Buy Dorzolamide-SOLOFARM eye drops 20 mg/ml 10 ml 1 pc.
  • Buy Dorzolamide-SOLOFARM eye drops 20 mg/ml 10 ml 1 pc.

Dorzolamide

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2019-09-19
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Clinical Pharmacology

Antiglaucomal agent - carbonic anhydrase inhibitor

Indications

The drug is prescribed for adult patients with:

- ophthalmic hypertension;

- primary open-angle glaucoma;

- pseudoexfoliation glaucoma;

- secondary glaucoma (without block the angle of the anterior chamber of the eye).

The drug is prescribed to children:

- for the treatment of glaucoma in children from 1 week on monotherapy or as an adjunct to treatment with beta-blockers.

Composition

The composition of the drug in 1 ml

Active substance:

Dorzolamide hydrochloride 22.26 mg

in terms of dorzolamide 20.0 mg

Excipients:

Sodium citrate dihydrate 2.94 mg

Sodium hyaluronate 1.80 mg

Mannitol 23.0 mg

1 M solution of sodium hydroxide to pH 5.6

Water for injection up to 1.0 ml.

Dorzolamide is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Dorzolamide-SOLOFARM eye drops
Dorzopt K.O.Romparm Company S.R.L Romania eye drops
Trusopt Merck Sharp & Dohme USA eye drops

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Dorzolamide

Dosage and Administration

When using the drug Dorzolamide-SOLOpharm, the usual dosage is 1 drop to the affected eye (or both eyes) in the morning, afternoon and evening.

If you replace any antiglaucoma drug with Dorzolamide-SOLOpharm, you should start treatment with Dorzolamide-SOLOpharm from the day after the previous drug is canceled.

With simultaneous use of the drug Dorzolamide-SOLOpharm with other eye drops, they should be instilled with an interval of at least 10 minutes.

The procedure for working with a drip tube:

1. Separate one tube-dropper.

2. Open the tube-dropper (making sure that the solution is in the lower part of the tube-dropper, turn the rotating movements and separate the valve).

3. Instill the required amount of the drug in the eye.

The dose contained in the tube-dropper is sufficient for one instillation in both eyes. After a single use, the dropper tube should be discarded, even if the contents remain.

Adverse reactions

In clinical trials, the drug with dorzolamide in the form of eye drops was administered to 1108 patients as monotherapy or additional therapy to treatment with beta-blockers. In approximately 3% of patients, the drug was canceled due to local adverse reactions from the side of the eye, the most frequent of which were conjunctivitis and the reaction of the eyelids.

The side effects recorded during the research and during the post-registration period are classified by frequency (very often (≥1 / 10); often (≥1 / 100.1 / 10000,

The nervous system

Often: headache.

Seldom: dizziness, paresthesias.

On the part of the organ of vision

Very often: burning and pain.

Often: superficial point keratitis, lacrimation, conjunctivitis, inflammation of the eyelids, itching, irritation of the century, blurred vision.

Infrequently: iridocyclitis.

Rarely: eye redness, pain, hyperkeratosis of the eyelids, transient myopia (disappearing after drug withdrawal), corneal edema, decrease in intraocular pressure, detachment of the choroidal membrane of the eye after surgical interventions to restore the outflow of intraocular fluid.

On the part of the respiratory system,chest and mediastinum

Rarely: nosebleeds.

From the gastrointestinal tract

Often: nausea, bitter taste in the mouth.

Rarely: pharyngitis, dry mouth.

From the urinary tract

Rarely: urolithiasis.

From the skin and subcutaneous tissue

Seldom: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

General disorders and disorders at the site of administration

Often: asthenia, fatigue.

Rarely: allergic reactions - signs and symptoms of local reactions (from the eyelids) and systemic allergic reactions, including angioedema, urticaria, pruritus, rash, difficulty breathing, less often - bronchospasm.

Children

During a 3-month double-blind multicenter study using the active drug as a control, conducted with 184 children under the age of 6 years, the adverse reaction profile of the drug with dorzolamide in the form of eye drops was comparable to the profile of adverse reactions in adult patients. The most frequent adverse reactions associated with the use of the drug with dorzolamide in the form of eye drops in children under the age of 2 years were conjunctival injection (5.4%) and discharge from the eyes (3.6%). In children from 2 to 6 years old, the most frequent adverse reactions were burning sensation in the eye (12.1%), conjunctival injection (7.6%), eye pain (3%), and inflammation of the eyelids (3%).

Contraindications

- Age less than 1 week;

- hypersensitivity to the drug;

- chronic renal failure;

- pregnancy;

- breastfeeding period.

Carefully:

The drug has not been studied in patients with severe liver failure and, therefore, should be used in this category of patients with caution.

Drug interactions

Special studies on the interaction of the drug Dorzolamide-SOLOpharm with other drugs have not been conducted. In clinical studies, a drug with dorzolamide in the form of eye drops was prescribed in combination with other drugs without negative manifestations of drug-free interaction, including: with eye drops of timolol and betaxolol, as well as systemic drugs: inhibitors of angiotensin-converting enzyme (ACF), calcium channel blockers, diuretics , nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid), hormones (estrogen, insulin, thyroxin).

The possibility of mutual enhancement of the systemic effects of carbonic anhydrase inhibitors for internal use and the drug Dorzolamide-SOLOpharm with their simultaneous use is not excluded. Combined treatment with drugs that have a systemic effect and local carbonic anhydrase inhibitors has not been studied in clinical studies.

Dorzolamide-SOLOpharm is a carbonic anhydrase inhibitor, and although it is applied topically, it is partially absorbed and can have a systemic effect. In clinical studies, the use of drugs with dorzolamide in the form of eye drops was not accompanied by a violation of the acid-base balance. However, similar phenomena were observed with the use of carbonic anhydrase inhibitors, including as a result of interactions with other drugs (as a manifestation of toxicity in patients receiving high doses of salicylates). Thus, when administering the drug Dorzolamide-SOLOpharm, one should not forget about the possibility of such interdrug interactions.

The patient should inform the doctor about all medicines that he uses or plans to use, including those that are sold without a prescription.

Special attention should be paid to taking high doses of acetylsalicylic acid, since toxicity may increase.

Pregnancy and Lactation

Use of the drug is contraindicated in pregnancy and during breastfeeding.

Special instructions

In old age, sensitivity to dorzolamide may increase (dose reduction is required).

Impact on the ability to drive trans. Wed and fur .:

When using the drug is not recommended to drive and engage in potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions.

Overdosage

Symptoms

Electrolyte disturbances, the development of metabolic acidosis and the occurrence of drowsiness, nausea, dizziness, headache, weakness, unusual dreams, dysphagia are possible.

Treatment

Symptomatic therapy aimed at maintaining the vital functions of the body. Plasma electrolyte concentrations (especially potassium) and blood pH should be monitored.

Studies and clinical trials of Dorzolamide (Click to expand)
  1. A short radiosynthesis of 6-[C3H3]-dorzolamide at very high specific activity and optical purity
  2. Rapid high-performance liquid chromatographic assay of dorzolamide in rabbit aqueous humor
  3. Effects of (−)-carveol and HPMC on the in vitro ocular transport and the in vivo intraocular pressure lowering effects of dorzolamide formulations in normotensive New Zealand rabbits
  4. Applying Lipase Catalysis to Access the Enantiomers of Dorzolamide Intermediates
  5. Influence of various concentrations of terpene-4-ol enhancer and carbopol-934 mucoadhesive upon the in vitro ocular transport and the in vivo intraocular pressure lowering effects of dorzolamide ophthalmic formulations using albino rabbits
  6. Chiral separation and quantitation of dorzolamide hydrochloride enantiomers by high-performance liquid chromatography
  7. Chitosan nanoparticles loaded with dorzolamide and pramipexole
  8. Application of TLC-densitometry, first-derivative UV-spectrophotometry and ratio derivative spectrophotometry for the determination of dorzolamide hydrochloride and timolol maleate
  9. Simultaneous determination of dorzolamide HCL and timolol maleate in eye drops by two different spectroscopic methods
  10. Low level determination of dorzolamide and its de-ethylated metabolite in human plasma by liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry
  11. Influence of dorzolamide on corneal thickness, endothelial cell count and corneal sensibility
  12. A comparison of the efficacy and tolerability of dorzolamide and acetazolamide as adjunctive therapy to timolol
  13. Latanoprost versus combined therapy with timolol plus dorzolamide: IOP-lowering effect in open-angle glaucoma
  14. Dorzolamide and ocular blood flow in previously untreated glaucoma patients: a controlled double-masked study
  15. A comparison of the effects on intraocular pressure of latanoprost 0.005% and the fixed combination of dorzolamide 2% and timolol 0.5% in patients with open-angle glaucoma
  16. Timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination in primary open-angle glaucoma or ocular hypertensive patients
  17. Evaluation of retinal haemodynamics and retinal function after application of dorzolamide, timolol and latanoprost in newly diagnosed open-angle glaucoma patients
  18. Allergic contact dermatitis due to dorzolamide eyedrops
  19. Allergic contact blepharoconjunctivitis from dorzolamide
  20. Changes in intraocular pressure associated with topical dorzolamide and oral methazolamide in glaucomatous dogs
  21. Effects of twice daily application of 2% dorzolamide on intraocular pressure in normal cats
  22. Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT™) versus latanoprost 0.005% (XALATAN™) in the treatment of ocular hypertension or glaucoma: results from two randomized clinical trials
  23. Dorzolamide hydro­chloride: an anti­glaucoma agent
  24. Effects of glaucoma drugs on ocular hemodynamics in normal tension glaucoma: a randomized trial comparing bimatoprost and latanoprost with dorzolamide [ISRCTN18873428]

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