Trade Name: Norepinephrine Bitartrate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, SOLUTION, CONCENTRATE, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/mL

Storage and handling

NOREPINEPHRINE BITARTRATE Catecholamine [EPC],Catecholamines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Norepinephrine Bitartrate (Norepinephrine Bitartrate) which is also known as Norepinephrine Bitartrate and Manufactured by Amneal Biosciences LLC. It is available in strength of 1 mg/mL.

Norepinephrine Bitartrate (Norepinephrine Bitartrate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
  • Norepinephrine bitartrate injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ()
  • No data
  • Initial dose of 0.25 mL to 0.375 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low to normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation of vital organs. ()
  • The average maintenance dose ranges from 0.0625 mL to 0.125 mL per minute (from 2 mcg to 4 mcg of base). ()
  • Injection: 4 mg/4 mL (1 mg/mL norepinephrine base) sterile, clear, colorless or practically colorless to slightly yellow color solution in a single-dose amber glass vial.
  • Injection: 4 mg/4 mL (1 mg/mL) norepinephrine base in single-dose glass vial. ()
  • None.
  • None. ()
  • No data
  • The following adverse reactions are described in greater detail in other sections:
  • The most common adverse reactions are hypertension and bradycardia.
  • The following adverse reactions can occur:
  • Nervous system disorders:
  • Respiratory disorders:
  • Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn
  • No data
  • Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. ()
  • Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ()
  • No data
  • Elderly patients may be at greater risk of developing adverse reactions. ()
  • Overdosage with norepinephrine may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.
  • In case of overdosage, discontinue norepinephrine until the condition of the patient stabilizes.
  • Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.
  • Norepinephrine Bitartrate is (-)-u03b1-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.28 g/mol) and has the following structural formula:
  • Norepinephrine bitartrate injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine bitartrate, USP is freely soluble in water, slightly soluble in alcohol and practically insoluble in chloroform and in ether. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 0.2 mg of sodium metabisulfite as an antioxidant.It has pH of 3.0 to 4.5. The air in the containers has been displaced by nitrogen gas.
  • No data
  • Carcinogenesis, mutagenesis, and fertility studies have not been performed.
  • Norepinephrine Bitartrate Injection, USP is a sterile, colorless or practically colorless to slightly yellow color solution for injection intended for intravenous use. It contains the equivalent of 1 mg of norepinephrine base per 1 mL (4 mg/4 mL). It is available as 4 mg/4 mL in single-dose amber glass vials u00a0Supplied as:
  • Arrayn- 4 mg/4 mL (1 mg/mL):
  • 10 x 4 mL Single-Dose Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1576-7
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature.]
  • Store in original carton until time of administration to protect from light. Discard unused portion.
  • Risk of Tissue Damage
  • Advise the patient, family, or caregiver to report signs of extravasation urgently n
  • This productu2019s labeling may have been updated. For the most recent prescribing information, please visit www.amneal.com.
  • Manufactured by:
  • Amneal Pharmaceuticals Pvt. Ltd.
  • Parenteral Unit
  • Ahmedabad 382213, INDIA
  • Distributed by:
  • Amneal Pharmaceuticals LLC
  • Bridgewater, NJ 08807
  • Rev. 08-2020-01
  • NDC 70121-1576-1 Norepinephrine bitartrate injection, USP 4 mg/4 mL (1 mg/mL) R only Vial Label Amneal Pharmaceuticalsu00a0LLC
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  • NDC 70121-1576-7 Norepinephrine bitartrate injection, USP 4 mg/4 mL (1 mg/mL) R onlyCarton Label (10 vials in carton) Amneal Pharmaceuticalsu00a0LLC
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