Ialurex Uses

How do you administer this medicine?
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What is Ialurex?

Ialurex injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other treatments that did not work well.

Ialurex is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

Ialurex is to be administered only by or under the immediate supervision of your doctor.

Ialurex indications

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* Sores in the mouth, when applied to the skin as a gel.

* Eye surgery and corneal transplant, when injected by an eye surgeon.

Osteoarthritis, when injected into the joint by a healthcare provider. Despite being approved by the FDA for treatment of osteoarthritis by injection, results vary. Some people report a moderate improvement in joint stiffness and pain decrease with Ialurex treatment, but this is not always the case. Whether Ialurex might delay or lessen progressive joint damage with long-term use is unknown. Adjunctive therapy in: * Healing skin wounds and burns.

* Detached retina and other eye injuries.

* Preventing the effects of aging.

How should I use Ialurex?

Use Ialurex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Ialurex.

Uses of Ialurex in details

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Ialurex is used to treat knee pain caused by osteoarthritis (a disorder of joints that causes stiffness, pain and loss of movement due to breakdown of lubricating fluid between joints) when treatment with common painkillers or other physical therapy (exercise, physiotherapy etc.) does not provide adequate relief. It is also used for treatment of mouth sores, prevention of skin aging and during cataract surgery.

Ialurex description

Each bottle contains 100 mL soln plus 1 applicator for nasal use and 1 applicator for the use in the ear, sealed in a bag.

Inside the metal bottle, the soln remains isolated and not in contact with the propellant because it is contained within a bag made of nontoxic material. The propellant used is air and it is pressurized within the entire space surrounding the bag inside the metal bottle. The inhalation of Ialurex occurs via valve positioned above the bag.

With the system: The air is used like a gas propellant, so Ialurex does not damage the ozone layer. It is necessary to use preservatives so the possibility of allergic reaction is reduced. The bottle can be used in any direction so Ialurex is practical and easy to use.

Ialurex dosage

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No information provided.

How supplied

Ialurex® is supplied as a sterile, non-pyrogenic solution in 2 mL vials or 2 mL pre-filled syringes.

Detailed Device Description

Each vial or syringe contains:

Ialurex 20.0 mg

Sodium chloride 17.0 mg

Monobasic sodium phosphate • 2H0 1.2 mg

Water for injection q.s.* to 2.0 mL

*q.s. = up to

Directions For Use

Ialurex® is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

Precaution: Do not use Ialurex® if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25° C). DO NOT FREEZE.

Precaution: Strict aseptic administration technique must be followed.

Warning: Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because Ialurex can precipitate in their presence.

Inject subcutaneous lidocaine or similar local anesthetic prior to injection of Ialurex®.

Precaution: Remove joint effusion, if present, before injection of Ialurex®.

Do not use the same syringe for removing joint effusion and for injecting Ialurex®.

Take care to remove the tip cap of the syringe and needle aseptically.

Inject Ialurex® into the joint through a 20-gauge needle.

Precaution: The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Ialurex®. Inject the full 2 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.

REFERENCES

1. M. Carrabba et a l., 1991 Ialurex sodium salt (Ialurex®) in the treatment of patients with osteoarthritis of the knee: a controlled trial versus Orgotein, Final Report, April 1991. Data on file.

2. M. Carrabba et a l., 1995. Effectiveness and safety of 1, 3 and 5 injections of 20 mg/2 ml Ialurex® in comparison with a placebo and with arthrocentesis only, in the treatment of knee osteoarthritis. European Journal of Rheumatology and Inflammation 15:25-31.

3. M. Dougados et al., 1993. High molecular weight Ialurex (hyalectin) in osteoarthritis of the knee: a one-year placebo-controlled trial. Osteoarthritis and Cartilage 1:97-103.

4. R. Kotz and G. Kolarz, 1997 published as R. Kotz and G. Kolarz, 1999. Intra-articular Ialurex: duration of effect and results of repeated treatment cycles. The American Journal of Orthopedics, 28:5-7.

5. G. Leardini et a l., 1987. Intra-articular Ialurex (Ialurex®) in gonarthrosis. Clinical Trials Journal 24(4):341-350.

6. J.J. Scali, 1995. Intra-articular Ialurex in the treatment of osteoarthritis of the knee: a longterm study 15(1 ):57-62.

MANUFACTURED BY: Fidia Farmaceutici S.p. A., Via Ponte della Fabbrica 3/A - 35031 Abano Terme, Padua (PD), Italy. MANUFACTURED FOR: Fidia Pharma USA Inc., Parsippany, NJ 07054. Revised May 2014

Ialurex interactions

See also:
What other drugs will affect Ialurex?

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To date, there are no reports of incompatibilities (interactions) of Ialurex with other solutions for intra-articular administration. The patient may benefit from the concurrent use of oral analgesic and anti-inflammatory agents during the first days of treatment.

Incompatibiliies: There is a known incompatibility between Ialurex and quaternary ammonium salts eg, benzalkonium chloride which can be used as skin disinfectants. Ialurex must therefore never come into contact with such products, nor with medical or surgical equipment treated with these types of products, since Ialurex can precipitate in their presence.

Ialurex side effects

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What are the possible side effects of Ialurex?

Ialurex® was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Ialurex®; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the Ialurex®-treated subjects were gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache. Swelling and effusion, local skin reactions (ecchymosis and rash), and headache occurred at equal frequency in the Ialurex®- and placebo-treated groups. Ialurex® treated subjects had 48/164 (29%) incidents of gastrointestinal complaints that were not statistically different from the placebo-treated group. A statistically significant difference in the occurrence of pain at the injection site was noted in the Ialurex®-treated subjects: 38/164 (23%) in comparison to 22/168 (13%) in the placebo-treated subjects (p = 0.022). There were 6/164 (4%) premature discontinuations in Ialurex®-treated subjects due to injection site pain in comparison to 1/168 ( < 1%) in the placebo-treated subjects. These differences were not statistically significant. Two (2/164, 1.2%) Ialurex®-treated subjects and 3/168 (1.8%) placebo-treated subjects were reported to have positive bacterial cultures of effusion aspirated from the treated knee. The two Ialurex®-treated subjects and two of the placebo-treated subjects did not exhibit evidence of infection clinically or subsequently and were not treated with antibiotics. One of the placebo-treated subjects was hospitalized and received presumptive treatment for septic arthritis.

Ialurex® has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Ialurex® in Europe reveals that most of the events are related to local symptoms such as pain, swelling/effusion, and warmth or redness at the injection site. Usually such symptoms disappear within a few days by resting the affected joint and applying ice locally. Only sporadically have these events been more severe and longer lasting. Very rare cases of intra-articular infection have been reported. Strict aseptic technique must be followed in administering Ialurex®. Systemic allergic reactions rarely have been recorded. Isolated cases of an anaphylactic or anaphylactic-like reaction have been reported in post-marketing experience and they all resolved. Allergic-type signs and symptoms such as rash, pruritus, and urticaria also are very rare. A few cases of fever were reported. In some instances, they were associated with local reactions, in other cases, no association other than temporal was found with the use of the product.

Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Ialurex®. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. (Carrabba et al., 1995; Carrabba et al., 1991; Kotz and Kolarz, 1999; Scali, 1995).

Ialurex contraindications

See also:
What is the most important information I should know about Ialurex?

Active ingredient matches for Ialurex:

Hyaluronic Acid in Italy.

Sodium hyaluronate in Italy.


List of Ialurex substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Ialumar nasal/ear spray soln / bottle 100 mL x 1's (Meda Healthcare)
Jointmax 20 mg/2 mL x 3's
Jonexa 10.5 mg/1 mL x 4 mL x 1's
KINEFLEX 10MG INJECTION 1 vial / 2 ML injection each (Kinedex)$ 21.45
KINEFLEX ONE INJECTION 1 vial / 6 ML injection each (Kinedex)$ 115.91
KINEFLEX inj 20 mg x 2 mL x 2ml (Kinedex)$ 21.45
Kineflex 20mg Injection (Kinedex)$ 10.72
Kineflex NA Injection (Kinedex)$ 19.32
KINEFLEX ONE inj 48 mg x 6 mL x 6ml (Kinedex)$ 120.47
Gel; Ophthalmic; Hyaluronate Sodium 0.015% (Thea)
Lacure ophth soln 1 mg/mL 5 mL x 1's (Medilife)
Solution; Ophthalmic; Hyaluronate Sodium 0.4% (Sophia)
Solution; Ophthalmic; Hyaluronate Sodium 0.4% (Elmor)
Solution; Ophthalmic; Hyaluronate Sodium 0.25% (Chemedica)
Solution; Intra-Articular; Hyaluronate Sodium 10 mg / ml
LG HYAL 2000MG INJECTION 1 vial / 1 ML injection each (Micro Labs Ltd)$ 18.07
0.85ml (LGLSI)$ 14.46
LG Hyal 2000 - INJ / 0.85mg (LGLSI)$ 14.46
LG HYAL 2000 inj 10 mg x 0.85ml (LGLSI)$ 14.46
LG Hyal 2000 - INJ / 0.85mg (LGLSI)$ 14.46
LG HYRUAN Prefilled Syringe / 25mg / 2.5ml units (LGLSI)$ 30.12
25 mg x 2.5ml (LGLSI)$ 30.12
Lg Hyruan 25mg SYRING / 2.5ml (LGLSI)$ 30.12
LG HYRUAN inj 25 mg x 2.5ml (LGLSI)$ 30.12
Lg Hyruan 25mg SYRING / 2.5ml (LGLSI)$ 30.12

References

  1. PubChem. "HYALURONIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "HYALURONIC ACID". http://www.drugbank.ca/drugs/DB08818 (accessed September 17, 2018).
  3. MeSH. "Adjuvants, Immunologic". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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