Patanol

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 4/25/2023

Drug Summary

What Is Patanol?

Patanol (olopatadine hydrochloride ophthalmic solution) 0.1 % is an antihistamine used to treat ocular (eye) symptoms of allergic conditions, such as inflammation, itching, watering, and burning.

What Are Side Effects of Patanol?

Patanol may cause serious side effects including:

  • severe burning, stinging, or irritation after using the medicine,
  • eye swelling,
  • redness of the eye,
  • severe discomfort, and
  • crusting or drainage from the eye

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Patanol include:

  • headache,
  • blurred vision,
  • burning/stinging/redness/dryness/ irritation/itching of the eye,
  • eyelid swelling,
  • a feeling as if something is in your eye,
  • puffy eyelids,
  • stuffy or runny nose,
  • cough,
  • sore throat,
  • weakness,
  • back pain, or
  • unusual or unpleasant taste in your mouth.

A serious allergic reaction to Patanol is unlikely, but seek immediate medical attention if you have symptoms of a serious allergic reaction including rash, itching or swelling (especially of the face/tongue/throat), dizziness, or trouble breathing.

Dosage for Patanol

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

What Drugs, Substances, or Supplements Interact with Patanol?

There may be other drugs that can interact with Patanol. 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.

Patanol During Pregnancy and Breastfeeding

Patanol should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Patanol (olopatadine hydrochloride ophthalmic solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description

DESCRIPTION

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.

Indications & Dosage

INDICATIONS

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

DOSAGE AND 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

Side Effects & Drug Interactions

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.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

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 ┬ÁL 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.

Overdose & Contraindications

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) .

Clinical Pharmacology

CLINICAL PHARMACOLOGY

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.

Medication Guide

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.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.