IMMPHENTIV 100 ug/mL

Phenylephrine Hydrochloride · INJECTION · Hikma Pharmaceuticals USA Inc.

No Recall History

Plain English

IMMPHENTIV is a injection containing phenylephrine hydrochloride at 100 ug/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name: IMMPHENTIV
Generic Name: Phenylephrine Hydrochloride
NDC Code (Product): 0641-6245
Manufacturer: Hikma Pharmaceuticals USA Inc.
Strength: 100 ug/mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA203826
Marketing Start: 03/09/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use1,270 reports

pemphigus979 reports

joint swelling950 reports

pain920 reports

drug ineffective909 reports

rheumatoid arthritis904 reports

pericarditis898 reports

systemic lupus erythematosus897 reports

infusion related reaction886 reports

wound878 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. IMMPHENTIV injection 100 mcg/mL is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION IMMPHENTIV Injection 100 mcg/mL: Do NOT dilute prior to administration ( 2.1 ) Dosing for Perioperative Hypotension - Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Phenylephrine Hydrochloride Injection 10 mg/mL: MUST BE DILUTED before administration. ( 2.1 ) Dosing for Perioperative Hypotension Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.2 ) Dosing for Patients with Vasodilatory Shock Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute titrated to effect ( 2.2 ) 2.1 General Administration Instructions Phenylephrine Hydrochloride Injection is injected by bolus intravenous infusion or in dilute solution as a continuous intravenous infusion. 2.2 Preparation of Phenylephrine Hydrochloride Injection Preparing a 100 mcg/mL Solution for Intravenous Bolus Administration For intravenous bolus administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of Phenylephrine Hydrochloride Injection 10 mg/mL and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final co…

Contraindications

4 CONTRAINDICATIONS The use of IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL is contraindicated in patients with: Hypersensitivity to the products or any of their components Hypersensitivity to the products or any of their components ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate ( 7.1 ) Antagonistic effects on and by α-adrenergic blocking agents ( 7.2 ) 7.1 Agonists The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline. β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate 7.2 Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. 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 disorders : Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Immune system disorders : Sulfite sensitivity Nervous system disorders : Headache, nervousness, paresthesia, tremor Psychiatric disorders : Excitability Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders : Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is IMMPHENTIV used for?

IMMPHENTIV contains Phenylephrine Hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.

Is IMMPHENTIV a controlled substance?

IMMPHENTIV is not classified as a controlled substance by the DEA.

What is the generic name for IMMPHENTIV?

The generic name for IMMPHENTIV is Phenylephrine Hydrochloride. There are 12 other brand versions of Phenylephrine Hydrochloride.

What is the NDC code for IMMPHENTIV 100 ug/mL?

The NDC (National Drug Code) for IMMPHENTIV 100 ug/mL is 0641-6245, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0641-6245

Package NDC

0641-6245-10

Other Phenylephrine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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