Phenylephrine Hydrochloride
FDA Drug Information • Also known as: 4 Way Fast Acting, Actifed, Basic Care Nasal, Better Living, Biorphen, Careone Fast Acting Nasal,...
- Brand Names
- 4 Way Fast Acting, Actifed, Basic Care Nasal, Better Living, Biorphen, Careone Fast Acting Nasal, Childrens Sudafed Pe Nasal Decongestant, Crane Safety Sinus Decongestant, Cvs Health Four Actions Nasal Decongestant, Dg Health Nasal Four, Dover Sudanyl Pe, Ephrine Nose Drops, Equaline Nasal, Equate Nasal, Extra Strength Nasal, Extra Strength Sinus Relief Nasal Decongestant, Gencare-Nasal Decongestant Pe, Good Neighbor Pharmacy Fast Acting Nasal, Good Neighbor Pharmacy Nasal Four, Good Sense Nasal Decongestant Pe, Good Sense Nasal Four, Green Guard Allergy 2 Relief, Heb Nasal, Immphentiv, Medi-First Plus Sinus Decongestant, Medi-First Sinus Decongestant, Medique Medi-Phenyl, Nasal, Nasal And Sinus Decongestant, Nasal Decongestant Pe, Neo-Synephrine Maximum, Neo-Synephrine Mild, Neo-Synephrine Regular, Phenylephrine Hydrochloride, Phenylephrine Hydrochloride Phenylephrine Hydrochloride, Preparation H, Publix, Quality Choice, Revivol-Xr, Sudafed Pe Sinus Congestion, Topcare Nasal Four, Valumeds Nasal Decongestant Phenylephrine Hcl
- Route
- ORAL
- Dosage Form
- TABLET
- Product Type
- HUMAN OTC DRUG
Description
11 DESCRIPTION Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, topical α -adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9 H 13 NO 2 .HCl Molecular Weight: 203.67 g/mol Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Chemical Structure
What Is Phenylephrine Hydrochloride Used For?
1 INDICATIONS AND USAGE Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For patients 1 year of age and older : ( 2.1 ) Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye. To obtain a greater degree of mydriasis, use 10% strength For pediatric patients less than 1 year of age : ( 2.2 ) Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye. 2.1 General Dosing Recommendations In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed 2.2 Dosing in Pediatric Patients Less Than 1 Year of Age In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Effects [See Warnings and Precautions (5.2) ] Elevation in Blood Pressure [See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1 ) Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur. 6.2 Systemic Adverse Reactions A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients. Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [ See Warnings and Precautions ( 5.2 and 5.3 )].
Drug Interactions
7 DRUG INTERACTIONS Atropine-like drugs: May exaggerate the adrenergic pressor response ( 7.1 ) Potent inhalation anesthetic agents: May potentiate cardiovascular depressant effects ( 7.1 ) 7.1 Agents That May Exaggerate Pressor Responses Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.
Contraindications
4 CONTRAINDICATIONS The 10% strength is contraindicated in: Patients with hypertension, or thyrotoxicosis ( 4.1 ) Pediatric patients less than 1 year of age due to increased risk of systemic toxicity ( 4.2 ) 4.1 Cardiac and Endocrine Disease Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. 4.2 Pediatric Patients Less Than 1 Year of Age Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration (2.2) ].
Pregnancy and Breastfeeding
8.1 Pregnancy Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman.
Overdosage
10 OVERDOSAGE Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, clear, colorless to yellow color, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 70756-614-30 5 mL in 10 mL bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle. Storage: Store at 20° to 25°C (68° to 77°F). See USP Controlled room temperature. Keep container tightly closed. Protect from light and excessive heat. Do not use if solution is brown or contains precipitate.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.