Drug Interaction:
Toxicity asociated with high dose of salicylate therapy
Indication:
Approved by FDA on December 1994
LIST OF DRUGS DURING 2004
Sr.No- 235
Name of the Drug- Dorzolamide (20mg) +
Timolol (5mg) per ml Eye drops Pharmacological Classification- For reduction of elevated IOP
Date of Approval- 01-09-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Dorzolamide Ophthalmic 03-10-2003
2.Dorzolamide 20mg + 01-09-2004
Timolol 5mg per ml eye drops
Elevated ocular pressure
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Dorzolamide 2% + 28-08-2004
Timolol 0.5% eye drops
For the reduction of elevated intra ocular pressure in
patients with open ankle glaucoma or ocular hypertension
who are insufficiently responsive to beta-blockers
2. Each ml contains: 18-11-2013
Dorzolamide Hydrochloride 2mg/ml +
Timolol Maleate ophthalmic solution
(preservative free formulation of Approved FDC)
For the treatment of elevated intra ocular pressure in patients
with open angle glaucoma or pseudoexfoliative glacoma when
topical bet-blockers monotherapy is not sufficient
Elevated ocular pressure
Adverse Reaction:
Ocular bleeding ,stinging, or discomfort immediately following admin, bitter taste following admin, superficial puncuate keratitis, signs and symptoms of ocular allergic reactions, blurred vision.
Contra-Indications:
Hypersens to the product
Special precautions:
Corneal endothelium effects.
Acute angle glaucoma, Occular effects, Bacterial keratitis.
Dosages/ Overdosage Etc:
Approved by FDA on December 1994
Indication-
Elevated ocular pressure
Dosage:
One drop in the affected eye(s) 3 times a day. Dorzolamide may be used concomittantly with other topical opthalmic drug products to lower intrtaocular pressure.,
Patient Information:
1. Advise patients that if they develop any ocular reactions, particularly conguntivitis and ild reactions, they discontinue use and seek their physicians advise.
2. If more than one topical opthalmic drugs is being used, administer the drugs at least 10 minutes apart.
3. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to opthalmic dorzolamide or to any sulfonamide, furosemide, or thiazide diuretic, oral antidiabetic or carbonic anhydrase inhibitor-type glaucoma ,dichlorphenamide or other related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
4. Pregnancy- before taking this medicine make sure that your doctor knows if you are pregnant or if you may become pregnant.
5. Breast feeding- it may be necesary to use another medicine or stop breast-feeding during treatment. Be sure you have discussed this with your doctor.
7. Children- no specific information available comparing use of dorzolamide in children with use in other age groups
8. Elderly- this medicine has not been shown to cause diffeent side effects or problems in older people than in adults
9.Other medicines- tell your doctor if you are taking any of the following- Silver preparations- for the eye such as silver nitrate, - opthalmic dorzolamide should not be used with opthalmic silver preparations,since a chemical reaction may occur
10.Other medical problems- Especially kidney disease or Liver disease - use of opthalmic dorzolamide may lead to increased side effects from the medication Kidney stones - use of opthalmic dorzolamide may make this condition worse
11. Missed dose- If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule. Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Dorzolamide is a carbonic anhdrase inhibitor formulated for topical opthalmic use. It catalyses the reversible action involving the hydration of carbon dooxide and the dehydration of carbonic acid.
Pharmacokinetics:
When topically applied ,dorzolamide reaches the systemic circulation.
Pregnancy and lactation:
Pregnancy:
Use during pregnancy only the potential benefit justifies the risk to,the fetus.
Lactation:
Because of the potential risk, decide whether to discontinue the drug or discontinue nursing depending on he importance of the drug to the mother
Manufacturer Details