Nordrine25 mg/5 ml

Nordrine is a sympathomimetic amine used clinically for the following indications:

Established / approved use

• Treatment and prevention of clinically important hypotension occurring in the setting of anaesthesia, most commonly hypotension induced by spinal or epidural anaesthesia (e.g., during caesarean section or other surgery performed under regional anaesthesia).

Other / adjunct and historical uses (formulation-dependent)

• As an oral or topical nasal decongestant in combination products, to relieve nasal and sinus congestion associated with colds, allergies, or sinusitis.
• As a mild bronchodilator in some older oral preparations for reversible bronchospasm; this use has largely been superseded by more selective and safer bronchodilators (e.g., beta-2 agonists) and is now uncommon.

Nordrine has limited and generally unreliable benefit in hypotension due to shock, haemorrhage, or circulatory collapse, and is not recommended as first-line therapy in these settings.

Each formulation of Ephedrine Hydrochloride contains ephedrine hydrochloride as the active ingredient. It is available (formulation and strength vary by market) as:

• Injection: ephedrine hydrochloride solution for slow intravenous, intramuscular, or subcutaneous injection (commonly supplied as ampoules)
• Tablet: oral tablets, typically 15 mg to 60 mg
• Syrup: oral liquid, typically 15 mg/5 mL

Exact strengths and available dosage forms vary by manufacturer and country; refer to the specific product label.

Nordrine is a sympathomimetic amine that acts as a mixed direct- and indirect-acting agonist at alpha- and beta-adrenergic receptors. Structurally related to amphetamine and originally derived from Ephedra species, it has been used in medicine for nearly a century, most importantly today as a vasopressor for anaesthesia-related hypotension. Because of its stimulant properties, several countries have historically restricted over-the-counter sale of Nordrine-containing products to limit misuse and diversion.

Sympathomimetic (adrenergic) agent; vasopressor used in anaesthesia. Formulations intended for decongestant or bronchodilator use fall under the nasal decongestant / bronchodilator sympathomimetic subclass.

Ephedrine Hydrochloride is a non-catecholamine sympathomimetic amine with mixed direct and indirect adrenergic agonist activity.

• Direct effect: weak direct agonism at alpha-1, beta-1, and beta-2 adrenergic receptors.
• Indirect effect: stimulates release of endogenous norepinephrine from sympathetic nerve terminals, which is the dominant mechanism of its pressor action.

The net effect is increased heart rate, cardiac contractility, and systemic vascular resistance, raising blood pressure; beta-2 mediated effects also produce mild bronchodilation and CNS stimulation. Ephedrine Hydrochloride is well absorbed orally, is largely excreted unchanged in urine (excretion is pH-dependent), and has an elimination half-life of approximately 3 to 6 hours. Tachyphylaxis (diminishing pressor response) can occur with repeated or closely spaced doses due to depletion of norepinephrine stores.

Nordrine injection should be given by slow intravenous injection under continuous blood pressure and heart rate monitoring; it may alternatively be given by intramuscular or subcutaneous injection. It should be inspected visually for particulate matter and discoloration before use, and administered only by, or under the direct supervision of, a qualified healthcare professional trained in anaesthesia/critical care. Oral tablets or syrup should be swallowed with water, with or without food, as directed by the product label or physician.

Nordrine has several clinically significant drug interactions:

• Monoamine oxidase inhibitors (MAOIs): concurrent use (or use within 14 days of stopping an MAOI) can precipitate a hypertensive crisis; this combination is contraindicated (see Contraindications).
• Tricyclic antidepressants: may potentiate the pressor (blood pressure-raising) effect of Nordrine.
• Other sympathomimetics (e.g., other decongestants, stimulants): additive cardiovascular stimulation, increasing risk of hypertension and arrhythmia.
• Volatile general anaesthetics (e.g., halothane, cyclopropane): increased risk of cardiac arrhythmia when given concurrently with Nordrine.
• Antihypertensive agents: their blood pressure-lowering effect may be reduced by Nordrine.
• Ergot alkaloids and oxytocic drugs: additive vasoconstrictor/hypertensive effect, particularly relevant during obstetric anaesthesia.
• Cardiac glycosides (e.g., digoxin) and quinidine: increased risk of cardiac arrhythmia.

Common side effects of Nordrine (systemic/oral or injectable use) include:

• Tachycardia and palpitations
• Hypertension
• Anxiety, restlessness, or nervousness
• Tremor
• Headache
• Insomnia
• Nausea, vomiting, or sweating
• Difficulty with urination (especially in men with prostatic enlargement)

Less common effects include anginal pain, cardiac arrhythmias, and (rarely) precipitation of angle-closure glaucoma. With topical/nasal use, local irritation of the nasal mucosa may occur. Seek medical attention for chest pain, severe headache, irregular heartbeat, or fainting.

Pregnancy: Nordrine is commonly used, under specialist anaesthesia supervision, to manage hypotension caused by spinal or epidural anaesthesia during procedures such as caesarean section; this specific clinical use is well established in obstetric anaesthesia practice and is administered by a physician who weighs maternal and fetal risk/benefit. For other (non-anaesthesia) indications, Nordrine should be used in pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should always be consulted.

Lactation: Nordrine passes into breast milk and has been associated with infant irritability and sleep disturbance; routine use while breastfeeding is not recommended outside the supervised anaesthesia setting. Consult a physician before use while breastfeeding.

Nordrine should be used with caution in patients with:

• Cardiovascular disease, including ischaemic heart disease, cardiac arrhythmias, and hypertension
• Hyperthyroidism
• Diabetes mellitus
• Renal impairment
• Prostatic hypertrophy/urinary retention
• Angle-closure glaucoma (caution warranted even outside acute narrow-angle attacks)

Blood pressure and heart rate should be monitored during and after administration, particularly with injectable use. Nordrine has stimulant properties and a recognised potential for misuse and abuse (for example, as a weight-loss aid or performance stimulant); this has led several countries to restrict over-the-counter sale and closely regulate products containing Nordrine, partly also due to its use as a precursor chemical in illicit manufacture of methamphetamine. It should be used only as directed and dispensed/sold in accordance with local pharmacy regulations. Tachyphylaxis (reduced effect with repeated dosing) may occur.

Overdose of Nordrine can cause severe hypertension, dangerous cardiac arrhythmias, chest pain, seizures, severe headache, vomiting, and confusion. If overdose is suspected, seek immediate medical attention or contact a poison control centre/emergency services right away. Treatment is supportive and should only be given in a hospital/emergency setting; do not attempt specific home treatment.

Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.

Elderly: may be more sensitive to the cardiovascular (hypertensive, arrhythmogenic) effects of Nordrine; use the lowest effective dose with close monitoring.

Renal impairment: use with caution, as excretion is partly renal and pH-dependent; monitor for accumulation or exaggerated effect.

Hepatic impairment: no specific dose adjustment is well established for Nordrine; use with general caution.

Pregnancy and lactation: see Pregnancy and Lactation section above.

Pediatric patients: see Pediatric Uses section below.

Nordrine for anaesthesia-related hypotension is used as a single dose or a small number of intermittent doses during a procedure, not as ongoing therapy. Oral use for decongestant or bronchodilator purposes should be limited to short-term, symptomatic use (typically a few days) unless otherwise directed by a physician; Nordrine is not intended for long-term or chronic administration.

Sympathomimetic amine; adrenergic agonist (mixed direct- and indirect-acting); vasopressor.

Ephedrine Hydrochloride raises blood pressure mainly by triggering release of stored norepinephrine from sympathetic nerve terminals (indirect action), together with weak direct stimulation of alpha- and beta-adrenergic receptors. This increases heart rate, cardiac output, and vascular tone. See Pharmacology for full detail.

C

Safety and efficacy of Nordrine for routine oral (decongestant/bronchodilator) use in infants and young children have not been formally established, and such use is generally not recommended without specific medical advice. For anaesthesia-induced hypotension, Nordrine is used in pediatric anaesthesia under specialist supervision with weight-based dosing determined by the anaesthesiologist. Use in children should always be directed and monitored by a physician.