Fluoresin sodium - @ -Ophthalmic agents - Ophthalmic diagnostic products- (Mar 2006)
Drug Name:
Fluoresin sodium - @ -Ophthalmic agents - Ophthalmic diagnostic products- (Mar 2006)
List Of Brands:
Indication Type Description:
Indication:
Angiography /Angioscopy
LIST OF DRUGS DURING 2006
Sr.No- 24
Name of the Drug- Fluorescein Sodium Solution for Injection
(100mg/ml) Pharmacological Classification- Ophthalmological diagnostic agent
Date of Approval- 02-03-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Fluoresin sodium solution for 02-03-2006
Injection 100mg/ml
Ophthalmological diagnostic agent
Adverse Reaction:
Most common adverse reaction is nausea
Headache. GI distress, syncope, vomiting, hypotension, and other symptoms of hypersensitivity
Cardiac arrest, severe shock, convulsions, thrombophlebitis at the site of injection and rare
cases of death have been reported
Generalized hives and itching , bronchospasm, and anaphylaxis, have been reported
A strong taste may develop at thev site of injection
Contra-Indications:
Hypersensitivity to any component of the component.
Special precaution/Warnings-
Extravasation- care must be taken to avoid extravasation during injectionbecause of the
high pH of fluorescein solution can result in severe local tissue damage
Special risk patients - excercise caution in patients with a history of allergy or bronchial
asthma. . An emergenct tray including 0.1% ephnephrine for IM or Iv use , an antihistamine
soluble steroid and aminophylline fo IV use and oxygen must always be available in case
of an emergency
Pregnancy- avoid angiography on patients who are pregnant, especialy those in the first
trimester.
Lactation-excecise caution when fluoresin is administered to a nursing woman.
Children- safety and efficacy in children have not been established
Dosages/ Overdosage Etc:
Indication-
Angiography /Angioscopy
Dosage-
Inject contents of the ampule/vial rapidly into the antecubical vein after taking precautions
to avoid extravasation
For children the dose is calculated on the basis of 35mg in 10 pounds of body weight.
Store - at 15C to 25C ( 59 to 77 F ). Protect from freezing.
Patient Information:
Skin will attain a temporory yellowish discoloration.
Urine attains a bright yellow color
Discoloration of the skin fades in 6 to 12 hours hours, urine fluorescence in 24 to 36 hours
Pregnancy and lactation:
Pregnancy-
Avoid angiography on patients who are pregnant, especialy those in the first
trimester.
Lactation-
Excecise caution when fluoresin is administered to a nursing woman.
Children-
Safety and efficacy in children have not been established