What are the possible side effects of Ostenil Plus?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Difficulty with moving
- muscle pain or stiffness
- pain in the joints
- Swelling or redness in the joints
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Side effects of Ostenil Plus in details
Ostenil Plus® was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Ostenil Plus®; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the Ostenil Plus®-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 Ostenil Plus®- and placebo-treated groups. Ostenil Plus® 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 Ostenil Plus®-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 Ostenil Plus®-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%) Ostenil Plus®-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 Ostenil Plus®-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.
Ostenil Plus® has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Ostenil Plus® 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 Ostenil Plus®. 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 Ostenil Plus®. 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).
What is the most important information I should know about Ostenil Plus?
- Someone may need to drive you home from the doctor's office, hospital, or clinic after you receive Ostenil Plus. Discuss any questions or concerns with your doctor.
- You may experience a temporary inflammation in your knee after using Ostenil Plus. If the inflammation is severe or continues, contact your doctor.
- Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting, standing on your feet) for at least 48 hours after you are injected with Ostenil Plus. Ask your doctor when you should begin physical activities again.
- Ostenil Plus should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ostenil Plus, contact your doctor. You will need to discuss the benefits and risks of using Ostenil Plus while you are pregnant. It is not known if Ostenil Plus is found in breast milk. If you are or will be breast-feeding while you use Ostenil Plus, check with your doctor. Discuss any possible risks to your baby.
Ostenil Plus contraindications
- Ostenil Plus gel is contraindicated for use in breast augmentation, or for implantation into bone, tendon, ligament, or muscle,
- Ostenil Plus gel is contraindicated for patients with a history of known hypersensitivity to avian proteins.
- Ostenil Plus gel must not be injected into blood vessels. Introduction of Ostenil Plus gel into the vasculature may occlude the vessels and could cause infarction or embolization.
References
- European Chemicals Agency - ECHA. "Hyaluronic acid: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
- HSDB. "HYALURONIC ACID". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
- NCIt. "Hyaluronic Acid: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ostenil Plus are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ostenil Plus. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
1 consumer reported side effects
Did you experience side effects while taking Ostenil Plus drug?According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Ostenil Plus drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
| Users | % | ||
|---|---|---|---|
| No side effects | 1 | 100.0% | |
Consumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
