Sitafein I.V. Infusion/Oral Kullanim Icin Solution Iceren Ampul

Description

Sitafein finds its place within the realm of methylxanthines, acting as a central nervous system stimulant.

Sitafein serves as a therapeutic ally in the short-term treatment of premature apnea, a condition characterized by the cessation of breathing, primarily observed in infants born with a gestational age falling between 28 and less than 33 weeks. These sporadic instances of breath-holding stem from the underdevelopment of the infant’s breathing center.

How is it administered?

Sitafein offers versatility in administration, with two viable routes:

1. Intravenous: Through intravenous infusion, this medication delivers 60 mg of caffeine citrate per vial, equivalent to 30 mg/3 ml of caffeine. The solution is complemented by auxiliary substances such as sodium citrate dihydrate, sodium hydroxide and/or hydrochloric acid, and water for injection.
2. Oral: Alternatively, Sitafein can be administered orally, ensuring a convenient option for neonatal care.

Packaging

Each container boasts 10 vials, each with a 5 ml capacity, containing 3 ml of solution. This meticulous packaging facilitates precise dosage administration.

Precautions

While Sitafein stands as a valuable therapeutic tool, precautions must be observed:

• Allergic Sensitivity: Exercise caution if your newborn displays hypersensitivity to caffeine citrate or any components within Sitafein.
• Seizures: Vigilance is required if your infant experiences seizures.
• Cardiac Considerations: In cases of existing heart disease in the neonate, Sitafein should be administered with care.
• Renal and Hepatic Health: Babies with kidney or liver issues necessitate careful monitoring during Sitafein treatment.
• Gastric Concerns: Infants prone to frequent regurgitation of stomach acid should be closely observed.
• Urinary Changes: If your infant exhibits abnormal urination patterns, it merits medical attention.
• Weight and Feeding: A decrease in weight gain or food intake warrants scrutiny.
• Theophylline History: If your infant has previously received theophylline treatment for respiratory issues, it should be communicated to the healthcare provider.
• Maternal Caffeine Intake: Additionally, the maternal consumption of caffeine prior to birth merits consideration in the overall assessment.

Before initiating Sitafein treatment for the temporary alleviation of breathing issues in prematurely born infants, it is imperative to exclude other potential causes and, if necessary, address them under the guidance of your child’s healthcare provider.

Interactions

As of current data, no interactions between Sitafein and food or drink have been reported. However, vigilance is essential when considering new research findings in this regard.

Sitafein Precautions

During pregnancy, it is essential to consult your healthcare provider or pharmacist before utilizing Sitafein. Caffeine has the potential to pass into breast milk, necessitating a cautious approach to high-caffeine products or coffee consumption during pregnancy.

Ingredients

Delving into the heart of Sitafein I.V. Infusion/Oral Kullanim Icin Solution Iceren Ampul reveals its core constituents:

• Active Ingredient: Each vial boasts 60 mg of caffeine citrate, equating to 30 mg/3 ml of caffeine.
• Auxiliary Substances: The solution is complemented by sodium citrate dihydrate, sodium hydroxide and/or hydrochloric acid, and water for injection.

Deciphering Caffeine Citrate

What is Caffeine Citrate?

Caffeine citrate emerges as a pivotal medication in addressing breathing cessation in premature infants, particularly those born at less than 35 weeks or weighing less than 2 kilograms (4.4 lbs), once other underlying causes have been methodically ruled out.

The Science Behind Caffeine Citrate

Caffeine citrate shares structural ties with other methylxanthines such as theophylline and theobromine. It serves as a multifaceted agent, encompassing roles as a bronchial smooth muscle relaxant, central nervous system stimulant, cardiac muscle stimulant, and diuretic.

Mechanism of Action

While the exact mechanisms underpinning caffeine citrate’s effectiveness in addressing apnea of prematurity remain a subject of ongoing research, several hypotheses have emerged:

• Stimulation of the Respiratory Center: Caffeine citrate is believed to stimulate the respiratory center, promoting enhanced minute ventilation.
• Reduced Threshold to Hypercapnia: It may lower the threshold for hypercapnia, enhancing the body’s response to elevated carbon dioxide levels.
• Augmented Skeletal Muscle Tone: Caffeine citrate can increase skeletal muscle tone.
• Mitigated Diaphragmatic Fatigue: It has the potential to reduce diaphragmatic fatigue.
• Elevated Metabolic Rate: Caffeine citrate can boost metabolic rates.
• Increased Oxygen Consumption: It is associated with heightened oxygen consumption.

The majority of these effects are attributed to caffeine’s ability to antagonize adenosine receptors, particularly the A1 and A2 subtypes. This antagonism has been observed in receptor binding assays and is relevant at concentrations approximating therapeutic levels.

Pharmacokinetics

Upon oral administration of 10 mg caffeine base/kg to preterm neonates, peak plasma levels (Cmax) for caffeine vary between 6 to 10 mg/L. The mean time to reach peak concentration (Tmax) spans from 30 minutes to 2 hours, unaffected by formula feeding. The absolute bioavailability in preterm neonates, however, warrants further examination.

Caffeine swiftly permeates the brain, with levels in the cerebrospinal fluid of preterm neonates mirroring their plasma levels. The mean volume of distribution of caffeine in infants (0.8 to 0.9 L/kg) slightly surpasses that in adults (0.6 L/kg).

Conclusion

In the realm of neonatal care, Sitafein I.V. Infusion/Oral Kullanim Icin Solution Iceren Ampul stands as a significant asset. Its precise administration, multifaceted mechanisms, and careful considerations make it a vital tool in addressing premature apnea.

However, diligent precaution and consultation with healthcare professionals remain pivotal. The journey of healthcare is a complex one, and Sitafein is a noteworthy guide within this landscape, but it should always be employed under the guidance of experienced healthcare providers.