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SUCCINYLCHOLINE CHLORIDE 20 mg/mL Injection, Solution — NDC 71872-7166-01 package photo

SUCCINYLCHOLINE CHLORIDE 20 mg/mL Injection, Solution

by Medical Purchasing Solutions, LLC · 1 VIAL, MULTI-DOSE in 1 BAG (71872-7166-1) / 10 mL in 1 VIAL, MULTI-DOSE
NDC 71872-7166-01
🏷️ FDA NDC (as labeled) 71872-7166-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Succinylcholine Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 27, 2025 — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0623-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71872-7166-1
Product NDC 71872-7166
11-digit billing NDC 71872716601
RxCUI 1594589
UNII I9L0DDD30I
Application # ANDA211432
SPL Set ID 896a4238-667d-45b0-e053-2a95a90a60dd
Established class (EPC) Depolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Depolarizing Blockade
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-20
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SUCCINYLCHOLINE CHLORIDE
Why two NDCs? The FDA registers this code as 71872-7166-1 — a 5-4-1 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 package segment → 71872-7166-01. 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 Depolarizing Neuromuscular Blocker class.

Pharmacologic class Depolarizing Neuromuscular Blocker
Drug family (ATC) Choline derivatives
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.

🏭 Manufacturer & labeler

LabelerMedical Purchasing Solutions, LLC
Application holderAMNEAL EU LTD
FDA applicationANDA211432 (ANDA)
Labeler code71872
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio250 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Succinylcholine temporarily relaxes all your skeletal muscles — including the muscles in your throat and airway — so that the anesthesia team can quickly and safely place a breathi...
  • What exactly does succinylcholine do, and why would I need it?
  • No — succinylcholine only relaxes your muscles. It has no effect on your consciousness or your ability to feel pain. You would always be under general anesthesia when this drug is...
  • Will I be awake or feel anything while succinylcholine is working?
📖 Read our full Succinylcholine 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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.8 mg / 1 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 0.2 mg / 1 mL UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 mLPer 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.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Succinylcholine Chloride 20 mg/mL 00143-9338-25 Hikma 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 00404-9983-20 Henry 1 vial — AP FDA listed —
Quelicin 20 mg/mL 00409-6629-02 Hospira, 25 vials — AP FDA listed —
Anectine 20 mg/mL 00781-3411-95 Sandoz 10 vials — AP FDA listed —
Anectine 20 mg/mL 00781-9053-95 Sandoz 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 14445-0407-25 Indoco 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 31722-0981-31 Camber 25 vials — AP FDA listed —
Succinylcholine Chloride 200 mg/10mL 42571-0371-87 Micro 25 vials — AP FDA listed —
Succinylcholine 20 mg/mL 43598-0666-25 Dr.Reddy's 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 51662-1525-01 HF 10 ml — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 55150-0315-25 Eugia 25 vials — — FDA listed —
Succinylcholine Chloride 20 mg/mL 63323-0943-10 Fresenius 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 66794-0232-42 Piramal 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 68083-0450-25 Gland 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 69918-0700-11 Nordic 10 vials — AP Discontinued —
Succinylcholine Chloride 20 mg/mL 70069-0301-25 Somerset 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70069-0783-10 Somerset 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70121-1581-05 Amneal 25 vials — — Discontinued —
Succinylcholine Chloride 20 mg/mL 70518-4409-00 REMEDYREPACK 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70710-1377-02 Zydus 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70756-0613-10 Lifestar 10 vials — — FDA listed —
Succinylcholine Chloride 20 mg/mL 70771-1352-07 Zydus 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71288-0719-11 Meitheal 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71839-0121-25 BE 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mLthis 71872-7166-01 Medical 1 vial — — FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7167-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7221-01 Medical 1 vial — AP FDA listed —
Succinylcholine 20 mg/mL 71872-7241-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7272-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7275-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7279-01 Medical 1 vial — AP FDA listed —
Anectine 20 mg/mL 72572-0750-10 Civica, 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 73043-0021-01 Devatis, 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 84549-0301-25 ProPharma 10 ml — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 82449-0232-02 STERISCIENCE 10 syringes — 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71872-7166-01 You're viewing this 1 VIAL, MULTI-DOSE in 1 BAG (71872-7166-1) / 10 mL in 1 VIAL, MULTI-DOSE 2019-05-13 Active

🧭 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) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 71872-7166-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71872-7166-01, written without dashes as 71872716601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71872-7166-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7166) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Medical Purchasing Solutions, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Purchasing Solutions, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning ~1 min read ▾

WARNING RISK OF CARDIAC ARREST FROM HYPERKALEMIC RHABDOMYOLYSIS There have been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest and death after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne’s muscular dystrophy. This syndrome often presents as peaked T-waves and sudden cardiac arrest within minutes after the administration of the drug in healthy appearing pediatric patients (usually, but not exclusively, males, and most frequently 8 years of age or younger).

There have also been reports in adolescents. Therefore, when a healthy appearing infant or child develops cardiac arrest soon after administration of succinylcholine, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. This should include administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation.

Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. However, extraordinary and prolonged resuscitative efforts have resulted in successful resuscitation in some reported cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently.

Since there may be no signs or symptoms to alert the practitioner to which patients are at risk, it is recommended that the use of succinylcholine in pediatric patients should be reserved for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible (see PRECAUTIONS : Pediatric Use and DOSAGE AND ADMINISTRATION ).

🎯 Indications and Usage 29 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The dosage of succinylcholine chloride injection should be individualized and should always be determined by the clinician after careful assessment of the patient (see WARNINGS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear and colorless should not be used.

Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. Adults For Short Surgical Procedures The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg succinylcholine chloride injection given intravenously.

The optimum dose will vary among individuals and may be from 0.3 mg/kg to 1.1 mg/kg for adults. Following administration of doses in this range, neuromuscular blockade develops in about 1 minute; maximum blockade may persist for about 2 minutes, after which recovery takes place within 4 to 6 minutes. However, very large doses may result in more prolonged blockade.

A 5 mg to 10 mg test dose may be used to determine the sensitivity of the patient and the individual recovery time (see PRECAUTIONS ). For Long Surgical Procedures The dose of succinylcholine administered by infusion depends upon the duration of the surgical procedure and the need for muscle relaxation. The average rate for an adult ranges between 2.5 mg and 4.3 mg per minute.

Intermittent intravenous injections of succinylcholine may also be used to provide muscle relaxation for long procedures. An intravenous injection of 0.3 mg/kg to 1.1 mg/kg may be given initially, followed, at appropriate intervals, by further injections of 0.04 mg/kg to 0.07 mg/kg to maintain the degree of relaxation required. Pediatrics For emergency tracheal intubation or in instances where immediate securing of the airway is necessary, the intravenous dose of succinylcholine chloride injection is 2 mg/kg for infants and small pediatric patients; for older pediatric patients and adolescents the dose is 1 mg/kg (see BOX WARNING and PRECAUTIONS : Pediatric Use ).

It is currently known that the effective dose of succinylcholine chloride injection in pediatric patients may be higher than that predicted by body weight dosing alone. For example, the usual adult intravenous dose of 0.6 mg/kg is comparable to a dose of 2 mg/kg to 3 mg/kg in neonates and infants to 6 months and 1 mg/kg to 2 mg/kg in infants up to 2 years of age. This is thought to be due to the relatively large volume of distribution in the pediatric patient versus the adult patient.

Rarely, intravenous bolus administration of succinylcholine chloride injection in infants and pediatric patients may result in malignant ventricular arrythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia. In such situations, an underlying myopathy should be suspected. Intravenous bolus administration of succinylcholine chloride injection in infants or pediatric patients may result in profound bradycardia or, rarely, asystole.

As in adults, the incidence of bradycardia in pediatric patients is higher following a second dose of succinylcholine chloride injection. Whereas bradycardia is common in pediatric patients after an initial dose of 1.5 mg/kg, bradycardia is seen in adults only after repeated exposure. The occurrence of bradyarrhythmias may be reduced by pretreatment with atropine (see PRECAUTIONS : Pediatric Use ).

Intramuscular Use If necessary, succinylcholine chloride injection may be given intramuscularly to infants, older pediatric patients or adults when a suitable vein is inaccessible. A dose of up to 3 mg/kg to 4 mg/kg may be given, but not more than 150 mg total dose should be administered by this route. The onset of effect of succinylcholine chlo…

⛔ Contraindications 118 words ▾

CONTRAINDICATIONS Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury.

The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.

⚠️ Warnings ~3 min read ▾

WARNINGS Succinylcholine should be used only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of carbon dioxide. The clinician must be prepared to assist or control respiration. To avoid distress to the patient, succinylcholine should not be administered before unconsciousness has been induced.

In emergency situations, however, it may be necessary to administer succinylcholine before unconsciousness is induced. Succinylcholine is metabolized by plasma cholinesterase and should be used with caution, if at all, in patients known to be or suspected of being homozygous for the atypical plasma cholinesterase gene. Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported.

These reactions have, in some cases, been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs.

Risk of Death due to Medication Errors Administration of succinylcholine chloride results in paralysis, which may lead to respiratory arrest and death; this progression may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.

Hyperkalemia ( see BOX WARNING) Succinylcholine should be administered with GREAT CAUTION to patients suffering from electrolyte abnormalities and those who may have massive digitalis toxicity, because in these circumstances succinylcholine may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. GREAT CAUTION should be observed if succinylcholine is administered to patients during the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury (see CONTRAINDICATIONS ).

The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are undetermined.

Patients with chronic abdominal infection, subarachnoid hemorrhage, or conditions causing degeneration of central and peripheral nervous systems should receive succinylcholine with GREAT CAUTION because of the potential for developing severe hyperkalemia. Malignant Hyperthermia Succinylcholine administration has been associated with acute onset of malignant hyperthermia, a potentially fatal hypermetabolic state of skeletal muscle. The risk of developing malignant hyperthermia following succinylcholine administration increases with the concomitant administration of volatile anesthetics.

Malignant hyperthermia frequently presents as intractable spasm of the jaw muscles (masseter spasm) which may progress to generalized rigidity, increased oxygen demand, tachycardia, tachypnea and profound hyperpyrexia. Successful outcome depends on recognition of early signs, such as jaw muscle spasm, acidosis, or generalized rigidity to initial administration of succinylcholine for tracheal intubation, or failure of tachycardia to respond to deepening anesthesia. Skin mottling, rising temperature and coagulopathies may occur later in the course of the hypermetaboli…

🤒 Adverse Reactions 162 words ▾

ADVERSE REACTIONS Adverse reactions to succinylcholine consist primarily of an extension of its pharmacological actions. Succinylcholine causes profound muscle relaxation resulting in respiratory depression to the point of apnea; this effect may be prolonged. Hypersensitivity reactions, including anaphylaxis, may occur in rare instances.

The following additional adverse reactions have been reported: cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea, increased intraocular pressure, muscle fasciculation, jaw rigidity, postoperative muscle pain, rhabdomyolysis with possible myoglobinuric acute renal failure, excessive salivation, and rash. There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) associated with use of neuromuscular blocking agents, including succinylcholine.

These reactions, in some cases, have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences at 1-855-266-3251 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 99 words ▾

Drug Interactions Drugs which may enhance the neuromuscular blocking action of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, diethylether, isoflurane, desflurane, metoclopramide and terbutaline. The neuromuscular blocking effect of succinylcholine may be enhanced by drugs that reduce plasma cholinesterase activity (e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase (see PRECAUTIONS ).

If other neuromuscular blocking agents are to be used during the same procedure, the possibility of a synergistic or antagonistic effect should be considered.

🤰 Pregnancy ~1 min read ▾

Pregnancy Risk Summary It is also not known whether succinylcholine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with succinylcholine chloride. Succinylcholine should be given to a pregnant woman only if clearly needed.

The estimated background risk of major birth defects and miscarriage for 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% to 4% and 15% to 20%, respectively.

Clinical Considerations Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum. Therefore, a higher proportion of patients may be expected to show increased sensitivity (prolonged apnea) to succinylcholine when pregnant than when nonpregnant. Labor and Delivery Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section.

While small amounts of succinylcholine are known to cross the placental barrier, under normal conditions the quantity of drug that enters fetal circulation after a single dose of 1 mg/kg to the mother should not endanger the fetus. However, since the amount of drug that crosses the placental barrier is dependent on the concentration gradient between the maternal and fetal circulations, residual neuromuscular blockade (apnea and flaccidity) may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in, the mother.

🧒 Pediatric Use ~2 min read ▾

Pediatric Use Safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. There are rare reports of ventricular dysrhythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who receive succinylcholine (see BOX WARNING ). Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne’s muscular dystrophy whose clinical signs were not obvious.

The syndrome often presents as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients are usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents.

There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk.

Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation has resulted in successful resuscitation in some of the reported cases.

Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently (see WARNINGS ). Since it is difficult to identify which patients are at risk, it is recommended that the use of succinylcholine in pediatric patients should be reserved for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible.

As in adults, the incidence of bradycardia in pediatric patients is higher following the second dose of succinylcholine. The incidence and severity of bradycardia is higher in pediatric patients than adults. Pre-treatment with anticholinergic agents, e.g., atropine, may reduce the occurrence of bradyarrhythmias.

🧓 Geriatric Use 83 words ▾

Geriatric Use Clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 85 words ▾

OVERDOSAGE Overdosage with succinylcholine may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal respiration is assured.

Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II) (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~2 min read ▾

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

Subsequent neuromuscular transmission is inhibited so long as adequate concentration of succinylcholine remains at the receptor site. Onset of flaccid paralysis is rapid (less than one minute after intravenous administration), and with single administration lasts approximately 4 to 6 minutes. Succinylcholine is rapidly hydrolyzed by plasma cholinesterase to succinylmonocholine (which possesses clinically insignificant depolarizing muscle relaxant properties) and then more slowly to succinic acid and choline (see PRECAUTIONS ).

About 10% of the drug is excreted unchanged in the urine. Succinylcholine levels were reported to be below the detection limit of 2 mcg/mL after 2.5 minutes of an intravenous bolus dose of 1 mg/kg or 2 mg/kg in fourteen (14) anesthetized patients. The paralysis following administration of succinylcholine is progressive, with differing sensitivities of different muscles.

This initially involves consecutively the levator muscles of the face, muscles of the glottis and finally the intercostals and the diaphragm and all other skeletal muscles. Succinylcholine has no direct action on the uterus or other smooth muscle structures. Because it is highly ionized and has low fat solubility, it does not readily cross the placenta.

Tachyphylaxis occurs with repeated administration (see PRECAUTIONS ). Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I block) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II block). This may be associated with prolonged respiratory muscle paralysis or weakness in patients who manifest the transition to Phase II block.

When this diagnosis is confirmed by peripheral nerve stimulation, it may sometimes be reversed with anticholinesterase drugs such as neostigmine (see PRECAUTIONS ). Anticholinesterase drugs may not always be effective. If given before succinylcholine is metabolized by cholinesterase, anticholinesterase drugs may prolong rather than shorten paralysis.

Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates both autonomic ganglia and muscarinic receptors which may cause changes in cardiac rhythm, including cardiac arrest. Changes in rhythm, including cardiac arrest, may also result from vagal stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in pediatric patients (see PRECAUTIONS : Pediatric Use ).

These effects are enhanced by halogenated anesthetics. Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the fasciculation phase, and slight increases which may persist after onset of complete paralysis (see WARNINGS ). Succinylcholine may cause slight increases in intracranial pressure immediately after its injection and during the fasciculation phase (see PRECAUTIONS ).

As with other neuromuscular blocking agents, the potential for releasing histamine is present following succinylcholine administration. Signs and symptoms of histamine mediated release such as flushing, hypotension and bronchoconstriction are, however, uncommon in normal clinical usage. Succinylcholine has no effect on consciousness, pain threshold or cerebration.

It should be used only with adequate anesthesia (see WARNINGS ).

📦 How Supplied / Storage and Handling 143 words ▾

HOW SUPPLIED Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in 10 mL multiple-dose vials. Each mL contains succinylcholine chloride, USP 20 mg. It is available as follows: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial: NDC 70121-1581-1 25 Vials in a Carton: NDC 70121-1581-5 Summary of content and characteristics of the solutions: Container Size (mL) mg/mL mg (total) mOsmol/mL Multiple-dose Fliptop Vial 10 mL 20 mg/mL 200 mg 0.338 Refrigeration of the undiluted agent will assure full potency until expiration date.

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

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev.

12-2018-01

📋 Description 213 words ▾

DESCRIPTION Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as an ultra short-acting, depolarizing, skeletal muscle relaxant, see HOW SUPPLIED for summary of content and characteristics of the solutions. The solutions are for intramuscular or intravenous use. Succinylcholine Chloride is chemically designated as Ethanaminium, 2,2’-[(1,4-dioxo-1,4-butanediyl) bis(oxy)] bis [N, N, N-trimethyl-, dichloride, dihydrate, its molecular formula is C 14 H 30 Cl 2 N 2 O 4 .2H 2 O and its molecular weight is 397.34.

It has the following structural formula: Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. Succinylcholine chloride, USP is a white, odorless, crystalline powder. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether.

The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Solution intended for multiple-dose administration contains methylparaben, 0.18% and propylparaben, 0.02% as preservatives.

Product not requiring dilution (multiple-dose fliptop vial) contains sodium chloride to render isotonic. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED section for characteristics.

Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water. 1

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