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Status:
US Approved Rx
(2000)
Source:
ANDA040314
(2000)
Source URL:
First approved in 1959
Source:
ANDA084306
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Tropicamide (Mydriacyl) is an anticholinergic used as a mydriatic.Tropicamide belongs to the group of medicines called anti-muscarinics. Tropicamide blocks the receptors in the muscles of the eye (muscarinic receptors). These receptors are involved controlling the pupil size and the shape of the lens. By blocking these receptors, tropicamide produces dilatation of the pupil (mydriasis) and prevents the eye from accommodating for near vision (cycloplegia). Tropicamide is given as eye drops to dilate the pupil and relax the lens so that eye examinations can be carried out thoroughly.
Status:
US Approved Rx
(1975)
Source:
ANDA084300
(1975)
Source URL:
First approved in 1953
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Cyclopentolate (cyclopentolate hydrochloride) is a parasympatholytic anticholinergic used solely to obtain mydriasis or cycloplegia. This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.
Status:
US Approved OTC
Source:
21 CFR 341.12(j) cough/cold:antihistamine pheniramine maleate
Source URL:
First approved in 1948
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Pheniramine is an antihistamine used to treat allergic conditions such as hay fever or urticaria. It is generally sold in combination with other medications, rather than as a stand-alone drug. Allergies are caused by an excessive type 1 hypersensitivity response of the body to allergens, mediated by inappropriate histamine signalling. By inhibiting the binding of histamine, antihistamines decrease the normal histamine response from cells, consequently decreasing allergic symptoms. Antihistamines such as pheniramine appear to compete with histamine for histamine H1- receptor sites on effector cells. The antihistamines antagonize those pharmacological effects of histamine which are mediated through activation of H1- receptor sites and thereby reduce the intensity of allergic reactions and tissue injury response involving histamine release. Antihistamines suppress the histamine-induced wheal (swelling) and flare (vasodilation) response by blocking the binding of histamine to its receptors on nerves, vascular smooth muscle, glandular cells, endothelium, and mast cells. They effectively exert competitive antagonism of histamine for H1-receptors. Pheniramine is marketed under the trade name Avil and Visine-A among others).
Status:
US Approved OTC
Source:
21 CFR 346.12(d) anorectal:vasoconstrictor phenylephrine hydrochloride
Source URL:
First marketed in 1934
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Berefrine (also known as phenylephrine oxazolidine), a prodrug of phenylephrine, is a mydriatic agent. Berefrine was developed for improving ocular absorption and reducing systemic side effects.
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Enfenamic acid (under brand name tromaril) is an anthranilic acid derivative with potent anti-inflammatory, anti-arthritic, analgesic and antipyretic actions. It has additional unique property of anti-platelet aggregation activity, without disturbing any other blood coagulation factors. It also differs from other non-steroidal anti-inflammatory agents like indomethacin, in producing diuresis and natriuresis. In the clinical study, tromaril showed itself as a strong and effective drug for use in various eye diseases.
Status:
US Previously Marketed
Source:
VASOCORT HYDROXYAMPHETAMINE HYDROBROMIDE by SKF
(1961)
Source URL:
First marketed in 1935
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Hydroxyamphetamine is a derivative of amphetamines. Hydroxyamphetamine is intended mainly as local eye drops for diagnostic purposes. It is indirect sympathomimetic agent which cause dilation of the eye pupil before diagnostic test. Among the minor side effects from its use are: change in color vision, difficulty seeing at night, dry mouth, headache, increased sensitivity of eyes to sunlight, muscle stiffness or tightness and temporary stinging in the eyes. The main use of hydroxyamphetamines as eye drops is the diagnosis of Horner's syndrome which is characterized by nerve lesions. Hydroxyamphetamine hydrobromide is a component of FDA approved brand drug - Paremyd sterile ophthalmic solution (Hydroxyamphetamine hydrobromide, USP 1.0%, Tropicamide, USP 0.25%). Hydroxyamphetamine is an indirect-acting sympathomimetic, while tropicamide acts as a parasympatholytic.
Status:
US Previously Marketed
First marketed in 1911
Class (Stereo):
CHEMICAL (EPIMERIC)
Methylatropine (methylatroponium) is a belladonna derivative. In 1902 the Bayer Company introduced atropine methonitrate, a quaternary ammonium salt of atropine (Eumydrin), as a mydriatic for dilation of the pupil during ophthalmic examination. Due to its highly polar nature it penetrates less readily into the central nervous system than atropine and was therefore introduced for relieving pyloric spasms in infants. Atropine methyl nitrate is a muscarinic acetylcholine receptor antagonist that does not cross the blood-brain barrier. Atropine methyl nitrate has been used for its peripheral muscarinic effects (targeting the bladder, respiratory tract, and to block parasympathetic signaling to the heart, among others) and to separate central from peripheral nervous system effects, or to protect against peripheral side effects when using muscarinics that do cross the blood brain barrier.
Status:
Possibly Marketed Outside US
Source:
LISSAMINE GREEN
Source URL:
First approved in 2021
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acid green 50 (Lissamine Green B) is a synthetically produced organic acid dye with two aminophenyl groups. Acid green 50 is extensively used as a food dye and has a medical application as a staining agent. Due to its low toxicity and ability to stain dead and damaged cells the dye (in form of lissamine green strips) was approved as a tool for diagnosis of eye diseases associated with the damage of ocular surface epithelial cells.
Status:
Possibly Marketed Outside US
Source:
ROBENGATOPE by Photogen Technologies
Source URL:
First approved in 2013
Source:
GloStrips by Nomax Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Rose bengal sodium (RB) is a small molecule, halogenated xanthene being developed by Provectus Biopharmaceuticals (formerly Provectus Pharmaceuticals). It is commonly used in eye drops to stain damaged conjunctival and corneal cells and thereby identify damage to the eye. The stain is also used in the preparation of Foraminifera for microscopic analysis, allowing the distinction between forms that were alive or dead at the time of collection. A form of rose bengal is also being studied as a treatment for certain cancers and skin conditions. The cancer formulation of the drug, known as PV-10, is currently undergoing clinical trials for melanoma and breast cancer. Recently, interest in RB as a therapeutic cancer treatment has increased due to significant anti-tumor responses with direct tumor injection in human clinical trials for metastatic melanoma. In these patients, there has been the implication that RB may mount a T-cell mediated anti-tumor response and impart antigen-specific responses in distant bystander lesions.
Status:
US Approved Rx
(2000)
Source:
ANDA040314
(2000)
Source URL:
First approved in 1959
Source:
ANDA084306
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Tropicamide (Mydriacyl) is an anticholinergic used as a mydriatic.Tropicamide belongs to the group of medicines called anti-muscarinics. Tropicamide blocks the receptors in the muscles of the eye (muscarinic receptors). These receptors are involved controlling the pupil size and the shape of the lens. By blocking these receptors, tropicamide produces dilatation of the pupil (mydriasis) and prevents the eye from accommodating for near vision (cycloplegia). Tropicamide is given as eye drops to dilate the pupil and relax the lens so that eye examinations can be carried out thoroughly.