Trade Name: Phenylephrine hydrochloride

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, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/mL

Storage and handling

PHENYLEPHRINE HYDROCHLORIDE alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Phenylephrine hydrochloride (Phenylephrine hydrochloride) which is also known as Phenylephrine hydrochloride and Manufactured by Amneal Biosciences LLC. It is available in strength of 10 mg/mL.

Phenylephrine hydrochloride (Phenylephrine hydrochloride) 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
  • Phenylephrine hydrochloride injection, 10 mg/mL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. ()
  • Phenylephrine hydrochloride injection, 10 mg/mL, is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.
  • Dilute before administration. (n n
  • Dosing for treatment of hypotension during anesthesia
  • Bolus intravenous injection: 40 mcg to 100 mcg every 1 to 2 minutes as needed, not to exceed 200 mcg. ()
  • Intravenous infusion: 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min. ()
  • Adjust the dose according to the pressor response (i.e. titrate to effect). ()
  • Phenylephrine hydrochloride injection USP, 10 mg/mL, for intravenous use, is available in following vial sizes:
  • Injection ()
  • 5 mL pharmacy bulk package vials containing 50 mg phenylephrine hydrochloride (10 mg/mL). ()
  • 10 mL pharmacy bulk package vials containing 100 mg phenylephrine hydrochloride (10 mg/mL). ()n
  • None
  • None ()
  • Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension: Phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. ()n Peripheral and Visceral Ischemia: Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs. ()n
  • Skin and Subcutaneous Necrosis: Extravasation during intravenous administration may cause necrosis or sloughing of tissue. ()n Bradycardia: Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. ()
  • Adverse reactions to phenylephrine hydrochloride are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of phenylephrine hydrochloride are listed below by body system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
  • Cardiac disordersn- Arrayn- Arrayn- Arrayn- Arrayn- Array
  • Most common adverse reactions during treatment: nausea, vomiting, and headache. ()n n n n
  • Agonistic effects
  • (increase in phenylephrine hydrochloride blood pressure effect)
  • (decrease in phenylephrine hydrochloride blood pressure effect)
  • 7.1
  • 7.2
  • No data
  • Overdose of phenylephrine hydrochloride can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.n
  • Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)--hydroxy-u03b1-[(methylamino)methyl]benzyl alcohol hydrochloride, and its structural formula is depicted below:
  • Phenylephrine hydrochloride, USP is a white or practically white crystals with a molecular formula of CHNO u2022 HCl and a molecular weight of 203.67. It is freely soluble in water and in alcohol.
  • Phenylephrine hydrochloride injection USP, 10 mg/mL is sensitive to light.
  • Each mL contains: phenylephrine hydrochloride USP, 10 mg; sodium chloride 3.5 mg; trisodium citrate dihydrate 4 mg; citric acid monohydrate 1 mg; and sodium metabisulfite u00a02 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.n
  • No data
  • Carcinogenesis
  • Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131 times the human daily dose (HDD) of 10 mg/60 kg/day based on body surface area) or rats administered approximately 50 mg/kg/day (48 times HDD) based on body surface area comparisons.
  • Mutagenesis
  • Phenylephrine hydrochloride tested negative in the bacterial reverse mutation assay (strains TA98, TA100, TA1535 and TA1537), the chromosomal aberrations assay, the sister chromatid exchange assay, and the rat micronucleus assay. Positive results were reported in only one of two replicates of the mouse lymphoma assay.
  • Impairment of Fertility
  • Phenylephrine did not impair mating, fertility, or reproductive outcome in normotensive male rats treated with 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9 times the HDD) for 28 days prior to mating and for a minimum of 63 days prior to sacrifice and female rats treated with the same dosing regimen for 14 days prior to mating and through Gestation Day 6. This dose was associated with increased mortality in both male and female rats and decreased body weight gain in treated males. There were decreased caudal sperm density and increased abnormal sperm reported in males treated with 3 mg/kg/day phenylephrine (2.9 times the HDD).
  • The evidence for the efficacy of phenylephrine hydrochloride injection is derived from studies of phenylephrine hydrochloride in the published literature. The literature support includes 16 studies evaluating the use of intravenous phenylephrine to treat hypotension during anesthesia. The 16 studies include 9 studies where phenylephrine was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 6 studies in non-obstetric surgery under general anesthesia, and 1 study in non-obstetric surgery under combined general and neuraxial anesthesia. Phenylephrine has been shown to raise systolic and mean blood pressure when administered either as a bolus dose or by continuous infusion following the development of hypotension during anesthesia.n
  • Phenylephrine Hydrochloride Injection, USP is a sterile, clear, colorless solution and supplied in 5 mL and 10 mL glass vials. Each mL contains phenylephrine hydrochloride USP, .
  • Arrayn- 50 mg/5 mL (10 mg/mL) 5 mL vial Pharmacy Bulk Package:
  • 5 mL Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1578-1
  • 10 Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1578-7
  • Arrayn- Array
  • 10 mL Vial u00a0in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1579-1
  • Store phenylephrine hydrochloride injection USP, 10 mg/mL at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Protect from light. Store in carton until time of use. Vial stoppers are not made with natural rubber latex.
  • The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.n
  • If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how phenylephrine hydrochloride injection works.
  • Manufactured by:n Ahmedabad 382213, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 12-2019-01
  • NDC: 70121-1578-1 Name: Phenylephrine Hydrochloride Injection, USP Strength: 10 mg/mL (5 mL) Rx Only Vial Label Amneal Pharmaceuticals LLC
  • NDC: 70121-1578-7 Name: Phenylephrine Hydrochloride Injection, USP Strength: 10 mg/mL (5 mL) Rx OnlyCarton Amneal Pharmaceuticals LLC
  • NDC: 70121-1579-1 Name: Phenylephrine Hydrochloride Injection, USP Strength: 10 mg/mL (10 mL) Rx Only Vial Label Amneal Pharmaceuticals LLC
  • NDC: 70121-1579-1 Name: Phenylephrine Hydrochloride Injection, USP Strength: 10 mg/mL (10 mL) Rx Only Carton Amneal Pharmaceuticals LLC

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