Phenylephrine Hydrochloride (Phenylephrine Hydrochloride)

Trade Name : Phenylephrine Hydrochloride

Paragon BioTeck, Inc.

SOLUTION/ DROPS

Strength 2.5 mg/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Phenylephrine Hydrochloride (Phenylephrine Hydrochloride) which is also known as Phenylephrine Hydrochloride and Manufactured by Paragon BioTeck, Inc.. It is available in strength of 2.5 mg/mL per ml. Read more

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.     Read less

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Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% is indicated to dilate the pupil.
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil [n n n n n n ].n nn n nn
  • No data
  • For patients 1 year of age and older, apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% at 3 to 5 minute intervals up to a maximum of 3 drops per eye [ n n n ].n n n
  • In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye [ n n n ].n n n
  • Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%.
  • Phenylephrine Hydrochloride Ophthalmic Solution, 10% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.
  • 2.5% and 10% sterile ophthalmic solutions [n n n n n n ].nttttttttn nn n nn
  • No data
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients [ n n n ].n n n
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients [ n n n ].n n n
  • No data
  • Not for injection. Topical ophthalmic use only [ n n n ].n n n
  • Reports of serious cardiovascular reactions, some fatal, with phenylephrine hydrochloride 10% solution. Monitor blood pressure in patients with cardiovascular disease [ n n n ].n n n
  • Significant elevations in blood pressure have been reported. Caution in pediatric patients less than 5 years of age, and in patients with elevated blood pressure [ n n n ].n n n
  • Rebound miosis has been reported one day after instillation [ n n n ].n n n
  • The following serious adverse reactions are described below and elsewhere in the labeling:nttttttnttttttu2022tCardiac Disease n n n n n n nttttttu2022tElevation in Blood Pressure n n n n n n nttttttnttttttThe 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.ntttttn nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Paragon BioTeck, Inc. at 1-888-424-1192 or FDA at 1-800-FDA-1088 or n n n n
  • Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision and photophobia [ n n n ].n n n
  • Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [ n n n ].n n n
  • Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients.nntPhenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.
  • May exaggerate the adrenergic pressor response in patients taking atropine-like drugs [ n n n ].n n n
  • May potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents [ n n n ].n n n
  • No data
  • 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.
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is a sterile, clear, colorless, topical mydriatic agent for ophthalmic use. The chemical name is (R)-3-hydroxy-u03b1-[(methylamino)methyl]benzenemethanol hydrochloride. Phenylephrine hydrochloride is represented by the following structural formula:
  • Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C n n n H n n n NO n n n -HCl.n nn
  • Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains: ACTIVE: phenylephrine hydrochloride 25 mg (2.5%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; boric acid, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.0-6.4). The solution has a tonicity of 500 mOsm/kg. PRESERVATIVE: benzalkonium chloride 0.01%.
  • Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 10% contains: ACTIVE: phenylephrine hydrochloride 100 mg (10%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.3-6.7). The solution has a tonicity of 1000 mOsm/kg. PRESERVATIVE: benzalkonium chloride 0.01%.
  • No data
  • Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter iridesn n n n n n n
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solutionu00a0 with a fill volume of 15 mL in a 15 mL opaque, white low density polyethylene (LDPE) bottle with a linear low density polyethylene (LLDPE) dropper tip and red cap. (NDC 42702-102-15)n n n n n n n
  • Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solutionu00a0 with a fill volume of 5 mL in a 10 mL opaque, white LDPE bottle with a LLDPE dropper tip and red cap. (NDC 42702-103-05)
  • Storage and Handling:
  • Store in a refrigerator at 2u00b0 to 8u00b0C (36u00b0-46u00b0F).
  • After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.
  • Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.u00a0u00a0n Inform patients they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.
  • Paragon BioTeck, Inc.
  • Portland, OR 97239
  • u00a9Paragon BioTeck, Inc.
  • No data

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