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, non-pyrogenic solution used for intravenous infusion. This specific formulation includes the active pharmaceutical ingredients Carbidopa and Levodopa, which are primarily indicated in the management of Parkinson’s disease and related movement disorders.

This infusion provides:

• Hydration and electrolyte replenishment through 0.9% sodium chloride (normal saline).
• Neurological therapeutic benefit from the combined effects of Carbidopa and Levodopa.

Carbidopa is a peripheral dopa-decarboxylase inhibitor, which prevents the premature conversion of Levodopa into dopamine outside the brain, enhancing its delivery to the central nervous system. Levodopa serves as the metabolic precursor to dopamine and helps restore dopamine levels in the brains of patients with Parkinson’s disease.

This combination is typically used in patients who cannot tolerate oral medication or during acute exacerbations where rapid symptom control is required intravenously. MEDISAL’s 50ml polypropylene bag ensures a stable, ready-to-use formulation with ease of storage and administration in hospital or clinical settings.

Clinical Indications Include:

• Parkinson’s disease (especially advanced stages).
• Parkinsonism induced by encephalitis, carbon monoxide, or manganese poisoning.
• Patients with dysphagia or gastrointestinal limitations to oral therapy.

This preparation must be administered under medical supervision, with consideration of fluid and electrolyte balance and careful titration of the dopaminergic dose.

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

Proper administration of 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbidopa + Levodopa requires clinical precision. It is given as an intravenous (IV) infusion by a qualified healthcare professional in hospital or clinical settings.

Usage Instructions:

• Inspect the polypropylene bag for particulate matter, discoloration, or leakage before use. Discard if any anomaly is noted.
• Administer using a sterile IV set and aseptic techniques.
• Do not mix with other drugs in the same IV line unless compatibility is established.

Dosing Guidelines:

• Typically infused at a controlled rate over 30–60 minutes, depending on the patient's needs and response.
• The infusion rate should be based on the severity of Parkinsonian symptoms, patient weight, renal function, and concurrent therapies.
• Initial doses are often conservative and titrated upwards gradually to avoid adverse effects such as orthostatic hypotension or dyskinesias.

Special Precautions:

• Continuous cardiac monitoring may be needed, especially in patients with cardiovascular comorbidities.
• Hydration status and serum electrolytes (sodium, potassium) should be monitored regularly.
• Patients with renal impairment may require dose adjustment or slower infusion rates.

Administration should be halted if signs of hypersensitivity, arrhythmia, or intolerable adverse effects are observed. It is essential that treatment is individualized and supervised by experienced medical personnel familiar with Parkinson's disease pharmacotherapy.

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

The therapeutic efficacy of 0.9% Sodium Chloride Injection, USP [MEDISAL] infused with Carbidopa and Levodopa lies in the synergistic pharmacological actions of its active components.

Mechanisms Involved:

• Levodopa is a metabolic precursor to dopamine. After crossing the blood-brain barrier, it is converted to dopamine by the enzyme aromatic L-amino acid decarboxylase (AADC). This process restores depleted dopamine levels in the basal ganglia, improving motor control and reducing Parkinsonian symptoms.
• Carbidopa inhibits the enzyme AADC in peripheral tissues, preventing the conversion of Levodopa into dopamine before it reaches the brain. This reduces peripheral side effects like nausea and allows more Levodopa to reach the brain.

Benefits of Combined Use:

• Enhanced central nervous system (CNS) delivery of dopamine.
• Lower required doses of Levodopa due to increased bioavailability.
• Reduced incidence of peripheral side effects (nausea, vomiting, hypotension).

Role of 0.9% Sodium Chloride:

• Acts as a vehicle for the administration of Carbidopa + Levodopa.
• Replenishes fluid and electrolytes, supporting hemodynamic stability during treatment.

The combination works rapidly when delivered intravenously and can provide crucial symptomatic relief in patients unable to tolerate oral treatment, particularly during Parkinsonian crises, surgical procedures, or advanced disease stages.

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

Drug interactions are critical when using 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbidopa + Levodopa. Concomitant medications, dietary habits, and disease conditions can all affect its efficacy and safety profile.

Significant Drug Interactions:

• Monoamine Oxidase Inhibitors (MAOIs): Non-selective MAO inhibitors can cause hypertensive crisis if used with Levodopa. At least a 14-day washout is required before initiating therapy.
• Antipsychotics (e.g., Haloperidol, Risperidone): These may antagonize the effects of Levodopa by blocking dopamine receptors.
• Antihypertensives: Additive hypotensive effects may occur, particularly with beta-blockers and diuretics.
• Iron supplements: Can reduce Levodopa absorption and efficacy when given concurrently.
• Pyridoxine (Vitamin B6): Can enhance the peripheral metabolism of Levodopa, reducing its efficacy unless Carbidopa is present.

Dietary Considerations:

• High-protein meals may impair Levodopa absorption due to competition for transport across the gut-blood barrier.

Special Note:

• Combining with other dopaminergic agents may increase the risk of dyskinesia and psychiatric symptoms.

Clinicians should perform a full medication review and adjust dosages as needed to minimize potential interactions. Monitoring blood pressure, mental status, and motor response during therapy is advised.

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

The dosage of 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbidopa + Levodopa must be individualized, considering the patient’s clinical condition, severity of Parkinson’s disease, prior response to oral therapy, and concurrent medications.

General Dosage Guidelines:

• Start with the lowest effective dose to minimize side effects.
• Typical starting dosage delivers Levodopa (up to 100 mg) and Carbidopa (up to 25 mg) in 50 ml, infused over 30–60 minutes.
• Doses may be repeated every 6 to 8 hours depending on symptom control and tolerability.

Titration:

• Dose adjustments should be done gradually (no more than every 2–3 days) to avoid sudden changes in dopaminergic activity.
• Patients previously stabilized on oral formulations may need equivalent IV doses adjusted for bioavailability differences.

Special Populations:

• Renal impairment: May require slower infusion rates and electrolyte monitoring.
• Geriatric patients: Often require lower starting doses due to increased sensitivity to side effects.

All dosing must be guided by clinical response and safety monitoring, under direct medical supervision.

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

While 0.9% Sodium Chloride Injection, USP [MEDISAL] with Carbidopa + Levodopa is generally well-tolerated when administered appropriately, it can lead to several adverse effects. These may range from mild to severe and often depend on dose, duration, and the patient’s underlying health status.

Common Side Effects:

• Nausea and vomiting (especially early in therapy).
• Dizziness or lightheadedness due to orthostatic hypotension.
• Headache or fatigue during or post-infusion.
• Involuntary movements (dyskinesia) such as twitching, facial grimacing, or limb jerking.

Less Common but Serious Side Effects:

• Confusion, hallucinations, or vivid dreams—more frequent in elderly patients.
• Severe hypotension, especially with rapid IV infusion.
• Arrhythmias or palpitations due to dopaminergic stimulation.
• Allergic reactions including rash, itching, or anaphylaxis (rare).

Local IV Site Reactions:

• Redness, swelling, or irritation at the injection site.
• Phlebitis with prolonged use or improper technique.

Monitoring Tips:

• Regular blood pressure and ECG monitoring during infusion.
• Observe for signs of mental status changes or behavioral shifts.
• Adjust dosing or discontinue treatment if side effects become intolerable.

Patients and caregivers should report any new or worsening symptoms immediately. Prompt medical evaluation is essential to manage and mitigate risks effectively.

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

The use of 0.9% Sodium Chloride Injection, USP [MEDISAL] containing Carbidopa + Levodopa is contraindicated in specific medical situations where the risks outweigh the therapeutic benefits. A thorough pre-treatment evaluation is necessary to rule out these conditions.

Absolute Contraindications:

• Known hypersensitivity to Carbidopa, Levodopa, or any formulation excipients.
• Concurrent use of non-selective MAO inhibitors (e.g., phenelzine, tranylcypromine) due to risk of hypertensive crisis. A washout period of at least 14 days is necessary.
• Narrow-angle glaucoma, as Levodopa can increase intraocular pressure.
• Undiagnosed skin lesions or history of melanoma, as Levodopa may activate latent melanoma.

Relative Contraindications (use with caution):

• Severe cardiovascular disease: Risk of arrhythmias or hypotension during infusion.
• End-stage renal failure or significant electrolyte imbalance: Sodium load from saline and drug clearance may be problematic.
• Psychiatric disorders: Levodopa may exacerbate hallucinations or psychosis.
• Pregnancy and lactation: Not recommended unless the potential benefits clearly outweigh risks.

Patients must undergo a full medical history and physical examination, including ophthalmologic and dermatologic assessments, before initiating therapy. Use in children is generally not advised unless under strict specialist care.

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

Proper storage of 0.9% Sodium Chloride Injection, USP [MEDISAL] is essential to maintain its sterility, efficacy, and safety. This solution is supplied in a ready-to-use 50ml polypropylene bag and should be handled with care.

Storage Guidelines:

• Store at 15°C to 25°C (59°F to 77°F), away from extreme temperatures.
• Protect from freezing, which may compromise the integrity of the plastic container and the stability of the active ingredients.
• Avoid direct sunlight and prolonged exposure to UV light.

Handling Instructions:

• Inspect the bag for leaks, discoloration, or particulates before use.
• Do not use if the solution appears cloudy or if the bag is damaged.
• Once opened, use immediately; do not store partially used bags for future use.

Disposal:

• Dispose of unused or expired product in accordance with local medical waste protocols.
• Do not flush the solution or container down the drain.

Label and Batch Information: Always check the expiration date and batch number before administration to ensure product validity and traceability.

Following proper storage recommendations ensures therapeutic effectiveness and prevents potential harm due to product degradation or contamination.