Lumigan eye drops 0.01% Allergan decreased in internal pressure (3ml)

Dosage form Bottle x 3ml
Specifications Bimatoprost

Ingredient

Composition information	Content
Bimatoprost	0.01%

Uses

Indications

Lumigan (0.01%bimatoprost eye solution) is indicated to reduce internal hypertension in patients with open angle or glaucoma.

Pharmacokic of

Mechanism of action: Bimatoprost is a prostamide a similar synthetic substance.

Prostaglandin in structure - has the effect of lowering pressure. This substance selectively exactly the effect of natural substances is Prostamide. Bimatoprost is thought to lower the internal pressure (IOP) in humans by increasing the release of the raft (trabecular meshwork) and the grape - enhancer membrane. Interior pressure increases are the main risk of glaucoma visual loss. The higher the internal pressure level, the more likely to cause visual and visual loss.

pharmacokinetic

absorption

After dripping a small drop of Bimatoprost eye solution 0.01%/day on both eyes of 15 healthy volunteers for two weeks, the peak concentration in the blood is reached after 10 minutes and lower than the lower limit can be detected (0.025ng/ml) most volunteers within 1.5 hours after eye drops. The average peak concentration value (CMAX) and the area under the curve (AUC0 - 24 hours) are 0.08ng/ml and 0.09ng/hour/ml and equivalent on Saturday and 14th day, showing that it has achieved a stable state in the first week of small drugs. There is no significant body accumulation during the research period.

Distribution

Bimatoprost is moderately distributed into the body tissue with the distribution voltage in a stable state of 0.67L/kg. In human blood, bimatoprost exists mainly in plasma. About 12% bimatoprost does not attach to human plasma.

Metabolism

After small eyes, bimatoprost is the main circulation in the blood once the week has been completely in the body. Bimatoprost will then be metabolized through oxidation reactions, n removading ethyl, glucuronic complexes to form different metabolites.

Elimination

After the bimatoprost intravenous injection has been marked radioactive (3.12kg/kg) for 6 healthy volunteers, the peak concentration of the blood of unchanged drugs is 12.2ng/ml and rapidly reduced with a selling time of about 45 minutes. The total bimatoprost clearance in the blood is 1.5L/hour/kg. About 67% of the dose is excreted in the urine, while 25% of the dose is found in feces.

Before taking Lumigan eye drops 0.01% Allergan decreased in internal pressure (3ml)

How to use

eye drops. The recommended dose is 1 drop in the eyes, 1 time/day in the evening.

Dosage

Lumigan dosage (0.01% bimatoprost eye solution) should not be over 1 time/day because there are many times as small substances similar to prostaglandin reduces the pressure of intraocular pressure.

The decrease in the internal pressure starts about 4 hours after the first time, the maximum effect is reached in about 8 - 12 hours.

Lumigan (0.01%bimatoprost eye solution) can be used simultaneously with other eye drops to lower the internal pressure. If you use more than a small eye drop, the drugs must be spaced at least 5 minutes apart.

What to do when overdose?

If the Lumigan overdose occurs (0.01%bimatoprost eye solution), symptomatic treatment is required.

In studies in mice and rats, when drinking up to 100mg/kg/day, there was no toxicity. By mg/m2, this dose is at least 100 times higher than the toxic doses of a lumigan bottle (0.01%bimatoprost eye solution) for a 10kg children.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.

Side Effects

Clinical trial

Because clinical studies have been conducted in very different conditions, the adverse reaction rate is observed in clinical studies of a drug that cannot be compared with the proportion of other medication clinical studies and may not reflect the observed ratio in practice.

In a clinical study with small solutions of 0.01%Bimatoprost eye solution, the most common adverse reaction is conjunctival conjunctiva (26%). About 0.5% of patients discontinued treatment due to conjunctival congestion with small eye solution Bimatoprost 0.01%.

Other adverse reactions (reports in 1 to 10% of patients) related to eye -catching bimatoprost eye solution 0.01% including eyelid red rash, eye irritation, itchy eye, itchy eyelids, lashes, shallow spotted corneal.

Other adverse reactions (reports in 1 to 10%) are not related to the eye, including the hair, the drug irritation, the skin pigmentation.

After being marketed

The following side effects have been determined during the use of Lumigan (0.01%bimatoprost eye solution) in clinical practice. Because it is voluntarily reported from an unknown population, the frequency of the side effects cannot be estimated.

The events, have been chosen based on the severity, frequency of the report, the causes may be related to Lumigan (0.01%bimatoprost eye solution) or a combination of elements, including eye pain.

Notify the doctor with unwanted effects when using the drug.

Warnings

Read the instructions carefully before use.

If you need information, please consult your doctor.

This drug is only used by a doctor.

Contraindicated

Lumigan (0.01%bimatoprost eye solution) Contraindicated for patients with hypersensitivity to Bimatoprost or any ingredients of the drug.

Precautions when taking drugs

There is a report as a small bimatoprost eye solution that changes the pigment tissue. The most frequent changes reported include increased pigmentation in the iris, the pitch around the eye (eyelid) and eyelashes. The pigment is expected to increase when still using bimatoprost.

The change in pigmentation is due to increasing the amount of melanin (pigmented seeds) in the epidermis to form a pigment than the increase in the number of epidermal cells to form a pigment. After stopping the use of bimatoprost, changing pigmentation in the iris can last for a long time, while changing the pigment in the tissue around the eye and eyelashes has been reported to be recovered in some patients. The patient must be notified of the likelihood of increased pigmentation. The long -term impact of hyperpigmentation is not well known.

The color change of iris may not be detected for months to many years. Typically, the brown pigment around the pupil, which can spread in a concentric shape towards the periphery of the iris, but all or part of the iris can be slightly brown. The small brown spots of the iris are not affected by the treatment.

While therapy with Lumigan (0.01%bimatoprost eye solution) can be continued for patients with hyperactical hygiene in the iris, these patients need to be checked regularly (see the information for patients).

Change eyelashes

Lumigan (0.01%bimatoprost eye solution) can gradually change the eyelashes and feathers in the eye. These changes include increasing length, thickness and number of eyelashes. Change eyelashes often recover when stopped treatment.

Inflammation in the eye

Lumigan (0.01%bimatoprost eye solution) should be used cautiously in patients with inflammation in the eye (for example, grape vascular inflammation) because inflammation may be worse.

Phú Hàng point

Points, including follicles were recorded during treatment with small bimatoprost eye solution. Be careful when using LumigonP (0.01%Bimatoprost eye solution) for patients without a patient's lens using a fake lens with the following cover of tearing lens or in patients who are known to be at risk of closed angle glaucoma, inflammatory glaucoma or glaucoma new vessels.

Not yet evaluated the effect of Lumigan (0.01%Bimatoprost eye solution) in the treatment of glaucoma angle of inflammation or glaucoma.

bacterial keratitis

There has been a report on bacterial keratitis associated with the use of multi -dose eye drops. The vial of the patient is unintentionally contaminated and in most cases the cornea or breaking the eye epithelium (see information for the patient).

Use when wearing contact lenses

contact lenses must be removed before the Lumigan (0.01%Bimatoprost eye solution) and after 15 minutes of the drug, the glasses can be worn.

The ability to drive and operate machinery

as well as with any small eye preparations, if you are faded at a time when the drug is faint, the patient should wait until it is clear before driving or using machines.

Pregnancy and lactation

Pregnancy

Pregnant women group c.

The teratogenic effect. In studies on the development of embryos/fetuses in mice and pregnant mice have recorded miscarriage when taking bimatoprost oral doses at least 33 times in mice and 97 times in rats compared to the dosage on humans based on the area under the curve (AUC) in the blood.

With a dose of 41 times the dose in human relying on the area under the curve (AUC) in the blood, the length of pregnancy is reduced in the mother rat, the rate of fetal death, the rate of failure after grafting the embryo for the last time, the mortality rate in the child mouse and after birth increases, the weight of the child's mouse is reduced.

There is no adequate and well -controlled research on the use of Lumigan (0.01%bimatoprost eye solution) for pregnant women. Because animal reproduction studies are not always predicted in humans, Lumigan (0.01%Bimatoprost eye solution) should only be used during pregnancy if the benefits of using drugs for mothers are higher than possible for the fetus.

breastfeeding women

Although in animal studies shows that Bimatoprost is excreted through the mother's milk, it is unclear whether Lumigan (0.01%Bimatoprost eye solution) is excreted through human milk. Because there are many drugs excreted in breast milk, be careful when using Lumigan (0.01%bimatoprost eye solution) for breastfeeding women.

Other special subjects

used in children under 16 years of age: Not recommended because it is related to increased pigmentation after use for a long time in chronic diseases. Used in older adults: No overall difference in safety or effectiveness between old patients and young patients.

Hepatic failure: In patients with a history of liver or ALT, abnormal AST and/or bilirubin at a basic level, 0.01% bimatoprost does not adversely affect liver function within 48 months.

Drug interaction

There is no study of interaction. It is not sure to have drug interactions in humans due to the low concentration of bimatoprost (below 0.2ng/ml) which has been observed during the whole week of the whole body after the small -dose of Bimatoprost dose 0.01%.

Bimatoprost is transferred to a biological form in many enzymes and many ways, and there is no effect on liver metabolic enzymes in the liver, which has been observed in preclinical studies on mice and monkeys.

In clinical studies, Lumigan eye small solution - 0.03% (multi -dose) bimatoprost eye solution has been used simultaneously with some eye drops without any evidence of interaction.

Sharing Lumigan with eye drops Glaucoma is not the type of beta inhibitors that have not been evaluated in Glaucoma therapy.

The effect of reducing the internal pressure IOP of substances similar to prostaglandin (e.g. lumigan can be reduced in patients with glaucoma or glaucoma when used with other prostaglandin substances.

Storage

You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer.

You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.

Keep pills out of reach of children and pets.

Expiry date: 24 months from the date of manufacture.

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