Registered Tanzania · TMDA

Pamidol

Edetate Calcium Disodium (anhydrous basis) mg,Hydrochloric acid MU/0.5 mL,Iopamidol 370 mg,Water for Injection MU/0.5 mL

TZ10H010 Injection various INN generic

What it does

Disodium is a compound that may be used in various medical applications, particularly in maintaining electrolyte balance.

Commonly used for: maintaining salt and water balance in the body, supporting kidney function

Read more in plain English ↓

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

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Registration & product details

Registration no.
TZ10H010
Registration date
2025-03-24
Expiry date
2030-03-23
Status
Registered/Compliant
Active ingredient
Edetate Calcium Disodium (anhydrous basis) mg,Hydrochloric acid MU/0.5 mL,Iopamidol 370 mg,Water for Injection MU/0.5 mL
Dosage form
Injection
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
V08AB - Watersoluble, nephrotropic, low osmolar X-ray contrast media
Drug group
VARIOUS
RxNorm RxCUI
5966
Country of origin
INDIA
Manufacturer location
Survey No. 101/2 & 102/1 Daman Industrial Estate, Bhimpore, Daman, Marwad, Dadra and Nagar Haveli and Daman and Diu 396210, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:48:49 · updated 2026-09-28 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About disodium

Disodium is a compound that may be used in various medical applications, particularly in maintaining electrolyte balance.

What it treats

  • maintaining salt and water balance in the body
  • supporting kidney function

How it works

Disodium helps to regulate the levels of sodium in the body, which is important for many bodily functions, including nerve and muscle activity.

Who it's for

It is usually prescribed for individuals who need help with electrolyte balance, such as those with certain kidney conditions or those undergoing specific treatments.

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

About edetate

Edetate is used to treat conditions caused by metal poisoning, such as lead or mercury poisoning.

What it treats

  • metal poisoning
  • lead poisoning
  • mercury poisoning

How it works

Edetate works by binding to heavy metals in the body, helping to remove them through urine.

Who it's for

It is for individuals who have been exposed to harmful levels of certain metals.

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

About hydrochloric

Hydrochloric acid is a substance that helps with digestion in the stomach.

What it treats

  • stomach acidity issues
  • digestive problems

How it works

It aids in breaking down food and absorbing nutrients in the stomach.

Who it's for

It is used for people who have low stomach acid or certain digestive disorders.

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

About iopamidol

Iopamidol is a contrast agent used in medical imaging to help visualize internal organs and structures during procedures.

What it treats

  • imaging studies
  • X-rays
  • CT scans

How it works

Iopamidol enhances the visibility of certain areas in the body by absorbing X-rays, making it easier for doctors to see and diagnose conditions.

Who it's for

Iopamidol is for patients undergoing imaging tests who need clearer pictures of their internal organs.

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

Clinical monograph: disodium

BNF-referenced

Disodium is a chemical compound composed of two sodium ions. It is not commonly referenced as a standalone drug but is often found in various formulations and compounds, particularly in the context of sodium salts. Disodium salts can have various applications in medicine, including as electrolytes in intravenous solutions and in the formulation of certain medications.

Indications

  • Electrolyte replacement
  • Volume expansion in hypovolemic patients
  • Management of hyponatremia
  • Support in intravenous fluid therapy

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients, as dosages may vary based on the formulation and clinical condition.

Adults: Refer to specific product information or clinical guidelines for dosage recommendations, as disodium is often part of combination products.

Mechanism of action

Disodium compounds often function by providing sodium ions that are essential for various physiological processes. Sodium ions play a critical role in maintaining osmotic balance, nerve impulse transmission, and muscle contraction. In the context of intravenous solutions, disodium helps to restore electrolyte balance in patients.

Pharmacodynamics

The pharmacodynamics of disodium is primarily related to its role in electrolyte balance and fluid homeostasis. Sodium ions are vital for the function of excitable tissues, including neurons and muscle cells. Changes in sodium levels can affect blood pressure, hydration status, and overall cellular function.

Pharmacokinetics

The pharmacokinetics of disodium compounds depend on their specific formulation and route of administration. When administered intravenously, disodium is rapidly distributed in the extracellular fluid, where it helps to maintain osmotic pressure. Sodium is primarily excreted by the kidneys, and its levels can be influenced by fluid intake, dietary sodium, and renal function.

Pregnancy

Use with caution. Consult a healthcare provider for specific guidance.

Breast-feeding

Use with caution. Consult a healthcare provider for specific guidance.

Storage

Store at room temperature, away from moisture and direct sunlight.

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: edetate

BNF-referenced

Edetate, also known as edetic acid or disodium edetate, is a chelating agent used primarily to treat heavy metal poisoning, particularly lead and mercury. It works by binding to metal ions in the bloodstream, facilitating their excretion from the body. Edetate is also utilized in certain diagnostic procedures and as part of treatment regimens for conditions associated with calcium overload.

Indications

  • Lead poisoning
  • Mercury poisoning
  • Calcium overload
  • Certain diagnostic procedures involving heavy metals

Dosage

Children: Refer to the BNF for Children for appropriate dosing information tailored for paediatric patients.

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated, considering factors such as the severity of metal poisoning and renal function.

Mechanism of action

Edetate functions by forming stable complexes with divalent and trivalent metal ions, including lead and calcium, through its multiple carboxylate and amine groups. This chelation renders the metals more soluble and promotes their renal excretion, thereby reducing their toxic effects in the body.

Pharmacodynamics

The chelation of metals by edetate decreases the free metal concentration in the bloodstream, which mitigates the toxic effects associated with heavy metal accumulation. The efficacy of edetate in removing metals such as lead has been well documented, and its ability to bind calcium can influence calcium homeostasis in certain clinical scenarios.

Pharmacokinetics

Edetate is administered intravenously, with rapid distribution throughout the extracellular fluid. It is primarily excreted unchanged by the kidneys. The onset of action occurs quickly after administration, and the duration depends on the dose and the patient's renal function. The elimination half-life is approximately 1 hour but may vary based on renal clearance.

Contra-indications

  • Hypersensitivity to edetate or any component of the formulation
  • Severe renal impairment
  • Active bleeding disorders

Adverse effects

  • Hypocalcemia
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Rash
  • Fever

Interactions

  • May enhance the effects of anticoagulants
  • Concurrent use with calcium supplements may reduce effectiveness
  • May interfere with the absorption of certain medications due to changes in gastrointestinal motility

Precautions

  • Use with caution in patients with renal impairment
  • Monitor electrolyte levels, particularly calcium, during treatment
  • Assess the patient's hydration status before administration

Pregnancy

Limited data on the use of edetate in pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised as it is not known whether edetate is excreted in human milk. Weigh the risks and benefits before use.

Storage

Store in a cool, dry place, protected from light. Do not freeze.

Formulations

  • Edetate disodium injection
  • Edetate calcium disodium injection

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: hydrochloric

Hydrochloric acid, commonly known as stomach acid, is a clear, colorless solution that is produced in the stomach. It plays a critical role in digestion by creating an acidic environment that aids in the breakdown of food and activates digestive enzymes. In a pharmaceutical context, hydrochloric acid is used in various formulations to adjust pH levels, facilitate drug absorption, and as a component in sterile preparations.

Indications

  • Adjustment of pH in pharmaceutical formulations
  • Facilitation of drug absorption
  • Used in sterile preparations

Dosage

Children: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Adults: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Mechanism of action

Hydrochloric acid dissociates in aqueous solution to release hydrogen ions (H+), leading to a decrease in pH. This acidic environment promotes the activation of pepsinogen to pepsin, an enzyme essential for protein digestion. Additionally, the acidity aids in the absorption of certain minerals and drugs that require an acidic environment for optimal bioavailability.

Pharmacodynamics

The primary pharmacodynamic action of hydrochloric acid is the maintenance of gastric acidity, which is essential for normal digestive processes. The acidic environment helps in denaturing proteins, activating digestive enzymes, and providing a barrier against pathogenic microorganisms. Its effects can influence the absorption and efficacy of various medications, particularly those that are pH-dependent.

Pharmacokinetics

Hydrochloric acid does not undergo significant systemic absorption when used in its normal contexts, as it acts locally within the gastrointestinal tract. The amount of hydrochloric acid produced by the stomach varies with food intake and physiological needs. It is secreted by parietal cells in the gastric mucosa, and its secretion is regulated by neural, hormonal, and local factors. The half-life of hydrochloric acid is not applicable as it is continuously produced and neutralized within the gastrointestinal tract.

Contra-indications

  • Hypersensitivity to hydrochloric acid or any of its components
  • Severe renal impairment
  • Active gastrointestinal bleeding

Adverse effects

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting
  • Esophageal irritation
  • Gastric mucosal irritation
  • Electrolyte imbalances

Interactions

  • May interact with alkaline substances, potentially neutralizing hydrochloric acid
  • Caution with antacids as they may affect the efficacy of hydrochloric acid

Precautions

  • Use with caution in patients with a history of gastritis or gastric ulcers
  • Monitor electrolytes in prolonged use
  • Use cautiously in patients with respiratory conditions due to potential aspiration risks

Pregnancy

Hydrochloric acid is classified as a category C drug. Use during pregnancy only if clearly needed and the potential benefits justify the risks to the fetus.

Breast-feeding

There is limited data on the excretion of hydrochloric acid in human milk. Use with caution during breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight and heat. Ensure the container is tightly closed.

Formulations

  • Oral solutions
  • Injectable forms
  • Tablets

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: iopamidol

BNF-referenced

Iopamidol is an iodinated contrast medium used primarily for diagnostic imaging procedures, such as computed tomography (CT) scans and angiography. It enhances the visibility of internal structures in radiographic imaging by absorbing X-rays due to its high iodine content. This agent is used for intravascular administration to improve the contrast of vascular, organ, and tissue imaging.

Indications

  • Computed tomography (CT) imaging
  • Angiography
  • Intravenous urography
  • Myelography

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidance in paediatric patients, as doses may vary based on age, weight, and specific imaging requirements.

Adults: The typical adult dose for iopamidol varies depending on the specific procedure and imaging requirements. For CT imaging, a common dose is 100-200 mL, administered intravenously. Refer to the BNF for specific dosing recommendations based on the procedure.

Mechanism of action

Iopamidol increases the contrast of vascular structures by absorbing X-rays, which allows for clearer imaging during radiological procedures. It may induce an elevation in serum potassium levels through the release of potassium into intravascular spaces, although studies indicate that the elevation caused by iopamidol is less significant compared to other contrast agents.

Pharmacodynamics

Iopamidol functions primarily as a contrast agent in diagnostic imaging, enhancing the clarity of images by increasing the attenuation of X-rays. Its pharmacodynamic properties include a low osmolality which reduces the risk of adverse reactions compared to high-osmolar contrast agents. The release of potassium may influence electrolyte balance, but the clinical significance of this is generally minimal.

Pharmacokinetics

Iopamidol is administered intravenously and is rapidly distributed in the vascular system. It is not significantly metabolized in the body and is primarily excreted unchanged by the kidneys. The elimination half-life in healthy individuals is approximately 2 hours, with renal clearance being the major route of elimination.

Adverse effects

  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Injection site reactions
  • Hypotension
  • Allergic reactions including anaphylaxis

Interactions

  • Concurrent use with metformin may increase the risk of lactic acidosis in patients with renal impairment
  • Other nephrotoxic agents may increase the risk of renal toxicity

Precautions

  • Use with caution in patients with renal impairment
  • Hydration is recommended to reduce the risk of renal complications
  • Monitor serum creatinine levels in patients at risk for contrast-induced nephropathy

Pregnancy

Use only if clearly needed, as the risk to the fetus cannot be ruled out.

Breast-feeding

Iopamidol is excreted in breast milk, but the effects on the nursing infant are unknown. A decision should be made to discontinue breastfeeding or discontinue the drug.

Storage

Store at room temperature, away from light. Do not freeze.

Formulations

  • Iopamidol 370 mg iodine/mL solution for injection
  • Iopamidol 300 mg iodine/mL solution for injection

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

Molecular reference: disodium

PubChem CID 141233

Molecular formula: Na2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: edetate

PubChem CID 6144

Molecular formula: C10H12N2O8Na4

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: iopamidol

PubChem CID 65492

Molecular formula: C17H22I3N3O8

Mechanism of action

To test the hypothesis that iodinated contrast media may induce an elevation in serum potassium level, /contrast media was administered to rabbits and tested in-vitro according to four protocols./ Protocol A: After intravenous infusion of contrast media into six rabbits, alterations of potassium ion concentrations were measured. Protocol B: Fresh rabbit blood was mixed in vitro with contrast media, and the fluctuations in potassium were monitored over a 30-minute period. Protocol C: Similar to protocol B, except that blood from humans with no reaction to contrast media was used. For protocol A, blood potassium levels increased above baseline levels. The elevations were statistically significant (P < .05). For protocol B, diatrizoate and ioxaglate caused a gradual increase in blood potassium levels, but iopamidol did not. In protocol C, all three contrast media caused statistically significant elevation in potassium levels. The release of potassium was statistically significant at 5 minutes (P < .05 for diatrizoate and ioxaglate, and P < .01 for iopamidol). The mean release rates (+/- standard deviation) by means of linear regression analysis were 0.0190 mmol/min +/- 0.0112 with diatrizoate, 0.0159 mmol/min +/- 0.0057 with iopamidol, and 0.0088 mmol/min +/- 0.0033 with ioxaglate. Iodinated contrast media increase blood potassium levels causing release of potassium into intravascular spaces. This potassium release may play some role in contrast medium-induced adverse reactions. The synthesis of prostaglandins and other metabolic products of arachidonic acid (AA) was investigated in isolated perfused lungs of hamsters during the infusion of various concentrations of meglumine diatrizoate and iopamidol. Forty nmol of (14)C-AA was infused into the pulmonary circulation with radiographic contrast media (RCM), and prostaglandins, thromboxanes, and metabolites of lipoxygenases were analyzed from the nonrecirculating perfusion effluent. Arachidonate infusion increased the perfusion pressure. This pressor response was decreased by iopamidol ... The amount of radioactivity was decreased in the perfusion effluent and increased in lung lipids by iopamidol. ... Almost all arachidonate metabolites were decreased significantly by iopamidol when compared with hypertonic saline ...

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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