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Pep Plus
Vitamin B Complex + Zinc
Pep Plus
Vitamin B Complex + Zinc
Indications
Vitamins B and Zinc deficiencies
Indication detailsView
This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
DosageView
Syrup-
- Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
- Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
- Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
- Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
Side effectsView
This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
ContraindicationsView
Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
InteractionsView
Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
Pregnancy & lactationView
This is recommended in pregnancy and lactation.
Overdose effectsView
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
StorageView
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Pep Plus
Vitamin B Complex + Zinc
Pep Plus
Vitamin B Complex + Zinc
Indications
Vitamins B and Zinc deficiencies
Indication detailsView
This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
DosageView
Syrup-
- Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
- Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
- Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
- Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
Side effectsView
This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
ContraindicationsView
Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
InteractionsView
Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
Pregnancy & lactationView
This is recommended in pregnancy and lactation.
Overdose effectsView
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
StorageView
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Pep Sweet
Aspartame
Pep Sweet
Aspartame
Indications
Sugar substitute
Indication detailsView
Used as a diet supplement and sugar substitute.
Therapeutic classView
Oral nutritional preparations
PharmacologyView
Aspartame is a low-calorie sweetener used to sweeten a wide variety of low- and reduced-calorie foods and beverages, including low-calorie tabletop sweeteners. Aspartame is composed of two amino acids, aspartic acid and phenylalanine, as the methyl ester. Aspartic acid and phenylalanine are also found naturally in protein containing foods, including meats, grains and dairy products. Methyl esters are also found naturally in many foods such as fruits and vegetable and their juices. Upon digestion, aspartame breaks down into three components (aspartic acid, phenylalanine and methanol), which are then absorbed into the blood and used in normal body processes. Neither aspartame nor its components accumulates in the body. These components are used in the body in the same ways as when they are derived from common foods.
Aspartame is 180 to 200 times sweeter than sucrose, it is metabolized as a protein and its subsequent amino-acids used up in there respective mechanisms.
Aspartame is 180 to 200 times sweeter than sucrose, it is metabolized as a protein and its subsequent amino-acids used up in there respective mechanisms.
DosageView
According to individual taste. 1 pellet is equivalent in sweetness to 1 tsf of sugar.
Side effectsView
Constipation; faecal impaction; haemorrhoids; abdominal discomfort or pain; heartburn; flatulence; nausea; vomiting; diarrhoea; increased bleeding tendency (chronic use); osteoporosis; steatorrhoea (high doses); skin rashes; pruritus of the tongue, skin and perianal region; hyperchloraemic acidosis.
ContraindicationsView
Complete biliary obstruction, hypersensitivity.
PrecautionsView
If pregnant or breast-feeding, seek advice of a health professional before use.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pep-2
Zinc Sulfate Monohydrate
Pep-2
Zinc Sulfate Monohydrate
Indications
Zinc deficiency
Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
- Place the tablet in a teaspoon
- Add adequate amount of water
- Let the tablet dissolve completely
- Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Pep-20
Zinc Sulfate Monohydrate
Pep-20
Zinc Sulfate Monohydrate
Indications
Zinc deficiency
Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
- Place the tablet in a teaspoon
- Add adequate amount of water
- Let the tablet dissolve completely
- Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Pep-20
Zinc Sulfate Monohydrate
Pep-20
Zinc Sulfate Monohydrate
Indications
Zinc deficiency
Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
- Place the tablet in a teaspoon
- Add adequate amount of water
- Let the tablet dissolve completely
- Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Pepcon Plus
Magaldrate + Simethicone
Pepcon Plus
Magaldrate + Simethicone
Indications
Peptic ulcer disease
Indication detailsView
This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.
Therapeutic classView
Antacids, Anti-dyspeptic/Carminatives
PharmacologyView
This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.
DosageView
Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.
Side effectsView
Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
ContraindicationsView
Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.
PrecautionsView
Care should be taken in decreased kidney function, hypophosphataemia and weak people.
InteractionsView
It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.
Pregnancy & lactationView
Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.
Overdose effectsView
Over dosage with this formulation is a rare case.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Pepcon Plus
Magaldrate + Simethicone
Pepcon Plus
Magaldrate + Simethicone
Indications
Peptic ulcer disease
Indication detailsView
This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.
Therapeutic classView
Antacids, Anti-dyspeptic/Carminatives
PharmacologyView
This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.
DosageView
Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.
Side effectsView
Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
ContraindicationsView
Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.
PrecautionsView
Care should be taken in decreased kidney function, hypophosphataemia and weak people.
InteractionsView
It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.
Pregnancy & lactationView
Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.
Overdose effectsView
Over dosage with this formulation is a rare case.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peplo
Omeprazole
Peplo
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Peplo
Omeprazole
Peplo
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Pepnor
Jeerakaddarishta Carminative
Pepnor
Jeerakaddarishta Carminative
Indications
Severe diarrhea
Indication detailsView
This syrup is indicated in dyspepsia or indigestion, abdominal colic, nausea and anorexia. It is also effective in diarrhea, false labor pain due to gas, GI problem after delivery and provide nutritional supplement to the lactating mothers. It also helps to treat reactive arthritis due to diarrhea or dysentery
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Cuminum cyminum: Cumin contains volatile oil chiefly fatty-oil (10-15%), fatty acid,petroselic acid and palmitic acid. Cuminin and flavones are chief constituents. Fatty oil of Cumin has an antimicrobial effect.It stunts mycelium growth and toxin production.Volatile oil relaxes the gut as a whole and reduces the intestinal gas,bloating and flatulence.It is indicated in dyspepsia and diarrhea.
Cinnamomum zeylanicum: It is cordial,stimulant and tonic.In flatulence and spasmodic affections of the alimentary canal,it is proved as efficient carminative and antispasmodic.
Elettaria cardamomum: Ela has carminative and stimulant properties. It is used either as adjuvant or corrective of cordial,tonic and purgative medicines.
Cinnamomum tamala: It is a mild astringent and flavoring agent. Its oil is a powerful germicide.
Mesua ferrea: Flower contains essential oil, two bitter substances with bitter principle mesuol 1%. Antibiotic activity of mesuol has been found. It has astringent, carminative and expectorant properties. It is also useful for burning anus,blood dysentery and bleeding piles.
Zingiber officinale: In ancient Ayurvedic texts it is regarded very high for its beneficial effects for respiratory and digestive properties. It is used for multiple purposes like; constipation, indigestion, dyspepsia, arthritis & stiffness of joints. Ginger helps to combat gas either preventing the formation of gas in the stomach and intestines or helping with the expulsion of gas that has already built up.
Myristica fragrans: Jatipal contains acetic acid, fragransin, eugenol and myristicine. In Gl system, it is indicated in Diarrhea. It acts as tonic, digestive and also effective in Entamoeba histolytica and Ecoli.
Cyperus rotundus: In modern ayurvedic medicine it is used for treating fever, digestive system disorder, dysmenorrhea and other maladies. Several pharmacologically active substances have been identified in Cyperus rotundus e.g a-cyperone, (3-selinene, cyperene, cyperotundone, sugeonol, kobusone, and isokobusone which are scientifically proved for treating nausea, fever and inflammation.
Trachyspermum ammi: A preliminary pharmacological study of the oil indicates that it has a parasympathomimetic effect and produced contraction of the isolated ileum. It increases the secretion of pancreatic and intestinal enzymes like lipase, trypsin and amylase which helps to digest carbohydrate, protein and fat. It also increases the secretion of bile from the hepatocyte which plays an important role in fat digestion and absorption.
Syzygium aromaticum: Cloves are used in Ayurveda called "Lavang". In India, Chinese medicine, western herbal medicine and dentistry essential oil of this plant is used as an anodyne (painkiller).
Cloves are used as a carminative to increase hydrochloric acid in the stomach and to improve peristalsis.
Cinnamomum zeylanicum: It is cordial,stimulant and tonic.In flatulence and spasmodic affections of the alimentary canal,it is proved as efficient carminative and antispasmodic.
Elettaria cardamomum: Ela has carminative and stimulant properties. It is used either as adjuvant or corrective of cordial,tonic and purgative medicines.
Cinnamomum tamala: It is a mild astringent and flavoring agent. Its oil is a powerful germicide.
Mesua ferrea: Flower contains essential oil, two bitter substances with bitter principle mesuol 1%. Antibiotic activity of mesuol has been found. It has astringent, carminative and expectorant properties. It is also useful for burning anus,blood dysentery and bleeding piles.
Zingiber officinale: In ancient Ayurvedic texts it is regarded very high for its beneficial effects for respiratory and digestive properties. It is used for multiple purposes like; constipation, indigestion, dyspepsia, arthritis & stiffness of joints. Ginger helps to combat gas either preventing the formation of gas in the stomach and intestines or helping with the expulsion of gas that has already built up.
Myristica fragrans: Jatipal contains acetic acid, fragransin, eugenol and myristicine. In Gl system, it is indicated in Diarrhea. It acts as tonic, digestive and also effective in Entamoeba histolytica and Ecoli.
Cyperus rotundus: In modern ayurvedic medicine it is used for treating fever, digestive system disorder, dysmenorrhea and other maladies. Several pharmacologically active substances have been identified in Cyperus rotundus e.g a-cyperone, (3-selinene, cyperene, cyperotundone, sugeonol, kobusone, and isokobusone which are scientifically proved for treating nausea, fever and inflammation.
Trachyspermum ammi: A preliminary pharmacological study of the oil indicates that it has a parasympathomimetic effect and produced contraction of the isolated ileum. It increases the secretion of pancreatic and intestinal enzymes like lipase, trypsin and amylase which helps to digest carbohydrate, protein and fat. It also increases the secretion of bile from the hepatocyte which plays an important role in fat digestion and absorption.
Syzygium aromaticum: Cloves are used in Ayurveda called "Lavang". In India, Chinese medicine, western herbal medicine and dentistry essential oil of this plant is used as an anodyne (painkiller).
Cloves are used as a carminative to increase hydrochloric acid in the stomach and to improve peristalsis.
DosageView
Children under 12 years: 1-2 teaspoonfuls (5-10 ml) two to three times daily.
Adult: 2-3 teaspoonfuls (10-15 ml) three times daily.
Adult: 2-3 teaspoonfuls (10-15 ml) three times daily.
Side effectsView
There is no known significant side effect
ContraindicationsView
There is no evidence available on contraindication but it may happen in patients who are hypersensitive to any of its ingredients. Ginger is contraindicated in people suffering from gallstones as it promotes the production of bile. So Jeerakaddarishta Carminative should be taken carefully in obstructive jaundice due to Cholelithiasis.
InteractionsView
Anticoagulant drugs like warfarin, aspirin
Pregnancy & lactationView
No adverse effect of Jeerakaddarishta Carminative syrup has been reported.
StorageView
Store at cool and dry place away from direct sunlight. Keep the medicine out of the reach of children
Peptacid
Aluminium Hydroxide + Magnesium Hydroxide + Simethicone
Peptacid
Aluminium Hydroxide + Magnesium Hydroxide + Simethicone
Indications
Upper Gl bloating
Indication detailsView
This is indicated for symptomatic relief of hyperacidity associated with the peptic ulcer, gastritis, peptic oesophagitis, gastric hyperacidity, heartburn, sour stomach or hiatus hernia. It is effective in the prevention of stress ulceration and GI bleeding. It acts as an antiflatulent to alleviate the symptoms of gas including post operative gas pain. This rapidly relieves acid pain, disperses gastric foam and facilitates eructation of gas and air.
Therapeutic classView
Antacids
PharmacologyView
This is the mixture of non-systemic acid neutralizing substances and antiflatulent. This preparation offers reliability as well as long action. Aluminium Hydroxide and Magnesium Hydroxide induce the relief of ulcer by neutralizing gastric acid secreted from parietal cells of the stomach. The clinical use of simethicone is based on its antifoam properties. Simethicone spreads on the surface of aqueous liquids, forming a film of low surface tension and causing collapse of foam bubbles. Simethicone repeatedly allows mucous surrounded gas bubbles in the GI tract to coalesce and be expelled.
This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.
Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.
This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.
Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.
DosageView
Tablet: 1-2 tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.
Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.
Side effectsView
Gastrointestinal side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
ContraindicationsView
This should not be administered in patients with renal failure or hypophosphataemia or in those who are severely debilitated. It is also contraindicated in alkalosis and hypermagnesaemia, where abdominal distention may be due to partial or complete intestinal obstruction.
PrecautionsView
This should be used with caution in patients with kidney disease.
InteractionsView
All antacids may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs. Antacids decrease the bioavailability of theophyline, tetracycline, quinolone antibiotics, isoniazide, ketoconazole, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacine, nitrofurantoin, fluoride, phosphate, propanolol, atenolol, digoxins, vitamins etc. Antacids increase the bioavailability of some drugs; e.g. sulphonamides, levodopa, valproic acid, enteric coated aspirin etc.
Pregnancy & lactationView
It is advised to avoid antacid preparations in the first trimester of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptacid
Aluminium Hydroxide + Magnesium Hydroxide + Simethicone
Peptacid
Aluminium Hydroxide + Magnesium Hydroxide + Simethicone
Indications
Upper Gl bloating
Indication detailsView
This is indicated for symptomatic relief of hyperacidity associated with the peptic ulcer, gastritis, peptic oesophagitis, gastric hyperacidity, heartburn, sour stomach or hiatus hernia. It is effective in the prevention of stress ulceration and GI bleeding. It acts as an antiflatulent to alleviate the symptoms of gas including post operative gas pain. This rapidly relieves acid pain, disperses gastric foam and facilitates eructation of gas and air.
Therapeutic classView
Antacids
PharmacologyView
This is the mixture of non-systemic acid neutralizing substances and antiflatulent. This preparation offers reliability as well as long action. Aluminium Hydroxide and Magnesium Hydroxide induce the relief of ulcer by neutralizing gastric acid secreted from parietal cells of the stomach. The clinical use of simethicone is based on its antifoam properties. Simethicone spreads on the surface of aqueous liquids, forming a film of low surface tension and causing collapse of foam bubbles. Simethicone repeatedly allows mucous surrounded gas bubbles in the GI tract to coalesce and be expelled.
This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.
Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.
This is used in the treatment of flatulence and meteorism for the elimination of gas, air or foam from the gastro-intestinal tract prior to radiography and for the relief of abdominal distension and dyspepsia.
Simethicone is physiologically inert; it does not appeared to be absorbed from the GI tract to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in the feces.
DosageView
Tablet: 1-2 tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.
Suspension: 1-2 teaspoonful 1-3 hours after meal and at bedtime or as directed by the physician.
Side effectsView
Gastrointestinal side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
ContraindicationsView
This should not be administered in patients with renal failure or hypophosphataemia or in those who are severely debilitated. It is also contraindicated in alkalosis and hypermagnesaemia, where abdominal distention may be due to partial or complete intestinal obstruction.
PrecautionsView
This should be used with caution in patients with kidney disease.
InteractionsView
All antacids may increase or decrease the rate and/or extent of absorption of concomitantly administered oral drugs. Antacids decrease the bioavailability of theophyline, tetracycline, quinolone antibiotics, isoniazide, ketoconazole, ethambutol, some antimuscarinic drugs, benzodiazepines, phenothiazines, ranitidine, indomethacine, nitrofurantoin, fluoride, phosphate, propanolol, atenolol, digoxins, vitamins etc. Antacids increase the bioavailability of some drugs; e.g. sulphonamides, levodopa, valproic acid, enteric coated aspirin etc.
Pregnancy & lactationView
It is advised to avoid antacid preparations in the first trimester of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptex
Esomeprazole
Peptex
Esomeprazole
Indication detailsView
Esomeprazole is indicated:
- To relieve from chronic heartburn symptoms and other symptoms associated with GERD
- For the healing of erosive esophagitis
- For maintenance of healing of erosive esophagitis
- In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
- Zollinger-Ellison Syndrome
- Acid related Dyspepsia
- Duodenal & Gastric ulcer
PharmacologyView
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.
Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.
Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.
Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.
Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.
Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.
Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
DosageView
Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive
Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).
Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.
Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.
AdministrationView
Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
Side effectsView
The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
ContraindicationsView
Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.
PrecautionsView
General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.
Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
InteractionsView
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.
Pediatric usageView
Paediatric Use: Safety and effectiveness in paediatric patients have not been established.
Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out
Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.
Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out
Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.
Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
Overdose effectsView
A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.
ReconstitutionView
Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Peptex
Esomeprazole
Peptex
Esomeprazole
Indication detailsView
Esomeprazole is indicated:
- To relieve from chronic heartburn symptoms and other symptoms associated with GERD
- For the healing of erosive esophagitis
- For maintenance of healing of erosive esophagitis
- In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
- Zollinger-Ellison Syndrome
- Acid related Dyspepsia
- Duodenal & Gastric ulcer
PharmacologyView
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.
Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.
Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.
Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.
Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.
Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.
Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.
Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.
DosageView
Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive
Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).
Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.
Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.
AdministrationView
Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.
Side effectsView
The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
ContraindicationsView
Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.
PrecautionsView
General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.
Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.
InteractionsView
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.
Pediatric usageView
Paediatric Use: Safety and effectiveness in paediatric patients have not been established.
Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out
Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.
Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out
Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.
Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.
Overdose effectsView
A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.
ReconstitutionView
Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Peptid
Famotidine
Peptid
Famotidine
Indication detailsView
Famotidine is indicated in-
- Gastric ulcer
- Duodenal ulcer
- Anastomotic ulcer
- Acute stress ulcer
- Reflux esophagitis and
- Zollinger-Ellison syndrome.
PharmacologyView
Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.
DosageView
Tablet:
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
- For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
- For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
- <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
- Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
- Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
- Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks
- Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
- Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Maintenance therapy: 40 mg at daily night.
- Reflux esophagitis: 2 mg/kg/day
- Zollinger-Ellison Syndrome: 40 mg 3 times daily.
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
Side effectsView
Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
ContraindicationsView
Known hypersensitivity to any component of the drug.
PrecautionsView
The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.
InteractionsView
No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptid
Famotidine
Peptid
Famotidine
Indication detailsView
Famotidine is indicated in-
- Gastric ulcer
- Duodenal ulcer
- Anastomotic ulcer
- Acute stress ulcer
- Reflux esophagitis and
- Zollinger-Ellison syndrome.
PharmacologyView
Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.
DosageView
Tablet:
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
- For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
- For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
- <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
- Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
- Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
- Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks
- Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
- Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Maintenance therapy: 40 mg at daily night.
- Reflux esophagitis: 2 mg/kg/day
- Zollinger-Ellison Syndrome: 40 mg 3 times daily.
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
Side effectsView
Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
ContraindicationsView
Known hypersensitivity to any component of the drug.
PrecautionsView
The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.
InteractionsView
No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptid
Famotidine
Peptid
Famotidine
Indication detailsView
Famotidine is indicated in-
- Gastric ulcer
- Duodenal ulcer
- Anastomotic ulcer
- Acute stress ulcer
- Reflux esophagitis and
- Zollinger-Ellison syndrome.
PharmacologyView
Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.
DosageView
Tablet:
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
- For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
- For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
- <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
- Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
- Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
- Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks
- Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
- Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Maintenance therapy: 40 mg at daily night.
- Reflux esophagitis: 2 mg/kg/day
- Zollinger-Ellison Syndrome: 40 mg 3 times daily.
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
Side effectsView
Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
ContraindicationsView
Known hypersensitivity to any component of the drug.
PrecautionsView
The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.
InteractionsView
No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptid
Famotidine
Peptid
Famotidine
Indication detailsView
Famotidine is indicated in-
- Gastric ulcer
- Duodenal ulcer
- Anastomotic ulcer
- Acute stress ulcer
- Reflux esophagitis and
- Zollinger-Ellison syndrome.
PharmacologyView
Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.
DosageView
Tablet:
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
- For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
- For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.
Powder for Suspension: Gastroesophageal Reflux Disease(GERD):
- <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
- Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
- Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
- Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks
- Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
- Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
- Maintenance therapy: 40 mg at daily night.
- Reflux esophagitis: 2 mg/kg/day
- Zollinger-Ellison Syndrome: 40 mg 3 times daily.
Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.
Side effectsView
Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
ContraindicationsView
Known hypersensitivity to any component of the drug.
PrecautionsView
The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.
InteractionsView
No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Peptil H
Ranitidine Hydrochloride
Peptil H
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.