Potential API Contraindications

 

Prednisolone Phosphate

  • Adverse Reactions: 
    • Secondary ocular infection 
    • Glaucoma 
    • Increased intraocular pressure 
    • Optic nerve damage 
    • Subcapsular posterior cataract
    • Blurred vision 
    • Dysgeusia (altered taste) 
    • Eye irritation 
    • Eye pain
    • Foreign body sensation of eye
    • Headache 
    • Hypersensitivity reaction 
    • Pruritis (itching)
    • Skin rash 
    • Transient burning 
    • Stinging of the eyes 
    • Urticaria (rash of round red welts or swelling) 
    • Visual Disturbance 
  • Contraindications:
    • Cataracts
    • Corneal thinning 
    • Glaucoma 
    • Immunosuppression 
    • Systemic Absorption 

Moxifloxacin

  • Adverse Reactions: 
    • Eye irritation 
    • Conjunctivitis 
    • Decreases visual acuity 
    • Eye discomfort or pain 
    • Pruritus
    • Lacrimation 
    • Ocular hyperemia (dilation and redness of the conjunctival vessels) 
    • Subconjunctival hemorrhage (bright red patch appearing in the white of the eye)
    • Xerophthalmia (abnormal dryness of the conjunctiva and cornea of the eye) 
  • Contraindications: 
    • Hypersensitivity to moxifloxacin or other quinolones in any component or other forms 

Bromfenac

  • Adverse Reactions: 
    • Anterior chamber inflammation 
    • Iritis (inflammation of the iris)
    • Ocular hypertension 
    • Vitreous Opacity (seeing floaters on the eye)
    • Eye pain 
    • Abnormal sensation in the eyes
    • Conjunctival Hyperemia (dilation and redness of the conjunctival vessels)
    • Eye irritation (burning/stinging) 
    • Eye pruritus 
    • Eye redness 
  • Contraindications:
    • Allergic cross-reactivity to nonsteroidal anti-inflammatory drugs (NSAIDS) 

Gatifloxacin

  • Adverse Reactions:
    • Conjunctival hemorrhage (red patch appearing in the white of the eye) 
    • Conjunctival irritation 
    • Conjunctivitis 
    • Decreased visual acuity 
    • Dry eye syndrome 
    • Eye discharge 
    • Eye irritation 
    • Eye pain and redness 
    • Eyelid edema (eyelid swelling)
    • Blepharitis (inflammation of eyelid)
    • Increased lacrimation 
    • Keratitis (inflammation of the cornea of the eye)
    • Papillary conjunctivitis (allergic reaction of the eye)
      • Small round bumps develop on the underside of the eyelid 
    • Blurred vision 
  • Contraindications:
    • Hypersensitivity to Gatifloxacin or quinolones in any component or form 

Dexamethasone

  • Adverse Reactions: Implant or Injection 
    • Cataract (incidence increases in patients requiring a second injection) 
    • Conjunctival hemorrhage
    • Corneal edema 
    • Increased intraocular pressure 
    • Iritis 
    • Anterior chamber inflammation 
    • Blepharitis
    • Blepharoptosis (drooping of the upper eyelid) 
    • Blurred vision 
    • Conjunctival edema 
    • Conjunctival hyperemia 
    • Conjunctivitis 
    • Corneal erosion 
    • Cystoid macular edema 
    • Decreased visual acuity 
    • Eye pain 
    • Foreign body sensation 
    • Keratitis
    • Ocular hypertension
    • Ophthalmic inflammation 
    • Photophobia 
    • Retinal hole without detachment 
    • Secondary cataract 
    • Vitreous detachment 
    • Vitreous opacity 
    • Xerophthalmia (abnormal dryness of the conjunctiva and cornea of the eye)
  • Adverse Reactions: solution or suspension 
    • Eye discomfort 
    • Eye irritation 
    • Abnormal sensation in the eyes (foreign body sensation of eye) 
    • Blurred vision 
    • Conjunctivitis 
    • Crusting of eyelid 
    • Dry eye syndrome 
    • Eye pruritis 
    • Increased lacrimation 
    • Keratitis 
    • Ocular hyperemia 
    • Photophobia 
    • Burning sensation 
    • Cataract 
    • Decreased visual acuity 
    • Eye perforation 
    • Glaucoma (with optic nerve damage) 
    • Inadvertent filtering bleb 
    • Stinging of the eyes 
    • Visual field defect 
    • Blepharoptosis (drooping of the upper eye lid)
    • Corneal erosion 
    • Endophthalmitis (infection inside the eye) 
    • Eye pain 
    • Hypotony of eye (vitreous leakage from injection) 
    • Injury to the eye region 
    • Mydriasis (dilation of the pupil) 
    • Retinal detachment 
  • Contraindications: Implant or Injection 
    • Intracanalicular insert: 
      • Active corneal, conjunctival or canalicular infections including epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections and fungal diseases
      • In patients with a posterior lens capsule that is torn or ruptured 
    • Intravitreal ocular implant: 
      • Hypersensitivity to dexamethasone or any component of the formulation
      • Glaucoma with a cup to disc ratio of >0.8
      • Active corneal, conjunctival or canalicular infections including epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections and fungal diseases
      • In patients with a posterior lens capsule that is torn or ruptured
    • Ophthalmic suspension, solution, ointment:
      • Hypersensitivity to dexamethasone or any component of the formulation
      • Active corneal, conjunctival or canalicular infections including epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections and fungal diseases
      • In patients with a posterior lens capsule that is torn or ruptured

Tropicamide

  • Adverse Reactions:
    • Blurred vision 
    • Photophobia 
    • Stinging of eyes 
    • Superficial punctate keratitis
    • Increased intraocular pressure 
  • Contraindications: 
    • Hypersensitivity to tropicamide or any component of the formulation 

Phenylephrine

  • Adverse Reactions:
    • Burning sensation of eyes
    • Eye irritation
    • Miosis (excessive constriction of the pupil of the eye) 
    • Visual disturbance
    • Vitreous opacity 
  • Contraindications:
    • Hypertension and thyrotoxicosis in infants younger than 1 year 

Timolol

  • Adverse Reactions:
    • Burning sensation of eyes 
    • Stinging of the eyes 
    • Blepharitis 
    • Blepharoptosis (drooping of the upper eye lid)
    • Blurred vision 
    • Cataract 
    • Choroidal detachment following filtration surgery 
    • Conjunctival injection 
    • Conjunctivitis 
    • Cystoid macular edema 
    • Decreased corneal sensitivity 
    • Decreased visual acuity
    • Diplopia (double vision)  
    • Eye discharge 
    • Eye pain 
    • Eye pruritus 
    • Foreign body sensation of the eye 
    • Hyperemia 
    • Keratitis
    • Lacrimation 
    • Visual disturbance 
    • Xerophthalmia (abnormal dryness of the conjunctiva and cornea of the eye)
  • Contraindications:
    • Documented cross-reactivity for other ophthalmic beta-adrenergic blocking agents 

Brimonidine

  • Adverse Reactions:
    • Burning 
    • Follicular conjunctivitis 
    • Visual disturbance 
    • Blepharitis 
    • Blepharoconjunctivitis (inflammation of the eye lid and conjunctiva)
    • Blurred vision 
    • Cataract 
    • Conjunctival edema 
    • Conjunctival hemorrhage 
    • Conjunctivitis 
    • Decreased visual acuity 
    • Dry eye syndrome 
    • Epiphora (watery eye)
    • Eye discharge 
    • Eye irritation 
    • Eyelid disease 
    • Eyelid edema 
    • Eye pain 
    • Keratitis 
    • Photophobia 
    • Sting of eyes
    • Superficial punctate keratitis 
    • Visual field defect 
    • Vitreous detachment 
    • Vitreous opacity 
  • Contraindications:
    • Hypersensitivity to Brimonidine 
    • Use in infants 
    • Concomitant use of MOA inhibitors 

Dorzolamide

  • Adverse Reactions:
    • Burning sensation of eyes 
    • Eye discomfort 
    • Stinging of eyes
    • Superficial punctate keratitis 
    • Blurred vision 
    • Conjunctivitis 
    • Eyelid irritation 
    • Eye redness 
    • Lacrimation 
    • Photophobia 
    • Xerophthalmia (abnormal dryness of the conjunctiva and cornea of the eye)
    • Iridocyclitis (inflammation of the iris and the ciliary body)
    • Crusting of the eyelid
    • Epistaxis 
    • Myopia
    • Ocular pain 
  • Contraindications:
    • Hypersensitivity to Dorzolamide or any other form

Latanoprost

  • Adverse Reactions: 
    • Eye Pain 
    • Stinging of the eyes
    • Ocular Hyperemia 
    • Conjunctival Hyperemia 
    • Eye Discharge 
    • Increased eyelash length 
    • Increased eyelash thickness
    • Punctuate keratitis 
    • Blurred vision 
    • Eye pruritis
    • Burning sensation of the eyes 
    • Iris hyperpigmentation 
    • Decreased visual acuity 
    • Eyelid pain 
    • Lacrimation 
    • Crusting of eyelid 
    • Dry eye syndrome 
    • Photophobia 
    • Eyelid Edema 
    • Conjunctival edema 
  • Contraindications:
    • Hypersensitivity to latanoprost 
    • Hypersensitivity to benzalkonium chloride (preservative)  

Bimatoprost

  • Adverse Reactions: 
    • Eye hyperemia (dilation and redness of the conjunctival vessels)
    • Eye edema
    • Eye hemorrhage
    • Eye irritation
    • Eye pain
    • Eye pruritus (itching)
    • Erythema of eyelid (Redness)
    • Eyelids pruritus (itching)
    • Growth of eyelashes
    • Instillation site irritation
    • Punctate keratitis
    • Skin hyperpigmentation
    • Vision blurred
    • Visual acuity reduced
    • Dry eye
  • Contraindications:
    • Bimatoprost is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.

Atropine

  • Adverse Reactions:
    • Blurred Vision 
    • Decreased lacrimation 
    • Decreased visual acuity (reversible, healthy eye) 
    • Eye irritation 
    • Eye pain 
    • Eyelid edema 
    • Papillary conjunctivitis 
    • Photophobia 
    • Stinging of eyes 
    • Superficial Keratitis 
  • Contraindications:
    • Hypersensitivity to Atropine or any form 
    • Primary Glaucoma or tendency toward angle-closure glaucoma (narrowing or closure of anterior chamber)
    • Documentation of an allergic cross-sensitivity for anticholinergic medication 

Ketorolac

  • Adverse Reactions:
    • Burning sensation of the eyes
    • Stinging of the eyes 
    • Blurred vision 
    • Conjunctival hyperemia 
    • Corneal edema 
    • Corneal infiltrates 
    • Eye irritation or pain 
    • Eyelid edema 
    • Increased intraocular pressure 
    • Lacrimation 
    • Ocular edema 
    • Ocular hyperemia 
    • Superficial eye infection 
    • Superficial keratitis 
    • Swelling of the eye 
    • Corneal ulcer 
    • Dry eye syndrome 
    • Corneal erosion 
    • Corneal perforation
    • Corneal thinning
  • Contraindications:
    • Hypersensitivity to ketorolac or any other form 
    • Documentation of a cross-sensitivity reaction to other NSAIDs 

 

Reference

  • Lexi-Comp Online®, Lexi-drugs, Hudson, Ohio: Lexi-comp, Inc.; September 9th, 2021. 

 

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*Compounded drugs are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. 503A compounding pharmacies are not required to comply with cGMP requirements but can be inspected by FDA. References available upon request.

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