ACOEAZE

(Acotiamide Tablets) 100mg

100mg Film-Coated Tablets

COMPOSITION

Each film-coated tablet contains:
Acotiamide Hydrochloride Hydrate
100mg
TM
۱۰۰ ملی گرام
ایکوایز
گولیاں
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THERAPEUTIC INDICATIONS

Postprandial fullness, upper abdominal fullness, and early satiety in functional dyspepsia.tiktok live Apk latest version

DOSAGE AND METHOD OF ADMINISTRATION

The usual adult dosage is 100 mg of Acotiamide HCI Hydrate orally administered three times a day before meals.

CONTRAINDICATIONS

Patients with a history of hypersensitivity to the ingredients of this drug.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Precautions Related to Dosage and Administration
Discontinuation of administration of this drug should be considered if symptoms do not improve after one month of administration of this drug. If symptoms persist, the possibility of organic disease should be considered, and in addition to upper gastrointestinal endoscopy, other examinations should be considered if necessary.
Important Precautions
This drug is an acetylcholinesterase inhibitor and enhances the action of acetylcholine.
If the symptoms continue to improve, consider discontinuing the administration of this drug, and be careful not to administer it carelessly for a long period of time.
Children
No clinical trials have been conducted in children, etc.
Elderly
If any abnormalities are observed, appropriate measures such as suspension of administration should be taken. In general, physiological functions (renal function, liver function, etc.) are decreased.

DRUG INTERACTIONS

Precautions for co-administration (Pay attention to co-administration)


FERTILITY, PREGNANCY, AND LACTATION

Pregnant women

Pregnant women or women who may become pregnant should only be administered if the therapeutic benefits are judged to outweigh the risks.
Lactating women
Consider the therapeutic benefit and the benefit of breastfeeding and consider continuing or discontinuing breastfeeding. It has been reported that it is excreted in the milk of rats.

ADVERSE DRUG REACTIONS

The following adverse reactions may occur. Patients should be carefully monitored, and if any abnormalities are observed, appropriate measures such as discontinuing administration should be taken.

ALT increase, AST increase, y-GTP increase

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at [email protected]

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics properties Mechanism of Action
It showed acetylcholinesterase inhibitory action.
Gastrointestinal hypermotility
It was shown to enhance postprandial gastric antrum motility in dogs and rats. In addition, it was shown to improve clonidine-

induced gastric antral hypomotility in dogs and rats. Improvement of delayed gastric emptying
It was shown to improve Clonidine-induced delayed gastric emptying in rats.
Pharmacokinetic properties
Blood concentration
Single dose
A300A
When one tablet of this drug (100 mg as Acotiamide Hydrochloride hydrate) was administered orally in a single dose to a healthy adult male on an empty stomach, the plasma unchanged drug concentration over time and pharmacokinetic parameters were as follows.
Single-dose pharmacokinetic parameters
Dose

AUC

AUC calculated by extrapolating from the last measurement point to infinit

Repeated doses

Healthy adult men were given 1 tablet (100 mg of Acotiamide HCI Hydrate) at a time three times a day for 9 days (single dose on the 1st day, before every meal on days 3 to 8, and single dose on the 9th day). When the drug was administered orally repeatedly before meals, the plasma concentration reached almost a steady state from the third administration on the third day. Furthermore, there was almost no change in pharmacokinetics after repeated administration.

Absorption

Dietary Effects

When one tablet of this drug (100 mg of Acotiamide HCI Hydrate) was orally administered to healthy adult men on an empty stomach, before or after meals, C was highest when administered before meals, increasing by 62.7% compared to when administered under fasting conditions. Furthermore, C., for postprandial administration was 59.6% of that for preprandial administration. AUC last was the lowest for postprandial administration, decreasing to 76.8% and 80.0% compared to fasting and pre-prandial administration, respectively.

Distribution

Plasma protein binding rate
The plasma protein binding rate obtained by the in vitro equilibrium dialysis method was 84.21% to 85.95% for human plasma and 82.64% to 85.10% for human serum albumin thought to be albumin.

Metabolism

Acotiamide solution (600 mg/103 μCi) was orally administered to 6 healthy adult males on an empty stomach, 60.0% of the radioactivity in plasma was due to unchanged drug. In addition, de-isopropyl forms, unchanged glucuronide conjugates, and deisopropyl glucuronide conjugates were found in plasma.

Metabolic Enzymes

In vitro metabolism studies using human CYP-expressing microsomes indicate that this drug is metabolized to deisopropyl by CYP2C8, CYP1A1, or CYP3A4. In addition, an in vitro metabolism test using human UGT-expressing microsomes suggests that this drug is metabolized to the unchanged glucuronide conjugate by UGT1A8 or UGT1A9.

Excretion

Acotiamide solution (600 mg/103 μCi) was orally administered to 6 healthy adult males on an empty stomach, 92.7% and 92.7% of the total radioactivity was detected in feces and urine, respectively, within 216 hours after administration. 5.3% was excreted.

PRECLINICAL SAFETY DATA

Information based on non-clinical studies
In a 24-month carcinogenicity study in rats, endometrial adenocarcinoma occurred in 5/50 cases, 8/50 cases, and 5 cases in the 200 mg/kg/day, 600 mg/kg/day, and 2,000 mg/kg/day groups, respectively. It was observed in 1/50 patients and significantly increased in the 600 mg/kg/day (approximately 100 times the clinical dose) group. On the other hand, no genotoxic or estrogenic effects were observed with this drug. In addition, up to 2,000 mg/kg/day (approximately 330 times the clinical dose) in a 24-month carcinogenicity study in mice, and up to 2,000 mg/kg/day in a two-stage uterine carcinogenicity study using genetically modified animals.

PRESENTATION

ACOEAZE 100mg Tablets are available in Alu-Alu blister in a pack size of 20’s (2×10’s) tablets.

REGISTRATION NUMBER

ACOEAZE 100mg Tablets
MANUFACTURING LICENSE NUMBER
123123
000016

INSTRUCTIONS

To be sold on the prescription of a registered medical practitioner only.
Protect from sunlight, moisture and heat.
Do not store and transport above 30°C.
Keep all medicines out of sight & reach of children.
Product contains Lactose.
Note: For detailed information please refer to SPC available
on website finerone.com
SEARLE
Manufactured by:”
The Searle Company Limited,
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