Product Information

IMPRIMIS PHARMACEUTICALS, INC.

Product Information

Imprimis specializes in compounding customized medications to meet unique patient needs. As with all compounded medications, dosages may be customized to meet the individual needs of a patient. Only a prescribing physician may determine the appropriate use for their patient for an Imprimis compounded medication.

Compounded medications, made for the specific needs of a patient, are by their nature, not reviewed nor approved by the U.S. Food and Drug Administration (“FDA”).

All Imprimis facilities, where our compounded medications are produced, are inspected by FDA.

All active pharmaceutical ingredients contained in Imprimis’ compounded medications are obtained from FDA-registered entities.

When applicable, Imprimis compounded medications include components of FDA-approved drugs, as required under federal law.

Imprimis compounded medications may be ordered by a prescribing physician only when there is not a sufficient commercially available drug to meet a patient’s clinical need. Prescribing physicians may contact Imprimis’ pharmacists to discuss whether one of our compounded medications may be suitable for the clinical needs of a patient.

Regardless of a patient’s ability to afford an FDA-approved commercially available medication, FDA guidance prohibits Imprimis from copying any commercially available FDA-approved product.

Imprimis formulations are intended for professional use only.

Because Imprimis’ compounded medications do not have a recommended label for use and often include FDA-approved drugs which contain active bulk drug ingredients, FDA has requested we provide you with the following risks relating to certain active bulk drug ingredients:

TECHNIQUE-RELATED RISKS

Risks associated with transzonular injection via cannula include:

  • Ciliary body hemorrhage
  • Vitreous floaters
  • Blurred vision

ACTIVE INGREDIENT-RELATED RISKS

Triamcinolone Acetonide, Moxifloxacin Hydrochloride

  • Elevated intraocular pressure
  • Glaucoma
  • If a lens is still present, cataract formation
  • Allergic reactions
  • Vitreous floaters
  • Blurred vision

Moxifloxacin Hydrochloride

  • Allergic reactions
  • Prolonged use may result in overgrowth of non-susceptible organisms, including fungi.

Prednisolone Acetate, Gatifloxacin, Bromfenac

  • Elevated intraocular pressure
  • Glaucoma
  • Allergic reactions
  • Hyphema
  • Keratitis
  • Increased potential for corneal healing problems
  • Corneal thinning
  • Corneal erosion
  • Corneal ulceration
  • Corneal perforation
  • If a lens is still present, cataract formation

Prednisolone Acetate, Gatifloxacin

  • Elevated intraocular pressure
  • Glaucoma
  • Allergic reactions
  • Increased potential for corneal healing problems
  • Corneal thinning
  • Corneal erosion
  • Corneal ulceration
  • Corneal perforation
  • If a lens is still present, cataract formation

Prednisolone Acetate, Bromfenac

  • Elevated intraocular pressure
  • Glaucoma
  • Allergic reactions
  • Hyphema
  • Keratitis
  • Increased potential for corneal healing problems
  • Corneal thinning
  • Corneal erosion
  • Corneal ulceration
  • Corneal perforation
  • If a lens is still present, cataract formation

Timolol, Latanoprost

  • Use of timolol, including topical ophthalmic timolol, is contraindicated in patients with (i) bronchial asthma or a history of bronchial asthma; (ii) with second or third degree atrioventricular block; (iii) with overt cardiac failure; (iv) with severe chronic obstructive pulmonary disease
  • There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
  • Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
  • Masking of the signs and symptoms of acute hypoglycemia
  • Increased pigmentation of the iris
  • Increased pigmentation of the periorbital tissue (eyelid)
  • Increased pigmentation and growth of the eyelashes
  • Latanoprost should not be used in patients with active intraocular inflammation
  • Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule

Brimonidine, Dorzolamide

  • Hypersensitivity reactions
  • Potentiation of syndromes associated with vascular insufficiency
  • Fatigue/drowsiness
  • Corneal edema in patients with low endothelial cell counts
  • Lethargy/Coma in patients under two years of age

Timolol, Brimonidine, Dorzolamide

  • Use of timolol, including topical ophthalmic timolol, is contraindicated in patients with (i) bronchial asthma or a history of bronchial asthma; (ii) with second or third degree atrioventricular block; (iii) with overt cardiac failure; (iv) with severe chronic obstructive pulmonary disease
  • There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
  • Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
  • Masking of the signs and symptoms of acute hypoglycemia
  • Hypersensitivity reactions
  • Potentiation of syndromes associated with vascular insufficiency
  • Corneal edema in patients with low endothelial cell counts

Timolol, Dorzolamide, Latanoprost

  • Use of timolol, including topical ophthalmic timolol, is contraindicated in patients with (i) bronchial asthma or a history of bronchial asthma; (ii) with second or third degree atrioventricular block; (iii) with overt cardiac failure; (iv) with severe chronic obstructive pulmonary disease
  • There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
  • Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism.
  • Masking of the signs and symptoms of acute hypoglycemia
  • Hypersensitivity reactions
  • Corneal edema in patients with low endothelial cell counts
  • Increased pigmentation of the iris
  • Increased pigmentation of the periorbital tissue (eyelid)
  • Increased pigmentation and growth of the eyelashes
  • Latanoprost should not be used in patients with active intraocular inflammation
  • Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule

Timolol, Brimonidine, Dorzolamide, Latanoprost

  • Use of timolol, including topical ophthalmic timolol, is contraindicated in patients with (i) bronchial asthma or a history of bronchial asthma; (ii) with second or third degree atrioventricular block; (iii) with overt cardiac failure; (iv) with severe chronic obstructive pulmonary disease
  • There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
  • Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
  • Masking of the signs and symptoms of acute hypoglycemia
  • Hypersensitivity reactions
  • Corneal edema in patients with low endothelial cell counts
  • Increased pigmentation of the iris
  • Increased pigmentation of the periorbital tissue (eyelid)
  • Increased pigmentation and growth of the eyelashes
  • Latanoprost should not be used in patients with active intraocular inflammation
  • Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule
  • Potentiation of syndromes associated with vascular insufficiency