Quickly and completely absorbed after oral administration. Bioavailability is 90 to 100%.
We describe the development testosterone propionate of tolerance and cross-tolerance with other nitro compounds by prolonged continuous treatment with high doses of isosorbide – 5 -mononitrata. To prevent degradation or loss of effectiveness, to avoid continuous administration of high doses.
Indications for use:
Prevention of angina attacks in patients with coronary heart disease, including after myocardial infarction;
treatment of chronic heart failure (in combination therapy).
- hypersensitivity to organic nitrates or other ingredients;
- acute circulatory disorders (shock, circulatory collapse);
- acute myocardial infarction with severe arterial hypotension;
- cardiogenic shock, if you do not provide a sufficiently high end-diastolic pressure in the left ventricle through the use of intra-aortic counterpulsation or by introducing tools that have a positive inotropic effect;
- toxic pulmonary edema;
- anemia (severe);
- marked hypotension (systolic blood pressure less than 90 mmHg and diastolic blood pressure less than 60 mmHg).
- concomitant use of phosphodiesterase inhibitors, including sildenafil, vardenafil, tadalafil, since they potentiate the effect of nitrates antihypertensive;
- hereditary galactose intolerance, lactase deficiency or malabsorption syndrome of glucose and galactose;
- childhood and adolescence to 18 years (effectiveness and safety have been established).Carefully
- hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade;
- low filling pressure in acute myocardial infarction, left ventricular failure. There should be no reduction in systolic blood pressure below 90 mm Hg. Article .;
- aortic and / or mitral stenosis;
- tendency to orthostatic vascular disorders of regulation;
- glaucoma (risk of increased intraocular pressure);
- severe renal impairment;
- hepatic insufficiency (risk of methemoglobinemia);
- hemorrhagic stroke;
- diseases accompanied by increased intracranial pressure;
- recently transferred craniocerebral injury.
Pregnancy and breast-feeding
For security reasons Monocinque administered ® can be used during pregnancy and lactation only strictly prescribed by a doctor, after a thorough evaluation of the benefits and possible risks, because to date, little is known about the consequences of its use in pregnant women and nursing mothers. If a nursing mother still takes, you need to install parental monitoring for the development of the possible effects of the drug.
Dosage and administration:
Inside, after a meal with water, without chewing.
The frequency of administration and duration of treatment set individually.
Start therapy tselesooobrazno with 1/2 tablet (20 mg) 2 times a day. Then gradually increase the dose to the therapeutic:. 1 tablet (40 mg) to receive 2-3 times a day at intervals of 7-8 hours
maximum testosterone propionate daily dose is 120 mg.
Before the drug at therapeutic doses, no – no significant side effects usually do not develop. Very often (≥10%): “Nitrate” headache can occur in the beginning of the treatment, and with continued therapy usually lasts for several days. Often (≥1% – <10%): after the first dose or after increasing the dose of the drug can occur lowering blood pressure and / or the development of orthostatic hypotension, which may be accompanied by tachycardia, dizziness, and weakness. From the nervous system: stiffness, drowsiness, blurred vision, decreased ability to rapid mental and motor reactions (especially at the beginning of treatment). Rarely (≥0,1% – <1%): There may be nausea, vomiting, possibly feeling light burning tongue, dry mouth. . facial flushing and skin allergic reactions . Marked reduction in blood pressure is accompanied by worsening angina (a paradoxical reaction to nitrates) Cases of collaptoid states, sometimes with bradyarrhythmia and syncope. Individual cases (<0.01%): exfoliative dermatitis.
Lowering blood pressure with orthostatic dysregulation, reflex tachycardia, and headache. It may appear weakness, dizziness, “tides” of heat, nausea, vomiting and diarrhea.
Should expect methemoglobinemia, cyanosis, dyspnea and tachypnea due to the formation of nitrite ions as a result of the metabolism of isosorbide mononitrate in high doses (20 mg / kg body weight) .
Very high doses can lead to increased intracranial pressure with the appearance of cerebral symptoms.
in chronic overdose may cause a higher level of methemoglobin, although the clinical significance of this has not been definitively established. Therapy: in addition to general recommendations, such as gastric lavage and laying the patient in a horizontal position (legs raised high), should monitor the main indicators of vital signs and adjust if necessary. Patients with severe hypotension and / or shock should be administered liquid; in exceptional cases, to improve blood circulation can be performed infusion noradrenaline (norepinephrine), and / or dopamine. Introduction of epinephrine (adrenaline) and related compounds is contraindicated. Depending on testosterone propionate the severity, the following safeners are used in cases of methemoglobinemia:
- Vitamin C 1 g orally or in the form of the sodium salt intravenously
- methylene blue: 50 ml of a 1% solution of methylene blue intravenously
- toluidine blue: initially 2.4 mg / kg body weight intravenously; then, if necessary, may be repeated administration of 2 mg / kg body weight with an interval between doses in one hour.
- Oxygen therapy, hemodialysis, exchange transfusion
Interaction with other drugs
When applied with other vasodilators, antihypertensive agents, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, blockers “slow” calcium channel (BCCI), diuretic, antipsychotic agents (neuroleptics) or tricyclic antidepressants, inhibitors of phosphodiesterase, including sildenafil, vardenafil, tadalafil, as well as with ethanol may increase antihypertensive action Monocinque administered drug® .
barbiturates accelerate metabolism and reduce the concentration of isosorbide mononitrate in the blood.
Reduces the effect of vasopressors.
in combination with amiodarone, propranolol, BCCI (verapamil, nifedipine, etc.) may strengthening anti-anginal effect.
Under the influence of beta-agonists, alpha-blockers (dihydroergotamine, etc.) may reduce the antianginal effects (tachycardia and excessive reduction of blood pressure).
The combined use with M-holinoblokatorami (atropine, and others.) increases the likelihood of increased intraocular pressure.
Adsorbents, binders and overlying drugs reduce the absorption of isosorbide mononitrate of the gastrointestinal tract.
The therapeutic effect of norepinephrine (noradrenaline) decreases while admission to nitro compounds.
Monocinque ® should not be used for the relief of acute attacks of angina and acute myocardial infarction.
During therapy requires control of blood pressure and heart rate.
Avoid abrupt discontinuation of the drug (dose reduced gradually).
Perhaps the development of tolerance to monocinque ® or cross-tolerance to other nitro compounds (reducing the effectiveness of the drug as a result of previous use of other nitro compounds). To prevent the development of tolerance to the action Monocinque administered ® , should be avoided in the continuous administration of high doses.
For patients with circulatory lability may develop symptoms of acute circulatory failure even when receiving the first formulation. “Nitrate” Headaches can be largely prevented if at the beginning of therapy, take 1/2 tablet Monocinque administered ® in the morning and in the evening:
During the period of treatment should be to exclude the use of ethanol.
Effects on ability to drive and use machines
During treatment is not recommended to drive vehicles and doing other potentially hazardous activities that require a rapid psychomotor reactions.