Solzin Capsule is indicated for maintenance therapy in patients with Wilson’s disease who have been previously stabilized with a chelating agent.
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Wilson’s disease (hepatolenticular degeneration) is an autosomal recessive disorder characterized by impaired biliary excretion of copper, leading to excessive copper accumulation in the liver and subsequently in other organs such as the brain, kidneys, eyes, bones, and muscles.
Initially, excess copper is stored within hepatocytes. Once storage capacity is exceeded, copper enters systemic circulation and deposits in extrahepatic tissues, particularly the brain. This results in neurological manifestations (e.g., tremors, ataxia, speech disturbances) and psychiatric symptoms (e.g., irritability, depression, reduced work performance). Progressive hepatic copper accumulation causes hepatocellular injury, inflammation, necrosis, and ultimately cirrhosis.
Management includes dietary copper restriction and chelation therapy to remove excess copper. Chelating agents are used initially to rapidly reduce copper toxicity. Once clinical stabilization is achieved, maintenance therapy with zinc is initiated to prevent further copper absorption. Ongoing clinical monitoring is essential to ensure disease stability.
Gastrointestinal: Gastric irritation
Laboratory abnormalities: Transient elevations in alkaline phosphatase, amylase, and lipase, suggestive of pancreatitis
These enzyme elevations may persist for weeks to months but typically normalize or remain near the upper limit of normal within 1–2 years of therapy.
Adults: 50 mg elemental zinc orally three times daily
Children ≥10 years & pregnant women: 25 mg elemental zinc three times daily may be effective if adherence is assured
Limited clinical data suggest that children aged 10 years and above can be maintained on 75–150 mg elemental zinc daily in divided doses. Safety and efficacy in children under 10 years have not been established.
Acute zinc overdose is rare. In suspected overdose:
A fatal case has been reported following accidental ingestion of approximately 28 g zinc sulfate, resulting in renal failure, hemorrhagic pancreatitis, and hyperglycemic coma.
Clinical studies in Wilson’s disease patients have shown no significant pharmacodynamic interactions between zinc acetate (50 mg t.i.d.) and:
Ascorbic acid (1 g daily)
Penicillamine (1 g daily)
Trientine (1 g daily)
Thus, no additional precautions are required when zinc is administered with vitamin C or approved chelating agents. However, safety data are lacking for concurrent use with other therapies for Wilson’s disease.
Solzin Capsule is contraindicated in patients with known hypersensitivity to zinc acetate or any component of the formulation.
Solzin is not recommended for the initial treatment of symptomatic Wilson’s disease due to the delayed onset of zinc-mediated copper absorption blockade.
Initial therapy should involve chelating agents, as neurological worsening may occur during early copper mobilization.
Zinc therapy may be initiated only after clinical stabilization and may be continued as maintenance, depending on patient response.
Pregnancy:
Available studies indicate no increased risk of fetal abnormalities when zinc is administered during pregnancy. While fetal risk appears minimal, zinc acetate should be used only when clearly indicated. Discontinuation of anti-copper therapy during pregnancy may lead to copper toxicity.
Lactation:
Zinc is excreted in breast milk and may cause copper deficiency in the nursing infant. Breastfeeding is not recommended during zinc therapy.
Store below 30°C, protected from light and moisture.
Keep out of reach of children.
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