Dexamethasone
JFDA label: Fortecortin inj
Mechanism of Action
Agonist of Glucocorticoid receptor — Glucocorticoid receptor agonist
| Target | Action | Gene / class |
|---|---|---|
| Glucocorticoid receptor efficacy | AGONIST | NR3C1 |
Indications
Approved
- Acne Vulgaris — acne
- Addison Disease — primary adrenal insufficiency
- Adrenal Hyperplasia, Congenital — classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- Adrenocortical Hyperfunction — adrenal gland hyperfunction
- Anemia, Aplastic — Aplastic anemia
- Anemia, Hemolytic — hemolytic anemia
- Arthritis, Gouty — gout
- Arthritis, Juvenile — juvenile idiopathic arthritis
- Arthritis, Psoriatic — psoriatic arthritis
- Arthritis, Rheumatoid — rheumatoid arthritis
- Asthma — asthma
- Bursitis — frozen shoulder
- Chorioretinitis — Chorioretinitis
- Choroiditis — choroiditis
- Colitis, Ulcerative — ulcerative colitis
- Conjunctivitis, Allergic — allergic conjunctivitis
- Corneal Injuries — Corneal scarring
- Crohn Disease — Crohn's disease
- Dermatitis — dermatitis
- Dermatitis Herpetiformis — dermatitis herpetiformis
- Dermatitis, Atopic — atopic eczema
- Dermatitis, Contact — contact dermatitis
- Dermatitis, Exfoliative — exfoliative dermatitis
- Dermatitis, Seborrheic — seborrheic dermatitis
- Diabetic Retinopathy — diabetic retinopathy
- Erythema Multiforme — erythema multiforme
- Eye Diseases — eye inflammation
- Hemorrhoids — hemorrhoid
- Herpes Simplex — Herpes simplex infection
- Herpes Zoster Ophthalmicus — ophthalmic herpes zoster
- Hypercalcemia — Hypercalcemia
- Infections — infection
- Inflammation — inflammation
- Iridocyclitis — Iridocyclitis
- Iritis — iritis
- Keratitis — keratitis
- Leukemia — leukemia
- Lupus Erythematosus, Systemic — systemic lupus erythematosus
- Lymphoma — lymphoma
- Macular Edema — macular retinal edema
- Multiple Sclerosis — multiple sclerosis
- Mycosis Fungoides — mycosis fungoides
- Myocarditis — myocarditis
- Nasal Obstruction — Nasal congestion
- Neoplasms — neoplasm
- Nephrotic Syndrome — nephrotic syndrome
- Ophthalmia, Sympathetic — sympathetic ophthalmia
- Optic Neuritis — optic neuritis
- Osteoarthritis — osteoarthritis
- Pemphigus — pemphigus vulgaris
- Peptic Ulcer — Peptic ulcer
- Pneumonia — pneumonia
- Psoriasis — psoriasis
- Pulmonary Eosinophilia — eosinophilic pneumonia
- Purpura, Thrombocytopenic, Idiopathic — autoimmune thrombocytopenic purpura
- Rhinitis, Allergic — allergic rhinitis
- Rhinitis, Allergic, Seasonal — allergic rhinitis
- Sarcoidosis — sarcoidosis
- Serum Sickness — type III hypersensitivity reaction disease
- Spondylitis, Ankylosing — ankylosing spondylitis
- Stevens-Johnson Syndrome — Stevens-Johnson syndrome
- Synovitis — synovitis
- Tennis Elbow — lateral epicondylitis
- Tenosynovitis — tenosynovitis
- Thrombocytopenia — Thrombocytopenia
- Thyroiditis, Subacute — subacute thyroiditis
- Trichinellosis — trichinosis
- Tuberculosis, Meningeal — meningeal tuberculosis
- Tuberculosis, Pulmonary — pulmonary tuberculosis
- Uveitis — uveitis
- Uveitis, Posterior — posterior uveitis
Off-label
- Amyloidosis
- Amyloidosis, Familial
- Anemia
- Anemia, Refractory
- Anemia, Refractory, with Excess of Blasts
- Anemia, Sickle Cell
- Appendicitis
- Atrioventricular Block
- Back Pain
- Blast Crisis
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Blepharitis
- Brain Neoplasms
- Breast Carcinoma In Situ
- Breast Neoplasms
- Bronchiolitis
- Bronchiolitis Obliterans Syndrome
- Bronchopulmonary Dysplasia
- Burkitt Lymphoma
- Carcinoma, Hepatocellular
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Carcinoma, Squamous Cell
- Castleman Disease
- Cataract
- Cholangiocarcinoma
- Choroidal Neovascularization
- Chronic Pain
- Colorectal Neoplasms
- Conjunctivitis, Viral
- Corneal Edema
- Cysticercosis
- Deafness
- Deglutition Disorders
- Dry Eye Syndromes
- Dyspnea
- Encephalitis, Herpes Simplex
- Endocrine Gland Neoplasms
- Endometrial Neoplasms
- Fasciitis, Plantar
- Fatigue
- Genital Neoplasms, Female
- Genital Neoplasms, Male
- Glaucoma
- Glomerulonephritis
- Glomerulosclerosis, Focal Segmental
- Gout
- Graft vs Host Disease
- Granuloma, Lethal Midline
- HELLP Syndrome
- Headache
- Hearing Loss
- Hearing Loss, Sensorineural
- Heart Failure
- Hematologic Neoplasms
- Hematoma, Subdural, Intracranial
- Hemorrhage
- Hernias, Diaphragmatic, Congenital
- Histiocytosis, Langerhans-Cell
- Histiocytosis, Sinus
- Hodgkin Disease
- Hypersensitivity
- Hypocalcemia
- IgA Vasculitis
- Immune System Diseases
- Immunoglobulin Light-chain Amyloidosis
- Influenza, Human
- Intestinal Obstruction
- Intracranial Hypertension
- Kidney Failure, Chronic
- Knee Injuries
- Lassa Fever
- Leiomyoma
- Leptospirosis
- Leukemia, Biphenotypic, Acute
- Leukemia, Erythroblastic, Acute
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Megakaryoblastic, Acute
- Leukemia, Monocytic, Acute
- Leukemia, Myeloid, Acute
- Leukemia, Myelomonocytic, Acute
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Plasma Cell
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lichen Planus
- Lichen Planus, Oral
- Liposarcoma, Myxoid
- Liver Cirrhosis
- Liver Neoplasms
- Lung Diseases, Obstructive
- Lung Neoplasms
- Lymphohistiocytosis, Hemophagocytic
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Mantle-Cell
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell, Peripheral
- Macular Degeneration
- Malaria
- Mastoiditis
- Melanoma
- Meniere Disease
- Meningitis
- Meningitis, Cryptococcal
- Mesothelioma
- Migraine Disorders
- Mouth Neoplasms
- Multiple Myeloma
- Multiple Sclerosis, Chronic Progressive
- Myelodysplastic Syndromes
- Nasopharyngeal Carcinoma
- Nausea
- Neck Pain
- Neoplasm Metastasis
- Neoplasms, Plasma Cell
- Nephrosis
- Nervous System Diseases
- Neuralgia
- Otitis Externa
- Otitis Media
- Ovarian Hyperstimulation Syndrome
- Ovarian Neoplasms
- POEMS Syndrome
- Paget Disease, Extramammary
- Pain
- Pancreatic Neoplasms
- Papilledema
- Pelvic Organ Prolapse
- Pharyngitis
- Plasmacytoma
- Pneumonia, Viral
- Postoperative Complications
- Postoperative Nausea and Vomiting
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
- Pregnancy
- Premature Birth
- Prostatic Neoplasms
- Prostatic Neoplasms, Castration-Resistant
- Pulmonary Fibrosis
- Purpura, Thrombotic Thrombocytopenic
- Radiculopathy
- Rectal Neoplasms
- Red-Cell Aplasia, Pure
- Renal Insufficiency, Chronic
- Respiratory Distress Syndrome
- Respiratory Insufficiency
- Retinal Vein Occlusion
- Rhinitis, Allergic, Perennial
- Rotator Cuff Injuries
- Sarcoma
- Sciatica
- Severe Acute Respiratory Syndrome
- Sleep Apnea, Obstructive
- Small Cell Lung Carcinoma
- Smoldering Multiple Myeloma
- Specific Language Disorder
- Stomach Neoplasms
- Strabismus
- Subarachnoid Hemorrhage
- Tonsillitis
- Toxoplasmosis, Cerebral
- Tuberculosis
- Urinary Bladder Neoplasms
- Urinary Tract Infections
- Uveitis, Anterior
- Uveitis, Intermediate
- Vaginosis, Bacterial
- Vitreoretinopathy, Proliferative
- Vomiting
- Waldenstrom Macroglobulinemia
- Wet Macular Degeneration
- Wounds and Injuries
- Wrist Fractures
- Xerostomia
Contraindications
Source: openFDA
- Systemic fungal infections (see WARNINGS regarding amphotericin B). Hypersensitivity to any component of this product, including sulfites (see WARNINGS ). Absolute
Adverse Reactions
Endocrine disorders (1)
Very Common Adrenal suppression
Metabolism and nutrition disorders (2)
Very Common Hyperglycaemia
Common Weight gain / fluid retention
Gastrointestinal disorders (1)
Uncommon GI bleeding (with NSAIDs)
Musculoskeletal and connective tissue disorders (1)
Uncommon Avascular necrosis
Psychiatric disorders (2)
Very Common Insomnia
Common Mood changes (euphoria, mood lability)
Eye disorders (1)
Common Posterior subcapsular cataract
Infections and infestations (1)
Common Immunosuppression
Dosing
Source: openFDA
Warnings & Precautions
Source: openFDA
Warnings & Precautions
Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. Anaphylactoid and hypersensitivity reactions have been reported for dexamethasone sodium phosphate (see ADVERSE REACTIONS ). Dexamethasone sodium phosphate injection contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Corticosteroids may exacerbate systemic fungal infections and therefore, should not be used in the presence of such infections unless they are needed to control drug reactions due to amphotericin B. Moreover, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive failure. In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results. In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding. Corticosteroids may activate latent amebiasis. Therefore, it i
Pregnancy & Lactation
Pregnancy
Caution
Antenatal corticosteroids (usually betamethasone preferred) are standard of care for fetal lung maturation at 24–34 weeks in threatened preterm labour. For maternal indications, prednisolone (minimal placental transfer) preferred
Lactation
Local injections, such as for tendinitis, are not expected to cause any adverse
Chemistry & Properties
| Formula | C22H29FO5 |
|---|---|
| Molecular weight | 392.47 g/mol |
| IUPAC name | (8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one |
| CAS | 50-02-2 |
| PubChem CID | 5743 |
| InChIKey | UREBDLICKHMUKA-CXSFZGCWSA-N |
| logP | 1.9 (XLogP 1.9) |
| Polar surface area | 94.83 Ų |
| H-bond acceptors / donors | 5 / 3 |
| Drug-likeness (QED) | 0.67 |
| Lipinski violations | 0 |
SMILES
C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)COBiology & Pharmacokinetics
Pharmacokinetics
| BBB penetrant | Yes (logBB -0.15) |
|---|
Enzyme interactions
| Enzyme | Role | Detail |
|---|---|---|
| CYP2C8 | Inhibitor | — |
| CYP3A4 | Substrate | — |
Receptor binding (top 5)
| Target | Action | Affinity |
|---|---|---|
| Mineralocorticoid receptor (NR3C2) | Agonist | pIC50 9.0 |
| Glucocorticoid receptor (NR3C1) | Binding | pKi 8.9 |
| Glucocorticoid | Binding | pKi 8.2 |
| Mineralocorticoid receptor (NR3C2) | Binding | pKi 8.1 |
| COX-2 | Binding | pKi 6.9 |
Transporters
ASBT (Inhibitor)BCRP (Inhibitor)BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MDR1 (Inhibitor)MRP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)MRP4 (Inhibitor)MRP5 (Inhibitor)OATP (Inhibitor)OATP1A2 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)OATP2B1 (Inhibitor)P-gp (Inhibitor)MDR1 (Substrate)P-gp (Substrate)PEPT1 (Substrate)Transporter(unspecified) (Substrate)
Drug–drug interactions (100+, DDInter)
| Interacting drug | Severity | Management |
|---|---|---|
| Adalimumab | major | |
| Amiodarone | major | |
| Avapritinib | major | |
| Axitinib | major | |
| Bacillus calmette-guerin substrain tice live antigen | major | |
| Baricitinib | major | |
| Bedaquiline | major | |
| Bempedoic acid | major | |
| Benzhydrocodone | major | |
| Bosutinib | major | |
| Brexucabtagene autoleucel | major | |
| Brigatinib | major | |
| Bupropion | major | |
| Butorphanol | major | |
| Capmatinib | major | |
| Caspofungin | major | |
| Certolizumab pegol | major | |
| Cinoxacin | major | |
| Ciprofloxacin | major | |
| Cladribine | major | |
| Cobimetinib | major | |
| Daclatasvir | major | |
| Darolutamide | major | |
| Dasatinib | major | |
| Deferasirox | major | |
| Deflazacort | major | |
| Delafloxacin | major | |
| Desirudin | major | |
| Desmopressin | major | |
| Dinutuximab | major | |
| Doravirine | major | |
| Encorafenib | major | |
| Enoxacin | major | |
| Entrectinib | major | |
| Erdafitinib | major | |
| Etanercept | major | |
| Everolimus | major | |
| Fedratinib | major | |
| Fentanyl | major | |
| Fingolimod | major |
Showing 40 of 100+.
Registered Products (43)
| Brand | Form / strength | Pack | Agent | Citizen (JOD) |
|---|---|---|---|---|
| Dexonium | Ampoule (as Sodium) 8 mg/2 ml | 1 amp pack varies | شركة مستودع ادوية الوسق | 0.360 |
| Zenos Ampoules [4 mg/ml], | Ampoule 4 mg/ml | 1 pack varies | Hikma Pharmaceuticals Co.Ltd/Jordan | 0.700 |
| Detroz | Solution 0.35 %, 0.1 % | 5 ml | Dar Al Dawa Development and Investment Co Ltd/Jordan | 0.850 |
| Apidex eye drops | Ophthalmic Solution 0.1 % | 10 ml | Amman Pharmaceutical Indusries | 0.950 |
| Detroz-P | Injection 1 mg/ml, 3500 IU/ml, 6000 IU/ml | 5 ml | Dar Al Dawa Development and Investment Co Ltd/Jordan | 1.140 |
| Gentadex eye ear drops | Ophthalmic Solution 0.3 %, 0.1 % | 10 ml | Amman Pharmaceutical Industries Co | 1.150 |
| Apidexol Elixir | Solution 0.01 % | 100 ml | Amman Pharmaceutical Indusries | 1.350 |
| F-Corten Amp | Ampoule 4 mg/1 ml | 3 amp pack varies | Petra Drug Store | 1.660 |
| Optidex-T Ophthalmic Suspension | Ophthalmic Solution 0.3 %w/v, 0.1 %w/v | 5 ml | شركة مستودع ادوية الايمان | 1.700 |
| Tobradex Eye Oint | Ointment 3 mg/g, 1 mg/g | 3.5 g tube | The Jordan Drugstore Co | 1.730 |
| Lofoto (0.3 + 0.1)% w/v | Solution 0.3 %, 0.1 % | 5 ml | Sun Set Drug Store | 1.740 |
| Phenidex eye drops | Ophthalmic Solution 0.5 %, 0.1 % | 10 ml | Amman Pharmaceutical Indusries | 1.840 |
| DECADRON Elixir | Suspension 0.5 mg/5 ml | 100 ml | Adatco Drug Store | 1.910 |
| Neodex Eye/Ear drops | Ophthalmic Solution 5 mg, 1 mg | 10 ml | Amman Pharmaceutical Indusries | 1.910 |
| Gentadexa Eye,Ear Drop | Ear Drops 0.3 %, 0.1 % | 10 ml | Jarzeem Drug Store | 2.000 |
| Dexazone | Ampoule 4 mg/1 ml | 2 ml | Alkilani Drugstore | 2.170 |
| Phenidexoline | Solution 0.5 %, 0.025 %, 0.1 % | 10 ml | Amman Pharmaceutical Industries Co | 2.210 |
| Tobrason Eye Suspension | Suspension 0.3 %, 0.1 % | 5 ml pack varies | Amman Pharmaceutical Industries Co | 2.310 |
| Tobrason Eye Ointment | Ointment 0.3 %, 0.1 % | 5gm pack varies | Amman Pharmaceutical Industries Co | 2.350 |
| Salidex Solution | Solution 20 mg, 1.2 mg | 30 ml | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 2.400 |
| Tobradex Eye Drops | Ophthalmic Solution 0.3 %, 0.1 % | 5 ml | The Jordan Drugstore Co | 2.430 |
| Maxitrol Eye Drops | Ophthalmic Solution 1 mg/ml, 6.000 IU/ml, 3.500 IU/ml | 5 ml | The Jordan Drugstore Co | 2.460 |
| DEX (Dexamethasone Sodium Phosphate Injection USP) | Injection 8 mg/2 ml | 10 amp | AL Rahma Drug Store | 2.610 |
| Emacort Topical Solution | Solution 2 %, 0.12 % | 30 ml | JERASH PHARMACEUTICALS LTD.CO/JORDAN | 2.610 |
| Salicort Oint | Ointment 3 %, 0.12 % | 30gm | Hayat Pharmaceutical Industries CO.PLC/JORDAN | 3.460 |
| Salidex Ointment | Ointment 3 %, 0.12 % | 30 g tube | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 3.480 |
| DEXAMED TAB | Tablet 0.5 mg | 100 tab | Al Hilal Drug Store | 3.510 |
| Emacort Ointment | Ointment 3 %, 1.2 mg/g | 30 g tube | JERASH PHARMACEUTICALS LTD.CO/JORDAN | 3.940 |
| DEXAMED AMP | Ampoule 8 mg/2 ml | 10 amp pack varies | Al Hilal Drug Store | 4.330 |
| Tobrason Eye Suspension | Suspension 0.3 %, 0.1 % | 10 ml pack varies | Amman Pharmaceutical Industries Co | 4.390 |
| Dexamethasone Amp | Ampoule 4 mg/ml | 10 amp pack varies | AL Rahma Drug Store | 4.780 |
| Leviosa | Solution 1.32 mg/1 ml, 5.12 mg/1 ml | 5 ml | Almutanabbe Drug Store | 13.690 |
| Dexan | Ampoule 8 mg/2 ml | 10 amp | Joinhub Pharma LLP | 19.670 |
| Dexakam | Ampoule 4 mg/ml | 100 amp | Argon drug store | 23.900 |
| Dexonium | Ampoule (as Sodium) 8 mg/2 ml | 100 amp pack varies | شركة مستودع ادوية الوسق | 27.600 |
| DEXAMED AMP | Ampoule 8 mg/2 ml | 100 amp pack varies | Al Hilal Drug Store | 39.360 |
| Dexamethasone Sodium Phosphate USP 40 solution for I.V/I.M | Solution (as Disodium) 8 mg/2 ml | 100 amp | AL-Faiasel Drug Store | 39.830 |
| Dexamethasone Amp | Ampoule 4 mg/ml | 100 amp pack varies | AL Rahma Drug Store | 43.020 |
| F-Corten Amp | Ampoule 4 mg/1 ml | 100 amp pack varies | Petra Drug Store | 47.030 |
| Zenos Ampoules [4 mg/ml], | Ampoule 4 mg/ml | 100 amp pack varies | Hikma Pharmaceuticals Co.Ltd/Jordan | 63.000 |
| Fortecortin inj | Injection 8 mg/2 ml | 100 vial | Nabulsi Drug Store | 69.120 |
| Fortecortin inj | Injection 4 mg/ml | 100 vial | Nabulsi Drug Store | — |
| Ozurdex | Implant 700 mcg | 1 Intraviteral Implant In applicator | Arab Company for Medical & Agricultural Products | — |