INTRODUCTION

DUROLANE contains Sodium hyaluronate which belongs to the group of medicine called viscoelastic supplements. It is used to treat pain in knee osteoarthritis among patients who have failed to respond adequately to simple analgesics and conservative non-pharmacologic therapy. Sodium hyaluronate is available as a salt form of hyaluronic acid. Hyaluronic acid is a natural polysaccharide present in very high amounts in the synovial fluid (fluid surrounding the joint) and acts as a lubricant and shock absorber in between joints.

People with knee osteoarthritis suffer a very low concentration of hyaluronic acid in their synovial fluid. Intra-articular administration of DUROLANE supplements hyaluronic acid to the synovial fluid and lubricates and cushions the joint. It also provides relief from joint friction and pain. It helps in absorption of shock created from normal physical activity like walking, running, jumping etc. This medicine should only be given as an intra-articular injection (in between joints). People taking this injection, or any other visco-supplementation should be advised to avoid any prolonged (for more than an hour) or strenuous activities (like lifting heavy weights, running, jumping) within 48 hours following intra-articular injection. Before administration, remove any joint effusion if present.

The most common side effect of this medicine are injection site reactions such as joint pain, swelling, redness and warmth. Contact your doctor if these symptom bothers you. DUROLANE is not recommended for use in pregnant or breastfeeding women and children under 18 years of age. Consult your doctor before taking. Before taking this medicine, inform your doctor if you have liver disease or had it in the past. Do not take this medicine, if you have any infection or inflammation at the joint cavity. Consult your doctor before taking.

USES OF DUROLANE

• Treats osteoarthritis of the knee

HOW DUROLANE WORKS

In people with knee osteoarthritis, intra-articular administration of DUROLANE supplements the required amount of hyaluronic acid directly into the synovial fluid. This leads to enhanced joint lubrication and absorption of shock created from normal physical activity like walking, running, cycling or jumping. As a result, friction in between joint and pain are relieved.

DIRECTIONS FOR USE

This medicine will be given to you only by an orthopedic surgeon in between the joints (intra-articular injection). Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Strict aseptic condition must be followed during the process.

Before administration, remove any joint effusion if present. Do not inject this medicine intravascularly because it may lead to unwanted systemic side effects. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF DUROLANE

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Musculoskeletal pain:

Try to rest and relax. Keep a hot pack on the affected area, as it may ease the pain. Avoid walking or jogging while you are feeling uncomfortable. If your symptom does not get better, speak to your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• quaternary ammonium salts or chlorhexidine (used as topical disinfectants)

SYNOPSIS

MORE INFORMATION

Store in a refrigerator at 2-8°C and keep out of reach of children.

FAQs ABOUT DUROLANE

Can DUROLANE cause joint swelling?

Yes. Although this medicine is used to treat joint pain, it may cause joint swelling in some individuals. Contact your doctor if this symptom bothers you.

How to take DUROLANE?

It is not meant for self-administration. It will be given to you only by an orthopedic surgeon in between the joints (intra-articular injection). Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition.

Who should take DUROLANE?

It is recommended for use in patients who have failed to respond adequately to simple analgesics and conservative non-pharmacologic therapy.

REFERENCES

1. Harsh Mohan. The Musculoskeletal system. Joints. Textbook of Pathology. 6th Edition. 2010. Page – 850- 851.

2. Ferring Pharmaceuticals. Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on June 2012] [Accessed 18th December 2020] https://clinicaltrials.gov/ct2/show/NCT00988091

3. A S Dixon, R K Jacoby, H Berry, E B Hamilton. Clinical trial of intra-articular injection of sodium hyaluronate in patients with osteoarthritis of the knee. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 1988. [Accessed 18th December 2020] https://pubmed.ncbi.nlm.nih.gov/3063436/

4. Emmanuel Maheu, Bernard Avouac, Renée Liliane Dreiser and Thomas Bardin. A single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate vs 0.8% hylan G-F 20 in the treatment of symptomatic knee osteoarthritis: A 6-month, multicenter, randomized, controlled non-inferiority trial. PLOS ONE. December 2019. [Accessed 18th December 2020] https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226007

5. Hanmi Pharm Co., Ltd. U.S. Food & Drug Administration. [Accessed 18th December 2020] https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170016D.pdf

6. Savient Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Accessed 18th December 2020] https://www.accessdata.fda.gov/cdrh_docs/pdf/p010029b.pdf

7. Fidia Farmaceutici S.p.A. Health Products Regulatory Authority (HPRA). [Revised on December 2009] [Accessed 18th December 2020] https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0814-001-001_05042016103037.pdf

8. Fidia Farmaceutici S.p.A. Hyalgan.com. [Revised on May 2014] [Accessed 18th December 2020] https://hyalgan.com/wp-content/uploads/2016/02/hyalgan_pi.pdf

9. Cipla. Ltd. HYRUAN OneTM Injection (Cross-linked Hyaluronic Acid 20mg/mL). Ciplamed.com [Revised on January 2019] [Accessed 18th December 2020] https://ciplamed.com/content/hyruan-onetm-injection

10. Genzyme Biosurgery, A division of Genzyme Corporation. SYNVISC ONE® HYLAN G-F 20. [Revised on September 2014] [Accessed 18th December 2020] https://products.sanofi.us/synviscone/synviscone.html

11. Central Drugs Standard Control Organisation (CDSCO). Sodium Hyaluronate Injection 8mg/vial (6ml Pre-filled syringe for Intra Articular use only). [Revised on April 2012] [Accessed 18th December 2020] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Blood calcium levels
• Rheumatoid Factor IgG Antibody
• Rheumatoid Factor IgM Antibody