Universal reference book for medicines
Product name: NANIPRUS (NANIPRUS)

Active substance: sodium nitroprusside

Type: Peripheral Vasodilator

Manufacturer: SOPHARMA (Bulgaria)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for infusions
in the form of an unformulated tablet with coarse mesh structure or coarse-grained powder from light orange with a brownish tint to orange;
lyophilizate solution is a clear liquid of light brown color.
1 amp.

sodium nitroprusside 30 mg

Excipients: sodium citrate dihydrate.

Solvent: water d / and (5 ml).

Ampoules of dark glass with a volume of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Peripheral vasodilator.
Has arteriodilating, venodilating and antihypertensive action.
Naniprus reduces the tone of the arteries and veins due to direct myotropic action.
Expanding the peripheral arterial vessels, sodium nitroprusside reduces afterload, reduces the filling pressure of the left ventricle, reduces blood pressure. Expanding the peripheral veins, reduces preload on the heart, which leads to improved systemic and intracardiac hemodynamics, reducing pressure in the small circle of the circulation. In some cases, it causes a reflex tachycardia.
The mechanism of action is associated with both activation of guanylate cyclase and with increased intracellular cyclic guanosine monophosphate, and with suppression of the current of calcium ions (direct inhibition of the entry of calcium ions through slow channels) and violation of phosphorylation of myosin.

Antihypertensive effect develops in the first minute after intravenous administration.
The effect of the drug is short-lived because of rapid metabolism in the blood.
PHARMACOKINETICS

Distribution

With intravenous injection, sodium nitroprusside is rapidly distributed and reaches V d corresponding to extracellular space (volume).

Metabolism and excretion

Metabolized completely within a few minutes by erythrocyte enzymes, with the formation of iron ions, cyanides and methemoglobin.
Methemoglobin and cyanide are released slowly into blood plasma from erythrocytes and reaching the liver, are transformed into thiocyanate with the participation of thiosulphate and rhinogenase enzyme. Thiocyanate is excreted by the kidneys (up to 80%).
In patients with normal renal function, T 1/2 of the blood plasma is about 3 days.
The renal clearance of thiocyanate is about 2.2 ml / min. It penetrates through the BBB and placental barrier, in small amounts is excreted in breast milk.
Pharmacokinetics in special clinical cases

With renal insufficiency T 1/2 from the blood plasma can increase by 2-3 times.

INDICATIONS

- hypertensive crisis;

- controlled arterial hypotension during surgical interventions (to reduce blood loss);

- acute heart failure if it is necessary to rapidly decrease the post-loading of the left ventricle, to reduce the filling pressure of the left ventricle;

- acute left ventricular failure with pulmonary edema.

DOSING MODE

Introduce IV in the form of infusion.

Naniprus treatment is performed in a hospital with the ability to monitor blood pressure, carry out resuscitation and if funds are available to treat cyanide intoxication.

Intravenous bolus administration of Naniprus is contraindicated.

The dose is set individually for constant monitoring of blood pressure.

Hypertensive crisis, controlled arterial hypotension during surgical interventions

Adults: for patients who did not receive antihypertensive drugs, the dose is usually 3 μg / kg / min.
The initial dose is 0.3-1.5 μg / kg / min. The dose is increased gradually (by 0.5 μg / kg / min every 5 minutes) until the antihypertensive effect is achieved. The dose is adjusted so that the decrease in blood pressure during the first hour of infusion does not exceed 25% of the baseline, because of the risk of myocardial, brain or kidney ischemia. The maximum dose for adults is 8-10 μg / kg / min.
If the administration for 10 min at a rate of 10 mcg / kg / min does not cause an adequate lowering of blood pressure, it is recommended that the infusion be stopped immediately.

Do not exceed a dose of more than 500 μg / min.

To control arterial hypotension during surgery or against the background of taking antihypertensive drugs 3 hours before infusion , it is enough to enter a total dose of 1 mg / kg of body weight.

To avoid compensatory reaction (sharp increase in catecholamines and renin, tachycardia), especially in young patients, the dose should be gradually increased until the desired therapeutic effect is achieved.
The rate of administration is also reduced gradually, within 10-30 min to avoid a sharp increase in blood pressure.
Children: experience of using the drug Naniprus in children is limited.
The average dose is the same as for adult patients.
Patients of advanced age (over 65 years): treatment is started with the introduction of Naniprus in low doses, tk.
elderly patients are more sensitive to the drug (faster development of antihypertensive effect).
Duration of treatment

When the antihypertensive effect is achieved, the administration should be continued for only a few hours to avoid the risk of cyanide intoxication.
Treatment with Nanipressum should not be performed more than 72 hours. After the end of the drug, it is necessary to start an alternative treatment with antihypertensive agents for oral administration.
Heart failure

The initial dose is 10-15 μg / min, with a gradual increase every 10 minutes to 10-15 μg / min.
If necessary, to achieve a satisfactory therapeutic effect, the dose can be increased in the range of 10-200 μg / min.
If during the administration of the drug symptoms of arterial hypotension, hypoperfusion or some other adverse reactions develop, the speed of infusion should be reduced or discontinued.

Infusion introduction can be continued until the moment of safe transition to therapy inside.
As a rule, the drug should be applied no more than 72 hours.
Rules for the preparation and administration of an infusion solution

Naniprus in the form of lyophilized powder should be used only for the preparation of a diluted infusion solution.
The infusion solution is prepared immediately before use (it is not allowed to use the solution after 4 hours after cooking).
The contents of 1 ampoule of the drug are diluted in the attached solvent.
The resulting solution is further diluted in 500 ml of a 5% solution of dextrose (glucose) or 0.9% sodium chloride solution, protecting the infusion solution from exposure to light. Infusion is carried out with the help of an infusion pump with continuous monitoring of blood pressure.
The entire infusion system must be isolated from direct sunlight with a black plastic bag.

Infusion solution should not be mixed with other drugs.

SIDE EFFECT

Adverse reactions are due to the ability of the drug to rapidly and significantly reduce blood pressure or toxicity of its main metabolites (cyanide and thiocyanate).

Possible: nausea, vomiting, increased sweating, headache, anxiety, dizziness, muscle spasms, hyperreflexia, rapid decrease in blood pressure, tachycardia, bradycardia, discomfort behind the sternum, abdominal pain;
when used in excessively high doses - the development of intoxication with cyanides (vomiting, loss of consciousness, tissue hypoxia); with a rapid cessation of infusion - the syndrome "ricochet". These symptoms disappear when the rate of infusion slows down or when the infusion is temporarily stopped.
Dermatological reactions: very rarely - skin rashes, itching, erythema (require discontinuation of infusion).

Local reactions: redness, swelling, acute phlebitis.

Other: rarely - decrease in platelet count;
very rarely - hypothyroidism.
CONTRAINDICATIONS

- symptomatic (compensatory) arterial hypertension (with arteriovenous shunting or coarctation of the aorta);

acute violation of cerebral circulation;

- increased intracranial pressure;

- arterial hypotension;

- chronic heart failure associated with reduced peripheral vascular resistance;

- aortic stenosis;

- hypovolemia;

- hypothyroidism (thiocyanate suppresses the absorption and binding of iodine);

- Vitamin B hypovitaminosis B 12 ;

- deficiency of sulforyl transferase (rhodanase) in patients with Leber's eye atrophy;

- atrophy of the optic nerve;

- glaucoma;

- severe hepatic impairment;

- severe renal failure;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to the active and auxiliary substances.

In emergency situations (according to vital indications), these contraindications are relative.

With caution should be used in patients with hypothermia, hyponatremia, ischemic heart disease, in elderly patients.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: marked renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindication: severe hepatic impairment.

APPLICATION FOR CHILDREN

Children: experience of using the drug Naniprus in children is limited.
The average dose is the same as for adult patients.
APPLICATION IN ELDERLY PATIENTS

Patients of advanced age (over 65 years): treatment is started with the introduction of Naniprus in low doses, tk.
elderly patients are more sensitive to the drug (faster development of antihypertensive effect).
SPECIAL INSTRUCTIONS

The development of hypertensive crisis with concomitant cerebrovascular phenomena is not an indication for Naniprus treatment.
The decision is made in the presence of visceral complications with an immediate threat to life.
In patients with hyponatremia and impaired renal function, prolonged treatment with Naniprus can result in higher plasma concentrations of the main thiocyanate metabolite.
Because the latter suppresses the absorption of iodine from the thyroid gland, symptoms of hypothyroidism may appear.
In young patients, in order to prevent a pronounced compensatory reaction associated with a sharp increase in the levels of catecholamines and renin, increasing and decreasing the dose are carried out gradually.

The entire infusion system must be isolated from direct sunlight with a black plastic bag.

The drug is used only in a hospital.

OVERDOSE

Symptoms: a marked decrease in blood pressure, sometimes the development of lactic acidosis may be an early symptom of an overdose.
In severe overdose in blood plasma, the level of cyanide increases.
Treatment: if symptoms of an overdose appear, stop Naniprus infusion immediately.
As an antidote, 1% solution of sodium nitrite can be used in combination with 20-50 ml of a solution of sodium thiosulfate (12.5 g in 50 ml of a 5% solution of dextrose (glucose).) Respiratory resuscitation, oxygen therapy and symptomatic agents - analeptics, cardiovascular agents, -Salt solutions, acid-base correcting agents, oxycobalamine 2.5 g (2.5 g in 100 ml 0.9% sodium chloride solution) for 7.5 min.
DRUG INTERACTION

Ganglia-blockers, general anesthetic agents, beta-blockers, diuretics, slow calcium channel blockers (diltiazem), ACE inhibitors (captopril) can enhance the antihypertensive effect of sodium nitroprusside.

Because
sodium nitroprusside is a donator of nitric oxide, it can not be used simultaneously with PDE5 inhibitors (sildenafil, vardenafil, tadalafil).
When combined with estrogen or sympathomimetics, the antihypertensive effect of Nanipresses is reduced.

Do not mix Naniprus infusion solution with other medicines.

TERMS OF RELEASE FROM PHARMACY

The drug is intended for hospital use only.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, dry, protected from light, at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 5 years.
Ready-made infusion solution must be used within 4 hours after its preparation.

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