DRUGS & SUPPLEMENTS

Dorzox

Name: Dorzox drug & pharmaceuticals. Dorzox available forms, doses, prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Dorzox uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions controlled clinical trials:
Overdosage
Dosage and administration
How supplied
How to use the drop-tainer®* bottle
Principle display panel
Dorzox reviews

INDICATIONS AND USAGE

Dorzox Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

CONTRAINDICATIONS

Dorzox Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product.

WARNINGS

Dorzox 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 Dorzox 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.

PRECAUTIONS

General

The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzox Ophthalmic Solution has not been studied in patients with acute angle closure glaucoma.

Dorzox Ophthalmic Solution has not been studied in patients with severe renal impairment. Because Dorzox Ophthalmic Solution and its metabolite are excreted predominantly by the kidney, Dorzox Ophthalmic Solution is not recommended in such patients.

Dorzox 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 Dorzox 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, Dorzox 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 Dorzox Ophthalmic Solution. The concomitant administration of Dorzox 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

Dorzox 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 Dorzox 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 Dorzox Ophthalmic Solution administration.

Drug Interactions

Although acid-base and electrolyte disturbances were not reported in the clinical trials with Dorzox 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 Dorzox Ophthalmic Solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a two-year study of Dorzox 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 Dorzox 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 Dorzox 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.

Pregnancy

Teratogenic Effects. Pregnancy Category C. Developmental toxicity studies with Dorzox 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. Dorzox Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

In a study of Dorzox 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 Dorzox 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.

Pediatric Use

Safety and IOP-lowering effects of Dorzox Ophthalmic Solution have been demonstrated in pediatric patients in a 3-month, multi center, double masked, active-treatment-controlled trial.

Geriatric Use

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 Dorzox 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 Dorzox 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 Dorzox 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 Dorzox 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.

OVERDOSAGE

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 Dorzox Ophthalmic Solution in the affected eye(s) three times daily.

Dorzox 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.

HOW SUPPLIED

Dorzox Ophthalmic Solution is a slightly opalescent, nearly colorless, slightly viscous solution.

Dorzox 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

Storage

Store Dorzox Ophthalmic Solution at 2° - 25°C (36° -77°F). Protect from light.

Rx only

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 Dorzox 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 Dorzox Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Dorzox Ophthalmic Solution has been added and you will get the full amount of Dorzox 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 Dorzox Ophthalmic Solutions, please consult your doctor.

*DROP-TAINER® is a registered trademark of Alcon Research, Ltd.

SANDOZ

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

9006757-0511

PRINCIPLE DISPLAY PANEL

NDC 61314-019-10

Dorzolamide HCl Ophthalmic Solution

2%*

dorzolamide equivalent

(dorzolamide HCl 22.3 mg/mL)

Rx only

STERILE

10 mL

FOR TOPICAL APPLICATION IN THE EYE

SANDOZ

Dorzox pharmaceutical active ingredients containing related brand and generic drugs:

Dorzolamide Hydrochloride

Dorzox available forms, composition, doses:

Drops; Ophthalmic; Dorzolamide Hydrochloride 2%

Dorzox destination | category:

Human:
Antiglaucoma preparations
Carbonic anhydrase inhibitors

Dorzox Anatomical Therapeutic Chemical codes:

S01EC03 - Dorzolamide

Dorzox pharmaceutical companies:

Cipla

References

Dailymed."DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"dorzolamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"dorzolamide". http://www.drugbank.ca/drugs/DB0086... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dorzox?

Depending on the reaction of the Dorzox after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dorzox 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 Dorzox 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.

Review

sdrugs.com conducted a study on Dorzox, 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 Dorzox 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.