Sodium Salts ( * )- (FDC- List )-(June 2006)
Drug Name:Sodium Salts ( * )- (FDC- List )-(June 2006)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Interacting drugs -summary
Sodium bicarbonate +
Chlorpropamide / Lithium / Methotrexate / Salicylates / Tetracyclines
renal clearance of these agents may be increased due to alkalization
of the urine, possibly resulting in a decreased pharmacologic effect.
Anorexiants/ Flecainide / Mecarnylamine / Quinidine/ Sympathomimetics
renal cleaanace of these agents may be decreased due to alkalization
of the urine possibly resulting in increased pharmacolgic or toxic effect.
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 66
Name of the Drug- Super Oxidized solution
(containing Water 99.9% with salts like
Sodium hypocholrite, hypochlorous acid,
Hydrogen peroxide ozone, Chlorine Chloride,
Sodium hydroxide, Sodium Carbonate and
sodium chloride) Pharmacological Classification- For use as cleaning and debililating agents in
wounds management care
Date of Approval- 12-06-2006
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
1.Pemetexed Disodium 500mg/100mg 04-12-2008
Powder for Sol. (Addl.Indication)
As monotherapy for second line treatment of Patients with locally
Advanced or metastic No-small Cell Lung Cancer other than
predominantly squamous cell Histology
2.Pemetered Disodium 500mg/100mg 08-10-2008
Powder for Sol. (Addl.Indication)
In combination with Cisplatin is indicated for the first line treatment
of patients with locally advanced or metastatic Non-small Cell Lung
Cancer other than predominantly Squamous cell Histology
3.Pemetered Disodium 500mg/100mg 16-01-2010
Powder for Injection(Addl.Indication)
Indicated as a monotherapy for the maintenance treatment of locally
Advanced or Metastatic Non-small cell lung (NSCLC) other than
predominantly squamous cell Histology in patients whose disease
has nor progressed immediately following Platimum -based
Chemotherapy. First Line treatment should be Doublet with
Gemcitabine, paclitaxel or Docetaxel
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Mixture of sodium salt + May 1975
Methyl Glucamine salt of 35 diacetamido-
2.4.6, - triobenzoic acid
2. NACL 0.53g + 23-07-2007
KCL 0.3g +
Sodium citrate 0.58g +
Dextrose anhydrous 2.7g per 200ml
ORS in solution
For oral rehydration in various etiology
3. NACL 0.125mg + 22-04-1996
KCL 150mg +
NaHCo3 0.250gm +
Citric Acid anhydrous 0.577gm +
Dextrose anhydrous 2.650gm ORS tablets
ORS tablets
.Rice based ORS citrate containing each sachet: 09-12-1993
Nacl 3.5g+
KCL 1.5g +
Sodium Citrate 2.9gm +
Extruded Rice 50.0gm
Oral rehydration salts
5.Rice based ORS electrolyte containing each sachet: 09-12-1993
Nacl 1.25gm+
Sodium Citrate 2.90gm +
Extruded Rice 50.0gm
Oral rehydration salts
6. Sodium Chloride 20.047mg + Nov 1978
Pot Chloride 0.522gm +
Mag.Chloride 0.366gm +
Cal Chloride 0.859gm +
Sod Acetate 19.054gm per 100ml Dialysis Fluid
7.Sodium Chloride 20.475mg + Nov 1978
Pot Chloride 0.783gm +
Mag.Chloride 0.534gm +
Cal Chloride 0.972gm+
Sod Acetate 19.054gm per 100ml Dialysis fluid
8.Sod ZChloride 558mg+ May 1973
Pot Chloride 14.9mg +
Mag Chloride 10.16mg +
Cal Chloride dihydrate 21.9mg +
20/6 Molar lactate 1.34ml +
Dextrose Anhydrous 1.54gm per 100ml
9.Sodium Chloride 6.80gm + 02-11-2010
Pot Chloride 0.30gm +
Cal chloride dihydrate 3.27gm +
Mag. chloride hexahydrate 0.20gm +
Sod acetate trihydrate 3.27gm +
l-Malic acid 0.67gm in 1000ml solution for infusion
Replacement of extracellular fluid losses in case of
isotonic dehydration, especially if acidosis is being
imminent or present
Prevention of extracellular volume depletion
Adverse Reaction:
Nausea and vomiting Side effects associated- exacerbation of peptic ulcers, mild hyperventilation and mild respiratory alkalosis amy occur due tostructural similarities between sodium benzoate and salicylates.
If adverse reaction does occur, discontinue administration , evaluate the patient and institute appropiate therapeutic countermeasures.
Contra-Indications:
None reported
Special preacutions-
Adjunctive therapy- not intended as sole therapy for UCE patients. Combine as adjunct therapy with dietary management (low protein diet) and amino acid supplementation. for optimal results.
Hyperbilirubinemia- use with caution in neonates with hyperbilirubinemia, as in vitro experiments suggest that benzoate competes with bilirubi binding sites on albumin.
Neonatal hyperammonemic coma- the benefits of treating neonatal hyperammonemic coma with the drug have not established. The treatment of choice in neonatal hyperammoniaemic coma is hemodialysis. Peritoneal dialysis may be helpul if not avilable.
Warning-
Sodium- because of the sodium content of the product ,consider the possibilitry of hypernattremia. Use with great care.in all patients with CHF severe renal insufficiency, and in clinical states in which sodium retention with edema.
In patients with diminished renal function administration of solutions containing sodium ions may result in sodium retention.
Benzyl alcohol- some of these products contain benzyl alcohol which has been associated with fatal -gasping syndrome- in premature infants.
Hypersensitivity- do not administer to patients with known hypersentivities to sodium benzoate or sodium phenylacetate.
No such cases of hypersensitivites have beeb reported.
Pregnancy- Safety for use during pregnancy has not been established. Use only when potential outweigh the hazards of the fetus.
Lactation- use caution when administering to a nursing woman
Dosages/ Overdosage Etc:
Indication:
Prevention of extracellular volume depletion
Dosage:
Overdosage-
Symptoms
Alkalosis
Hyperirritability
Tetany
Treatment
1. Discontinue sodium bicarbonate
2. Control symptoms alkalosis by rebreathing air from paper bag or rebreathing mask.
3. If more severe, by parentral injections of calcium gluconate ( to control tetany and hyperexcitability
4. Corect severe alkalosis by IV infusion of 2.14% ammonium chloride except in patients with hepatic disease.
Missed dose-
1. If you miss a dose of this medicine and remember within 2 hours take the missed dose right away with food or liquids.
2. Then go back to yourregular dosing schedule.
3. However, if do not remember until later skip the missed dose and then go back to your regular dosing schedule
4. Do not double doses
Pharmacology/ Pharmacokinetics:
Pharmacology- Sodium benzoate and sodium phenylacetate are metabolically active compounds that decrease elevated ammonia concentrations in patients with inborn errors of ureagenesis. The mechanism of this actions are conjugation reactions involving acylation of amoino acids, which results in decreased ammonia formation .
Pharmacokinetics-
A majority of the administerdc compounds (approximately 80% to 100% ) was excreted by the kidneys within 24 hours as the respective conjugation product, hippurate or phenylacetylglutamine. The major sites of metabolism of benzoate and phenylacetate are the liver and kidneys.
Pregnancy and lactation:
Pregnancy- Safety for use during pregnancy has not been established. Use only when potential outweigh the hazards of the fetus. Lactation- Use caution when administering to a nursing woman
