International reference: 6 US FDA recalls for this ingredient

Lack of Assurance of Sterility (norepinephrine)

Lack of Assurance of Sterility (norepinephrine)

GMP Deviation; A foreign stopper was observed during packaging of a lot of product. (norepinephrine)

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. (norepinephrine)

Lack of Assurance of Sterility (norepinephrine)

Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. (norepinephrine)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in South Africa.

Registered South Africa · SAHPRA

PRESSAVELL

NOREPINEPHRINE (NORADRENALINE) TARTRATE EQUIVALENT TO NOREPINEPHRINE (NORADRENALINE)

59/5.1/0684 INN generic

What it does

Norepinephrine is a medication often used to help increase blood pressure and improve blood flow in critical situations.

Commonly used for: low blood pressure (hypotension), septic shock, cardiac arrest

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
59/5.1/0684
Registration date
2026/03/24
Expiry date
-
Status
Registered
Active ingredient
NOREPINEPHRINE (NORADRENALINE) TARTRATE EQUIVALENT TO NOREPINEPHRINE (NORADRENALINE)
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:30:28 · updated 2026-10-18 04:02:35

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Norepinephrine is a medication often used to help increase blood pressure and improve blood flow in critical situations.

What it treats

  • low blood pressure (hypotension)
  • septic shock
  • cardiac arrest

How it works

Norepinephrine works by narrowing blood vessels and increasing heart rate, which helps to raise blood pressure.

Who it's for

This medication is for patients experiencing severe drops in blood pressure, often in emergency or hospital settings.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: norepinephrine

BNF-referenced

Norepinephrine, also known as noradrenaline, is a catecholamine that acts primarily as a potent vasoconstrictor and inotropic agent. It is used clinically to manage hypotension, particularly in shock states such as septic shock, and to increase cardiac output in certain conditions. Norepinephrine is administered intravenously, as it is rapidly metabolized when given via other routes.

Indications

  • Septic shock
  • Cardiogenic shock
  • Severe hypotension
  • Acute heart failure

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines in paediatric patients.

Adults: The usual starting dose is 0.05 to 0.1 micrograms/kg/min, which may be titrated to achieve the desired blood pressure response.

Mechanism of action

Norepinephrine functions as a peripheral vasoconstrictor by acting on alpha-adrenergic receptors. It stimulates the heart as an inotropic agent and dilates coronary arteries through its activity on beta-adrenergic receptors. The drug is a potent alpha agonist with relatively little action on beta-2 receptors, making it effective in raising systemic vascular resistance and blood pressure.

Pharmacodynamics

Norepinephrine acts on alpha-1 and alpha-2 adrenergic receptors, leading to vasoconstriction and an increase in systemic vascular resistance. Its primary effect is to elevate blood pressure by increasing peripheral vascular resistance, making it critical in the treatment of hypotensive states.

Pharmacokinetics

Norepinephrine is rapidly metabolized in the body, primarily by catechol-O-methyltransferase and monoamine oxidase. Its half-life is short, necessitating continuous intravenous infusion for sustained effects. The distribution volume is low, and it is primarily excreted in urine as metabolites.

Contra-indications

  • hypersensitivity to norepinephrine
  • uncontrolled hypertension
  • hypovolemia
  • mesenteric or peripheral vascular thrombosis

Adverse effects

  • arrhythmias
  • hypertension
  • bradycardia
  • extravasation leading to tissue necrosis
  • anxiety
  • headache
  • nausea
  • palpitations

Interactions

  • MAO inhibitors may enhance the pressor effects of norepinephrine
  • tricyclic antidepressants may increase the risk of hypertension
  • general anesthetics may increase the risk of cardiovascular effects
  • adrenergic blockers may antagonize the effects of norepinephrine

Precautions

  • monitor blood pressure continuously during administration
  • ensure adequate hydration before use
  • use with caution in patients with cardiovascular disease
  • avoid extravasation; if occurs, treat promptly

Pregnancy

Norepinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is classified as category C.

Breast-feeding

It is unknown whether norepinephrine is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

Store at room temperature, protected from light. Do not freeze.

Formulations

  • solution for injection

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: norepinephrine

PubChem CID 439260

Molecular formula: C8H11NO3

Mechanism of action

Norepinephrine functions as a peripheral vasoconstrictor by acting on alpha-adrenergic receptors. It is also an inotropic stimulator of the heart and dilator of coronary arteries as a result of it's activity at the beta-adrenergic receptors. The pharmacological actions of norepinephrine and epinephrine have been extensively compared in vivo and in vitro. Both drugs are direct agonists on effector cells, and their actions differ mainly in the ratio of their effectiveness in stimulating alpha and beta2-receptors. They are approximately equipotent in stimulating beta1-receptors. Norepinephrine is a potent alpha agonist and has relatively little action on beta-2 receptors; however, it is somewhat less potent than epinephrine on the alpha receptors of most organs. During cold exposures there is an immediate release of catecholamines (e.g., norepinephrine, dopamine), which activate the sympathetic nervous system to reduce heat loss via peripheral vasoconstriction and shift substrate utilization toward fatty acid metabolism for heat production.

Pharmacodynamics

Noradrenaline acts on both alpha-1 and alpha-2 adrenergic receptors to cause vasoconstriction. Its effect in-vitro is often limited to the increasing of blood pressure through antagonising alpha-1 and alpha-2 receptors and causing a resultant increase in systemic vascular resistance.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.