Triamcinolone Acetonide Injectable Suspension USP 10mg/ml Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Triamcinolone Acetonide Injectable Suspension USP 10mg/ml Taj Pharma
Triamcinolone Acetonide Injectable Suspension USP 50mg/5ml Taj Pharma
Triamcinolone Acetonide Injectable Suspension USP 40mg/ml Taj Pharma
Triamcinolone Acetonide Injectable Suspension USP 80mg/2ml Taj Pharma|
Triamcinolone Acetonide Injectable Suspension USP 200mg/5ml Taj Pharma
Triamcinolone Acetonide Injectable Suspension USP 400mg/10ml Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION| 

   a) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide…………10mg/ml
   Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml
   b) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide………50mg/5ml
   Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

   c) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide…………40mg/ml
   Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

   d) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide………80mg/2ml
   Excipient(s) with known effects Benzyl alcohol………………………….15mg/ml

   e) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide………200mg/5ml
   Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

   f) Triamcinolone Acetonide Injectable Suspension USP contains:
   Triamcinolone acetonide……400mg/10ml
   Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Sterile aqueous suspension for injection.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required: Allergic states, e.g. bronchial asthma. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection (see section 4.2); Endocrine disorders, e.g. primary or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or Respiratory disorders – as an adjunctive, short-term therapy; Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas; Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

4.2 Posology and method of administration

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma is for Intra-articular/Intramuscular injection ONLY. The safety and efficacy of administration by other routes has yet to be established (see sections 4.3 and 4.4). Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.

Intra-Articular Injection: For intra-articular administration or injection into tendon sheaths and bursae, the dose of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma Injection may vary from 5 mg to 10 mg (0.125 – 0.25 ml) for smaller joints and up to 40 mg (1.0 ml) for larger joints, depending on the specific disease entity being treated. Single injections into several sites for multiple joint involvement, up to a total of 80 mg, have been given without undue reactions.

It is recommended that, when injections are given into the sheaths of short tendons, Adcortyl Injection (triamcinolone acetonide 10 mg/ml) should be used (see section 4.4 re Achilles tendon).

Intramuscular Injection: To avoid the danger of subcutaneous fat atrophy, it is important to ensure that deep intramuscular injection is given into the gluteal site. The deltoid should not be used. Alternate sides should be used for subsequent injections.

Adults and Children over 12 Years: The suggested initial dose is 40 mg (1.0 ml) injected deeply into the upper, outer quadrant of the gluteal muscle. Subsequent dosage depends on the patient’s response and period of relief. Patients with pollen asthma who do not respond to conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single dose of 40-100 mg given when allergic symptoms appear (see section 4.4).

Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Children from 6-12 Years of Age: The suggested initial dose of 40 mg (1.0 ml injected deeply into the gluteal muscle should be scaled according to the severity of symptoms and the age and weight of the child. Triamcinolone Acetonide Injectable Suspension USP Taj Pharma is not recommended for children under six years. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases (see section 4.4).

Triamcinolone withdrawal: In patients who have received more than physiological doses of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma (more than one injection during a three week period), withdrawal should not be abrupt. The dose should be reduced and the dosage interval increased until a dose of not more than 40 mg and a dosage interval of at least three weeks have been achieved as the dose of systemic corticosteroid is reduced. Clinical assessment of disease activity may be needed.

Abrupt withdrawal of short term systemic corticosteroid treatment is appropriate if it is considered that the disease is unlikely to relapse. A single dose, which is not repeated within a three week period, is unlikely to lead to clinically relevant hpa-axis suppression in the majority of patients. However, in the following patient groups, gradual withdrawal of systemic corticosteroid therapy should always be considered:

Patients who have had repeated courses of systemic corticosteroids.

When a course of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma has been prescribed within one year of cessation of long-term therapy (months or years).

Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Systemic infections unless specific anti-infective therapy is employed.

Administration by intravenous, intrathecal epidural, or intraocular injection.

4.4 Special warnings and precautions for use

Warnings:

Adequate studies to demonstrate the safety of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head.

Cases of serious anaphylactic reactions and anaphylactic shock, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

(Intra-Articular Injection):

Corticosteroids should not be injected into unstable joints.

Patients should be specifically warned to avoid over-use of joints in which symptomatic benefit has been obtained. Severe joint destruction with necrosis of bone may occur if repeated intra-articular injections are given over a long period of time. Care should be taken if injections are given into tendon sheaths to avoid injection into the tendon itself. Repeated injection into inflamed tendons should be avoided as it has been shown to cause tendon rupture.

Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with depot corticosteroids.

(Intramuscular Injection):

During prolonged therapy a liberal protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with negative nitrogen balance and wasting of skeletal muscle.

Precautions:

Intra-articular injection should not be carried out in the presence of active infection in or near joints. The preparation should not be used to alleviate joint pain arising from infectious states such as gonococcal or tubercular arthritis.

Undesirable effects may be minimised using the lowest effective dose for the minimum period, and by administering the daily requirement, whenever possible, as a single morning dose on alternate days. Frequent patient review is required to titrate the dose appropriately against disease activity (see section 4.2).

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.

Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

Chickenpox and measles are of particular concern since these normally minor illnesses may be fatal in immunosuppressed patients.

Unless they have had chickenpox, patients receiving parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non- immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; varicella-zoster immunoglobulin should preferably be given within 3 days of exposure and not later than 10 days. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Patients should be advised to avoid exposure to measles and to seek medical advice without delay if exposure occurs. Prophylaxis with normal immunoglobulin may be needed.

During corticosteroid therapy antibody response will be reduced and therefore affect the patient’s response to vaccines. Live vaccines should not be administered.

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Special Precautions:

Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

Recent intestinal anastomoses, diverticulitis, thrombophlebitis, existing or previous history of severe affective disorders (especially previous steroid psychosis), exanthematous disease, chronic nephritis, or renal insufficiency, metastatic carcinoma, osteoporosis (post-menopausal females are particularly at risk); in patients with an active peptic ulcer (or a history of peptic ulcer). Myasthenia gravis. Latent or healed tuberculosis; in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics. In acute psychoses; in acute glomerulonephritis. Hypertension; congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver failure.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Therefore, co-administration of triamcinolone acetonide and ritonavir is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.5).

Corticosteroid effects may be enhanced in patients with hypothyroidism or cirrhosis and decreased in hyperthyroid patients.

Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.

Menstrual irregularities may occur and in postmenopausal women vaginal bleeding has been observed. This possibility should be mentioned to female patients but should not deter appropriate investigations as indicated.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies.

All corticosteroids increase calcium excretion

Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

This product contains 15 mg/ml benzyl alcohol and must not be given to premature babies or neonates. Benzyl Alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.

Use in Children:

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma is not recommended for children under six years. Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible, therefore growth and development of children on prolonged corticosteroid therapy should be carefully observed.

Use in Elderly:

The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalaemia.

Anticholinesterases: Effects of anticholinesterase agent may be antagonised.

Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.

Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.

Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.

Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): There may be increased metabolic clearance of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.

Human growth hormone: The growth-promoting effect may be inhibited.

CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Co-administration with strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone is not recommended because increased systemic corticosteroid adverse effects may occur (see section 4.8). If the potential benefit of co-administration outweighs the increased risk of systemic corticosteroid side-effects, patients should be monitored for these effects. During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression (see section 4.4).

Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.

Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated (see section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy:

The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate / lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important.

As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Breast-feeding:

Corticosteroids may pass into breast milk, although no data are available for triamcinolone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (≥1/10,000); Not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions.

Intra-Articular Injection: Following local injection, relief of pain and swelling and greater freedom of movement are usually obtained within a few hours.

Intramuscular Injection: Provides an extended duration of therapeutic effect and fewer side effects of the kind associated with oral corticosteroid therapy, particularly gastro-intestinal reactions such as peptic ulceration. Studies indicate that, following a single intramuscular dose of 80 mg triamcinolone acetonide, adrenal suppression occurs within 24 – 48 hours and then gradually returns to normal, usually in approximately three weeks. This finding correlates closely with the extended duration of therapeutic action of triamcinolone acetonide.

5.2 Pharmacokinetic properties

Triamcinolone acetonide may be absorbed into the systemic circulation from synovial spaces. However clinically significant systemic levels after intra-articular injection are unlikely to occur except perhaps following treatment of large joints with high doses. Systemic effects do not ordinarily occur with intra-articular injections when the proper techniques of administration and the recommended dosage regimens are observed.

Triamcinolone acetonide is absorbed slowly, though almost completely, following depot administration by deep intramuscular injection; biologically active levels are achieved systemically for prolonged periods (weeks to months). In common with other corticosteroids, triamcinolone is metabolised largely hepatically but also by the kidney and is excreted in urine. The main metabolic route is 6-beta-hydroxylation; no significant hydrolytic cleavage of the acetonide occurs.

In view of the hepatic metabolism and renal excretion of triamcinolone acetonide, functional impairments of the liver or kidney may affect the pharmacokinetics of the drug.

5.3 Preclinical safety data

See section 4.6

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol, Polysorbate 80, Carmellose sodium, Sodium chloride, Water.

6.2 Incompatibilities

The injection should not be physically mixed with other medicinal products.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze. Store in an upright position.

6.5 Nature and contents of container

Carton containing glass vials 5 x 1 ml.

6.6 Special precautions for disposal and other handling

No special handling instructions.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PATIENT INFORMATION LEAFLET

TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP
10MG/ML / 50MG/5ML / 40MG/ML / 80MG/2ML / 200MG/5ML / 400MG/10ML
TAJ PHARMA

INTRA-ARTICULAR / INTRAMUSCULAR INJECTION

Triamcinolone Acetonide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection is a steroid medicine,prescribed for many different conditions, including serious illnesses.
• You need to take it regularlyto get the maximum benefit.
• Don’t stop taking this medicinewithout talking to your doctor – you may need to reduce the dose gradually.
• Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection can cause side effects in some people(read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.
• Some side effects only happen after weeks or months.These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’:always keep it with you and show it to any doctor or nurse treating you.
• Keep away from people who have chicken pox or shingles,if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

WHAT IS IN THIS LEAFLET

1. What Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection is and what it is used for
2. What you need to know before you are given Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection
3. Receiving Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection
4. Possible side effects
5. How to store Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection
6. Content of the pack and other information1. WHAT TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP TAJ PHARMA IA/IM INJECTION IS AND WHAT IT IS USED FOR

The name of this medicine is Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection. Each injection contains triamcinolone acetonide 10mg/ml / 50mg/5ml / 40mg/ml / 80mg/2ml / 200mg/5ml / 400mg/10ml as the active ingredient. Triamcinolone acetonide belongs to a group of medicine called corticosteroids (steroids).

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis.

It is also for the treatment of various allergic disorders including asthma, blood disorders, hormone problems, rheumatic fever, and problems associated with digestive system, kidneys, lungs or skin.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP TAJ PHARMA IA/IM INJECTION

Do not receive Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection if;

• You have had an allergic reaction to a similar medicine or any of the ingredients in this medicine. See section 6 for full list of ingredients
• You are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection is not recommended for children under 6 years.

You must tell your doctor if:

• You have had any recent infection [including tuberculosis (TB)]
• You have had recent bowel surgery
• You have, or have had a bowel disorder or stomach ulcer
• You have an infection or inflammation of the veins in your legs
• You have had any mental health disorders or epilepsy
• You have had any kidney, liver or thyroid(gland in the neck) problems as the dose of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma may need to be adjusted
• You have recently suffered from any form of cancer
• You have thin or brittle bones (osteoporosis)
• You have myasthenia gravis (a disease which causes weak muscles)
• You have high blood pressure or heart failure
• You or someone in your family has glaucoma (increased pressure in your eyes).
• You are diabetic as your insulin dose may need to be changed

Check with your doctor first:

• If you are taking triamcinolone acetonide [Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection] and medicines to control HIV (anti-retrovirals) or fungal infections (anti-fungals) because you could experience more adverse effects and your doctor may wish to monitor you carefully. Refer to list of medicines mentioned in “Taking other medicines with Adcortyl IA/ID Injection.”
• If you have ever had severe depressionor manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection.
• If any of your close family has had these illnesses.

If any of these applies to you, talk to a doctor before taking Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection.

Steroid medicines suppress your body’s natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor as soon as possible.

While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any vaccination without consulting your doctor.

You must take care not to over-use a joint which feels better after you receive Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection. The joint will still need to recover from the inflammation which caused your symptoms.

Taking other medicines with Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection

Please tell your doctor if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Adcortyl and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

This is especially important if you are taking;

• Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as corticosteroids can increase the chance of bleeding from the gut.
• Anti-retroviral inhibitors and anti-fungals: ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, and telithromycin because increased adverse effects may occur, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression
• Warfarin or other medicines to thin the blood
• Oral contraceptive pill or hormone replacement therapy (HRT)
• Human growth hormone
• A medicine called ciclosporin
• A medicine called rifampicin

or medicines to treat;

• High blood pressure or irregular heart beat (e.g. digoxin)
• Myasthenia gravis (a disease which causes weak muscles)
• Epilepsy or other sorts of fits (e.g. phenytoin)
• Tuberculosis (TB)
• Diabetes
• Thyroid problems

If you are taking any of these medicines, or are not sure, please consult your doctor.

If you are due to have surgery

Before surgery and anaesthesia (even at the dentist) you should tell the doctor or dentist that you are being treated with Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant, or if you are breast-feeding you should make sure you discuss this with your doctor as soon as possible before receiving Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection.

Driving and using machines

This medicine does not usually affect your ability to drive or operate machinery but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or problems with your vision.

Steroid Treatment Card

Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine.

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse – before having any surgery or emergency treatment or if any new treatment is prescribed.

Dentist – before having any dental surgery

Pharmacist – before buying any medicine

Optician – it is advisable to have regular eye tests

Important information about the ingredients of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection contains 15 mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection must not be given to premature or newly born babies

3. RECEIVING TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP TAJ PHARMA IA/IM INJECTION

The effect of the injection will vary from patient to patient and further injections may be given to you when symptoms return and not at regular intervals.

The usual doses are;

Use in inflammatory joint disorders:

The dose of injection into a joint or tendon sheath depends upon the size of the joint to be treated and the severity of the condition which is being treated. Doses of 5-10 mg (0.125-0.25 ml) for smaller joints and up to 40 mg (1.0 ml) for larger joints usually give relief of symptoms.

This medicine should not be used for injection into the Achilles tendon.

Use in allergic disorders:

The usual starting dose is 40 mg (1.0 ml) injected deeply into the upper outer area of the buttock. If you require a further injection, this should be made into the same area on the other buttock. Some patients with pollen asthma find that one injection of 40-100 mg lasts throughout the pollen season.

Your doctor will advise you whether it is wise for you to have further injections.

Deep intramuscular injection must be given into the large muscles of the buttock and not into the upper arm or the thigh.

This medicine should not be given into a vein.

If you are receiving long-term intramuscular treatment with Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection your doctor may advise you to eat more protein. This should help to reduce the gradual loss of weight that can sometimes occur with long-term treatment.

Treatment with steroids is usually kept as short as possible and must not be stopped abruptly. Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets, or, if they have recently finished a course of Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injections, may need to start taking oral steroid tablets for a while.

Mental health problems while taking Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection

Mental health problems can happen while taking steroids like Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection (see also section 4 Possible Side Effects).

• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone taking this medicine), shows any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or stopped.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious effects: tell a doctor straight away

Steroids including Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection can cause serious mental health problems. These are uncommon in both adults and children.

• Mood changes, mental health disorders, feeling dependent on the medicine, trouble sleeping, fits or epilepsy, fainting and dizziness
• Feeling depressed, including thinking about suicide.
• Feeling high (euphoria and mania) or moods that go up and down.
• Feeling anxious/irritable, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of the following side effects talk to a doctor straight away.

Serious cases of anaphylactic reactions (i.e. a serious allergic reaction) and anaphylactic shock including death have been reported. If you notice any of the following, contact your doctor immediately:

• Swelling of the face, lips or throat
• Breathing difficulties
• Skin itching, redness or a rash

As these may be signs of an allergic reaction

Common: may affect up to 1 in 10 people

• Increased risk of infection
• Injection site reactions
• Headache
• Joint pain

Uncommon: may affect up to 1 in 100 people

• Changes in blood chemicals, which can cause fluid retention
• Heart failure or irregular heart beat
• Weak or fragile bones or muscles, poor healing of broken bones or destruction of the ends of bones, decrease in muscle mass, muscle or bone pain, muscular weakness/discomfort, bone fracture
• Loss of bone tissue (osteoporosis)
• Thin/fragile skin, rashes, stretch marks, bruising, sweating, flushing and increased hair growth, itchy bumps, loss/darkening of skin colour
• Indigestion, stomach pain, stomach ulcers and perforation, bloating, increased appetite and weight loss, inflammation of the pancreas/oesophagus, stomach bleeding
• Eye problems including inflammation, glaucoma and cataracts, blindness, bulging of the eye, damage to the cornea or white of eye
• Infection of the nose
• Irregular periods/ postmenopausal women may also experience vaginal bleeding
• Fungal or Viral eye infections
• Yeast infections e.g. thrush
• Tiredness and tingling, Increased pressure in the brain
• Increased appetite
• Weight loss
• Less tolerance to carbohydrates
• Mild form of diabetes with no obvious symptoms
• Inadequately controlled diabetes mellitus, high blood sugar
• Pain, swelling and worsening of the pain in the injected joint
• Impaired healing
• High body temperature
• Treatment with steroids can stop the body from producing some hormones and may slow or stop children’s growth.
• Hormone production by certain glands may be increased or decreased.
• Vertigo
• High/low blood pressure
• Abnormal blood clots
• Longstanding chronic infections such as tuberculosis could be made worse

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effect you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP TAJ PHARMA IA/IM INJECTION

Keep this medicine out of the sight and reach of children.

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection will be kept in the pharmacy until it is given to you by your doctor or nurse.

It should not be used after the expiry date shown on the outer packaging.

It should not be stored above 25°C nor should it be allowed to freeze.

The container should be kept in the outer carton.

6. Content of the pack and other information

What Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection contains

a) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide…………10mg/ml
Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

b) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide………50mg/5ml
Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

c) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide…………40mg/ml
Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

d) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide………80mg/2ml
Excipient(s) with known effects Benzyl alcohol………………………….15mg/ml

e) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide………200mg/5ml
Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

f) Triamcinolone Acetonide Injectable Suspension USP contains:
Triamcinolone acetonide……400mg/10ml
Excipient(s) with known effects Benzyl alcohol……………………………15mg/ml

The other ingredients are; benzyl alcohol, polysorbate 80, carmellose sodium, sodium chloride and water.

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection) is an effective way to treat various illnesses involving inflammation in the body. Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

What Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection looks like and contents of the pack

Triamcinolone Acetonide Injectable Suspension USP Taj Pharma IA/IM injection is a sterile aqueous suspension for injection and is supplied in 1ml/2ml/5ml/10ml glass vials.

7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com