Katanol
Katanol Uses, Dosage, Side Effects, Food Interaction and all others data.
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. Olopatadine Nasal Spray contains 0.6% w/v Olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine Hydrochloride, which is equivalent to 600 mcg of Olopatadine (base). Olopatadine Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.
Inflammatory reactions in response to various stimuli are mediated by endogenous mediators and other pro-inflammatory factors. Histamine receptor activation and mast cell degranulation are primary mechanisms that cause inflammatory reactions such as ocular itching, hyperemia, chemosis, eyelid swelling, and tearing of seasonal allergic conjunctivitis. Olopatadine is an anti-allergenic molecule and mast cell stabilizer that inhibits the in vivo type 1 immediate hypersensitivity reaction. By blocking the effects of histamine, olopatadine works to reduce the symptoms of allergies and inflammation at various sites of administration, including the eyes and nose. It has shown to exert antihistaminic effects in isolated tissues, animal models, and humans. Olopatadine also demonstrated dose-dependent inhibition of immunologically-stimulated release of histamine from rat basophilic leukemia cells and human conjunctival mast cells in vitro. Olopatadine has a relatively rapid onset of action and prolonged duration, where it was shown to mediate anti-histaminic effects at 5 minutes to 24 hours post-administration.
While olopatadine is a non-sedating antihistamine agent, there have been reports of somnolence in some patients taking nasal olopatadine during clinical trials. Temporary blurred vision or other visual disturbances were observed following ophthalmic administration. Olopatadine has negligible effects on alpha-adrenergic, dopamine, muscarinic type 1 and 2, and serotonin receptors. In clinical trials, there was no evidence of any effect of olopatadine on QT prolongation was observed following intranasal administration.
| Trade Name | Katanol |
| Generic | Olopatadine Hydrochloride + Olopatadine |
| Weight | 1.11mg Eq To 1.0mg |
| Type | Drops |
| Therapeutic Class | |
| Manufacturer | Ciron Drugs & Pharma Pvt Ltd |
| Available Country | India, Nigeria |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Olopatadine Nasal Spray is an H1 receptor antagonist used for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.
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.Katanol is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Seasonal Allergic Conjunctivitis, Seasonal Allergic Rhinitis
How Katanol works
Histamine is a biogenic vasoactive amine that binds to its receptors, which are G-protein coupled receptors. Signaling through the histamine H1 receptor is thought to primarily promote the activation of inflammatory reactions, such as allergy, asthma, and autoimmune diseases. H1 receptor signaling activates the intracellular transcription factors, such as IP3, PLC, PKC, DAG, and intracellular calcium ions, which all work to activate further downstream cascades. Activated downstream cascades lead to the production of cytokines, the release of mast cell inflammatory mediators, synthesis of prostacyclins, activation of platelet factor, as well as the synthesis of nitric oxide, arachidonic acid, and thromboxane, which all contribute to inflammatory reactions.
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, which is explained by a unique receptor binding pocket that consists of the aspartate residue in the third transmembrane helix and other sites in the H1 receptor. 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. It also decreases chemotaxis and inhibits eosinophil activation. In vitro, olopatadine was shown to inhibit epithelial cell intercellular adhesion molecule-1 (ICAM-1), which promotes the recruitment of migrating pro-inflammatory mediators.
Dosage
Katanol dosage
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.
Administer OlopatadineNasal Spray by the intranasal route only.
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- 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. Administer Olopatadine Nasal Spray by the intranasal route only. 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. 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.Side Effects
A bitter taste in the mouth, nosebleeds, or irritation/soreness in the nose may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.Toxicity
Based on the findings of an acute toxicity study in animals, the oral LD50 of olopatadine was >1150 mg/kg in mice and >3870 mg/kg in rats. The Lowest published toxic dose via the oral route was 20 mg/kg in rat and 0.1 mg/kg in mouse.
There are no known reports on overdosage following oral, ophthalmic, or intranasal administration of olopatadine. Likely symptoms of antihistamine overdose may include drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in children. In case of suspected overdose, supportive and symptomatic treatment is recommended.
Precaution
Before initial use, Olopatadine Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Nasal Spray into the eyes. Patients should be informed to avoid spraying Olopatadine Nasal Spray in their eyes.
Patients should be advised not to wear a contact lens if their eye is red. Olopatadine 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, Olopatadine Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Nasal Spray into the eyes. Patients should be informed to avoid spraying Olopatadine 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.Interaction
Interaction with other medications have not been investigated.
Specific drug interaction studies have not been conducted with Olopatadine ophthalmic solution.Volume of Distribution
In an open-label study consisting of healthy Chinese subjects receiving oral administration of olopatadine, the mean apparent volume of distribution was 133.83 L.
Elimination Route
Ocular administration of olopatadine in healthy subjects resulted in the Cmax of 1.6 ± 0.9 ng/mL, which was reached after about 2.0 hours. The AUC was 9.7 ± 4.4 ngxh/mL.
The average absolute bioavaiability of intranasal olopatadine is about 57%. Following intranasal administration in healthy subjects, the Cmax of 6.0 ± 8.99 ng/mL at steady-state was reached between 30 minutes to 1 hour after twice daily intranasal administration. The average AUC was 66.0 ± 26.8 ng·h/mL. In patients with seasonal allergic rhinitis, the Cmax of 23.3 ± 6.2 ng/mL at steady-state was reached between 15 minutes and 2 hours post-dosing and the average AUC was 78.0 ± 13.9 ng·h/mL.
Half Life
Following ocular administration, the elimination half-life of olopatadine was 3.4 ± 1.2 hours. In oral pharmacokinetics study, the elimination half-life was reported to be 8 to 12 hours.
Clearance
In an open-label study consisting of healthy Chinese subjects receiving oral administration of olopatadine, the mean apparent oral clearance (CL/F) was 23.45 L/h.
Elimination Route
Olopatadine is mainly eliminated through urinary excretion. Following oral administration, about 70% and 17% of the total dose was recovered in the urine and feces, respectively.
Pregnancy & Breastfeeding use
Pregnancy Category C; No adequate and well-controlled studies in pregnant women have been conducted. Olopatadine Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Lactation: It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Olopatadine Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.
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.Contraindication
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.Special Warning
There have been no reported overdoses with Olopatadine Nasal Spray.
Geriatric Use: No overall differences in safety or effectiveness have been observed betweents.Acute Overdose
There is no information on Olopatadine overdose. However, excessive use of any medication can have serious consequences. If you suspect an overdose, seek medical attention without delay.Storage Condition
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.Innovators Monograph
You find simplified version here Katanol
