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DEXAMETHASONE (IM/IV) 8/MG 5/AMP
- Sku : I-001635
Key features
DEXAMETHASONE (IM/IV) is an intramuscular/intravenous solution containing the active ingredient dexamethasone sodium phosphate at 4 mg/mL. It acts as a glucocorticoid receptor agonist, altering gene transcription to suppress inflammatory cytokine production, reduce leukocyte trafficking, and decrease capillary permeability and edema. It is used for conditions responsive to systemic corticosteroids, including severe allergic and inflammatory states, acute exacerbations of asthma or COPD, cerebral edema, and as adjunctive therapy in adrenal insufficiency or shock; use in COVID-19 requiring oxygen or ventilation is guideline-supported where applicable. Supplied as a 4 mg/mL solution for IM/IV administration in 2 mL ampoules (8 mg per ampoule).- Brand: DEXAMETHASONE
- Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
- Strength: 4mg/ml
- Dosage Form: Solution
- Pack Size: 2 ml
- Route: Intravenous use
- Prescription Status: Prescription
- Therapeutic Class: Hormonal
- Pharmacological Group: Corticosteroids (Systemic)
- Drug Class: Systemic corticosteroid (synthetic glucocorticoid); ATC H02AB02; pharmacologic class: Corticosteroid hormone receptor agonist.
- Manufacturer: EIPICO
- Country of Origin: Egypt
- SFDA Registration No.: 16-201-92
- Shelf Life: 36 months
- Storage: do not store above 30°c
- Symptom Target: Severe allergic/inflammatory states, cerebral edema, shock
- Sedating: No
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Indications
Approved Uses
Indications depend on local label; generally for conditions responsive to systemic corticosteroids including severe allergic/inflammatory states, acute asthma/COPD exacerbations, cerebral edema, and adrenal insufficiency/shock adjunct where indicated; COVID-19 requiring oxygen/ventilation is guideline-supported but may be label-dependent.
Dosage & Administration
Dosing by Condition
Dosing is indication-specific and individualized; typical adult examples: cerebral edema 10 mg IV once then 4 mg IV q6h; severe allergic reaction 4-8 mg IV; antiemetic adjunct 8-20 mg IV pre-chemotherapy; COVID-19 requiring oxygen/ventilation 6 mg IV daily up to 10 days.
Initial Dose
8mg IV/IM for most acute indications
Maintenance Dose
4-8mg IV/IM every 6-12 hours depending on indication
Maximum Dose
No single universal maximum; typical regimens vary by indication-commonly up to ~24 mg/day for cerebral edema, while higher doses (e.g., up to ~40 mg/day or more) may be used short-term in life-threatening situations per specialist protocols.
Children's Dosage
Anti-inflammatory/immunosuppressive: 0.08-0.3mg/kg/day IV/IM in divided doses q6-12h. Croup: 0.6mg/kg IM/IV single dose (max 10mg). Cerebral edema: 0.5-1mg/kg IV loading dose, then 0.2-0.5mg/kg/day in divided doses
Dose Adjustment Notes
If used beyond a few days or at supraphysiologic doses, taper gradually to avoid HPA-axis suppression; use the lowest effective dose and consider stress-dose increases during major stress (surgery, severe infection) in patients with adrenal suppression.
How to Take
IV use (per SFDA route): administer by slow IV injection or dilute and give by IV infusion using aseptic technique; do NOT give intrathecally/epidurally; inspect solution/ampoule and discard if particulate/discolored; administer by trained healthcare professional.
How to Prepare
Ready-to-use solution in ampoule (SFDA: solution, 2 mL ampoule); may be given IV directly (slow IV injection) or diluted for IV infusion in compatible fluids such as 0.9% sodium chloride or 5% dextrose; inspect for particles/discoloration and discard unused portion per aseptic practice.
Side Effects
Common Side Effects
Common: hyperglycemia, fluid retention/edema, increased appetite/weight gain, insomnia, mood changes, hypertension, GI upset (nausea/dyspepsia), and injection-site pain; with longer use: acne/easy bruising can occur.
Side Effect Frequency
Common/expected with systemic corticosteroids: hyperglycemia, insomnia, increased appetite, mood changes, GI upset; with higher dose/longer duration: fluid retention/weight gain, hypertension, hypokalemia, infection risk, GI bleeding/ulceration, psychiatric effects, adrenal suppression; rare but serious: avascular necrosis, opportunistic infections.
Safety & Warnings
Warnings & Precautions
Key precautions: increased infection risk and masking of infection; avoid live vaccines at immunosuppressive doses; monitor for HPA-axis suppression and taper after prolonged use; monitor glucose (diabetes), BP/edema (HF/HTN), electrolytes (hypokalemia), GI risk (PUD/NSAIDs), bone health (osteoporosis/AVN), psychiatric effects, and ocular effects (glaucoma/cataract); use caution in patients with comorbid HTN, diabetes, PUD, osteoporosis, glaucoma, psychiatric illness, and in frail/elderly; consider excipient-related hypersensitivity if applicable to the specific ampoule.
Age Restriction
No absolute minimum age; can be used in pediatrics (including neonates) when clinically indicated, with specialist oversight and attention to formulation excipients (e.g., benzyl alcohol if present).
Special Populations
Children
Anti-inflammatory/immunosuppressive: 0.08-0.3mg/kg/day IV/IM in divided doses q6-12h. Croup: 0.6mg/kg IM/IV single dose (max 10mg). Cerebral edema: 0.5-1mg/kg IV loading dose, then 0.2-0.5mg/kg/day in divided doses
Storage & Patient Advice
Preparation Instructions
Ready-to-use solution in ampoule (SFDA: solution, 2 mL ampoule); may be given IV directly (slow IV injection) or diluted for IV infusion in compatible fluids such as 0.9% sodium chloride or 5% dextrose; inspect for particles/discoloration and discard unused portion per aseptic practice.
Missed Dose
In hospital/clinic administration: doses are given by healthcare professionals; if a scheduled dose is missed, administer as soon as feasible per prescriber and do not double-re-time subsequent doses based on clinical need.
Stopping the Medicine
Do not stop abruptly after prolonged or high-dose therapy; taper gradually based on duration/dose and clinical status.
Overdose
Acute overdose is unlikely to be immediately life-threatening; expected effects include hyperglycemia, hypertension, fluid retention, mood changes, and electrolyte disturbances; chronic excessive exposure can cause Cushingoid features and adrenal suppression-management is supportive with monitoring (glucose/electrolytes/BP) and tapering if on prolonged therapy.
Patient Counseling
Administered by a healthcare professional; do not stop abruptly if used for more than a few days (taper as directed); report signs of infection (fever/chills) and avoid exposure to chickenpox/measles; monitor blood glucose if diabetic; report significant mood changes, swelling/rapid weight gain, or GI bleeding (black/tarry stools); inform all healthcare providers you are receiving corticosteroid therapy.
Monitoring Requirements
Monitor blood glucose, blood pressure, weight/fluid status, electrolytes (esp. potassium/sodium), signs of infection; with prolonged/repeated courses monitor intraocular pressure/cataracts, bone health (osteoporosis risk), and in children growth.
Pharmacology
Mechanism of Action
Glucocorticoid receptor agonist that alters gene transcription to suppress inflammatory cytokines/mediators, reduce leukocyte trafficking, and decrease capillary permeability/edema.
Bioavailability
IV: 100%; IM: effectively ~100% (complete systemic availability, with slower absorption)
Product Information
Available Dosage Forms
For this SFDA product: solution for injection in ampoules (4 mg/mL, 2 mL); other dexamethasone dosage forms exist (tablets, oral solution, ophthalmic/otic forms) but are separate products and not implied by this specific SFDA record.
Composition per Dose
Each 2ml ampoule: 8mg dexamethasone as dexamethasone sodium phosphate (4mg/ml)
Generic Availability
Yes
OTC Alternatives
No OTC alternative for systemic corticosteroid therapy
Symptom Target
Severe allergic/inflammatory states, cerebral edema, shock
Sedating
No
Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 10-07-2026
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