Bridion Injection
Sugammadex sodium
100mg/ml
MERCK SHARP & DOHME LTD
| Pack size | 10 Vials (2ml) |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 3618.00 AED |
Indications
Bridion Injection is used for:
Reversal of Neuromuscular Blockers
Adult Dose
Intravenous
Reversal of Neuromuscular Blockers
Selective relaxant binding agent for reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adults undergoing surgery
Doses and timing of administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred
Administer as single IV bolus injection infused over 10 seconds into existing IV line
Dose on actual body weight
For rocuronium and vecuronium
A dose of 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1-2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade
A dose of 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade
For rocuronium only
A dose of 16 mg/kg is recommended if there is a clinical need to reverse neuromuscular blockade soon (~3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium
The efficacy of the 16-mg/kg dose following administration of vecuronium has not been studied
Child Dose
Renal Dose
Administration
IV Administration
Administer by IV bolus into existing running IV line (see IV compatibilities)
Ensure the infusion line is adequately flushed (eg, with 0.9% NaCl) between sugammadex sodium and administration of other drugs
Contra Indications
Known hypersensitivity to sugammadex or any of its components
Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (ie, anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex
Not recommended for patients with severe renal impairment (CrCl <30 mL/min) and those on dialysis
Precautions
Marked bradycardia reported, some resulting in cardiac arrest, within minutes following sugammadex administration
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured
A small number of patients experienced a delayed or minimal response to sugammadex; it is important to monitor ventilation until recovery occurs
Lower than recommended sugammadex doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended
Drugs that potentiate neuromuscular blockade (eg, aminoglycosides, opioids) are used in the postoperative phase, so special attention should be paid to the possibility of recurrence of neuromuscular blockade
Do not use to reverse blockade induced by nonsteroidal neuromuscular blocking agents (eg, succinylcholine, benzylisoquinolinium compounds)
Risk of adverse reactions may be greater in patients with impaired renal function; care should be taken in the elderly when selecting dose, may be useful to monitor renal function
Do not use to reverse neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium
Lactation
Unknown if distributed in human breast milk
Present in rat milk
Pregnancy-Lactation
Pregnancy
There are no data on use in pregnant women to inform any drug-associated risks
In animal reproduction studies, there was no evidence of teratogenicity following daily IV administration to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg
However, there was an increase in the incidence of incomplete ossification of the sternebra and reduced fetal body weights in rabbits
Lactation
Unknown if distributed in human breast milk
Present in rat milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Toremifene has a relatively high binding affinity for sugammadex, and therefore, some displacement of vecuronium or rocuronium from the sugammadex binding complex could occur and result in recurrence of neuromuscular blockade
Hormonal contraceptives
May bind to progestogen, thereby decreasing progestogen exposure
Administration of a bolus dose of sugammadex is considered to be equivalent to missing dose(s) of oral contraceptives containing an estrogen or progestogen; if an oral contraceptive is taken on the same day that sugammadex is administered, the patient must use an additional, nonhormonal contraceptive method or backup method of contraception (eg, condoms and spermicides) for the next 7 days
In the case of hormonal hormonal contraceptives not taken orally, the patient must use an additional, hormonal contraceptive method or backup method of contraception (eg, condoms and spermicides) for the next 7 days
Sugammadex may also interfere with serum progesterone assay
Adverse Effects
Side effects of Sugammadex sodium :
>10%
Pain (36-52%)
Nausea (23-26%)
Vomiting (11-15%)
Hypotension (4-13%)
1-10%
Headache (5-10%)
Pyrexia (5-9%)
Hypertension (5-9%)
Airway complication of anesthesia (1-9%)
Anesthetic complication (1-9%)
Procedural complication (1-8%)
Cough (1-8%)
Chills (3-7%)
Incision site pain (4-6%)
Abdominal pain (4-6%)
Dizziness (3-6%)
Pain in extremity (1-6%)
QT interval abnormal (1-6%)
Oropharyngeal pain (3-5%)
Insomnia (2-5%)
Tachycardia (2-5%)
Bradycardia (1-5%)
Pruritus (2-3%)
Flatulence (1-3%)
Hypoesthesia (1-3%)
Anxiety (1-3%)
Wound hemorrhage (1-2%)
Dry mouth (1-2%)
Restlessness (1-2%)
Depression (1-2%)
Decreased RBCs (1-2%)
Increased CPK (1-2%)
Musculoskeletal pain (1-2%)
Myalgia (1-2%)
Erythema (1-2%)
Hypocalcemia (1-2%)
Mechanism of Action
Selective relaxant binding agent; forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction
Note
Bridion 100mg/ml Injection manufactured by MERCK SHARP & DOHME LTD. Its generic name is Sugammadex sodium. Bridion is availble in United Arab Emirates.
Farmaco UAE drug index information on Bridion Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.