Cisatracurium Besylate (Cisatracurium Besylate)

Trade Name : Cisatracurium Besylate

Somerset Therapeutics, LLC

INJECTION

Strength 2 mg/mL

CISATRACURIUM BESYLATE Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cisatracurium Besylate (Cisatracurium Besylate) which is also known as Cisatracurium Besylate and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 2 mg/mL per ml. Read more

Cisatracurium Besylate (Cisatracurium Besylate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Dosage and Administration (2.1) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2018
Warnings and Precautions, Residual Paralysis (5.1)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2018
Warnings and Precautions, Risk of Death Due to Medication Errors (5.5) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2018

Cisatracurium besylate injection, USP is indicated:
Limitations of Use
Cisatracurium besylate injection, USP is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated:
Limitations of Use:
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action

as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1)
to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1)
for mechanical ventilation in the ICU in adults (1)u00a0

ou00a0u00a0u00a0 Dosage and administration instructions in adults, pediatric patients, geriatric patients, patients with neuromuscular disease, burns, end-stage renal disease, and patients undergoing coronary artery bypass graft surgery with induced hypothermia (2.2, 2.3, 2.4, 2.5)
ou00a0u00a0u00a0 Continuous infusion rates (2.6)
ou00a0u00a0u00a0 Preparation instructions (2.7)
ou00a0u00a0u00a0 Drug compatibility (2.8)

Administer intravenously only by or under the supervision of experienced clinicians familiar with drug's actions and possible complications (2.1)
Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate injection antagonist are immediately available (2.1)
Use a peripheral nerve stimulator to determine adequacy of blockade (e.g., need for additional doses), minimize risk of overdosage or underdosage, assess extent of recovery from blockade, potentially limit exposure to toxic metabolites through dose titration, and facilitate more rapid reversal of cisatracurium besylate injection -induced paralysis (2.1)
See the Full Prescribing Information for:

Cisatracurium besylate injection is available as clear, colorless to slightly yellow or greenish yellow solution in the following strengths:
Injection:

10 mg/5 mL (2 mg/mL) in single-dose vials (3)
20 mg/10 mL (2 mg/mL) and benzyl alcohol as a preservative in multiple-dose vials (3)
200 mg/20 mL (10 mg/mL) in single-dose vials (3)

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate injection have been reported .
The use of 10 mL cisatracurium besylate injection multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol .

Known hypersensitivity to cisatracurium (4)
10 mL multiple-dose vials contain benzyl alcohol and are contraindicated in pediatric patients less than 1 month of age and low birth-weight infants (4)

No data

Residual Paralysis:
Benzyl Alcohol:
Risk of Seizure:
Hypersensitivity Reactions and Anaphylaxis:
Risk of Death due to Medication Errors:
Inadequate Anesthesia:

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

Succinylcholine:
Inhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine:
Phenytoin and Carbamazepine:

No data

Patients with Hemiparesis or Paraparesis:

Overdosage with neuromuscular blocking agents may result in neuromuscular blockade beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured.
Once recovery from neuromuscular block begins, further recovery may be facilitated by administration of a cholinesterase inhibitor (e.g., neostigmine, edrophonium) in conjunction with an appropriate cholinergic inhibitor. Cholinesterase inhibitors should not be administered when complete neuromuscular blockade is evident or suspected because the reversal of paralysis may not be sufficient to maintain a patent airway and support an appropriate level of spontaneous ventilation.
For providers treating patients treated with cholinesterase inhibitors:
The onset of antagonism may be delayed in the presence of debilitation, cachexia, carcinomatosis, and the concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular block or separately cause respiratory depression . Under such circumstances the management is the same as that of prolonged neuromuscular block.

Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1-[1u03b1,2u03b1(1'*,2'*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]
bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is CHNO and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is CHNOS and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:
The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/ distilled water system at 25u00b0C.
Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 and 20 mL vials. The pH is adjusted to 3.0 to 3.8 with benzenesulfonic acid.

No data

Carcinogenesis
Long-term animal studies to evaluate the carcinogenic potential of cisatracurium besylate have not been performed.
Mutagenesis
Cisatracurium besylate was evaluated in a battery of four genotoxicity assays. Evaluation of cisatracurium besylate in the mouse lymphoma forward gene mutation assay resulted in mutations in the presence and absence of exogenous metabolic activation. The bacterial reverse gene mutation (Ames) assay, human lymphocyte chromosomal aberration assay, and an rat bone marrow cytogenetic assay did not demonstrate evidence of mutagenicity or clastogenicity.
Impairment of Fertility
Studies to determine if cisatracurium besylate impacts fertility have not been completed.

No data

Cisatracurium Besylate Injection, USP is clear, colorless to slightly yellow or greenish yellow solution supplied as follows:
Storage
Refrigerate cisatracurium besylate injection, USP at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) in the carton to preserve potency. Protect from light. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25u00b0C/77u00b0F), use cisatracurium besylate injection, USP within 21 days, even if re-refrigerated.

Hypersensitivity Reactions Including Anaphylaxis
Advise the caregiver and/or family that severe hypersensitivity reactions have occurred with cisatracurium besylate injection .
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Wintac Limited u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Bangalore 562123u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
India
Code No.: KR/DRUGS/KTK/28/289/97
Manufactured for:
Somerset Therapeutics, LLC
Hollywood, FL 33024
ST-CAB/P/01

2 mg/mL (5 mL) container label
2 mg/mL (5 mL) carton
2 mg/mL (5 mL) Inner carton u2013 Pack of 10's
10 mg/mL (20 mL) container label
10 mg/mL (20 mL) carton
10 mg/mL (20 mL) Inner carton u2013 Pack of 10's

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Cisatracurium Besylate (Cisatracurium Besylate)

Trade Name : Cisatracurium Besylate

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Cisatracurium Besylate (Cisatracurium Besylate)

Trade Name : Cisatracurium Besylate

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

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