Quick Ophthalmic Drug Search

YUTIQ (fluocinolone acetone (0.18 mg) intravitreal implant)

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Anti-inflammatory Corticosteroids

Indications/Usage:

Indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Typical Dosing:

►Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, recommended:

For ophthalmic intravitreal injection.
YUTIQ is a non-bioerodible intravitreal implant in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day, and lasting 36 months.
Administration:
- The intravitreal injection procedure should be carried out under aseptic conditions, which include use of sterile gloves, a sterile drape, a sterile caliper, and a sterile eyelid speculum (or equivalent).
- Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.
- The injection procedure for YUTIQ is as follows:
  - Just prior to injection, administer topical and/or subconjunctival anesthesia at the injection site (inferotemporal quadrant recommended).
  - Administer 2-3 drops of a broad-spectrum microbicide into the lower fornix. The lids may be scrubbed with cotton-tipped applicators soaked with a broad-spectrum microbicide. Place a sterile lid speculum. Have the patient look up and apply additional microbicide solution to the injection site. Allow 30-60 seconds for the topical antiseptic to dry prior to injection of YUTIQ.
  - Optimal placement of YUTIQ is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the aid of callipers for point of entry into the sclera.
  - Using sterile procedure, open the sterile foil pouch containing YUTIQ.
  - Remove the YUTIQ applicator from the sterile pouch by grasping the barrel of the applicator; do not grasp the plunger.
  - Remove the black plunger stop from the plunger.
  - Carefully remove the protective cap from the needle and inspect the needle tip to ensure it is not bent.
  - Remove the trombone wire from the distal end of the needle. Prior to injection, keep the applicator tip above the horizontal plane to ensure that the YUTIQ implant does not fall out of the applicator.
  - Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival and scleral needle entry sites will not align. Care should be taken to avoid contact between the needle and the lid margin or lashes.
  - Insert the needle through the conjunctiva and sclera up to the positive stop of the applicator.
  - Depress the plunger at the back of the applicator fully to deliver the YUTIQ implant into the back of the eye.
  - Remove the YUTIQ applicator from the eye and discard in biohazard sharps container.
  - Remove the lid speculum and perform indirect ophthalmoscopy to verify adequate central retinal artery perfusion, absence of any other complications, and to verify the placement of the implant. Scleral depression may enhance visualisation of the implant. Immediate measurement of intraocular pressure (IOP) may be performed at the discretion of the ophthalmologist.
Following the injection, patients should be monitored for change in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report without delay any symptoms suggestive of endophthalmitis.

How Supplied:

Sterile single use preloaded applicator supplied with 25 gauge needle

Preservatives:

None listed in package insert.

Storage:

Store between 59° – 86°F (15° – 30°C).

Cost: Compare Prices

Special Purchasing Instructions: How to Purchase

Mechanism of Action:

Corticosteroids inhibit inflammatory responses to a variety of inciting agents including multiple inflammatory cytokines. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

Corticosteroids are thought to act by inhibition of phospholipase A via induction of inhibitory proteins collectively called lipocortins. It is postulated that these proteins control biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting release of the common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A .

Contraindications:

Contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. YUTIQ is also contraindicated in patients with known hypersensitivity to any components of this product.

Adverse Reactions:

Adverse reactions associated with ophthalmic steroids including YUTIQ include cataract formation and subsequent cataract surgery, elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
The most common ocular adverse reactions reported from clinical trials were cataract (56%), visual acuity reduced (15%), macular edema (11%), uveitis (10%), conjunctival hemorrhage (8%), eye pain (8%), hypotony of eye (7%), anterior chamber inflammation (5%), dry eye (4%), vitreous opacities (4%), conjunctivitis (4%), posterior capsule opacification (4%), ocular hyperemia (4%), vitreous haze (3%), foreign body sensation in eyes (3%), vitritis (3%), vitreous floaters (3%), eye pruritus (3%), conjunctival hyperemia (2%), ocular discomfort (2%), macular fibrosis (2%), glaucoma (2%), photopsia (2%), vitreous hemorrhage (2%), iridocyclitis (1%), eye inflammation (1%), choroiditis (1%), eye irritation (1%), visual field defect (1%), and lacrimation increased (1%).
The most common non-ocular adverse reactions reported from clinical trials were nasopharyngitis (5%), hypertension (3%), and arthralgia (2%).
The most common elevated IOP related adverse reactions reported from clinical trials were IOP elevation ≥ 10 mmHg from baseline (22%), IOP elevation > 30 mmHg (12%), any IOP-lowering medication (43%), and any surgical intervention for elevated IOP (2%).
Consult package insert for additional information.

Warnings & Precautions:

Intravitreal injection-related effects: Intravitreal injections, including those with YUTIQ, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. Hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. Patients should be monitored following the intravitreal injection [See Patient Counseling Information (17) in package insert].
Steroid-related effects:
- Use of corticosteroids including YUTIQ may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
- Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
Risk of implant migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
Patient counseling information:
- Steroid-related effects:
  - Advise patients that a cataract may occur after treatment with YUTIQ. If this occurs, advise patients that their vision will decrease, and they will need an operation to remove the cataract and restore their vision.
  - Advise patients that they may develop increased intraocular pressure with YUTIQ treatment, and the increased IOP may need to be managed with eye drops or surgery.
  - Intravitreal injection-related effects: Advise patients that in the days following intravitreal injection of YUTIQ, they are at risk for potential complications including, but not limited to, the development of endophthalmitis or changes in intraocular pressure.
  - When to seek physician advice: Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist.
  - Driving and using machines: Inform patients that they may experience temporary visual blurring after receiving an intravitreal injection. Advise patients not to drive or use machines until this has been resolved.
Consult package insert for additional information.

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

Pregnancy:
- Risk summary:
  - Adequate and well-controlled studies with YUTIQ have not been conducted in pregnant women to inform drug associated risk. Animal reproduction studies have not been conducted with YUTIQ. It is not known whether YUTIQ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. YUTIQ should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
  - All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation:
- Risk summary: Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production. Clinical or nonclinical lactation studies have not been conducted with YUTIQ. It is not known whether intravitreal treatment with YUTIQ could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide in human milk, or affect breastfed infants or milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for YUTIQ and any potential adverse effects on the breastfed child from YUTIQ.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZADITOR (ketotifen (0.025%) ophthalmic solution)

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Antihistamines and Mast Cell Stabilizer Combinations

Indications/Usage:

Used for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Typical Dosing:

►Itching due to pollen, ragweed, grass, animal hair and dander.

Adults and children ≥ 3 years of age:
- Put 1 drop in the affected eye(s) twice daily, every 8 – 12 hours, no more than twice per day.
Children < 3 years of age:
- Consult a doctor.

How Supplied:

5 mL bottles

Preservatives:

benzalkonium chloride

Storage:

Store between 39° – 77°F (4° – 25°C).

Cost: Compare Prices

Assistance: Payment Assistance

Mechanism of Action:

None listed in package insert.

Contraindications:

None listed in package insert.

Adverse Reactions:

None listed in package insert.

Warnings & Precautions:

Warnings for patients:
- For external use only.
- Do not use:
  - If solution changes color or becomes cloudy.
  - If you are sensitive to any ingredient in this product.
  - To treat contact lens related irritation.
- When using this product:
  - Do not touch tip of container to any surface to avoid contamination.
  - Remove contact lenses before use.
  - Wait at least 10 minutes before reinserting contact lenses after use.
  - Replace cap after each use.
- Stop use and ask a doctor if you experience any of the following:
  - Eye pain.
  - Changes in vision.
  - Redness of the eye.
  - Itching worsens or lasts for more than 72 hours.
- Keep out of reach of children.
  - If swallowed, get medical help or contact a Poison Control Center right away.

Minimum Patient Age: ≥3 Years

Pregnancy/Nursing Considerations:

None listed in package insert.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZERVIATE (cetirizine (0.24%) ophthalmic solution)

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Antihistamines

Indications/Usage:

Indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Typical Dosing:

►Itching associated with allergic conjunctivitis, recommended:

Instill 1 drop in each affected eye twice daily (approximately 8 hours apart).
The single-use containers are to be used immediately after opening and can be used to dose both eyes.
Discard the single-use container and any remaining contents after administration.

How Supplied:

Multi dose bottle:
- 5 mL bottles
- 7.5 mL bottles
Single use vials:
- 30 vials in 1 carton (0.2 mL each)
  - 5 vials packaged in foil pouch (6 pouches per carton)

Preservatives:

benzalkonium chloride

Storage:

Store at 59° – 77°F (15° – 25°C).
Store single-dose containers in the original foil pouch until ready to use.

Cost: Compare Prices

Assistance: Payment Assistance

Mechanism of Action:

ZERVIATE is a histamine-1 (H1) receptor antagonist (antihistamine) and an inhibitor of release of histamine from mast cells. Its effects are mediated via selective inhibition of H 1 histamine receptors. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.

Contraindications:

None listed in package insert.

Adverse Reactions:

The most commonly reported adverse reactions occurred in approximately 1% – 7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced.
Consult package insert for additional information.

Warnings & Precautions:

Contamination of tip and solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep the bottle closed when not in use.
Contact lens wear:
- Patients should be advised not to wear a contact lens if their eye is red.
- ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE.
- The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses.
- Lenses may be reinserted after 10 minutes following administration of ZERVIATE.

Minimum Patient Age: ≥2 Years

Pregnancy/Nursing Considerations:

Pregnancy:
- Risk summary: There were no adequate or well-controlled studies with ZERVIATE™ (cetirizine ophthalmic solution) 0.24% in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation:
- Risk summary:
  - Cetirizine has been reported to be excreted in human breast milk following oral administration. Multiple doses of oral dose cetirizine (10 mg tablets once daily for 10 days) resulted in systemic levels (Mean C_max = 311 ng/mL) that were 100 times higher than the observed human exposure (Mean C_max = 3.1 ng/mL) following twice-daily administration of cetirizine ophthalmic solution 0.24% to both eyes for one week [See Clinical Pharmacology 12.3 in package insert]. Comparable bioavailability has been found between the tablet and syrup dosage forms. However, it is not known whether the systemic absorption resulting from topical ocular administration of ZERVIATE could produce detectable quantities in human breast milk.
  - There is no adequate information regarding the effects of cetirizine on breastfed infants, or the effects on milk production to inform risk of ZERVIATE to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZERVIATE and any potential adverse effects on the breastfed child from ZERVIATE.
Consult package insert for additional information.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZIOPTAN (tafluprost (0.0015%) ophthalmic solution)

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Prostaglandin Analogs

Indications/Usage:

Indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Typical Dosing:

►Elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, recommended:

Instill 1 drop in the conjunctival sac of the affected eye(s) once daily in the evening.
The dose should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the IOP-lowering effect.
Reduction of the IOP starts approximately 2 – 4 hours after the first administration with the maximum effect reached after 12 hours.
May be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.
The solution from 1 individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.

How Supplied:

0.3 mL in 10 single-use containers per pouch

Preservatives:

None listed in package insert.

Storage:

Store refrigerated at 36º – 46°F (2º – 8°C).
During shipment ZIOPTAN^®may be maintained at temperatures up to 104ºF (40ºC) for a period not exceeding 2 days. Mail-order prescriptions received after two days of the dispensing date noted on the prescribing label should not be used.
Store in the original pouch.
After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 30 days at room temperature 68º – 77°F (20º – 25°C).
Protect from moisture.
Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 30 days after first opening the pouch.

Cost: Compare Prices

Mechanism of Action:

Tafluprost acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Contraindications:

None listed in package insert.

Adverse Reactions:

The most common ocular adverse reaction observed in patients treated with tafluprost was conjunctival hyperemia which was reported in a range of 4% to 20% of patients. Approximately 1% of patients discontinued therapy due to ocular adverse reactions.
Ocular adverse reactions reported at an incidence of ≥ 2% in these clinical studies included ocular stinging/irritation (7%), ocular pruritus including allergic conjunctivitis (5%), cataract (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), growth of eyelashes (2%) and vision blurred (2%).
Non-ocular adverse reactions reported at an incidence of 2% to 6% in these clinical studies in patients treated with tafluprost 0.0015% were headache (6%), common cold (4%), cough (3%) and urinary tract infection (2%).
Consult package insert for additional information.

Warnings & Precautions:

Pigmentation:
- Tafluprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as tafluprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of tafluprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.
- Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with ZIOPTAN^® can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Eyelash changes: ZIOPTAN^® may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular inflammation: ZIOPTAN^® should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis) because the inflammation may be exacerbated.
Macular edema: Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. ZIOPTAN^® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

Pregnancy:
- Teratogenic effects: Pregnancy Category C:
  - In embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. Tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. Tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. In rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on C_max. In rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on C_max. At the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/mL).
  - In a pre- and postnatal development study in rats, increased mortality of newborns, decreased body weights and delayed pinna unfolding were observed in offsprings. The no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison.
  - There are no adequate and well-controlled studies in pregnant woman. Although animal reproduction studies are not always predictive of human response, ZIOPTAN^® should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
  - Women of childbearing age/potential should have adequate contraceptive measures in place.
Nursing mothers: A study in lactating rats demonstrated that radio-labeled tafluprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ZIOPTAN^® is administered to a nursing woman.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZIRGAN (ganciclovir (0.15%) ophthalmic gel)

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Antivirals

Indications/Usage:

Indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

Typical Dosing:

►Acute herpetic keratitis, recommended:

Instill 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

How Supplied:

5 g tubes

Preservatives:

benzalkonium chloride

Storage:

Store at 59° – 77°F (15° – 25°C).
Do not freeze.

Cost: Compare Prices

Assistance: Payment Assistance

Mechanism of Action:

ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains the active ingredient, ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.

Contraindications:

None listed in package insert.

Adverse Reactions:

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Warnings & Precautions:

Topical ophthalmic use only: ZIRGAN is indicated for topical ophthalmic use only.
Avoidance of contact lenses: Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ZIRGAN.

Minimum Patient Age: ≥2 Years

Pregnancy/Nursing Considerations:

Pregnancy:
- Teratogenic effects: Pregnancy Category C:
  - Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/g/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. Effects observed in rabbits included: fetal growth retardation, embryo lethality, teratogenicity, and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/ microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryo lethality. Daily intravenous doses of 90 mg/kg/day (14,000x the human oculardose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach (See Carcinogenesis, Mutagenesis, Impairment of Fertilty in package insert).
  - There are no adequate and well-controlled studies in pregnant women. ZIRGAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when ZIRGAN is administered to nursing mothers.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZITHROMAX (azithromycin (250 mg; 500 mg; 600 mg) tablets; (100 mg/5 mL; 200 mg/5 mL) oral suspension)

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Antibiotics

Indications/Usage:

Indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms: uncomplicated skin and skin structure infections in adults due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications.

This medication has a broad FDA approval for "skin and skin structure infections." Under our interpretation of this indication we have linked this medication with conditions we understand to be categorized as "skin and skin structure infections." This is our medical opinion and may not be true in all clinical circumstances.

Typical Dosing:

►Skin/skin structure (uncomplicated):

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

►Inclusion (chlamydial) conjunctivitis:

1000 mg single dose.

►Hordeolum:

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Dosing for inclusion (chlamydial) conjunctivitis and hordeolum are based on professional judgment. This is our medical opinion and may not be true in all clinical circumstances.

How Supplied:

Tablets:
- 250 mg tablets
- 500 mg tablets
- 600 mg tablets
Oral supension:
- 100 mg/5 mL oral suspension (15 mL bottles)
- 200 mg/5 mL oral suspension (15 mL, 22.5 mL, 30 mL bottles)

Preservatives:

None listed in package insert.

Storage:

Tablets:
- Store at 59° – 86°F (15° – 30°C).
Suspension:
- Store dry powder below 86°F (30°C).
- Store constituted suspension between 41° – 86°F (5° – 30°C).
- Discard when full dosing is completed.

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Mechanism of Action:

Azithromycin is a macrolide antiibiotic that acts by binding the 23S rRNA of the 50S ribosomal subunit of susceptible microorganisms inhibiting bacterial protein synthesis and impeding the assembly of the 50S ribosomal subunit.

Contraindications:

Contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.

Contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Adverse Reactions:

In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious adverse reactions of angioedema and cholestatic jaundice were reported. Approximately 0.7% of the patients (adults and pediatric patients) from the 5-day multiple-dose clinical trials discontinued ZITHROMAX (azithromycin) therapy because of treatment-related adverse reactions. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related adverse reactions was 0.6%.
In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related adverse reactions was approximately 1%. Most of the adverse reactions leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. [see Clinical Studies (14.2) in package insert].
Adults:
- Multiple-dose regimens:
  - Overall, the most common treatment-related adverse reactions in adult patients receiving multiple-dose regimens of ZITHROMAX were related to the gastrointestinal system with diarrhea/loose stools (4% – 5%), nausea (3%) and abdominal pain (2% – 3%) being the most frequently reported.
  - No other treatment-related adverse reactions occurred in patients on the multiple-dose regimens of ZITHROMAX with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following:
    - Cardiovascular: Palpitations, chest pain.
    - Gastrointestinal: Dyspepsia, flatulence, vomiting, melena and cholestatic jaundice.
    - Genitourinary: Monilia, vaginitis and nephritis.
    - Nervous system: Dizziness, headache, vertigo and somnolence.
    - General: Fatigue.
    - Allergic: Rash, pruritus, photosensitivity and angioedema.
- Single 1-gram dose regimen:
  - Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of ZITHROMAX were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.
  - Adverse reactions that occurred in patients on the single one-gram dosing regimen of ZITHROMAX with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%) and vaginitis (1%).
- Single 2-gram dose regimen: Overall, the most common adverse reactions in patients receiving a single 2-gram dose of ZITHROMAX were related to the gastrointestinal system. Adverse reactions that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%) and dizziness (1%). The majority of these complaints were mild in nature.
Pediatric patients:
- Single and multiple-dose regimens: The types of adverse reactions in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients.
- With any of the treatment regimens, no other adverse reactions occurred in pediatric patients treated with ZITHROMAX with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following:
  - Cardiovascular: Chest pain.
  - Gastrointestinal: Dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools and oral moniliasis.
  - Hematologic and lymphatic: Anemia and leukopenia.
  - Nervous system: Headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia.
  - General: Fever, face edema, fatigue, fungal infection, malaise and pain.
  - Allergic: Rash and allergic reaction.
  - Respiratory: Cough increased, pharyngitis, pleural effusion and rhinitis.
  - Skin and appendages: Eczema, fungal dermatitis, pruritus, sweating, urticaria and vesiculobullous rash.
  - Special senses: Conjunctivitis.
Consult package insert for additional information.

Warnings & Precautions:

Hypersensitivity:
- Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including acute generalized exanthematous pustulosis (AGEP), Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. (See CONTRAINDICATIONS (4.1) in package insert).
- Fatalities have been reported. Cases of drug reaction with eosinophilia and systemic symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.
- If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Hepatotoxicity: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Infantile hypertrophic pyloric stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
QT prolongation:
- Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
  - Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure.
  - Patients on drugs known to prolong the QT interval.
  - Patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Clostridioides difficile (formerly Clostridium difficile) associated diarrhea (CDAD):
- CDAD has been reported with use of nearly all antibacterial agents, including ZITHROMAX, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
- C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Use in sexually transmitted infections: ZITHROMAX, at the recommended dose, should not be relied upon to treat syphilis. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea performed at the time of diagnosis. Appropriate antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
Development of drug-resistant bacteria: Prescribing ZITHROMAX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
General patient counseling:
- ZITHROMAX tablets and oral suspension can be taken with or without food.
- Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.
- The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
- Direct patients or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.
- Patients should be counseled that antibacterial drugs including ZITHROMAX (azithromycin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZITHROMAX (azithromycin) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZITHROMAX (azithromycin) or other antibacterial drugs in the future.
- Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Consult package insert for additional information.

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

Pregnancy:
- Risk summary:
  - Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data in package insert). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see Data in package insert).
  - The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Lactation:
- Risk summary: Azithromycin is present in human milk (see Data in package insert). Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see Clinical Considerations in package insert). There are no available data on the effects of azithromycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZITHROMAX and any potential adverse effects on the breastfed infant from ZITHROMAX or from the underlying maternal condition.
- Clinical considerations: Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZOVIRAX (acyclovir (200 mg) capsules; (400 mg; 800 mg) tablets; (200 mg/5 mL) oral suspension)

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Antivirals

Indications/Usage:

Indicated for the acute treatment of herpes zoster (shingles) and for the treatment of chickenpox (varicella).

Typical Dosing:

►Herpes zoster (acute):

800 mg every 4 hours orally, 5 times daily for 7 – 10 days.

►Herpes simplex keratitis (acute):

Adults:
- 400 mg orally 5 times daily for 7 – 10 days.
Children:
- 12 – 15 mg/kg/day in divided doses for 7 – 10 days.

►Herpes simplex keratitis (prophylaxis):

Adults:
- 400 mg orally twice daily after recurrent bouts of herpes simplex keratitis.

►Chickenpox:

Children (≥ 2 years of age):
- 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and children > 40 kg:
- 800 mg 4 times daily for 5 days.
- Intravenous ZOVIRAX is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
- When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.

►Additional information for Renal Impairment is in Notes below.

Dosing for herpes simplex keratitis is based on professional judgment. This is our medical opinion and may not be true in all clinical circumstances.

How Supplied:

Capsules:
- 200 mg capsules
Tablets:
- 400 mg tablets
- 800 mg tablets
Oral suspension:
- 200 mg/5 mL oral suspension (473 mL bottles)

Preservatives:

None listed in package insert (capsules, tablets); methylparaben, propylparaben (oral suspension)

Storage:

Store at 59° – 77°F (15° – 25°C).
Protect tablets and capsules from moisture.

Cost: Compare Prices

Mechanism of Action:

Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV).

The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK.

Contraindications:

Contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Adverse Reactions:

Herpes simplex:
- Short-term administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with ZOVIRAX 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo.
- Long-term administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with ZOVIRAX were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with ZOVIRAX for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).
Herpes zoster: The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral ZOVIRAX 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).
Chickenpox: The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral ZOVIRAX at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%)
Observed during clinical practice:
- In addition to adverse events reported from clinical trials, the following events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to ZOVIRAX, or a combination of these factors.
- General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.
- Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (See PRECAUTIONS in package insert).
- Digestive: Diarrhea, gastrointestinal distress, nausea.
- Hematologic and lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.
- Hepatobiliary tract and pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.
- Musculoskeletal: Myalgia.
- Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
- Special senses: Visual abnormalities.
- Urogenital: Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (See WARNINGS in package insert).

Warnings & Precautions:

ZOVIRAX capsules, tablets, and suspension are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (See ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE in package insert). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
Dosage adjustment is recommended when administering ZOVIRAX to patients with renal impairment (See DOSAGE AND ADMINISTRATION in package insert). Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.
Information for patients:
- Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered ZOVIRAX, or they have any other questions.
- Patients should be advised to maintain adequate hydration.
- Herpes zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.
- Chickenpox: Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.
Consult package insert for additional information.

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

Pregnancy:
- Teratogenic effects: Pregnancy Category B:
  - Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels.
  - There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of ZOVIRAX and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. ZOVIRAX should be administered to a nursing mother with caution and only when indicated.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

Additional information for renal impairment:

►Patients with acute or chronic renal impairment:

Dose modifications for patients with impaired renal function:
- Normal dosage regimen: 200 mg every 4 hours:
  - CrCl: > 10 mL/min/1.73 m²:
    - Adjusted dosage regimen: 200 mg every 4 hours, 5x daily.
  - CrCl: 0 – 10 mL/min/1.73 m²:
    - Adjusted dosage regimen: 200 mg every 12 hours.
- Normal dosage regimen: 400 mg every 12 hours:
  - CrCl: > 10 mL/min/1.73 m²:
    - Adjusted dosage regimen: 400 mg every 12 hours.
  - CrCl: 0 – 10 mL/min/1.73 m²:
    - Adjusted dosage regimen: 200 mg every 12 hours.
- Normal dosage regimen: 800 mg every 4 hours:
  - CrCl: > 25 mL/min/1.73 m²:
    - Adjusted dosage regimen: 800 mg every 4 hours, 5x daily.
  - CrCl: 10 – 25 mL/min/1.73 m²:
    - Adjusted dosage regimen: 800 mg every 8 hours.
  - CrCl: 0 – 10 mL/min/1.73 m²:
    - Adjusted dosage regimen: 800 mg every 12 hours.
Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.
Bioequivalence of dosage forms: ZOVIRAX Suspension was shown to be bioequivalent to ZOVIRAX Capsules (n = 20) and 1 ZOVIRAX 800-mg tablet was shown to be bioequivalent to 4 ZOVIRAX 200-mg capsules (n = 24).
Consult package insert for additional information.

ZYLET (loteprednol etabonate (0.5%) – tobramycin (0.3%) ophthalmic suspension)

?

Antibiotic–Steroid Combination Medications

Indications/Usage:

Indicated for use as a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and 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.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulasenegative), including penicillin-resistant strains. Streptococci, including some of the Group Abeta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

This medication has a broad FDA approval for "inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe." We have linked this medication with conditions we understand to be categorized as "inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe." This is our medical opinion and may not be true in all clinical circumstances.

Typical Dosing:

►Steroid-responsive inflammatory ocular conditions, recommended:

Apply 1 – 2 drops of ZYLET^® into the conjunctival sac of the affected eye every 4 – 6 hours. During the initial 24 – 48 hours, the dosing may be increased, to every 1 – 2 hours.
Frequency should be decreased gradually as warranted by improvement in clinical signs.
Care should be taken not to discontinue therapy prematurely.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation [See Warnings and Precautions (5.3) in package insert].

How Supplied:

5 mL bottles
10 mL bottles

Preservatives:

benzalkonium chloride

Storage:

Store upright at 59º – 77ºF (15º – 25ºC).
Protect from freezing.
Shake vigorously before using.

Cost: Compare Prices

Assistance: Payment Assistance

Mechanism of Action:

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Arachidonic acid is released from membrane phospholipids by phospholipase A₂. Corticosteroids are capable of producing a rise in intraocular pressure.

Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.

The anti-infective component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulasenegative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Contraindications:

Contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Adverse Reactions:

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.
- Zylet:
  - Ocular adverse reactions include injection (approximately 20%) and superficial punctuate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation.
  - Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.
  - The incidence of non-ocular reactions reported in approximately 14% of subjects was headache; all other non- ocular reactions had an incidence of less than 5%.
- Loteprednol etabonate ophthalmic suspension 0.2% – 0.5%:
  - Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
  - In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.
- Tobramycin ophthalmic solution 0.3%: The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
Secondary Infection:
- The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.
- The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
- Secondary bacterial ocular infection following suppression of host responses also occurs.

Warnings & Precautions:

Intraocular pressure (IOP) increase:
- Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma.
- If this product is used for 10 days or longer, intraocular pressure should be monitored.
Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation.
Delayed healing: The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Bacterial infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Viral infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
Aminoglycoside hypersensitivity: Sensitivity to topically applied aminoglycosides may occur in some patients. If hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

Pregnancy:
- Teratogenic effects:
  - Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb fixtures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥ 50 mg/kg/day) and embryotoxicity (increased post- implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥ 50 mg/kg/day). Treatment of rats at 0.5 mg/kg/day (6 times the maximum daily clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day.
  - Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.
  - Reproductive studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. Zylet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids that appear in human milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Zylet is administered to a nursing woman.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZYMAXID (gatifloxacin (0.5%) ophthalmic solution)

?

Antibiotics

Indications/Usage:

Indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus mitis group*; Streptococcus oralis*; Streptococcus pneumoniae. Aerobic gram-negative bacteria: Haemophilus influenzae.

*Efficacy for this organism was studied in fewer than 10 infections.

Typical Dosing:

►Bacterial conjunctivitis caused by susceptible strains of listed organisms:

Patients ≥ 1 year of age:
- Instill 1 drop every 2 hours in the affected eye(s) while awake, up to 8 times on day 1.
- Instill 1 drop 2 – 4 times daily in the affected eye(s) while awake on days 2 – 7.

►Recurrent corneal erosion:

Follow normal dosing patterns.

How Supplied:

2.5 mL bottles

Preservatives:

benzalkonium chloride

Storage:

Store at 59° – 77°F (15° – 25°C).
Protect from freezing.

Cost: Compare Prices

Assistance: Payment Assistance

Mechanism of Action:

Gatifloxacin is a quinolone antimicrobial. Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross-resistance has been observed between systemic gatifloxacin and some other fluoroquinolones.

Resistance to gatifloxacin in vitro develops via multiple-step mutations. Resistance to gatifloxacin in vitro occurs at a general frequency of 1 x 10-7 to 10-10.

Gatifloxacin has been shown to be active against most isolates of the following organisms both microbiologically and clinically, in conjunctival infections as described in the INDICATIONS AND USAGE (Section 1) in package insert.

Aerobic Gram-Positive Bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:
Haemophilus influenzae

*Efficacy for this organism was studied in fewer than 10 infections.

Contraindications:

Contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [See Warnings and Precautions (5.1) in package insert].

Adverse Reactions:

Most common adverse reactions occurring in ≥ 1 % of patients in gatifloxacin study included worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.
Additional adverse reactions reported with other formulations of gatifloxacin ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.
Consult package insert for additional information.

Warnings & Precautions:

Hypersensitivity: Some patients receiving topical ophthalmic gatifloxacin experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose. Rare cases of Stevens-Johnson Syndrome were reported in association with topical ophthalmic gatifloxacin use. If an allergic reaction to gatifloxacin occurs, discontinue the drug [See Patient Counseling Information (17) in package insert].
Growth of resistant organisms with prolonged use: Prolonged use of ZYMAXID^® may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, as slit lamp biomicroscopy and where appropriate, fluoroscein staining.
Corneal endothelial cell injury: ZYMAXID^® is for topical ophthalmic use. ZYMAXID^® may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.

Minimum Patient Age: ≥1 Year

Pregnancy/Nursing Considerations:

Pregnancy:
- Risk summary: There are no available data on the use of ZYMAXID^® in pregnant women to inform a drug-associated risk. Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.
Lactation:
- Risk summary: There is no information regarding the presence of ZYMAXID^® in human milk, the effect of gatifloxacin on breastfed infants, or the effect of gatifloxacin on milk production. Gatifloxacin was found in the breast milk of rats following oral administration of gatifloxacin during lactation. However, systemic levels of gatifloxacin following topical ocular administration are low [See Clinical Pharmacology (12.3) in package insert], and it is not known whether gatifloxacin would be present in maternal milk at measurable levels following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZYMAXID^® and any potential adverse effects on the breastfed child from ZYMAXID^®.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE

ZYRTEC (cetirizine hydrochloride (10 mg) capsules, liquid filled; (10 mg) tablets, orally disintegrating; (10 mg) tablets)

?

Antihistamines

Indications/Usage:

Used for the temporary relief of the following symptoms due to hay fever or other upper respiratory allergies: runny nose; sneezing; itchy, watery eyes; itching of the nose or throat.

Typical Dosing:

►Runny nose; sneezing; itchy, watery eyes; itching of the nose or throat:

Adults and children ≥ 6 years of age:
- One 10 mg capsule or tablet once a day.
- A 5 mg product may be appropriate for less severe symptoms.
- Do not take more than one 10 mg capsule or tablet in 24 hours.
- Orally disintegrating tablet melts in mouth. Can be taken with or without water.
Adults ≥ 65 years of age:
- Ask a doctor.
Children < 6 years of age:
- Ask a doctor.
Individuals with liver or kidney disease:
- Ask a doctor.

How Supplied:

Capsules:
- 10 mg capsules
Tablets, orally disintegrating:
- 10 mg orally disintegrating tablets
Tablets:
- 10 mg tablets

Preservatives:

None listed in package insert.

Storage:

Store at 68° – 77°F (20° – 25°C).
Avoid high humidity and excessive heat above 104°F (40°C).
Protect from light.

Cost: Compare Prices

Mechanism of Action:

None listed in package insert.

Contraindications:

None listed in package insert.

Adverse Reactions:

None listed in package insert.

Warnings & Precautions:

Warnings for patients:
- Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
- Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
- When using this product:
  - Drowsiness may occur.
  - Avoid alcoholic drinks.
  - Alcohol, sedatives, and tranquilizers may increase drowsiness.
  - Be careful when driving a motor vehicle or operating machinery.
- Stop use and ask a doctor if: an allergic reaction to this product occurs. Seek medical help right away.
- If pregnant or breast-feeding:
  - If breast-feeding: not recommended.
  - If pregnant: ask a health professional before use.
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

If pregnant or breast-feeding:
- If breast-feeding: not recommended.
- If pregnant: ask a health professional before use.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE (Capsules)
AVAILABLE HERE (Tablets)
AVAILABLE HERE (Tablets, orally disintegrating)

ZYRTEC CHILDREN'S (cetirizine hydrochloride (5 mg/5 mL) oral solution; (10 mg) tablets, orally disintegrating)

?

Antihistamines

Indications/Usage:

Used for the temporary relief of the following symptoms due to hay fever or other upper respiratory allergies: runny nose; sneezing; itchy, watery eyes; itching of the nose or throat.

Typical Dosing:

►Runny nose; sneezing; itchy, watery eyes; itching of the nose or throat:

Tablets, orally disintegrating:
- Adults and children ≥ 6 years of age:
  - One 10 mg tablet once a day.
  - A 5 mg product may be appropriate for less severe symptoms.
  - Do not take more than one 10 mg tablet in 24 hours.
  - Orally disintegrating tablet melts in mouth. Can be taken with or without water.
- Adults ≥ 65 years of age:
  - Ask a doctor.
- Children < 6 years of age:
  - Ask a doctor.
- Individuals with liver or kidney disease:
  - Ask a doctor.
Oral solution:
- Adults and children ≥ 6 years of age:
  - 5 mL or 10 mL once a day depending upon severity of symptoms.
  - Do not take more than 10 mL in 24 hours.
- Adults ≥ 65 years of age:
  - 5 mL once a day.
  - Do not take more than 5 mL in 24 hours.
- Children 2 to < 6 years of age:
  - 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours.
  - Do not give more than 5 mL in 24 hours.
- Children < 2 years of age:
  - Ask a doctor.
- Individuals with liver or kidney disease:
  - Ask a doctor.
- Use only with enclosed dosing cup.

How Supplied:

Oral solution:
- 5 mg/5 mL oral solution
Tablets, orally disintegrating:
- 10 mg orally disintegrating tablets

Preservatives:

None listed in package insert (tablets); sodium benzoate (oral solution)

Storage:

Store at 68° – 77°F (20° – 25°C).
Avoid high humidity and excessive heat above 104°F (40°C).
Protect from light.

Cost: Compare Prices

Mechanism of Action:

None listed in package insert.

Contraindications:

None listed in package insert.

Adverse Reactions:

Drowsiness may occur.

Warnings & Precautions:

Warnings for patients:
- Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
- When using this product:
  - Drowsiness may occur.
  - Avoid alcoholic drinks.
  - Alcohol, sedatives, and tranquilizers may increase drowsiness.
  - Be careful when driving a motor vehicle or operating machinery.
- Stop use and ask a doctor if: an allergic reaction to this product occurs. Seek medical help right away.
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Minimum Patient Age: Not established/unknown

Pregnancy/Nursing Considerations:

If pregnant or breast-feeding:
- If breast-feeding: not recommended.
- If pregnant: ask a health professional before use.

Black Box Warnings:

None listed in package insert.

Notes:

DRUG INFORMATION IS DERIVED FROM PACKAGE INSERT(S):
AVAILABLE HERE (Solution)
AVAILABLE HERE (Tablets, orally disintegrating)

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