Medication Guide App

Silicone Oil 5000 Centistokes (Parenteral-Local)


VA CLASSIFICATION
Primary: OP900

Commonly used brand name(s): AdatoSil 5000.

Another commonly used name is
polydimethylsiloxane . {01}
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Surgical aid (ophthalmic)—

Indications

Accepted

Retinal detachment (treatment)—Silicone oil is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments when other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly following perforating injuries or in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, or giant tears.
—Silicone oil is also indicated in the treatment of retinal detachments due to acquired immunodeficiency syndrome (AIDS)-related CMV retinitis and other viral infections. {01} {05} {07} {08} {09} {10} {13} {14} {16} {20} {21} {22} {23} {24} {25} {27}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Silicone oil is a sterile, highly purified long chain polydimethylsiloxane. It is a clear colorless liquid at room temperature with a viscosity of 5000 to 5400 centistokes (nominal 5000 centistokes). It has a specific gravity of between 0.96 and 0.98 grams per cubic centimeter at 25° C. It has a refractive index of between 1.403 and 1.405 at 25° C. {01}

Mechanism of action/Effect:

Provides a physical retinal tamponade. {01}

Onset of action:

Immediately upon placement of product. {01}

Duration of action:

Until product is physically removed. {01}


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of silicone oil in children. {02}


Geriatrics


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of silicone oil in the elderly. {02}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this product should not be used when the following medical problem exists:
» Pseudophakia with silicone intraocular lenses (IOLs)    (silicone oil can chemically interact with and opacify silicone elastomers; use of silicone oil is contraindicated in patients with pseudophakia who have IOLs {01})


Risk-benefit should be considered when the following medical problem exists
Sensitivity to silicone oil

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Ophthalmologic examinations    (patients should be scheduled for follow-up examinations at regular intervals; patients should be monitored for signs of glaucoma, cataracts, and keratopathy complications; in addition, since there is a possible correlation between the migration of silicone oil into the anterior chamber and the appearance of corneal changes, such as edema, hazing or opacification, Descemet folds, or decompensation, {01} patients' corneal status should be regularly monitored and early corrective action should be taken, if necessary, including extraction of the oil from the anterior chamber; {02} large bubbles or droplets of oil found in the anterior chamber can be removed manually by syringe {01})




Side/Adverse Effects

Note: There is a possible correlation between the migration of silicone oil into the anterior chamber and the appearance of corneal changes, such as edema, hazing or opacification, Descemet folds, or decompensation. {01} {16}
Temporary increases in pressure {01} {16} {19} {26} that occur more than 3 weeks after silicone oil placement result from the silicone oil causing a mechanical blockage of the pupil, causing a mechanical blockage of a previously executed inferior iridectomy, or forcing its way anteriorly, thereby resulting in chamber angle closure. These conditions may normalize spontaneously or can be corrected by surgical treatment. If surgical treatment is needed, some of the oil may be withdrawn to relieve the mechanical force of the oil interface. Presence of silicone oil droplets in the anterior chamber may also cause a chronic outflow obstruction of the trabecular meshwork. In the majority of patients with outflow obstruction, elevated intraocular pressure can be managed with antiglaucoma medication. {01}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Anterior chamber oil migration{01}{03}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment; eye pain; eye redness; headache; tearing)—incidence 17 to 20%
    
cataract{01}{03}{11}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment)—incidence 50 to 70%
    
glaucoma{01}{03}{19}{29} (abdominal pain; eye pain; eye redness; headache; nausea or vomiting; tearing)—incidence approximately 20%
    
keratopathy{01}{06}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment; eye pain; eye redness; swelling of eye; tearing)—incidence 8 to 20%

Incidence less frequent
—incidence greater than 2%    
Angle blockade{01}{29} (abdominal pain; eye pain; eye redness; headache; nausea or vomiting; tearing)
    
macular pucker{01}{29}
optic nerve atrophy{01}{29}
traction detachment{01}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment)
    
phthisis{01}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment; eye pain; eye redness; tearing)
    
redetachment of retina{01}{29}
vitreous hemorrhage{01}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment; seeing floaters or light flashes)
    
rubeosis iridis{01}{03}{29} (eye pain; eye redness; headache)
    
temporary intraocular pressure (IOP) increase{01}{16}{19}{26}{29} (abdominal pain; eye pain; eye redness; headache; nausea or vomiting; tearing)

Incidence rare
—incidence less than 2%    
Aniridia{01}{29} (sensitivity to light)
    
choroidal detachment{01}{29}
cystoid macular edema{01}{29}
proliferative vitreoretinopathy (PVR) reproliferation{01}{16}{17}{29}
subretinal silicone oil{01}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment)
    
endophthalmitis{01}{29} (blurred vision or other change in vision not present before treatment, or returning or getting worse after treatment; eye pain; eye redness; headache; tearing)
    
retinal tear{01}{29} (seeing floaters or light flashes)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Silicone Oil 5000 Centistokes (Parenteral-Local).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this product
»   Conditions affecting use, especially:
Sensitivity to silicone oil
Other medical problems, especially pseudophakia with silicone intraocular lenses (IOLs)

Proper use of this product

» Proper dosing

Precautions before receiving this product
» Discussing with physician the possible serious or long-term side effects that may be caused by product

Precautions after receiving this product
» Importance of having progress checked regularly by physician


Side/adverse effects
Signs of potential side effects, especially anterior chamber oil migration, cataract, glaucoma, keratopathy, angle blockade, macular pucker, optic nerve atrophy, traction detachment, phthisis, redetachment of retina, vitreous hemorrhage, rubeosis iridis, temporary intraocular pressure (IOP) increase, aniridia, choroidal detachment, cystoid macular edema, proliferative vitreoretinopathy (PVR) reproliferation, subretinal silicone oil, endophthalmitis, or retinal tear


General Dosing Information
Silicone oil can be used in conjunction with, or following, standard retinal surgical procedures, including scleral buckle surgery, vitrectomy, membrane peeling, and retinotomy or relaxing retinectomy. {01}

The safety and effectiveness of long-term use of silicone oil have not been established. {01} It is recommended that silicone oil be removed {01} {04} {12} {15} {18} within 1 year following instillation if the retina is stable, attached, and without significant remnants of proliferation. There is insufficient clinical evidence to support justification for longer term tamponade. However, in patients at high risk for subsequent detachment or upon the development of phthisis and shrinkage due to hypotony, the physician should determine whether or not the oil should be removed. In addition, in order to minimize the number of invasive traumatic experiences, it may be desirable to avoid the removal of silicone oil in patients with acquired immunodeficiency syndrome (AIDS)-related cytomegalovirus (CMV) retinitis who are at high risk for subsequent detachment and who have a shortened expected lifespan. {01}

Silicone oil can be removed {01} {04} {12} {15} {18} from the posterior chamber by withdrawal with a normal 10 mL syringe and a wide bore 1 mm cannula. By repeated oil-fluid exchange, most of the remaining small silicone oil droplets can be mobilized and removed from the eye. Alternatively, oil can be passively removed by infusion of an appropriate aqueous solution under the oil bubble while the oil is allowed to effuse out of a sclerotomy incision or a limbal incision (in aphakic patients). {01}

In clinical studies, successful reattachment of the retina occurred in 64 to 75% of the patients who were treated with silicone oil. This rate varied depending on the specific etiology of the disease and the severity of the condition. In AIDS-related CMV retinitis patients who received silicone oil as a primary means for reattaching the retina, attachment rates were as high as 90% within an average 6-month follow-up period. {01}

In clinical studies, 45 to 70% of patients who received silicone oil showed improvement in visual acuity at 6 months after treatment. In 15 to 26% of patients, visual acuity did not change. In 15 to 30% of patients, worsening of visual acuity occurred. Deterioration of visual acuity in treated patients appeared to be related to subsequent detachment of the retina, further progression of retinal disease, or keratopathy and cataract complications. In AIDS-related CMV retinitis patients, improvement or maintenance of visual acuity occurred in 57% of the patients within an average 6-month follow-up period. In 33% of AIDS-related CMV retinitis patients, further decline in visual acuity occurred within 4 or 5 months of oil instillation and was due to the continuing progression of retinal and optic nerve disease or the development of oil-related cataracts. {01}


Parenteral Dosage Forms

SILICONE OIL 5000 CENTISTOKES FOR INJECTION

Usual adult and adolescent dose
Surgical aid (ophthalmic)
Intracavitary, a sufficient quantity injected into the vitreous to achieve a retinal tamponade. Eighty percent to 100% of the vitreous space may be filled with the oil while {01} existing fluid or air is exchanged {02} at the same time. Care should be taken to prevent high intraocular pressure from developing during the exchange. Because the silicone oil is less dense than is the aqueous fluid in the eye, a basal iridectomy at the 6 o'clock meridian (Ando iridectomy) is recommended to minimize oil-induced pupillary block and early angle-closure glaucoma. It may be desirable to have the patient assume a face-down posture during the first 24 hours following surgery. {01}


Usual pediatric dose
See Usual adult and adolescent dose. {02}

Usual geriatric dose
See Usual adult and adolescent dose. {02}

Size(s) usually available:
U.S.—


10 mL single-use vial (Rx) [AdatoSil 5000{01}]

Note: The product contains no additional ingredients. {01}


Canada—
Not commercially available.

Packaging and storage:
Store between 8 and 24 °C (46 and 75 °F), unless otherwise specified by manufacturer. {01} {28} Protect from freezing.

Preparation of dosage form:
The sterile vial of silicone oil should be aseptically removed from the peel-back pouch and deposited onto the sterile tray. The oil should be loaded into a sterile Luer-Lok screw syringe or Luer-Lok syringe adaptable to an automated pump system. Introduction of air bubbles into the oil should be avoided by careful withdrawal of the oil into the syringe. The oil may be injected into the vitreous from the syringe via a syringe needle or a single-use cannulated infusion line. Subretinal fluid may be drained with a flute needle concurrently with the silicone oil infusion. {01}

Stability:
Silicone oil should not be resterilized. {01}

Silicone oil is stable for 2 years. {28} See packaging for expiration date. {28}

Incompatibilities:
Silicone oil should not be mixed with any other substance prior to injection. {01}

Auxiliary labeling:
   • For the eye.



Developed: 02/27/1996



References
  1. AdatoSil package insert (Escalon Ophthalmics—US), Rec 12/8/94.
  1. Reviewer comment on Introductory Version Volume 1 monograph, 4/5/95.
  1. Karel I, Kalvodova B. Long-term results of pars plana vitrectomy and silicone oil for complications of diabetic retinopathy. Eur J Ophthalmol 1994 Jan-Mar; 4(1): 52-8.
  1. Hutton WL, Azen SP, Blumenkranz MS, et al. The effects of silicone oil removal. Silicone Study Report 6. Arch Ophthalmol (Paris) 1994 Jun; 112(6): 778-85.
  1. Ferrone PJ, McCuen BW 2nd, de Juan E Jr, et al. The efficacy of silicone oil for complicated retinal detachments in the pediatric population. Arch Ophthalmol (Paris) 1994 Jun; 112(6): 773-7.
  1. Choi WC, Choi SK, Lee JH. Silicone oil keratopathy. Korean J Ophthalmol 1993 Dec; 7(2): 65-9.
  1. van Meurs JC, Mertens DA, Peperkamp E, et al. Five-year results of vitrectomy and silicone oil in patients with proliferative vitreoretinopathy. Retina 1993; 13(4): 285-9.
  1. McCuen BW 2nd, Azen SP, Stern W, et al. Vitrectomy with silicone oil or perfluoropropane gas in eyes with severe proliferative vitreoretinopathy. Silicone Study Report No. 3. Retina 1993; 13(4): 279-84.
  1. Lim JI, Enger C, Haller JA, et al. Improved visual results after surgical repair of cytomegalovirus-related retinal detachments. Ophthalmology 1994 Feb; 101(2): 264-9.
  1. Regillo CD, Vander JF, Duker JS, et al. Repair of retinitis-related retinal detachments with silicone oil in patients with acquired immunodeficiency syndrome. Am J Ophthalmol 1992 Jan 15; 113(1): 21-7.
  1. Borislav D. Cataract after silicone oil implantation. Doc Ophthalmol 1993; 83(1): 79-82.
  1. Pearson RV, McLeod D, Gregor ZJ. Removal of silicone oil following diabetic vitrectomy. Br J Ophthalmol 1993 Apr; 77(4): 204-7.
  1. Leaver PK. Vitrectomy and fluid/silicone oil exchange for giant retinal tears: 10-year follow-up. Ger J Ophthalmol 1993 Feb; 2(1): 20-3.
  1. Wilson-Holt N, Gregor Z. Spontaneous relieving retinotomies in diabetic silicone filled eyes. Eye 1992; 6(Pt 5): 461-4.
  1. Eckardt C, Behrendt S, Zwick A. Results of silicone oil removal from eyes treated with retinectomies. Ger J Ophthalmol 1992; 1(1): 2-6.
  1. Wiedemann P, Heimann K. Retinal detachment in eyes with congenital glaucoma. Retina 1992; 12(3 Suppl): S51-S54.
  1. De Molfetta V, Bottoni F, Arpa P, et al. The effect of simultaneous internal tamponade on fluid compartmentalization and its relationship to cell proliferation. Retina 1992; 12(3 Suppl): S40-S45.
  1. Kampik A, Hoing C, Heidenkummer HP. Problems and timing in the removal of silicone oil. Retina 1992; 12(3 Suppl): S11-S16.
  1. Nguyen QH, Lloyd MA, Heuer DK, et al. Incidence and management of glaucoma after intravitreal silicone oil injection for complicated retinal detachments. Ophthalmology 1992 Oct; 99(10): 1520-6.
  1. Eller AW, Gardner TW, D'Antonio JA. A survey of intraocular silicone oil use in the United States. Ophthalmology 1992 Jul; 99(7): 1174-6.
  1. Vitrectomy with silicone oil or perfluoropropane gas in eyes with severe proliferative vitreoretinopathy: results of a randomized clinical trial. Silicone Study Report 2. [see comments]. Comment in: Arch Ophthalmol (Paris) 1992 Jun; 110(6): 768-9; Comment in: Arch Ophthalmol (Paris) 1993 Apr; 111(4): 428; discussion 429; Comment in: Arch Ophthalmol (Paris) 1994 Jun; 112(6): 728-9. Arch Ophthalmol (Paris) 1992 Jun; 110(6): 780-92.
  1. Vitrectomy with silicone oil or sulfur hexafluoride gas in eyes with severe proliferative vitreoretinopathy: results of a randomized clinical trial. Silicone Study Report 1. [see comments]. Comment in: Arch Ophthalmol (Paris) 1992 Jun; 110(6): 768-9; Comment in: Arch Ophthalmol (Paris) 1993 Apr; 111(4): 428; discussion 429. Arch Ophthalmol (Paris) 1992 Jun: 110(6): 770-9.
  1. Leaver PK. Use of intravitreal liquid silicone. Int Ophthalmol Clin 1992 Spring; 32(2): 81-93.
  1. Camacho H, Bajaire B, Mejia LF. Silicone oil in the management of giant retinal tears. Ann Ophthalmol 1992 Feb; 24(2): 45-9.
  1. Sell CH, McCuen BW 2nd, Landers MB 3rd, et al. Long-term results of successful vitrectomy with silicone oil for advanced proliferative vitreoretinopathy. Am J Ophthalmol 1987 Jan 15; 103(1): 24-8.
  1. Barr CC, Lai MY, Lean JS, et al. Postoperative intraocular pressure abnormalities in the Silicone Study. Silicone Study Report 4. Ophthalmology 1993 Nov; 100(11): 1629-35.
  1. Blumenkranz MS, Azen SP, Aaberg T, et al. Relaxing retinotomy with silicone oil or long-acting gas in eyes with severe proliferative vitreoretinopathy silicone study report 5. The Silicone Study Group. Am J Ophthalmol 1993 Nov 15; 116(5): 557-64.
  1. Manufacturer's comment, 8/95.
  1. Reviewers' consensus on monograph revision of 6/25/95.
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