NDC 0046-1065 Phospholine Iodide Ophthalmic

Echothiophate Iodide

NDC Product Code 0046-1065

NDC CODE: 0046-1065

Proprietary Name: Phospholine Iodide Ophthalmic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Echothiophate Iodide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information 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. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat high pressure inside the eye (due to conditions such as certain types of glaucoma) and other eye problems (such as accommodative esotropia). It works by causing the pupil to shrink, decreasing the amount of fluid within the eye, and affecting certain eye muscles.

NDC Code Structure

  • 0046 - Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.

NDC 0046-1065-05

Package Description: 1 KIT in 1 KIT * 6.25 mL in 1 BOTTLE (0046-1465-05) * 5 mL in 1 BOTTLE (0046-1162-05)

Price per Unit: $17.73400 per ML

NDC Product Information

Phospholine Iodide Ophthalmic with NDC 0046-1065 is a a human prescription drug product labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The generic name of Phospholine Iodide Ophthalmic is echothiophate iodide. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 205739 and 310049.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POTASSIUM ACETATE (UNII: M911911U02)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • MANNITOL (UNII: 3OWL53L36A)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Labeler Code: 0046
FDA Application Number: NDA011963 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 12-04-1959 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 06-30-2022 What is the End Marketing Date?
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.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Phospholine Iodide Ophthalmic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.LAB-0813-3.0 Revised August 2018

Description

Chemical name: (2-mercaptoethyl) trimethylammonium iodide O,O-diethyl phosphorothioateStructural formulaC9H23INO3PS           M.W. 383.23   Echothiophate iodide for ophthalmic solution occurs as a white, crystalline, water-soluble, hygroscopic solid having a slight mercaptan-like odor. When freeze-dried in the presence of potassium acetate, the mixture appears as a white amorphous deposit on the walls of the bottle.Each package contains materials for dispensing 5 mL of eyedrops: (1) bottle containing sterile echothiophate iodide for ophthalmic solution 6.25 mg (0.125%) with 40 mg potassium acetate. Sodium hydroxide or acetic acid may have been incorporated to adjust pH during manufacturing; (2) a 5 mL bottle of sterile diluent containing chlorobutanol (chloral derivative), 0.55%; mannitol, 1.2%; boric acid, 0.06%; and sodium phosphate, 0.026%; (3) sterilized dropper.

Clinical Pharmacology

Echothiophate iodide for ophthalmic solution is a long-acting cholinesterase inhibitor for topical use which enhances the effect of endogenously liberated acetylcholine in iris, ciliary muscle, and other parasympathetically innervated structures of the eye. It thereby causes miosis, increase in facility of outflow of aqueous humor, fall in intraocular pressure (IOP), and potentiation of accommodation.Echothiophate iodide for ophthalmic solution will depress both plasma and erythrocyte cholinesterase levels in most patients after a few weeks of eyedrop therapy.

Reduction Of Elevated Iop

Echothiophate iodide for ophthalmic solution is indicated for the reduction of elevated IOP.

Accommodative Esotropia

Concomitant esotropias with a significant accommodative component.

Contraindications

  • Active uveal inflammation.Most cases of angle-closure glaucoma without iridectomy, due to the possibility of increasing angle block.Hypersensitivity to the active or inactive ingredients.

Warnings

1. Succinylcholine should be administered only with great caution, if at all, prior to or during general anesthesia to patients receiving anticholinesterase medication because of possible respiratory or cardiovascular collapse.2. Caution should be observed in treating elevated IOP with echothiophate iodide for ophthalmic solution in patients who are at the same time undergoing treatment with systemic anticholinesterase medications, because of possible adverse additive effects.

General

1. Digital compression of the nasolacrimal ducts for a minute or two following instillation to minimize drainage into the nasal chamber is recommended. To prevent possible skin absorption, hands should be washed following instillation.2. Discontinue use of the medication if cardiac irregularities occur.3. Anticholinesterase drugs should be used with caution, if at all, in patients with marked vagotonia, bronchial asthma, spastic gastrointestinal disturbances, peptic ulcer, pronounced bradycardia and hypotension, recent myocardial infarction, epilepsy, parkinsonism, and other disorders that may respond adversely to vagotonic effects.4. Echothiophate iodide for ophthalmic solution should be used with caution, where there is a prior history of retinal detachment.5. Temporary discontinuance of medication is necessary if salivation, urinary incontinence, diarrhea, profuse sweating, muscle weakness, or respiratory difficulties occur.6. Patients receiving echothiophate iodide for ophthalmic solution who are exposed to carbamate- or organophosphate-type insecticides and pesticides should be warned of the additive systemic effects possible from absorption of the pesticide through the respiratory tract or skin. During periods of exposure to such pesticides, the wearing of respiratory masks, and frequent washing and clothing changes may be advisable.

Drug Interactions

Echothiophate iodide for ophthalmic solution potentiates other cholinesterase inhibitors such as succinylcholine or organophosphate and carbamate insecticides. Patients undergoing systemic anticholinesterase treatment should be warned of the possible additive effects of echothiophate iodide for ophthalmic solution.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No data is available regarding carcinogenesis, mutagenesis, and impairment of fertility.

Teratogenic Effects

Animal reproduction studies have not been conducted with echothiophate iodide for ophthalmic solution. It is also not known whether echothiophate iodide for ophthalmic solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Echothiophate iodide for ophthalmic solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from echothiophate iodide for ophthalmic solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have been established.

Geriatric Use

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

Adverse Reactions

1. Although the relationship, if any, of retinal detachment to the administration of echothiophate iodide for ophthalmic solution has not been established, retinal detachment has been reported in a few cases during the use of echothiophate iodide for ophthalmic solution in adult patients without a previous history of this disorder.2. Stinging, burning, lacrimation, lid muscle twitching, conjunctival and ciliary redness, browache, induced myopia with visual blurring may occur.3. Activation of latent iritis or uveitis may occur.4. Iris cysts may form, and if treatment is continued, may enlarge and obscure vision. This occurrence is more frequent in children. The cysts usually shrink upon discontinuance of the medication or by reducing the frequency of instillation. Rarely, they may rupture or break free into the aqueous. Regular examinations are advisable when the drug is being prescribed for the treatment of accommodative esotropia.5. Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals.6. Lens opacities have been reported with echothiophate iodide.7. Paradoxical increase in IOP may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine.8. Cardiac irregularities.

Dosage And Administration

DIRECTIONS FOR PREPARING EYEDROPS1. Use aseptic technique.2. Tear off aluminum seals, and remove and discard rubber plugs from both drug and diluent containers.3. Pour diluent into drug container.4. Remove dropper assembly from its sterile wrapping. Holding dropper assembly by the screw cap and, WITHOUT COMPRESSING RUBBER BULB, insert into drug container and screw down tightly.5. Shake for several seconds to ensure mixing.6. Do not cover nor obliterate instructions to patient regarding storage of eyedrops.

Elevated Iop

Echothiophate iodide for ophthalmic solution one drop instilled twice a day, just before retiring and in the morning. A change in therapy is indicated if, at any time, the tension fails to remain at an acceptable level on this regimen.Two doses a day are preferred to one in order to maintain as smooth a diurnal tension curve as possible, although a single dose per day or every other day has been used with satisfactory results. The daily dose or one of the two daily doses should always be instilled just before retiring to avoid inconvenience due to the miosis.

Technique

Technique in the administration of echothiophate iodide for ophthalmic solution may include finger pressure at the inner canthus exerted for a minute or two following instillation of the eyedrops, to potentially minimize drainage into the nose and throat. Excess solution around the eye should be removed with tissue and any medication on the hands should be rinsed off.

(See "DOSAGE AND ADMINISTRATION")

In Diagnosis

One drop may be instilled once a day in both eyes on retiring, for a period of two or three weeks. If the esotropia is accommodative, a favorable response will usually be noted which may begin within a few hours.

In Treatment

Echothiophate iodide for ophthalmic solution is prescribed at the lowest frequency which gives satisfactory results. After the initial period of treatment for diagnostic purposes, the schedule may be reduced to one drop every other day. The maximum usually recommended dosage is one drop once a day, although more intensive therapy has been used for short periods.

Duration Of Treatment

In therapy, there is no definite limit so long as the drug is well tolerated. However, if the eyedrops, with or without eyeglasses, are gradually withdrawn after about a year or two and deviation recurs, surgery should be considered. As with other miotics, tolerance may occasionally develop after prolonged use. In such cases, a rest period may restore the original activity of the drug.

How Supplied

Each package contains sterile echothiophate iodide for ophthalmic solution, sterile diluent, and dropper for dispensing 5 mL eyedrops. NDC 0046-1065-056.25 mg package for 0.125%White amorphous deposit on bottle walls. Aluminum crimp seal is green.

Handling And Storage

Prior to reconstitution: Store under refrigeration (2° to 8° C).After reconstitution: Store at room temperature (approximately 25° C). Do not refrigerate. Discard any unused solution after 4 weeks.

Principal Display - 5 Ml Bottle Label

NDC 0046-1162-05 STERILE DILUENT FOR PREPARING Phospholine Iodide®(echothiophate iodide for ophthalmic solution)5 mL (1/6 fl oz)EYEDROPS

Principal Display - 6.25 Mg/5 Ml Bottle Label

NDC 0046-1465-05Rx only Phospholine Iodide®(echothiophate iodide for ophthalmic solution)0.125% (1/8%) 6.25 mg/5 mLEach 5 mL contains 6.25 mg of echothiophate iodide With 40 mg Potassium Acetate for preparing 5 mL eyedrops. See accompanying descriptive literature.

* Please review the disclaimer below.