Check the route before every application or injection.
Skin, dental, nasal and injectable products are not interchangeable. Injections can cause systemic steroid effects and serious infection; epidural use is not approved. Do not abruptly stop prolonged systemic therapy without a plan. New severe joint pain with fever after injection needs urgent assessment.
Warnings and precautionsIndications
Selected local and systemic indications depend on the product.
Skin, oral mucosa and nasal indications
Selected 0.1% skin cream/ointment relieve inflammatory and itchy manifestations of corticosteroid-responsive dermatoses. Sun dental paste is adjunctive temporary relief for oral inflammatory lesions and traumatic ulcerative lesions; skin products must not replace it. OTC Nasacort temporarily relieves allergic nasal congestion, rhinorrhea, sneezing and itchy nose at age ≥ 2; it is not for the common cold.
Selected injectable indications and limits
Amneal 40 mg/mL suspension: IM treatment when oral therapy is not feasible for listed severe allergic, inflammatory, rheumatic, endocrine, hematologic, renal and other disorders; IA/soft-tissue use is short-term adjunctive treatment for acute gouty arthritis, bursitis, nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis and osteoarthritis synovitis. Zilretta is IA management of knee osteoarthritis pain; repeat-dose safety/efficacy is not demonstrated, and shoulder/hip OA is not evaluated. This overview is not a disease-specific systemic steroid protocol.
Product scope and clinical boundaries
This reference covers six selected U.S. acetonide labels. Other skin strengths/vehicles, 10/80 mg/mL injections, dedicated ophthalmic formulations and triamcinolone hexacetonide need their own labels and specialist directions. The selected 40 mg/mL suspension is IM/IA only, not IV, intradermal or an ophthalmic substitute. Zilretta is not substitutable with other triamcinolone injections.
Dosage and administration
Use route-specific directions and the least exposure that controls disease.
Skin and dental application
| Selected product | Directions |
|---|---|
| 0.1% skin cream / ointment | Apply thinly to affected skin 2–3 times daily; cream rubs in gently. External use, avoid eyes. Cover/occlude only when directed; tight diapers/plastic pants can act as occlusion. No universal treatment duration or maximum grams is supplied in these labels. |
| 0.1% dental paste | Press a small dab (~¼ inch) onto the lesion until a thin film forms; do not rub/spread. Apply at bedtime; if needed 2–3 times daily, preferably after meals. Investigate if repair is inadequate after 7 days; patient section also says contact dentist/physician if no improvement within 2 weeks. Stop when controlled. |
OTC nasal dosing by age
Shake well before every use. Prime new bottle and re-prime after > 2 weeks unused per enclosed insert; read spray/cleaning directions. Spray while sniffing gently; do not spray into eyes/mouth or share bottle. No doubled missed dose.
| Age | Once-daily sprays into EACH nostril |
|---|---|
| ≥ 12 years | 2 sprays initially; reduce to 1 when symptoms improve. |
| 6 to < 12 years | 1 spray; may increase to 2 if not improving, then reduce to 1 when improved. Adult supervision. |
| 2 to < 6 years | 1 spray; adult supervision. |
| < 2 years | Do not use. |
| Review threshold | If symptoms fail to improve after 1 week, stop and consult. Child use > 2 months/year needs clinician discussion because of growth risk. |
Clinician-administered injection dosing
These selected doses require trained aseptic administration, individual indication/risk assessment and the exact product. They are not repeat-injection schedules.
| Product / route | Selected labeled dosing |
|---|---|
| Amneal 40 mg/mL · systemic IM | Suggested adult initial 60 mg deep gluteal; usually adjusted 40–80 mg according to response/duration, some respond to ≤ 20 mg. Avoid deltoid because of local atrophy. Disease-specific high-dose regimens require specialist review. |
| Amneal · IA / local | Initial 2.5–5 mg smaller joints or 5–15 mg larger joints. Adult doses up to 10 mg smaller areas / 40 mg larger areas usually sufficient; up to 80 mg total across several joints has been given. Do not equate that historical total with a universal dose. |
| Zilretta · IA knee only | Single 32 mg delivered in 5 mL using supplied diluent/adapter and full IFU. Not for small joints; no established repeat-dose regimen. Not IM, IV, intradermal, SC, epidural, intrathecal or intraocular. |
Organ function, withdrawal and preparation
No fixed renal/hepatic dose algorithm is provided for these selected forms. Systemic steroids require caution with renal insufficiency, HF/hypertension, electrolyte disturbance and cirrhosis (enhanced effects). Individualize dose/duration; prolonged systemic treatment needs gradual clinician-directed withdrawal and stress-dose planning, not an arbitrary universal taper. Amneal suspension: shake, inspect for clumping/agglomeration (discard if present), inject promptly after withdrawal. Zilretta: only supplied diluent, strict asepsis, prompt injection; prepared vial may be held up to 4 hours ambient and gently resuspended before withdrawal.
Safety
Risk increases with absorbed dose, duration, occlusion and co-therapy.
Warnings and precautions
- Skin/dental products: systemic absorption can cause HPA suppression, Cushing effects, hyperglycemia and growth effects; risk rises with large areas, prolonged use, damaged barriers or occlusion. Irritation, sensitization or uncontrolled infection requires reassessment/discontinuation.
- Nasal spray: discuss unhealed nasal injury/surgery/ulcers, other steroids, eye infection, glaucoma/cataracts before use. Stop and consult for severe/frequent nosebleeds, vision change, persistent infection symptoms or exposure to chickenpox/measles/TB.
- Injection: anaphylaxis can be fatal; check ingredients including benzyl alcohol. The selected Amneal injection is not IV; epidural corticosteroid use is unapproved and associated with stroke, paralysis and death. Avoid unapproved intrathecal/ocular routes.
- Systemic/IA exposure can suppress immunity, mask infection and reactivate latent disease. Amneal warns about TB, hepatitis B (screen before prolonged immunosuppression), fungal infection, amebiasis and Strongyloides hyperinfection. Avoid infection-site injection; assess hot, swollen, painful joint with fever for septic arthritis.
- Adrenal suppression can persist after treatment; illness, surgery or trauma may require rapidly acting replacement steroid under clinician direction. Long-acting IM suspension is unsuitable for acute stress replacement. Do not abruptly stop prolonged therapy.
- Injection precautions include fluid retention, hypertension, hypokalemia, glucose elevation, GI perforation/bleeding, mood/psychotic effects, osteoporosis/necrosis, myopathy, ocular pressure/cataracts and impaired wound healing. Review cardiac/renal, ulcer, bone, psychiatric and eye risks.
- Live/live-attenuated vaccines are contraindicated during immunosuppressive corticosteroid doses; other vaccine response may be reduced. Pediatric benzyl-alcohol exposure can be toxic, particularly in premature/neonatal patients; consider all sources.
Contraindications
All selected products preclude hypersensitivity to their ingredients; Zilretta also specifies corticosteroid hypersensitivity. Dental paste is additionally contraindicated with fungal, viral or bacterial infection of the mouth/throat. OTC Nasacort: do not use below age 2. Amneal IM corticosteroid use is contraindicated in idiopathic thrombocytopenic purpura; live vaccines are contraindicated during immunosuppressive doses. Infection-site injection and unapproved routes remain important restrictions even when listed in warnings rather than section 4.
Boxed warning status
These selected current U.S. labels have no boxed warning. The selected immediate-release injection prominently warns about serious neurologic events with epidural administration; absence of a box does not establish that route as safe or approved.
Adverse reactions and excess exposure
Skin/dental effects include burning, itching, dryness, contact dermatitis, infection and tissue atrophy; skin effects also include striae, folliculitis, pigment changes and acne-like eruptions. Injection can cause post-injection flare, joint/tendon injury and systemic steroid reactions above. Zilretta trial reactions include sinusitis, cough and contusions. Nasal labeling highlights nosebleeds, vision change and growth risk without assigning trial incidence. Excess local or injected steroid exposure can cause systemic toxicity; contact medical care/Poison Help (U.S. 1-800-222-1222) for overdose. Chronic excess needs a supervised reduction plan.
Drug interactions
Interaction relevance rises with systemic exposure.
Clinically relevant interactions
Selected injection labels describe systemic corticosteroid interactions; topical/OTC nasal labels do not provide an equivalent full interaction table. Review all steroid routes together.
| Combination | Clinical action |
|---|---|
| Strong CYP3A4 inhibitors, including ritonavir/cobicistat | Amneal warns increased triamcinolone concentrations/systemic toxicity; assess benefit/risk and monitor. Enzyme inducers can reduce exposure. |
| Insulin / other antidiabetics | Monitor glucose; doses may need clinician adjustment. |
| Warfarin | Effects vary; monitor INR/coagulation frequently. |
| Potassium-depleting diuretics / amphotericin B / digoxin | Monitor potassium; hypokalemia can raise arrhythmia risk. |
| NSAIDs / aspirin | More GI toxicity; review bleeding/ulcer risk and salicylate changes. |
| Cyclosporine / estrogens / macrolides / cholestyramine | Can alter exposure/activity; review regimen and toxicity/response. |
| Anticholinesterases / aminoglutethimide / isoniazid | Specialist review for severe weakness or altered steroid/drug effect. |
| Vaccines / skin tests / multiple steroids | Immunosuppressive doses preclude live vaccines, may reduce vaccine response and suppress skin-test responses; assess cumulative exposure. |
Use in specific populations
Route, age and absorbed exposure determine population risks.
Pregnancy and lactation
Skin/dental labels lack adequate pregnancy studies and advise use only when benefit justifies risk; avoid extensive/prolonged skin exposure. Injectable pregnancy data are limited and animal studies identify developmental risks; infants exposed to systemic maternal steroids need assessment for adrenal effects. Zilretta has no direct human pregnancy data, and other-route evidence has limited applicability. Milk/infant effects are incompletely characterized for local forms; systemic steroids enter milk. Discuss route-specific benefits/risks. OTC Nasacort directs pregnant/breastfeeding users to a health professional.
Pediatric and geriatric considerations
Skin treatment in children uses the least effective amount and monitors growth/systemic effects; no universal minimum age is specified. Dental-paste pediatric safety/efficacy is unknown. Nasacort is for age ≥ 2 with age-specific dosing and review beyond 2 months/year. Selected IM/IA steroid pediatric regimens are disease-specific; label class divided-dose ranges are not converted here into a depot-injection schedule. Zilretta pediatric safety/effectiveness is not established. Older adults may be more sensitive despite no overall injection-trial differences; dental-paste trials had insufficient older participants.
Renal and hepatic impairment
The selected skin, dental and nasal labels give no fixed renal/hepatic adjustment. Absorbed corticosteroids are primarily hepatically metabolized with renal/biliary excretion. Injection requires attention to renal fluid/electrolyte effects, BP/edema and enhanced effects in cirrhosis; individualize rather than applying an unvalidated percentage reduction.
Clinical pharmacology
Glucocorticoid signaling suppresses inflammatory pathways.
Mechanism of action
Triamcinolone acetonide activates glucocorticoid-receptor pathways with anti-inflammatory/immunomodulating effects; topical labels also describe antipruritic and vasoconstrictive effects. Exact topical anti-inflammatory mechanisms are incompletely established. Zilretta’s PLGA microspheres provide prolonged local release.
Pharmacokinetics and pharmacodynamics
- Skin / oral mucosa
- Absorption varies with vehicle, barrier damage/inflammation, area, duration and skin occlusion. No universal plasma half-life predicts safety for every local product.
- Immediate-release IM suspension
- Effect can last weeks. Studied single IM 60–100 mg caused adrenal suppression within 24–48 hours, usually recovering in 30–40 days; this is not a repeat-dose instruction.
- Zilretta IA
- Systemically absorbed despite local delivery; study cortisol suppression began within 12–24 hours and normalized within 30–42 days.
- Formulation distinction
- Extended-release IA exposure differs from conventional IA suspension; label expressly prohibits substitution. Adrenal effects can outlast symptom benefit.
Monitoring and counseling
Track response, local complications and cumulative steroid exposure.
Monitoring parameters
- Skin/dental: response, irritation, infection and atrophy; evaluate HPA suppression when large/prolonged/occluded exposure warrants (urinary free cortisol or ACTH stimulation per label).
- Nasal: response by 1 week, nosebleeds, vision and child growth/use duration; review all steroid products.
- Injection: infection/septic joint, glucose, BP/edema, electrolytes, mood, bone/muscle and ocular effects according to exposure/risk. Amneal recommends intraocular-pressure monitoring if systemic therapy continues > 6 weeks.
- Before prolonged immunosuppression assess hepatitis B and relevant latent infections per current Amneal warnings; arrange withdrawal and stress-dose plans.
Patient counseling information
Use the exact form only for its prescribed route/condition. Do not cover skin without instructions or rub dental paste in. Read Nasacort insert, avoid sharing and do not double a missed dose. Inform clinicians of all steroid use and injections; do not abruptly stop prolonged systemic therapy. Seek urgent care for airway swelling, severe infection, post-injection hot/swollen painful joint with fever, marked mood disturbance or serious eye symptoms. Avoid chickenpox/measles exposure during systemic immunosuppression and seek prompt advice if exposed.
Product identification
Confirm route, vehicle, strength and exact packaging.
Representative product
Encube triamcinolone acetonide 0.1% skin cream contains 1 mg/g. Example 15 g tube NDC 21922-062-04; also 30/80 g tubes and 454 g jar. Skin cream is not dental paste, nasal spray or injection.
Dosage forms and strengths
| Selected form | Strength / route |
|---|---|
| Encube cream / ointment | 0.1% = 1 mg/g · skin only |
| Sun dental paste | 0.1% = 1 mg/g · oral mucosal lesion |
| Nasacort Allergy 24HR | 55 mcg per spray · intranasal |
| Amneal suspension | 40 mg/mL · IM/IA; selected vials 1, 5 and 10 mL; contains benzyl alcohol |
| Zilretta kit | 32 mg delivered in 5 mL · IA knee only; powder vial contains 40 mg in microspheres, not all deliverable. |
| Other forms | Other concentrations, vehicles, ophthalmic injections and hexacetonide are outside these selected-label directions. |
Storage and handling
Skin cream: 15–30°C, avoid excess heat and protect from freezing. Selected skin ointment: 20–25°C. Dental paste: tightly closed at 20–25°C. Nasacort: 20–25°C; keep package/insert. Amneal 40 mg/mL: 20–25°C in carton, upright, do not refrigerate; allowed excursions 15–30°C, avoid temperatures below 20°C as label directs; discard single-dose remainder, opened multidose maximum 28 days at 15–25°C per label. Zilretta unopened kit: 2–8°C; if refrigeration unavailable, sealed kit ≤ 25°C up to 3 weeks then discard; no freezing or > 25°C exposure. Prepared-vial hold is separate: up to 4 hours ambient, resuspend. Keep securely away from children.
References
Original sources for the clinical and product information.
- DailyMed / National Library of MedicineEncube triamcinolone acetonide · 0.1% cream
Full public manufacturer label and patient instructions; SPL version 4, effective 20260707. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineEncube triamcinolone acetonide · 0.1% ointment
Full public manufacturer label and patient instructions; SPL version 4, effective 20260706. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineSun triamcinolone acetonide · 0.1% dental paste
Full public manufacturer label and patient instructions; SPL version 6, effective 20250915. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineNasacort Allergy 24HR · OTC 55 mcg/spray
Full public manufacturer label and patient instructions; SPL version 38, effective 20260114. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineAmneal triamcinolone acetonide · 40 mg/mL immediate-release injection
Full public manufacturer label and patient instructions; SPL version 22, effective 20260212. Product-specific directions reviewed October 1, 2026.
- DailyMed / National Library of MedicineZilretta · extended-release knee injection
Full public manufacturer label and patient instructions; SPL version 7, effective 20260603. Product-specific directions reviewed October 1, 2026.