Olotak Kt

Olotak Kt 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.

Olotak Kt
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Olotak Kt
Generic	Ketorolac Tromethamine + Olopatadine
Weight	5mg
Type	Eye Drops
Therapeutic Class
Manufacturer	Pharmtak Ophtalmics India Pvt Ltd
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain. Ketorolac ophthalmic solution helps relieve pain, inflammation, and light sensitivity after ocular surgery. It may also be used to decrease eye inflammation or redness caused by seasonal allergies.

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.

Olotak Kt is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Seasonal Allergic Conjunctivitis, Seasonal Allergic Rhinitis

How Olotak Kt 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

Olotak Kt dosage

Tablet: Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection: Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours. Single-Dose Treatment-IM Dosing (Adult): Patients <65 years of age: One dose of 60 mg. Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg. IV Dosing (Adult): Patients <65 years of age: One dose of 30 mg. Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg. IV or IM Dosing (2 to 16 years of age): IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg. IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg. Multiple-Dose Treatment (IV or IM)- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine. Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days. Eye Drops: Adults: 1 drop in each eye 4 times daily.

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.

Side Effects

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

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.

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

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction. Eye Drops: Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Lopadol ophthalmic solution should not be administered while wearing contact lenses.

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.

Interaction

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.Anti-coagulants: Enhance anti-coagulant effect. Beta Blocker: Reduce the anti-hypertensive effect . ACE Inhibitors: Increase the risk of renal impairment. Methotrexate: Enhance the toxicity of methotrexate.

Interaction with other medications have not been investigated.

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

US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

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.

Contraindication

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.