C a s e S t u d i e s

Altraday TM

Aceclofenac 200mg SR + Rabeprazole sodium 20mg EC Capsule

Altraday TM

Aceclofenac 200mg SR + Rabeprazole sodium 20mg EC Capsule

Strategies

Best Practices

and

in Case Management

C a s e S t u d i e s

Ranbaxy Laboratories LimitedWestern Edge -1, Unit No. 201-204, 2nd Floor, Western Express Highway Borivali, Mumbai -400 066

Abridged prescribing information:

Composition: Each Capsule contains: Aceclofenac BP 200 mg (sustained release pellets), Rabeprazole Sodium 20 mg (enteric coated pellets),Excipients q.s Colours Red Oxide of Iron. Approved colours in capsule shell. Indications: Relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Contraindications: known hypersensitivity to Aceclofenac, Rabeprazole, Benzimidazole or any of its constituents. h/O asthma, urticaria, allergic-type reactions after taking aspirin, NSAIDs. History of active or suspected peptic ulcer or gastro-intestinal bleeding, moderate to severe renal impairment. Pregnancy and lactation, unless there are compelling reasons for doing so. The lowest effective dosage should be used.Treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. Precautions: Aceclofenac + Rabeprazole-Hematological Effects: Rabeprazole- Blood dyscrasias (thrombocytopenia and neutropenia)- uncomplicated , resolved on discontinuation of Rabeprazole. Aceclofenac- Anemia due to fluid retention, occult , gross GI blood loss, effect upon erythropoiesis. Patients on long-term treatment to check their hemoglobin, hematocrit after any signs, symptoms of anemia. Inhibition of platelet aggregation , prolonged bleeding time seen but their effect on platelet function is quantitatively less, shorter duration, reversible. Alterations in platelet function, like coagulation disorders or patients receiving anticoagulants, to be monitored. Aceclofenac cannot substitute corticosteroids or treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Prolonged corticosteroid therapy should be tapered slowly if a decision is made to discontinue corticosteroids. Hepatic effects: Mild elevation in liver tests in up to 15% of patients taking NSAIDs. Notable elevations of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) (approximately 3 or more times the upper limit of normal) reported in approximately 1% of patients in clinical trials with NSAIDs. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure reported. A patient with symptoms and or signs suggesting liver dysfunction, with abnormal LFT to be evaluated for development of a more severe hepatic reaction while on therapy with Aceclofenac. Dosage: ALTRADAY capsules - oral administration to be swallowed whole with a sufficient quantity of liquid. ALTRADAY capsules should be taken with or after food. For adults the recommended dose is one ALTRADAY capsule once daily, preferably at bedtime or as directed by the physician.

Cardiovascular Risk:Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk . Aceclofenac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery).Gastrointestinal Risk:NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

Altraday

Use in special populationsPregnancy: Aceclofenac- Pregnancy category C. Rabeprazole - Pregnancy category B. Drug should be used during pregnancy only if clearly needed. NSAID use may result in delay onset and increase duration of labour. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from aceclofenac a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Paediatric use: Aceclofenac: Not recommended for use in children. Rabeprazole: Safety and effectiveness of Rabeprazole in pediatric patients have not been established. Geriatrics: Caution should be exercised in elderly. Renal insufficiency: There is no evidence that the dosage of Aceclofenac need to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised. Hepatic insufficiency: Caution should be exercised in patients of hepatic failure. Side Effects: Aceclofenac: Majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhoea, and occasional occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal hepatic enzyme and serum creatinine levels have also been reported. If serious adverse reactions occur, Aceclofenac should be withdrawn. Rabeprazole: Rabeprazole were generally well tolerated during clinical trials. The observed undesirable effects have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth.

Altraday TM

Aceclofenac 200mg SR + Rabeprazole sodium 20mg EC Capsule

In Painful Inflammatory Conditions like,Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondilitis

Better than NSAIDs aloneEffective Pain Relief Along with Protection from Gastric Injury

1,2,3

Dosage :

Once a day

Ref: 1. AAOS Clinical Practice Guideline; Pg no-IV, R14; Published by the American Academy of Orthopaedic Surgeons 2008 2. Connors LG, Reicin A, et al.Gastroenterology 2003;124:288-92. 3. Rahme E, Barkun A et al. Am J Gastroenterol 2008;103:872-82

Spherical aceclofenac pellet size from 14 to 20mm

Thinner the coating earlier the release

Thicker the coating later the release

Unique Pellet Thickness Technology

To be sold on Prescription of a Registered Medical Practitioner only.KEEP THIS AND ALL OTHER MEDICATIONS SAFELY OUT OF REACH OF CHILDREN

Aceclofenac or Diclofenac alone has the potential 1,3to cause Gastric Injury

Full prescribing information available on request.

ALT/0913/09

Disclaimer:“The information provided here is purely for educational purpose and in no way should be considered as offering medical advice. It is mandatory to refer to appropriate sources for confirmation. The content of this material does not necessarily reflect the opinions of Ranbaxy Laboratories Limited. General comments in this are based on indexed journals literature and should not be taken as a formal consultation or recommendation for a patient, disease state, or treatment approach. No part of this material may be reproduced in any manner.” Although great care has been taken in compiling and checking the information, the authors and its servants or agents shall not be responsible or in anyways liable for any errors, omissions or inaccuracies in this publication whether arising from negligence or otherwise however, or for any consequences arising therefrom. All rights reserved.

Trusted medicines . Healthier lives

Topic Page No.

Aneurysmal Bone Cyst (ABC) 1 - 5A 50 year old male presented with chief complaints of pain and swelling in the upper part of his left thigh since last four years, inability to walk since last two years.

The field of medicine and surgery pose challenges daily.

No two patients may respond similarly to a particular treatment regimen.

The additional challenges faced by orthopedicians are of failed previous

surgeries.

In this series of “Strategies and Best Practices in Case Management”,

we present a compilation of difficult to treat cases from renowned orthopedicians across India; to understand the early diagnosis,

the underline causes and new approaches to the management.

We hope these studies provide you the necessary insight in handling

such cases and is clinically relevant in your day to day practice.

With Best wishes,

Thank You.

Medical Team

Ranbaxy Laboratories Limited.

Contents:

We thank Dr. V. K. Nijhawan

Dr. Manish DhawanDr. Brajesh Nandan

for their case contribution Sir Ganga Ram Hospital,

New Delhi

In conclusion, selective arterial embolization can reduce the risk of intraoperative bleeding and possibledamage to adjacent vital structures in the management of aggressive aneurysmal bone cysts. It can beconsidered a primary treatment for lesions which sizemakes other types of treatment uneasy or hazardous, for instance when the lesion extends around iliac vessels, the lumbar plexus or sciatic nerve.

Selective arterial embolization in the treatment of an Aneurysmal Bone Cyst of the pelvis(JBR–BTR, 2003, 86: 325-328.)

Strategies and Best Practices in Case Management

5

1

Clinical Presentation

Past History

• A 50 year old male presented with chief complaints of pain and swelling in the upper part of his left thigh since last four years, inability to walk since last two years.

• Six years back he was diagnosed as Tb hip. On ATT for 6 months but observed no improvement, then Girdlestone arthroplasty was done.

• Pain and swelling increased progressively from the last two years .

• Referred to AIIMS for further management .• Diagnosed as a case of ABC in Nov.2010.

• General • Local- (Lt. hip) : Diffuse swelling of size

approximately 15 x10 cm present over hip and posterolateral aspect of thigh.

• Tender• Hard in consistency.• Local temperature raised• Scar • ROM–Painful and Restricted

– Eccentric, expansible, lytic lesion of metaphysis.– Cortical attenuation and destruction.– Rim of reactive bone – Head and neck of femur cannot be appreciated.

Examination

Radiological

ill-defined soft tissue shadow present in trochanteric and gluteal region

Radiological

MRI

Lesion measuring 12x12x12 cm in AP, transverse and craniocaudal dimensions.T1W ; iso signal intensity with focal areas of hyper intense signal in inferior component of this lesion suggestive of hemorrhagic blood products admixed with soft tissue signal on T2W images

Strategies and Best Practices in Case Management

After Three Weeks Follow-Up

Discussion

Discussion

• The term Aneurysmal Bone Cyst (ABC) was first used by Jaffe and Lichtenstein to describe two examples of blood-filled cyst in which tissue from the cyst wall contained conspicuous spaces, areas of hemosiderin deposition, giant cells, and occasional bone trabecular.

• Osteolytic, hyperplastic, hyperemic-hemorrhagic lesion of unknown origin

• Epidemiology– 80% before 20 years of age, rare after 30 years old– Most common sites: long bones LE > UE– 30% secondary lesions due to pre-existing tumor

Strategies and Best Practices in Case Management

4

Walker assisted for walking on second post – operation day

• Radiographs– Eccentric, expansible, lytic lesion of metaphysis– Cortical attenuation or destruction– Rim of reactive bone – Fluid-Fluid levels on MRI are characteristic

• Histology– Cavernous spaces filled with blood, lacking

endothelial lining– Fibroblastic cells, multinucleated giant cells and thin

strands of bone• Treatment– Excision, curettage, and bone grafting – Resection in case of an expendable bone– Other modalities include adjuvant cryo, chemical

cautery, injection of steroids– Radiation not recommended• Prognosis– Local recurrence rate approx 10%, increased if open

physic

Abstract• The treatment of bone metastases and aggressive

primary lesion is frequently palliative, aiming toachieve satisfactory pain control and to prevent ortreat pathological fractures. For lesions involving thefemur, internal fixation frequently fails; therefore,prosthetic reconstruction may be the optimal choicefor treatment.

Aneurysmal Bone Cyst (ABC)

References- AJO (Dec 2010)

Post-operative Radiograph

Reconstruction

Canal preparation and acetabula component fixation

Prosthesis fixation

Strategies and Best Practices in Case Management

Gross specimen

Biopsy

• Gross specimen size -17 x 11 x 9 cm• Superior margin; Grossly no tumor identified.• Inferior margin; Focal bony tissue• Microscopic examination; numerous variable sized

blood filled and vascular spaces, lined by flattened cells, spindle shaped cells and numerous osteoclast type of giant cells

• There is fibrosis with hemosiderin deposits between these spaces.

• Diagnosis; Aneurysmal bone cyst.

Post-operative RadiographMRI

Strategies and Best Practices in Case Management

Operative steps

2 3