phenylephrine hydrochloride
Phenylephrine Hydrochloride is an alpha-1 adrenergic agonist used to treat Fissure in Ano, Open-Angle Glaucoma, Hemorrhoids, Hypotension.
Alpha-1 Adrenergic Agonist · by Mankind Pharma
Generic of Immphentiv
Key facts
- Active ingredient
- Phenylephrine Hydrochloride
- Drug class
- Alpha-1 Adrenergic Agonist
- Form
- Solution, Injectable, Drops, Tablet
- Strength
- Phenylephrine Hydrochloride 10%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- fissure in ano, open-angle glaucoma, hemorrhoids
- Manufacturer
- Mankind Pharma
- What the pharmacy pays
- ~$8.59 per ml — not your price
- FDA application
- ANDA216496
What is Phenylephrine Hydrochloride?
From the FDA label: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
How to use
Phenylephrine Hydrochloride is sold in more than one form (Solution, Injectable, Drops and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA216496 — follow the label that came with the product you were actually prescribed.
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 phenylephrine hydrochloride ophthalmic solution 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
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 Northstar Rx LLC at 1-800-206-7821 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…
Warnings
Important safety information
Not for injection: Topical ophthalmic use only ( 5.1 ) Serious cardiovascular reactions with 10% strength: Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ) Significant elevations in blood pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment ( 5.3 ) Rebound miosis: Reported one day after instillation ( 5.4 ) 5.1 Topical Ophthalmic Use Only Phenylephrine hydrochloride ophthalmic solution 10% is not indicated for injection. 5.2 Cardiovascular Reactions There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. 5.3 Elevation of Blood Pressure A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored. 5.4 Rebound Miosis Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.
Who should not take Phenylephrine Hydrochloride
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) ].
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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.
Drug class
May treat (source: NIH RxClass)
See how Phenylephrine Hydrochloride ranks — best-rated alpha-1 adrenergic agonist for:
Dosage forms
Solution, Injectable, Drops and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Phenylephrine Hydrochloride treat?
- Phenylephrine Hydrochloride (Phenylephrine Hydrochloride) may be used to treat fissure in ano, open-angle glaucoma, hemorrhoids, hypotension, pruritus ani, vasomotor rhinitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Phenylephrine Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $8.59 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Phenylephrine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Phenylephrine Hydrochloride. To pay less, Phenylephrine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Phenylephrine Hydrochloride?
- Phenylephrine Hydrochloride is marketed by Mankind Pharma. You can see Mankind Pharma's full profile, rating, and other products on pharmaranks.
- Is Phenylephrine Hydrochloride a brand-name or generic drug?
- Phenylephrine Hydrochloride is a generic medication; its active ingredient is Phenylephrine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Phenylephrine Hydrochloride available over the counter?
- No. Phenylephrine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Phenylephrine Hydrochloride come in?
- Phenylephrine Hydrochloride is currently marketed as solution, injectable, drops and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Phenylephrine Hydrochloride?
- Phenylephrine Hydrochloride is classified as alpha-1 adrenergic agonist, per the FDA's Established Pharmacologic Class.
- Is Phenylephrine Hydrochloride FDA-registered?
- Phenylephrine Hydrochloride is on record with the U.S. FDA under application number ANDA216496. You can verify this on its official FDA label.
- Is Phenylephrine Hydrochloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Phenylephrine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Phenylephrine Hydrochloride?
- Phenylephrine Hydrochloride's side effects are taken directly from its FDA label. From the label: 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 phenylephrin… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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