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Bifril

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Indications:

Hypertension: ZOFENIL is indicated in the treatment of essential hypertension with mild to moderate. - Myocardial infarction in acute phase: ZOFENIL is indicated for the treatment initiated during the first 24 hours of a myocardial infarction in acute phase, with or without signs or symptoms of heart failure, hemodynamically stable patients not receiving thrombolytic therapy.

Contraindications:

Hypersensitivity to zofenopril or any other IEC or any of the excipients; - History of angioedema (angioedema) associated with taking an ACE inhibitor; - Angioedema, Hereditary / idiopathic; - Severe hepatic impairment; - Pregnancy: ZOFENIL-cons is indicated in cases of pregnancy and should not be used in women during their reproductive years without effective contraception. Fetal exposure to ACE inhibitors during the second and third trimesters of pregnancy has been associated with neonatal hypotension, renal failure, distortion of the face or skull and / or death. Maternal oligohydramnios has also been reported indicating a decrease in renal function of fetuses. Limb contractures, craniofacial deformities, hypoplastic lung development and retarded intrauterine growth have been reported in association with oligohydramnios. Children exposed in utero to ACE inhibitors should be closely monitored because of the risk of hypotension, oliguria and hyperkalemia. Oliguria should be treated by maintaining blood pressure and renal perfusion. It is not known whether fetal exposure limited to the first trimester of pregnancy may cause fetotoxicity. Women who become pregnant as ACE inhibitors should be aware of potential danger to the fetus;

Adverse reactions:

The frequency of adverse events were classified by system class / body as follows: Very common (= 1 / 10) common (1 / 100, <1 / 10) Uncommon (> = 1 / 1000, <1 / 100), rare (> = 1 / 10000, <1 / 1000); very rare (<= 1 / 10000). - General disorders: . Frequent: asthenia. . Uncommon: Weakness. - Gastro-intestinal: Common: nausea / vomiting. - Disorders of the musculoskeletal and connective tissue: Uncommon: muscle cramps. - Nervous system disorders: Common: dizziness, headache. - Respiratory disorders, thoracic and mediastinal: Frequent: coughing. - Skin and subcutaneous tissue: . Uncommon: rash. . Rare: angioedema. The following side effects have been observed in association with ACE inhibitor therapy: - Cardiovascular: Severe hypotension occurred after initiation or increase in salary. This occurs especially in risk groups. Symptoms such as dizziness, weakness, visual disturbances, often with loss of consciousness (syncope) can occur. Individual cases of tachycardia, palpitations, arrhythmia, angina, myocardial infarction, transient ischemic attacks and cerebral haemorrhage have been reported with ACE inhibitors in combination with hypotension. Very rarely peripheral edema, orthostatic hypotension and chest pain have been reported. - Musculoskeletal system: Occasionally myalgia and muscle cramps may occur. - Renal: Renal failure can occur or intensify. Acute renal failure has been reported. - Respiratory: The appearance of cough was documented in a substantial number of patients treated with ACE inhibitors. Rarely dyspnea, sinusitis, rhinitis, glossitis, bronchitis and bronchospasm have been reported. ACE inhibitors have been implicated in the occurrence of angioedema in a small number of patients involving the face and oropharyngeal tissues. In some isolated cases, angioneurotic edema involving the upper airway obstruction caused fatal airway. - Gastrointestinal: Occasionally, nausea, abdominal pain, vomiting, diarrhea, constipation and dry mouth. Isolated cases of cholestatic jaundice, hepatitis, pancreatitis and intestinal obstruction have been reported with ACE inhibitors. - Skin and appendages: Occasionally allergic reactions or hypersensitivity may occur as rash, pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia. These reactions may be accompanied by fever, myalgia, arthralgia, eosinophilia and / or increased rates of antinuclear antibodies. - Nervous system: Occasionally, headache, dizziness and fatigue, more rarely, depression, mood swings, insomnia, paresthesia, weakness, impaired balance, confusion, tinnitus, blurred vision and taste disturbances. - Biologically: Increased urea and creatinine plasma, reversible upon discontinuation of treatment, particularly in cases of renal failure, severe heart failure and renovascular hypertension. In some patients decreases in hemoglobin, hematocrit, platelets and white cells have been reported. This includes agranulocytosis and pancytopenia. It has been reported cases of hemolytic anemia in patients with impaired glucose-6-phosphate dehydrogenase. Increases in liver enzymes and serum bilirubin have been reported. - In general terms: Occasionally an increased sweating, flushing and abnormal urination may occur.

Interactions:

Associations not suitable potassium-sparing diuretics or potassium supplements. ACE inhibitors attenuate diuretic induced potassium loss. The potassium-sparing diuretics such as eg. spironolactone, triamterene or amiloride, potassium supplements, or salt substitutes based on potassium can lead to significant increases in serum potassium. Use them with caution and with frequent monitoring of serum potassium if they are given because of hypokalemia. Precautions for using diuretics. In patients on diuretics and especially those with salt depletion and / or hypovolemia, you may experience an excessive reduction of blood pressure after initiation of therapy with ACE inhibitors. The possibility of hypotensive effects may be reduced by initiating therapy at lower doses of ACE inhibitor. Further increases in dosage with caution. Lithium. Concomitant administration of ACE inhibitors and lithium can reduce the excretion of lithium. We recommend frequent monitoring of serum lithium levels. Anesthetics. ACE inhibitors may potentiate the hypotensive effects of some anesthetics. Narcotics / Antipsychotics. Orthostatic hypotension may occur. Antihypertensive agents. b-blockers,-blockers and diuretics may increase the hypotensive effect of ACE inhibitors. Cimetidine. May increase the risk of hypotension. Cyclosporine. Increased risk of renal dysfunction in cases of concomitant use of ACE inhibitors. Allopurinol. Increased risk of hypersensitivity reactions in cases of concomitant use of ACE inhibitors. The data for other ACE inhibitors indicate an increased risk of leukopenia when used in combination. Insulin or oral hypoglycemic agents. Increased risk of hypoglycemia in cases of concomitant use of ACE inhibitors. Haemodialysis with high flux dialysis membranes. Increased risk of anaphylactoid reactions to concomitant use of ACE inhibitors. Cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. You may have an increased risk of leukopenia in cases of concomitant use of ACE inhibitors. To consider non-steroidal anti-inflammatory drugs. The administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor. It was also reported that NSAIDs and ACE inhibitors exert an additive effect on serum potassium and renal function may decrease. These effects are in principle reversible and occur particularly in patients with impaired renal function. Antacids. Reduce the bioavailability of ACE inhibitors. Sympathomimetics. May reduce the antihypertensive effects of ACE inhibitors. Alcohol. Potentiates the hypotensive effect. Food. May reduce the speed but not the extent of zofenopril calcium. Interaction with other medicines are no clinical data on the interaction with drugs metabolized by CYP enzymes. However, in vitro studies have shown no interactions with these drugs

Warnings:

Breastfeeding: calcium is excreted in breast milk, ZOFENIL should not be used in nursing mothers; - Women in their reproductive period without effective contraception; - Bilateral stenosis of renal artery stenosis or unilateral in a solitary kidney. - Children: The safety and effectiveness in children Pregnancy ZOFENIL-cons is indicated in cases of pregnancy and should not be used in women during their reproductive years without effective contraception. Fetal exposure to ACE inhibitors during the second and third trimesters of pregnancy has been associated with neonatal hypotension, renal failure, distortion of the face or skull and / or death. Maternal oligohydramnios has also been reported indicating a decrease in renal function of fetuses. Limb contractures, craniofacial deformities, hypoplastic lung development and retarded intrauterine growth have been reported in association with oligohydramnios. Infants exposed in utero to ACE inhibitors should be closely monitored because of the risk of hypotension, oliguria and hyperkalemia. Oliguria should be treated by maintaining blood pressure and renal perfusion. It is not known whether fetal exposure limited to the first trimester of pregnancy may cause fetotoxicity. Women who become pregnant as ACE inhibitors should be informed of the potential danger to the fetus. Breastfeeding: Calcium is excreted in breast milk, ZOFENIL should not be used in nursing mothers.

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