KENACORT

                       KENACORT

      TRIAMCINOLONE ACETONIDE       INJECTION I.P.

                         IM/IA USE ONLY

COMPOSITION:

Each ml contains;

Triamcinolone Acetonide I.P.              40mg

Benzyl alcohol I.P                             0.9%w/v

Water for injection I.P.                              q.s

DESCRIPTIONS:

PHARMACOLOGICAL ACTION:

   1.PHARMACODYNAMICS / MECHANISMS OF ACTION

Triamcinolone acetonide is essentially devoid of mineralocorticoid activity when administered in therapeutic doses, causing little or no sodium retention with potassium excretion minimal or absent.

2.PHARMACOKINETICS :

          A.Absorption

                        Triamcinolone acetonide absorption is rapid, achieving maximum Triamcinolone acetonide levels of 10.5 ng/mL.

          B.Distribution

                   The volume of distribution was 103L.

          C.Excretion

                      Triamcinolone acetonide is generally eliminated with a total body clearance of 37 L/h.

          D.Half-life

                     The half-life of Triamcinolone acetonide is 2 hours.

INDICATION AND USES :

        

           Where oral therapy is not suitable, injectable corticosteroid therapy is indicated for intramuscular use as follow ;

   Allergic states: Control of severe or incapacitating allergic condition uncontrollable to adequate trials of conventional treatment in bronchial asthma atopic dermatitis, contact dermatitis perennial or seasonal allergic rhinitis.

    Dermatologic disease: Bullous dermatitis herpetiformis, pemphigus, severe erythema multi forming.

    Endocrine disorders: Nonsuppurative thyroiditis.

     Gastrointestinal diseases: To tried the patients over a critical period of the disease in regional enteritis and ulcerative colitis.

     Hematologic disorders: Acquired hemolytic anemia.

    Neoplastic diseases: For the palliative management of leukemias and lymphomas.

     Oedematous state: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or nephrotic syndrome due to lupus erythematosus.

   Ophthalmic disease: Severe chronic allergic and inflammatory processes involving the eye. 

PRECAUTIONS & WARNINGS :

          (a) General:

                        This product like many other steroid formulations is sensitive to heat.it should not be autoclaved when it is desirable to sterilize the exterior I the vial.

The lowest possible dose of corticosteroid should be used to control the condition under treatment. when the reduction in dosage is possible, the reduction should be gradual.

Make an individual decision about each patient decision in regard to dose and duration of treatment and as to whether daily or intermittent therapy should be used as the application of treatment wi glucocorticoids are dependent on the size of the does and the duration of treatment

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy,  often for chronic conditions.

          (b) Cardio-Renal

                     As sodium retention with resultant edema and potassium loss may occur in patient s receiving corticosteroids,  these agents should be used with congestive heart failure.hypertension,  renal insufficiency.

             (c)Endocrine

                     Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.concurrently.

               (d)Gastrointestinal

                        Steroids should be used with caution in active or latent peptic ulcers, diverticulitis fresh intestinal anastomosis,  and nonspecific ulcerative colitis since they may increase the risk of a perforation.

Sings of operational irritation following gastrointestinal perforation in patients receiving corticosteroids.

             (e) Intra-articular and soft tissue administration

                  Intra-particularly injected corticosteroids may be systemically absorbed. appropriate examination of any won't fluid presents is necessary to exclude a septic process.

A marked increase in pain accompanied by local swelling further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed appropriate antimicrobial therapy should be instituted

. Injection of a steroid into an infected site to be avoided. Local injection of a steroid into a previously infected joint is not usually recommended. Corticosteroid injection into unstable joints is generally recommended.

             (f) Serious Neurologic adverse reactions with Epidural administration

       Epidural injection of corticosteroids at times causes serious neurologic events.

      Other events occurring occasionally with Epidural injection of corticosteroids are spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.

      The septic and effectiveness of Epidular administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

        (g) Infection

                    Patients who are on Triamcinolone acetonide are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen ( viral bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. This infection may be mild to severe.

with increasing doses of corticosteroids,  the rate of occurrence of infectious complications increases. corticosteroids may also mask some signs of current infection.

             (h) Fungal infection

                           Triamcinolone acetonide injection may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.

                 (I) Tuberculosis

                           The use of corticosteroids in patients with active tuberculosis restricted to those cases of fulminating or disseminated tuberculosis regimens. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.

During prolonged corticosteroid therapy, it is essential that these patients should receive chemoprophylaxis.

             (j) Ophthalmic

                          Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves,  and may enhance the establishment of secondary ocular infections due to bacteria,  fungi,  or viruses. The use of oral corticosteroids should not be used in active ocular herpes simplex. Administration or triamcinolone acetonide injection intraocularly or into the nasal turbinates is not recommended. Intraocular injection of corticosteroids formulations containing benzyl alcohol, such as kenacort injection, is not recommended because of potential toxicity from benzyl alcohol.

ADVERSE / SIDE EFFECT:

Allergic Reaction:
       Hypersensitive reaction, anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular
.              Circulatory collapse, bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement.

Dermatologic
           Acne, allergic, dermatitis, cutaneous and subcutaneous atrophy.

Endocrine
       Decreased the carbohydrate glycosuria, glucose tolerance, hirsutism, hypertrichosis

Fluid and Electrolyte Disturbance
     Congestive heart failure in susceptible patients, hypokalemic alkalosis, fluid retention, potassium loss, sodium retention

Gastrointestinal
       Abdominal intention, elevation in serum liver enzyme levels, increase appetite, perforation of the small and large intestine.

Metabolic
       Negative nitrogen balance due to protein catabolism

Ophthalmic
       Exophthalmos, rare blindness associated with particular injections.

DOSAGES:

    Adult dose;

         3 to 48mg per day depending upon the specific disease.

         The average dose is 40mg(1ml) administrated intramuscularly once a week.

   Pediatric dosage;

        0.11 to 1.6mg/kg per day.

OVERDOSAGE:

                  Treatment of acute overdosage is supportive and symptomatic therapy. It is advisable that the dosage of the corticosteroid may be reduced only temporarily or alternate day treatment may be introduced for chronic overdosage in the face of severe disease requiring continuous steroid therapy.

DRUG INTERACTION:

1.AMINOGLUTETHIMIDE

      Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression.

2.AMPHOTERICIN B-INJECTION AND POTASSIUM DEPLETING AGENTS:

      When corticosteroid is administered concomitant with potassium-depleting agents(i.e, amphotericin B, diuretics) there is an increased risk for hyponatremia at times leading to cardiac enlargement and congestive heart failure.

3.ANTIBIOTIC:

   Macrolide antibiotics have been reported.

4.ANTICHOLINESTERAGE

             Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients.

5.ANTICOAGULANTS

     Co-administration of corticosteroid and warfarin usually results in inhibition of responses to warfarin.

6.ANTIDIABETICS

            Co-administration of corticosteroid and antidiabetics may increase blood glucose concentration.

7.ANTITUBERCULAR DRUGS

            Serum concentrations of isoniazid may be decreased.

      Manufactured by;
             Nitin Lifesciences Ltd.
      Marketing by;
             Abbott Healthcare Pvt. Ltd.