Nitroprussiat Fides 50 mg powder for injection solution

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

NITROPRUSSIAT FIDES 50 mg powder for injectable solution

Sodium Nitroprusside

Read the entire leaflet carefully before you start using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are serious effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Nitroprussiat Fides Injectable is and what it is used for
2. What you need to know before using Nitroprussiat Fides Injectable
3. How to use Nitroprussiat Fides Injectable
4. Possible adverse effects
5. How to store Nitroprussiat Fides Injectable
6. Contents of the pack and other information

1. What Nitroprussiat Fides Inyectable is and what it is used for

Nitroprussiat Fides Inyectable, whose active substance is sodium nitroprusside, belongs to a group of medicines called antihypertensives, which help control high blood pressure (hypertension).

Nitroprussiat Fides Inyectable is indicated for:

• The treatment of hypertensive crises and refractory malignant hypertension (hypertension that does not respond to other treatments).
• Controlled hypotension during anesthesia, to reduce bleeding in surgical procedures. The surgeon and anesthesiologist must evaluate the suitability of treatment with nitroprusside on an individual basis.

2. What you need to know before using Nitroprussiat Fides Injectable

Do not use Nitroprussiat Fides Injectable

• If you are allergic to sodium nitroprusside or to any of the other ingredients of this medicine (listed in section 6).
• If you have compensatory hypertension, such as arteriovenous shunts or coarctation of the aorta (narrowing of a segment of the aorta).
• If you are at ASA class 5 risk, equivalent to patients who are moribund and not expected to survive without surgical intervention.
• If you have uncorrected anemia or hypovolemia (reduced circulating blood volume).
• If cerebral circulation is inadequate (cerebrovascular insufficiency).
• The use of sodium nitroprusside to induce controlled hypotension during anesthesia is contraindicated if you have hepatic disease, severe renal disease, Leber's optic atrophy (degeneration of retinal cells leading to vision loss), tobacco amblyopia (dimmed vision due to tobacco use), or diseases associated with vitamin B12 deficiency.
• If you are taking medications containing riociguat, a soluble guanylate cyclase stimulator.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Nitroprussiat Fides.

• Nitroprussiat Fides Injectable must never be administered directly without dilution, but only as a diluted intravenous infusion in glucose saline solution.

• During treatment with Nitroprussiat Fides Injectable, your doctor should monitor your blood pressure (every 5 minutes at the beginning of the infusion, then every 15 minutes), heart rate, and acid-base balance.

• Adverse effects due to cyanide or thiocyanate (potentially toxic metabolites of sodium nitroprusside) may occur during treatment (see section 4: Possible side effects). In the presence of renal and/or hepatic impairment, or when treatment lasts longer than 3 days or high doses of Nitroprussiat Fides Injectable are used, your doctor may consider it necessary to monitor blood levels of cyanide and thiocyanate.

• Abrupt discontinuation of the intravenous infusion may cause rebound hypertension. Therefore, the infusion should be discontinued gradually over 15–30 minutes.

• Careful dosage monitoring of Nitroprussiat Fides Injectable is required in cases of acute coronary or cerebrovascular insufficiency, and in patients with renal or hepatic impairment.

• With chronic treatment, high doses, and/or in patients with renal or hepatic impairment, accumulation of cyanide or thiocyanate—potentially toxic metabolites of sodium nitroprusside—may occur.

• Hypertensive patients are more sensitive to the effects of sodium nitroprusside than those with normal blood pressure. Patients receiving antihypertensive medications are also more sensitive to the hypotensive effect of sodium nitroprusside. In such cases, the dose of sodium nitroprusside should be reduced.

• In patients with anemia or hypovolemia (reduced blood volume), these conditions should be corrected as much as possible before administering sodium nitroprusside—or any vasodilator—to control hypotension during anesthesia.

• Administration of Nitroprussiat Fides Injectable must be strictly supervised by trained medical personnel and should only be performed in settings equipped for continuous arterial pressure monitoring.

Use of Nitroprussiat Fides with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Nitroprussiat Fides Injectable is completely incompatible with other medications and must always be administered separately. It must not be administered directly, but only as an intravenous infusion diluted in isotonic glucose solution (sterile 4.7–5% glucose in water).

Concomitant use of sodium nitroprusside and other antihypertensive agents may enhance the hypotensive effect.

The use of Nitroprussiat Fides with riociguat, a soluble guanylate cyclase stimulator, is contraindicated, as concomitant use may cause severe hypotension (see also “Do not use Nitroprussiat Fides Injectable”).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The potential use of Nitroprussiat Fides Injectable in pregnant women has not been fully established. Therefore, it should be used only when potential benefits outweigh possible risks.

It is unknown whether sodium nitroprusside is excreted in significant amounts in human milk; therefore, its use is not recommended during breastfeeding.

Driving and use of machines

It is not known how this medicine affects the ability to drive or operate machinery. Therefore, tasks requiring special attention should not be performed until the individual response to the medicine has been determined.

Nitroprussiat Fides Injectable contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially “sodium-free”.

3. How to use Nitroprussiat Fides Inyectable

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

The dosage will be adjusted by the physician in each case according to the desired hypotensive effect, which must be monitored by frequent blood pressure measurements.

As a general guideline, in patients not receiving any antihypertensive medication, the average dose of Nitroprussiat Fides Inyectable is 3 (0.5–8) μg/kg/min, whereas lower doses are required in patients receiving concomitant oral antihypertensive agents.

It is recommended not to exceed a dose of 1.5 μg/kg/min when inducing controlled hypotension during anesthesia.

Infusion of Nitroprussiat Fides Inyectable may be continued until the patient can be satisfactorily managed with oral antihypertensive medication.

Method of administration:

Preparation of infusion solution and precautions:

The contents of the vial should be dissolved in 5 ml of 5% glucose in water solution (no other solvent should be used). This stock solution is then diluted in 500–1000 ml of isotonic glucose solution (sterile 4.7–5% glucose in water), taking care from this point onward to protect the solution from light (by wrapping the infusion bottle in the aluminum foil provided in the package). Once prepared, the solution should be used immediately.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the user's responsibility and normally should not exceed 24 hours at 2–8 °C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Nitroprussiat Fides Inyectable acts rapidly; therefore, it must be administered as a continuous infusion (drop by drop), with careful regulation of the infusion rate in order to achieve a gradual reduction in blood pressure to the desired level. For this reason, administration of Nitroprussiat Fides Inyectable must necessarily be supervised by trained medical personnel, who must continuously monitor blood pressure.

Use in children

In children not receiving antihypertensive medication, the average dose of Nitroprussiat Fides Inyectable is 3 (0.5–8) μg/kg/min, whereas lower doses are required in patients receiving concomitant oral antihypertensive agents.

The potential use of Nitroprussiat Fides Inyectable in very young children has not yet been well established.

Use in patients over 65 years of age

Elderly patients may be more sensitive to the hypotensive effects of sodium nitroprusside.

If you use more Nitroprussiat Fides Inyectable than you should

Signs of overdose may manifest as excessive hypotension or symptoms of cyanide or thiocyanate toxicity (see section 4: Possible side effects).

In case of overdose with Nitroprussiat Fides Inyectable, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the name of the medicine and the amount ingested). Bring this leaflet with you.

If you forget to use Nitroprussiat Fides Inyectable

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects are listed below, classified according to the following frequency categories:

• Very common (more than 1 in 10 patients): hypotensive crises (particularly associated with intravenous infusion that is too rapid), which resolve rapidly upon reducing or stopping administration of the medicine. Nervousness, disorientation, headache, nausea, vomiting, and abdominal pain.

• Uncommon (less than 1 in 100 patients, but more than 1 in 1,000 patients): signs of cyanide or thiocyanate toxicity, such as tinnitus (ringing or buzzing in the ears), blurred vision, hypothyroidism, metabolic acidosis (decrease in blood pH), confusion, psychosis (mental state involving loss of contact with reality), ataxia (lack of coordination in body movements), and dyspnea (difficulty breathing or shortness of breath). The risk of these adverse reactions increases with prolonged treatment, high doses, and/or in patients with renal or hepatic impairment. Undesirable effects from cyanide may be minimized by administering hydroxocobalamin (vitamin B12) concomitantly with Nitroprussiat Fides Inyectable.

• Rare (less than 1 in 1,000 patients, but more than 1 in 10,000 patients): methemoglobinemia (a blood disorder in which the body cannot recycle hemoglobin), hyperreflexia (exaggerated reflexes), somnolence, miosis (pupil constriction), tachycardia (rapid pulse), arrhythmias (cardiac rhythm disturbances), hyperventilation (faster and/or deeper breathing than normal), rash (changes in the skin affecting color, appearance, and texture), and weakness.

• Very rare (frequency not known): hypoxia (lack of oxygen), myasthenia (a disease characterized by muscle weakness), muscle cramps, excessive sweating, loss of consciousness.

The required monitoring of the medication's effects by specialized personnel makes the risk of intoxication with Nitroprussiat Fides Inyectable highly unlikely.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nitroprussiat Fides Injectable

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nitroprussiat Fides for injection

• The active substance is sodium nitroprusside. Each vial contains 50 mg of sodium nitroprusside.
• The other components are: sodium citrate, anhydrous citric acid, and water for injections.

Appearance of the product and contents of the pack

Orange-pink lyophilized powder.

Nitroprussiat Fides 50 mg powder for injectable solution is supplied in cartons containing 1 vial with lyophilized powder and aluminum foil to protect the infusion solution from light once prepared.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

LABORATORIO REIG JOFRE, S.A.
C/ Gran Capitán, 10, 08970 Sant Joan Despí
Barcelona - Spain

Further information about this medicinal product can be requested by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent revision of this package leaflet: August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/