Acofide is a novel selective acetylcholinesterase (AChE) inhibitor developed by Zeria in Japan and jointly developed with Astellas.

1. Drug name

Common name: Acotiamide

English name: Acofide/Acotiamide

Product Name: Acotiamide

II. Indications

This product is suitable for functional dyspepsia, specifically including:

Dysmotility subtype: Postprandial fullness and early satiety caused by delayed gastric emptying.

Epigastric pain syndrome: Upper abdominal pain associated with gastric motility disorders.

It can be used to improve gastric motility, promote gastric emptying, and alleviate symptoms of indigestion.

III. Specifications and Characteristics

Specification: Each tablet (or each capsule) contains 100mg of Acotiamide Hydrochloride (calculated as Acotiamide).

Characteristics: White to almost white tablets or capsules.

IV. Main Components

Each tablet (capsule) contains 100mg of acotiamide hydrochloride.

V. Usage and Dosage

Adult conventional dosage: 100mg each time (i.e., 1 tablet/capsule), 3 times a day, taken orally 15-30 minutes before meals.

Course of treatment: It is generally recommended to take the medication continuously for 4 weeks, and the duration can be extended according to the condition and doctor's guidance.

Special populations (such as the elderly and individuals with impaired liver or kidney function) generally do not require dosage adjustments, but should use the medication under the supervision of a physician.

VI. Dose adjustment

Generally, no adjustment is necessary.

If a dose is missed, it should be taken as soon as possible. However, if it is close to the next scheduled dose, the missed dose should be skipped and the medication should be taken as per the original plan. It is prohibited to take a double dose.

If vomiting occurs after taking the medication, decide whether a supplementary dose is necessary based on the timing of the vomiting. If vomiting occurs shortly after taking the medication (within 30 minutes, for example), it is recommended to consult a doctor about whether a supplementary dose is necessary.

VII. Medication Precautions

Before and after meals: It must be taken 15-30 minutes before meals to enhance gastric motility and promote gastric emptying.

Handling of missed doses: As mentioned above, take the missed dose as soon as possible, but do not double the dose.

Vomiting management: If vomiting occurs immediately after taking the medication, a supplementary dose may be necessary; if vomiting occurs a longer time after taking the medication, a supplementary dose is generally not required.

Special precautions: It is not recommended to use this product in combination with anticholinergic drugs or other drugs that inhibit gastric motility, as this may affect the therapeutic effect.

Long-term medication monitoring: If long-term medication is required, symptoms and adverse reactions should be regularly assessed.

VIII. Medication for special populations

Children: Safety and effectiveness not established, not recommended for use.

Pregnant and lactating women: Data is insufficient, avoid use unless potential benefits outweigh risks.

Elderly individuals: Generally, no dosage adjustment is necessary, but closer monitoring may be required.

Liver dysfunction: Generally, no adjustment is needed for mild to moderate impairment; use with caution due to insufficient data for severe impairment.

Renal insufficiency: generally no adjustment is needed for mild to moderate impairment; use with caution due to insufficient data for severe impairment.

IX. Adverse reactions

Common adverse reactions (incidence rate > 1%) include:

Gastrointestinal reactions: diarrhea, nausea, abdominal pain, and constipation.

Nervous system: Headache, dizziness.

Others: rash, fatigue.

Serious adverse reactions (rare):

Elevated liver enzymes, allergic reaction.

If severe rash, jaundice, or persistent diarrhea occurs, discontinue the medication immediately and seek medical attention.

X. Contraindications

Individuals allergic to acotiamide or any excipients are prohibited from using this product.

It is prohibited for individuals with severe hepatic and renal insufficiency to use this product (unless adequate clinical monitoring is conducted).

Pregnant and lactating women, as well as children, are prohibited from using this product (unless there is a clear clinical necessity and after physician assessment).

XI. Drug Interactions

Combined use with anticholinergics (such as atropine) or gastric motility inhibitors (such as domperidone): may reduce the efficacy of acotiamide, avoid combined use.

Combined use with CYP450 enzyme inhibitors/inducers: Acotiamide is primarily metabolized by CYP3A4. Co-administration with strong CYP3A4 inhibitors (such as ketoconazole) may increase plasma drug concentration, necessitating monitoring for adverse reactions. Co-administration with inducers (such as rifampin) may reduce efficacy, requiring dose adjustment.

Combined use with anticoagulants (such as warfarin): Data is limited, use with caution, and monitor coagulation function.

It has no clear interactions with other digestive system drugs (such as proton pump inhibitors), but physicians should be consulted when used in combination.

XII. Storage method

Store at room temperature (15-30°C), avoiding moisture and direct sunlight.

Keep out of reach of children.

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