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Drug information on Fairgenol-H (Disodium Edetate) from FDC Limited


  Topical Solution
FDC Limited
Generic : Disodium Edetate
1.55% w/v /40% w/v

Drug Name : Disodium Edetate

Disodium Edetate generic Disodium edetate is prescribed • In emergency situations to lower the levels of excess calcium in the blood • To control irregular heartbeats or ventricular arrhythmias that occur due to accumulation of toxic levels of digitalis / digoxin , a drug given for heart conditions Disodium edetate is also known as disodium EDTA (ethylenediaminetetraacetic acid). NOTE: Edetate disodium is approved by the FDA only for treating critically high blood calcium levels, which are rare in occurrence. It is seldom used nowadays because safer methods of reducing serum calcium are available.
More Info about Disodium Edetate

Pallavi Singh
Written & Compiled by Pharmacist Pallavi Singh, M. Pharmacy (Pharmacy Practice)
Suchitra Chari
Medically Reviewed by Suchitra Chari, M.S. M.Sc.
Last Updated on Dec 12, 2017
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Medical Condition(s) for which Fairgenol-H may be prescribed

Overview of Fairgenol-H

• Disodium edetate is a chelating agent used for lowering very high serum calcium (hypercalcemia) levels in emergency situations.

Side effects of Fairgenol-H

  Gastrointestinal disorder: Nausea, vomiting, diarrhea

  Skin: Exfoliative dermatitis, toxic skin and mucous membrane reactions, transient burning and pricking

  Hematological: Thrombophlebitis, febrile reactions, hyperuricemia, anemia

  Others: Numbness, headache

Dosage & When it is to be taken (Indications)

Dosage of disodium edetate injection
Adults: Daily dose of 50 mg/kg per body weight up to a maximum dose of 3 kg in 24 hours
Children: Daily dose is 40 mg/kg per body weight up to a maximum dose of 70 mg/kg in 24 hours

How to use Fairgenol-H?

• Disodium edetate is given as an intravenous infusion only after dilution in 500 ml of 5% dextrose injection or 0.5% (0.9% for children) sodium chloride injection.
• It has to be administered only by a health care professional in a hospital or clinic setting. Final concentration for children should not be more than 3%.

When is Fairgenol-H not to be taken? (Contraindications)

Disodium edetate is contraindicated in patients

• Allergic to the drug
• Who have problems in the passage of urine (anuria)
• For the treatment of generalized atherosclerosis (formation of plaque in blood vessels) that occurs due to old age

NOTE: Disodium edetate is strongly contraindicated to be used instead of the other EDTA agent, calcium disodium EDTA or calcium disodium versenate used to treat serious cases of lead poisoning, or to be used in non FDA approved "chelation therapies" that falsely claim to improve the cardiovascular system. Wrong uses of the drug in both the above cases have lead to fatalities in the past.

Warnings and Precautions for Fairgenol-H

• The rapid intravenous injection could produce a high serum concentration of disodium edetate quickly and cause fatal decreases in serum calcium levels.
• Toxicity appears to be dependent upon both total dosage and speed of administration.
• Disodium edetate treatment has the potential to cause electrolyte imbalance; hence cardiac function should be assessed before and during treatment.

Other Precautions for Fairgenol-H

The patient should lay in bed for a time after treatment due to the postural hypotension.
Do not use unless the solution is clear and the container is intact.

Use with caution on patients with
• Heart disease
• Limited cardiac reserve
• Congestive heart failure
• Low potassium levels
• Pregnant and nursing women

Edetate disodium has the potential to cause
• Low serum magnesium levels during prolonged therapy
Low blood sugar

Drug Interactions of Fairgenol-H

• Serum calcium detected by the oxalate method of determination tends to be low in the presence of edetate disodium.

Storage Conditions for Fairgenol-H

• Store in a cool, dry place.
• Keep containers tightly closed.

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