Latanoprost
Generic Name: latanoprost
Brand Names:
Latanoprost
11 DESCRIPTION Latanoprost is a prostaglandin F 2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5- dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C 26 H 40 O 5 and its chemical structure is: Latanoprost is a colorless to yellow thick hygroscopic oil that is very soluble in acetonitrile and freely soluble in acetonitrile, ethanol, chloroform and dimethyl sulfoxide. It is practically insoluble in water.
Overview
11 DESCRIPTION Latanoprost is a prostaglandin F 2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5- dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C 26 H 40 O 5 and its chemical structure is: Latanoprost is a colorless to yellow thick hygroscopic oil that is very soluble in acetonitrile and freely soluble in acetonitrile, ethanol, chloroform and dimethyl sulfoxide. It is practically insoluble in water.
Uses
1 INDICATIONS AND USAGE Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of latanoprost ophthalmic solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including latanoprost ophthalmic solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: • Iris pigmentation changes [see Warnings and Precautions ( 5.1 )] • Eyelid skin darkening [see Warnings and Precautions ( 5.1 )] • Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions ( 5.2 )] • Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions ( 5.3 )] • Macular edema, including cystoid macular edema [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (5 to 15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate kera...
Warnings
5 WARNINGS AND PRECAUTIONS • Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) • Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Latanoprost 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 latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. 4 CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data]. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Latanoprost ophthalmic solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 50 mcg/mL (0.005%).
Frequently Asked Questions
What is Latanoprost used for?▼
1 INDICATIONS AND USAGE Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
What are the side effects of Latanoprost?▼
6 ADVERSE REACTIONS The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: • Iris pigmentation changes [see Warnings and Precautions ( 5.1 )] • Eyelid skin darkening [see Warnings and Precautions ( 5.1 )] • Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions ( 5.2 )] • Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions ( 5.3 )] • Macular edema, including cystoid macular edema [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (5 to 15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate kera...
Can I take Latanoprost during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data]. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S.
What are the important warnings for Latanoprost?▼
5 WARNINGS AND PRECAUTIONS • Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) • Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Latanoprost 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 latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. 4 CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.