FDA records indicate that there are no current recalls for this drug.
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Dyloject Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Dyloject is an NSAID indicated in adults for the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioid analgesics.
History
There is currently no drug history available for this drug.
Other Information
Dyloject Injection is a clear, colorless solution for intravenous administration. Each mL of aqueous solution contains 37.5 mg of diclofenac sodium (34.8 mg of diclofenac), 333 mg hydroxypropyl betadex (HPβCD), 5 mg monothioglycerol, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.
Diclofenac sodium, a nonsteroidal anti-inflammatory drug, is designated chemically as benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino] monosodium salt, with a molecular formula of C14H10Cl2NNaO2. The molecular weight is 318.13. The structural formula of diclofenac sodium is:
Sources
Dyloject Manufacturers
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Hospira, Inc.
Dyloject | Hospira, Inc.
Use for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
For intravenous administration only.
For the treatment of acute pain, the recommended dose of Dyloject is 37.5 mg administered by intravenous bolus injection over 15 seconds every 6 hours as needed, not to exceed 150 mg/day.
To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Dyloject.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.
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