PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL
phenylephrine hydrochloride · SOLUTION/ DROPS · Caplin Steriles Limited
PHENYLEPHRINE HYDROCHLORIDE is a solution/ drops containing phenylephrine hydrochloride at 25 mg/mL, taken ophthalmic. Manufactured by Caplin Steriles Limited.
Key Facts
- Brand Name
- PHENYLEPHRINE HYDROCHLORIDE
- Generic Name
- phenylephrine hydrochloride
- NDC Code (Product)
65145-149- Manufacturer
- Caplin Steriles Limited
- Strength
- 25 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA215183
- Marketing Start
- 01/23/2025
Recall History
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Qualitest Pharmaceuticals
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Mid Valley Pharmaceutical
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE 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.
Dosage & Administration
2 DOSAGE & ADMINISTRATION 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. ( 2 ) 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. (2) Intravenous infusion: 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min. (2) Adjust the dose according to the pressor response (i.e., titrate to effect). (2) 2.1 General Dosage and Administration Instructions Phenylephrine hydrochloride Injection, 10 mg/mL must be diluted before administration as an intravenous bolus or continuous intravenous infusion to achieve the desired concentration: Bolus : Dilute with normal saline or 5% dextrose in water Continuous infusion : Dilute with normal saline or 5% dextrose in water. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. The diluted solution should not be held for more than 4 hours at room temperature …
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS Agonistic effects (increase in Phenylephrine hydrochloride injection blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids ( 7.1 ) Antagonistic effects (decrease in Phenylephrine hydrochloride injection blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents ( 7.2 ) 7.1 Interactions that Augment Pressor Effect The increasing blood pressure effect of Phenylephrine hydrochloride injection is increased in patients receiving: Monoamine oxidase inhibitors (MAOI) Oxytocin and oxytocic drugs Tricyclic antidepressants Angiotensin, aldosterone Atropine Steroids, such as hydrocortisone Norepinephrine transporter inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate 7.2 Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of Phenylephrine hydrochloride injec…
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions to Phenylephrine hydrochloride injection are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of Phenylephrine hydrochloride injection 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 disorders : Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders : Epigastric pain, vomiting, nausea Nervous system disorders : Headache, blurred vision, neck pain, tremors Vascular disorders : Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders : Dyspnea Skin and subcutaneous tissue disorders : Pruritis Most common adverse reactions during treatment: nausea, vomiting, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Provepharm Inc., at 1–833-727-6556 or safety-us@provepharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is PHENYLEPHRINE HYDROCHLORIDE used for?
PHENYLEPHRINE HYDROCHLORIDE contains phenylephrine hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is PHENYLEPHRINE HYDROCHLORIDE a controlled substance?
PHENYLEPHRINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for PHENYLEPHRINE HYDROCHLORIDE?
The generic name for PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride. There are 9 other brand versions of phenylephrine hydrochloride.
What is the NDC code for PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL?
The NDC (National Drug Code) for PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL is 65145-149, listed by Caplin Steriles Limited.
Other PHENYLEPHRINE HYDROCHLORIDE Dosages
Other Phenylephrine Brands
See all →- 4 Way Fast Acting10 mg/mL0067-2086
- Phenylephrine hydrochloride10 mg/mL81284-212
- Phenylephrine Hydrochloride10 mg/mL0641-6188
- Cold Terminator Cold Relief325 mg/184269-2556
- Better Living1 g/100mL21130-728
- Phenylephrine hydrochloride10 mg/mL42023-214
- Nasal Four1 g/100mL42507-648
- dg health nasal four1 g/100mL55910-802
- Phenylephrine Hydrochloride100 mg/mL70512-866
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)