Trispray55 mcg/spray

Established / Approved Uses

• Topical (cream/ointment/lotion): Trispray 55 mcg/spray is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including atopic dermatitis/eczema, contact dermatitis, psoriasis (localized plaques), seborrheic dermatitis, and other inflammatory skin conditions.
• Intranasal spray: Trispray 55 mcg/spray nasal spray is indicated for the relief of nasal symptoms of seasonal and perennial allergic rhinitis (sneezing, rhinorrhea, nasal itching, and congestion) in adults and children.
• Dental/oral paste: Trispray 55 mcg/spray dental paste is indicated as an adjunctive treatment and for temporary relief of symptoms associated with oral inflammatory and ulcerative lesions (e.g., aphthous ulcers/mouth ulcers, trauma-related lesions).
• Injectable (intramuscular/intra-articular/intralesional suspension): Trispray 55 mcg/spray injection is indicated as adjunctive short-term therapy for acute episodes or exacerbations of corticosteroid-responsive conditions when oral therapy is not feasible, including rheumatic disorders (e.g., rheumatoid arthritis, osteoarthritis, bursitis), severe allergic and dermatologic conditions, selected endocrine, gastrointestinal, hematologic, ophthalmic, renal, and respiratory conditions, and certain neoplastic diseases, when systemic or local corticosteroid effect is required.

Adjunct / Guideline-Supported Use

In allergic rhinitis, Trispray 55 mcg/spray nasal spray is often used together with, or as an alternative to, oral antihistamines depending on symptom severity. Intra-articular Trispray 55 mcg/spray is used as an adjunct to rest, physiotherapy, and other standard measures for localized joint inflammation, not as monotherapy for the underlying disease.

Not all forms of Trispray 55 mcg/spray are marketed for every indication above in every country; use only the form and indication prescribed by your physician.

Trispray 55 mcg/spray is a synthetic glucocorticoid corticosteroid available in several dosage forms and strengths, including:

• Topical cream/ointment: Trispray 55 mcg/spray 0.1% (also available as 0.025% and 0.5% in some markets)
• Intranasal spray: Trispray 55 mcg/spray 55 mcg per metered spray
• Dental/oral paste: Trispray 55 mcg/spray 0.1% in an adhesive oral base
• Injectable suspension: Trispray 55 mcg/spray 10 mg/mL or 40 mg/mL for intramuscular, intra-articular, or intralesional use

Trispray 55 mcg/spray is a synthetic corticosteroid with potent anti-inflammatory, antipruritic, and immunosuppressive properties. It is formulated in several ways to target different clinical problems: a topical preparation for inflammatory skin disease, an intranasal spray for allergic rhinitis, an adhesive oral paste for mouth ulcers/oral inflammatory lesions, and an injectable suspension for intramuscular, intra-articular, or intralesional use when a localized or short-term systemic corticosteroid effect is needed.

Regardless of the form used, Trispray 55 mcg/spray works by suppressing the inflammatory response at the cellular level, which underlies its effectiveness across these different indications.

Corticosteroid (topical, intranasal, dental/oral, and injectable glucocorticoid) — Trispray 55 mcg/spray belongs to the synthetic glucocorticoid class of corticosteroids.

Trispray 55 mcg/spray is a synthetic glucocorticoid that binds to intracellular glucocorticoid receptors, altering gene transcription to produce anti-inflammatory, antipruritic, vasoconstrictive, and immunosuppressive effects. It inhibits the release of inflammatory mediators (prostaglandins, leukotrienes, cytokines), reduces capillary permeability, decreases infiltration of inflammatory cells (neutrophils, eosinophils, lymphocytes) into affected tissue, and stabilizes lysosomal membranes.

• Topical: Local anti-inflammatory and vasoconstrictive action reduces erythema, edema, and pruritus in the skin.
• Intranasal: Reduces mucosal inflammation and mediator release responsible for allergic rhinitis symptoms.
• Dental paste: Local anti-inflammatory effect on oral mucosal lesions, with the adhesive base providing a protective barrier.
• Injectable: Produces both local (intra-articular/intralesional) and systemic (intramuscular) anti-inflammatory and immunosuppressive effects; also affects carbohydrate, protein, and fat metabolism and suppresses the hypothalamic-pituitary-adrenal (HPA) axis at higher/prolonged doses.

• Topical: Wash and dry the affected area before application. Apply a thin film and rub in gently. Wash hands after application unless hands are the treated area.
• Intranasal: Shake the bottle gently, prime before first use, tilt head slightly forward, and spray into each nostril while sniffing gently; avoid spraying directly onto the nasal septum.
• Dental paste: Apply to dry mucosa with a clean fingertip; do not rub in — a smooth film will form. Avoid eating or drinking immediately afterward.
• Injectable: Must be administered by a qualified healthcare professional using proper aseptic technique, by intramuscular, intra-articular, or intralesional injection only.

• Live/live-attenuated vaccines: Concurrent use of Trispray 55 mcg/spray (particularly the injectable form at immunosuppressive doses) may reduce vaccine efficacy and increase risk of infection from live vaccines; live vaccines should generally be avoided during significant systemic corticosteroid exposure.
• CYP3A4 inhibitors/inducers (relevant mainly to systemic/injectable use): Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase corticosteroid exposure/effect; strong inducers (e.g., rifampin, phenytoin, carbamazepine) may reduce efficacy.
• NSAIDs and other ulcerogenic drugs: Concurrent use with systemic/injectable Trispray 55 mcg/spray may increase the risk of gastrointestinal ulceration or bleeding.
• Anticoagulants: Systemic corticosteroid use may alter the effect of oral anticoagulants; monitor coagulation parameters more closely.
• Other topical products: Concurrent use of other topical corticosteroids or occlusive products on the same skin area is not recommended, as it may increase systemic absorption.

Topical

Common: burning, itching, irritation, dryness at the application site. Less common: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, skin atrophy, striae, telangiectasia, perioral dermatitis, and allergic contact dermatitis, particularly with prolonged or occlusive use.

Intranasal

Headache, nasal irritation/dryness, epistaxis (nosebleed), sore throat, and cough. Rarely, nasal septal perforation with prolonged use.

Dental Paste

Local burning, stinging, dryness, blistering or peeling of oral mucosa; secondary oral fungal infection (candidiasis) with prolonged use.

Injectable

Injection-site reactions (pain, atrophy, hypopigmentation), and — particularly with repeated or systemic-dose use — fluid retention, hypertension, hyperglycemia, mood/behavioral changes, increased susceptibility to infection, menstrual irregularities, and (with long-term use) osteoporosis, cushingoid features, and adrenal suppression.

Pregnancy: Corticosteroids, including Trispray 55 mcg/spray, have been shown to be teratogenic in animal studies when given systemically. Adequate, well-controlled studies in pregnant women are lacking. Trispray 55 mcg/spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, particularly with the injectable (systemic-exposure) form; topical, intranasal, and dental-paste forms carry lower systemic exposure but should still be used only as directed by a physician, in the smallest effective amount, for the shortest necessary duration. Consult a physician before use during pregnancy.

Lactation: It is not known whether topically or locally applied Trispray 55 mcg/spray is excreted in human breast milk in clinically significant amounts, though systemic corticosteroids are excreted in breast milk in small quantities. Caution is advised; avoid applying topical Trispray 55 mcg/spray directly to the breast/nipple area before breastfeeding, and use the lowest effective dose. Consult a physician before use while breastfeeding.

• Not for prolonged or occlusive use: Prolonged use of topical Trispray 55 mcg/spray, use over large body surface areas, or use under occlusive dressings increases the risk of systemic absorption and hypothalamic-pituitary-adrenal (HPA) axis suppression, especially in children.
• Avoid the eyes: Topical and dental-paste forms should not contact the eyes; may increase risk of glaucoma or cataract with inadvertent ocular exposure.
• Infection risk/masking: Trispray 55 mcg/spray may mask signs of infection or reduce resistance to new infection; do not use on untreated skin, oral, or systemic infections without appropriate concurrent anti-infective therapy.
• Injectable route restrictions: The injectable suspension must not be given intravenously. It is not approved for and must not be given by the epidural or intrathecal route — serious neurologic events (including arachnoiditis, paralysis, and stroke) have been reported with epidural corticosteroid injection.
• Do not stop abruptly after prolonged use: Following prolonged therapy with systemic-equivalent doses (particularly repeated injectable use), corticosteroids should be withdrawn gradually to avoid adrenal insufficiency; consult a physician before stopping.
• Metabolic effects: May cause or worsen hyperglycemia; use with caution in diabetes. Use cautiously in patients with hypertension, congestive heart failure, renal insufficiency, active or latent peptic ulcer disease, diverticulitis, myasthenia gravis, or osteoporosis.
• Growth monitoring in children: Long-term corticosteroid use (any route with significant systemic exposure) may affect growth velocity in pediatric patients; growth should be monitored periodically.

Acute overdose with Trispray 55 mcg/spray is unlikely to be immediately life-threatening with a single topical, intranasal, or dental-paste application, but chronic excessive use of any form may lead to systemic corticosteroid effects, including HPA-axis suppression and cushingoid features. Accidental ingestion of topical or dental preparations, or inadvertent excessive injectable dosing, should be treated as a medical concern. If overdose or accidental ingestion is suspected, seek immediate medical attention or contact a poison control center; do not attempt unsupervised home treatment. Management is supportive and symptomatic, guided by a healthcare professional.

Store at room temperature (below 30°C), away from light and moisture. Keep the container tightly closed and out of reach of children. Do not freeze the nasal spray or injectable suspension. Discard any injectable suspension vial as directed by your pharmacist once opened.

• Pediatric patients: Use of topical and dental-paste Trispray 55 mcg/spray in young children should be limited in duration and surface area due to a higher risk of HPA-axis suppression; the intranasal spray is approved from 2 years of age for allergic rhinitis at reduced dosing. See Pediatric Uses for details.
• Elderly: No specific dose adjustment is established, but elderly patients may be more susceptible to skin thinning (topical) and to systemic corticosteroid adverse effects (osteoporosis, hyperglycemia, hypertension) with the injectable form; use the lowest effective dose.
• Renal impairment: No formal dose adjustment is established for Trispray 55 mcg/spray; use with caution given potential for fluid retention with systemic exposure.
• Hepatic impairment: No formal dose adjustment is established; systemic corticosteroid effects may be more pronounced in significant hepatic impairment — use with caution.
• Pregnancy and lactation: See Pregnancy and Lactation section.

Duration of Trispray 55 mcg/spray therapy depends on the form and indication. Topical use is generally limited to the shortest period necessary to control symptoms (commonly up to 2–3 weeks continuously; re-evaluate if longer treatment is being considered). Dental paste is used until lesions resolve, with medical reassessment if no improvement within 7 days. Intranasal spray may be used for the duration of allergic symptom exposure (e.g., a pollen season) under medical guidance, with periodic reassessment for longer-term use. Injectable Trispray 55 mcg/spray doses are typically spaced at intervals determined by the treating physician (repeat intra-articular injections are generally limited in frequency per joint per year) to reduce cumulative systemic and local risk.

Corticosteroids; Glucocorticoids; Topical/Intranasal/Injectable Anti-inflammatory Agents

Trispray 55 mcg/spray is a synthetic glucocorticoid that binds to glucocorticoid receptors and modulates gene expression, suppressing the synthesis and release of inflammatory mediators (prostaglandins, leukotrienes, cytokines), reducing vascular permeability and inflammatory cell infiltration, and producing anti-inflammatory, antipruritic, and immunosuppressive effects at the site of application or systemically after injection.

C

Use of Trispray 55 mcg/spray in children should follow formulation-specific guidance:

• Topical: Not generally recommended in children under 2 years for prolonged use; children are more susceptible to HPA-axis suppression due to a larger skin-surface-to-body-weight ratio. Treatment courses in children should be limited (commonly no more than 5 days) and confined to the smallest area necessary, under medical supervision.
• Intranasal spray: Approved for allergic rhinitis in children 2 years and older, at a reduced dose (1 spray per nostril once daily); safety and efficacy below age 2 have not been established.
• Dental paste: Use in young children should be supervised by a caregiver to prevent swallowing; safety and efficacy in very young children are not well established.
• Injectable: Safety and efficacy established with weight-based dosing under specialist supervision; long-term use may suppress growth, so growth and development should be monitored periodically in children receiving repeated or prolonged therapy.