Drugs Details

Drugs Info of Pataday, Patanol
Drugs Details
  • Drugs Type  : Multum
  • Date : 7th Mar 2015 04:11 am
  • Brand Name : Pataday, Patanol
  • Generic Name : olopatadine ophthalmic (Pronunciation: OH loe PAT a deen)
Descriptions

PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1 % is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below:

Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride

Each mL of PATANOL contains: Active: 1.11 mg olopatadine hydrochloride equivalent to 1 mg olopatadine.

Preservative: benzalkonium chloride 0.01 %. Inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and purified water. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.

What are the possible side effects of olopatadine ophthalmic (Pataday, Patanol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using olopatadine ophthalmic and call your doctor at once if you have severe redness, swelling, burning, stinging, drainage, crusting, or other irritation when using the eye drops.

Less serious side effects may include:

  • mild burning, stinging, irritation, itching, redness, or dryness of the eyes;
  • blurred vision;
  • feeling that something is in your eye;
  • puffy...

Read All Potential Side Effects and See Pictures of Patanol »

What are the precautions when taking olopatadine (Patanol)?

Before using olopatadine hydrochloride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your...

Read All Potential Precautions of Patanol »


This monograph has been modified to include the generic and brand name in many instances.

Indications

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

Dosage Administration

The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.

How Supplied

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is supplied as follows:

5 mL in plastic DROP-TAINER© dispenser.

5 mL: NDC 0065-0271-05

Storage: Store at 39°F-77°F (4°C-25°C)

ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. Revised: August 2002. FDA Rev date: 4/17/2003


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.

Read the Patanol (olopatadine) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility: Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 µL drop size, these doses were 78,125 and 31,250 times higher than the maximum recommended ocular human dose (MROHD). No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Olopatadine administered to male and female rats at oral doses of 62,500 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of 7,800 times the maximum recommended ocular human use level.

Pregnancy: Pregnancy Category C. Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 93,750 times the MROHD and rabbits treated at 400 mg/kg/day, or 62,500 times the MROHD, during organogenesis showed a decrease in live fetuses. There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Nursing Mothers: Olopatadine has been identified in the milk of nursing rats following oral administration. 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 PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is administered to a nursing mother.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL (olopatadine) .


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1-antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

Results from an environmental study demonstrated that PATANOL (olopatadine) was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that PATANOL (olopatadine) , when subjects were challenged with antigen both initially and up to 8 hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Patients should be advised not to wear a contact lens if their eye is red. PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1 % should not be used to treat contact lens related irritation. The preservative in PATANOL (olopatadine) , benzalkonium chloride, 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 ten minutes after instilling PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% before they insert their contact lenses.
This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

OLOPATADINE - OPHTHALMIC SOLUTION

 

(oh-low-PAT-uh-deen)

 

COMMON BRAND NAME(S): Pataday, Patanol

 

USES: This medication is an antihistamine used to treat itching and redness in the eyes due to allergies.

This medication is not recommended for the treatment of eye irritation due to wearing contact lenses.

 

HOW TO USE: Apply this medication in the affected eye(s) usually once or twice a day as directed by your doctor, depending on the brand of eye drops you are prescribed.

Wash your hands before each use. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 10 minutes after each dose.

Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and apply the prescribed number of drops. Look downward and gently close your eye for 1 to 2 minutes. Place one finger at the inside corner of your eye near the nose and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye.

Do not rinse the dropper. Replace the dropper cap after each use.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Continue using it for the full time prescribed.

Wait at least 5 minutes in between applying this medicine and any other eye medication (e.g., drops or ointments) you may be using. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Inform your doctor if your condition persists or worsens.

 

 

Consumer Overview Side Effect

SIDE EFFECTS: Headache, blurred vision, burning/stinging/redness/dryness of the eye, eyelid swelling, or a feeling as if something is in your eye may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Patanol (olopatadine) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using olopatadine hydrochloride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store the US product between 39-77 degrees F (4-25 degrees C) away from light and moisture. Do not store in the bathroom.

Store the Canadian product between 39-86 degrees F (4-30 degrees C) away from light and moisture. Do not store in the bathroom.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

 

Patient Detailed Side Effect

Brand Names: Pataday, Patanol

Generic Name: olopatadine ophthalmic (Pronunciation: OH loe PAT a deen)

  • What is olopatadine ophthalmic (Patanol)?
  • What are the possible side effects of olopatadine ophthalmic (Patanol)?
  • What is the most important information I should know about olopatadine ophthalmic (Patanol)?
  • What should I discuss with my healthcare provider before using olopatadine ophthalmic (Patanol)?
  • How should I use olopatadine ophthalmic (Patanol)?
  • What happens if I miss a dose (Patanol)?
  • What happens if I overdose (Patanol)?
  • What should I avoid while using olopatadine ophthalmic (Patanol)?
  • What other drugs will affect olopatadine ophthalmic (Patanol)?
  • Where can I get more information?

What is olopatadine ophthalmic (Patanol)?

Olopatadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of itching or watery eyes.

Olopatadine ophthalmic is used to treat ocular (eye) symptoms of allergic conditions, such as inflammation, itching, watering, and burning.

Olopatadine ophthalmic may also be used for other purposes not listed in this medication guide.

Patanol

What are the possible side effects of olopatadine ophthalmic (Patanol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using olopatadine ophthalmic and call your doctor at once if you have severe redness, swelling, burning, stinging, drainage, crusting, or other irritation when using the eye drops.

Less serious side effects may include:

  • mild burning, stinging, irritation, itching, redness, or dryness of the eyes;
  • blurred vision;
  • feeling that something is in your eye;
  • puffy eyelids;
  • stuffy or runny nose, cough, sore throat;
  • weakness;
  • back pain;
  • headache; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Patanol (olopatadine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about olopatadine ophthalmic (Patanol)?

Before using olopatadine ophthalmic, tell your doctor if you have any type of infection in your eye.

Do not use olopatadine ophthalmic while you are wearing contact lenses. Olopatadine ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 10 minutes after using olopatadine before putting your contact lenses in.

Avoid wearing contact lenses while your eyes are red or irritated.

Avoid using other eye medications not prescribed by your doctor.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Stop using olopatadine ophthalmic and call your doctor at once if you have severe redness, swelling, burning, stinging, drainage, crusting, or other irritation when using the eye drops.

Side Effects Centers
  • Patanol
  • Pataday

Patient Detailed How Take

What should I discuss with my healthcare provider before using olopatadine ophthalmic (Patanol)?

You should not use this medication if you are allergic to olopatadine.

Before using olopatadine ophthalmic, tell your doctor if you have any type of infection in your eye.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether olopatadine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication in a child younger than 3 years old without the advice of a doctor.

How should I use olopatadine ophthalmic (Patanol)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Patanol
  • Pataday

Patient Detailed Avoid Taking

What happens if I miss a dose (Patanol)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Patanol)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of olopatadine ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while using olopatadine ophthalmic (Patanol)?

Do not use olopatadine ophthalmic while you are wearing contact lenses. Olopatadine ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 10 minutes after using olopatadine before putting your contact lenses in.

Avoid wearing contact lenses while your eyes are red or irritated.

Avoid using other eye medications not prescribed by your doctor.

What other drugs will affect olopatadine ophthalmic (Patanol)?

There may be other drugs that can interact with olopatadine ophthalmic. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about olopatadine ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.03. Revision date: 12/15/2010.

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Healthwise

Side Effects Centers
  • Patanol
  • Pataday

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