Hemady 20 mg/1
dexamethasone · TABLET · Edenbridge Pharmaceuticals LLC.
Hemady is a prescription corticosteroid tablet containing 20 mg of dexamethasone that you take by mouth to reduce inflammation and suppress immune system activity in various conditions. Your doctor will determine the appropriate dose and duration based on your specific medical needs.
Key Facts
- Brand Name
- Hemady
- Generic Name
- dexamethasone
- NDC Code (Product)
82111-955- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA211379
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 10/03/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage: 20 mg or 40 mg orally once daily, on specific days depending on the protocol regimen. ( 2 ) 2.1 Recommended Dosage The recommended dosage of HEMADY is 20 mg or 40 mg, orally, once daily, on specific days depending on the treatment regimen. Refer to the Prescribing Information of the other anti-myeloma products used in combination with HEMADY for specific HEMADY dosing. HEMADY can be administered with or without food. 2.2 Dose Modification for Elderly Patients Dose-reduction for HEMADY is recommended for elderly patients, due to increased toxicity in these patients. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with HEMADY, for dosing recommendations in elderly patients.
Contraindications
4 CONTRAINDICATIONS HEMADY is contraindicated in patients with: Hypersensitivity to dexamethasone, or any of the excipients. Rare instances of anaphylactic reactions have been reported [see Adverse Reactions ( 6 ), Description ( 11 )] . Systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections [see Warnings and Precautions ( 5.2 )] . • Patients with hypersensitivity to dexamethasone ( 4 ) • Patients with systemic fungal infections ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Avoid concomitant use of strong CYP3A4 inhibitors or inducers. ( 7.1 ) • Concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism. ( 7.2 ) 7.1 Effect of Other Drugs on HEMADY Strong CYP3A4 inhibitors Coadministration of strong and moderate CYP3A4 inhibitors increased dexamethasone exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . Avoid coadministration of strong CYP3A4 inhibitors or consider alternative medication that are not strong CYP3A4 inhibitors. If concomitant use of strong CYP3A4 inhibitors cannot be avoided, closely monitor for adverse drug reactions. Strong CYP3A4 inducers Coadministration of strong CYP3A4 inducers may decrease dexamethasone exposure [see Clinical Pharmacology ( 12.3 )] , which may result in loss of efficacy. Avoid coadministration of strong CYP3A4 inducers or consider alternative medication that are not CYP3A4 inducers. If concomitant use strong CYP3A4 inducers cannot be avoided, consider increasing the dose of HEMADY. Cholestyram…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: Hypersensitivity [see Contraindications ( 4 )] Alterations in Endocrine Function [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infections [see Warnings and Precautions ( 5.2 ) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions ( 5.3 )] Venous and Arterial Thromboembolism [see Warnings and Precautions ( 5.4 )] Vaccination [see Warnings and Precautions ( 5.5 )] Ophthalmic Effects [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforation [see Warnings and Precautions ( 5.7 )] Osteoporosis [see Warnings and Precautions ( 5.8 )] Myopathy [see Warnings and Precautions ( 5.9 )] Behavioral and Mood Disturbances [see Warnings and Precautions ( 5.10 )] Kaposi's Sarcoma [see Warnings and Precautions ( 5.11 )] HEMADY in Combination with Anti-Myeloma Products [see Warnings and Precautions ( 5.12 )] Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.13 )] The following adverse reactions associated with the use of HEMADY or other corticosteroids were identified in clinical trials or po…
Frequently Asked Questions
What is Hemady used for?
Hemady is a prescription corticosteroid tablet containing 20 mg of dexamethasone that you take by mouth to reduce inflammation and suppress immune system activity in various conditions. Your doctor will determine the appropriate dose and duration based on your specific medical needs.
Is Hemady a controlled substance?
Hemady is not classified as a controlled substance by the DEA.
What is the generic name for Hemady?
The generic name for Hemady is dexamethasone. There are 11 other brand versions of dexamethasone.
What is the NDC code for Hemady 20 mg/1?
The NDC (National Drug Code) for Hemady 20 mg/1 is 82111-955, listed by Edenbridge Pharmaceuticals LLC..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)