Dorzoptic T

Dorzoptic T

dorzolamide + timolol

Manufacturer:

Cooper

Distributor:

SB Pharma
Full Prescribing Info
Contents
Dorzolamide HCl, timolol maleate.
Description
Each ml contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
Excipients/Inactive Ingredients: The other ingredients are: Mannitol, Hydroxyethyl cellulose, Sodium citrate, Sodium hydroxide, Water for injection.
Preservative: Benzalkonium chloride.
Action
Dorzoptic T Eye Drops contains two medicines: dorzolamide and timolol.
Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
Timolol belongs to a group of medicines called "beta-blockers".
These medicines lower the pressure in the eye in different ways.
Indications/Uses
Dorzoptic T Eye Drops is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eye drop medicine used alone is not adequate.
Dosage/Direction for Use
Always use Dorzoptic T Eye Drops exactly as the doctor has told to.
If there are any questions on the use of this product, ask the doctor or pharmacist.
Check with the doctor or pharmacist if unsure. The appropriate dosage and duration of treatment will be established by the doctor.
The recommended dose is one drop in the affected eye(s) in the morning and in the evening.
If using Dorzoptic T Eye Drops with another eye drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of the drug without consulting the doctor.
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 of the container, wash hands before using this medicine and keep the tip of the container away from contact with any surface.
If the medication may be contaminated, or if an eye infection develops, contact the doctor immediately concerning continued use of this bottle.
Forgetting Dorzoptic T Eye Drops: It is important to use Dorzoptic T Eye Drops as prescribed by the doctor.
If a dose is missed, use it as soon as possible. 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.
Stopping Dorzoptic T Eye Drops: If wanting to stop using this medicine, talk to the doctor first.
Overdosage
If too many drops are instilled in the eye or any of the contents of the container is swallowed, among other effects, light-headedness, difficulty breathing, or slowed heart rate may be felt. Contact the doctor immediately.
Contraindications
Do not use Dorzoptic T Eye Drops: if allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of Dorzoptic T Eye Drops (listed in Description); if with current or with history of respiratory problems, such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough); if with a slow heartbeat, heart failure, or disorders of heart rhythm (irregular heartbeats); if with severe kidney disease or problems, or a prior history of kidney stones; if with excess acidity of the blood caused by a build up of chloride in the blood (hyperchloremic acidosis).
If unsure whether to use Dorzoptic T Eye Drops, contact the doctor or pharmacist.
Special Precautions
Tell the doctor about current or history of any eye problems or any of the following medical problems: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure; disturbances of heart rate such as slow heartbeat; breathing problems, asthma or chronic obstructive pulmonary disease; poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome); diabetes as timolol may mask signs and symptoms of low blood sugar; overactivity of the thyroid gland as timolol may mask signs and symptoms.
Also tell the doctor: before having an operation if using Dorzoptic T Eye Drops as timolol may change the effects of some medicines used during anaesthesia; if with muscle weakness or have been diagnosed as having myasthenia gravis; if any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids develop (contact the doctor immediately); if an eye infection develops, an eye injury is received, having eye surgery, or a reaction including new or worsening symptoms develop.
When Dorzoptic T Eye Drops is instilled into the eye it may affect the entire body.
Use in patients with liver impairment: Tell the doctor about any liver problems currently present or have suffered from in the past.
Dorzoptic T Eye Drops contains benzalkonium chloride: If soft contact lenses are worn, remove them before using Dorzoptic T Eye Drops and wait at least 15 minutes before reinsertion (the preservative benzalkonium chloride may possibly discolour the lenses).
Benzalkonium chloride may cause ocular irritation.
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 Dorzoptic T Eye Drops, such as blurred vision, which may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until feeling well or vision is clear.
Use in Children: There is limited experience with Dorzoptic T Eye Drops in infants and children.
Use in the Elderly: In studies with Dorzolamide Hydrochloride and Timolol Maleate Eye Drops, the effects of Dorzolamide Hydrochloride and Timolol Maleate Eye Drops were similar in both elderly and younger patients.
Use In Pregnancy & Lactation
Ask the doctor or pharmacist for advice before taking any medicine.
Use in pregnancy: Do not use Dorzoptic T Eye Drops if pregnant unless the doctor considers it necessary.
Use in breast-feeding: Do not use Dorzoptic T Eye Drops if breast-feeding. Timolol may get into the milk. Ask the doctor for advice before taking any medicine during breast-feeding.
Side Effects
Like all medicines, Dorzoptic T Eye Drops can cause side effects, although not everybody gets them.
The patient can usually carry on taking the drops, unless the effects are serious. If worried, talk to a doctor or pharmacist. Do not stop using Dorzoptic T Eye Drops without speaking to the doctor.
Serious side effects: Stop using Dorzoptic T Eye Drops and seek medical advice immediately if the following develops: generalized allergic reactions including swelling beneath the skin (that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing), hives or itchy rash, localized and generalized rash, itchiness; or a severe sudden life-threatening allergic reaction.
The frequency of possible side effects listed as follows is defined using the following convention: Very common (affects more than 1 user in 10); Common (affects 1 to 10 users in 100); Uncommon (affects 1 to 10 users in 1,000); Rare (affects 1 to 10 users in 10,000); Not known (frequency cannot be estimated from the available data).
The following adverse reactions have been reported with dorzolamide/timolol eye drops or one of its components either during clinical trials or during post marketing experience: Very common: Burning and stinging of the eyes, taste perversion.
Common: Redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), weakness/tiredness, and fatigue.
Uncommon: Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, difficulty breathing (dyspnoea), indigestion, and kidney stones.
Rare: Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, temporary short-sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in the ear, low blood pressure, changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), cerebral ischaemia (reduced blood supply to the brain), chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack, Raynaud's phenomenon, swelling or coldness of hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, impaired lung function, runny or stuffed nose, nose bleed, constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery coloured appearance (psoriasiform rash), Peyronie's disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Steven-Johnson syndrome, toxic epidermal necrolysis).
Like other medicines applied into eyes, timolol maleate is absorbed into the blood. This may cause similar side effects as seen with oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed additional side effects include reactions seen within the class of beta-blockers when used for treating eye conditions: Not known: Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.
If any side effects occur, talk to the doctor or pharmacist. This includes any side effects not previously listed.
Drug Interactions
Dorzoptic T Eye Drops can affect or be affected by other medicines being used, including other eye drops for the treatment of glaucoma.
Tell the doctor if using or intending to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes.
Tell the doctor or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if: taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin); taking medicines to treat a disturbed or irregular heartbeat (such as calcium channel blockers, beta-blockers or digoxin); using another eye drop that contains a beta-blocker; taking another carbonic anhydrase inhibitor such as acetazolamide; taking monoamine oxidase inhibitors (MAOIs) which are used to treat depression; taking a parasympathomimetic medicine which may have been prescribed to help pass urine (parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel); taking narcotics such as morphine used to treat moderate to severe pain; taking medicines to treat diabetes; taking antidepressant known as fluoxetine and paroxetine; taking a sulfa medicine; taking quinidine (used to treat heart conditions and some types of malaria).
Caution For Usage
Discard Dorzoptic T Eye Drops 28 days after first opening.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
Instructions for use: Always wash hands before applying eye drops.
Apply the eye drops in the following way: 1. Remove protective cap.
2. Tilt the head back and look at the ceiling.
3. Gently pull the lower eyelid down until there is a small pocket.
4. Squeeze the upturned dropper bottle to release a drop into the eye.
5. Whilst keeping the affected eye closed, press finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 2 minutes. This helps to stop timolol getting into the rest of the body.
Avoid touching the dropper tip against the eye or anything else.
Replace and tighten the cap straight after use.
Storage
Store at temperature ≤25°C.
Keep the bottle in the outer carton in order to protect from light.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Dorzoptic T eye drops
Packing/Price
5 mL x 1's
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