Each vial ampoule of 80 mg/2ml injectable suspension of PHARMACORT contains: ACTIVE SUBSTANCE: Triamcinolone acetonide 80.0 mg, Carmellose sodium15.0 mg, Sodium chloride 13.2 mg, Polysorbate 800.8mg, Benzyl alcohol 18.0 mg, Water for injection q.s.2.0 ml.
Pharmaceutical form and contents
Injectable suspension for intramuscular or intra-articular administration
Package of 80 mg/2 ml:
Pharmacotherapeutic category: Corticosteroid
Maketing authorisation holder:
PHARMATEX ITALIA S.R.L
20121 MILAN (ITALY)
Manufacturer and final releaser:
84020 PALOMONATE (SA) ITALY
The intramuscular administration of the PHARMACORT (injectable suspension of triamcinolone acetonide) is indicated in systemic corticosteroid therapy of morbus conditions such as allergic states (control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment), dermatoses general arthritis and other affections of the connective tissues. The intramuscular administration is particularly useful in the aforesaid diseases when oral corticosteroid therapy is not feasible.
PHARMACORT can be administered intra-articularly or intrabursally or directly in the tendon sheath and cystic tendon formations. These routes of administration allow to effect a valid short term local therapy of pain, of the swelling and articular rigidity caused by traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis and tenositis.
In the treatment of the general arthritis disease, triamcinolone acetonide given intra-articularly is intended to support other conventional therapeutic measures. Morbus processes of localized character such as the traumatic arthritis or bursitis, may represent typical indications for instituting intra-articular administration.
Hypersensitivity to triamcinolone acetonide. Infection and fungal infection can’t be controled by particular theraphy. Some cases in virus infection, evoling phase of disease as hesper simplex and zona with showing in eyes, scab disease, goutte, latent peptic ulcer, mental illness, acute ultravirus hepatitis, deterioration (local administration), diabites depend on insuline.
The drug is not recommended in children under 6 years.
the drug is not intended for intravenous use
During the prolonged corticoid therapy, a diet rich is proteins is recommended.
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy. Therefore, in any situation of stress occuring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secrection may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.
Psychic derangement may appear when corticosteroid are used, such as euphoria, insomnia, alteration of humour and personality depression gravis or symptom of real psychosis. A preexisting emotional instability or psychotic tendencies may worsen by corticosteroids.
The drug associated with acetylsalicylic acid should be given with caution to subjects affected by hypothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis. If there is a probality of impending perforation, abscesses or other pyogenic infections. Caution must also be used in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, diabetes mellitus, osteoporosis and myasthenia gravis, when steroids are used as direct or adjunctive therapy.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.
Following intramuscular administration: menstrual irregularities may be observed in women. Since in the pregnancy the spontaneous remission of some diseases may appear such as rheumatoid arthritis, the hormonal treatment should be avoided as much as possible.
Unlike oral administration of corticosteroids, the suprarenal insufficiency creates no problem when the drug is given intramuscularly. However, this problem should be considered in the prolonged treatment when an adequate support of corticosteroid treatment is required in case of stressful situation such as trauma, surgery, and severe diseases.
Following intra-articular administration: accidental injection of the suspension in periarticular soft tissues is not harmful but is the most frequent cause of therapeutic failure.
Following intra-articular steroid therapy, care should be taken to avoid oversure of joints in which symptomatic benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial affects of the steroid. Unstable joints should not be injected. Repeated intra-articular injection may in some cases result in instability of the joint.
The intra-articular injection is well tolerated. Appropriate examination of any joint fluid present 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.
Avoid intra-articular injection in the joints underwent infections.
The corticosteroid associated with acetylsalicylic acid should be given with caution to subjects affected by hypothrombinemia.
Concurrent use of PHARMACORT and non-steroidal anti-inflammatory drugs may increase the risk of incidence of peptic ulcer and gastrointestinal hemorrhage.
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampicin may increase the clearance and may require increases in PHARMACORT dose to achieve the desired response.
There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.
Concurrent use of potassium dispersal diuretics such as thiazides and furosemide may cause an excessive loss of potassium
The drug is not intended for intravenous use.
The drug is not recommended in children below 6 years.
The area around the injection site is prepared in sterile way.
Intramuscular injection is given profoundly into the gluteal muscle region. Local atrophy is frequently caused by subcutaneous deposing of the suspension. In oder to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections.
Local injection of a steroid into a previously infected joint is to be avoided.
Because rare instances of anaphylactoid reactions have occured in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
In patients on corticosteroid therapy subjected to any unusal stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.
Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excrection of potassium. These effects are less likely to occur with the synthetic derivates except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids, however, the reponse to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage of the optic nerves, and may enhance the establishment of secondary occular infections due to fungi or virus.
The use of PHARMACORT in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculous regimen. 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, these patients should receive chemoprophylaxis.
The suspension has not to be injected through intraocular way. Some cases of ophthalmities, eye's inflammations, increase of intraocular pressure, eyesight troubles included eyesight loss in consequence of intravitreal administration, have been reported.
IN PREGNANCY AND EARLY INFANCY, PHARMACORT SHOULD BE GIVEN ONLY IF CLEARLY NEEDED AND UNDER DIRECT CONTROL OF A PHYSICIAN
Dosage and administration
Systemic administration: for adults and children above 12 years the recommended initial dose is 60 mg. The usual ranges from 40 mg to 80 mg and must be individualized according to the severity of the disease and response of the patient. In same cases the symptomatology may be well controlled with a dosage of 20 mg or even less. Patients affected by pollenosis or pollen asthma having no response to the insensitive therapy and other conventional therapies may obtain a remission of symptoms for entire pollen season receiving a single injection of 40 – 100 mg.
For children, the recommended initial dosage will have to be reduced (6 – 12 years: 40 mg) although the dosage should be governed by the severity of the condition rather than by strict adherence to the ration indicated by age or body weight.
The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining dosage.
Since the duration of effect of PHARMACORT is variable the successive dosage of the drug should be administered only after reappearing of symptoms and not at pre-established time intervals.
Intramuscular injection should be profound and given in the region of gluteus muscles. Intramuscular distribution should be assured. In adults a 4 cm long syringe needle is recommended. In obese subjects the needle should be even longer. Alternate the injection site at each successive administration.
Local administration: for intra-articular or intrabursal administration or direct administration in the tendon sheath and cystis tendon formations, the dosage of PHARMACORT depends on severity of condition and on size of joint or size of area localized for treatment. In adults, the dosage up to 10 mg is prescribed for more restricted areas and up to 40 mg for more extended area. In evolving forms the doses up to 80 mg have been administered by single injection at different sites.
Very often only a single local dose of triamcinolone acetonide is sufficient to induced the complete remission of symptomatology; in some cases, however, several injections should be employed to obtain good results. The duration of the therapeutic response is variable from case to case: in some subjects the regression of symptomatology may be permanent after administration of one or two injections and in some other cases the treatment requiring even the period of several months may be needed.
With intra-articular or intrabursal administration or direct administration in the tendon sheath and cystic tendon formations the institution of local anesthetic may sometimes be required. All precautions should be observed when local anesthetic is to be instituted. It should be injected into soft tissues surrounding the area which is to be treated by corticosteroid local injection. A small quantity of anesthetic may be instilled into the joint.
In case of considerable endoarticular effusion the preventive aspiration of synovial liquid is recommended. The aspiration should not be complete. This facilitates the remission of symptomatology avoiding meanwhile an excessive dilution of steroid that is injected in situ.
Proceed then with intra-articular administration following the prescribed technique for articular cavity injection.
For the treatment of cystic tendon formations the PHARMACORT is injected directly into the cystic cavity. In the treatment of the conditions such as tendinitis or tenosynovitis, care should be taken to inject the suspension into the tendon sheath rather than into the sustance of the tendon. The tendon may be rapidly palpated when placed on a stretch. When treating conditions such as epicondylitis, the area of the greatest tenderness should be outlined carefully and the suspension infiltrated into the area. For ganglia of the tendon sheaths, the suspension is injected directly into the cyst.
In the treatment of conditions such as peritendinitis, shoulder periarthritis, rheumatic nodules, fibrosis, some traumatic knee ligament lesions (such as lateral tendon hypertension) the PHARMACORT may be injected into more pronounced pain area.
Note: before use, shake well the suspension contained in a vial. The suspension should be injected immediately after withdrawing. Avoid possible deposit of the suspension in a syringe. Use all precautions to avoid infection. The needle must not penetrate the blood vessel.
During the corticosteroid therapy particularly in the prolonged and intense treatment, the following adverse reactions may be observed:
- Fluid and electrolyte disturbances that may rarely cause hypertension and congestive cardiac insufficiency;
- Musculoskeletal alterations such as osteoporosis, myopathy, bone fragility, spontaneous fracture of long bones, tendon rupture;
- Gastrointestinal disturbances that may cause or activate peptic ulcer with possible subsequent perforation and hermorrhage;
- Dermatologic alteration such as impaired wound healing, thin fragile skin, petechiae and ecchymoses, abnormal fat deposit hyperpigmentation, hirsutism, eruption of formation of acne;
- Neurological disturbances such as increased intracranial pressure with papilledema (pseudoturmo cerebri) endocranial pressure increase, vertigo, convulsions;
- Endocrine disturbances such as menstrual irregularities, development of Cushingoid state, suppression of growth in children, hypoaction of suprarenal hypophysis, decreased carbohydrate tolerance and possible manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents;
- Ophtamic disturbances such as posterior subcapsular cataracts, glaucoma, increased intraocular pressure, exophthalmos;
- Other disturbance such as insomnia, syncope episodes, anaphylactic reactions, necronising angiitis, thrombophlebitis, negative nitrogen balance due to protein catabolism;
- Following intramuscular administration: in some cases local pain of certain intensity, formation of abscesses, Charcot like arthropathy, cutaneous atrophy, local hypopigmentation;
- Following intra-articular administration: temporary pain, skin irritation at site of injection, local depigmentation, occasional increase of articular disturbances.
The risk of adverse effects are reduced when the intructions for use indicated on the leaflet are strictly followed.
Doctor or pharmacist is to be accordingly by a patient about adverse effects not report on the leaflet.
Shelf - life and storage
The product in integral condition has a shelf-life of 36 months.
Store at controlled room temperature 15-300C
Attention: do not use the product after expiry date indicated on the box and avoid freezing
Keep out of the reach of children
Revision effected by the health ministry: 12.05.2005