Description

SODIBIC is a versatile pharmaceutical product formulated with sodium bicarbonate, available in various dosage forms to meet diverse clinical needs. Manufactured by Aspen Pharmacare Australia Pty Ltd and Phebra Pty Ltd, it is designed to address conditions such as metabolic acidosis, bicarbonate replacement, and urinary alkalinization.

Dosage Forms

Oral Capsule

• Strength: 840 mg per capsule
• Appearance: Hard, opaque, ivory-colored capsules containing white powder
• Packaging: Available in bottles of 100, with options for larger bulk packs

Injectable Solution

• Concentration: 8.4% w/v (84 mg/mL)
• Packaging: Offered in 10 mL and 100 mL glass vials
• Excipients: Includes disodium edetate and water for injections, free from common allergens and preservatives
• Administration: Intended for intravenous use, preferably via a central line

Oral Solution

An unlicensed or “special” product, this oral solution is tailored for specific patient needs when standard licensed medicines are unsuitable.

Mechanism of Action

SODIBIC acts as a systemic alkalinizing agent, increasing plasma bicarbonate levels, buffering excess hydrogen ions, and raising blood pH. This mechanism helps in the treatment of various conditions, including heartburn, acid indigestion, and certain types of poisoning.

Administration

• Oral Capsules: Should be taken as directed by healthcare professionals.
• Injectable Solution: Dosage is determined based on clinical conditions and administered by healthcare providers.
• Oral Solution: Dosing is individualized, emphasizing its role as a tailored therapeutic option.

Precautions and Contraindications

SODIBIC should be used with caution in patients with conditions such as renal failure, hypernatremia, and metabolic alkalosis. Monitoring of acid-base status and serum electrolytes is recommended during therapy. It is crucial to manage dosing carefully, particularly in vulnerable populations such as pregnant women, children, and the elderly.

Potential Adverse Effects

Possible side effects include metabolic alkalosis, electrolyte imbalances, and local reactions at the injection site. Drug interactions may occur, affecting the absorption and effectiveness of other medications. Proper management and consultation with healthcare professionals are advised to mitigate these risks.

Storage Instructions

Store SODIBIC below 30°C, keeping it away from moisture and light. The injectable solution is intended for single use, with any unused portion to be discarded appropriately. Compliance with local disposal regulations is essential to ensure safe handling.

Regulatory Information

SODIBIC is not scheduled as a controlled medicine in Australia and is listed on the Pharmaceutical Benefits Scheme (PBS) for capsules. The oral solution remains an unlicensed product, emphasizing its specialized application in clinical practice.