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TOBRADEX ST
Overview
What is TOBRADEX ST?
TOBRADEX ST (tobramycin / dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg.
The chemical name of tobramycin is -3-amino-3-deoxy-α-D-glucopyranosyl-(14)--[2,6-diamino-2,3,6-trideoxy-α-D--hexopyranosyl-(16)]-2-deoxy- L-streptamine. It has a molecular formula of CHNO and a molecular weight of 467.52. The chemical structure is:
The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of CHFOand a molecular weight of 392.47. The chemical structure is:
Each mL of TOBRADEX ST contains: tobramycin 3 mg and dexamethasone 0.5 mg. benzalkonium chloride 0.1 mg. xanthan gum, tyloxapol, edetate disodium, sodium chloride, propylene glycol, sodium sulfate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
What does TOBRADEX ST look like?
What are the available doses of TOBRADEX ST?
TOBRADEX ST ophthalmic suspension contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone.
What should I talk to my health care provider before I take TOBRADEX ST?
How should I use TOBRADEX ST?
TOBRADEX ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: , including and (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other beta-hemolytic species, some nonhemolytic species, and some most and some .
Instill one drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
What interacts with TOBRADEX ST?
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What are the warnings of TOBRADEX ST?
Sorry No Records found
What are the precautions of TOBRADEX ST?
Sorry No Records found
What are the side effects of TOBRADEX ST?
Sorry No records found
What should I look out for while using TOBRADEX ST?
• TOBRADEX ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ()
• Hypersensitivity to any component of the medication ()
What might happen if I take too much TOBRADEX ST?
Sorry No Records found
How should I store and handle TOBRADEX ST?
Store original packages at room temperature; avoid excessive heat.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.TOBRADEX ST is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.NDC 0065-0652-25: 2.5 mLNDC 0065-0652-05: 5 mLNDC 0065-0652-10: 10 mLStorageStore at 2° to 25°C (36° to 77°F).Protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dexamethasone is a potent corticoid. Corticoids suppress the inflammatory response to a variety of agents and they can delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.
Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis. Tobramycin is included in this combination product to provide action against susceptible bacteria.
Non-Clinical Toxicology
• TOBRADEX ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ()• Hypersensitivity to any component of the medication ()
Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.
Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.
Digitalis Glycosides
Calcium Channel Blockers
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high-degree heart block, and heart failure.
ACE Inhibitors
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Isoproterenol and Dobutamine
Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.
Antidepressants
Anesthetic Agents
Warfarin
Neuroleptic Drugs
Thyroxine
Alcohol
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.
The most frequent adverse reactions to topical ocular tobramycin (TOBREX) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
The reactions due to the steroid component are: increased intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.
Secondary Infection.
The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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