing diuretic terapiya.Pri treatment of patients with severe renal impairment (creatinine clearance <30 ml / min) fosinopril, who need additional therapy with a diuretic it is recommended that the application of a loop diuretic (eg. furantril).
Hyperkalemia (high potassium content in the blood): When treated with ACE inhibitors, especially in the presence of renal and / or heart failure, can be found hyperkalemia. In most cases, these are one-off measured values, which spontaneously to normal despite continued treatment. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, concomitant use of potassium-sparing dnuretitsi, potassium products and / or potassium-containing salt substitutes, which should be used with caution in combination with fosinopril.
Hepatic impairment: Patients with hepatic impairment may have increased levels of fosinopril is due to impaired metabolism. Rarely, ACE inhibitors can be observed hepatic involvement (a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes fatal). In establishing jaundice or significant increase in liver enzymes during therapy with fosinopril, his administration should be discontinued.
Surgery and anesthesia: It is a significant reduction of blood pressure in patients treated with fosinopril during major surgery and / or when the anesthesia drugs that may cause hypotension. If hypotension occurs this mechanism, it can be corrected by infusion of a sufficient quantity of water-salt raztvori.Promeni in blood composition (neutropenia / agranulocytosis) and bone marrow suppression: Some ACE inhibitors may cause changes in the blood ( neutropenia, agranulocytosis) and bone marrow suppression, which is rare in uncomplicated patients but is more common in patients with renal dysfunction or suffering from connective tissue disease (systemic collagenosis, such as lupus erythematosus, scleroderma), and those using immunosuppressive therapy . Therefore, periodic monitoring of WBC count in these patients.
Apafshaktoidni reactions: There have been reports of anaphylactoid reactions in dialysis patients treated concomitantly with ACE inhibitors. During treatment with fosinopril not recommended dialysis and hemofiltration through high flux membranes. In such patients should be considered the possibility of using another type of dialysis membrane or antihypertensive drug from another class. Similar effects have been observed in the course of apheresis of low density lipoproteins with dextran sulfate and concomitant administration of ACE inhibitors and therefore it should be avoided.
Interaction with laboratory tests:
Fosinopril may lead to false low values of serum digoxin by a process of absorption with charcoal. It is the use of another diagnostic method. A few days before testing for parathyroid function, fosinopril therapy should be discontinued.
Application of Fozikard and intake of foods and drinks:
No need for a special diet during treatment with this product.
Pregnancy
Before taking any medicine, consult your doctor or lekuvagtsiya with farmatsevt.Fozikard is contraindicated during pregnancy. ACE inhibitors can cause injury and fetal death when administered to pregnant women. When pregnancy during treatment with Fozikard need immediate discontinuation of the product. Use of ACE inhibitors during the second and third trimester of pregnancy is associated with damage to the fetus and newborn, including hypotension, skull underdevelopment, anuria, reversible or irreversible renal failure and death. Reported oligohydroamnion (excess amniotic fluid), likely due to decreased renal function of the fetus. In such cases oligohydramnios combined with contractures of the fetal extremities, maxillofacial deformities and lungs underdevelopment.
Infants with data of intrauterine exposure to the action of fosinopril should be carefully examined for hypotension, oliguria and hyperkalemia.
Breastfeeding
Before taking any medicine, consult your doctor or farmatsevt.Fozinopril passes into breast milk. If its use is imperative, the patient should stop nursing.
Driving and using machines
At the beginning of treatment Fozikard can be a temporary occurrence of faintness and dizziness, which affect the ability to drive and use machines.
Important information about some of the ingredients of Fozikard:
This medicinal product contains lactose as an excipient, which makes it unsuitable for patients with lactase intolerance.
Taking other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines, even if they have not been prescribed by your doctor.
Potassium supplements and potassium-sparing diuretics: The use of potassium-sparing diuretics (eg. Slironolakton, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes both fosinopril may increase the risk of hyperkalemia (high potassium content in the blood). Close monitoring of serum potassium.
Diuretics (drugs that increase the flow of urine): Administration of diuretics enhances the antihypertensive effect of fosinopril. A sharp fall in blood pressure at the beginning of treatment with fosinopril in patients treated with diuretics. Hypotensive effects of fosinopril can be prevented by stopping treatment with a diuretic or by increasing salt intake at the beginning of treatment. If you need to continue treatment with diuretic therapy is reduced dose of fosinopril under medical supervision.
Lithium: ACE inhibitors reduce the renal clearance of lithium and increase the risk of lithium toxicity. The effects of lithium toxicity are reversible after discontinuation of treatment with fosinopril. During concomitant administration of lithium products and Staril requires frequent monitoring of serum lithium.
Antacids (products decrease stomach acidity): Antacids may decrease the absorption of fosinopril. If co-administration it must be done at an interval of two hours between them.
3. HOW TO TAKE FOZIKARD
Always Fozikard as instructed by your doctor. Medical prescription. Administered orally.
• Hypertension (high blood pressure);
Recommended initial dose - 10 mg once daily. The dosage may be gradually increased at intervals of 1-2 weeks, depending on the effect and tolerability to a maximum 40 mg once daily. With an insufficient response by the daily dose of 40 mg should be given combination therapy with the addition of diuretik.V cases of previous treatment with diuretics, it should be discontinued 2-3 days before the initial administration of Fozikard to avoid symptomatic hypotension ( a sharp drop in blood pressure).
• Heart failure:
Recommended starting dose -10 mg once daily. It is the beginning of the treatment is conducted under strict medical supervision. If the initial dose is well tolerated, it can be gradually increased depending on the clinical effect of weekly intervals, to a maximum of 40 mg once daily. In patients with heart failure and moderate or severe renal impairment or those active diuretic therapy, the recommended starting dose is 5 mg once dnevno.Kombiniraneto diuretic improves efficiency.
Dosage in renal or hepatic impairment: In patients with impaired renal or hepatic function is generally not required dose reduction due to the double time of excretion of fosinoprilat.
Elderly (over 65 years):
Does not require dose adjustment.
Children:
This product is not recommended for children. Its safety and efficacy have not been established.
Tablets should be taken with plenty of water, regardless of meals, preferably in the morning.
If you take more than the prescribed dose Fozikard:
When taking a higher dose than prescribed, immediately contact a doctor! In overdose, symptomatic and supportive treatment. Fozikard therapy should be discontinued and the patient should be put under strict medical supervision. Therapeutic measures depend on the nature and severity of clinical symptoms and include measures to reduce penetration of the drug in the blood and accelerate elimination from the body. Typical symptoms of overdose are severely lower blood pressure, electrolyte imbalance and renal failure. If severe hypotension, the patient should be placed in the supine position and rapidly infused necessary amount of saline. Staril a small extent removed by hemodialysis and peritoneal dializa.Pri manifestations of symptoms of overdose, immediately contact a doctor
If you forget to use Fozikard:
If you miss a dose, take it at the next regular intake without increasing the dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fozikard can cause adverse reaktsii.V most part side effects during treatment with fosinopril are mild, transient and do not require discontinuation of therapy.
The most commonly observed adverse reactions were: hypotension, weakness, dizziness, cough, nausea, vomiting.
Other possible side effects are:
General: Weakness, fever, sweating, cardiac chest pain.
Cardiovascular: Rare cases of angina pectoris, myocardial infarction, transient ischemic blood flow or cerebrovascular accident, which are secondary, due to a sharp drop in blood pressure.
Other related cases: orthostatic hypotension (when standing), syncope (fainting), heart rate, palpitations ,. arrhythmias, flushing, Raynaud's phenomenon.
Gastrointestinal: Dry mouth, heartburn, nausea, abdominal pain. In rare cases, vomiting, constipation, loss of appetite. There are isolated reports of involvement zadstomashtnata (pancreatitis), increase in serum bilirubin and / or liver enzymes, hepatitis (hepatocellular or cholestatic jaundice) during therapy with ACE inhibitors.
Respiratory: Dry tickly cough, bronchitis, sometimes shortness of breath, sinusitis, rarely bronchospasm, activation of existing asthma. Genitourinary: In rare cases, occurrence of oliguria (decreased urine output), progressive azotemia (increase of urea), acute renal failure.
Musculoskeletal: Muscle cramps, muscle and joint pain.
Neurological / Psychiatric: Vertigo, tinnitus, depression, drowsiness, insomnia, nervousness, mental confusion, impaired (blurred) vision.
Skin: Rash, in rare cases, urticaria, pruritus, photosensitivity.
Allergy / Angioedema: Angioedema (swelling of the face, extremities, lips, tongue, throat and / or vocal cords) is rarely observed, but can be fatal.
Hematologic: Rare cases of slightly altered blood parameters (decrease in hematocrit, hemoglobin concentration, leucopenia, neutropenia, thrombocytopenia, eosinophilia) and bone marrow suppression.
Other: There was an allergic syndrome, which may include the following events: positive antinuclear bodies, ESR, arthralgia or arthritis, myalgia, fever, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash and other skin manifestations. Changes in laboratory parameters: The observed changes in laboratory parameters were rarely of clinical significance. The most common is an increase in potassium and decreases in sodium in the blood. Reversible slight increase in blood urea nitrogen and serum creatinine were observed in a minority of patients treated with fosinopril.