Flecainide acetate 20 mg/mL oral suspension

White to pale-pink suspension.

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Class IC antiarrhythmic with proarrhythmia risk; requires careful clinical patient selection.
Active-drug context from another product’s labelling; it does not establish stability or dosing of this compounded preparation.

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Check yield and appearance. No analytical test limits given. Source appearance: white to pale pink.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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For the finished product the source specifies:
Amber plastic bottle, room temperature ≤25 °C. Avoid refrigeration: precipitation risk.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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Complete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

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A complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.

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Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

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Source period: 30 days under the permitted storage conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

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No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

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Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Capsule-filling equipment. Selection/qualification is defined locally.

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Pulverise tablets or capsule contents. Levigate with a little of the specified vehicle, dilute progressively, transfer quantitatively with rinses, make to final volume and mix.

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Stability is established for Tambocor and Flecainide BNM. Check strength: 20 mg/mL, not 25 mg/5 mL. Source permits 1:1 and SF vehicle alternatives; record the selection.

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Amber plastic bottle as specified by the sheet.

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Check yield and appearance. No analytical test limits given. Source appearance: white to pale pink.

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Amber plastic bottle, room temperature ≤25 °C. Avoid refrigeration: precipitation risk.

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Do not refrigerate: precipitation has been observed. This 20 mg/mL strength differs from a commercial 25 mg/5 mL liquid.

References: [1]

Flecainide acetate 20 mg/mL oral suspension
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Amber plastic bottle, room temperature ≤25 °C. Avoid refrigeration: precipitation risk.
Shake before use.
Do not refrigerate: precipitation has been observed. This 20 mg/mL strength differs from a commercial 25 mg/5 mL liquid.

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