ADVOPTIC
Brand:
ADVOPTIC
Manufacturer:
MEDLEY
Manufacturer Details
MEDLEY
Compositions:
Tobramycin sulphate 0.3%+ dexamethasone Na phos 1% Eye drops,
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Strength
|
Rate
|
Packing Style
|
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0.3%+1% eye drops
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98.00
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5ml
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List of Related Indications:
- Infection of the eye structres
List Of Drugs:
- Tobramycin - @ -Aminoglycoside- (FDC- List )- (Sep 2002)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Hypoglycaemic effect enhanced by dicoumarol, salicylates, sulphonamides, phenylbutazone, clofibrate, chloramphenicol and cyclophosphamide.
Hypoglycaemic symptoms masked by beta-blockers.
Hypoglycaemic effect reduced by corticosteroids, adrenaline oral contraceptives and thiazide diuretics.
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 30
Name of the Drug- Tobramycin Inhalation solution(300mg/5ml) Pharmacological Classification- For chronic pulmonary infection cystic fibrosis
Date of Approval- 22-03-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Tobramycin Inhaltion Solution 22-03-2006
300mg/5ml
For Chronic Pulmonary infection Cystic Fibrosis
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Tobramycin sulphate eq.to 12-09-2002
Tobramycin 3mg +
Fluromethanone 1mg per ml
Opthalmic suspension
Steroid Responsive Inflammatory Ocular Conditions
for which a Corticosteroid is indicated and where
Superficial Ocular Bacterial infection exists
Serious infections caused by Pseudomonas aeruginosa, E.coli.
Adverse Reaction:
Marked hypoglycaemia causing cerebral impairment,coma and death(overdose and poisoning) GI symptoms, skin rashes, hypoglycaemia. Rarely hyponatraemia and blood dyscrasias.
Contra-Indications:
Diabetic ketoacidosis, IDDM, neonates, pregnancy, lactation.
Special precautions: Renal/hepatic/adrenocortical/thyroid function impairment, stress(surgical,trauma).
Dosages/ Overdosage Etc:
Indications:
Serious infections caused by Pseudomonas aeruginosa, E.coli.
Dosage:
Use patients ideal body weight for dosage calculations. Adults- 3mg/kg/day in 3 equal dose every 8 hours.. Life threatening infections- 5mg.kg/day in 3or 4 equal doses. Reduce doses to 3mg.kg/day as soon as clinically indicated.
Children- 6 to 7.5mg/kg/day in 3 or 4 equally divided doses (2 to 2.5mg/kg every 8 hours or 1.5 or 1.9mg/kg every 6 hours). Premature or full term neonates(1 week or less than 1 week of age)- 4mg/kg/day in 2 equal doses every 12 hours.
Patient Information:
Refer Amikacin- aminoglycosides
Pharmacology/ Pharmacokinetics:
Pharmacology:
Tobramycin is an aminoglycoside antibiotic. Aminoglycoside antibiotics are bactericidal in action and in general exert their action by irreversibly binding to the 305 subunit of bactericidal ribosomes, thereby blocking the recognition step in the protein synthesis and causing misreading of the genetic code. The ribosome separates from the messenger RNA and cell death ensues.
Pregnancy and lactation:
Observe caution if required to be used during pregnancy and lactation
