Mega Lifesciences
Full Prescribing Info
The active substance is dorzolamide hydrochloride. Each ml contains 22.26 mg dorzolamide hydrochloride equivalent to 20 mg dorzolamide.
LAMISOPT is a slightly opalescent, nearly colorless, slightly viscous solution, with pH from 5.0 to 6.0 and osmolality 240-325 mOsmol/kg.
Excipients/Inactive Ingredients: The other ingredients are: Mannitol (E421), sodium citrate dehydrate (E331), hydroxyethyl cellulose, benzalkonium chloride, sodium hydroxide (E524) (for pH adjustment), water for injection.
LAMISOPT contains dorzolamide which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower raised pressure in the eye and to treat glaucoma. This medicine can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).
Dosage/Direction for Use
Always use this medicine exactly as the doctor has told. Check with the doctor or pharmacist if the patient is not sure. The appropriate dosage and duration of treatment will be established by the doctor.
When this medicine is used alone, the dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.
If the doctor has recommended the patient use this medicine with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of LAMISOPT in the affected eye(s) in the morning and in the evening.
If the patient is using this medicine with another eye drop, the drops should be instilled at least 10 minutes apart. Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision.
To avoid possible contamination, wash the hands before using this medicine and keep the tip of the container away from contact with any surface. If the patient thinks the medication may be contaminated, or if they develop an eye infection, contact the doctor immediately concerning continued use of this bottle.
Directions for use: 1. Before using this medicine for the first time, make sure the safety strip on the front of the bottle is unbroken. A small gap between the bottle and the cap is normal for an unopened bottle.
2. Tear off the safety strip to break the seal.
3. To open the bottle, unscrew the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent the dispenser from operating properly.
4. Tilt the head back and pull the lower eyelid down slightly to form a "pocket" between the eyelid and the eye.
5. Invert the bottle, and press lightly with the thumb or index finger until a single drop is dispensed into the eye as directed by the doctor. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP.
6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (do not over tighten) and then remove by turning the cap in the opposite direction as indicated by the arrows on the top of the cap.
7. Repeat steps 4 and 5 with the other eye if instructed to do so by the doctor.
8. Replace the cap by turning until it is firmly touching the bottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure.
Do not over tighten or the patient may damage the bottle and cap.
9. The dispenser tip is designed to provide a single drop; do NOT enlarge the hole of the dispenser tip.
10. After dispensing all doses, a small amount of the medicine will remain in the bottle. The patient should not be concerned because an extra amount of LAMISOPT has been added, and they have used the full amount of LAMISOPT that the doctor prescribed. Do not attempt to remove the excess medicine from the bottle.
If the patient uses more LAMISOPT than they should: If the patient puts too many drops in the eye or the contents of the container are swallowed, they should contact the doctor immediately.
If the patient forgets to use LAMISOPT: However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for the forgotten dose.
If the patient stops using LAMISOPT: If the patient wants to stop using this medicine talk to the doctor first.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use LAMISOPT if the patient is allergic to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in Description); if the patient has severe kidney impairment or problems, or a prior history of kidney stones.
Special Precautions
Tell the doctor about any medical problems the patient has now or has had in the past, including eye problems and eye surgeries, and about any allergies to any medications.
If the patient develops any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact the doctor immediately.
If the patient suspects that this medicine is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) stop its use and contact the doctor immediately.
Use in patients with liver impairment: Tell the doctor about any liver problems the patient now has or has suffered from in the past.
LAMISOPT contains benzalkonium chloride: This preservative may be deposited in soft contact lenses and may possibly discolour the lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. If the patient wears contact lenses, they should consult the doctor before using this medicine.
Driving and using machines: No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with this medicine, such as dizziness and blurred vision, which may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until the patient feels well or the vision is clear.
Use in Children: Dorzolamide has been studied in infants and children less than 6 years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to the doctor.
Use in Elderly: In studies with dorzolamide, the effects of dorzolamide were similar in both elderly and younger patients.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Use in pregnancy: The patient should not use this medicine during pregnancy. Tell the doctor if the patient is pregnant or intends to become pregnant.
Use in breast-feeding: If treatment with this medicine is required, breast-feeding is not recommended. Tell the doctor if the patient is breastfeeding or intends to breast-feed.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient develops allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, they should stop using this medicine and seek immediate medical advice.
The following side effects have been reported with dorzolamide either during clinical trials or during post-marketing experience: Very common side effects (more than 1 user in 10): Burning and stinging of the eyes.
Common side effects (1 to 10 users in 100): Disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), discharge with itching of the eyes (conjunctivitis), irritation/inflammation of the eyelid, blurred vision, headache, nausea, bitter taste, and fatigue.
Uncommon side effects (1 to 10 users in 1,000): Inflammation of the iris.
Rare side effects (1 to 10 users in 10,000): Tingling or numbness of the hands or feet, temporary short sightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment, following filtration surgery), eye pain, eyelid crusting, low pressure in the eye, swelling of the cornea (with symptoms of visual disturbances), eye irritation including redness, kidney stones, dizziness, nose bleed, throat irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
Tell the doctor if the patient is using, has recently used or might use any other medicines (including eye drops), particularly another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa drug.
Caution For Usage
Do not throw away any medicines. Ask the pharmacist on how to throw away medicines no longer used. These measures will help protect the environment.
This medicine does not require any special storage conditions.
LAMISOPT should be used within 28 days after the bottle is opened.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01EC03 - dorzolamide ; Belongs to the class of carbonic anhydrase inhibitors. Used in the treatment of glaucoma.
Eye drops 20 mg/mL (slightly opalescent, nearly colorless, slightly viscous solution) x 5 mL x 1's.
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