(RxWiki News) From prescription to over-the-counter — a common arthritis pain gel is now available without a prescription.
Voltaren (diclofenac sodium) is the first prescription-strength over-the-counter (OTC) topical nonsteroidal anti-inflammatory drug (NSAID) gel for arthritis pain.
As of February of this year, the US Food and Drug Administration (FDA) approved the switch for Voltaren from prescription to OTC. Now, the arthritis pain gel is available to the public and can be bought without a prescription.
This new OTC medication provides patients access to osteoarthritis pain relief and offers an alternative to oral pain relievers like ibuprofen (Motrin) and acetaminophen (Tylenol).
Because it is prescription-strength, this new OTC drug offers patients a stronger topical treatment option for arthritis pain.
Now that this medication is available OTC, it will no longer be available by prescription, the FDA noted.
Diclofenac sodium is approved to provide temporary relief of arthritis pain only in the following areas: hand, wrist, elbow, foot, ankle and knee.
OTC Voltaren contains diclofenac sodium topical gel, 1%, which is the same strength as the prescription-strength formula.
The FDA originally approved Voltaren in 2007 to provide relief from pain due to osteoarthritis — specifically joint pain in the feet, hands and knees. This medication does not provide pain relief right away. In fact, it may take up to seven days to work. This drug is not approved to treat pain due to bruises, strains, sprains or sports injuries.
Use the dosing card to measure a dose of this medication:
- For each upper-body area (hand, wrist or elbow), measure out 2.25 inches (2 grams).
- For each lower-body area (foot, ankle or knee), measure out 4.5 inches (4 grams).
This drug is meant to be applied four times daily. However, it should not be used on more than two body areas at the same time.
If you need to use the gel for more than 21 days, consult your physician before continuing. There is a risk of liver damage if this gel is used longer than recommended or with other diclofenac products.
Follow the instructions on the drug labels to ensure safe use, the FDA recommended. If you have any questions about this medication or how to use it, speak with your health care provider.
The approval of the nonprescription version of Voltaren was granted to GlaxoSmithKline plc.
