GOPTEN 2 mg. 98 capsules

Abbott
GOPTEN 2 mg. 98 capsules
€ 45.00
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Active substance: Trandolapril
Other ingredients: corn starch, lactose, polyvidone, sodium stearyl fumarate, gelatin, titanium dioxide, erythrosine, and iron oxide yellow.



GOPTEN caps. 2 mg
 

Qualitative and quantitative composition:

Active substance: Trandolapril
Other ingredients: corn starch, lactose, polyvidone, sodium stearyl fumarate, gelatin, titanium dioxide, erythrosine, and iron oxide yellow.
Pharmaceutical form and quantity in one box:
Each package Gopten ® 2 mg contains 98 capsules.
Indications
Mild to moderate hypertension. Impaired left ventricular function after myocardial infarction. Has been shown to improve survival Gopten after myocardial infarction in patients with left ventricular dysfunction (dysfunction of the left ventricle) (ejection fraction <35%) with or without symptoms of heart failure and / or no residual ischemia. Prolonged treatment with Gopten significantly reduced mortality from cardiovascular disease. It leads to a significant reduction in the risk of sudden death in cases of severe or resistant heart failure treatment.
Special warnings and precautions for use
Gopten should not be used in patients with aortic stenosis or obstruction of outgoing blood flow.

Impaired renal function:

In patients with severe renal impairment may require dose reduction of Gopten; their renal function should be carefully monitored. In the event the dominant renal function did not change. In patients with renal insufficiency, congestive heart failure or unilateral or bilateral renal artery stenosis in patients with one kidney and a renal transplant, the risk of renal impairment. For early detection like renal impairment is reversible upon withdrawal of the drug.
Some hypertensive patients with no prior renal disease may develop minor and usually transient, increases in blood urea nitrogen and serum creatinine when Gopten was concomitantly with a diuretic. You may need a dosage adjustment Gopten and / or withdrawal of the diuretic. Also, in patients with renal insufficiency should determine the risk of hyperkalemia and regularly check the electrolyte status of the patient.

Impaired hepatic function:

As trandolapril is a prodrug metabolized to the active substance in the liver, particular caution and close monitoring of patients with impaired hepatic function.

Symptomatic hypotension:

In patients with uncomplicated hypertension, symptomatic hypotension is rarely seen after the initial dose Gopten, and after increasing the dose of Gopten. Symptomatic hypotension is more likely to occur in patients with aqueous or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. Therefore, in these patients, diuretic therapy should be discontinued and volume and / or salt depletion should be corrected before initiating therapy with Gopten.

Angioneurotic edema:

In rare cases, ACE inhibitors such as trandolapril may cause angioedema including swelling of the face, extremities, tongue and / or larynx. Patients with angioneurotic edema must immediately discontinue Gopten and monitored until resolution of edema. Angioneurotic edema of the face usually resolves spontaneously. Eden, covering not only the face but also the glottis may be life-threatening due to the risk of airway obstruction. Angioneurotic edema covering the tongue, glottis or larynx requires immediate subcutaneous 0,3 -0,5 ml solution of adrenaline (1:1000), along with other appropriate therapeutic measures for the occasion.
Caution should be exercised in patients with a history of idiopathic angioedema. Gopten is contraindicated if angioneurotic edema was an adverse reaction to an ACE inhibitor.

Cough:

During treatment with an ACE inhibitor is likely to occur on a dry and non-productive cough, which resolved with withdrawal of the drug.
Drug Interactions

Diuretics:

Patients on diuretics and especially the volume and / or sodium depletion, can be observed very low blood pressure and / or renal dysfunction. Following initiation of therapy with an ACE inhibitor, the risk of hypotension can be reduced by discontinuation of the diuretic, by increasing the pre-salt intake and by starting treatment with a low dose, eg. 0,5 mg Gopten ®. Further increase in dose should be done carefully.
Lithium
Co-administration of ACE inhibitors and lithium may reduce the excretion of lithium. Serum lithium levels should be monitored regularly.

Antihypertensive drugs:

Often an increase in the hypotensive effect of ACE inhibitors.
Allopurinol, cytostatic, immunosuppressive agents, systemic corticosteroids or procainamide:
Edoremennata use with ACE inhibitors leads to increased risk of leucopenia.

NSAIDs:

The appointment of NSAIDs may reduce the antihypertensive effect of ACE inhibitors.

Antacid:

Antacids reduce the bioavailability of ACE inhibitors (recommended these products be considered separately).

Antidiabetic agents:

Although clinical studies have not shown an increased risk of hypoglycemia in diabetic patients treated concomitantly with insulin or oral antidiabetic agents and ACE inhibitors may occasionally occur hypoglycemia. Therefore, in diabetic patients treated with oral antidiabetic agents and Gopten, blood sugar levels should be monitored closely, especially at the beginning of therapy or when increasing the dose.
Use in children and pregnant

Pregnancy

When people are not conducted adequate and well-controlled studies. ACE-inhibitors pass through the placenta and can cause fetal and neonatal morbidity and death when taken by pregnant women. Therefore, ACE inhibitors are contraindicated in pregnancy.

Breastfeeding

Due to lack of data, if treatment is needed during breastfeeding should be discontinued or nursing or therapy Gopten ®.

Children

Safety and effectiveness in children Gopten ® has not been studied.
Effects on ability to drive and use machines
Some side effects associated with lowering blood pressure may impair the ability of patients to concentrate and react, and in prticular their ability to drive or use machines. This applies mainly to the initial phases of treatment.

Dosage

Dosing in elderly hypertensive patients with normal renal and hepatic function without acute heart failure
The usual dose is 2 mg Gopten ® once daily. It can be increased to a maximum dose of 4 mg Gopten ® once daily.
Dosage in adults with impaired left ventricular function after myocardial infarction. After myocardial infarction therapy should begin as early as the third day. Treatment should be initiated at a daily dose of 0,5 mg Gopten ® gradually increased to 4 mg Gopten ® as a single daily dose.
Dosage in adults with pre-existing diuretic therapy, diuretic therapy should be discontinued at least 3 days before starting therapy Gopten ® and / or early treatment with 0,5 mg Gopten as a single daily dose. Dosage adjustment in renal impairment
In patients with mild to moderate renal impairment (creatinine clearance 10-70 ml / min) is recommended usual dosage for adults and the elderly. In patients with severe renal impairment (creatinine clearance <10 ml / min) is also recommended usual dosage for adults and the elderly, but the maximum daily dose should not exceed 2 mg. In these patients, treatment should be initiated under close medical supervision.

Usage

Gopten ® should be taken once daily in the dosage at the same time of day. The capsules should be swallowed whole with some liquid. Since absorption Gopten not affected by food, it can be taken before, during or after meals.

Side effects

Adverse effects were generally mild. In long-term clinical trials Gopten most frequently reported adverse events were cough, headache, malaise and dizziness.
Overdose
The symptoms expected with ACE inhibitors, including severe hypotension, shock, bradycardia, electrolyte disturbances and renal failure. In case of overdose after recent intake should consider gastric lavage. Blood pressure should be monitored and if hypotension, can be taken to increase blood volume.
Abuse and dependence
No risk of abuse and dependence treatment with Trandolapril.
Storage conditions and shelf life
Store at room temperature.
This medicinal product must not be stored after LABELLING date.
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