Itoper 50m Tablets
Itoper (Itopride hydrochloride) is an orally active gastroprokinetic agent. It is chemically designated as N-14-[2-(Dimethylamino) ethoxy]benzyl]-3,4-dimethoxybenzamide hydrochloride. Itopride hydrochloride is a substituted benzamide. It has an empirical formula of CHN₂O HCI and molecular weight of 394.89 g/mol.
COMPOSITION:
Itoper Tablet 50mg Each film coated tablet contains: Itopride HCI MS…………50mg Mfg. Specs:: HIGH-G
Mechanism of Action Itoper (Itopride hydrochloride) activates gastrointestinal propulsive motility due to its dopamine D. antagonizing activity and acetylcholin- esterase inhibitory activity Itopride activates acetylcholine release and inhibits Its degradation.
Pharmacodynamics
- * Itoper (Itopride hydrochloride) also has antiemetic action through interaction with De receptors located in the chemoreceptor trigger zone
- * Itoper (Itopride hydrochloride) has been shown to accelerate gastric emptying in humans.
- * The action of Itoper is highly specific for the upper gastrointestinal tract. Itoper does not affect serum gastrin levels.
- Pharmacokinetics:
Absorption
Itaper (Itopride hydrochloride) is rapidly and almost completely absorbed from the gastrointestinal tract. Relative bioavailability is determined to be 60% because of liver first pass digestion. There is no impact of food on bioavailability. Peak plasma levels (Cntax 0.28 µg/mL) are reached after 0.5 to 0.75 hours after 50mg of itopride hydrochloride.
Also for the following multiple oral doses ranging from 50mg to 200mg tl.d.. lopride hydrochloride and its metabolites showed linear pharmacoki- netics over a treatment period of seven days, with minimal accumula- tion.
Approximately 96% of Itaper (Itopride hydrochloride) is bound to plasma proteins. Albumin accounts for most of the binding. Alpha-1 -acid-glycoprotein accounts for less than 15% of binding.
Metabolism: Itaper (Itopride hydrochloride) undergoes extensive hepatic
metabolism in humans. Three (3) metabolites have been distinguished, of
which only one exerts minor activity without pharmacological relevance (approximately 2-3% of that itopride). The essential metabolite in people is the N-oxide, produced by oxidation of the tertiary amine N-dimethyl bunch. Itoper is metabolized by a flavin-de- pendent mano-oxygenase (FMO). The abundance and efficiency of The human FMO- isozymes can be subjected to genetic polymor- phisms, which can lead to a rare autosomal recessive condition known as trimethylaminuria (fish odor syndrome).
The half-life of lloper may therefore be longer in trimethylaminuria
patients. Also for the in vivo of pharmacokinetic studies on CYP-mediated reactions
revealed that loper showed neither inhibitory nor inductory effect on
CYP2C19 and CVP2E1 CYP coritent and uridine diphosphate
glucuronosyl transferase activities were not altered with the
administration of itopride
The urinary excretions of Itoper and its N-oxide were 3.7% and 75.4%, respectively, in healthy subjects after oral administration of a single therapeutic dose. The terminal phase half-life of Itoper was approximately six (6) hours
THERAPEUTIC INDICATIONS:
Functional Dyspepsia
Non-Ulcer Dyspepsia (chronic gastritis) e,
* Sensation of bloating
* Early satiety
Upper abdominal pain or discomfort
* Anorexia
* Heartbum
Nausea and Vomiting
Adults
Also for the of in dose may be reduced according to the patient’s age and symptoms (see PRECAUTIONS).
ADVERSE REACTIONS:
Blood and lymphatic system disorders
Leukopenia and thrombocytopenia
Immune system disorders
Anaphylactoid reaction
Endocrine disorders
Increased prolactin level and gynecomastia
Dizziness, headache and tremor
Gastrointestinal disorders
The runs, clogging, stomach torment, expanded spit and queasiness
Hepato-biliary disorders
Jaundice
Skin and subcutaneous tissue disorders:
Rash, redness and itching
Expanded AST (SGOT), expanded ALT (SGPT), Expanded gamma-GTP, expanded basic phosphatase and expanded bilirubin.
PRECAUTIONS:
General
Itoper (Itopride hydrochloride) enhances the action of acetylcholine and may produce cholinergic side effects.
Drug Interactions:
Also for the in of since Itoper has gastrokinetic effects it could influence the absorption of concomitantly orally administered drugs.
There are no satisfactory and very much controlled examinations in pregnant ladies There are no known effects of Itoper on labor or delivery.
Geriatric Use:
Pediatric Use:
There have been no detailed instances of excess in people.
INSTRUCTIONS:
Store below 30°C.
Protect from light and moisture.
Keep all meds out of the span of kids.
HOW SUPPLIED:
Itoper (Itopride hydrochloride) 50mg film coated tablets are available in Alu-Alu pack of 10’s.
خوراک
ڈاکٹر کی ہدایت کے مطابق استعمال کریں۔
ہدایات:
دوا کو ۳۰ ڈگری سینٹی گریڈ سے کم درجہ حرارت پر رکھیں ۔
روشنی اور نمی سے بچائیں۔
تمام دوائیں بچوں کی پہنچ سے دور رکھیں ۔
صرف رجسٹر ڈ میڈیکل پریکٹشنر کے نسخے پر فروخت کریں۔