0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL] Injection/Solution for

What is 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

0.9% Sodium Chloride Injection, USP [MEDISAL] is a sterile, isotonic solution primarily used for intravenous (IV) infusion. It is prepared with 0.9% Sodium Chloride (NaCl) in water, which is a balanced electrolyte solution designed to mimic the body's natural sodium levels. This product is delivered in a 100ml polypropylene bag for easy infusion.

Carbimazole, the active pharmaceutical ingredient, is an antithyroid medication that works by inhibiting the thyroid gland’s ability to produce thyroid hormones. When used in conjunction with this sodium chloride solution, Carbimazole is typically administered intravenously under specific medical conditions.

The primary therapeutic use of 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbimazole is for patients requiring a controlled release of the antithyroid agent, particularly in acute settings where oral administration may not be feasible. It is commonly used to manage hyperthyroidism and control thyroid storm until thyroid function stabilizes.

This solution ensures the patient maintains optimal fluid and electrolyte balance during the treatment with Carbimazole.

How to use 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

The administration of 0.9% Sodium Chloride Injection, USP [MEDISAL] containing Carbimazole should always be performed under the supervision of a qualified healthcare provider. Follow these general guidelines to ensure safe and effective use:

• Preparation: Inspect the solution for particulate matter, discoloration, or leaks. Only use if the solution is clear and the bag is intact.
• Dosage: The dosage will vary based on the patient's age, medical condition, and the severity of the thyroid disorder. The typical dosage should be determined by a healthcare provider.
• Administration: The infusion is typically delivered through an intravenous line, with a recommended rate of administration as determined by the attending physician.
• Infusion Rate: The recommended infusion rate for Carbimazole in 0.9% Sodium Chloride should be slow to avoid potential adverse reactions. The infusion rate must be closely monitored to prevent rapid changes in blood pressure or sodium levels.
• Monitoring: Continuous monitoring of the patient's vital signs, particularly heart rate and blood pressure, is necessary during infusion. Frequent thyroid function tests may be required to adjust the dosage.
• Use with Caution: Ensure the patient is not allergic to Carbimazole or Sodium Chloride before administering. Keep emergency equipment ready for any potential allergic reactions or complications.

It is crucial that the solution is administered as prescribed, and adjustments to the treatment plan should only be made by healthcare professionals based on patient response and laboratory results.

Mode of Action 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

0.9% Sodium Chloride Injection, USP [MEDISAL] works as an intravenous solution to maintain electrolyte balance, primarily through the action of sodium chloride (NaCl). Sodium is a critical element for maintaining fluid balance and proper cell function within the human body. When infused, it helps to ensure that the body does not suffer from electrolyte imbalances, especially in conditions such as dehydration or sodium depletion.

Carbimazole, the active ingredient in this formulation, exerts its effects by inhibiting the synthesis of thyroid hormones (T3 and T4) in the thyroid gland. It achieves this by blocking the enzyme thyroperoxidase, which is involved in the iodination of tyrosine residues in thyroglobulin. This action reduces the formation of thyroxine (T4) and triiodothyronine (T3), which are key hormones in the regulation of metabolic processes. By decreasing these hormones, Carbimazole effectively treats hyperthyroidism and thyroid storms.

In Summary:

• Sodium chloride maintains electrolyte balance in the body.
• Carbimazole inhibits thyroid hormone synthesis, reducing excess thyroid activity.
• This combination allows for better control of hyperthyroid conditions and stabilization of the patient’s fluid and electrolyte status.

Through this combined action, the solution helps manage the physiological balance while providing the antithyroid benefits of Carbimazole.

0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL] Interactions 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbimazole can interact with various medications and conditions. Understanding potential drug interactions is crucial for patient safety.

• Antithyroid Medications: Carbimazole itself may interact with other antithyroid agents like propylthiouracil, as concurrent use may increase the risk of side effects such as agranulocytosis.
• Anticoagulants (e.g., Warfarin): Carbimazole may alter thyroid hormone levels, which can impact the efficacy of anticoagulants, requiring close monitoring of INR (International Normalized Ratio).
• Beta-Blockers: The use of beta-blockers (e.g., propranolol) with Carbimazole can enhance the effects of thyroid hormone reduction, leading to an increased risk of bradycardia and hypotension.
• Corticosteroids: Corticosteroids may exacerbate the side effects of Carbimazole, particularly in terms of immunosuppression, requiring careful patient observation.
• Diuretics: When used alongside diuretics, which alter electrolyte balance, the sodium load from the 0.9% Sodium Chloride Injection may need to be adjusted to prevent hypernatremia or dehydration.
• Food and Herbal Supplements: Some food and herbal supplements, particularly those rich in iodine (e.g., kelp), may reduce the efficacy of Carbimazole by providing exogenous sources of iodine, which could counteract the medication’s effect.

Always consult a healthcare provider before starting any new medication or supplement while on this treatment.

Dosage of 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

The dosage of 0.9% Sodium Chloride Injection, USP [MEDISAL] containing Carbimazole depends on several factors, including the patient's age, weight, medical condition, and severity of hyperthyroidism. Here is an overview of typical dosage recommendations:

• Adult Dosing: Carbimazole is typically dosed between 5 mg and 15 mg daily, depending on the severity of hyperthyroidism. The exact dose is determined by thyroid function tests and clinical response. IV administration may be used for more rapid action in acute cases.
• Pediatric Dosing: In children, the dosage is carefully calculated based on weight. It generally ranges from 5 mg to 10 mg per day, and continuous monitoring is crucial to ensure safety and efficacy.
• Thyroid Storm Management: For patients in thyroid crisis, higher doses may be administered intravenously initially. The exact dose should be decided by a healthcare provider based on the patient's clinical status.
• Maintenance Dose: After achieving stabilization, the dose is often reduced to a maintenance dose, typically ranging between 5 mg and 10 mg per day, but again, this should be based on laboratory findings and clinical evaluation.

It is important to follow the exact dosage instructions provided by a healthcare provider. Overuse or underuse can lead to significant risks, including thyroid hormone imbalance and electrolyte disturbances.

Possible side effects of 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

As with any medication, 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbimazole can cause side effects, some of which can be serious. Below is a detailed overview of potential adverse effects:

Common Side Effects:

• Nausea and vomiting, especially early in the treatment phase.
• Fatigue, drowsiness, or dizziness, which may impair the ability to perform tasks requiring mental alertness.
• Headaches or mild gastrointestinal discomfort.

Severe Side Effects:

• Agranulocytosis (a decrease in white blood cell count), which increases the risk of infections. Patients should report fever or signs of infection promptly.
• Severe skin reactions, including rash or urticaria, which may require discontinuation of the medication.
• Hepatic dysfunction (e.g., jaundice), though rare, has been reported in some patients.
• Thrombocytopenia (low platelet count), which can increase the risk of bleeding.
• Severe allergic reactions such as anaphylaxis, although this is uncommon.

Monitoring and Management:

• Regular blood tests, including CBC and liver function tests, should be conducted to monitor for hematological or hepatic abnormalities.
• In case of severe side effects, immediate discontinuation of the medication and symptomatic treatment are necessary.

Patients should notify their healthcare provider of any new symptoms or side effects, especially if they experience signs of infection, jaundice, or bleeding.

0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL] Contraindications 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbimazole has specific contraindications, and it should not be used in certain conditions:

• Hypersensitivity: Contraindicated in patients with a known hypersensitivity to Carbimazole or any component of the formulation.
• Severe Liver Disease: Carbimazole can exacerbate liver dysfunction, making it unsuitable for patients with severe hepatic impairment.
• Agranulocytosis History: Patients with a history of agranulocytosis or other hematological disorders should avoid Carbimazole due to the risk of further blood count abnormalities.
• Pregnancy (First Trimester): Carbimazole is contraindicated during the first trimester of pregnancy, as it can lead to fetal malformations. It may be used in later stages only when the benefits outweigh the risks.
• Breastfeeding: Carbimazole is not recommended during breastfeeding as it can be excreted in breast milk.

Before administering, a full clinical evaluation should be conducted, including liver function tests and a complete blood count, to assess suitability for treatment.

Storage of 0.9% SODIUM CHLORIDE INJECTION, USP [MEDISAL]

0.9% Sodium Chloride Injection, USP [MEDISAL] should be stored according to the following guidelines to ensure the solution's stability and efficacy:

• Storage Temperature: Keep the product in a cool, dry place, stored between 15°C to 25°C (59°F to 77°F).
• Avoid Freezing: Freezing the solution can compromise the container and its contents, making it unsafe for use.
• Light Protection: Protect the infusion bag from direct sunlight and excessive heat.
• Expiration Date: Always check the expiration date before use. Do not use past the expiration date.
• Discard Unused Portions: Any unused portion should be discarded immediately after use as the product is for single-use only.

Ensure that storage and disposal practices comply with local regulations to ensure environmental safety and patient well-being.