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🏅 FDA Orphan Designation

Dyural 80-Lm

METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL

Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC

Indicated for:
IgA pemphigusStevens-Johnson syndromeAcute adrenal insufficiencyCongenital adrenal hyperplasiaHIV-associated cancerDiamond-Blackfan anemiaImmune thrombocytopeniaExfoliative ichthyosisClassic mycosis fungoidesEosinophilic gastroenteritisBronchiolitis obliteransMixed-type autoimmune hemolytic anemiaPyomyositisRare malignant epithelial tumor of liver and intrahepatic biliary tractCongenital dyserythropoietic anemia type IOccipital pachygyria and polymicrogyriaCongenital disorder of glycosylation with neurological involvementDermatitis herpetiformis
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (18)

pemphigus

Population: all ages

severe erythema multiforme (Stevens-Johnson syndrome)

Population: all ages

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy,…

Population: all ages

congenital adrenal hyperplasia

Population: all ages

hypercalcemia associated with cancer

Population: all ages

pure red cell aplasia

Population: all ages

select cases of secondary thrombocytopenia

Population: all ages

exfoliative dermatitis

Population: all ages

mycosis fungoides

Population: all ages

To tide the patient over a critical period of the disease in regional enteritis (systemic therapy)

Population: all ages

To tide the patient over a critical period of the disease in ulcerative colitis

Population: all ages

Acquired (autoimmune) hemolytic anemia

Population: all ages

nonsupportive thyroiditis

Population: all ages

indicated in adults for the production of local or regional anesthesia or analgesia for diagnostic and therapeutic procedures

Population: adults

congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia)

Population: all ages

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seru…

Population: all ages

Trichinosis with neurologic or myocardial involvement

Population: all ages

Bullous dermatitis herpetiformis

Population: all ages

Indications & Usage

1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic. Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 ) Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1 , 5.4 , 5.5 , 5.7 , 5.9) ] . INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involveme

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.