Hexatrione Injection, Suspension
Product Images NDC 59137-570

Product Visual Gallery

This gallery contains 28 technical images submitted to the FDA as part of the official labeling for Hexatrione (NDC 59137-570). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medexus Pharma, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Ampoule Label (Hexatrione Ampoule)

HEXATRIONE is an injectable suspension with 2% triamcinolone hexacetonide for intra-articular administration. It comes in a 2-mL glass ampoule with a concentration of 20mg/mL. This medication is only available with a prescription from List 1. The lot number is DMA86, and the expiration date is 03-2023.*

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Carton (Hexatrione Carton)

This is a medication called Hexatrione, manufactured by Medeus Pharma in Chicago and by Laboratories ETHYPHARM in France. Each pack has an NDC code of 59137-570-01. The medication contains 20mg of tramcnolone hexaceonide, and includes the preservative Benzyl Alcohol. It is a single-use medication, and must be kept out of reach of children. It should be stored below 30°C (85°F), and protected from light. The medication contains polysorbate 80, sorbitol at 70%, water, and sodium hydroxide and hydrochloric acid for pH adjustment.*

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Hexatrione Dhcp 12.8.2021 Final Page 01

This is a letter from Medexus Pharma to healthcare professionals dated December 8, 2021, regarding an ongoing shortage of Aristospan®. In coordination with the U.S. Food and Drug Administration (FDA), Medexus Pharma is importing Hexatrione 2% from France as an alternative to Aristospan®. The hexatrione product is supplied in a pre-scored One Point Cut (OPC) ampule determined by the manufacturer's strength of the injectable suspension - triamcinolone hexacetonide. Medexus offers a 2mL ampule of Hexatrione 2% intra-articular injectable suspension with a total strength of 40mg/2mL. It is important to note that there are differences in packaging and labeling between Aristospan® and the Hexatrione 2% product including strength per ampoule, total volume, and lack of barcode. Alternative procedures are recommended to ensure the correct drug product is administered to individual patients.*

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Hexatrione Dhcp 12.8.2021 Final Page 02

Hexatrione 2% is an injectable suspension of Triamcinolone Hexacetonide which has the same active substance concentration as Aristospan, which is 20 mg/mL. It is supplied in a pre-scored One Point Cut (OPC) ampoule which can be easily and safely opened without the risk of splintering or sharp edges. A filtered needle is not recommended, and a needle bore gauge between 19 and 25 should be used for intra-articular use. It is available for order by contacting Medexus' customer service, and reporting of any adverse events or quality problems experienced with the use of this product is encouraged. Detailed prescribing information can be found in the enclosed FDA approved package insert.*

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Hexatrione Dhcp 12.8.2021 Final Page 03

The text contains information regarding a pharmaceutical company called Medexus, with instructions on how to report adverse medical effects of their product, Hexatrione 2%. It also includes contact information for Medexus' Medical Affairs department. The letter is signed by the Director of Regulatory Affairs and includes the company's address and phone/fax numbers.*

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Hexatrione Dhcp 12.8.2021 Final Page 04

This is a product comparison table for the US Approved Product Aristospan® Hexatrione 2% which is a triamcinolone hexacetonide injectable suspension indicated as adjunctive therapy for short-term administration in various conditions including acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The product comparison is between the US Approved Product and the Imported Product with both having the same concentration of triamcinolone hexacetonide (20 mg/mL) and similar excipients including sorbitol, polysorbate 80, and benzyl alcohol. The container closure and route of administration of both products are also the same. The information is provided by Medexus Pharma located in Chicago.*

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Hexatrione Dhcp 12.8.2021 Final Page 05

Hexatrione 2% (triamcinolone hexacetonide) is an injectable suspension used for treating lesions. It is a milky white suspension and can be mixed with 1% or 2% Lidocaine Hydrochloride. Diluents containing methylparaben, propylparaben, phenaol, etc. should be avoided. Dilutions retain full potency for one week, and dilutions should be discarded after 7 days. It is not advisable to dilute Hexatrione 2% before injection. It is recommended to store it between 20-25°C and protected from light. Medexus Pharma is the supplier based in Chicago.*

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Hexatrione Dhcp 12.8.2021 Final Page 06

This is a pharmaceutical product called "Aristospan®" (triamcinolone hexacetonide injectable suspension, USP) manufactured by Sandoz Canada Inc. It comes in a 1 mL vial and is for intra-articular and intravenous use, only under the prescription. It is protected from light and needs to be shaken well prior to use. The lot number and expiration date are indicated in the label. The text also mentions another product called "Hexatrione® 2 percent" which comes in a 2-mL (glass) ampoule for intra-articular administration and manufactured by Ethypharm. The lot number and expiration date are also indicated on the label. The company's contact information is also included.*

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Hexatrione Dhcp 12.8.2021 Final Page 07

Aristospan is an injectable suspension intended for intra-articular use only. It contains 20 mg of triamcinolone hexacetonide per mL, along with inactive ingredients such as sorbitol solution, hydrochloric acid and benzyl alcohol. The dosage of Aristospan may vary from 2 to 20 mg every three weeks, depending on the patient. However, it is not intended for intravenous use, and should be stored within a temperature range of 20°C to 25°C. This product is manufactured by Sandoz Canada Inc. and Medexus Pharma Inc. It is a sterile solution of 100 mg/5 mL that comes in vials of 5 mL.*

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Hexatrione Dhcp 12.8.2021 Final Page 08

MEDEXUS B PHARMA produces Hexatrione, which is a Triamcinolone hexacetonide injection used for various inflammatory conditions. Each milliliter (mL) of Hexatrione has 20 mg of triamcinolone hexacetonide. It also includes inactive ingredients such as sorbitol solution 50%, polysorbate 80 of 0.4%, water for injection, and Benzyl alcohol 0.90%. Sodium hydroxide and hydrochloric acid are utilized if necessary for adjusting pH. Hexatrione should be used only for single-use and must be kept far from children. The product contains benzyl alcohol as a preservative. The manufacturer's address is available at the end of the document.*

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Hexatrione Dhcp 12.8.2021 Final Page 09

Aristospan® is a sterile suspension containing 20mg/mL of micronized triamcinolone hexacetonide in various inactive ingredients. It is not intended for use in newborns or for intravenous use. Aristospan® is for intra-articular use only. The hexacetonide ester of the synthetic glucocorticoid triamcinolone is relatively insoluble in water. Glucocorticoids, both naturally occurring and synthetic, are steroids that are easily absorbed from the gastrointestinal tract.*

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Hexatrione Dhcp 12.8.2021 Final Page 10

Aristospan is a drug primarily used for its anti-inflammatory effects on acute and subacute bursitis, acute gouty arthritis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis. It is not recommended for epidural administration as serious neurologic events such as spinal cord infarction, paraplegia, and stroke resulting in death have been reported. Benzyl alcohol, present in Aristospan, has been associated with a fatal “Gasping Syndrome™ in infants of low birth weight. Anaphylactoid reactions are a rare possibility in patients receiving corticosteroid therapy.*

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Hexatrione Dhcp 12.8.2021 Final Page 11

This text provides important information on the potential risks and side effects associated with corticosteroid therapy. The increased dosage of rapidly acting corticosteroids is suggested for patients under any unusual stress before, during, and after the stressful situation. However, high doses of corticosteroids should not be used for patients suffering from traumatic brain injury. Corticosteroids can cause cardiovascular and renal problems, hypothalamic-pituitary adrenal axis suppression, metabolic alterations, increased susceptibility to infection, and exacerbation of systemic fungal infections. Patients under corticosteroid therapy should be carefully monitored for the development of any of these conditions.*

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Hexatrione Dhcp 12.8.2021 Final Page 12

This text discusses some of the potential risks and complications associated with the use of corticosteroids. It emphasizes the need for caution when using these drugs in patients with certain latent or active infections, and recommends close observation in those who have been exposed to viral infections. The text also notes the possible neurologic and ophthalmic effects of corticosteroids.*

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Hexatrione Dhcp 12.8.2021 Final Page 13

This text provides detailed precautionary measures for the use of corticosteroids, a type of steroid medication. The text advises against using oral corticosteroids for the treatment of optic neuritis and active ocular herpes simplex. The product is sensitive to heat and should not be autoclaved to sterilize the exterior of the vial. It also suggests that the lowest possible dose of corticosteroids should be used to control the condition, and that when dosage reduction is possible, it should be gradual. The text warns of possible complications of treatment with glucocorticoids, and advises a risk/benefit decision for each individual case as to the dose and duration of treatment. Different bodily systems are highlighted for special consideration. There is an enhanced effect of corticosteroids in patients with cirrhosis. Intra-articularly injected corticosteroids may be systemically absorbed.*

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Hexatrione Dhcp 12.8.2021 Final Page 14

Appropriate examination of joint fluid is necessary to exclude septic process. Steroid injections should be avoided in infected joints. Corticosteroid injections in unstable joints are not recommended as it may result in damage to joint tissues. Corticosteroids decrease bone formation and increase bone resorption which may lead to inhibition of bone growth and, at any age, the development of osteoporosis. Controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, but they do not affect the natural history of the disease. Acute myopathy, psychiatric derangements, and elevated intraocular pressure may occur due to the use of corticosteroids.*

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Hexatrione Dhcp 12.8.2021 Final Page 15

This is a medication guide for patients taking corticosteroids. Patients should not stop taking the medication abruptly and should seek medical advice if they develop fever or other signs of infection. They must also be wary of exposure to chickenpox or measles and seek medical advice if exposed. The guide provides information on drug interactions with medications such as aminoglutethimide, amphotericin B injection, and antidiabetics. It also contains information on interactions with anticoagulants and antitubercular drugs. Cholestyramine may increase the clearance of corticosteroids.*

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Hexatrione Dhcp 12.8.2021 Final Page 16

This text provides information on drugs and other agents that may interact with corticosteroids, including cyclosporine, digitalis glycosides, estrogens, hepatic enzyme inducers, ketoconazole, nonsteroidal anti-inflammatory agents, skin tests, and vaccines. The text also notes that corticosteroids may affect sperm motility and number in some patients, but there are no adequate studies in animals to determine whether they have a potential for carcinogenesis or mutagenesis.*

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Hexatrione Dhcp 12.8.2021 Final Page 17

This text serves as a warning for the use of corticosteroids in pregnant women and nursing mothers due to potential teratogenic effects and adverse effects on infants. It also warns of the potential dangers of benzyl alcohol, a preservative found in some corticosteroid products, particularly in premature and low-birth-weight infants. While studies have shown that the efficacy and safety of corticosteroids in the pediatric population are similar to that in adults, pediatric patients should be carefully monitored for adverse effects. Overall, caution should be exercised when administering corticosteroids, particularly in vulnerable populations.*

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Hexatrione Dhcp 12.8.2021 Final Page 18

This text discusses the potential negative impact of corticosteroids on growth velocity in pediatric patients, even at low doses and in the absence of laboratory evidence of HPA axis suppression. It recommends monitoring linear growth in pediatric patients treated with corticosteroids and titrating to the lowest effective dose to minimize potential growth effects. The text also states that no overall differences in safety or effectiveness were observed between elderly and younger subjects in clinical experience. The adverse reactions section lists various potential reactions, including cardiovascular issues, dermatological issues, and endocrine-related issues, among others.*

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Hexatrione Dhcp 12.8.2021 Final Page 19

This text describes the possible side effects of using corticosteroids, including fluid and electrolyte imbalances, gastrointestinal issues such as abdominal distention and peptic ulcers, metabolic complications such as protein catabolism, musculoskeletal problems like osteoporosis and muscle weakness, neurologic and psychiatric conditions such as depression and vertigo, and ophthalmic concerns such as glaucoma and cataracts. Overdose can be treated with supportive therapy, while chronic overdosing may require temporary dosage reductions or alternate day treatment. The text also notes that the medication contains benzyl alcohol.*

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Hexatrione Dhcp 12.8.2021 Final Page 20

Aristospan (triamcinolone hexacetonide injectable suspension, USP) is a medication used to treat various diseases, and the initial dosage ranges from 2 to 48 mg per day. Dosage requirements are variable and need individualization based on the patient's disease and response. In pediatric patients, initial doses range from 0.11 to 1.6 mg/kg/day. The medication should be administered using strict aseptic administration techniques and can be mixed with Lidocaine Hydrochloride for dilution. It is essential to gradually withdraw the medication after long-term therapy, and the medication's varying properties should be considered based on the mode of administration.*

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Hexatrione Dhcp 12.8.2021 Final Page 21

Aristospan (triamcinolone hexacetonide injectable suspension, USP) is used for intra-articular injection. The dosage to be administered depends on the size of the joint to be injected, the degree of inflammation, and the amount of fluid present. Large joints (such as knee, hip, shoulder) generally require 10 to 20 mg, while small joints (such as interphalangeal, metacarpophalangeal) require 2 to 6 mg. The usual frequency of injection into a single joint is every three or four weeks, and injection more frequently than that is generally not advisable. Aristospan (triamcinolone hexacetonide injectable suspension, USP), 20 mg/mL is available as 1 mL fill in a 2 mL vial and 5 mL fill in a 10 mL vial. It should be stored at 20°-25°C (68°-77°F), protected from light, and should not be frozen.*

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Hexatrione Dhcp 12.8.2021 Final Page 22

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Hexatrione Dhcp 12.8.2021 Final Page 23

Hexatrione is a medication that contains Triamcinolone hexacetonide and is used for its anti-inflammatory effect. It is administered by intra-articular injection and has a slow resorption rate. However, multiple injections or short-term use can increase the risk of systemic corticosteroids. The medication is compatible with breastfeeding, but lactating women should be aware of the risk of accumulation of benzyl alcohol, which may cause metabolic acidosis. Possible side effects include infection, inflammation, calcification of the joint, headaches, flushing, skin weakening, and allergic reactions. The medication should be stored below 30°C and protected from light, and the product should be used immediately after opening. Not applicable information includes overdose, preclinical safety data, dosimetry, prescription and delivery conditions, and names in Member States of the European Economic Area.*

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Hexatrione Dhcp 12.8.2021 Final Page 24

This is a set of instructions explaining how to safely and easily open One Point Cut (OPC) ampoules, which contain medicinal products. The ampoules have a colored dot that indicates the location of a score to make opening easier and reduce the risk of sharp edges. The work area must be kept sterile, and hands and the outside of the ampoules must be disinfected. To open the ampoule without an opener, grasp the bottom with one hand and the top with the other hand, placing the thumb on the colored dot and the index finger on the opposite side, and apply even pressure until it breaks with a clean snap. If the ampoule shatters, it should be discarded. If it is too hard to open, a different ampoule should be used or an opener can be employed.*

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Hexatrione Dhcp 12.8.2021 Final Page 25

This text provides instructions and safety precautions for opening one point cut (OPC) ampoules using an ampoule opener. The user is advised to hold the ampoule, remove any liquid from the top, and place the opener over the neck below the bulbous part. The bottom of the ampoule is to be held firmly, and light, even pressure applied to snap the ampoule open away from the colored dot, to prevent shattering or unintended injury to the user. The text provides safety precautions against applying pressure in any other direction, pushing or twisting the ampoule, and causing unintended injuries to the operator.*

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Hexatrione Dhcp 12.8.2021 Final Page 26

This text provides instructions on how to properly open an ampoule containing medicine. It emphasizes the importance of not exerting too much force when attempting to open the vial and suggests the use of an ampoule opener if necessary. It also warns against using medicine from a shattered or contaminated ampoule. Lastly, it mentions the importance of developing an individual opening technique through experience.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.