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Cisatracurium Besylate 10 mg/mL Injection — NDC 70069-0151-01 package photo
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Cisatracurium Besylate 10 mg/mL Injection — NDC 70069-151-01 (Billing 70069-0151-01)

by Somerset Therapeutics, LLC · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of Cisatracurium Besylate 10 mg/mL Injection from Somerset Therapeutics, LLC, marketed since Feb 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70069-0151-01
🏷️ FDA NDC (as labeled) 70069-151-01 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial Pack sizes2 compare ↓
Main listing for product 70069-151 · Also comes in: 10 vials 70069-151-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class III · Nov 26, 2025 — Subpotent product:out of specification assay results observed during long term stability testing. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0236-2026
Lots / codes: Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26 · reported Dec 24, 2025
Class III · Nov 26, 2025 — Subpotent product:out of specification assay results observed during long term stability testing. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0237-2026
Lots / codes: Lot #: A250020, Exp Date 06/30/2026 · reported Dec 24, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Cisatracurium Besylate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Nov 26, 2025 — Subpotent product:out of specification assay results observed during long term stability testing. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0238-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-151-01
Product NDC 70069-151
11-digit billing NDC 70069015101
NCPDP billing unit ML — per mL (volume)
RxCUI 199212, 1730194
UNII 80YS8O1MBS
UPC 0370069141014, 0370069151013, 0370069141106, 0370069151105
Application # ANDA206791
SPL Set ID ed91f65b-e002-43bd-bfa0-5ce8b89119e6
Established class (EPC) Nondepolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Nondepolarizing Blockade
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-04
Route INTRAVENOUS
Dosage form INJECTION
Substance CISATRACURIUM BESYLATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 74200013102035
GPI class Cisatracurium Besylate (PF)
GCN Seq No 024613
GCN 32770
HICL code 010278
Ingredient (HICL) Cisatracurium Besylate
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S7
Therapeutic class — intermediate (HIC2) Affect Primarily Skeletal Muscle
HIC3 code S7A
Therapeutic class — specific (HIC3) Neuromuscular Blocking Agents
AHFS code 12:20.20.00
AHFS class Neuromuscular Blocking Agents
FDB label name CISATRACURIUM 200 MG/20 ML VL
FDB brand name Cisatracurium Besylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 024613
  • GCN: 32770
  • GPI-14 (Medi-Span): 74200013102035
  • HICL (First Databank): 010278
  • AHFS class code: 12:20.20.00
  • RxCUI (RxNorm): 199212
Why two NDCs? The FDA registers this code as 70069-151-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70069-0151-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nondepolarizing Neuromuscular Blocker class.

Pharmacologic class Nondepolarizing Neuromuscular Blocker
Drug family (ATC) Other quaternary ammonium compounds
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CISATRACURIUM 200 MG/20 ML VL Ingredient Cisatracurium Besylate
📗 Our plain-language guide HelloPharmacist
  • It relaxes your muscles during anesthesia so a breathing tube can be placed and surgery can be done safely. It is also used in adults on a breathing machine in the ICU. You will al...
  • It is given only through an IV by trained clinicians, either as an injection or a continuous drip. They adjust the amount to how you respond and check your muscles with a nerve sti...
  • Side effects are uncommon. They can include a slow heart rate, low blood pressure, flushing, airway tightening or a rash. Your care team watches for these and can treat them quickl...
  • Yes. Mention any allergic reactions to anesthesia medicines, muscle diseases like myasthenia gravis, and kidney or liver problems. Also tell them about medicines such as phenytoin,...
📖 Read our full Cisatracurium guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70069-0151-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 20 mL in 1 VIAL 2019-02-04 — Active
70069-0151-10 70069-151-10 10 VIAL in 1 CARTON / 20 mL in 1 VIAL 2019-02-04 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial in 1 carton / 20 ml in 1 vial.
What NDC number is used to bill for this package of Cisatracurium Besylate 10 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cisatracurium Besylate 10 mg/mL 00143-9160-10 Hikma 10 vials — AP FDA listed —
Cisatracurium Besylate 10 mg/mL 00409-1103-01 Hospira, 10 vials — AP FDA listed —
cisatracurium besylate 10 mg/mL 00781-3153-95 Sandoz 1 vial — AP FDA listed —
Cisatracurium Besylate 10 mg/mL 31722-0312-10 Camber 10 vials — AP FDA listed —
Cisatracurium 10 mg/mL 63323-0418-20 Fresenius 10 vials — AP FDA listed —
Cisatracurium besylate 10 mg/mL 65145-0137-01 Caplin 1 vial — AP FDA listed —
Cisatracurium besylate 10 mg/mL 68083-0487-01 Gland 1 vial — AP FDA listed —
Cisatracurium Besylate 10 mg/mLthis 70069-0151-01 Somerset 1 vial — AP FDA listed —
Cisatracurium besylate 10 mg/mL 70436-0114-82 Slate 10 vials — AP FDA listed —
cisatracurium besylate 10 mg/mL 70710-1534-06 Zydus 10 vials — AP FDA listed —
Cisatracurium Besylate 200 mg/20mL 71288-0713-21 Meitheal 10 vials — AP FDA listed —
Cisatracurium Besylate 200 mg/20mL 72485-0513-10 Armas 10 vials — AP FDA listed —
cisatracurium besylate 10 mg/mL 72785-0009-06 Zydus 10 vials — AP FDA listed —
Cisatracurium Besylate 10 mg/mL 83634-0655-20 Avenacy, 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA206791 (ANDA)
Labeler code70069
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio184 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE Cisatracurium besylate injection, USP is indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older 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: 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) Limitations of Use: Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) 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: o 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) o Continuous infusion rates (2.6) o Preparation instructions (2.7) o Drug compatibility (2.8)

2.1Important Dosage and Administration Instructions Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.5)] . Important administration instructions: Cisatracurium besylate injection is for intravenous use only.

Administer cisatracurium besylate injection in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications. Use cisatracurium besylate injection only if the following are immediately available: personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy); and an antagonist of cisatracurium besylate injection [see Overdosage (10)]. The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate injection dosage on the patient's responses to the initial doses.

Use a peripheral nerve stimulator to: o Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate). o Minimize risk of overdosage or underdosage. o Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine). o Appropriately titrate doses to potentially limit exposure to toxic metabolites. o Facilitate more rapid reversal of the cisatracurium besylate injection-induced paralysis.

2.2Recommended Cisatracurium Besylate Injection Dose for Performing Tracheal Intubation Tracheal Intubation in Adults Prior to selecting the initial cisatracurium besylate injection bolus dose, consider the desired time to tracheal intubation and the anticipated length of surgery, factors affecting time to onset of complete neuromuscular block such as age and renal function, and factors that may influence intubation conditions such as the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia.

In conjunction with a propofol/nitrous oxide/oxygen induction-intubation technique or a thiopental/nitrous oxide/oxygen induction-intubation technique, the recommended starting weight-based dose of cisatracurium besylate injection is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection. Doses up to 0.4 mg/kg have been safely administered by bolus intravenous injection to healthy patients and patients with serious cardiovascular disease [see Clinical Pharmacology (12.2)]. Patients with… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 112 words ▾

3 DOSAGE FORMS AND STRENGTHS Cisatracurium besylate injection is available as clear, colorless to slightly yellow or greenish yellow solution in the following strengths: 10 mg of cisatracurium per 5 mL (2 mg/mL) in single-dose vials (equivalent to 2.68 mg/mL cisatracurium besylate) 20 mg of cisatracurium per 10 mL (2 mg/mL) in multiple-dose vials (equivalent to 2.68 mg/mL cisatracurium besylate) with benzyl alcohol as a preservative. 200 mg of cisatracurium per 20 mL (10 mg/mL) in single-dose vials. 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)

⛔ Contraindications 80 words ▾

4 CONTRAINDICATIONS Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate injection have been reported [see Warnings and Precautions (5.4)] . 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 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)] .

Known hypersensitivity to cisatracurium (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Residual Paralysis: Patients with neuromuscular diseases are at higher risk. Use a lower initial bolus dose and consider using a reversal agent in these patients. (2.2, 5.1) Benzyl Alcohol: Consider combined daily load of benzyl alcohol from all sources when the 10 mL multiple dose vials are used in infants (4, 5.2) Risk of Seizure: Monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites (5.3) Hypersensitivity Reactions and Anaphylaxis: Severe hypersensitivity reactions including anaphylactic reactions have been reported.

Consider cross-reactivity among neuromuscular blocking agents, both depolarizing and non-depolarizing. (4, 5.4) Risk of Death due to Medication Errors: Accidental administration can cause death. (5.5) Inadequate Anesthesia: Use cisatracurium besylate injection in the presence of appropriate sedation or general anesthesia and monitor patients to ensure level of anesthesia is adequate (5.6)

5.1Residual Paralysis Cisatracurium besylate injection has been associated with residual paralysis. Patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome) and carcinomatosis may be at higher risk of residual paralysis; thus, a lower maximum initial bolus is recommended in these patients [see Dosage and Administration (2.2) and Use in Specific Populations (8.10)] . To prevent complications resulting from cisatracurium besylate injection-associated residual paralysis, extubation is recommended only after the patient has recovered sufficiently from neuromuscular blockade.

Consider use of a reversal agent especially in cases where residual paralysis is more likely to occur [see Overdosage (10)] .

5.2Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative in 10 mL Multiple-Dose Vials Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including cisatracurium besylate injection (10 mL multiple-dose vials). This warning is not applicable to the 5 mL and 20 mL cisatracurium besylate injection single-dose vials because these vials do not contain benzyl alcohol. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

When prescribing the 10 mL multiple-dose cisatracurium besylate injection vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including cisatracurium besylate injection (multiple-dose vials contain 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations (8.4)] . The use of 10 mL cisatracurium besylate injection multiple-dose vials is contraindicated in pediatric patients less than 1 month of age and low birth-weight infants because these patients are more likely to develop benzyl alcohol toxicity [see Contraindications (4)] .

5.3Risk of Seizure Laudanosine, an active metabolite of cisatracurium besylate injection, has been shown to cause seizures in animals. Cisatracurium besylate injection -treated patients with renal or hepatic impairment may have higher metabolite concentrations (including laudanosine) than patients with normal renal and hepatic function [see Clinical Pharmacology (12.3)] . Therefore, patients with renal or hepatic impairment receiving extended administration of cisatracurium besylate injection may be at higher risk of seizures.

The level of neuromuscular blockade during long-term cisatracurium besylate injection administration should be monitored with a nerve stimulator to titrate cisatracurium besylate injection administration to the patients' needs and limit exposure to toxic metabolites.

5.4Hypersensitivity Reactions Including Anaphylaxis Severe hypersensitivity reactions, including fatal and life-threatening anaphyl… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS 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

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)] .

Table 3 displays adverse reactions that occurred at a rate of less than 1%. Table 3.Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Intensive Care Unit Patients The adverse reactions presented below were from studies involving 68 adult ICU patients who received cisatracurium besylate injection in conjunction with other drugs in US and European clinical studies [see Clinical Studies (14.3)] .

One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (range: 167 and 270 minutes) among 28 patients administered cisatracurium besylate injection and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium.

6.2Postmarketing Experience The following events have been identified during post-approval use of cisatracurium besylate injection in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisatracurium besylate injection: anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, myopathy.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Succinylcholine: May decrease time to onset of maximum neuromuscular blockade (7.1) Inhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: May potentiate or prolong neuromuscular blockade action of cisatracurium besylate injection. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade.

Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.9, 7.1)

7.1Clinically Significant Drug Interactions Table 4 displays clinically significant drug interactions with cisatracurium besylate injection Table 4 Clinically Significant Drug Interactions with Cisatracurium Besylate Injection Drug or Drug Class Clinical Implications* Succinylcholine The use of succinylcholine prior to cisatracurium besylate injection administration may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration of neuromuscular blockade. Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve

1.25Minimum Alveolar Concentration (MAC) may prolong the duration of action of initial and maintenance doses of cisatracurium besylate injection. This may potentiate the neuromuscular blockade. Antibiotics† Local anesthetics Magnesium salts Procainamide Lithium Quinidine May prolong the neuromuscular blockade action of cisatracurium besylate injection.

Phenytoin, Carbamazepine May increase resistance to the neuromuscular blockade action of cisatracurium besylate injection resulting in shorter durations of neuromuscular blockade and infusion rate requirements may be higher. * The use of peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of cisatracurium besylate injection, and to determine whether adjustments need to be made to the dose with subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate

7.2Drugs Without Clinically Significant Drug Interactions with Cisatracurium Besylate Injection In clinical studies, propofol had no effect on the duration of action or dosing requirements for cisatracurium besylate injection. Cisatracurium besylate injection is not compatible with propofol for Y-site administration.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Patients with Hemiparesis or Paraparesis: Perform neuromuscular monitoring on non-paretic limb (8.9)

8.1Pregnancy Risk Summary The 10 mL cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. Therefore, if cisatracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely.

However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] . There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg (see Data).

The estimated background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy. Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats. In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV).

In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m2 comparison). Neither of these studies revealed maternal or fetal toxicity or malformations.

8.2Lactation Risk Summary The 10 mL cisatracurium besylate injection multiple-dose vials contains the preservative benzyl alcohol. Therefore, if cisatracurium besylate injection is needed during lactation, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely.

However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2) and Use in Specific Populations (8.4)] . There are no data on the presence of cisatracurium besylate in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cisatracurium besylate injection and any potential adverse effects on the breastfed child from cisatracurium besylate injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of cisatracurium besylate injection as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The 10 mL cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. Therefore, if cisatracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely.

However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] . There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg (see Data).

The estimated background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy. Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats. In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV).

In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m2 comparison). Neither of these studies revealed maternal or fetal toxicity or malformations.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of cisatracurium besylate injection as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery in pediatric patients 1 month through 12 years of age were established from three studies in pediatric patients [see Dosing and Administration (2.2, 2.5) and Clinical Studies (14.2)] . The three open-label studies are summarized below. The safety and effectiveness of cisatracurium besylate injection have not been established in pediatric patients less than 1 month of age.

Tracheal Intubation A study of 0.15 mg/kg cisatracurium besylate injection evaluated 230 pediatric patients (ages 1 month to 12 years). Excellent or good intubating conditions were produced 120 seconds following 0.15 mg/kg of cisatracurium besylate injection in 88 of 90 of patients induced with halothane and in 85 of 90 of patients induced with thiopentone and fentanyl. The study also evaluated 50 pediatric patients during opioid anesthesia, with maximum neuromuscular blockade achieved in an average of about 3 minutes and a clinically effective block for 36 minutes in patients ages 2 to 12 years, and maximum neuromuscular block in about 2 minutes and a clinically effective block for about 43 minutes in infants 1 to 23 months [see Clinical Studies (14.2)] .

In a study of 0.1 mg/kg cisatracurium besylate injection administered in 16 pediatric patients (ages 2 to 12 years) during opioid/nitrous oxide/oxygen anesthesia, maximum neuromuscular blockade was achieved in an average of 2.8 minutes with a clinically effective block for 28 minutes [see Clinical Studies (14.2)] . Skeletal Muscle Relaxation During Surgery In a study of cisatracurium besylate injection administered during halothane/nitrous oxide/oxygen anesthesia, 18 pediatric patients (ages 2 to 12 years) were scheduled for surgical procedures that required neuromuscular block for 60 minutes or longer.

The average duration of continuous infusion was 62.8 minutes (range: 17 to 145 minutes). The overall mean infusion rate for 9 patients whose infusion was 45 minutes or longer was 1.7 mcg/kg/minute (range: 1.19 to 2.14 mcg/kg/minute). Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative in 10 mL Multiple-Dose Vials Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative.

In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

When prescribing the 10 mL multiple-dose cisatracurium besylate injection vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including cisatracurium besylate injection (multiple-dose vials contain 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.2)] . This warning is not applicable to the 5 mL and 20 mL cisatracurium besylate injection single-dose vials because these vials do not contain benzyl alcohol.

The use of 10 mL cisatracurium besylate injection multiple-dose vials is contraindicated in pediatric patients less than 1 month of age and low birth-weight infants because these patients are more likely to develop benzyl alcohol toxicity.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the total number of subjects (135) in clinical studies of cisatracurium besylate injection, 57, 63, and 15 subjects were 65-70 years old, 70-80 years old, and greater than 80 years old, respectively. The geriatric population included a subset of patients with significant cardiovascular disease [see Clinical Pharmacology (12.3)] . Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients, consider extending the interval between administering cisatracurium besylate injection and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)] .

The time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients, a difference that should be taken into account when selecting a neuromuscular blocking agent (e.g., the need to rapidly secure the airway) and when initiating laryngoscopy [see Clinical Pharmacology (12.3)] . Minor differences in the pharmacokinetics of cisatracurium between elderly and young adult patients were not associated with clinically significant differences in the recovery profile of cisatracurium besylate injection following a single 0.1 mg/kg dose.

Besides the differences noted above, no overall differences in safety or effectiveness were observed between geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger subjects, but greater sensitivity of some older individuals to cisatracurium besylate injection cannot be ruled out.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE 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. Neostigmine: Administration of 0.04 to 0.07 mg/kg of neostigmine at approximately 10% recovery from neuromuscular blockade (range: 0 to 15%) produced 95% recovery of the muscle twitch response and a T 4 :T 1 ratio ≥ 70% in an average of 9 to 10 minutes. The times from 25% recovery of the muscle twitch response to a T 4 :T 1 ratio ≥ 70% following these doses of neostigmine averaged 7 minutes.

The mean 25% to 75% recovery index following reversal was 3 to 4 minutes. Edrophonium: Administration of 1 mg/kg of edrophonium at approximately 25% recovery from neuromuscular blockade (range: 16% to 30%) produced 95% recovery and a T4:T1 ratio ≥ 70% in an average of 3 to 5 minutes. For providers treating patients treated with cholinesterase inhibitors: Use a peripheral nerve stimulator to evaluate recovery and antagonism of neuromuscular blockade Evaluate for evidence of adequate clinical recovery (e.g., 5-second head lift and grip strength).

Support ventilation until adequate spontaneous ventilation has resumed. 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 [see Drug Interactions (7.1)] . Under such circumstances the management is the same as that of prolonged neuromuscular block.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cisatracurium besylate injection binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors such as neostigmine .

12.2Pharmacodynamics The average ED95 (dose required to produce 95% suppression of the adductor pollicis muscle twitch response to ulnar nerve stimulation) of cisatracurium is 0.05 mg/kg (range: 0.048 to 0.053) in adults receiving opioid/nitrous oxide/oxygen anesthesia. The pharmacodynamics of various cisatracurium besylate injection doses administered over 5 to 10 seconds during opioid/nitrous oxide/oxygen anesthesia are summarized in Table 5. When the cisatracurium besylate injection dose is doubled, the clinically effective duration of blockade increases by approximately 25 minutes.

Once recovery begins, the rate of recovery is independent of dose. Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve

1.25MAC (Minimum Alveolar Concentration) prolonged the clinically effective duration of action of initial and maintenance cisatracurium besylate injection doses, and decreased the average infusion rate requirement of cisatracurium besylate injection. The magnitude of these effects depended on the duration of administration of the volatile agents: Fifteen to 30 minutes of exposure to

1.25MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection. In surgical procedures during enflurane or isoflurane anesthesia greater than 30 minutes, less frequent maintenance dosing, lower maintenance doses, or reduced infusion rates of cisatracurium besylate injection were required. The average infusion rate requirement was decreased by as much as 30% to 40% [see Drug Interactions (7.1)] .

The onset, duration of action, and recovery profiles of cisatracurium besylate injection during propofol/oxygen or propofol/nitrous oxide/oxygen anesthesia were similar to those during opioid/nitrous oxide/oxygen anesthesia (see Table 5). Repeated administration of maintenance cisatracurium besylate injection doses or a continuous cisatracurium besylate injection infusion for up to 3 hours was not associated with development of tachyphylaxis or cumulative neuromuscular blocking effects. The time needed to recover from successive maintenance doses did not change with the number of doses administered when partial recovery occurred between doses.

The rate of spontaneous recovery of neuromuscular function after cisatracurium besylate injection, infusion was independent of the duration of infusion and comparable to the rate of recovery following initial doses (see Table 5). Pediatric patients including infants generally had a shorter time to maximum neuromuscular blockade and a faster recovery from neuromuscular blockade compared to adults treated with the same weight-based doses (see Table 5). Table 5.

Pharmacodynamic Dose Response* of Cisatracurium Besylate Injection During Opioid/Nitrous Oxide/Oxygen Anesthesia C isatracurium Besylate Dose Time to 90% Block in minutes Time to Maximum Block in minutes 5% Recovery in minutes 25% Recovery in minutes 95% Recovery in minutes T 4 :T 1 Ratio‡ ≥ 70% in minutes 25%-75% Recovery Index in minutes Adults 0.1 mg/kg (2 × ED 95 ) (n § = 98) 3.3 (1.0-8.7) 5.0 (1.2-17.2) 33 (15-51) 42 (22-63) 64 (25-93) 64 (32-91) 13 (5-30) 0.15|| mg/kg (3 × ED 95 ) (n = 39) 2.6 (1.0-4.4) 3.5 (1.6-6.8) 46 (28-65) 55 (44-74) 76 (60-103) 75 (63-98) 13 (11-16) 0.2 mg/kg (4 × ED 95 ) (n = 30) 2.4 (1.5-4.5) 2.9 (1.9-5.2) 59 (31-103) 65 (43-103) 81 (53-114) 85 (55-114) 12 (2-30) 0.25 mg/kg (5 × ED 95 ) (n = 15) 1.6 (0.8-3.3) 2.0 (1.2-3.7) 70 (58-85) 78 (66-86) 91 (76-109) 97 (82-113) 8 (5-12) 0.4 mg/kg (8 × ED 95 ) (n = 15) 1.5 (1.3-1.8) 1.9 (1.4-2.3) 83 (37-103) 91 (59-107) 121 (110-134) 126 (115-137) 14 (10-18) Infants (1-23 months… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Cisatracurium besylate injection binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors such as neostigmine .

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Cisatracurium Besylate Injection, USP is clear, colorless to slightly yellow or greenish yellow solution supplied as follows: Strength (mg of Cisatracurium Besylate ) Containers Size NDC# Preservative 10 mg/5 mL (2 mg/mL) 5 mL Single-dose vials Pack of 1 70069- 141 -01 Does not contain benzyl alcohol Pack of 10's 70069- 141 -10 20 mg/10 mL (2 mg/mL) 10 mL Multiple-dose vials Pack of 1 70069- 161 -01 Contains 0.9% w/v benzyl alcohol [see Warnings and Precautions (5.2)] Pack of 10's 70069- 161 -10 200 mg/20 mL (10 mg/mL) 20 mL Single-dose vials Pack of 1 70069- 151 -01 Does not contain benzyl alcohol Pack of 10's 70069- 151 -10 Discard unused portion of the 5 mL and 20 mL single-dose vials.

Storage Refrigerate cisatracurium besylate injection, USP at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Protect from light. DO NOT FREEZE.

Upon removal of the unused vial from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection, USP within 21 days, even if re-refrigerated.

📋 Description ~1 min read ▾

11 DESCRIPTION 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 injection contains cisatracurium besylate as the active pharmaceutical ingredient.

Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 R -[1α,2α(1' R *,2' R *)]]-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 C 53 H 72 N 2 O 12 and the molecular weight is 929.2.

The molecular formula of cisatracurium as the besylate salt is C 65 H 82 N 2 O 18 S 2 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 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection.

Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.0 and 3.8. Image

💬 Information for Patients 57 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Including Anaphylaxis Advise the caregiver and/or family that severe hypersensitivity reactions have occurred with cisatracurium besylate injection [see Warnings and Precautions (5.4)] . Trademarks are the property of their respective owners. Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Customer Care # 1-800-417-9175 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-CAB/P/05 1201392

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The neuromuscular blocking activity of cisatracurium besylate injection is due to parent drug. Cisatracurium plasma concentration-time data following IV bolus administration are best described by a two compartment open model (with elimination from both compartments) with an elimination half-life (t 1/2 β) of 22 minutes, a plasma clearance (CL) of 4.57 mL/min/kg, and a volume of distribution at steady state (V ss ) of 145 mL/kg. Results from population pharmacokinetic/pharmacodynamic (PK/PD) analyses from 241 healthy surgical patients are summarized in Table 6.

Table 6. Key Population PK/PD Parameter Estimates for Cisatracurium in Healthy Surgical Patients* Following 0.1 (2 × ED 95 ) to 0.4 mg/kg (8 × ED 95 ) of Cisatracurium Besylate injection Parameter Estimate † Magnitude of Interpatient Variability (CV) ‡ CL (mL/min/kg) 4.57 16% V ss (mL/kg) § 145 27% k eo (min-1) ll 0.0575 61% EC 50 (ng/mL) ¶ 141 52% * Healthy male non-obese patients 19-64 years of age with creatinine clearance values greater than 70 mL/minute who received cisatracurium besylate injection during opioid anesthesia and had venous samples collected † The percent standard error of the mean (% SEM) ranged from 3% to 12% indicating good precision for the PK/PD estimates. ‡ Expressed as a coefficient of variation; the %SEM ranged from 20% to 35% indicating adequate precision for the estimates of interpatient variability. § Vss is the volume of distribution at steady state estimated using a two-compartment model with elimination from both compartments.

Vss is equal to the sum of the volume in the central compartment (Vc) and the volume in the peripheral compartment (Vp); interpatient variability could only be estimated for Vc. ll Rate constant describing the equilibration between plasma concentrations and neuromuscular block ¶ Concentration required to produce 50% T 1 suppression; an index of patient sensitivity. The magnitude of interpatient variability in CL was low (16%), as expected based on the importance of Hofmann elimination. The magnitudes of interpatient variability in CL and volume of distribution were low in comparison to those for k eo and EC 50 .

This suggests that any alterations in the time course of cisatracurium besylate injection-induced neuromuscular blockade were more likely to be due to variability in the PD parameters than in the PK parameters. Parameter estimates from the population PK analyses were supported by noncompartmental PK analyses on data from healthy patients and from specific populations. Conventional PK analyses have shown that the PK of cisatracurium are proportional to dose between 0.1 (2 × ED 95 ) and 0.2 (4 × ED 95 ) mg/kg cisatracurium.

In addition, population PK analyses revealed no statistically significant effect of initial dose on CL for doses between 0.1 (2 × ED 95 ) and 0.4 (8 × ED 95 ) mg/kg cisatracurium. Distribution The volume of distribution of cisatracurium is limited by its large molecular weight and high polarity. The Vss was equal to 145 mL/kg (Table 6) in healthy 19- to 64-year-old surgical patients receiving opioid anesthesia.

The Vss was 21% larger in similar patients receiving inhalation anesthesia. The binding of cisatracurium to plasma proteins has not been successfully studied due to its rapid degradation at physiologic pH. Inhibition of degradation requires nonphysiological conditions of temperature and pH which are associated with changes in protein binding.

Elimination Organ-independent Hofmann elimination (a chemical process dependent on pH and temperature) is the predominant pathway for the elimination of cisatracurium. The liver and kidney play a minor role in the elimination of cisatracurium but are primary pathways for the elimination of metabolites. Therefore, the t½β values of metabolites (including laudanosine) are longer in patients with renal or hepatic impairment and metabolite concentrations may be higher after long-term administration [see Warnings and Precautions… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics The average ED95 (dose required to produce 95% suppression of the adductor pollicis muscle twitch response to ulnar nerve stimulation) of cisatracurium is 0.05 mg/kg (range: 0.048 to 0.053) in adults receiving opioid/nitrous oxide/oxygen anesthesia. The pharmacodynamics of various cisatracurium besylate injection doses administered over 5 to 10 seconds during opioid/nitrous oxide/oxygen anesthesia are summarized in Table 5. When the cisatracurium besylate injection dose is doubled, the clinically effective duration of blockade increases by approximately 25 minutes.

Once recovery begins, the rate of recovery is independent of dose. Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve

1.25MAC (Minimum Alveolar Concentration) prolonged the clinically effective duration of action of initial and maintenance cisatracurium besylate injection doses, and decreased the average infusion rate requirement of cisatracurium besylate injection. The magnitude of these effects depended on the duration of administration of the volatile agents: Fifteen to 30 minutes of exposure to

1.25MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection. In surgical procedures during enflurane or isoflurane anesthesia greater than 30 minutes, less frequent maintenance dosing, lower maintenance doses, or reduced infusion rates of cisatracurium besylate injection were required. The average infusion rate requirement was decreased by as much as 30% to 40% [see Drug Interactions (7.1)] .

The onset, duration of action, and recovery profiles of cisatracurium besylate injection during propofol/oxygen or propofol/nitrous oxide/oxygen anesthesia were similar to those during opioid/nitrous oxide/oxygen anesthesia (see Table 5). Repeated administration of maintenance cisatracurium besylate injection doses or a continuous cisatracurium besylate injection infusion for up to 3 hours was not associated with development of tachyphylaxis or cumulative neuromuscular blocking effects. The time needed to recover from successive maintenance doses did not change with the number of doses administered when partial recovery occurred between doses.

The rate of spontaneous recovery of neuromuscular function after cisatracurium besylate injection, infusion was independent of the duration of infusion and comparable to the rate of recovery following initial doses (see Table 5). Pediatric patients including infants generally had a shorter time to maximum neuromuscular blockade and a faster recovery from neuromuscular blockade compared to adults treated with the same weight-based doses (see Table 5). Table 5.

Pharmacodynamic Dose Response* of Cisatracurium Besylate Injection During Opioid/Nitrous Oxide/Oxygen Anesthesia C isatracurium Besylate Dose Time to 90% Block in minutes Time to Maximum Block in minutes 5% Recovery in minutes 25% Recovery in minutes 95% Recovery in minutes T 4 :T 1 Ratio‡ ≥ 70% in minutes 25%-75% Recovery Index in minutes Adults 0.1 mg/kg (2 × ED 95 ) (n § = 98) 3.3 (1.0-8.7) 5.0 (1.2-17.2) 33 (15-51) 42 (22-63) 64 (25-93) 64 (32-91) 13 (5-30) 0.15|| mg/kg (3 × ED 95 ) (n = 39) 2.6 (1.0-4.4) 3.5 (1.6-6.8) 46 (28-65) 55 (44-74) 76 (60-103) 75 (63-98) 13 (11-16) 0.2 mg/kg (4 × ED 95 ) (n = 30) 2.4 (1.5-4.5) 2.9 (1.9-5.2) 59 (31-103) 65 (43-103) 81 (53-114) 85 (55-114) 12 (2-30) 0.25 mg/kg (5 × ED 95 ) (n = 15) 1.6 (0.8-3.3) 2.0 (1.2-3.7) 70 (58-85) 78 (66-86) 91 (76-109) 97 (82-113) 8 (5-12) 0.4 mg/kg (8 × ED 95 ) (n = 15) 1.5 (1.3-1.8) 1.9 (1.4-2.3) 83 (37-103) 91 (59-107) 121 (110-134) 126 (115-137) 14 (10-18) Infants (1-23 months of age) 0.15 mg/kg** (n = 18-26) 1.5 (0.7-3.2) 2.0 (1.3-4.3) 36 (28-50) 43 (34-58) 64 (54-84) 59 (49-76) 11.3 (7.3-18.3) Pediatric Patients 2-12 years 0.08 mg/kg ¶ (2 × ED 95 ) (n = 60) 2.2 (1.2-6.8) 3.3 (1.7-9.7) 22 (11-38) 29 (20-46) 52 (37-64) 50 (37-62) 11 (7-15) 0.1 mg/kg (n = 16) 1.7 (1.3-2.7) 2.8 (1.8-6.7) 21 (13-31) 28 (2… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Skeletal Muscle Relaxation for Intubation of Adult Patients The efficacy of cisatracurium besylate injection to provide skeletal muscle relaxation to facilitate tracheal intubation during surgery was established in six studies in adult patients. In all these studies patients had general anesthesia and mechanical ventilation. Cisatracurium besylate injection doses between 0.15 and 0.2 mg/kg were evaluated in 240 adults.

Maximum neuromuscular blockade generally occurred in within 4 minutes for this dose range. When administered during induction using thiopental or propofol and co-induction agents (i.e., fentanyl and midazolam), excellent to good intubating conditions were generally achieved within 2 minutes (excellent intubation conditions most frequently achieved with the 0.2 mg/kg dose of cisatracurium besylate injection). Following the induction of general anesthesia with propofol, nitrous oxide/oxygen, and co-induction agents (e.g., fentanyl and midazolam), good or excellent conditions for tracheal intubation occurred in 96/102 (94%) patients in 1.5 to 2 minutes following cisatracurium besylate injection doses of 0.15 mg/kg and in 97/110 (88%) patients in 1.5 minutes following cisatracurium besylate injection doses of 0.2 mg/kg.

In Study 1, the clinically effective duration of action for 0.15 and 0.2 mg/kg cisatracurium besylate injection using propofol anesthesia was 55 minutes (range: 44 to 74 minutes) and 61 minutes (range: 41 to 81 minutes), respectively. In Studies 2 and 3, cisatracurium besylate injection doses of 0.25 and 0.4 mg/kg were evaluated in 30 patients under opioid/nitrous oxide/oxygen anesthesia and provided 78 (66-86) and 91 (59-107) minutes of clinical relaxation, respectively. In Study 4, two minutes after fentanyl and midazolam were administered, patients received thiopental anesthesia.

Intubating conditions were assessed at 120 seconds following administration of 0.15 mg/kg or 0.2 mg/kg of cisatracurium besylate injection in 51 patients (see Table 11). Table 11. Intubating Conditions at 120 Seconds after Cisatracurium Besylate Injection Administration with Thiopental Anesthesia in Adult Surgery Patients in Study 4 Cisatracurium Besylate 0.15 mg/kg (n = 26) Cisatracurium Besylate 0.20 mg/kg (n = 25) Excellent and Good 88% 96% 95% CI 76,100 88,100 Excellent 31% 60% Good 58% 36% *Excellent: Easy passage of tube without coughing.

Vocal cords relaxed and abducted. Good: Passage of tube with slight coughing and/or bucking. Vocal cords relaxed and abducted.

Excellent intubating conditions were more frequently achieved with the 0.2 mg/kg dose (60%) than the 0.15 mg/kg dose (31%) when intubation was attempted 120 seconds following cisatracurium besylate injection. Study 5 evaluated intubating conditions after 3 and 4 × ED 95 (0.15 mg/kg and 0.20 mg/kg) following induction with fentanyl and midazolam and either thiopental or propofol anesthesia. This study compared intubation conditions produced by these doses of cisatracurium besylate injection after 90 seconds.

Table 12 displays these results. Table 12. Intubating Conditions at 90 Seconds after Cisatracurium Besylate Injection Administration with Thiopental or Propofol Anesthesia in Study 5 Intubating Condition Cisatracurium Besylate 0.15 mg/kg with Propofol (n = 31) Cisatracurium Besylate 0.15 mg/kg with Thiopental (n= 31) Cisatracurium Besylate 0.20 mg/kg with Propofol (n= 30) Cisatracurium Besylate 0.20 mg/kg with Thiopental (n = 28) Excellent and Good 94% 90% 93% 96% 95% CI 85,100 80,100 84,100 90,100 Excellent 58% 55% 70% 57% Good 35% 35% 20% 39% * Excellent: Easy passage of tube without coughing.

Vocal cords relaxed and abducted. Good: Passage of tube with slight coughing and/or bucking. Vocal cords relaxed and abducted.

Excellent intubating conditions were more frequently observed with the 0.2 mg/kg dose when intubation was attempted 90 seconds following cisatracurium besylate injection.

14.2Skeletal Muscle Relaxation for Intuba… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 111 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 in vitro mouse lymphoma forward gene mutation assay resulted in mutations in the presence and absence of exogenous metabolic activation.

The in vitro bacterial reverse gene mutation (Ames) assay, in vitro human lymphocyte chromosomal aberration assay, and an in vivo 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 108 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 in vitro mouse lymphoma forward gene mutation assay resulted in mutations in the presence and absence of exogenous metabolic activation.

The in vitro bacterial reverse gene mutation (Ames) assay, in vitro human lymphocyte chromosomal aberration assay, and an in vivo 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.

📄 Package Label / Principal Display Panel 80 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2 mg/mL (5 mL) container label 2 mg/mL (5 mL) carton 2mg/mL (5mL) – Inner Carton – 10's Pack 10 mg/mL (20 mL) – Container Label 10 mg/mL (20 mL) carton 10 mg/mL (20 mL) Inner carton – 10's Pack 2mg/mL (5mL) - Container Label 2mg/mL (5mL) - Carton Label 2mg/mL (5mL) - Innercarton 10s Pack 10mg/mL (20mL) - container label 10mg/mL (20 mL) carton label 10 mg/mL (20 mL) inner carton - pack of 10s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (70069-0151-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Somerset Therapeutics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70069-0141-01 · Somerset 70069-0161-01 · Somerset →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.