Alchek Ophthalmic Solution

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Olopatadine Hydrochloride

Indications

Patadin eye drops is indicated for the treatment of signs and symptoms (itchy, watery, red and swollen eyes and/or eyelids) of allergic conjunctivitis including vernal keratoconjunctivitis, vernal keratitis, blepharitis, blepharoconjunctivitis and giant papillary conjunctivitis.

Alchek Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Alchek tablet is indicated in the treatment of allergic rhinitis (swelling of the nasal membranes
caused by an allergy to pollen and mold spores in the air) and allergic skin conditions. It helps to relieve allergy symptoms such as skin rashes, swelling, hives (itchy, painful eruptions that sting), itching, sneezing, runny or stuffy nose.

Pharmacology

Olopatadine, an antihistamine, works by blocking the action of histamine in the body, which reduces allergy symptoms. Olopatadine hydrochloride treats sneezing, itching, runny nose, and other nasal symptoms of allergies.

Mode of Action: Olopatadine is an anti-allergic molecule that works via several mechanisms. As a mast cell stabilizer, it stabilizes rodent basophils and human conjunctival mast cells and inhibits the immunologically-stimulated release of histamine. Olopatadine acts as an antagonist at the histamine H1 receptors with high selectivity, Upon binding, olopatadine blocks the H1 receptor signaling pathway, inhibiting the release of inflammatory mediators, such as tryptase, prostaglandin D2, TNF-alpha, as well as pro-inflammatory cytokines.

Pharmacokinetics: Absorption: Olopatadine was absorbed with individual peak plasma concentrations observed between 30 minutes and 1 hour after twice daily intranasal administration of Olopatadine Nasal Spray. Distribution: The protein binding of olopatadine was moderate at approximately 55% in human serum, and independent of drug concentration over the range of 0.1 to 1000 ng/mL. Metabolism: Olopatadine is not extensively metabolized. Based on plasma metabolite profiles of olopatadine, at least six minor metabolites circulate in human plasma. Elimination: The plasma elimination half-life of olopatadine is 8 to 12 hours. Olopatadine is mainly eliminated through urinary excretion

Dosage

Eye Drops–

  • 0.1%: One drop in each affected eye two times per day at an interval of 6 to 8 hours.
  • 0.2%: One drop in the affected eye once a day.
  • 0.7%: One drop in each affected eye once a day.

Nasal Spray–

  • Administer Olopatadine Nasal Spray by the intranasal route only.
  • Adults and Adolescents 12 years of age and older: Two sprays per nostril twice daily.\
  • Children 6 to 11 years of age: One spray per nostril twice daily.

Tablet–

  • Adults: Take 1 tablet (5 mg of the active ingredient) at a time, twice daily, in the morning and before going to bed. The dosage may be adjusted according to the disease, age or symptoms.
  • Children 7 years old or over: Take 1 tablet (5 mg) at a time, twice daily, in the morning and before going to bed.
  • If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time. Do not stop taking this medicine unless your doctor instructs you to do so.

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Administration

How to use the Nasal Spray-

  • Shake the bottle gently and remove the dust cover.
  • Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
  • Gently blow the nose to clear the nostrils.
  • Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
  • Breathe out through your mouth.
  • Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

  • Remove the dust cover.
  • Gently pull off the nasal applicator.
  • Wash the applicator and dust cover in warm water.
  • Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
  • Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Interaction

Formal drug-drug interaction studies were not conducted for Alchek Nasal Spray. Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected.

Contraindications

It is contraindicated in persons with a known hypersensitivity to any component of this product. Olopatadine 5 mg tablet is not recommended for use if you are allergic to it. Inform your doctor about your current medications and pre-existing medical conditions to make sure this medicine is safe for you.

Side Effects

Rarely headaches have been reported. Other adverse effects: asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion.

Pregnancy & Lactation

Olopatadine was found not to be teratogenic in rats and rabbits. There are, however, no adequate and well controlled studies in pregnant women. This drug should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine is administered to a nursing mother.

Precautions & Warnings

Patients should be advised not to wear a contact lens if their eye is red. Alchek ophthalmic solution should not be used to treat contact lens related irritation. Benzalkonium Chloride, preservative of Patadin, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least 10 minutes after instillation of Patadin eye drops before they insert their contact lenses. The treatment should be discontinued in the presence of an allergic reaction.

Before initial use, Alchek Nasal Spray by releasing 5 sprays or until a fine mist appears. When Alchek Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Alchek Nasal Spray into the eyes. Patients should be informed to avoid spraying Alchek Nasal Spray in their eyes.

Olonex Tablet should be used as prescribed by your doctor. Take it at the same time every day to maintain a constant level of this medicine in your body. Avoid taking more than the recommended dose. Do not stop taking this medicine without consulting your doctor, as your symptoms may reoccur.

Use in Special Populations

Geriatric Use: No overall differences in safety or effectiveness have been observed betweents.

Overdose Effects

There is no information on Alchek overdose. However, excessive use of any medication can have serious consequences. If you suspect an overdose, seek medical attention without delay.

Therapeutic Class

Ophthalmic Non-Steroid drugs

Storage Conditions

Store at room temperature and protect from light. It is desirable that the contents should not be used more than one month after first opening of the bottle.