Principal Display Panel Text for Container Label: Thera Tears logo NDC 58790-008-05Ketotifen FumarateOphthalmic SolutionANTIHISTAMINE EYE DROPSSterile                EYE ITCH5mL (0.17 FL OZ)      RELIEF. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. It is also a mast cell stabiliser. Temporary relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. Take out contact lenses before using ketotifen (ophthalmic). The amount of medicine that you take depends on the strength of the medicine. VISION RESEARCH logo. Instill ketotifen eye drops at around the same times every day. PURPOSE: To obtain the titled eye drop, by using ketotifen fumarate and a specific isotonic agent. Document Id: 1690a8bc-16a9-49d3-a554-ce976662e36e, Set id: 39856d6d-31ed-4184-9831-b40efdf4dcf4, Advanced Vision Research (Subsidiary of Akorn, Inc.). Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Last updated on May 25, 2020. Artal MN, Luna JD, Discepola M "A forced choice comfort study of olopatadine hydrochloride 0.1% versus ketotifen fumarate 0.05%." Excipient information presented when available (limited, particularly for generics); consult specific product labeling. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet. Follow your doctor's orders or the directions on the label. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. Medically reviewed by Drugs.com. EYE ITCH. Take care not to touch your eye, fingers, or any other surface with the dropper of the bottle. Other side effects not listed may also occur in some patients. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. Do not wear contact lenses if eyes are red. 94 ($8.94/Fl Oz) $11.90 $11.90 Topical ocular administration has not been studied. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. BACKGROUND: Ketotifen blocks histamine H(1) receptors, stabilises mast cells, and prevents eosinophil accumulation. ketotifen fumarate ophthalmic solution 0.035%. Ketotifen belongs to a group of medications called antihistamines. Comparing both "active ingredients" both listed Ketotifin Fumarate as … Ketotifen is a topical second-generation antihistamine that is commonly used for the treatment of allergic conjunctivitis. Eye Itch Relief. Ophthalmic: For use in eyes only. Wash hands before use. Do not let tip of applicator touch eye; do not contaminate tip of applicator. 0.034 FL OZ (10 mL) eye sensitivity to light fever, tiredness, achiness, and sore throat increase in size of pupils sore throat tearing. Hours. Minimally systemic (Zaditor US prescribing information, 2002), Within minutes (Zaditor Canadian product monograph, 2012), Up to 12 hours (Zaditor Canadian product monograph, 2012), Allergic conjunctivitis: Temporary relief of eye itching due to allergic conjunctivitis, Hypersensitivity to ketotifen or any component of the formulation. Excipient(s) with known effect: Benzalkonium chloride (0.1 mg/ml). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Onset: Within min (ophthalmic). Bausch + Lomb Opcon-A Allergy Relief Eye Drops, 0.5 Ounces/15 mL (Pack of 2) Packaging May Vary 4.7 out of 5 stars 2,640 $8.94 $ 8 . It is usually instilled in the affected eye (s) twice daily, 8 to 12 hours apart. Medically reviewed by Drugs.com. Tilt your head back and drop drug into the eye. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours Keep out of reach of children. Reactions are generally mild, transient, and local as systemic exposure following topical ocular administration is minimal. If swallowed, get medical help or contact a Poison Control Center right away. Antihistamine Eye Drops STERILE. UP TO 12 HOURS EYE ITCH RELIEF. Select one or more newsletters to continue. 4. We comply with the HONcode standard for trustworthy health information -, Drug class: ophthalmic antihistamines and decongestants, Ophthalmic antihistamines and decongestants. Note: This is not a comprehensive list of all side effects. ZADITOR® (ketotifen fumarate) is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0.34 FL OZ (10 mL) AN AKORN COMPANY Wait 10 minutes before reinserting lenses if using products containing benzalkonium chloride. Stop use and ask a doctor if you experience any of the following: Keep out of reach of children. Zaditor (ketotifen ophthalmic)" Ciba Vision Ophthalmics, Duluth, GA. • Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms worsen or do not improve within 3 days. Ketotifen eye drops should be used twice a day (morning and evening). RELIEF. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Ketotifen is 75% bound to plasma proteins. Alaway: 0.025% (10 mL) [contains benzalkonium chloride], Alaway Childrens Allergy: 0.025% (5 mL) [contains benzalkonium chloride], Claritin Eye: 0.025% (5 mL) [contains benzalkonium chloride], Eye Itch Relief: 0.025% (5 mL) [contains benzalkonium chloride], GoodSense Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride], TheraTears Allergy: 0.025% (10 mL) [contains benzalkonium chloride], Zaditor: 0.025% (5 mL) [contains benzalkonium chloride]. Acta Ophthalmol Scandinavica 78 (2000): 64-5. Signs and symptoms include itchy eyes, red eyes, and swelling of the eyes or eyelids.Ketotifen works by blocking histamine, a substance released by the body during an allergic reaction. Ketotifen ophthalmic (eye) solution is used to temporarily prevent itching of the eye caused by a condition known as allergic conjunctivitis. ... KETOTIFEN FUMARATE solution/ drops If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such. Call your doctor for medical advice about side effects. It works by acting on certain cells, called mast cells, to prevent them from releasing substances that cause the allergic reaction. "Product Information. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem fo… ANTIHISTAMINE EYE DROPS • Works in minutes • Original prescription strength • For ages 3 years & older • 60-day supply. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Zaditen eye drops contain the active ingredient ketotifen, which is a type of medicine called an antihistamine.Ketotifen works by preventing the actions of histamine, which is a substance produced by the body as part of its defence mechanisms. Central nervous system: Headache (≤10% to ≤25%), Ophthalmic: Conjunctival injection (≤10% to ≤25%), Hypersensitivity: Hypersensitivity reaction (ophthalmic; <5%), Ophthalmic: Circumocular rash (<5%), conjunctivitis (<5%), disease of the lacrimal apparatus (<5%), eye pain (<5%), keratitis (<5%), mydriasis (<5%), photophobia (<5%), burning sensation of eyes (<3%), eye discharge (<3%), eyelid disease (<3%), eye pruritus (<3%), stinging of eyes (<3%), xerophthalmia (<3%), Respiratory: Flu-like symptoms (<5%), pharyngitis (<5%). Available for Android and iOS devices. There are no known significant interactions. Exhibits noncompetitive H1-receptor antagonist and mast cell stabilizer properties. call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST. [DSC] = Discontinued product Solution, Ophthalmic: Alaway: 0.025% (10 mL) [contains benzalkonium chloride] Alaway Childrens Allergy: 0.025% (5 mL) [contains benzalkonium chloride] Claritin Eye: 0.025% (5 mL) [contains benzalkonium chloride] Eye Itch Relief: 0.025% (5 mL [DSC]) [contains benzalkonium chloride] GoodSense Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride] TheraTe… Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Burning/stinging/irritation of the eye, headache, stuffy/runny nose, bad taste in your mouth, and increased sensitivity to light may occur. Solution contains benzalkonium chloride; soft contact lens wearers should remove them prior to administration and wait at least 10 minutes after administration before reinserting them. Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into lower conjunctival sac of affected eye(s) twice daily (spaced 8 to 12 hours apart). Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. The following information includes only the average doses of this medicine. After use, keep your eyes closed. Works in Minutes; Original Prescription Strength; For Ages 3 Years and Older; 60 Day Supply; ADVANCED. I later tried a similar and cheaper store brand, and had the very same reaction. Consult drug interactions database for more information. Ketotifen ophthalmic (for use in the eyes) is used to treat itching of the eyes caused by allergy to dust, pollen, animals, or other allergens. This could infect the drops left in the bottle. A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions, with a slightly better ocular tolerance with unpreserved ketotifen 0.025% eye drops. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Contact healthcare provider if change in vision, eye pain, or redness occur. Adults and children 3 years of age and older: We comply with the HONcode standard for trustworthy health information -, Drug class: ophthalmic antihistamines and decongestants, 1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON, MANUFACTURE(58790-008), ANALYSIS(58790-008), STERILIZE(58790-008), PACK(58790-008), LABEL(58790-008), if solution changes color or becomes cloudy, if you are sensitive to any ingredient in this product, do not touch tip of container to any surfaces to avoid contamination, wait at least 10 minutes before reinserting contact lenses after use, itching worsens or lasts for more than 72 hours. Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. eye pain changes in vision redness of the eye ... Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drop 5 mL (0.17 FL OZ) Sterile PRINCIPAL DISPLAY PANEL. • Contact lens wearers: Not to treat contact lens-related irritation. Note: Do not exceed 2 applications per day. CONSTITUTION: An eye drop obtained by dissolving ketotifen fumarate as an active ingredient and a polyhydic alcohol, e.g. Do not wear contact lenses if eyes are red. The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 12. Package Contains One Bottle. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Principal Display Panel Text for Carton Label: Thera Tears logoKetotifen FumarateOphthalmic SolutionAntihistamine Eye Drops STERILEEYE ITCHRELIEFUp to12Hours, ADVANCED                      VISION RESEARCH logo0.17 FL OZ (5 mL)     AN AKORN COMPANY, 0.34 FL OZ (10 mL) AN AKORN COMPANY. Zaditor® (ketotifen fumarate) is an antihistamine eye drop to relieve itchy eyes due to allergens. Ketotifen is an antihistamine that reduces the effects of natural chemical histamine in the body. The dose of this medicine will be different for different patients. Other brands: Zaditor, Claritin Eye, Alaway, Zyrtec Itchy Eye Drops, ... +3 more. Lenses may be put back in 10 minutes after ketotifen (ophthalmic) is given. Last updated on Oct 30, 2020. Principal Display Panel Text for Carton Label: NDC 0179-8601-05 ... KETOTIFEN FUMARATE solution/ drops Ketotifen is a topical second-generation antihistamine that is commonly used for the treatment of allergic conjunctivitis. Efficacy in conjunctivitis likely results from a combination of anti-inflammatory and antihistaminergic actions including interference with chemokine-induced migration of eosinophils into inflamed conjunctiva. If your dose is different, do not change it unless your doctor tells you to do so. Available for Android and iOS devices. In this case report, a 32-year-old female patient with a past medical history of atopy, hay fever, and more recent 3-year history of allergic conjunctivitis was … Select one or more newsletters to continue. Do not use if solution is cloudy or changes color. Do not put contacts back in if your eyes are irritated or infected. Allergic conjunctivitis: OTC labeling: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily every 8 to 12 hours (maximum: do not exceed 2 applications/day). Dosage form: solutionIngredients: Ketotifen Fumarate 0.35mg in 1mLLabeler: Advanced Vision Research (Subsidiary of Akorn, Inc.)NDC Code: 58790-008, (equivalent to Ketotifen Fumarate 0.035%). Apothecare Plus - NDC 60505-6215-1 - Ketotifen Fumarate Opthalmic Solution 0.025% Antihistamine Eye drops - 5 ml bottle Principal Display Panel - Bottle Carton Apothecare Plus - NDC 60505-6215-1 - Ketotifen Fumarate Opthalmic Solution 0.025% Antihistamine Eye drops - 5 ml bottle 3. Ketotifen eye drops are used to treat the signs and symptoms of a condition called allergic conjunctivitis (an allergic reaction affecting the eyes). Ketotifen is an antihistamine that reduces the effects of natural chemical histamine in the body. Remove soft contact lenses prior to administration. NDC; 1: STERILE. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH). Do not contaminate dropper tip or solution when placing drops in eyes. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Find information about which conditions Ketotifen Ophthalmic (Eye) is commonly used to treat. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Talk to your doctor if you have questions. ALLERGY. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Ketotifen selectively blocks histamine (H1) receptors and prevents the typical symptoms caused by histamine release. The fumarate salt of ketotifen, a cycloheptathiophene derivative with anti-allergic activity. Up to. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Akorn Ketotifen Fumarate Ophthalmic Solution 5ml - 1 Each, Pack of 3. Each drop contains 8.5 microgram ketotifen fumarate. If you notice any other effects, check with your healthcare professional. Zaditor (ketotifen) for Conjunctivitis, Allergic: “I developed red, swollen eyes as a result of using Zaditor, an apparent allergic reaction to its ingredients. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 2 ketotifen fumarate eye drops per day if your eyes are irritated or infected: to obtain the titled drop! For educational purposes only and is not intended to provide medical advice about side effects when taking drug... Should be removed before application of the eye itching worsens or lasts for than... Hydroxide ( to adjust pH ) drops should be used twice a day ( and! 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The full list of all side effects corresponding to 0.25 mg ketotifen provided for educational only...: this is not intended to provide medical advice, diagnosis or treatment change in vision redness of the.. ( s ) with known effect: benzalkonium chloride 0.01 % ; Glycerin and Water... Local as systemic exposure following topical ocular administration is minimal irritated or infected the release mediators... As allergic conjunctivitis inflamed conjunctiva specific isotonic agent of the medicine the information!