Adrenocortine Ampoules 1 ml

Adrenocortine Ampoules 1 ml

Description:

Adrenocortine Ampoules 1 ml is a prescription injectable medicine containing tetracosactide 1 mg/ml for intramuscular (i.m.) use. Tetracosactide is a synthetic analogue of adrenocorticotropic hormone (ACTH) that stimulates the adrenal cortex to produce glucocorticoids, mineralocorticoids and, to a lesser extent, androgens. It is used both as a diagnostic aid in suspected adrenocortical insufficiency and as a short-term therapeutic alternative in conditions where glucocorticoid treatment is indicated but oral therapy is not tolerated or is ineffective. This product must be administered under strict medical supervision.

Indications:

• Diagnostic evaluation of suspected adrenocortical insufficiency (ACTH stimulation test) to assess adrenal cortex function.
• Short-term therapy in diseases where systemic glucocorticoids are indicated, particularly when oral glucocorticoids are not tolerated or ineffective.
• Adjunctive treatment in rheumatoid arthritis and osteoarthrosis when standard glucocorticoid therapy is inadequate.
• Short-term treatment of inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease, where glucocorticoids are indicated in principle.
• Other conditions responsive to glucocorticoid therapy, at the discretion of the treating specialist.

Active Ingredients / Key Components:

• Tetracosactide (synthetic ACTH 1–24) – 1 mg/ml (per 1 ml ampoule) for intramuscular injection.
• Excipients: The full list of excipients (inactive ingredients, preservatives, stabilizers) is not available in the provided information. Please refer to the official package leaflet for complete composition.

Dosage & Administration / How to Use:

• Route of administration: Intramuscular (i.m.) injection only. Must be administered by a physician or qualified healthcare professional.
• Diagnostic use (ACTH stimulation test): The exact dose, timing, and sampling protocol (baseline and post-injection cortisol levels) are determined by the treating physician according to standard diagnostic guidelines and patient-specific factors. Do not self-administer.
• Therapeutic use: Dose, frequency, and duration are individualized based on the condition being treated, disease severity, and patient response. Treatment is generally short-term and should not be continued longer than necessary.
• General instructions: The ampoule should be inspected visually before use; do not use if the solution is discolored or contains particles (if applicable). Use aseptic technique when drawing up and administering the injection.
• Missed dose: If a scheduled dose is missed, contact your doctor for instructions. Do not double the dose to make up for a missed injection.
• Do not self-inject. Always follow the dosing schedule and instructions provided by your healthcare provider.

Clinical Benefits:

• Provides a reliable diagnostic tool to assess adrenal cortex function and detect adrenocortical insufficiency.
• Stimulates endogenous glucocorticoid production, offering an alternative to exogenous steroid therapy in selected patients.
• Can be beneficial in patients who cannot tolerate oral glucocorticoids due to gastrointestinal or other issues.
• May help improve symptoms of inflammatory and autoimmune conditions (e.g., rheumatoid arthritis, inflammatory bowel disease) when used as short-term adjunct therapy.
• Allows physicians to evaluate both adrenal reserve and therapeutic responsiveness in conditions requiring glucocorticoid action.

Warnings & Contraindications:

• Prescription-only medicine: Use only under the supervision of a specialist physician experienced in adrenal and endocrine disorders.
• Contraindications: Known hypersensitivity to tetracosactide, natural ACTH, or any component of the formulation. Use with caution or avoid in patients with uncontrolled infections, severe hypertension, severe heart failure, or active peptic ulcer disease, as glucocorticoid-like effects may worsen these conditions.
• May cause or exacerbate fluid retention, hypertension, and electrolyte imbalance due to stimulation of mineralocorticoid production; careful monitoring is required in patients with cardiovascular or renal disease.
• Use with caution in patients with diabetes mellitus, as increased glucocorticoid production can raise blood glucose levels.
• Longer or repeated courses may increase the risk of adrenal suppression and typical glucocorticoid-related adverse effects; therapy should be as short as possible.
• Consult your doctor before use if pregnant, nursing, taking other medications (especially glucocorticoids, immunosuppressants, antidiabetics, antihypertensives), or if you have chronic medical conditions such as liver disease, kidney disease, heart disease, osteoporosis, or psychiatric disorders.
• Not intended for self-diagnosis or self-treatment. Do not use for general fatigue, bodybuilding, or performance enhancement.
• Keep out of reach of children.
• This product is used as a diagnostic and therapeutic tool under medical supervision and is not intended to diagnose, treat, cure, or prevent any disease without appropriate clinical evaluation and monitoring.

Side Effects:

• Common or expected effects (related to increased glucocorticoid/mineralocorticoid activity) may include: fluid retention, swelling (edema), increased blood pressure, changes in blood sugar, mood changes (e.g., irritability, euphoria), headache, or gastrointestinal discomfort.
• Less common but serious side effects may include: severe hypertension, heart failure exacerbation, significant electrolyte disturbances, adrenal suppression with prolonged or repeated use, increased susceptibility to infections, gastrointestinal bleeding or ulcer aggravation, and severe allergic reactions (rash, itching, swelling of face or throat, difficulty breathing).
• Seek immediate medical attention if you experience signs of a severe allergic reaction, chest pain, severe shortness of breath, sudden severe headache, confusion, or any other alarming symptom after injection.
• The exact frequency and profile of side effects depend on dose, duration, and individual patient factors. Your doctor will monitor you for adverse reactions during and after treatment or testing.

Storage Instructions:

Store in a cool, dry place away from direct sunlight, heat sources, and moisture. Keep ampoules in their original packaging until use to protect from light and contamination. Do not use after the expiry date printed on the pack. Keep container tightly closed (if applicable) and out of reach of children. Do not freeze unless the official leaflet specifically allows it. Dispose of used or expired ampoules according to local regulations or pharmacist guidance.

Specifications:

• Product type: Prescription injectable medicine for intramuscular use.
• Active ingredient strength: tetracosactide 1 mg/ml.
• Form: Sterile solution in glass ampoule for i.m. injection.
• Volume per unit: 1 ml ampoule.
• Pack size: Exact number of ampoules per box is not available in the provided information; please refer to the outer packaging.
• Intended users: Adults and, in selected cases, children, only under specialist medical supervision.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.