VECURONIUM BROMIDE 20 mg/1
VECURONIUM BROMIDE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Eugia US LLC
VECURONIUM BROMIDE is a injection, powder, lyophilized, for solution containing vecuronium bromide at 20 mg/1, taken intravenous. Manufactured by Eugia US LLC.
Key Facts
- Brand Name
- VECURONIUM BROMIDE
- Generic Name
- VECURONIUM BROMIDE
- NDC Code (Product)
55150-236- Manufacturer
- Eugia US LLC
- Strength
- 20 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206670
- Marketing Start
- 12/20/2018
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Sagent Pharmaceuticals Inc
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Pharmedium Services, LLC
Lack of sterility assurance.
Fresenius Kabi USA, LLC
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Ben Venue Laboratories Inc
Presence of Particulate Matter
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Vecuronium bromide for injection is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Dosage & Administration
DOSAGE AND ADMINISTRATION Vecuronium bromide for injection is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. Dosage must be individualized in each case. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only, especially regarding enhancement of neuromuscular blockade of vecuronium bromide by volatile anesthetics and by prior use of succinylcholine (see PRECAUTIONS: Drug Interactions ). To obtain maximum clinical benefits of vecuronium bromide and to minimize the possibility of overdosage, the monitoring of muscle twitch response to peripheral nerve stimulation is advised. The recommended initial dose of vecuronium bromide is 0.08 to 0.1 mg/kg (1.4 to 1.75 times the ED 90 ) given as an intravenous bolus injection. This dose can be expected to produce good or excellent non-emergency intubation conditions in 2.5 to 3 minutes after injection. Under balanced anesthesia, clinically required neuromuscular blockade lasts approximately 25 to 30 minutes, with recovery to 25% of…
Warnings
WARNINGS VECURONIUM SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND THE POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND REVERSAL AGENTS ARE IMMEDIATELY AVAILABLE. THE CLINICIAN MUST BE PREPARED TO ASSIST OR CONTROL RESPIRATION. TO REDUCE THE POSSIBILITY OF PROLONGED NEUROMUSCULAR BLOCKADE AND OTHER POSSIBLE COMPLICATIONS THAT MIGHT OCCUR FOLLOWING LONG-TERM USE IN THE I.C.U., VECURONIUM OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSES BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS AND WHO ARE FAMILIAR WITH APPROPRIATE PERIPHERAL NERVE STIMULATOR MUSCLE MONITORING TECHNIQUES (see PRECAUTIONS, Long Term Use in I.C.U. ). Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including VECURONIUM BROMIDE, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precaution…
Contraindications
CONTRAINDICATIONS Vecuronium bromide is contraindicated in patients known to have a hypersensitivity to it.
Drug Interactions
Drug Interactions Prior administration of succinylcholine may enhance the neuromuscular blocking effect of vecuronium and its duration of action. If succinylcholine is used before vecuronium, the administration of vecuronium should be delayed until the succinylcholine effect shows signs of wearing off. With succinylcholine as the intubating agent, initial doses of 0.04 to 0.06 mg/kg of vecuronium may be administered to produce complete neuromuscular block with clinical duration of action of 25 to 30 minutes (see CLINICAL PHARMACOLOGY ). The use of vecuronium before succinylcholine, in order to attenuate some of the side effects of succinylcholine, has not been sufficiently studied. Other nondepolarizing neuromuscular blocking agents (pancuronium, d-tubocurarine, metocurine, and gallamine) act in the same fashion as does vecuronium, therefore, these drugs and vecuronium, may manifest an additive effect when used together. There are insufficient data to support concomitant use of vecuronium and other competitive muscle relaxants in the same patient. Inhalational Anesthetics: Use of volatile inhalational anesthetics such as enflurane, isoflurane, and halothane with vecuronium will enh…
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reaction to nondepolarizing blocking agents as a class consists of an extension of the drug’s pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiration insufficiency or apnea. Inadequate reversal of the neuromuscular blockade is possible with vecuronium bromide as with all curariform drugs. These adverse reactions are managed by manual or mechanical ventilation until recovery is judged adequate. Little or no increase in intensity of blockade or duration of action with vecuronium bromide is noted from the use of thiobarbiturates, narcotic analgesics, nitrous oxide, or droperidol. See OVERDOSAGE for discussion of other drugs used in anesthetic practice which also cause respiratory depression. Prolonged to profound extensions of paralysis and/or muscle weakness as well as muscle atrophy have been reported after long-term use to support mechanical ventilation in the intensive care unit (see PRECAUTIONS, Long Term Use in I.C.U. ). The administration of vecuronium bromide has been associated with rare instances of hypersensitivit…
Frequently Asked Questions
What is VECURONIUM BROMIDE used for?
VECURONIUM BROMIDE contains VECURONIUM BROMIDE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is VECURONIUM BROMIDE a controlled substance?
VECURONIUM BROMIDE is not classified as a controlled substance by the DEA.
What is the generic name for VECURONIUM BROMIDE?
The generic name for VECURONIUM BROMIDE is VECURONIUM BROMIDE. There are 9 other brand versions of VECURONIUM BROMIDE.
What is the NDC code for VECURONIUM BROMIDE 20 mg/1?
The NDC (National Drug Code) for VECURONIUM BROMIDE 20 mg/1 is 55150-236, listed by Eugia US LLC.
Other VECURONIUM BROMIDE Dosages
Other Vecuronium Brands
See all →- Vecuronium Bromide10 mg/10143-9234
- Vecuronium Bromide1 mg/mL63323-781
- Vecuronium Bromide1 mg/mL68083-140
- Vecuronium Bromide10 mg/10mL71288-744
- Vecuronium Bromide20 mg/20mL71288-745
- Vecuronium Bromide10 mg/181565-206
- Vecuronium Bromide1 mg/mL63323-782
- Vecuronium Bromide1 mg/mL68083-139
- Vecuronium Bromide20 mg/20mL83301-0057
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)