QUELICIN Solution for injection (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Hospira, Inc.

Λέξεις κλειδιά

0409-6629 0409-6970

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BOXED WARNING SECTION

WARNING RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest and ...

1. Description

QUELICIN (Succinylcholine Chloride Injection, USP) is a sterile, nonpyrogenic solution to be used as an ultra short-acting, depolarizing, skeletal muscle relaxant See HOW SUPPLIED for summary of content ...

2. Clinical Pharmacology

Succinylcholine is a depolarizing skeletal muscle relaxant. As does acetylcholine, it combines with the cholinergic receptors of the motor end plate to produce depolarization. This depolarization may be ...

3. Indications and Usage

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

4. Contraindications

Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated ...

5. Warnings

Succinylcholine should be used only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation ...

6. Precautions

Reduced Plasma Cholinesterase Activity Succinylcholine should be used carefully in patients with reduced plasma cholinesterase (pseudocholinesterase) activity. The likelihood of prolonged neuromuscular ...

6.1. General

When succinylcholine is given over a prolonged period of time, the characteristic depolarization block of the myoneural junction (Phase I block) may change to a block with characteristics superficially ...

6.4. Drug Interactions

Drugs which may enhance the neuromuscular blocking action of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies performed in animals to evaluate carcinogenic potential of succinylcholine. Genetic toxicology studies have not been completed to evaluate the genotoxic potential of ...

6.7. Pregnancy

Risk Summary It is also not known whether succinylcholine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted ...

6.8. Labor and Delivery

Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. While small amounts of succinylcholine are known to cross the placental barrier, under normal conditions ...

6.9. Nursing Mothers

It is not known whether succinylcholine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised following succinylcholine administration to a nursing woman. ...

6.10. Pediatric Use

Safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. There are rare reports of ventricular dysrhythmias and cardiac arrest ...

6.11. Geriatric Use

Clinical studies of QUELICIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

Adverse reactions to succinylcholine consist primarily of an extension of its pharmacological actions. Succinylcholine causes profound muscle relaxation resulting in respiratory depression to the point ...

9. Overdosage

Overdosage with succinylcholine may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low ...

10. Dosage and Administration

The dosage of succinylcholine should be individualized and should always be determined by the clinician after careful assessment of the patient (see WARNINGS). Parenteral drug products should be inspected ...

11. How Supplied

QUELICIN (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in the following concentrations and packages: Unit of Sale Concentration NDC 0409-6970-10 1,000 ...

12. Storage and Handling

Store in refrigerator 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency.