Please email us at [email protected] with our item No, NDC#, UPC# or the product link if you have any quetions. We are located in Oceanside, California. Search over 110,000 items by Name, Item No., NDC, UPC (without dashes) or by Mfg.Name. Please note, Prescription items can only be ordered by a Drug Manufacturer, Wholesaler, Hospital, Governmental Medical Facility, VA, Pharmacy, Physician, Physician Assistant, Nurse Practitioner, Dentist, Podiatrist, Optometrist, Veterinarian, Naturopath, Licensed Lab, Physical Therapist & Pharmacist in their scope of practice. No order will ship, unless you you have provided us the Medical License (and DEA Lic. in case of controlled drug) and we had verified that. Rx items can only be shipped to AZ, AR, CA, CT, DE, FL, GA, GU, HI, IL, KS, KY, LA, ME, MA, MI, NJ, NY, PA, PR, TX, TN, VA, WA, WI and WV. If you are an International Physician or Pharmacist, please contact us before ordering.


Menu

Rx Item-Trusopt Plus 2% Drops 10Ml By Merck

NDC 00006-3519-36 UPC/GTIN No.3-00063-51936-6 Mfg.Part No.351936BRAND: TRUSOPT  NDC: 00006-3519-36,6351936 UPC: 3-00063-51936-6,300063519366 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Trusopt Plus 2% Drops 10Ml By Merck

$90.96$82.65

Item No.: RX663815 NDC No.6351936 UPC No.:300063519366 NDC No. 00006-3519-36 UPC/GTIN No. 3-00063-51936-6 MPN 351936 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx663815 Trusopt Plus 2% drops 10ml by Merck Item No. 3663815 NDC No. 00006351936 UPC No. 300063519366 Other Name Trusopt, Dorzolamide

Have a question?

TRUSOPT- dorzolamide hydrochloride solution
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

The dose is one drop of TRUSOPT Ophthalmic Solution in the affected eye(s) three times daily.



TRUSOPT 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.

3 DOSAGE FORMS AND STRENGTHS

Solution containing 20 mg/mL dorzolamide (22.3 mg of dorzolamide hydrochloride).

4 CONTRAINDICATIONS

TRUSOPT is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Sulfonamide Hypersensitivity
TRUSOPT 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 TRUSOPT. 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) and Patient Counseling Information (17.3)].

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 TRUSOPT 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 TRUSOPT. 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, TRUSOPT 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.

6 ADVERSE REACTIONS

6.1 Clinical Studies 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 TRUSOPT 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 approximately 1 to 5% of patients were conjunctivitis and lid reactions [see Warnings and Precautions (5.5)] , blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular reactions and systemic reactions 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 reactions profile of TRUSOPT was comparable to that seen in adult patients.

6.2 Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of TRUSOPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: signs and symptoms of systemic allergic reactions including angioedema, bronchospasm, pruritus, and urticaria; Stevens-Johnson syndrome and toxic epidermal necrolysis; dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery, eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.

7 DRUG INTERACTIONS

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 TRUSOPT. The concomitant administration of TRUSOPT 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 TRUSOPT.
DESCRIPTION

TRUSOPT� (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.

Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H -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 empirical formula is C10 H16 N2 O4 S3 ∙HCl
Dorzolamide hydrochloride 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.

TRUSOPT Sterile Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of TRUSOPT 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells (RBCs), but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a reduction in intraocular pressure (IOP).

TRUSOPT Ophthalmic Solution contains dorzolamide hydrochloride, an inhibitor of human carbonic anhydrase II. Following topical ocular administration, TRUSOPT reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.

NDC 00006-3519-36 UPC/GTIN No.3-00063-51936-6 Mfg.Part No.351936
RX ITEM-Trusopt Plus 2% Drops 10Ml By Me
NDC 00006-3519-36 UPC/GTIN No.3-00063-51936-6 Mfg.Part No.351936

BRAND: TRUSOPT  NDC: 00006-3519-36,6351936 UPC: 3-00063-51936-6,300063519366
Trusopt Plus 2% Drops 10Ml By Merck
BRAND: TRUSOPT NDC: 00006-3519-36,6351936 UPC: 3-00063-51936-6,300063519366

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Generic
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.