G Oral Plus ORS with Zinc

G-Oral Plus ORS with Zinc

Combi Pack of 2 pouches of ORAL REHYDRATION SALTS BP 20.5g each and 10 DISPENSIBLE ZINC SULFATE Tablets USP

Restores Body Fluids and Electrolytes Lost Due To Dehydration

 

Composition: Each Sachet contains

(To produce 1000ml)

Sodium Chloride BP        2.60g

Potassium Chloride BP   1.50g

Sodium Citrate BP            13.50g

Excipients                            q.s.

Concentrations in mmol/Litre
Sodium                                 75mmol/L
Chloride                               65mmol/L
Potassium                           20mmol/L
Citrate                                  10mmol/L
Glucose                                 75mmol/L
Total osmolarity               245.0mmol/L

 

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Oral Rehydration Salts

Sodium Chloride/Potassium Chloride Salts/Electrolytes
Sodium Bicarbonate Acid Neutraliser
Glucose Anhydrous Carbohydrate Electrolyte carrier

Zinc supplementation

Zinc is an essential trace element involved in many enzymes systems. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infections and failure to thrive in children. Symptoms of less severe deficiency include distorted or absent perceptions of taste and smell and poor wound healing.

 

Pharmacokinetic properties

Oral Rehydration Salts

Glucose has been shown to greatly enhance the absorption of salts and water. The concentration used in G-Oral Plus is very effective and has been demonstrated as giving a twenty five-fold enhancement of absorption compared with isotonic saline. Also, as the solution is more palatable, patient compliance is increased.

Zinc supplementation

Zinc is absorbed from the gastrointestinal tract and distributed throughout the body. Plasma zinc levels range from 70 to 110µg/dL and about 50% of this is loosely bound to albumin. About 7% is amino-acid bound and the rest is tightly bound to alpha 2-macroglobulins and other proteins.

 

Indications

Oral Rehydration Salts (ORS) is primarily indicated for the replacement of fluid and electrolytes and maintenance of hydration in diarrhea, vomiting, excessive sweating of varied etiology and other conditions where there is a loss of water and electrolytes. Continue treatment until diarrhea stops/dehydration is corrected or as directed by physician.

Zinc Sulfate is a source of zinc which is an essential trace element and involved in a number of body enzyme systems and used for the treatment of zinc deficiency.

 

Method of administration

ORS: Dissolve entire contents of one sachet in 1 litre of freshly boiled and cooled water. Stir until powder is completely dissolved. Do not boil solution after constitution. Use within 24 hours of reconstitution.

Zinc supplementation: Zinc tablets must be given once a day and repeat every day until the course is complete. Zinc Sulfate tablets may be dispersed in (5ml) breast milk or freshly boiled and cooled water on a tablespoon. Older children can swallow the tablet with water.

 

Dosage

Oral Rehydration Salts: Infants – 1 lire over 24 hours period.

Child – 1 litre over 8 – 24 hours period, according to the age.

Adult – Drink freely as required.

Zinc supplementation: Adult – 1 tablet once daily

Children – 6 month – 12 years one tablet once daily

Children less than 6 months – half (1/2) tablet should be dissolved in 5ml of water once daily or as prescribed by physician.

 

Warning and precaution

Oral Rehydration Salts

Use with caution in patients with pre-existing blood disorders, gout, dental disease, liver disease or heart disease. These are not appropriate for patients with gastrointestinal obstruction, oliguric or anuric renal failure oral rehydration salts should be reconstituted only with water.

Zinc supplementation

Zinc Sulfate Tablets may interfere with uptake of certain antibiotics, penicillamine, sodium valporate, ethambul etc. Do not co-administer Zinc Sulfate tablets with above drugs.

 

Side effects

Oral zinc sulfate supplements can cause side effects such as heartburn and nausea. Rare side effects include fever, sore throat, mouth sores, weakness and fatigue. Excessive use of ORS can cause swelling of the limbs, sickness, diarrhea, stomach paints, thirst, dry mouth, fever, headache, dizziness, restlessness, irritability, weakness, increased sodium and potassium levels.

 

Overdose

Oral Rehydration Salts

In oral electrolyte replacement therapy, toxicity is rare in previously healthy people. In subjects with renal impairment, hypenatremia and hyperkalemia might occur.

In the event of significant overdose serum electrolytes should be evaluated by means of full biochemical profile under hospital conditions and the physician should take the appropriate measures. This is particularly important in the very young and in cases of severe hepatic or renal failure.

Zinc supplementation

Zinc sulfate is corrosive in overdosage. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach; ulceration of the stomach followed by perforation may occur. Gastric lavage and emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as sodium calcium edentate may be useful.

 

Contraindication

G-Oral Plus is contraindicated in patients who are hypersensitive to ORS and Zinc or any component of the product.

 

Storage

Store in a cool dry place

 

Presentation

2 sachets of 20.5g each and a blister pack of 10 tablets.

KEEP MEDICINE OUT OF REACH OF CHILDREN

 

NAFDAC REG. NO. : B4-4549

 

Manufactured for

GREENLIFE PHARMACEUITICALS LTD

2, Bank Lane, Off Town Planning Way,

Ilepeju, Lagos, Nigeria

Tel 01-555 6918, 555 0780

Email greenlife2001@yahoo.com

Website www.greenlifepharm.com

 

Manufactured in India by

Globela Pharma Pvt. Ltd

357, GIDC, Sachin,

Surat – 394230

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