SYNACTHEN DEPOT 1 MG

What is SYNACTHEN DEPOT?

SYNACTHEN DEPOT 1 MG contains TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE) : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 00253952, held by ATNAHS PHARMA UK LIMITED, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as dormant, status dated 09-Jul-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is SYNACTHEN DEPOT used for?

SYNACTHEN DEPOT is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. It is also used in the treatment of certain conditions that are responsive to corticoids, including: Collagen Diseases: Acute rheumatic fever; rheumatoid arthritis; lupus erythematosus; periarteritis nodosa, psoriatic arthritis; scleroderma; rheumatoid spondylitis; Still's disease. Dermatologic Diseases: Exfoliative dermatitis; dermatomyositis; pemphigus. Endocrine Diseases: Panhypopituitarism. Eye Diseases: Choroiditis; conjunctivitis; iritis; keratitis; optic neuritis; sympathetic ophthalmia; uveitis. Hemolytic Diseases: Acquired hemolytic jaundice. Other Diseases: Nephrotic syndrome; ulcerative colitis; Bell's palsy; acute exacerbations of multiple sclerosis, and as adjuvant treatment in cases of acute gout.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Diagnostic Use for the Investigation of Adrenocortical Insufficiency: - 5-hour test: 1 mg SYNACTHEN DEPOT intramuscularly (I.M.) at about 10 a.m. Plasma cortisol estimated before and 4-6 hours after injection. - 30-Minute Screening Test: 1 mg SYNACTHEN DEPOT I.M. after blood sample at time 0. Further blood sample 30 minutes after injection. - 3-Day Test (Procedure A): 30-minute test on day 1. 1 mg SYNACTHEN DEPOT I.M. on days 2 and 3. Second 30-minute test on day 4. - 3-Day Test (Procedure B): Urinary cortisol levels determined on 24-hour collections for 5 days. 1 mg SYNACTHEN DEPOT I.M. daily from day 3. Therapeutic Use: - Average dose: 0.5 - 1 mg I.M. twice a week, adjusted to individual requirements. - Acute cases or after prolonged steroid therapy: 1 mg I.M. daily for three days. Interval extended as response is obtained. - Maintenance: 0.5 - 1 mg every 2 or 3 days, or 2 mg weekly or longer intervals. Pediatric Dosage (3-15 years old): - 3-6 years: Initial 0.25 - 0.5 mg/day I.M. Maintenance 0.25 - 0.5 mg every 2 - 8 days. - 7-15 years: Initial 0.25 - 1 mg/day I.M. Maintenance 0.25 - 1 mg every 2 - 8 days. Route of Administration: Intramuscular injection, slowly and deeply into the gluteal region. Ampoules should be slightly shaken until suspension is uniform.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store in a refrigerator (2 - 8°C); protect from light. Store in the original package or keep the ampoules in the outer carton. Keep out of the sight and reach of children. Do not use after the expiry date shown on the box.

How is it supplied?

SYNACTHEN DEPOT (tetracosactide zinc injection) 1 mg/mL: Each 1 mL ampoule of milky-white suspension for intramuscular injection contains 1 mg tetracosactide as zinc hydroxide complex. Available in cartons of 1 ampoule.

Contraindications

Known or suspected hypersensitivity to tetracosactide (cosyntropin) and/or ACTH of animal origin or any excipients. Must not be used to treat asthma or other allergic conditions due to increased risk of anaphylactic reactions. Contraindicated in premature babies and neonates (less than 1 month) due to benzyl alcohol content. Acute psychosis. Untreated bacterial, fungal and viral infections. Active or latent peptic ulcer. Refractory congestive heart failure. Cushing's syndrome. Treatment of primary adrenocortical insufficiency. Adrenogenital syndrome. Not to be given intravenously.

Warnings and precautions

SYNACTHEN DEPOT MUST NOT BE GIVEN INTRAVENOUSLY. BENZYL ALCOHOL: Due to the presence of benzyl alcohol, SYNACTHEN DEPOT is not recommended in infants and children between 1 month of age and 3 years old, as it may cause toxic reactions and allergic reactions (gasping syndrome) and may result in death. It is contraindicated in premature babies and neonates (less than 1 month). Anaphylactic reactions: In rare cases, particularly in patients subject to asthma and/or other forms of allergy, severe anaphylactic reactions may occur, usually within 30 minutes after administration. SYNACTHEN DEPOT must not be used to treat asthma or other allergic conditions due to this increased risk. Conditions requiring careful consideration: If used in non-specific ulcerative colitis, diverticulitis, recent intestinal anastomosis, renal insufficiency, hypertension, thromboembolic tendencies, acute or chronic infections (especially varicella or vaccinia), exanthematous and fungal diseases, osteoporosis, and myasthenia gravis, risks should be weighed against benefits. Sodium and water retention: Administration for three consecutive days may cause sodium and water retention with risk of edema. Cushing's syndrome exacerbation: Marked and prolonged increase in circulating corticosteroid levels in patients with bilateral adrenal hyperplasia can cause severe exacerbation of Cushing's syndrome symptoms. Adrenal crisis: On extremely rare occasions, adrenal crisis has supervened during prolonged ACTH stimulation in patients with marked adrenal insufficiency. Steroid cover (e.g., 1 mg dexamethasone daily) may be given during the 3 days of SYNACTHEN DEPOT administration for diagnostic tests to prevent this. Hypersensitivity reactions: Allergic reactions may occur, tending to be more severe in patients susceptible to allergies (especially asthma). Injections should be given under medical supervision, and the patient observed for about 1 hour. Self-injection is not recommended. If prodromal signs occur, stop treatment. Local or systemic hypersensitivity reactions (marked redness/pain at injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushings, severe malaise, dyspnea, angioneurotic edema or Quincke's edema) require discontinuation of tetracosactide and avoidance of all ACTH preparations in the future. Live virus immunization: Must not be undertaken during treatment due to decreased antibody response and possible neurological complications.

What can be used instead?

Other Canadian products sharing ATC code H01AA02 TETRACOSACTIDE. 1 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies TETRACOSACTIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. TETRACOSACTIDE appears in 9 registered pack listings across 6 markets, published on 5 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.