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Laxat Eye Drop

Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Email: altinezvisions@gmail.com
Tel: 01-7418609, 08296588658, 0708900917

Brand Name

Laxat Eye Drop

Manufacturer

HANLIM PHARM.CO., LTD. 1007, YU-BANG DONG, YONG-IN SI, GYEONG-GI, KOREA.http://www.hanlim.com.

Therapeutic Class

Antiglaucoma preparations and Miotics

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Drop(NRN: A4-3066): Each mL contains Active: Latanoprost 0.05 mg Preservative: 10% Benzalkonium chloride solution 2.0 mg (as benzalkonium chloride 0.2 mg)

Pack size: In a bottle containing 2.5 mL.

Laxat

Pharmacology

Ocular hypotensive agent; a synthetic analog of prostaglandin F2α (PGF2α) that acts by increasing the amount of fluid drain from the eye, thereby causing a reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Indications

LAXAT Eye drops is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Contra-indications

Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

Precautions/Warnings

[Warnings]

Latanoprost has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissues (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as it is administered.

After discontinuation, 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 effects of increased pigmentation beyond 5 years are not known.

[Precautions]

General: Latanoprost may gradually increase the pigmentation of the iris.
The eye color change is due to increased melanin content in the stromal melanocytes of the iris rather than to an increase in the number of melanocytes. This change may not be noticeable for several months to years ( see WARNINGS).

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 Latanoprost can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 

During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant color changes may be permanent. Eyelid skin darkening, which may be reversible, has been reported in association with the use of Latanoprost (See WARNINGS). 

Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Latanoprost should be used with caution in patients with a history of intraocular inflammation (iritis/Uveitis) and should generally not be used in patients with active intraocular edema.

There is limited experience with latanoprost in the treatment of angle closure, inflammatory or neovascular glaucoma.
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTION, information for patients).

Information for patients (see WARNING and PRECAUTIONS):

Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of possibility of eyelid skin darkening which may be reversible after discontinuation of latanoprost. Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with latanoprost. These changes may result in a disparity between eyes in length, thickness, pigmentation number of eyelashes or vellus hairs, and/or direction of eyelash growth.

Eyelash changes are usually reversible upon discontinuation of treatment.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damages to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients also should be advised that if they develop intercurrent ocular condition (e.g, trauma or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of the multiple-dose container.

Patients should be advised that latanoprost contains benzalkonium chloride which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution.

Lenses may be reinserted 15 minutes following administration of latanoprost.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Interactions

In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost. If such drugs are used they should be administered at least five (5) minutes apart.

Carcinogenesis, Mutagenesis, Impairment of fertility: Latanoprost was not mutagenic in bacteria in mouse lymphoma or in mouse micronucleus tests. 

Chromosome aberrations were observed in vitro with human lymphocytes.

Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 µg/kg/day (approximately 2,800 times the recommended maximum human dose) for up to 20 and 24 months respectively.

Additional in vitro in vivo studies on unscheduled DNA synthesis in rats were negative.

Latanoprost has not been found to have any effect on male or female fertility in animal studies.

Pregnancy:

Teratogenic Effects: Pregnancy Category C.

Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. There are no adequate and well controlled studies in pregnant women, latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

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 latanoprost is administered to a nursing woman.

Padiatric Use:

Safety and effectiveness in padiatric patients have not been established.

Generic Use:

No Overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Effects

Eyelash changes (increased length, thickness, pigmentation and number of lashes): eyelid skin darkening; intraocular inflammation (iritis/Uveitis): iris pigmentation changes and macular edema, including cystoids macular edema.

Controlled clinical trials: The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on latanoprost in the three 6-month, multi-centre, double-masked, activecontrolled trials were blurred vision, burning and stinging, conjuctival hyperaemia, foreign body sensation, itching, increased pigmentation of the iris and punctuate epithelial keratopathy.

Local conjunctival hyperaemia was observed, however, less than 1% of the patients treated with latanoprost required discontinuation of therapy because of intolerance to conjunctival hyperaemia.

In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema and photophobia.

The following events were reported in less than 1% of the patients: conjunctivitis, diplopia and discharge from the eye.

During clinical studies, there were extremely rare reports of the following: retinal artery embolus, retinal detachment and vitreous haemorrhage from diabetic retinopathy.

The most common systemic adverse events seen with latanoprost were upper respiratory tract infection/cold/flu which occurred at a rate of approximately 4%. Chest pain/angina pectoris, muscle/joint/back pain and rash/allergic skin reaction each occurred at a rate of 1 to 2%.

Clinical practice: The following events have been identified during post marketing use of latanoprost in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events which have been chosen for inclusion due to either their seriousness, frequency reporting, possible causal connection to latanoprost or a combination of these factors include asthma and exacerbation of asthma, corneal edema and erosions, dyspnea, eyelash and vellus hair changes (increased length, thickness, pigmentation and number); eyelid skin darkening, herpes keratitis, intraocular inflammation (iritis/Uveitis), keratitis, macular edema, including cystoids macular edema, misdirected eyelashes sometimes resulting in eye irritation and toxic epidermal necrolysis.

Dosage & Administration

The recommended dosage is one drop (1.5µg) in the affected eye (s) once daily in the evening.

The dosage of Laxat eye drops should not exceed once daily since it has been shown that more frequent administration may decrease the intraocular pressure lowering effect.

Reduction of the intracocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Laxat eye drops may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Storage/Handling Recommendations

Protect from light.

Store unopened bottle under refrigerator at 2oC to 8oC (36Fo to 48Fo).

Once opened, the 2.5 mL container may be stored at room temperature up to 25oC (77Fo) for 6 weeks.

Review Date

2016-05-11 03:51:17