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A Medico-Marketing PPS on Triamcinolone

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  1. 1. Triamcinolone acetonide Shilpa Garg
  2. 2. Corticosteroids  Corticosteroids are man-made drugs that closely resemble cortisol, a hormone that adrenal glands produce naturally.  Corticosteroids are often referred to by the shortened term “steroids.”  Corticosteroids are different from the male hormone- related steroid compounds that some athletes abuse.
  3. 3. Corticosteroids  Corticosteroids act on the immune system by blocking the production of substances that trigger allergic and inflammatory actions, such as prostaglandins.  However, they also hamper the function of white blood cells which destroy foreign bodies and help keep the immune system functioning properly.  The interference with white blood cell function yields a side effect of increased susceptibility to infection.
  4. 4. Corticosteroids  Corticosteroids decrease inflammation by acting within cells to prevent the release of certain chemicals that are important in the immune system.  These chemicals are normally involved in producing immune and allergic responses, resulting in inflammation.  By decreasing the release of these chemicals in a particular area, inflammation is reduced.
  5. 5. Corticosteroids  This can help control a wide number of disease states, characterised by excessive inflammation.  They include severe allergic reactions, inflammation of the lungs in asthma and inflammation of the joints in arthritis.  The injection can be given as a single dose to people who suffer from hayfever and don't respond to conventional therapy.
  6. 6. How are Corticosteroids Beneficial?  When inflammation threatens to damage critical body organs, steroids can be organ-saving and in many instances, life-saving.  For example, steroids may prevent the progression of kidney inflammation which could lead to kidney failure in people who have lupus (a systemic disease that results from an autoimmune mechanism) or vasculitis (inflammation of a vessel). For these patients, steroid therapy may eliminate the need for kidney dialysis or transplantation.
  7. 7. How are Corticosteroids Beneficial? Low doses of steroids may provide significant relief from pain and stiffness for people with rheumatoid arthritis. Temporary use of higher doses of steroids may help a person recover from a severe flare-up of arthritis.
  8. 8. How to decide if Corticosteroids are the Right Treatment?  The decision to prescribe steroids is always made on an individual basis. The patient’s age, physical activity and other medications he is taking are considered before prescribing  The doctor will also make sure that the patient understand the potential benefits and risks of steroids before starting the treatment.  The potential benefits and risks of steroids vary with:  the nature and severity of the disease being treated;  the presence or absence of other treatment alternatives; and  the presence or absence of other significant medical problems.
  9. 9. Corticosteroids  Corticosteroids affect the strength of heart muscle and its response to natural chemicals affecting heart rate.  They affect the water and salt balance in the body and also enable the body to cope with stress. Stress includes changes in temperature, pain, fear, anxiety and illness and can be hazardous if the body is not equiped to cope, due to low levels of corticosteroids
  10. 10. Corticosteroids  Corticosteroids allow us to respond to stress by  increasing the rate and force of the heartbeat,  increasing blood supply to essential tissues (muscle, heart, brain),  increasing the body's supply of energy by raising blood sugar and by several other effects on body systems.
  11. 11. Corticosteroids  Corticosteroid Drugs Include:  Betamethasone  Budesonide  Cortisone  Dexamethasone  Hydrocortisone  Methylprednisolone  Prednisolone  Prednisone  Triamcinolone  Prednisone is the most commonly used type of steroid to treat certain rheumatologic diseases.
  12. 12. Corticosteroids  Corticosteroids are versatile in their mode of application. They can be given: orally  injected into the vein or muscle  applied locally to the skin  injected directly into inflamed joints   Corticosteroid drugs can also be used as ingredients contained in: eye products (to treat various eye conditions)  inhalers (to treat asthma or bronchial disease)  nasal drops and sprays (to treat various nasal problems)  topical creams, ointments, etc. (to treat various skin problems)   Corticosteroids can be used in conjunction with other drugs, and are prescribed for short-term and long-term use.
  13. 13. Triamcinolone acetonide  Triamcinolone acetonide is a more potent type of corticosteroid , being about 8 times as effective as prednisone.  A synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra- articular injection
  14. 14. Triamcinolone  Triamcinolone acetonide is a synthetic corticosteroid and is given by injection in many situations where a lasting corticosteroid effect is required.  This includes replacement therapy in people whose adrenal glands are not producing enough natural steroids (adrenal insufficiency) and decreasing inflammation in certain disease states.
  15. 15. Triamcinolone  Triamcinolone may also be given by injection directly into a joint to relieve inflammation and pain and increase mobility of the affected joint, in conditions such as arthritis.  Triamcinolone also decreases the numbers of white blood cells circulating in the blood. This is useful for the treatment of certain types of leukaemia, where there is an abnormally large production of certain white blood cells.  It is also used to treat some diseases which are caused by the immune system attacking the body's own tissues (auto immune diseases).
  16. 16. General Indications  An attack of the body by its immune system resulting in the destruction of red blood cells (autoimmune haemolytic anaemia)  Cancer of the lymph nodes  Hayfever  Inflammation of the bony projection at the end of a long bone e.g. humerus in the arm (epicondylitis)  Inflammation of the envelope (bursa) found around parts of the body which are subject to friction e.g. joints, muscles and tendons (bursitis)  Inflammation of the tissue surrounding a tendon (tenosynovitis)
  17. 17. General Indications  Inflammatory disorders e.g. asthma, arthritis, severe allergic reactions, Crohn's disease, systemic lupus erythematosus  Insufficient production of natural steroid hormones by the adrenal glands (adrenal insufficiency)  Joint injection in inflammatory disease of the joints (e.g. rheumatoid arthritis)  Joint injection in osteoarthritis with associated inflammation  Leukaemia
  18. 18. Indications and Usage  The intra-articular (within the cavity of a joint) or soft tissue administration of triamcinolone acetonide injectable, is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis  acute and sub-acute bursitis  acute nonspecific tenosynovitis  epicondylitis  rheumatoid arthritis  synovitis of osteoarthritis 
  19. 19. Indications and Usage  The intralesional (injected directly into a lesion) administration of triamcinolone acetonide injectable, is indicated for:  Alopecia (Baldness)  Discoid lupus erythematosus (Skin disease in which there are red scaly patches, especially over the nose and cheeks along with skin lesions)  Keloids (hard prominent irregular scar tissue in the skin)  Lichen planus (wide flat purple pimples on forearms, neck and thighs)
  20. 20. Indications and Usage  The intralesional (injected directly into a lesion) administration of triamcinolone acetonide injectable, is indicated for:  Lichen simplex chronicus (A thickened area of itching skin resulting from rubbing and scratching)  Psoriatic plaques  Necrobiosis lipoidica (patchy degeneration of skin causing areas of white scarring and thinning)  Also can be useful in cystic tumors of an aponeurosis (thin but strong fibrous sheet of tissue that replaces a tendon)
  21. 21. Dosage For the purpose of comparison, the following is the equivalent milligram Cortisone, 25 Triamcinolone, 4 dosage of the various glucocorticoids. Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 These dose relationships apply only to oral or intravenous administration of these compounds. Prednisone, 5 Dexamethasone, 0.75 When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative Methylprednisolone, 4 properties may be greatly altered.
  22. 22. Dosage : Intra-Articular Administration  The initial dose of triamcinolone acetonide injectable for intra-articular administration may vary from 2.5 mg to 5 mg for smaller joints and from 5 to 15 mg for larger joints, depending on the specific disease entity being treated.  Single injections into several joints, up to a total of 20 mg or more, have been given
  23. 23. Dosage : Intralesional  For intralesional administration, the initial dose per injection site will vary depending on the specific disease entity and lesion being treated. The site of injection and volume of injection should be carefully considered due to the potential for cutaneous atrophy.  Multiple sites separated by one centimeter or more may be injected, keeping in mind that the greater the total volume employed the more corticosteroid becomes available for systemic absorption and systemic effects. Such injections may be repeated, if necessary, at weekly or less frequent intervals.
  24. 24. Warnings and Precautions  Pregnancy  Teratogenic Effects: Pregnancy Category C  There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
  25. 25. Warnings and Precautions  Nursing Mothers  Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.
  26. 26. Warnings and Precautions  Pediatric Use  This product contains benzyl alcohol as a preservative.  Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients.  The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.
  27. 27. Warnings and Precautions  Pediatric Use  Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age).  Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.
  28. 28. Warnings and Precautions  Geriatric Use  No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
  29. 29. Adverse Reactions  The occurrence of side effects depends on the dose, type of corticosteroid and length of treatment.  Some side effects are more serious than others. Common side effects of systemic corticosteroid include:  Difficulty in sleeping (insomnia)  Depression  Thinning of the skin  Increased pressure inside the eye (glaucoma)  Irregular menstrual cycle  Decreased functioning of the adrenal gland (adrenal suppression)
  30. 30. Adverse Reactions  Common side effects of systemic corticosteroid include: Thinning of the bones (osteoporosis)  Ulceration of the stomach or intestine  Increased susceptibility to infections  Acne  An extreme allergic reaction (anaphylaxis)  Increased risk of fractures of the bones  Increased hair growth (hirsutism)  Yeast infection of the moist areas of the body, especially  the vagina (candidiasis)  Muscle wasting and weakness
  31. 31. Side Effects of Corticosteroids can be Minimized  To minimize the side effects of corticosteroids, doctors follow several guidelines:  Use steroids only when necessary.  Monitor the patient closely to detect the development of serious side effects. If possible, use local steroids for local problems.  Use the minimal dose required to gain control of the  disease. Reduce the dose gradually as long as the disease remains  under control. Monitor blood pressure often and treat if necessary.  Prescribe calcium supplements to help maintain bone  density.
  32. 32. Contraindications  Triamcinolone acetonide injectable is contraindicated in patients who are hypersensitive to any components of this product.  Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura (A rare autoimmune disorder characterized by an acute shortage of platelets with resultant bruising and spontaneous bleeding).
  33. 33. Overdosage  Treatment of acute overdosage is by supportive and symptomatic therapy.  For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
  34. 34. Glossary of Medical Terms  Gout: A condition that results from crystals of uric acid depositing in tissues of the body. Gout is characterized by an overload of uric acid in the body and recurring attacks of joint inflammation (arthritis).  Bursitis: Bursitis is inflammation of a bursa. A bursa is a tiny fluid-filled sac that functions as a gliding surface to reduce friction between tissues of the body. There are 160 bursae in the body. The major bursae are located adjacent to the tendons near the large joints, such as the shoulders, elbows, hips, and knees
  35. 35. Glossary of Medical Terms  Epicondylitis: Epicondylitis is an inflammation or damage to the area of an epicondyle of bone. An epicondyle is a projection of bone above a condyle (a rounded prominence at the end of a bone, usually where the bone connects to another bone) where ligaments and tendons are attached.  Epidural : Outside the dura, the outermost, toughest, and most fibrous of the three membranes (meninges) covering the brain and the spinal cord.