products-page-bottom-left-box

Garylyte

Agary Pharmaceutical Limited
Plot C39A, Amuwo Odofin Commercial Scheme, Along Alakoso Avenue, Amuwo Odofin, Lagos.
Email: agarypharm@gmail.com
Tel: 0809-275-6424, 0809-275-6425, 0808-745-4848.
Website: http://agarypharm.com/

Brand Name

Garylyte

Manufacturer

Agary Pharmaceutical Limited Plot C39A Amuwo Odofin Comm. Scheme, Along Alakoso Avenue, Amuwo Odofin, Lagos.

Therapeutic Class

Electrolyte replacement, Oral

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Powder (NRN: B4-3236): Each sachet contains: (To produce 1000 mL) Glucose Anhydrous BP 13.5 gm; Sodium Chloride BP 2.6 gm; Sodium Citrate BP 2.9 gm; Potassium Chloride BP 1.5 gm; Excipients q.s Colour & Orange Flavour added.

Concertation in mmol / litre
Sodium 75.0
Potassium 20.0
Chloride 65.0
Citrate 10
Glucose 75

Pack Size: 3 Sachets

Garylyte   2Garylyte orange  2

Pharmacology

Description:
Oral rehydration therapy (ORT); is a fluid replacement strategy used to prevent or treat dehydration due to diarrhea or vomiting.

Pharmacodynamics:
The reconstituted solution contains a mixture of sodium and potassium salts along with glucose, which facilitates the absorption of sodium and potassium from the intestine. Water is drawn from the bowel by the osmotic effect. As well as “drying up” the dehydration and loss of electrolytes caused by the diarrhoea is corrected by the water and electrolytes absorbed.

Pharmacokinetics:
Glucose
After oral administration glucose is completely absorbed by a sodium dependent uptake mechanism exhibiting saturation kinetics. Blood levels return to normal within two hours of ingestion.

Potassium Chloride
No specific control mechanisms limit absorption of potassium, which is usually complete. Potassium is excreted largely by the kidneys, though 10% is excreted by the colonic mucosa. Potassium excretion is reduced in patients with renal impairment and in the elderly, so extreme caution should be used in treating such patients with potassium salt.

Sodium Chloride
Readily absorbed from the gastrointestinal tract. Gut absorption, particularly in the particularly in the jejunum is enhanced by the addition of glucose. Under conditions of sodium balance, the excretion of sodium in the urine will match intake.

Indications

Oral rehydration salt is indicated for the treatment of dehydration due to diarrhoea or vomiting in infants, children and adults.

Contra-indications

Oral Rehydration Salt are contraindicated in patients exhibiting the following conditions:

Congestive cardiac failure, nephrotic syndrome, acute and chronic renal failure, ischaemic heart disease, adrenocortical insufficiency, hypokalaemic periodic paralysis, hyperkalaemia, hyperventilator states, chloride depletion due to continuous gastric fluid loss, metabolic or respiratory alkalosis, hypercalcaemia, hyperosmolar states in anuria or oliguria, oedematous sodium retaining conditions, hypertension, peripheral or pulmonary oedema or toxaemia of pregnancy, severe vomiting, dextrose malabsorption, in cases of diabetes mellites, thiamine deficiency, severe under-nutrition, haemodilution, hypophosphataemia, sepsis and trauma.

Oral rehydration salts are also contraindicated for use in patients undergoing treatment with the following:

Sodium retaining drugs (e.g. corticosteroids, NSAID’s carbenoxolone), diuretic known to produce hypochloraemic alkalosis.

Use in patients with pre-eclampsia is contraindicated. The product should only be administered if the expected benefit to the mother is thought to outweigh any possible risk to the foetus or neonate.

Precautions/Warnings

Administer with care in cases of acute dehydration, heat cramps, extensive tissue destruction or if patients are receiving potassium-sparing diuretics. Concurrent use with other potassium containing drugs may precipitate hyperkalaemia. It is very important to dissolve oral rehydration salts in water of the correct volume.

A weak solution will not contain optimum glucose and electrolyte concentration and a strong solution may give rise to electrolyte imbalance. Diarrhoea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought. In other age groups, if symptoms persist for more than 24 – 48 hours, consult a doctor.

If nausea and vomiting are present with the diarrhoea, small and frequent amounts of Oral Rehydration Salts should be drunk first. In infants, immediate medical assistance should be obtained. Use within one hour of reconstitution, or within 24 hour if stored in a refrigerator.

Severe continuing diarrhoea or other critical fluid losses may need supplementation with other parenteral fluids with Garylyte ORS. Close tightly after every use and keep away from moisture. Solution to be used within 24 hours.

Interactions

Interactions with Other Medicaments:

Potassium Chloride, ACE inhibitors (hyperkalaemia); Cyclosporin (increased risk of hyperkalemia); Potassium sparing diuretics where hyperkalaemia may result. No known interactions to other actives.

Adverse Effects

The following adverse effects have been reported although more commonly following excessive amounts:

Hypernatraemia, oedema, nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation, lacrimation, sweating, fever, tachycardia, renal failure, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching, coma, convulsion, hyperkalemia, gastro-intestinal ulceration, metabolic alkalosis, muscle hypertonicity, flatulence, dehydration and raised blood pressure.

Dosage & Administration

Oral rehydration solution (ORS) should be administered with a method that infant is familiar with e.g. baby bottle, cup or spoon. Breast feeding mothers may choose any of the mentioned methods to administer the solution to their infants.

ORS should be given in addition to and in between normal feeds/meals in small, frequent and slowly administered amounts depending upon age and severity of dehydration.

Each sachet dissolved in 1000 mL of water to make ORS solution. The solution must be freshly prepared every day. Discard unused solution after 24 hours.

Maintenance Therapy
Patients should be observed carefully to confirm adequate maintenance of hydration.
Frequent clinical observations should be made to ensure that adequate hydration is being maintained. The maximal dose of ORS should not be exceeded. If further fluid intake is required, free water should be given.

Infants less than 1 year of age should be given ½ to 1 cup (100-200 mL) of ORS for every time their bowels work.

Children 1 to 5 years of age should be given at least one cup (200 mL) for-every time their bowels work.

Older children and adults should drink enough ORS to quench their thirst and replace the fluid lost in every stool.

 Infants less than 1 year of age:   120 mL/kg/day 
 Children 1-2 years of age:  100 mL/kg/day
 Children 2 -4 years of age:  85 mL/kg/day
 Children 4-10 years of age:  70 mL/kg/day
 Children over 10 years and adults:  2 to 3 litres/day

Overdose and Treatment:

Iso-osmotic overload is managed by restricting sodium, potassium water intake plus measures to increase renal sodium, potassium and water output by using “loop diuretics” e.g. frusemide.

Storage/Handling Recommendations

Store below 30°C, protect from light and moisture.

STORE IN A DRY PLACE

Review Date

2017-09-14 06:41:50