Itopride HCl Indications Treatment of GI symptoms of functional, non ulcer dyspepsia (chronic gastritis) ie, feeling of abdominal bloatedness,

upper abdominal pain, heartburn, nausea and vomiting. Dosage Adults: Recommended Dose: 150 mg daily (50-mg tab taken orally 3 times a day before meals). Overdosage There have been no reported cases of overdose in humans. In case of excessive overdose, the usual measures of gastric lavage and symptomatic therapy should be applied. Administration Should be taken on an empty stomach (Take before meals.). Contraindications Known hypersensitivity to itopride HCl or any of the excipients. Patients in whom an increase in GI motility could be harmful eg, GI hemorrhage, mechanical obstruction or perforation. Special Precautions Itopride HCl enhances the action of acetylcholine and may produce cholinergic side effects. Data on long-term use are not available. Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Therefore, itopride HCl should not be used during pregnancy unless the benefits outweigh the potential risks. Labor and Delivery: There are no known effects of itopride HCl on labor or delivery. Use in lactation: Because itopride is excreted in milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Use in children: Safety of itopride in children <16 years has not been established. Use in the elderly: In general, appropriate caution should be exercised in the administration and monitoring of itopride HCl in elderly patients reflecting the greater frequency of decreased hepatic, renal function and of concomitant disease or other drug therapy. Adverse Drug Reactions The following adverse events have been reported in patients receiving itopride HCl. Blood and Lymphatic System Disorders: Leukopenia and thrombocytopenia. Immune System Disorders: Anaphylactoid reaction. Endocrine Disorders: Increased prolactin level and gynecomastia. Nervous System Disorders: Dizziness, headache, tremor. Gastrointestinal Disorders: Diarrhea, constipation, abdominal pain, increased saliva, and nausea. Hepatobiliary Disorder: Jaundice. Skin and Subcutaneous Tissue Disorders: Rash, redness, itching. Investigations: Increased AST (SGOT), increased ALT (SGPT), increased -GTP, increased alkaline phosphatase and increased bilirubin. Drug Interactions Metabolic interactions are not expected since itopride is primarily metabolized by flavine monooxygenase and not by CYP450. No changes in protein-binding have been seen with co-administration of warfarin, diazepam, diclofenac sodium, ticlopidine HCl, nifedipine and nicardipine HCl. Since itopride has gastrokinetic effects it could influence the absorption of concomitantly orally administered drugs. Particular caution should be taken with drugs with a narrow therapeutic index, sustained-release or enteric-coated formulations. Antiulcer drugs eg, cimetidine, ranitidine, teprenone and cetraxate do not affect the prokinetic action of itopride. Anticholinergic drugs may reduce the action of itopride. Storage Store at temperatures not exceeding 30C. Description Each tablet also contains the following inactive ingredients: Lactose, corn starch, carmellose, light

anhydrous silicic acid, magnesium stearate, hydroxypropylmethylcellulose 2910 2 (6 mm /s), macrogol 6000, titanium oxide and carnauba wax. The tablet is formulated to provide immediate-release. Itopride HCl is N-(4-(2(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzamide HCl. Itopride HCl is a substituted benzamide. It has an empirical formula of C20H26N2O4HCl and a molecular weight of 394.89 g/mol. Mechanism of Action Pharmacology: Mechanism of Action: Itopride HCl activates GI propulsive motility due to its dopamine D2 antagonizing activity and acetylcholinesterase inhibitory activity. Itopride activates acetylcholine release and inhibits degradation. Pharmacodynamics: Itopride HCl also has antiemetic action through interaction with D2 receptors located in the chemoreceptor trigger zone. Itopride HCl has been shown to accelerate gastric emptying in humans. The action of itopride HCl is highly specific for the upper GIT. It does not affect serum gastrin levels. Pharmacokinetics: Absorption: Itopride HCl is rapidly and almost completely absorbed from the GIT. Relative bioavailability is calculated to be 60% due to liver first-pass metabolism. There is no effect of food on bioavailability. Peak plasma levels (Cmax 0.28 mcg/mL) are reached after 30-45 min after 50 mg of itopride HCl. Following multiple oral doses ranging from 50-200 mg 3 times daily, itopride HCl and its metabolites showed linear pharmacokinetics over a treatment period of 7 days, with minimal accumulation. Distribution: Approximately 96% of itopride HCl is bound to plasma proteins. Albumin accounts for most of the binding. 1-acid glycoprotein accounts for <15% of binding. Metabolism: Itopride undergoes extensive hepatic metabolism in humans. Three metabolites have been identified, of which only 1 exerts minor activity without pharmacological relevance (approximately 2-3% of that of itopride). The primary metabolite in humans is the N-oxide generated by oxidation of the tertiary amine N-dimethyl group. Itopride is metabolized by a flavin-dependent monooxygenase (FMO3). The abundance and efficiency of the human FMO-isozymes can be subject to genetic polymorphisms, which can lead to a rare autosomal recessive condition known as trimethylaminuria (fish odor syndrome). The t of itopride may therefore be longer in trimethylaminuria patients. In vivo pharmacokinetic studies on CYP-mediated reactions revealed that itopride showed neither inhibitory nor inductory effect on CYP2C19 and CYP2E1, CYP content and uridine diphosphate glucuronosyl transferase activity were not altered with the administration of itopride. Excretion: Itopride HCl and its metabolites are primarily excreted in the urine. The urinary excretions of itopride 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 t of itopride HCl was approximately 6 hrs. Toxicology: Itopride has undergone extensive toxicological testing in various experimental models. The results of these studies are summarized in the table. Acute Toxicity Studies: Itopride was administered by the oral route in various experimental models. The LD50 values were high in all the groups, indicating that itopride has a wide range of safety. Subacute Toxicity Studies: Subacute toxicity studies were undertaken in rats, dogs and monkeys for a period of up to 3 months. No changes of toxicological significance were observed in these animals. Chronic Toxicity Studies: Itopride was administered orally to rats and dogs for 6 months and its effect on animals were observed. No treatment-related changes

of toxicological significance were seen. Studies in rats and rhesus monkeys indicated that itopride was not associated with physical dependence. Preclinical Safety Data: Itopride has been extensively evaluated for its clinical efficacy and tolerability in Japan and India. In Japan, the drug was evaluated in 572 patients. In India, the studies were undertaken in 6 centers with 179 patients. These studies enrolled patients suffering from gastric motility disorders like chronic gastritis, non-ulcer dyspepsia, reflux esophagitis and diabetic gastroparesis. The result of these clinical studies indicated that: Itopride was effective in providing moderate to complete relief of symptoms in 73-100% of the patients. Itopride effectively improved GI symptoms caused by reduced gastric motility like gastric fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting. Treatment with Ganaton (itopride) was consistently shown to be safe and well tolerated and did not cause prolongation of QT interval on ECG in these patients. Teratogenicity: Sub-acute toxicity studies were taken in rats, dogs and monkeys for a period of up to 3 months. No changes of toxicological significance were observed in these animals. Itopride was administered orally to rats and dogs for 6 months and its effect on animals were observed. No treatment-related changes of toxicological significance were seen. Studies in rats and rhesus monkeys indicated that itopride was not associated with physical dependence. Reverse mutations tests (Ames test), chromosomal aberration test and micronucleus test indicated that itopride was devoid of mutagenic potential. Studies in guinea pigs and mice revealed that itopride had no antigenic potential. Following oral administration of itopride 30, 100 and 300 mg/kg/day to rats and rabbits, no abnormalities in organogenesis and fetal developments were observed. MIMS Class GIT Regulators, Antiflatulents & Anti-Inflammatories

Pantoprazole Generic Name: Pantoprazole sodium Dosage Form: tablet, delayed release Indications and Usage for Pantoprazole Pantoprazole sodium delayed-release tablets are indicated for: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole sodium delayedrelease tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pediatric indication and usage information in pediatric patients ages 5 years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc. s Pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc. s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole Dosage and Administration Recommended Dosing Schedule Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

delayed-release tablets may be considered.

GELTAZINE

Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Generic : Aluminum hydroxide, Magnesium hydroxide, Oxethacaine Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated with GERD Adults Adults Adults 40 mg 40 mg 40 mg Once daily for up to 8 weeks* Once daily Twice daily Recommended Dosage: Pediatric dosing information in pediatric patients ages 5 years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc. s Pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc. s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Administration Instructions Directions for method of administration for the tablet dosage form are presented in Table 2. Table 2: Administration Instructions * Formulation Delayed-Release Tablets Route Oral Instructions* Maintenance of Healing of Erosive Esophagitis Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome PPD Drug Class: Needs a Prescription: Indications: Gastro/ Acid-Peptic Disease Agents/ Antacids No Symptomatic relief of peptic ulcers (gastric & duodenal), acute/chronic gastritis, esophagitis & heartburn associated w/ hiatus hernia, pregnancy, post-radiation or other conditions. 1-2 caps thrice daily 30 mins before meals & at bedtime or as recommended by a physician.

Contents Al(OH)3 (dried gel) 400 mg, Mg(OH)2 97.5 mg, oxethazaine 10 mg Indications Symptomatic relief of peptic ulcer, acute & chronic gastritis, esophagitis & heartburn associated w/ hiatus hernia, pregnancy & postradiation. Dosage 1 cap tid. Administration May be taken with or without food Special Precautions Renal insufficiency. Adverse Drug Reactions Constipation; CNS depressions. Drug Interactions Reduces absorption of chlordiazepoxide, Fe compd, digoxin, indomethacin, tetracyclines, chlormazine, propranolol.

Patients should be cautioned that Pantoprazole sodium delayed-release tablets should not be Antacids, Antireflux Agents & Antiulcerants ATC MIMS Class split, chewed, or crushed. Classification A02AX - Antacids, other combinations ; [?] Poison Schedule Non-Rx Swallowed whole, with or without food

Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole sodium delayed-release tablets.

Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole sodium