International reference: 3 US FDA recalls for this ingredient

Lack of Assurance of Sterility: Sterility of product is not assured. (elements)

Lack of Assurance of Sterility: Sterility of product is not assured. (elements)

Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance. (elements)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

Valid Ghana · FDA Ghana

CALSTAR TABLETS

Mineral elements

FDA/SD.243-040652 Mineral elements 400mg/ 100mg/ 4mg/ 200iu

What it does

Elements are essential substances that the body needs to function properly.

Commonly used for: supports overall health, maintains healthy bones and teeth, aids in energy production

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.243-040652
Registration date
2024-04-25
Expiry date
2026-12-31
Status
Valid
Active ingredient
Mineral elements
Dosage form
Mineral elements
Strength
400mg/ 100mg/ 4mg/ 200iu
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Influx Healthtech
Country of origin
-

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:10 · updated 2026-09-25 04:00:03

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

About elements

Elements are essential substances that the body needs to function properly.

What it treats

  • supports overall health
  • maintains healthy bones and teeth
  • aids in energy production

How it works

Elements are vital nutrients that help the body perform various functions, including building cells and supporting metabolism.

Who it's for

Suitable for everyone, especially those with dietary deficiencies or specific health conditions.

Cautions

  • • Excessive intake may lead to toxicity.
  • • Consult a healthcare professional if you have existing medical conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About mineral

Mineral supplements provide essential nutrients that help maintain overall health and support various bodily functions.

What it treats

  • nutritional deficiencies
  • bone health (osteoporosis prevention)
  • immune system support

How it works

Minerals are natural substances that your body needs to function properly. They help with processes like building strong bones and teeth, making hormones, and maintaining heart health.

Who it's for

Mineral supplements are suitable for individuals who may not get enough minerals from their diet, such as the elderly, pregnant women, or people with certain health conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: elements

Elements are fundamental substances that cannot be broken down into simpler substances by chemical means. They are the building blocks of matter and play critical roles in various biological processes. Essential elements for human health include macrominerals such as calcium, potassium, and magnesium, as well as trace elements like iron, zinc, and copper. Each element serves specific functions, including structural roles in cells, enzymatic reactions, and maintaining physiological balance.

Indications

  • Nutritional supplementation
  • Treatment of deficiencies (e.g., iron deficiency anemia)
  • Support for metabolic processes
  • Bone health maintenance (calcium)
  • Immune system support (zinc)
  • Neuromuscular function (magnesium)

Dosage

Children: Refer

Adults: Refer to specific guidelines for each element, as dosages vary widely based on the type, the individual's health status, and dietary sources.

Mechanism of action

The mechanism of action for each essential element varies according to its specific role in the body. For example, iron is a key component of hemoglobin, facilitating oxygen transport in the blood. Zinc plays a crucial role in enzymatic reactions as a cofactor for over 300 enzymes, while calcium is essential for muscle contraction, neurotransmission, and blood coagulation. Each element participates in unique biochemical pathways that contribute to overall health.

Pharmacodynamics

Pharmacodynamics of essential elements involves their interactions at the cellular and molecular levels, influencing various physiological and biochemical processes. For instance, calcium affects neurotransmitter release and muscle contraction, while magnesium is involved in ATP production and DNA synthesis. The balance of these elements is critical, as deficiencies or excesses can lead to various health issues, including metabolic disorders, cardiovascular diseases, and impaired immune function.

Pharmacokinetics

The pharmacokinetics of elements involves their absorption, distribution, metabolism, and excretion within the body. Absorption rates can vary significantly; for example, iron is primarily absorbed in the duodenum, while calcium absorption depends on the presence of vitamin D. Elements are distributed throughout the body via the bloodstream, where they are incorporated into tissues or stored in organs. Excretion mainly occurs through the kidneys, with some elements being eliminated through feces or sweat. The bioavailability of these elements can be influenced by dietary factors, age, and overall health status.

Pregnancy

Consult healthcare provider for guidance on use during pregnancy, as safety can vary based on the specific element and its form.

Breast-feeding

Consult healthcare provider for guidance on use during breastfeeding, as safety can vary based on the specific element and its form.

Storage

Store in a cool, dry place, away from light and moisture. Specific storage conditions can vary by element.

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

Clinical monograph: mineral

Mineralocorticoids are a class of steroid hormones that regulate sodium and potassium balance in the body, primarily through their action on the kidneys. They promote sodium retention, potassium excretion, and water retention, thus influencing blood pressure and fluid balance. Commonly used mineralocorticoids include aldosterone and synthetic analogs.

Indications

  • Primary adrenal insufficiency (Addison's disease)
  • Congenital adrenal hyperplasia
  • Orthostatic hypotension
  • Heart failure
  • Hypertension associated with hyperaldosteronism

Dosage

Children: Refer to the BNF for Children for appropriate dosing recommendations based on age and weight.

Adults: Refer to specific guidelines in the BNF for adequate dosing. Dosing should be individualized based on the condition being treated and patient response.

Mechanism of action

Mineralocorticoids exert their effects by binding to mineralocorticoid receptors (MR) in target tissues such as the kidneys, colon, and heart. This binding leads to the activation of genes responsible for sodium reabsorption, potassium secretion, and water retention, ultimately resulting in increased blood volume and blood pressure.

Pharmacodynamics

The pharmacodynamic effects of mineralocorticoids include increased renal tubular reabsorption of sodium and increased urinary excretion of potassium. These actions lead to fluid retention and increased blood pressure. Additionally, they have roles in electrolyte balance and the regulation of cardiovascular function.

Pharmacokinetics

Mineralocorticoids are typically administered orally or intravenously and are well absorbed from the gastrointestinal tract. They have variable half-lives depending on the specific compound used. The metabolism occurs primarily in the liver, and elimination is predominantly via renal excretion. The pharmacokinetics can be affected by various drug interactions, as seen with certain medications that alter their metabolism or clearance.

Interactions

  • cobicistat+mineralocorticoidreceptorantagonists: Severe (increases exposure)
  • dabrafenib+mineralocorticoidreceptorantagonists: Severe (decreases exposure)
  • bosentan+mineralocorticoidreceptorantagonists: Severe (decreases exposure)
  • idelalisib+mineralocorticoidreceptorantagonists: Severe (increases exposure)
  • clarithromycin+mineralocorticoidreceptorantagonists: Severe (increases exposure)
  • mitotane+mineralocorticoidreceptorantagonists: Severe (decreases exposure)
  • rifampicin+mineralocorticoidreceptorantagonists: Severe (decreases exposure)
  • stjohn’swort+mineralocorticoidreceptorantagonists: Severe (decreases exposure)
  • cenobamate+mineralocorticoidreceptorantagonists: Moderate (decreases exposure)
  • amiodarone+mineralocorticoidreceptorantagonists: Unknown (increases exposure)

Pregnancy

null

Breast-feeding

null

Storage

null

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

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.