Epidron

 25 mg/5 ml Injection
Renata PLC
5 ml ampoule: ৳ 12.05 (1 x 5: ৳ 60.25)
Indications

Approved Indications:

  • Hypotension:
    • Treatment of acute hypotensive episodes, including spinal anesthesia-induced hypotension.
    • Supportive therapy in shock states where vasoconstrictor support is needed.
  • Bronchial Asthma:
    • Symptomatic relief of bronchospasm and airway obstruction.
    • Used as a short-term bronchodilator in patients not responding adequately to first-line agents.
  • Nasal Congestion:
    • Relief of nasal and sinus congestion in rhinitis or sinusitis.

Off-Label / Clinically Accepted Uses:

  • Urinary incontinence (especially stress incontinence) via bladder sphincter stimulation.
  • Weight management / stimulant effects in select cases (limited clinical use, often discouraged due to safety concerns).
Dosage & Administration

Adults:

  • Hypotension (IV/IM): 5–25 mg slowly, repeat every 10–60 minutes as needed.
  • Bronchospasm (oral): 25 mg orally every 4–6 hours; maximum 150 mg/day.
  • Nasal congestion (oral): 25–50 mg every 4–6 hours as needed; maximum 150 mg/day.

Pediatrics:

  • Dose adjusted according to weight (approximately 0.5–1 mg/kg orally every 4–6 hours).
  • Maximum pediatric dose varies; careful monitoring recommended.

Special Populations:

  • Elderly: Start at lower doses; monitor cardiovascular response.
  • Renal/Hepatic Impairment: Use caution; adjust dose as necessary due to slower metabolism or excretion.

Routes of Administration: Oral, intravenous (IV), intramuscular (IM), subcutaneous (SC).
Duration: Short-term use preferred; avoid chronic administration due to cardiovascular risks.

Mechanism of Action (MOA)

Ephedrine Hydrochloride is a sympathomimetic amine with mixed-acting properties. It directly stimulates α-adrenergic receptors, causing vasoconstriction and increased blood pressure, and β-adrenergic receptors, resulting in bronchodilation and increased cardiac output. Additionally, it indirectly promotes the release of endogenous norepinephrine from sympathetic nerve terminals, enhancing both cardiovascular and respiratory effects. These actions collectively lead to elevated blood pressure, improved airway patency, and increased heart rate and cardiac contractility.

Pharmacokinetics
  • Absorption: Rapid oral absorption; onset 15–60 minutes orally.
  • Bioavailability: 70–90%.
  • Distribution: Widely distributed; crosses the blood-brain barrier; moderate plasma protein binding (~50%).
  • Metabolism: Partially metabolized in the liver.
  • Elimination: Excreted in urine, mainly as unchanged drug; urine pH affects excretion rate.
  • Half-Life: 3–6 hours depending on dose and renal function.
  • Onset of Action: IV: immediate; IM/SC: 5–15 minutes; oral: 15–60 minutes.
Pregnancy Category & Lactation
  • Pregnancy: Category C (FDA) – Animal studies show adverse effects; human data limited. Use only if potential benefit justifies risk.
  • Lactation: Excreted in breast milk; may cause tachycardia or irritability in infants. Use with caution or avoid during breastfeeding.
  • Data Limitations: Insufficient human studies; risk-benefit assessment required.
Therapeutic Class
  • Primary Class: Sympathomimetic amine
  • Subclass: Mixed-acting adrenergic agonist
Contraindications
  • Known hypersensitivity to Ephedrine or other sympathomimetics.
  • Severe hypertension or tachyarrhythmias.
  • Hyperthyroidism (risk of arrhythmia).
  • Pheochromocytoma.
  • Concurrent use of MAO inhibitors or within 14 days of discontinuation.
Warnings & Precautions
  • Cardiovascular Risk: Can cause hypertension, tachycardia, arrhythmias, myocardial ischemia; monitor in high-risk patients.
  • CNS Effects: May induce insomnia, anxiety, tremor, or seizures at high doses.
  • Urinary Retention: Caution in patients with prostatic hypertrophy.
  • Drug Dependence / Abuse: Potential for misuse due to stimulant properties.
  • High-Risk Groups: Elderly, patients with cardiovascular disease, thyroid disorders, or diabetes.
Side Effects

Common Adverse Effects:

  • Cardiovascular: palpitations, tachycardia, mild hypertension
  • CNS: nervousness, insomnia, headache, dizziness
  • Gastrointestinal: nausea, vomiting

Serious / Rare Adverse Effects:

  • Severe hypertension or hypertensive crisis
  • Arrhythmias or myocardial infarction
  • CNS: agitation, hallucinations, seizures
  • Urinary retention

Timing / Dose Dependence:

  • Adverse effects typically occur shortly after administration, especially with higher or repeated doses.
Drug Interactions
  • MAO Inhibitors: Severe hypertensive crisis; contraindicated.
  • Other Sympathomimetics: Additive cardiovascular stimulation; risk of hypertension, arrhythmia.
  • Antihypertensives (e.g., beta-blockers): May reduce efficacy.
  • Caffeine / CNS stimulants: Increased CNS stimulation; risk of insomnia, anxiety.
  • Enzyme Systems: Minimal CYP450 metabolism; interactions mainly pharmacodynamic.
Recent Updates or Guidelines
  • Cardiovascular Safety: Emphasis on cautious use in patients with heart disease or uncontrolled hypertension.
  • Short-Term Use: Guidelines recommend limiting use to acute episodes; chronic use discouraged due to cardiovascular risk.
  • Regulatory Status: Widely approved for hypotension and bronchospasm; some countries restrict use in OTC weight-loss or stimulant preparations due to safety concerns.
Storage Conditions
  • Temperature: 20°C–25°C (68°F–77°F); excursions 15°C–30°C allowed.
  • Humidity & Light: Protect from moisture and direct light.
  • Handling: Keep in original container; avoid crushing or splitting extended-release formulations.
  • Reconstitution: Not applicable; tablets and injections ready for use.
Available Brand Names