PHOSPHOLINE IODIDE OPHTHALMIC

Main information

  • Trade name:
  • PHOSPHOLINE IODIDE OPHTHALMIC- echothiophate iodide
  • Composition:
  • ECHOTHIOPHATE IODIDE 6.25 mg in 5 mL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHOSPHOLINE IODIDE  OPHTHALMIC- echothiophate iodide
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Echothiophate iodide for ophthalmic solution is indicated for the reduction of elevated IOP. Concomitant esotropias with a significant accommodative component. - 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.
  • Product summary:
  • Each package contains sterile echothiophate iodide for ophthalmic solution, sterile diluent, and dropper for dispensing 5 mL eyedrops. White amorphous deposit on bottle walls. Aluminum crimp seal is green. 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.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • New Drug Application
  • Authorization number:
  • 0046-1065-05, 0046-1162-05, 0046-1465-05
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

PHOSPHOLINE IODIDE OPHTHALMIC- echothiophate iodide

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

----------

Phospholine Iodide

(echothiophate iodide for ophthalmic solution)

Rx Only

DESCRIPTION

Chemical name: (2-mercaptoethyl) trimethylammonium iodide O,O-diethyl phosphorothioate

Structural formula

C H INO PS 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.

INDICATIONS AND USAGE

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

1. Active uveal inflammation.

®

9

23

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2. Most cases of angle-closure glaucoma without iridectomy, due to the possibility of increasing

angle block.

3. 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.

PRECAUTIONS

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.

Pregnancy

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 EYEDROPS

1. 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.

Accommodative Esotropia (Pediatric Use)

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.

Technique

(See "DOSAGE AND ADMINISTRATION")

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 0046-1065-05

6.25 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.

This product's label may have been updated. For current full prescribing information, please visit

www.pfizer.com.

www.pfizer.com.

LAB-0813-3.0

Revised August 2018

PRINCIPAL DISPLAY PANEL - Kit Carton

Pfizer

NDC 0046-1065-05

Phospholine Iodide

(echothiophate iodide

for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

This package contains sterile

echothiophate iodide with 40 mg

potassium acetate (sodium

hydroxide or acetic acid may have

been incorporated to adjust pH

during manufacturing) and 5 mL

(1/6 fl oz) sterile aqueous diluent,

in individual bottles for dispensing

5 mL of eyedrops of strength

shown when reconstituted.

Rx only

PACKAGE LABEL - PACKAGE LABEL - 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

PACKAGE LABEL - PRINCIPAL DISPLAY - 6.25 mg/5 mL - Bottle Label

NDC 0046-1465-05

®

Rx only

Phospholine Iodide

(echothiophate iodide

for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

Each 5 mL contains 6.25 mg of echothiophate iodide

With 40 mg Potassium Acetate for preparing 5 mL eyedrops.

See accompanying descriptive literature.

PHOSPHOLINE IODIDE OPHTHALMIC

echothiophate iodide kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 0 46 -10 6 5

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 46 -10 6 5-0 5

1 in 1 KIT

12/0 4/19 59

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

6 .25 mL

Pa rt 2

1 BOTTLE

5 mL

Part 1 of 2

PHOSPHOLINE IODIDE OPHTHALMIC

echothiophate iodide powder, for solution

®

Product Information

Ite m Code (Source )

NDC:0 0 46 -146 5

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ECHO THIO PHATE IO DIDE (UNII: BA9 QH3P0 0 T) (ECHOTHIOPHATE -

UNII:0 F350 BVT6 S)

ECHOTHIOPHATE

IODIDE

6 .25 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO TASSIUM ACETATE (UNII: M9 119 11U0 2)

40 mg in 5 mL

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 46 -146 5-0 5 6 .25 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 119 6 3

12/0 4/19 59

Part 2 of 2

STERILE DILUENT FOR PREPARING PHOSPHOLINE IODIDE

diluent solution

Product Information

Ite m Code (Source )

NDC:0 0 46 -116 2

Route of Administration

OPHTHALMIC

Inactive Ingredients

Ingredient Name

Stre ng th

CHLO RO BUTANO L (UNII: HM4YQM8 WRC)

27.5 mg in 5 mL

MANNITO L (UNII: 3OWL53L36 A)

6 0 mg in 5 mL

BO RIC ACID (UNII: R57ZHV8 5D4)

3 mg in 5 mL

SO DIUM PHO SPHATE (UNII: SE337SVY37)

1.3 mg in 5 mL

WATER (UNII: 0 59 QF0 KO0 R)

5 mL in 5 mL

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 46 -116 2-0 5

5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 119 6 3

12/0 4/19 59

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 119 6 3

12/0 4/19 59

Labeler -

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (113008515)

Revised: 5/2019