Product image of Ketotifeno Codramol (Ketotifen Hydrogen Fumarate) supplied by GNH India

Ketotifeno Codramol

Active Ingredient:
Ketotifen Hydrogen Fumarate
Origin:
EU

Ketotifeno Codramol (Ketotifen Hydrogen Fumarate)

Ketotifen Hydrogen Fumarate, the active ingredient in Ketotifeno Codramol, is a H1 receptor antagonist / mast cell stabilizer presented as an ophthalmic solution for ocular use. It treats allergic conjunctivitis and related eye‑allergy conditions in both adults and children.

GNH India supplies Ketotifeno Codramol as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Nutra Essential Otc, S.L.

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Indications & Clinical Uses

  • Ketotifeno Codramol is an ophthalmic antihistamine used to manage ocular allergic conditions.
  • Allergic conjunctivitis: reduces itching, redness and swelling of the eye.
  • Vernal keratoconjunctivitis: helps control chronic inflammation and photophobia.
  • Seasonal allergic eye disease: alleviates symptoms during pollen seasons.

How It Works

  • Ketotifen Hydrogen Fumarate blocks H1 histamine receptors on ocular mast cells and stabilizes their membranes, preventing degranulation. This dual action limits the release of histamine, prostaglandins and other inflammatory mediators, thereby reducing vascular permeability, itching and swelling in the conjunctiva and cornea.

Side Effects

Adverse reactions are generally mild and localized to the eye.

Common Side Effects

  • Burning or stinging sensation after instillation.
  • Transient eye irritation or redness.
  • Blurred vision lasting a few minutes.
  • Mild headache.
  • Dryness of the ocular surface.
  • Temporary tearing.

Serious or Rare Side Effects

  • Severe ocular inflammation or keratitis.
  • Corneal ulceration.
  • Allergic reaction with swelling of eyelids.
  • Anaphylactic response.
  • Persistent visual loss.
  • Acute intraocular pressure rise.

Precautions & Warnings

  • Before using Ketotifeno Codramol, consider the following precautions.
  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: use only if the benefit outweighs potential risk.
  • Contact lens wearers: remove lenses before instillation and wait before reinserting.
  • Concurrent ocular infection: avoid until infection is resolved.
  • Systemic antihistamines: monitor for additive sedation, although ocular use has minimal systemic absorption.
  • Store at room temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Ketotifeno Codramol may interact with other ophthalmic or systemic agents.

Major Interactions (Avoid)

  • Concurrent use with ophthalmic corticosteroids: may mask signs of infection.
  • Use with other mast cell stabilizers: increased risk of ocular irritation.

Moderate Interactions (Monitor Closely)

  • Systemic antihistamines: additive antihistaminic effect may increase drowsiness.
  • Topical NSAID eye drops: may enhance ocular irritation.
  • Preservative‑containing contact lens solutions: may increase discomfort.

Frequently Asked Questions

Ketotifeno Codramol is an ophthalmic preparation indicated for the relief of ocular allergy symptoms such as itching, redness, and swelling. It is commonly prescribed for allergic conjunctivitis, vernal keratoconjunctivitis, and seasonal allergic eye disease in patients who require targeted antihistamine and mast‑cell stabilizing therapy.

Ketotifen hydrogen fumarate works by blocking H1 histamine receptors on the surface of ocular mast cells and by stabilising those cells to prevent degranulation. This dual mechanism reduces the release of histamine and other inflammatory mediators, thereby decreasing vascular permeability, itching and swelling in the conjunctiva and cornea.

The dosage of Ketotifeno Codramol is determined by the prescribing clinician based on the severity of the condition and patient factors. Typically, one drop is instilled into the affected eye(s) as directed, but the exact frequency and duration should follow the healthcare professional’s instructions.

Safety data for ketotifen in pregnancy and lactation are limited. The product should only be used if the potential benefit justifies any possible risk to the fetus or infant. Pregnant or nursing women should discuss use with their healthcare provider before starting therapy.

To order Ketotifeno Codramol, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Ketotifeno Codramol combines H1‑receptor antagonism with mast‑cell stabilisation, offering both immediate symptom relief and longer‑term control of inflammation. Compared with agents such as olopatadine, which are primarily H1 antagonists, ketotifen may provide added benefit in chronic conditions where mast‑cell degranulation plays a major role.

Ketotifeno Codramol should be stored at room temperature, below 25 °C, in its original container. Protect the product from excessive light and moisture. Do not freeze. Keep the bottle tightly closed when not in use to maintain sterility and potency.

The medication is administered as an eye drop. The patient should wash their hands, tilt the head back, pull down the lower eyelid, and place a single drop into the conjunctival sac of the affected eye(s). The eye should be closed gently for a few seconds to allow absorption, and contact lenses should be removed before dosing.

Serious risks, although rare, include severe ocular inflammation, corneal ulceration, allergic reactions that may cause eyelid swelling, anaphylaxis, and sudden loss of vision. Any signs of worsening eye condition, intense pain, or visual changes should prompt immediate medical attention.

Ketotifeno Codramol should be avoided by individuals with a known hypersensitivity to ketotifen or any excipients in the formulation. It is also contraindicated in patients with active severe ocular infections until the infection is resolved, and caution is advised in those with uncontrolled glaucoma or intra‑ocular pressure issues.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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