4.1. Therapeutic Indications:
Urinary Tract Infections:
- Jedcorene effervescent granules is generally used as astrong urinary tract antiseptic for renal infections
including nephritis, pyelitis, pyelonephritis and cystitis.
- Jedcorene effervescent granules is used for prophylaxis and treatment of recurrent urinary tract
infections, especially when long-term therapy is considered necessary.

- Jedcorene effervescent granules should be used only after the urinary tract infection has been
eradicated by other appropriate anti-infectives and the drugs should not be used alone for acute
infections.
- Jedcorene effervescent granules is not effective in systemic bacterial infections and have no effect on
bacteria in blood or tissues outside the urinary tract.
- Jedcorene effervescent granules should not be used alone in the treatment of acute parenchymal
infections causing systemic symptoms.
- Efficacy of Jedcorene effervescent granules therapy should be monitored by periodic urine cultures.
Antibacterial effects of Jedcorene effervescent granules are maximal when urine pH is 5.5 or less.
Urinary pH should be monitored during Jedcorene effervescent granules therapy and supplementary
acidification, if required, may be achieved by dietary,regulation and/or concomitant administration of
acidifuing agents (e.g., ammonium chloride, ascorbic acid, methionine).
- Supplementary acidification is particularly important when the causative organisms are urea-splitting
strains of Enterobacter, Proteus, or Pseudomonas which increase urinary pH.
- In addition, some clinicians recommend that, to ensure adequate urinary concentrations of
formaldehyde, urine specific gravity should be monitored during Jedcorene effervescent granules
therapy and maintained above I .015 by restricting fluid intake.
- Jedcorene effervescent granules was introduced into medicine as solvent for uric acid & ureat crystals.
- Jedcorene effervescent granules is indicated for removal of small bladder and kidney stones.

The content of the sachet to be dissolved in half glass of water and drank immediately.

Warnings:
Pregnancy & Lactation:
Safe use during pregnancy & lactation has not been established.
Pregnancy: Jedcorene effervescent granules used only when necessary due to the emmenagogue
and uterine stimulating activity of its khellin contents.

Drug interactions :
Concomitant uses of jedcorene and chlorpromazine may precipitate seizures due to jedcorene
piprazine contents.
Formaldehyde and Sulfamethizole form an in soluble precipitate in acid urine therefore
Jedcorene should not be administrated concomitantly with Sulfamethizole due its hexamine
contents.
Drug-Disease Contraindications:
Most Significant: Disease of liver, epilepsy &renal Disease
Possibly Significant: Severe dehydration, metabolic acidosis and gout.
also data conflicts peprazine and chlorpromazine may precipitate seizures if used concomitantly.

- There are no adequate and controlled studies to date using hexamine in pregnant women and
hexamine preparations should be used during pregnancy only when clearly needed.
- Jedcorene effervescent granules used only when necessary due to the emmenagogue and uterine
stimulating activity of its khellin contents.
- Although safe use of hexamine during pregnancy has not been definitely established, the drugs
have been used in pregnant women without adverse effects to the fetus.
- One manufacturer states that there are no recognized uses for hexamine during labor or delivery.
- Because hexamine is distributed into milk and because of the potential for serious adverse effects
in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking
into account the importance of the drug to the woman.

No Effects

GI Side Effects: Because of Jedcorene effervescent granules piperazine citrate; hexamine &
khellin content, it may cause nausea, vomiting, diarrhea & cramps.
CNS: Because of Jedcorene effervescent granules piperazine citrate content it may cause tremors,
headache, vertigo, decreased reflexes, paresthesias, seizures ataxia, chorea, memory decrement.
Ophthalmolosic: Because of Jedcorene effervescent granules piperazine citrate content it may
cause nystagmus, blurred vision, cataracts, strabismus.
Allersic: Because of Jedcorene effervescent granules piperazine citrate; hexamine & khellin
content, it may cause urticaria, fever, rash, pruritus, stomatitis, skin reactions, pseudoallergic
reactions, reversible cholostatic icterus/jaundice, purpura, lacrimation, rhinorrhea, arthr algia.
broncho spasm cough.
Urinary Tract: Because of Jedcorene effervescent granules hexamine content it may cause
crystallirria, dysuria, and microscopic or, rarely, gross hematuria.
Miscellaneous: Because of Jedcorene effervescent granules piperazine citrate content it may
cause muscle weakness & hematuria.

- Bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria
have occurred following administration of higher than recommended dosages of
hexamine or its salts (8 g daily for 34 weeks) and are probably due to high concentrations
of formaldehyde in the urinary tract.
- Dysuria may be controlled by reducing dosage and/or reducing acidification of the urine.
- Acute massive piperazine overdosage can lead to paralysis and death, but the drug is
generally considered to have a wide margin of safety. The oral LD50 of piperazine salt in
mice is 11.4 g/kg.

Mechanism of action:
- Jedcorene effervescent granules reduce the pain caused by the trapped stone and helps ease the stone
down into the bladder by relaxing the muscles of the ureter due to its khellin contents.
- Also Jedcorene effervescent granules may have antispasmodic and diuretic effects due to its khellin.
- Jedcorene effervescent granules may act as a solvent for uric acid due to its piperazine contents. This
action may be attributed to the remarkable power of piperazine to dissolve the uric acid and producing
a soluble urate outside the body, but in clinical experience it has not proved equally successful.
- Jedcorene effervescent granules may have antibacterial effect due to its hexamine contents. The
antibacterial effect of hexamine is dependent upon the release of formaldehyde is a nonspecific
antibacterial agent which is usually bactericidal in action.
Spectrum:
- Formaldehyde us active against both gram-positive and gram-negative bacteria including
Enterobacter, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa,
Staphylococcus aureus, S. epidermidisma nd Enterococcus faecalis (formerly
Ste\reptococcus faecalis).
- Because formaldehyde has nonspecific antibacterial; activity, resistance does not usually
develop during prolonged therapy with hexamine.

Absorption:
Piperazine citrate is readily absorbed from the proximal sections of the GI tract. Hexamine is readily absorbed
from the GI tract. Approximately 10-30%o of an oral dose of hexamine is hydrolyzed by gastric acidity to
formaldehyde and ammonia. Following oral administration of a usual single dose of hexamine to healthy
fasting adults, concentrations of hexamine and formaldehyde in plasma are generally very low and
antibacterial activity in plasma is negligible.
Distribution:
Hexamine crosses the placenta and is distributed into milk.
Metabolism:
Piperazine citrate is partially metabolized by the liver, and the remainder is excreted in urine.

Elimination:
Rate of piperazine citrate elimination differs among clients although it is excreted nearly unchanged in the
urine within24 hr.
Within 24 hours, 70-90% or more of a single oral dose of hexamine is excreted intact in the urine by
glomerular filtration and tubular secretion. When the urine is acidic, hexamine is hydrolyzed to
formaldehyde and ammonia; maximum hydrolysis occurs when urine pH is 5.5 or less. Following oral
administration of a usual single dose of hexamine to fasting adults, peak concentrations of formaldehyde in
acidic urine average 1-85 mcg/ml and are attained within 2 hours.

Mutagenicity and carcinogenicity of Jedcorene Effervescent Granules:
There are no studies available on carcinogenicity,mutagenicity or teratogenicity of
Jedcorene effervescent granules.
Reproductive Toxicity of Jedcorene Effervescent Granules:
There are not adequate and controlled studies to date using hexamine in pregnant women
and hexamine preparations should be used during pregnancy only when clearly needed.
Because hexamine is distributed into milk and because of the potential for serious adverse
effects in nursing infants, a decision should be made whether to discontinue nursing or
drug ,taking into account the importance of the drug to the woman.
There is no studies available on Jedcorene effervescent granules & fertility

Citric Acid Anhydrous 1.4 gm
Sodium Bicarbonate 1.825 gm
Lemon Oil 0.00675 gm
Sucrose Powder 1.1 gm
Sodium Saccharin 0.0025 gm
Sunset Yellow
"F.D.&C Yellow No.6 – C.I.No. 15985" 0.00005 gm
Quinoline Yellow
"F.D.&C Yellow No.10 – C.I.No. 47005" 0.95 mg
Ethyl Alcohol 95 %* 0.2 ml

Not applicable

Store below 300c

Carton Box contains 12 sachets each of 5gm effervescent granules and a pamphlet.

Store below 300c and keep out of reach of children.
No special requirements for disposal of the product