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 an isotonic intravenous (IV) solution containing sodium chloride, which is used for a variety of medical purposes. This solution contains 0.9% sodium chloride (NaCl) in water, meaning it mirrors the electrolyte composition found in extracellular fluids in the human body, making it ideal for fluid and electrolyte replacement. The addition of carbonyl iron and folic acid enhances its use for specific conditions like anemia, iron deficiency, and folate deficiency.

• Formulation: 0.9% sodium chloride (NaCl) in water, with added carbonyl iron and folic acid, available in a 1000ml polypropylene bag for intravenous infusion.
• Indications: This injection is used for fluid replenishment, hydration, and as a diluent for other intravenous medications. The inclusion of carbonyl iron supports patients with iron deficiency anemia, while folic acid aids in the treatment of folate deficiency.
• Purpose: 0.9% Sodium Chloride Injection [Medisal] is primarily used in hospitals and clinics for restoring fluid balance, correcting electrolyte imbalances, and providing essential nutrients such as iron and folic acid through intravenous administration.
• Additional Benefits: Carbonyl iron is known for its high bioavailability and minimal gastrointestinal side effects, making it an effective treatment for iron deficiency without common side effects such as constipation. Folic acid is crucial for red blood cell formation and overall metabolic processes, especially in pregnant women or those with certain nutrient deficiencies.

This solution is primarily intended for use under medical supervision, where health professionals can monitor the patient’s response and adjust treatment as needed. It helps ensure proper hydration and replenishment of essential nutrients.

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

The administration of 0.9% Sodium Chloride Injection, USP [Medisal] must be done according to medical guidelines and under healthcare supervision. Below are the general guidelines for proper usage:

• Administration Route: The solution is administered intravenously (IV) via an infusion. It is critical to use the solution as prescribed by a healthcare professional.
• Preparation: Prior to use, inspect the 1000ml polypropylene bag to ensure the solution is clear, free from particulates, and properly sealed. Do not use the solution if the bag appears damaged or if the solution is discolored or contains foreign particles.
• Infusion Rate: The infusion rate will depend on the individual’s clinical condition, fluid balance, and physician’s orders. Typically, the infusion rate will be adjusted based on the patient’s response to treatment. In acute dehydration, the solution may be infused more rapidly initially.
• Monitoring: Patients receiving this injection should be monitored for any signs of fluid overload, electrolyte imbalances, or adverse reactions. Regular assessment of vital signs, including blood pressure and heart rate, should be performed during infusion.
• Combination with Other Medications: This solution may be used as a diluent for other intravenous medications. Always verify the compatibility of the drugs with sodium chloride injection before mixing, as certain medications may not be suitable for co-infusion.

It is essential to consult a healthcare provider to determine the appropriate infusion duration and rate based on the patient's needs. For optimal results, the healthcare team will tailor the infusion plan to the individual’s specific clinical condition.

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

0.9% Sodium Chloride Injection, USP [Medisal] works by restoring hydration and electrolyte balance in the body. As an isotonic solution, it does not alter the osmotic balance of cells, making it effective for fluid replacement without causing cellular damage. The additional components—carbonyl iron and folic acid—provide specific therapeutic benefits for managing anemia and deficiencies. Below is a breakdown of the actions:

• Electrolyte Balance: Sodium chloride (NaCl) is a critical electrolyte in the body, involved in regulating fluid balance, nerve function, and muscle contraction. The solution restores sodium levels in cases of dehydration, helping maintain proper extracellular fluid volume and electrolyte balance.
• Hydration: This solution replenishes fluid volume in the body, which is essential for maintaining normal blood pressure, heart function, and cellular hydration. It is particularly useful in cases of shock, dehydration, or fluid loss from excessive sweating, vomiting, or diarrhea.
• Iron Supplementation: Carbonyl iron is a form of iron with excellent bioavailability, which means it is easily absorbed and utilized by the body. This iron supplement helps restore hemoglobin levels in individuals suffering from iron deficiency anemia, a condition that can lead to fatigue, weakness, and other health issues.
• Folic Acid Action: Folic acid, or vitamin B9, plays a key role in the formation of red blood cells and the proper function of the nervous system. It is particularly important in pregnant women for preventing neural tube defects in the developing fetus and helps address folate deficiencies.

Thus, this injection not only helps with rehydration but also contributes to addressing specific deficiencies like iron and folate, supporting overall health and recovery during critical conditions.

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

Interactions with other drugs or conditions may occur while using 0.9% Sodium Chloride Injection, USP [Medisal]. It is important to be aware of these interactions to ensure effective treatment and prevent potential complications. Below are some of the key interactions:

• Iron Supplements: While carbonyl iron is included in this solution for treating iron deficiency anemia, caution should be exercised when combining it with oral or other intravenous iron supplements. Overdose of iron can lead to toxicity, which can cause organ damage, particularly in children.
• Diuretics: Medications like diuretics (e.g., furosemide) may alter sodium levels, causing fluid and electrolyte imbalances. When administered together with 0.9% Sodium Chloride Injection, close monitoring is essential to avoid complications such as sodium overload or dehydration.
• Antihypertensive Medications: Sodium chloride may interfere with the effects of blood pressure-lowering medications, as it can contribute to sodium and fluid retention. This may reduce the effectiveness of certain antihypertensive drugs, requiring adjustments in dosage.
• Folic Acid and Anticonvulsants: Long-term use of anticonvulsant drugs, such as phenytoin, can lower the effectiveness of folic acid. This interaction is important to consider, especially in patients receiving folic acid supplementation as part of their treatment.
• Chronic Kidney Disease: Patients with kidney dysfunction or renal failure may not be able to properly excrete excess sodium or iron, leading to fluid retention or iron overload. Caution is required when administering this solution to such patients, and monitoring of renal function is advised.

Always inform your healthcare provider of any medications you are taking to ensure that they can safely manage drug interactions during treatment with 0.9% Sodium Chloride Injection, USP [Medisal].

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

The dosage of 0.9% Sodium Chloride Injection, USP [Medisal] will vary depending on the patient's condition, age, weight, and medical history. The healthcare provider will adjust the dosage based on specific therapeutic needs. Below are general guidelines for its use:

• Fluid Replacement: For adults, the typical dose may range from 500 ml to 1 liter, depending on the degree of dehydration or fluid loss. In severe cases, more rapid administration may be required, but the infusion rate should be monitored carefully to avoid fluid overload.
• Pediatric Dosage: In children, the dose is typically based on body weight. A common guideline is 20 ml/kg of body weight for rehydration, administered over a period of several hours, depending on the severity of dehydration.
• Iron Deficiency Treatment: For iron deficiency anemia, this solution is typically used in conjunction with oral iron supplements or as part of a comprehensive treatment regimen. The exact dosage for iron supplementation will depend on the patient's iron deficiency level, typically determined through lab tests.
• Folic Acid Supplementation: Folic acid is usually given as part of a larger treatment regimen, and the exact dosage will depend on the patient’s clinical needs, including whether they are pregnant or have specific folate deficiencies.

It is essential that healthcare providers monitor patients receiving this solution, adjusting the dose based on clinical response and laboratory findings. Individualized treatment ensures safe and effective therapy.

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

0.9% Sodium Chloride Injection, USP [Medisal] is generally well tolerated, but as with any medication, side effects may occur. These can vary depending on the patient’s medical history, dosage, and overall health condition. Potential side effects include:

• Fluid Overload: Overadministration of this solution can lead to fluid retention, causing edema (swelling), shortness of breath, and high blood pressure. Patients with heart or kidney conditions are particularly at risk for fluid overload.
• Electrolyte Imbalances: Excessive sodium levels in the blood (hypernatremia) can occur, leading to symptoms such as confusion, fatigue, and muscle weakness. On the other hand, a deficiency of sodium (hyponatremia) may result in nausea, headache, and dizziness.
• Iron Toxicity: Carbonyl iron, when used in high doses or with other iron supplements, can cause iron toxicity. Symptoms of iron overdose include nausea, vomiting, abdominal pain, and organ damage.
• Allergic Reactions: Some individuals may experience allergic reactions to folic acid or other components of the solution, which can manifest as rash, itching, or swelling, particularly around the face or throat.
• Gastrointestinal Issues: Some patients may experience nausea, vomiting, or constipation as side effects of the carbonyl iron content.

If any side effects occur during administration, it is crucial to notify a healthcare provider immediately to adjust the treatment regimen and prevent further complications.

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

Contraindications are situations where a particular medicine should not be used due to potential harm. For 0.9% Sodium Chloride Injection, USP [Medisal], the following contraindications should be considered:

• Hypersensitivity: If the patient has a known hypersensitivity or allergy to sodium chloride, carbonyl iron, or folic acid, this injection should be avoided.
• Severe Heart Failure: Patients with severe heart failure or conditions with fluid retention may not be suitable candidates for intravenous sodium chloride solutions due to the risk of fluid overload and worsening of the condition.
• Renal Failure: In cases of severe kidney impairment or renal failure, the patient’s ability to excrete excess sodium or iron may be compromised, leading to the risk of electrolyte imbalances and iron overload. Close monitoring and dose adjustments are required if this treatment is absolutely necessary.
• Iron Overload: Patients with a history of iron overload conditions, such as hemochromatosis, should avoid iron supplementation, including the carbonyl iron in this product, as excessive iron can cause organ damage.
• Folic Acid Excess: Overuse of folic acid can mask certain symptoms of vitamin B12 deficiency, leading to neurological complications. It is important to use this solution cautiously in individuals with B12 deficiency or related conditions.

These contraindications ensure that the treatment is safe and effective for patients. Always consult a healthcare provider before starting treatment with 0.9% Sodium Chloride Injection, USP [Medisal].

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

Proper storage of 0.9% Sodium Chloride Injection, USP [Medisal] is essential to maintain its quality and effectiveness:

• Temperature: Store at room temperature (15°C to 25°C / 59°F to 77°F). Do not freeze the solution, as freezing may compromise its integrity.
• Protection from Light: Keep the injection bag away from direct sunlight to preserve its chemical stability.
• Expiry: Check the expiration date before use. Do not use the solution if it has expired to ensure safety and efficacy.
• Handling: Ensure that the storage area is clean and dry. Inspect the bag for any damage or discoloration before use. If the solution appears cloudy or contains particles, it should be discarded.

Following these storage guidelines will ensure the safety and effectiveness of 0.9% Sodium Chloride Injection, USP [Medisal] for its intended medical use.