NIPRIDE RTU Solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

EXELA PHARMA SCIENCES, LLC

Λέξεις κλειδιά

51754-1006 51754-1018 51754-1029

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION: Sodium Nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ...

1. Indications and Usage

1.1 Immediate Reduction of Blood Pressure Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. 1.2 Induction and Maintenance ...

2. Dosage and Administration

2.1 Inspection Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Sodium nitroprusside should be a clear colorless ...

3. Dosage Forms and Strengths

Injection: 50 mg/100 mL of 0.9% sodium chloride (0.5 mg/mL), 20 mg/100 mL of 0.9% sodium chloride (0.2 mg/mL), and 10 mg/50 mL of 0.9% sodium chloride (0.2 mg/mL). NIPRIDE RTU is supplied as a sterile, ...

4. Contraindications

Diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting). Inadequate cerebral circulation or in moribund patients (A.S.A. Class 5E) coming to emergency surgery. ...

5. Warnings and Precautions

5.1 Excessive Hypotension Sodium nitroprusside, can cause excessive hypotension leading to hypoperfusion of vital organs. Hypotension should resolve within 1-10 minutes after discontinuation of the nitroprusside ...

6. Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections: Hypotension [see Warnings and Precautions (5.1)] Cyanide Toxicity [see Warnings and Precautions ...

8.1. Pregnancy

Risk Summary Based on animal data and mechanism of action, sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus [see Clinical Pharmacology (12.3) and Clinical ...

8.2. Lactation

Risk Summary There is no information about the presence of sodium nitroprusside in human milk, the effects on the breastfed infant, or the effects on milk production. Thiocyanate, one of sodium nitroprusside ...

8.4. Pediatric Use

Efficacy in the pediatric population was established based on adult trials and supported by the dose-ranging trial (Study 1) and an open label trial of at least 12 hour infusion at a rate that achieved ...

10. Overdosage

Overdosage of nitroprusside can be manifested as excessive hypotension or cyanide toxicity [see Warnings and Precaution (5.1, 5.2)] or as thiocyanate toxicity [see Warnings and Precautions ...

11. Description

Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is: Sodium Nitroprusside has molecular formula Na2[Fe(CN)5 ...

12.1. Mechanism of Action

Sodium nitroprusside interacts with oxyhemoglobin to produce methemoglobin, cyanide, and nitric oxide (NO). NO then reacts with guanylate cyclase in vascular smooth muscle to produce cGMP that reduces ...

12.2. Pharmacodynamics

In association with the decrease in blood pressure, sodium nitroprusside administered intravenously to hypertensive and normotensive patients produces slight increases in heart rate and a variable effect ...

12.3. Pharmacokinetics

Infused sodium nitroprusside is rapidly distributed to a volume that is approximately coextensive with the extracellular space. The drug is cleared by intraerythrocytic reaction with hemoglobin (Hgb), ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies assessing sodium nitroprussides carcinogenicity and mutagenicity have not been conducted. Similarly, sodium nitroprusside has not been tested for effects on fertility.

13.2. Animal Toxicology and/or Pharmacology

The acute intravenous mean lethal doses (LD50) of nitroprusside in rabbits, dogs, mice, and rats are 2.8, 5.0, 8.4, and 11.2 mg/kg, respectively.

14. Clinical Studies

Baseline-controlled clinical trials have uniformly shown that sodium nitroprusside has a prompt hypotensive effect, at least initially, in all populations. With increasing rates of infusion, sodium nitroprusside ...

16.1. How Supplied

NIPRIDE RTU is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) Fliptop Vials (NDC 51754-1006-1), 20 mg/100 mL (0.2 mg/mL) Fliptop Vials (NDC 51754-1029-1) and 10 mg/50 mL (0.2 mg/mL) Fliptop ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].