Pred-G

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Pred-G

Classes

Ophthalmological Corticosteroid and Anti-infective Combinations

Administration
Ophthalmic Administration

Ophthalmic Suspension:
Gentamicin; prednisolone ophthalmic suspension is indicated for topical administration to the eye; do NOT administer parenterally.
Instruct patient on proper instillation of eye solution and suspension.
Wash hands before and after use.
Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
Shake suspension well prior to use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1—2 minutes following application to the eye.
To avoid contamination or the spread of infection, do not use dropper for more than one person.
 
Ophthalmic Ointment:
Instruct patient on proper application of eye ointment.
Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
To avoid contamination or the spread of infection, do not use tube for more than one person.

Adverse Reactions
Severe

ocular hypertension / Delayed / Incidence not known
visual impairment / Early / Incidence not known
keratitis / Delayed / Incidence not known
angioedema / Rapid / Incidence not known

Moderate

impaired wound healing / Delayed / Incidence not known
conjunctival hyperemia / Early / Incidence not known
blurred vision / Early / Incidence not known
cataracts / Delayed / Incidence not known
superinfection / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known

Mild

ocular pain / Early / Incidence not known
foreign body sensation / Rapid / Incidence not known
ocular discharge / Delayed / Incidence not known
ocular irritation / Rapid / Incidence not known
dysgeusia / Early / Incidence not known
lacrimation / Early / Incidence not known
rash / Early / Incidence not known

Common Brand Names

Pred-G

Dea Class

Rx

Description

Ophthalmic aminoglycoside antibiotic and corticosteroid combination
For inflammatory ocular conditions with superficial bacterial infection or risk of infection

Dosage And Indications
For steroid-responsive inflammatory ocular inflammation conditions (e.g., uveitis, bacterial conjunctivitis, corneal abrasion) for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular/ophthalmic infection exists.
NOTE: Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
Ophthalmic dosage (ointment) Adults and Geriatric

Apply a small strip of ointment (approximately 1/2 inch) into the conjunctival sac of the affected eye(s) 1—3 times daily. NOTE: No more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation.

Ophthalmic dosage (suspension) Adults

Instill 1 drop into the conjunctival sac 2—4 times daily. During the initial 24—48 hours, the dosing frequency may be increased to up to 1 drop every hour. NOTE: No more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation.

Dosing Considerations
Hepatic Impairment

No dosage adjustments are needed.

Renal Impairment

No dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Gentamicin; Prednisolone products.

How Supplied

Pred-G Ophthalmic Ointment: 0.3-0.6%
Pred-G Ophthalmic Susp: 0.3-1%

Maximum Dosage
Adults

24 drops/day per affected eye of the suspension (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to three times daily (dispense no more than 8 grams without re-evaluation).

Geriatric

24 drops/day per affected eye of the suspension (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to three times daily (dispense no more than 8 grams without re-evaluation).

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Since steroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial agent may be used when this inhibition is considered to be clinically significant.
 
Gentamicin: Gentamicin is bactericidal in action. Similar to other aminoglycosides, it works by inhibiting bacterial protein synthesis through irreversible binding to the 30 S ribosomal subunit of susceptible bacteria. Gentamicin is actively transported into the bacterial cell where it binds to receptors present on the 30 S ribosomal subunit. This binding interferes with messenger RNA (mRNA). As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. One aspect essential to aminoglycoside lethality is the need to achieve intracellular concentrations in excess of extracellular. Anaerobic bacteria are not susceptible to aminoglycosides due, at least in part, to a lack of an active transport mechanism for aminoglycoside uptake. Gentamicin exhibits post-antibiotic effect (PAE), and, resistance to aminoglycosides can occur (see Gentamicin monograph for more information).
Prednisolone: Glucocorticoids are naturally occurring hormones that prevent or suppress inflammation and immune responses when administered at pharmacological doses. At a molecular level, unbound glucocorticoids readily cross cell membranes and bind with high affinity to specific cytoplasmic receptors. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. Such actions can include: inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. Some of the net effects include reduction in edema or scar tissue as well as a general suppression of immune response. The degree of clinical effect is normally related to the dose administered. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Likewise, the numerous adverse effects related to corticosteroid use are usually related to the dose administered and the duration of therapy.

Pharmacokinetics

The combination of gentamicin and prednisolone is administered via the ophthalmic route as a suspension or an ointment.  The pharmacokinetics of these ophthalmic administered drug combinations have not been studied; systemic absorption is expected to be negligible. See individual drug monographs for additional information.

Pregnancy And Lactation
Pregnancy

The manufacturer of gentamicin; prednisolone ophthalmic preparations suggests that gentamicin; prednisolone should be used in pregnancy only if the potential benefit to the mother outweighs the risk to the fetus. In animal studies, ophthalmic administration of corticosteroids have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. No adequate studies in pregnant women are available.

The manufacturer states that due to the potential serious adverse reactions in breast-feeding infants, a decision should be made to either discontinue nursing while gentamicin; prednisolone is administered or to discontinue the medication. It is not known if ophthalmic administered prednisolone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Gentamicin is poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing.  Limited dosage and duration of use is recommended if the use of this combination is necessary. Short term use of usual moderate ocular doses for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.