DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Dorzolamide Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dorzolamide Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product.
Dorzolamide Ophthalmic Solution is a sulfonamide and although administered topically is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration with Dorzolamide Ophthalmic Solution. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzolamide Ophthalmic Solution has not been studied in patients with acute angle closure glaucoma.
Dorzolamide Ophthalmic Solution has not been studied in patients with severe renal impairment. Because Dorzolamide Ophthalmic Solution and its metabolite are excreted predominantly by the kidney, Dorzolamide Ophthalmic Solution is not recommended in such patients.
Dorzolamide Ophthalmic Solution has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of Dorzolamide Ophthalmic Solution. Many of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. If such reactions are observed, Dorzolamide Ophthalmic Solution should be discontinued and the patient evaluated before considering restarting the drug.
There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Dorzolamide Ophthalmic Solution. The concomitant administration of Dorzolamide Ophthalmic Solution and oral carbonic anhydrase inhibitors is not recommended.
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.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g., dorzolamide) after filtration procedures.
Information for Patients
Dorzolamide Ophthalmic Solution is a sulfonamide and although administered topically is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. Patients should be advised that if serious or unusual reactions or signs of hypersensitivity occur, they should discontinue the use of the product.
Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should discontinue use and seek their physician's advice.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.
Patients should be advised that Dorzolamide Ophthalmic Solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following Dorzolamide Ophthalmic Solution administration.
Although acid-base and electrolyte disturbances were not reported in the clinical trials with Dorzolamide Ophthalmic Solution, these disturbances have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions. Therefore, the potential for such drug interactions should be considered in patients receiving Dorzolamide Ophthalmic Solution.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a two-year study of Dorzolamide administered orally to male and female Sprague-Dawley rats, urinary bladder papillomas were seen in male rats in the highest dosage group of 20 mg/kg/day (250 times the recommended human ophthalmic dose). Papillomas were not seen in rats given oral doses equivalent to approximately 12 times the recommended human ophthalmic dose. No treatment-related tumors were seen in a 21-month study in female and male mice given oral doses up to 75 mg/kg/day (~900 times the recommended human ophthalmic dose).
The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class-effect of carbonic anhydrase inhibitors in rats. Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria, and diverse sodium salts.
No changes in bladder urothelium were seen in dogs given oral Dorzolamide for one year at 2 mg/kg/day (25 times the recommended human ophthalmic dose) or monkeys dosed topically to the eye at 0.4 mg/kg/day (~5 times the recommended human ophthalmic dose) for one year.
The following tests for mutagenic potential were negative: (1) in vivo (mouse) cytogenetic assay; (2) in vitro chromosomal aberration assay; (3) alkaline elution assay; (4) V-79 assay; and (5) Ames test.
In reproduction studies of Dorzolamide in rats, there were no adverse effects on the reproductive capacity of males or females at doses up to 188 or 94 times, respectively, the recommended human ophthalmic dose.
Teratogenic Effects. Pregnancy Category C. Developmental toxicity studies with Dorzolamide in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1.0 mg/kg/day (13 times the recommended human ophthalmic dose). There are no adequate and well-controlled studies in pregnant women. Dorzolamide Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In a study of Dorzolamide in lactating rats, decreases in body weight gain of 5 to 7% in offspring at an oral dose of 7.5 mg/kg/day (94 times the recommended human ophthalmic dose) were seen during lactation. A slight delay in postnatal development (incisor eruption, vaginal canalization and eye openings), secondary to lower fetal body weight, was noted. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dorzolamide Ophthalmic Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and IOP-lowering effects of Dorzolamide Ophthalmic Solution have been demonstrated in pediatric patients in a 3-month, multi center, double masked, active-treatment-controlled trial.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
ADVERSE REACTIONS Controlled clinical trials:
The most frequent adverse events associated with Dorzolamide Ophthalmic Solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10-15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. Events occurring in approximately 1-5% of patients were conjunctivitis and lid reactions, blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular events and systemic events were reported infrequently, including headache, nausea, asthenia/fatigue; and, rarely, skin rashes, urolithiasis, and iridocyclitis.
In a 3-month, double-masked, active-treatment-controlled, multicenter study in pediatric patients, the adverse experience profile of Dorzolamide Ophthalmic Solution was comparable to that seen in adult patients.
Clinical practice: The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Dorzolamide Ophthalmic Solution in clinical practice where these events were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to Dorzolamide Ophthalmic Solution, or a combination of these factors: signs and symptoms of systemic allergic reactions including angioedema, bronchospasm, pruritus, and urticaria; dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery, eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.
Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
DOSAGE AND ADMINISTRATION
The dose is one drop of Dorzolamide Ophthalmic Solution in the affected eye(s) three times daily.
Dorzolamide Ophthalmic Solution 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 ten minutes apart.
Dorzolamide Ophthalmic Solution is a slightly opalescent, nearly colorless, slightly viscous solution.
Dorzolamide Ophthalmic Solution is supplied in a white LDPE plastic DROP-TAINER® bottle, a natural dropper tip and an orange polypropylene cap as follows:
NDC 61314-019-05 5 mL, in a 8 mL bottle
NDC 61314-019-10 10 mL, in a 10 mL bottle
Store Dorzolamide Ophthalmic Solution at 2° - 25°C (36° -77°F). Protect from light.
HOW TO USE THE DROP-TAINER®* BOTTLE
The DROP-TAINER®* bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.
1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Dorzolamide Ophthalmic Solution.
2. Wash hands before each use.
3. Before using the medication for the first time, be sure the Safety Seal on the bottle is unbroken.
4. Tear off the Safety Seal to break the seal.
5. Before each use, shake once and remove the screw cap.
6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.
7. Tilt your head back and position the bottle above the affected eye.
8. With the opposite hand, place a finger under the eye. Gently pull down until a "V" pocket is made between your eye and lower lid.
9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication.
DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER.
DO NOT SQUEEZE THE SIDES OF THE BOTTLE.
KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE.
10. Repeat 6, 7, 8, & 9 with other eye if instructed to do so.
11. Replace screw cap by turning until firmly touching the bottle.
Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think that your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
The dispenser tip is designed to provide a pre-measured drop; therefore, do NOT enlarge the hole of the dispenser tip.
After you have used all doses, there will be some Dorzolamide Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Dorzolamide Ophthalmic Solution has been added and you will get the full amount of Dorzolamide Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.
WARNING: Keep out of reach of children.
If you have any questions about the use of Dorzolamide Ophthalmic Solutions, please consult your doctor.
*DROP-TAINER® is a registered trademark of Alcon Research, Ltd.
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Princeton, NJ 08540
PRINCIPLE DISPLAY PANEL
Dorzolamide HCl Ophthalmic Solution
(dorzolamide HCl 22.3 mg/mL)
FOR TOPICAL APPLICATION IN THE EYE
Dorzolamide pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Dorzolamide available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Dorzolamide destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Dorzolamide Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Dorzolamide pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Dorzolamide?
Depending on the reaction of the Dorzolamide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dorzolamide not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Dorzolamide addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Dorzolamide, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dorzolamide consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
The information was verified by Dr. Arunabha Ray, MD Pharmacology