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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

CYANOKIT Powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Meridian Medical Technologies, Inc.

Λέξεις κλειδιά

11704-370

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1. Indications and Usage

CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions If clinical suspicion of cyanide poisoning is high, administer CYANOKIT without delay. Comprehensive treatment of acute cyanide intoxication requires ...

3. Dosage Forms and Strengths

CYANOKIT (hydroxocobalamin for injection) for intravenous infusion consists of 1 vial, containing 5 g lyophilized hydroxocobalamin dark red crystalline powder for injection. After reconstitution, the vial ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Emergency Patient Management In conjunction with CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, ...

6. Adverse Reactions

Serious adverse reactions with hydroxocobalamin include allergic reactions, renal injury, and increases in blood pressure <em>[see Warnings and Precautions (5.2, 5.3, 5.4)]</em>.

6.1. Clinical Trials Experience

Experience in Healthy Subjects Because clinical trials were conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice. ...

6.3. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CYANOKIT. Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Formal drug interaction studies have not been conducted with CYANOKIT. Interference with Laboratory Tests Because of its deep red color, hydroxocobalamin has been found to interfere with colorimetric determination ...

8.1. Pregnancy

Risk Summary Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major ...

8.2. Lactation

Risk Summary Breastfeeding is not recommended during treatment with CYANOKIT. There are no data to determine when breastfeeding may be safely restarted following administration of CYANOKIT. Hydroxocobalamin ...

8.4. Pediatric Use

Safety and effectiveness of CYANOKIT have not been established in this population. In non-US marketing experience, a dose of 70 mg/kg has been used to treat pediatric patients.

8.5. Geriatric Use

Approximately 50 known or suspected cyanide poisoning victims aged 65 or older received hydroxocobalamin in clinical studies. In general, the safety and effectiveness of hydroxocobalamin in these patients ...

8.6. Renal Impairment

The safety and effectiveness of CYANOKIT have not been studied in patients with renal impairment. Hydroxocobalamin and cyanocobalamin are eliminated unchanged by the kidneys.

8.7. Hepatic Impairment

The safety and effectiveness of CYANOKIT have not been studied in patients with hepatic impairment.

10. Overdosage

No data are available about overdose with CYANOKIT in adults. Should overdose occur, treatment should be directed to the management of symptoms. Hemodialysis may be effective in such a circumstance, but ...

11. Description

Hydroxocobalamin, the active ingredient in CYANOKIT, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole, an antidote. ...

12.1. Mechanism of Action

Cyanide is an extremely toxic poison. In the absence of rapid and adequate treatment, exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting ...

12.2. Pharmacodynamics

Administration of CYANOKIT to cyanide-poisoned patients with the attendant formation of cyanocobalamin resulted in increases in blood pressure and variable changes in heart rate upon initiation of hydroxocobalamin ...

12.3. Pharmacokinetics

Following intravenous administration of hydroxocobalamin significant binding to plasma proteins and low molecular weight physiological compounds occurs, forming various cobalamin-(III) complexes by replacing ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term animal studies have not been performed to evaluate the carcinogenic potential of hydroxocobalamin. Mutagenesis Hydroxocobalamin was negative in the following mutagenicity assays: ...

14. Clinical Studies

14.1 Animal Toxicology and/or Pharmacology The effectiveness of CYANOKIT for treatment of cyanide poisoning has not been determined in humans because inducing cyanide poisoning in humans to study the drug ...

16.1. How Supplied

Each CYANOKIT carton (NDC 11704-370-01) consists of the following: One 250 mL glass vial, containing lyophilized hydroxocobalamin for injection, 5 g One sterile transfer spike One sterile intravenous infusion ...

16.2. Storage and Handling

Lyophilized form Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. CYANOKIT may be exposed during short periods to the temperature variations of ...

17. Patient Counseling Information

CYANOKIT is indicated for cyanide poisoning and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information. Erythema and Chromaturia Advise patients ...