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.

FDA Label Image

Ampoule Label (Hexatrione Ampoule)

Label for Hexatrione 2 Percent injectable suspension containing triamcinolone hexacetonide at 20 mg/mL in a 2 mL glass ampoule. The label specifies intra-articular use only and includes a warning to respect prescribed doses. The labeler is Ethypharm, and lot number DMA86 with an expiration date of 03-2023 is shown.*

FDA Label Image

Carton (Hexatrione Carton)

Packaging label for Hexatrione 2% Injectable Suspension containing 40 mg/2 mL triamcinolone hexacetonide for intra-articular use. The label indicates it is manufactured for Medexus Pharma, Inc. and manufactured by Laboratoires ETHYPHARM, Saint-Cloud, France. The carton contains a 2 mL ampoule and specifies instructions such as 'For Intra-Articular Use Only,' 'RX Only,' and storage conditions below 30°C (86°F). The label includes inactive ingredients and a barcode.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 01

Letter from Medexus Pharma, Inc. dated December 8, 2021, providing updated information on Hexatrione 2% (triamcinolone hexacetonide) injectable suspension, intra-articular, 20 mg/mL. It details FDA import authorization, product presentation in a 2 mL ampoule with 40 mg total strength, differences from FDA-approved Aristospan®, and the absence of a barcode on the imported product.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 02

Text document from Medexus Pharma discussing Hexatrione 2% (triamcinolone hexacetonide) injectable suspension. It describes the product concentration, appearance as a milky white suspension without crystalline formation, packaging in auto-breakable One Point Cut ampoules, and needle gauge recommendations for intra-articular use. It includes contact information for customer service and adverse event reporting guidelines.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 03

A document from Medexus Pharma, Inc. providing contact information for MedWatch reporting and medical affairs inquiries related to Hexatrione 2% (triamcinolone hexacetonide) injectable suspension. It includes a website link, phone numbers, and a signature from Khaled M Mohamed, Director of Regulatory Affairs.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 04

Product Comparison Table from Medexus Pharma showing US approved product Aristospan and imported product Hexatrione 2%. Both contain the active ingredient triamcinolone hexacetonide as a suspension with strength 20 mg/mL. The table compares formulation components, container closure system, and route of administration (intra-articular) for both products, highlighting similarities and differences.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 05

This text panel from Medexus Pharma provides detailed information about Hexatrione 2% (triamcinolone hexacetonide) injectable suspension. It describes the suspension's milky white appearance, dilution guidelines emphasizing that Hexatrione 2% should not be diluted before injection, storage conditions (20°-25°C and protection from light), and the product's packaging as a 2 mL ampoule under NDC 59137-570-01.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 06

Primary container label image showing two injectable suspension products, Aristospan and Hexatrione, both containing triamcinolone hexacetonide for intra-articular use. The Aristospan vial is labeled 20 mg/mL, 5 mL vial, with instructions to shake well and protect from light. The Hexatrione label states 2 percent strength, 2-mL glass ampoule, and emphasizes that it is for intra-articular administration only. Manufacturer names Sandoz and Ethypharm appear on the respective labels.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 07

Hexatrione 2% triamcinolone hexacetonide injection, suspension primary carton label for intra-articular use. The label shows strength 40 mg/2 mL (20 mg/mL concentration). The labeler is Medexus Pharma, Inc. The design includes purple and red colors, storage and handling instructions, inactive ingredient list, and barcode with NDC 59137-570-01.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 08

Drug facts text panel from Medexus Pharma for Hexatrione injection, suspension. It lists the active ingredient triamcinolone hexacetonide at 20 mg per mL and inactive ingredients including polysorbate 80, sorbitol, water for injection, hydrochloric acid, sodium hydroxide, and benzyl alcohol preservative. It includes instructions about pH adjustment and cautions such as single use and keeping out of reach of children.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 09

Chemical structure of triamcinolone hexacetonide shown within a text panel detailing a sterile injectable suspension formulation at 20 mg/mL, including inactive ingredients like polysorbate 80, sorbitol solution, benzyl alcohol, and pH adjustments. The structure illustrates the corticosteroid molecule with labeled atoms and bonds.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 10

This text panel provides information on the indications, usage, contraindications, and warnings for the corticosteroid drug triamcinolone hexacetonide, marketed as Aristospan. It highlights its intra-articular or soft tissue administration for inflammatory conditions, contraindications including hypersensitivity and specific disorders, and serious neurologic adverse reactions linked to epidural administration. It also notes the presence of benzyl alcohol in the product and associated toxicity risks, especially in neonates and low birth weight infants.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 11

Text panel from Hexatrione 2% injection, suspension, detailing precautions and effects of corticosteroids. It covers increased dosage indications, cardiovascular-renal effects, endocrine impact, and infection risks. Specific warnings include corticosteroid use in traumatic brain injury, effects on blood pressure and potassium, hypothalamic-pituitary adrenal axis suppression, and potential fungal infection exacerbation.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 12

Text excerpt covering special pathogens, tuberculosis, vaccination, viral infections, neurologic, and ophthalmic safety considerations related to corticosteroid use. It advises caution with infections, vaccination contraindications, and potential adverse effects on eyes and neurologic system.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 13

A text panel titled "PRECAUTIONS" for a corticosteroid product. It includes general cautions about heat sensitivity, dosage reduction, risk/benefit considerations, and reports of Kaposi's sarcoma and injection site atrophy. Sections cover cardio-renal effects, endocrine insufficiency from drug-induced secondary adrenocortical insufficiency, gastrointestinal cautions including risks with peptic ulcers and cirrhosis, and notes on intra-articular and soft tissue administration with potential systemic absorption.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 14

A text panel discussing cautions and adverse reactions related to intra-articular corticosteroid injection, including risks of septic arthritis, bone damage, neuro-psychiatric effects, psychic derangements, and increased intraocular pressure during steroid therapy.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 15

This text panel provides patient information and drug interactions for Hexatrione 2% (triamcinolone hexacetonide). It includes warnings about corticosteroid use, exposure to infections, and potential drug interactions with aminoglutethimide, amphotericin B, antibiotics, anticholinesterases, anticoagulants, antidiabetics, antitubercular drugs, and cholestyramine.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 16

This text panel lists drug interaction warnings and precautions related to corticosteroids, including cyclosporine, digitalis glycosides, estrogens, hepatic enzyme inducers, ketoconazole, NSAIDs, skin tests, and vaccines. It also addresses carcinogenesis, mutagenesis, and impairment of fertility concerns associated with corticosteroid use.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 17

A text panel detailing pregnancy, nursing mothers, and pediatric use precautions for Hexatrione 2% (triamcinolone hexacetonide) injection suspension. It includes information on teratogenic effects, breastfeeding cautions, benzyl alcohol risks in pediatric patients, and safety observations in pediatric corticosteroid use.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 18

This text panel includes warnings and precautions about growth effects of corticosteroids in pediatric patients, noting decreased growth velocity and the need for lowest effective doses. It covers geriatric use, stating no overall safety differences between elderly and younger subjects. The panel also lists adverse reactions alphabetically across multiple systems, including allergic, cardiovascular, dermatologic, and endocrine reactions.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 19

This text panel details various adverse reactions categorized by system such as Fluid and Electrolyte Disturbances, Gastrointestinal, Metabolic, Musculoskeletal, Neurologic/Psychiatric, Ophthalmic, and Other. It also includes a section on Overdosage treatment and a note about the presence of benzyl alcohol in the product. The text pertains to safety information for Hexatrione 2% injection suspension by Medexus Pharma, Inc.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 20

Text panel from Hexatrione 2% (triamcinolone hexacetonide injection, suspension) providing general dosing guidelines, pediatric dosage range, dosage adjustments, withdrawal recommendations, and directions for use including aseptic technique, use of topical ethylchloride spray, syringe agitation, and needle size. It also covers dilution instructions with lidocaine hydrochloride and cautions against certain diluents.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 21

This text panel covers intra-articular dosing guidelines and storage instructions for Aristospan (triamcinolone hexacetonide) injectable suspension, USP 20 mg/mL. It details average dosing based on joint size, frequency recommendations, and cautions on injection technique. It also provides storage temperature and handling instructions, packaging sizes with NDCs, and manufacturer information.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 22

Patient information leaflet and summary of product characteristics for Hexatrione 2 Percent suspension for injection (intra-articular). The text includes drug name, composition, pharmaceutical form, clinical particulars, dosage, contraindications, warnings, precautions, and detailed usage instructions. Updated on 24/09/2019 by ANSM.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 23

This image shows detailed drug information text for Hexatrione 2% suspension for injection intra-articular, including sections on breastfeeding, side effects, pharmacological properties, storage, package contents, marketing authorization, and handling instructions. The text explains pharmacodynamic and pharmacokinetic properties of triamcinolone hexacetonide and advises on usage precautions, side effects, and disposal.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 24

Instructional text for opening One Point Cut (OPC) ampoules, describing the ampoule features, preparation of the work area, and step-by-step guidance on opening the ampoules without an ampoule opener. The text emphasizes sterility, careful handling, and safety measures to avoid splintering or shattering.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 25

Instructional text with photos demonstrates how to open one point cut (OPC) ampoules using an ampoule opener. The instructions detail handling the ampoule, positioning the opener, and safely breaking the ampoule neck while avoiding glass shattering, applying pressure incorrectly, or causing injury. Safety warnings are also included.*

FDA Label Image

Hexatrione Dhcp 12.8.2021 Final Page 26

Text panel providing instructions on how to open ampoules safely. It advises to readjust the ampoule position if it does not break open easily, avoid forcing it open, use a different ampoule or opener if needed, and to not use the medication if the ampoule shatters or is contaminated with glass.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.