dorzolamide hydrochloride
Pharmaranks rates Dorzolamide Hydrochloride 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Dorzolamide Hydrochloride is a carbonic anhydrase inhibitor used to treat Open-Angle Glaucoma.
Carbonic Anhydrase Inhibitor · by Micro Labs
Generic of Trusopt
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Dorzolamide Hydrochloride
- Drug class
- Carbonic Anhydrase Inhibitor
- Form
- Solution, Drops
- Strength
- Dorzolamide Hydrochloride EQ 2% Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- open-angle glaucoma
- Manufacturer
- Micro Labs
- What the pharmacy pays
- ~$0.87 per ml — not your price
- FDA application
- ANDA204778
What is Dorzolamide Hydrochloride?
From the FDA label:Dorzolamide hydrochloride ophthalmic solution, USP is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride USP is described chemically as: (4 S-trans )-4-(ethylamino)-5,6-dihydro-6-methyl-4 H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is α 25° (C=1, water) = ~ -17°. 405 Its molecular formula is C 10 H 16 N 2 O 4 S 3 •HCl and its structural formula is: Dorzolamide hydrochloride USP has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution USP is supplied as a sterile, isotonic, buffered, clear, colorless to nearly colorless and slightly viscous solution. The pH of the solution is approximately 5.6, and the osmolarity is 260 to 330 mOsM. Each mL of dorzolamide hydrochloride ophthalmic solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride USP). Inactive ingredients are Mannitol, Hydroxyethyl cellulose, Sodium hydroxide, Tri Sodium citrate dihydrate, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. dorzolamide-structure.jpg
How to use
Dorzolamide Hydrochloride is sold in more than one form (Solution and Drops), and each is dosed differently. The instructions below come from the FDA label for application ANDA204778 — follow the label that came with the product you were actually prescribed.
The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily. Dorzolamide hydrochloride 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 five minutes apart. The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily. Dorzolamide hydrochloride ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. ( 2 )
Side effects
The most frequently reported adverse reactions associated with dorzolamide hydrochloride 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 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Controlled Clinical Trials: The most frequent adverse reactions associated with dorzolamide hydrochloride 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 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. Reactions occurring in…
Warnings
Important safety information
Sulfonamide Hypersensitivity ( 5.1 ) Bacterial Keratitis ( 5.2 ) Corneal Endothelium ( 5.3 ) Allergic Reactions ( 5.4 ) Acute Angle-Closure Glaucoma ( 5.5 ) 5.1 Sulfonamide Hypersensitivity Dorzolamide hydrochloride ophthalmic solution contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of dorzolamide hydrochloride 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 [see Contraindications (4) ]. 5.2 Bacterial Keratitis 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. 5.3 Corneal Endothelium Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing dorzolamide hydrochloride ophthalmic solution to this group of patients. 5.4 Allergic Reactions In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of dorzolamide hydrochloride 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 hydrochloride ophthalmic solution should be discontinued and the patient evaluated before considering restarting the drug [see Adverse Reactions (6) ]. 5.5 Acute Angle-Closure Glaucoma The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.
Who should not take Dorzolamide Hydrochloride
Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1) ]. Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product. ( 4 , 5.1 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride ophthalmic solution. ( 7.1 ) Potential acid-base and electrolyte disturbances. ( 7.2 ) 7.1 Oral Carbonic Anhydrase Inhibitors 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 hydrochloride ophthalmic solution. The concomitant administration of dorzolamide hydrochloride ophthalmic solution and oral carbonic anhydrase inhibitors is not recommended. 7.2 High-Dose Salicylate Therapy Although acid-base and electrolyte disturbances were not reported in the clinical trials with dorzolamide hydrochloride ophthalmic solution, these disturbances have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g., toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving dorzolamide hydrochloride ophthalmic solution.
Drug class
How this class works, per Carbonic Anhydrase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Dorzolamide Hydrochloride ranks — best-rated carbonic anhydrase inhibitor for:
Dosage forms
Solution and Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Dorzolamide Hydrochloride treat?
- Dorzolamide Hydrochloride (Dorzolamide Hydrochloride) may be used to treat open-angle glaucoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Dorzolamide Hydrochloride work?
- Dorzolamide Hydrochloride is a carbonic anhydrase inhibitor. These block the enzyme carbonic anhydrase, which normally helps the body recycle bicarbonate. In the kidneys this flushes more bicarbonate, sodium, and water into the urine, and in the eye it cuts production of the fluid that builds up pressure, which is why they treat conditions like glaucoma and altitude sickness.
- How is Dorzolamide Hydrochloride rated?
- pharmaranks gives Dorzolamide Hydrochloride a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Dorzolamide Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.87 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Dorzolamide Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dorzolamide Hydrochloride. To pay less, Dorzolamide Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Dorzolamide Hydrochloride?
- Dorzolamide Hydrochloride is marketed by Micro Labs. You can see Micro Labs's full profile, rating, and other products on pharmaranks.
- Is Dorzolamide Hydrochloride a brand-name or generic drug?
- Dorzolamide Hydrochloride is a generic medication; its active ingredient is Dorzolamide Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Dorzolamide Hydrochloride available over the counter?
- No. Dorzolamide Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Dorzolamide Hydrochloride come in?
- Dorzolamide Hydrochloride is currently marketed as solution and drops, per the FDA's National Drug Code Directory.
- What class of drug is Dorzolamide Hydrochloride?
- Dorzolamide Hydrochloride is classified as carbonic anhydrase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Dorzolamide Hydrochloride FDA-registered?
- Dorzolamide Hydrochloride is on record with the U.S. FDA under application number ANDA204778. You can verify this on its official FDA label.
- Has Dorzolamide Hydrochloride been recalled by the FDA?
- Dorzolamide Hydrochloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Dorzolamide Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Dorzolamide Hydrochloride a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Dorzolamide Hydrochloride?
- Dorzolamide Hydrochloride's side effects are taken directly from its FDA label. From the label: The most frequently reported adverse reactions associated with dorzolamide hydrochloride ophthalmic solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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dorzolamide hydrochloride
70/100