PANTEC-DSR Pantoprazole Sodium Sesquihydrate / Domperidone 40mg / 30mg Modified-Release Capsule 1's
RXDRUG-DRP-10046-30-1pc
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Features
Brand
Pantec-Dsr
Full Details
Dosage Strength
40 mg (in sustained release pellets) / 30 mg (in delayed release pellets)
Drug Ingredients
- Domperidone
- Pantoprazole
Drug Packaging
Modified-Release Capsule 1's
Generic Name
Pantoprazole Sodium Sesquihydrate / Domperidone
Dosage Form
Modified-Release Capsule
Registration Number
DRP-10046
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Symptomatic management of burning in various acid peptic disorders associated with nausea and vomiting; GERD, reflux esophagitis, non-ulcer dyspepsia, gastroparesis and idiopathic hiccup or any other peptic disease accompanied by nausea and/or vomiting (e.g acute gastritis including that induced by NSAIDs).
Dosage/Direction for Use
Usual oral dose one capsule daily before breakfast or as directed by physician.
Overdosage
Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions especially in children. In case of over dosage gastric lavage should be performed. Symptomatic and supportive measures are recommended.
Administration
Should be taken on an empty stomach.
Contraindications
Contraindicated in patients with known hypersensitivity to any component of the formulation, gastro-intestinal hemorrhage, perforation and prolactin-releasing pituitary tumor.
Special Precautions
Use with caution in patients with hepatic impairment, renal dysfunction and in elderly.
Adverse Reactions
The adverse reaction associated with Pantoprazole includes headache, dizziness, skin rash, pruritus.
There have been reports of dystonic reactions with domperidone. Plasma-prolactin concentrations may also be increased which may lead to galactorrhea or gynecomastia. Dry mouth, diarrhea, skin rashes, itching thirst, headache, drowsiness, nervousness may follow with treatment of Domperidone.
There have been reports of dystonic reactions with domperidone. Plasma-prolactin concentrations may also be increased which may lead to galactorrhea or gynecomastia. Dry mouth, diarrhea, skin rashes, itching thirst, headache, drowsiness, nervousness may follow with treatment of Domperidone.
Drug Interactions
Pantoprazole: No dosage adjustment is needed with concomitant use of following drugs: carbamazepine, digoxin, theophylline, antipyrine, cisapride, diclofenac, diazepam, glyburide, oral contraceptives (levonorgestrel / ethinylestradiol), metoprolol, ethanol, nifedipine, warfarin or phenytoin.
Domperidone: Anti-cholinergic agents and opioid analgesics may antagonize the effect of Domperidone.
Domperidone suppresses the peripheral effects (digestive disorders, nausea and vomiting) of dopaminergic agonists. Since Domperidone has gastro-kinetic effects, it could influence the absorption of concomitant orally administered drugs, particularly those with sustained release or enteric-coated formulations.
As Domperidone interferes with serum prolactin levels, it may interfere with other hyperprolactinemic agents and with some diagnostic tests.
Antacids and anti-secretory agents lower the oral bioavailability of Domperidone. They should be taken after meals and not before meals, i.e. they should not be taken simultaneously with Domperidone. Reduced gastric acidity impairs the absorption of Domperidone.
Oral bioavailability is decreased by prior administration of Cimetidine or Sodium Carbonate.
Domperidone: Anti-cholinergic agents and opioid analgesics may antagonize the effect of Domperidone.
Domperidone suppresses the peripheral effects (digestive disorders, nausea and vomiting) of dopaminergic agonists. Since Domperidone has gastro-kinetic effects, it could influence the absorption of concomitant orally administered drugs, particularly those with sustained release or enteric-coated formulations.
As Domperidone interferes with serum prolactin levels, it may interfere with other hyperprolactinemic agents and with some diagnostic tests.
Antacids and anti-secretory agents lower the oral bioavailability of Domperidone. They should be taken after meals and not before meals, i.e. they should not be taken simultaneously with Domperidone. Reduced gastric acidity impairs the absorption of Domperidone.
Oral bioavailability is decreased by prior administration of Cimetidine or Sodium Carbonate.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacologic classification: Proton Pump Inhibitor/Prokinetic.
Pharmacology: Pantoprazole is a proton pump inhibitor (PPI). It suppresses the terminal step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of stimulus. It is a weak base and it is highly ionized al low pH.
Domperidone is a benzimidazole derivative. It acts by selectively antagonizing the peripheral dopaminergic D2 receptors in the gastrointestinal wall, thereby enhancing gastrointestinal peristalsis and motility and increasing lower esophageal sphincter (LES) tone.
Pharmacokinetics: Pantoprazole: Pantoprazole is readily absorbed after oral administration. Following oral administration, the serum concentration of pantoprazole declines biexponentially with a terminal elimination half-life of approximately one hour. The peak plasma concentration (Cmax) is of 1.1 to 3.1 (mean 2.1) mg/L occurring within 2 to 4 (mean 2.7) hours (tmax) after ingestion of an enteric coated 40 mg tablet. The volume of distribution is low (mean 0.16 L/Kg) due to high degree of plasma protein binding (98%). Pantroprazole absorption is not affected by concomitant administration of antacids. Administration of pantoprazole with food may delay its absorption up to 2 hours or longer. The serum protein binding of pantoprazole is about 98%, primarily to albumin. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Pantoprazole metabolism is independent of the route of administration (intravenous or oral).
Approximately 71% of the dose is excreted in the urine with 18% excreted in the feces through biliary excretion.
Domperidone: The bioavailability of Domperidone on oral intake is increased when given after food. It is more than 90% bound to plasma protein and has terminal elimination half-life of 7.5 hours. It is mostly cleared from the blood by extensive metabolism. After 30% of oral dose is excreted in urine within 24 hours, almost entirely as metabolites; the remainder of a dose is excreted in faeces over several days, about 10% as unchanged drug. It does not readily cross the blood-brain barrier. Small amounts of Domperidone are distributed into breast milk, reaching concentrations about one-quarter of those in maternal serum.
Special populations: Pantoprazole: Geriatric: No dosage adjustment is recommended based on age.
Pediatric: Pharmacokinetics of Pantoprazole have not been investigated in patients below 18 years of age.
Gender: no dosage adjustment is recommended based on gender.
Renal Impairment: No dosage adjustment is needed in patients with renal impairment or in patients undergoing hemodialysis.
Hepatic Impairment: No adjustment is needed in patients with mild severe hepatic impairment.
Domperidone: Geriatric: No special precautions are necessary in older patients.
Pediatric: There may be an increased risk for extrapyramidal reactions in young children because of an incompletely developed blood brain barrier.
Hepatic impairment: There is no pharmacokinetic data published in patients with hepatic impairment.
Pregnant women: The safety of Domperidone has not been proven, therefore its use is not recommended in pregnant women.
Neonates: Domperidone is not recommended for use in neonates.
Breast milk: Domperidone may precipitate galactorrhea and improved postnatal lactation. It is secreted in breast milk in very small quantities and therefore is insufficient to be considered harmful.
Pharmacology: Pantoprazole is a proton pump inhibitor (PPI). It suppresses the terminal step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of stimulus. It is a weak base and it is highly ionized al low pH.
Domperidone is a benzimidazole derivative. It acts by selectively antagonizing the peripheral dopaminergic D2 receptors in the gastrointestinal wall, thereby enhancing gastrointestinal peristalsis and motility and increasing lower esophageal sphincter (LES) tone.
Pharmacokinetics: Pantoprazole: Pantoprazole is readily absorbed after oral administration. Following oral administration, the serum concentration of pantoprazole declines biexponentially with a terminal elimination half-life of approximately one hour. The peak plasma concentration (Cmax) is of 1.1 to 3.1 (mean 2.1) mg/L occurring within 2 to 4 (mean 2.7) hours (tmax) after ingestion of an enteric coated 40 mg tablet. The volume of distribution is low (mean 0.16 L/Kg) due to high degree of plasma protein binding (98%). Pantroprazole absorption is not affected by concomitant administration of antacids. Administration of pantoprazole with food may delay its absorption up to 2 hours or longer. The serum protein binding of pantoprazole is about 98%, primarily to albumin. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Pantoprazole metabolism is independent of the route of administration (intravenous or oral).
Approximately 71% of the dose is excreted in the urine with 18% excreted in the feces through biliary excretion.
Domperidone: The bioavailability of Domperidone on oral intake is increased when given after food. It is more than 90% bound to plasma protein and has terminal elimination half-life of 7.5 hours. It is mostly cleared from the blood by extensive metabolism. After 30% of oral dose is excreted in urine within 24 hours, almost entirely as metabolites; the remainder of a dose is excreted in faeces over several days, about 10% as unchanged drug. It does not readily cross the blood-brain barrier. Small amounts of Domperidone are distributed into breast milk, reaching concentrations about one-quarter of those in maternal serum.
Special populations: Pantoprazole: Geriatric: No dosage adjustment is recommended based on age.
Pediatric: Pharmacokinetics of Pantoprazole have not been investigated in patients below 18 years of age.
Gender: no dosage adjustment is recommended based on gender.
Renal Impairment: No dosage adjustment is needed in patients with renal impairment or in patients undergoing hemodialysis.
Hepatic Impairment: No adjustment is needed in patients with mild severe hepatic impairment.
Domperidone: Geriatric: No special precautions are necessary in older patients.
Pediatric: There may be an increased risk for extrapyramidal reactions in young children because of an incompletely developed blood brain barrier.
Hepatic impairment: There is no pharmacokinetic data published in patients with hepatic impairment.
Pregnant women: The safety of Domperidone has not been proven, therefore its use is not recommended in pregnant women.
Neonates: Domperidone is not recommended for use in neonates.
Breast milk: Domperidone may precipitate galactorrhea and improved postnatal lactation. It is secreted in breast milk in very small quantities and therefore is insufficient to be considered harmful.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
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