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OPTISOFT REDNESS RELIEF EYE DROP ( Each ml contains Naphazdine HCL 0.005% w/v

Naphazdine HCL

FDA/SD.265-050529 Naphazdine HCL 0.005% w/v

What it does

Naphazoline is used to relieve nasal congestion and swelling. It helps open up the nasal passages.

Commonly used for: nasal congestion, sinusitis, hay fever (allergic rhinitis)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.265-050529
Registration date
2026-05-07
Expiry date
2031-12-01
Status
Valid
Active ingredient
Naphazdine HCL
Dosage form
Naphazdine HCL
Strength
0.005% w/v
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Stericon Pharma
Country of origin
INDIA
Manufacturer location
No. 9R, Sub Layout of Plot No.9, 1st Phase, Bommasandra Industrial Area, RK Twp, Yarandahalli, Karnataka 560099, India

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:57 · updated 2026-10-20 04:00:12

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Naphazoline is used to relieve nasal congestion and swelling. It helps open up the nasal passages.

What it treats

  • nasal congestion
  • sinusitis
  • hay fever (allergic rhinitis)

How it works

Naphazoline works by narrowing the blood vessels in the nasal passages, which helps to reduce swelling and congestion.

Who it's for

This medicine is for adults and children who need relief from blocked noses due to colds or allergies.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: naphazdine

Naphazoline is a sympathomimetic agent that belongs to the imidazoline class of compounds. It is primarily used as a nasal decongestant due to its vasoconstrictive properties, which help reduce swelling and congestion in the nasal passages. Naphazoline is commonly found in over-the-counter nasal sprays and eye drops, often used for temporary relief of nasal congestion associated with colds, allergies, or sinusitis.

Indications

  • Nasal congestion due to colds
  • Allergic rhinitis
  • Sinusitis
  • Eye redness due to minor irritants

Dosage

Children: Refer to specific product labeling and guidelines, as dosing may vary based on formulation and age.

Adults: Refer to specific product labeling and guidelines, as dosing may vary based on formulation.

Mechanism of action

Naphazoline exerts its effects by stimulating alpha-adrenergic receptors, primarily alpha-1 receptors, in the smooth muscle of blood vessels. This stimulation leads to vasoconstriction, which reduces blood flow to the nasal mucosa, thereby decreasing edema and congestion. It may also have some action on alpha-2 receptors, contributing to its overall sympathomimetic effects.

Pharmacodynamics

The primary pharmacodynamic effect of naphazoline is vasoconstriction, leading to reduced blood flow in the nasal mucosa. This results in decreased nasal congestion and improved airflow. The onset of action is typically rapid, providing quick relief, and the effects can last for several hours. However, prolonged use can lead to rebound congestion, a phenomenon known as rhinitis medicamentosa.

Pharmacokinetics

Naphazoline is absorbed locally when administered intranasally or ophthalmically. Systemic absorption can occur, but the extent is generally low. The drug is metabolized primarily in the liver, and its metabolites are excreted in the urine. The half-life of naphazoline is relatively short, necessitating repeated dosing for sustained effects, particularly in the case of nasal congestion.

Contra-indications

  • Hypersensitivity to naphazoline or any component of the formulation
  • Narrow-angle glaucoma
  • Severe cardiovascular disease
  • Concurrent use with monoamine oxidase inhibitors (MAOIs)

Adverse effects

  • Local irritation or burning sensation in the nose
  • Dryness of nasal mucosa
  • Rebound congestion with prolonged use
  • Increased blood pressure
  • Tachycardia
  • Headache
  • Nausea

Interactions

  • Enhanced hypertensive effect when used with other sympathomimetics
  • Increased risk of adverse effects when used with MAOIs

Precautions

  • Use with caution in patients with hypertension
  • Caution in patients with diabetes mellitus or hyperthyroidism
  • Prolonged use should be avoided to prevent rebound congestion
  • Monitor patients with cardiovascular disorders closely

Pregnancy

Naphazoline is classified as pregnancy category C. Its safety in pregnancy has not been established, and it should be used only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether naphazoline is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Nasal spray
  • Ophthalmic solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.