The product information that follows concerns a prescription-only medicine and is intended for registered healthcare professionals in Pakistan. Please confirm to continue.
A prokinetic for the meal-related symptoms of functional dyspepsia — postprandial bloating, epigastric distention and early satiety.
Acosky® contains acotiamide HCl hydrate, a drug for functional gastrointestinal disorders. It acts on gastric motility rather than on acid, addressing the meal-related symptoms of functional dyspepsia.
Strengthens antral and gastric-body contraction by increasing available acetylcholine.
Increases postprandial antral motility and improves delayed gastric emptying.
One 100 mg film-coated tablet, three times a day before meals.
Functional dyspepsia describes persistent upper-abdominal symptoms without an organic cause on investigation. Meal-related symptoms — fullness after eating, early satiety and bloating — are often linked to impaired gastric accommodation and delayed emptying.
Before and during treatment, persistent symptoms warrant consideration of organic disease, including gastric malignancy, and further investigation such as upper GI endoscopy where appropriate.
As listed in the Acosky® prescribing information:
Acotiamide inhibits acetylcholinesterase (AChE) by a mixed type of inhibition, competitive and non-competitive. Suppressing the breakdown of acetylcholine released from cholinergic nerve terminals enhances ACh-induced contraction and motility of the gastric antrum and body, increasing postprandial antral motility and improving delayed gastric emptying.
The fundus relaxes to receive a meal; improved accommodation was reported in the gastric motility study below.
Increased ACh availability strengthens antral contractions that drive gastric emptying.
Acts on the cholinergic pathway governing gastric motility.
Figures below are taken from the primary publications and a peer-reviewed review of the Phase III programme. Full papers are available to healthcare professionals on request.
Both endpoints were significantly higher with acotiamide than with placebo.
p-values are for change from baseline within the acotiamide group; corresponding placebo changes were not significant (p = 0.08, 0.59 and 0.14).
Acosky® (acotiamide HCl hydrate) is indicated for the treatment of postprandial bloating, epigastric distention and early satiety in functional dyspepsia.
For the treatment of symptoms associated with functional dyspepsia, as specified in the approved prescribing information.
Adults: one 100 mg tablet three times a day, before meals, taken orally.
Single oral dose of one 100 mg tablet on an empty stomach in a healthy adult (mean ± SD):
| Dose (mg) | Tmax (h) | Cmax (ng/mL) | AUCinf (ng·h/mL) | t½ (h) |
|---|---|---|---|---|
| 100 | 2.42 ± 0.97 | 30.82 ± 13.33 | 171.3 ± 59.43 | 13.31 ± 6.91 |
With 100 mg three times daily for 9 days, plasma concentrations reached near steady state from the third dose on day 3, with almost no change in pharmacokinetics on repeated administration.
Cmax was highest with pre-meal administration (62.7% higher than fasting); after meals it was 59.6% of the pre-meal value. AUClast was lowest after meals.
Plasma protein binding 84.21–85.95% (human plasma), with albumin the main binding protein. Metabolised to a de-isopropyl form by CYP2C8, CYP1A1 or CYP3A4, and to a glucuronide conjugate by UGT1A8 or UGT1A9.
After an oral [14C] dose, 92.7% of radioactivity was excreted in faeces and 5.3% in urine within 216 hours.
| Brand | Acosky® |
|---|---|
| Generic | Acotiamide HCl hydrate |
| Strength | 100 mg (as acotiamide hydrochloride hydrate) per film-coated tablet |
| Dosage form | Film-coated tablet, oral |
| Pack | Blister pack of 20 tablets |
| Therapeutic area | Gastroenterology |
| Prescription status | Prescription-only medicine |
| DRAP registration no. | 129574 |
| Manufacturing licence no. | 000789 |
| Marketed by | Salventis Pharma SMC (Pvt.) Ltd., Islamabad |
| Storage | Below 30°C, dry place; protect from sunlight, heat and moisture |
