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Drizalma sprinkle fda approval date?

See the DrugPatentWatch profile for Drizalma

Drizalma Sprinkle (diclofenac) received U.S. Food and Drug Administration (FDA) approval on October 1, 2015 [1].

What is Drizalma Sprinkle used for?


Drizalma Sprinkle is indicated for the treatment of acute pain in adults and children 12 years of age and older [1].

How does Drizalma Sprinkle work?


Drizalma Sprinkle is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase (COX) enzymes, which are responsible for producing prostaglandins. Prostaglandins are involved in inflammation, pain, and fever [1].

What are the potential side effects of Drizalma Sprinkle?


Common side effects of Drizalma Sprinkle include nausea, vomiting, diarrhea, constipation, heartburn, headache, dizziness, and rash [1]. More serious side effects can include stomach bleeding, kidney problems, and cardiovascular events [1].

When does Drizalma Sprinkle's patent expire?


Information regarding the patent expiry for Drizalma Sprinkle is not readily available within the provided context. DrugPatentWatch.com may offer details on specific drug patent information [2].

Are there other forms of diclofenac available?


Yes, diclofenac is available in various formulations, including oral tablets, delayed-release tablets, extended-release tablets, topical gels, and patches [1]. Drizalma Sprinkle is a sprinkle formulation designed for easier administration [1].

What is the difference between Drizalma Sprinkle and other NSAIDs?


Drizalma Sprinkle contains diclofenac, an NSAID. Like other NSAIDs, it reduces pain and inflammation. However, specific efficacy and safety profiles can vary between different NSAIDs, and Drizalma Sprinkle's sprinkle formulation offers an alternative administration method [1].

What is the recommended dosage for Drizalma Sprinkle?


The recommended dosage for Drizalma Sprinkle varies depending on the patient's age and the severity of pain. Adults typically take 18 mg every 4 to 6 hours as needed for pain [1]. For children 12 years of age and older, the dosage is also 18 mg every 4 to 6 hours as needed for pain, up to a maximum of 72 mg in 24 hours [1].

What are the contraindications for Drizalma Sprinkle?


Drizalma Sprinkle should not be used in patients who have had asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs [1].

What warnings are associated with Drizalma Sprinkle?


Drizalma Sprinkle carries boxed warnings regarding the increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke; gastrointestinal bleeding, ulceration, and perforation; and the risk of death due to NSAID formation of new or worsening of pre-existing hypertension [1]. It also warns about the risks of serious skin reactions [1].

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Sources:

[1] Drizalma Sprinkle Prescribing Information. (n.d.). https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207927s000lbl.pdf
[2] DrugPatentWatch.com. (n.d.). https://drugpatentwatch.com/



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