Olopatadine Hydrochloride
Proficient Rx Lp
Human Prescription Drug
NDC 71205-345Olopatadine Hydrochloride is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Olopatadine Hydrochloride is 71205-345. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Olopatadine Hydrochloride drug includes Olopatadine Hydrochloride - 1.11 mg/mL . The currest status of Olopatadine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 71205-345 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Olopatadine Hydrochloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Olopatadine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | OLOPATADINE HYDROCHLORIDE - 1.11 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Jun, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA206306 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1111339
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0371205345051
|
| UPC stands for Universal Product Code. |
| UNII: | 2XG66W44KF
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Histamine Release [PE]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Histamine-1 Receptor Inhibitor [EPC]
Mast Cell Stabilizer [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71205-345-05 | 1 BOTTLE in 1 CARTON (71205-345-05) / 5 mL in 1 BOTTLE | 01 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Olopatadine hydrochloride olopatadine hydrochloride olopatadine hydrochloride olopatadine benzalkonium chloride sodium phosphate, dibasic, anhydrous sodium chloride sodium hydroxide hydrochloric acid water a clear, colorless solution
Indications and Usage:
Indications and usage olopatadine hydrochloride ophthalmic solution usp, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Warnings:
Warnings olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.
Dosage and Administration:
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.
Contraindications:
Contraindications olopatadine hydrochloride ophthalmic solution, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, 0.1%. warnings olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.
Adverse Reactions:
Adverse reactions 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, pruritus, rhinitis, sinusitis, and taste perversion. some of these events were similar to the underlying disease being studied.
Use in Pregnancy:
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.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use:
Geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
Description olopatadine hydrochloride ophthalmic solution usp, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective h 1 -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 olopatadine hydrochloride ophthalmic solution, usp contains: active: 1.11 mg olopatadine hydrochloride, usp equivalent to 1 mg olopatadine. preservative: benzalkonium chloride 0.01%. inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust ph); and water for injection. it has a ph of approximately 7 and an osmolality of approximately 300 mosm/kg. molecular structure
Clinical Pharmacology:
Clinical pharmacology olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine h 1 -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
Read more...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 olopatadine hydrochloride ophthalmic solution, 0.1% 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 olopatadine hydrochloride ophthalmic solution, 0.1%, 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.
How Supplied:
How supplied olopatadine hydrochloride ophthalmic solution usp, 0.1% is supplied as follows: 5 ml in ldpe bottle. 5 ml: ndc 71205-345-05 storage: store at 39°f-77°f (4°c-25°c). rx only for product inquiry call 1-800-417-9175. manufactured for: somerset therapeutics, llc somerset, nj 08873 relabeled by: proficient rx lp thousand oaks, ca 91320 code no.: kr/drugs/ktk/28/289/97 st-olp11/p/01 revised: 09/2018
Information for Patients:
Information for patients: 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. olopatadine hydrochloride ophthalmic solution, 0.1% should not be used to treat contact lens related irritation. the preservative in olopatadine hydrochloride ophthalmic solution 0.1%, 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 olopatadine hydrochloride ophthalmic solution, 0.1% before they insert their contact lenses.
Package Label Principal Display Panel:
Package label.principal display panel olopatadine hydrochloride ophthalmic solution usp, 0.1% ndc 71205-345-05 5 ml sterile container label 71205-345-05