ZN-VITAL® (Zinc Sulphate Oral solution USP)

ZN-VITAL® (Zinc Sulphate Oral solution USP)

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ZN-VITAL® (Zinc Sulphate Oral solution USP)

Therapeutic category: A07X (Various antidiarrheal)

Zinc inhibits cAMP induced chlorine dependent fluid secretion. It increases the absorption of water and electrolyte and also inhibits toxin induced cholera and an adjunct to antimicrobial (AM) treatment in bloody dysentery showed increase in the bactericidal antibody titers against shigella. It increases the level of brush border enzymes and intestinal epithelium regeneration.

Indication

Treatment of acute and persistent diarrhoea in infants and children aged up to 5 years along with Oral Rehydration salt (ORS) recommended by World Health Organization (WHO).

Contraindications

Hypersensitivity to Zinc Sulphate or any other ingredients used in the formulation

Side effects and adverse reactions

In clinical trials in children, administration of zinc sulfate was associated with vomiting or regurgitation. In one study vomiting attributed to administration of zinc sulfate was reported very common i.e. in 14% and regurgitation was reported commonly i.e. in 5-2% of the children. In most cases vomiting or regurgitation occurred within 10 minutes of the first dose and was not recurrent. Zinc salts may also case abdominal pain and dyspepsia. Signs of allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue or throat.

Dosage regimen and direction for use

To be administered orally.

For acute and persistence diarrhoea.

Children and less than 6 months: 5ml once daily for 10-14 days

Children aged 6 months to 5 years: 10ml once daily for 10-14 days

It is recommended that doses are given between meals and the dose repeated if the child vomits within 30 minutes

For missed doses, the missing dose can be taken as soon as possible, unless the next dose is due within 6 hours.

Pregnancy and lactation

Pregnancy: there are few data on the use of zinc sulfate in pregnant women. The use of zinc sulfate may be considered during pregnancy, if necessary.

Lactation: Zinc appears in human milk, but at therapeutic doses of zinc sulfate no effects on the breastfed infant are anticipated.

However, always consult your physician before taking this medicine.

Drug interactions

Zinc reduces absorption of tetracycline (but not doxycycline) and quinolones antibacterials. It also interfere with absorption of cephalexin, ceftibuten and reduces absorption of penicillamine. All these drugs needs at least three hours gap of administration with zinc.

Precaution and warning

This product contains sucrose if your diabetic do not use.

Do not exceed the stated dose.

Keep out of reach and sight of children.

Symptoms and treatment of overdosage

High doses of zinc cause emesis, irritation and corrosion of the gastrointestinal tract, including ulceration of the stomach and possible perforation. It also causes acute renal tubular necrosis and interstitial nephritis and copper deficiency, yellow skin or eye, metallic taste in the mouth.

Administration of milk or alkali carbonates and activated charcoal may be useful in cases of substantial ingestion of zinc, daily injection 50 to 70mg of Disodium or calcium edetate per kilogram body weight of the patient, in 3 to 6 divided doses up to 5 days.

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