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ALLER-NIL

Pack : 5 ml Pack

DESCRIPATION:

Allernil- Eye Drops (Cromolyn Sodium Ophthalmic Solution) is an anti-inflammatory medication used to treat allergysymptoms that affect the eyes, such as itching, burning, watering, swelling, redness, or sensitivity to light. Opticrom is available in generic form. Common side effects of Opticrom include burning or stinging of the eye after you use the eye drops, dry or irritated eyes, puffy eyes, or watery eyes.

COMPOSITION:

Label Claim: Each mL Contains :

  • Cromolyn Sodium USP……… 20 mg
  • Benzalkonium Chloride Solution USP….0.1mg
  • Aqueous Buffered Vehicle..………………...q.s.

PACKAGING

Primary packing - 5ml Opaque poly bottles White caps & Nozzles.

Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

AVAILABILITY

5ml of solution in White poly bottles with white caps & nozzles in properly sealed.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Keep in a cool & dark place. Below 30ºC.Do not allow to Freeze.

CLINICAL PHARMACOLOGY:

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell.

Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Cromolyn sodium has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity.

Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.

INDICATIONS AND USAGE:

Allernil- Eye Drops (Cromolyn Sodium Ophthalmic Solution) is is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

CONTRAINDICATIONS:

Allernil- Eye Drops (Cromolyn Sodium Ophthalmic Solution) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

WARNINGS :

Allernil- Eye Drops (Cromolyn Sodium Ophthalmic Solution) is for topical use only and not for injection or oral use.

DOSAGE AND ADMINISTRATION:

The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with Allernil- Eye Drops (Cromolyn Sodium Ophthalmic Solution).

SUPPLY:

Allernil- Eye Drops is supplied in one clear polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.

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