3 months to expiry Ghana · FDA Ghana

ORAPLUS+DIARRHOEA TREATMENT KIT SACHET

Zinc sulphate monohydrate

FDA/SD.235/060659 SACHET 2.6G/1.5G/2.9G/13.5G/20MG

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Registration & product details

Registration no.
FDA/SD.235/060659
Registration date
2023-06-21
Expiry date
2026-07-01
Status
3 months to expiry
Active ingredient
Zinc sulphate monohydrate
Dosage form
SACHET
Strength
2.6G/1.5G/2.9G/13.5G/20MG
Pack size
-
Therapeutic class
-
Country of origin
GHANA
Manufacturer location
Plot No.152/Block 29, GA, 288, 5164 Clinton Street, Accra, Ghana

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:11 · updated 2026-06-30 04:00:06

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

Clinical monograph: zincsulphate

Zinc sulfate is an inorganic compound used as a dietary supplement and for the treatment of zinc deficiency. It is essential for various biological functions, including immune system support, wound healing, and protein synthesis. Zinc plays a critical role in the activity of over 300 enzymes and is important for DNA synthesis and cell division. Zinc sulfate is often used in clinical settings to address various conditions associated with zinc deficiency.

Indications

  • Zinc deficiency
  • Wound healing
  • Diarrhea in children
  • Acne
  • Common cold
  • Immune support

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines based on the child's age, weight, and condition.

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated and the formulation used.

Mechanism of action

Zinc sulfate provides zinc ions (Zn²⁺) that are essential for numerous biological processes. Zinc acts as a cofactor for many enzymes, facilitating various biochemical reactions. It also plays a role in modulating immune responses, promoting the activity of T-lymphocytes, and influencing the production of cytokines. Furthermore, zinc is vital for maintaining structural integrity in proteins and cell membranes.

Pharmacodynamics

The pharmacodynamic effects of zinc sulfate primarily relate to its role in enzymatic functions and immune modulation. Zinc deficiency can impair immune function, leading to increased susceptibility to infections. Supplementation with zinc sulfate can enhance immune responses, improve wound healing, and contribute to overall health by restoring normal zinc levels in the body. Additionally, zinc has antioxidant properties, helping to combat oxidative stress.

Pharmacokinetics

Zinc sulfate is absorbed in the gastrointestinal tract, with an absorption rate that can vary based on the presence of food and other dietary factors. Peak plasma concentrations are typically reached within 2 to 3 hours after oral administration. Zinc is distributed throughout the body, particularly in skeletal muscle, bone, and the liver. The elimination half-life of zinc from the body is approximately 2 to 3 days, and it is primarily excreted through the kidneys and gastrointestinal tract.

Contra-indications

  • Hypersensitivity to zinc sulfate or any component of the formulation
  • Severe renal impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Metallic taste
  • Headache
  • Drowsiness
  • Fatigue

Interactions

  • Antibiotics (e.g., tetracyclines and quinolones) - zinc may impair absorption
  • Copper supplements - excessive zinc can lead to copper deficiency

Precautions

  • Use with caution in patients with renal impairment
  • Avoid high doses in patients with conditions requiring low zinc intake
  • Monitor for signs of zinc toxicity, especially with prolonged use

Pregnancy

Zinc is essential during pregnancy for proper fetal development, but supplementation should be done under medical guidance to avoid excessive intake.

Breast-feeding

Zinc is secreted in breast milk, and supplementation should be discussed with a healthcare provider to ensure adequate maternal and infant intake.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral solution
  • Effervescent tablets
  • Syrup

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.