Dapiprazole
Baradaina, Llc
Human Prescription Drug
NDC 53020-265Dapiprazole is a human prescription drug labeled by 'Baradaina, Llc'. National Drug Code (NDC) number for Dapiprazole is 53020-265. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Dapiprazole drug includes . The currest status of Dapiprazole drug is Active.
Drug Information:
| Drug NDC: | 53020-265 |
| 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: | Dapiprazole |
| 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: | Dapiprazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Baradaina, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 31 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| 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: | ANDA204902 |
| 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: | Baradaina, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309649
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53020-265-01 | 1 KIT in 1 CARTON (53020-265-01) * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01) | 31 Jul, 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:
Dapiprazole dapiprazole dapiprazole dapiprazole mannitol dapiprazole hydrochloride dapiprazole diluent diluent sodium chloride sodium hydroxide hypromellose 2208 (100 mpa.s) edetate sodium sodium phosphate, dibasic sodium phosphate, monobasic, monohydrate water benzalkonium chloride
Indications and Usage:
Indications and usage: dapiprazole hydrochloride ophthalmic solution is indicated in the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents. dapiprazole hydrochloride ophthalmic solution is not indicated for the reduction of intraocular pressure or in the treatment of open angle glaucoma.
Warnings:
Warning: for topical ophthalmic use only. not for injection. do not touch the dropper up to lids or any surface, as this may contaminate the solution. dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once a week.
Dosage and Administration:
Dosage and administration: two drops followed 5 minutes later by an additional 2 drops applied topically to the conjunctiva of each eye should be administered after the ophthalmic examination to reverse the diagnostic mydriasis. dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once per week. directions for preparing eyedrops: use aseptic technique. tear off aluminum seals, remove and discard rubber plugs from both drug and diluent vials pour diluent into drug vial. remove dropper assembly from its sterile wrapping and attach to the drug vial. shake container for several minutes to ensure mixing.
Contraindications:
Contraindications: miotics are contraindicated where constriction is undesirable; such as acute iritis, and in those subjects showing hypersensitivity to any component of this preparation.
Adverse Reactions:
Adverse reactions: in controlled studies the most frequent reaction to dapiprazole was conjunctival injection lasting 20 minutes in over 80% of patients. burning on instillation of dapiprazole hydrochloride ophthalmic solution was reported in approximately half of all patients. reactions occurring in 10% to 40% of patients included ptosis, lid erythema, lid edema, chemosis, itching, punctate keratitis, corneal edema, browache, photophobia and headaches. other reactions reported less frequently included dryness of eyes, tearing and blurring of vision.
Use in Pregnancy:
Pregnancy: reproduction studies have been performed in rats and rabbits at doses up to 128,000 (rat) and 27,000 (rabbit) times the human ophthalmic dose and revealed no evidence of impaired fertility or harm to the fetus due to dapiprazole hydrochloride. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients below the age of 4 have not been established.
Description:
Description: for ophthalmic use only. dapiprazole hydrochloride is an alpha-adrenergic blocking agent. dapiprazole hydrochloride is 5,6,7,8-tetrahydro-3-[2-(4- o .tolyl-1-piperazinyl)ethyl]- s -triazolo[4,3-a]pyridine hydrochloride. dapiprazole hydrochloride has the empirical formula c 19 h 27 n 5 ⢠hcl and a molecular weight of 361.93. the structural formula for dapiprazole hydrochloride is: dapiprazole hydrochloride is a sterile, white, lyophilized powder soluble in water. dapiprazole hydrochloride ophthalmic solution, 0.5% is a clear, colorless, slightly viscous solution for topical application. each ml (when reconstituted as directed) contains 5 mg of dapiprazole hydrochloride as the active ingredient. the reconstituted solution has a ph of approximately 6.6 and an osmolarity of approximately 415 mosm. the inactive ingredients include: mannitol (2%), sodium chloride, hydroxypropyl methylcellulose (0.4%), edetate sodium (0.01%), sodium phosphate dibasic, sodium phosphate monobasic, water for injection, and benzalkonium chloride (0.01%) as a preservative. dapiprazole hydrochloride ophthalmic solution, 0.5% is supplied in a kit consisting of one vial of dapiprazole hydrochloride (25 mg), one vial of diluent (5 ml) and one dropper for dispensing. structure
Clinical Pharmacology:
Clinical pharmacology: dapiprazole hydrochloride ophthalmic solution acts through blocking the alpha-adrenergic receptors in smooth muscle. dapiprazole hydrochloride ophthalmic solution produces miosis through an effect on the dilator muscle of the iris. dapiprazole hydrochloride ophthalmic solution does not have any significant activity on ciliary muscle contraction and, therefore does not induce a significant change in the anterior chamber depth or the thickness of the lens. dapiprazole hydrochloride ophthalmic solution has demonstrated safe and rapid reversal of mydriasis produced by phenylephrine and to a lesser degree tropicamide. in patients with decreased accommodative amplitude due to treatment with tropicamide, dapiprazole hydrochloride ophthalmic solution partially restores the accommodative amplitude. this activity is not only due to its miotic effect but also to a direct effect on accommodation. eye color affects the rate of pupillary constriction. in individuals with brown
Read more... irides, the rate of pupillary constriction may be slightly slower than in individuals with blue or green irides. eye color does not appear to affect the final pupil size. dapiprazole hydrochloride ophthalmic solution does not significantly alter intraocular pressure in normotensive eyes or in eyes with elevated intraocular pressure.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: dapiprazole has been shown to significantly increase the incidence of liver tumors in rats after continuous dietary administration for 104 weeks. this effect was found only in male rats treated with the highest dose administered in the study, i.e., 300 mg/kg/day, (80,000 times the human dose) and was not observed in male and female rats at doses of 30 and 100 mg/kg/day and female rats at doses of 300 mg/kg/day. negative results have been reported on the mutagenicity and impairment of fertility studies with dapiprazole hydrochloride.
How Supplied:
How supplied: dapiprazole hydrochloride ophthalmic solution, 0.5% - sterile is supplied as an outer package (ndc 53020-265-01) containing: ndc 53020-255-01 single vial of dapiprazole hydrochloride (25 mg) lyophilized powder ndc 53020-245-01 single vial of diluent (5 ml) single dropper for dispensing
Information for Patients:
Information to patients : miosis may cause difficulty in dark adaptation and may reduce the field of vision. patients should exercise caution when involved in night driving or other activities in poor illumination.
Package Label Principal Display Panel:
Principal display-container label sterile dapiprazole hci ophthalmic solution 0.5% e y e d r o p s rx only for use in the eyes 5 ml (when diluent is added) ââ baradaina, llc principal display panel container label