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Peptil H

Ranitidine Hydrochloride

Syrup 75 mg/5 ml Allopathic H2 receptor antagonist

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.

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.

StorageView

Store in a cool and dry place. protect from light.

Peptil H

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

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.

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.

StorageView

Store in a cool and dry place. protect from light.

Peptin

Zinc Sulfate Monohydrate

Syrup 4.05 mg/5 ml Allopathic Specific mineral preparations

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.

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.

Peptin-DS

Zinc Sulfate Monohydrate

Syrup 10 mg/5 ml Allopathic Specific mineral preparations

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.

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.

Pepto

Bismuth Subsalicylate

Oral Suspension 87.5 mg/5 ml Allopathic

Indication detailsView

Bismuth Subsalicylate is indicated for-

upset stomach
indigestion
heartburn
nausea and
diarrhea.

PharmacologyView

Antacid action: Bismuth Subsalicylate coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, produces bismuth oxychloride and salicylic acid thus reduces HCl.

Anti-diarrheal action: It stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli, disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.

Anti-inflammatory action: When hydrolyzed to salicylic acid, it inhibits prostaglandin G/H synthase ½. Thus reduces inflammation and Coats the irritated tissue to retard the expulsion of fluid.

DosageView

Adult (>16): 30 ml in dosing cup provided or 6x5 ml spoonful
Children (10-14 years): 15 mL (3 teaspoons)
Children (5-9 years): 7.5 mL (1.5 teaspoons)
Children (3-4 years): 5 mL (1 teaspoon)
Children under 3 years: Ask a doctor.
Use in the elderly: No special precaution is needed.
Patient is suffering from renal insufficiency: caution should be taken.

Repeat dose every ½ to 1 hour if needed. Not more than 8 doses to be taken in 24 hours.

Side effectsView

Black stool and black tongue is common with use of Bismuth Subsalicylate. Bismuth Subsalicylate should not be used if symptoms are severe or persist for more than 2 days. Do not exceed the recommended dose, shake the bottle before use. For oral use only.

ContraindicationsView

Bismuth Subsalicylate should not be used by patients hypersensitive to Aspirin or other salicylates or any ingredient in this formulation. Keep all medicines out of reach and sight of children.

PrecautionsView

Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation (thinning of the blood), diabetes or gout.

InteractionsView

Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.

Pregnancy & lactationView

There are no adequate data concerning the use of Bismuth Subsalicylate in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Bismuth Subsalicylate should not be used during lactation unless clearly necessary.

Overdose effectsView

Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate should be discontinued. Management of overdose is the same as that for salicylate overdose.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Pepto-Care

Bismuth Subsalicylate

Oral Suspension 87.5 mg/5 ml Allopathic

Indication detailsView

Bismuth Subsalicylate is indicated for-

upset stomach
indigestion
heartburn
nausea and
diarrhea.

PharmacologyView

Antacid action: Bismuth Subsalicylate coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, produces bismuth oxychloride and salicylic acid thus reduces HCl.

Anti-diarrheal action: It stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli, disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.

Anti-inflammatory action: When hydrolyzed to salicylic acid, it inhibits prostaglandin G/H synthase ½. Thus reduces inflammation and Coats the irritated tissue to retard the expulsion of fluid.

DosageView

Adult (>16): 30 ml in dosing cup provided or 6x5 ml spoonful
Children (10-14 years): 15 mL (3 teaspoons)
Children (5-9 years): 7.5 mL (1.5 teaspoons)
Children (3-4 years): 5 mL (1 teaspoon)
Children under 3 years: Ask a doctor.
Use in the elderly: No special precaution is needed.
Patient is suffering from renal insufficiency: caution should be taken.

Repeat dose every ½ to 1 hour if needed. Not more than 8 doses to be taken in 24 hours.

Side effectsView

Black stool and black tongue is common with use of Bismuth Subsalicylate. Bismuth Subsalicylate should not be used if symptoms are severe or persist for more than 2 days. Do not exceed the recommended dose, shake the bottle before use. For oral use only.

ContraindicationsView

Bismuth Subsalicylate should not be used by patients hypersensitive to Aspirin or other salicylates or any ingredient in this formulation. Keep all medicines out of reach and sight of children.

PrecautionsView

Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation (thinning of the blood), diabetes or gout.

InteractionsView

Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.

Pregnancy & lactationView

There are no adequate data concerning the use of Bismuth Subsalicylate in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Bismuth Subsalicylate should not be used during lactation unless clearly necessary.

Overdose effectsView

Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate should be discontinued. Management of overdose is the same as that for salicylate overdose.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Peptocid

Bismuth Subsalicylate

Oral Suspension 87.5 mg/5 ml Allopathic

Indication detailsView

Bismuth Subsalicylate is indicated for-

upset stomach
indigestion
heartburn
nausea and
diarrhea.

PharmacologyView

Antacid action: Bismuth Subsalicylate coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, produces bismuth oxychloride and salicylic acid thus reduces HCl.

Anti-diarrheal action: It stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli, disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.

Anti-inflammatory action: When hydrolyzed to salicylic acid, it inhibits prostaglandin G/H synthase ½. Thus reduces inflammation and Coats the irritated tissue to retard the expulsion of fluid.

DosageView

Adult (>16): 30 ml in dosing cup provided or 6x5 ml spoonful
Children (10-14 years): 15 mL (3 teaspoons)
Children (5-9 years): 7.5 mL (1.5 teaspoons)
Children (3-4 years): 5 mL (1 teaspoon)
Children under 3 years: Ask a doctor.
Use in the elderly: No special precaution is needed.
Patient is suffering from renal insufficiency: caution should be taken.

Repeat dose every ½ to 1 hour if needed. Not more than 8 doses to be taken in 24 hours.

Side effectsView

Black stool and black tongue is common with use of Bismuth Subsalicylate. Bismuth Subsalicylate should not be used if symptoms are severe or persist for more than 2 days. Do not exceed the recommended dose, shake the bottle before use. For oral use only.

ContraindicationsView

Bismuth Subsalicylate should not be used by patients hypersensitive to Aspirin or other salicylates or any ingredient in this formulation. Keep all medicines out of reach and sight of children.

PrecautionsView

Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation (thinning of the blood), diabetes or gout.

InteractionsView

Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.

Pregnancy & lactationView

There are no adequate data concerning the use of Bismuth Subsalicylate in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Bismuth Subsalicylate should not be used during lactation unless clearly necessary.

Overdose effectsView

Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate should be discontinued. Management of overdose is the same as that for salicylate overdose.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Peptofit

Bismuth Subsalicylate

Oral Suspension 87.5 mg/5 ml Allopathic

Indication detailsView

Bismuth Subsalicylate is indicated for-

upset stomach
indigestion
heartburn
nausea and
diarrhea.

PharmacologyView

Antacid action: Bismuth Subsalicylate coats ulcer surface, protecting it from acid and pepsin. It stimulates mucus and bicarbonate secretion and also reacts with HCl, produces bismuth oxychloride and salicylic acid thus reduces HCl.

Anti-diarrheal action: It stimulates absorption of water and electrolytes across the intestinal wall. In infectious diarrhea it binds with toxin produced by E.coli, disrupts cell, causing lysis of H.pylori and prevents adhesion of H.pylori in the cell wall of intestine.

Anti-inflammatory action: When hydrolyzed to salicylic acid, it inhibits prostaglandin G/H synthase ½. Thus reduces inflammation and Coats the irritated tissue to retard the expulsion of fluid.

DosageView

Adult (>16): 30 ml in dosing cup provided or 6x5 ml spoonful
Children (10-14 years): 15 mL (3 teaspoons)
Children (5-9 years): 7.5 mL (1.5 teaspoons)
Children (3-4 years): 5 mL (1 teaspoon)
Children under 3 years: Ask a doctor.
Use in the elderly: No special precaution is needed.
Patient is suffering from renal insufficiency: caution should be taken.

Repeat dose every ½ to 1 hour if needed. Not more than 8 doses to be taken in 24 hours.

Side effectsView

Black stool and black tongue is common with use of Bismuth Subsalicylate. Bismuth Subsalicylate should not be used if symptoms are severe or persist for more than 2 days. Do not exceed the recommended dose, shake the bottle before use. For oral use only.

ContraindicationsView

Bismuth Subsalicylate should not be used by patients hypersensitive to Aspirin or other salicylates or any ingredient in this formulation. Keep all medicines out of reach and sight of children.

PrecautionsView

Do not take with aspirin or other salicylates. Caution should be exercised by patients taking medicines for anti-coagulation (thinning of the blood), diabetes or gout.

InteractionsView

Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.

Pregnancy & lactationView

There are no adequate data concerning the use of Bismuth Subsalicylate in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Bismuth Subsalicylate should not be used during lactation unless clearly necessary.

Overdose effectsView

Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate should be discontinued. Management of overdose is the same as that for salicylate overdose.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Peptonil-R

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

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.

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.

StorageView

Store in a cool and dry place. protect from light.

Peptral

Omeprazole

Capsule (Delayed Release) 40 mg Allopathic Proton Pump Inhibitor

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-

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.

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.

Peptral

Omeprazole

Capsule (Delayed Release) 20 mg Allopathic Proton Pump Inhibitor

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-

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.

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.

Pepzol

Esomeprazole

Capsule (Delayed Release) 20 mg Allopathic

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 (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases 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.

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.

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.

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.

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.

Pepzol

Esomeprazole

Capsule (Delayed Release) 40 mg Allopathic

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 (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases 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.

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.

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.

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.

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.

Peranel

Perampanel

Tablet 4 mg Allopathic Adjunct anti-epileptic drugs

Indications

Partial seizures

Indication detailsView

Perampanel an anti-epileptic drug is indicated for:

Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy from 4 years of age and older.
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy from 12 years of age and older.

Therapeutic classView

Adjunct anti-epileptic drugs

PharmacologyView

Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which Perampanel exerts its antiepileptic effects in humans is unknown.

DosageView

Perampanel can be taken without regard to food. The dosage of Perampanel is as follows-

Starting dose: 2 mg once daily at bedtime. May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals.
Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime.
Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime.

Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime.

Severe Hepatic Impairment: Not recommended.

Severe Renal Impairment: Not recommended.

Elderly: Increase dose no more frequently than every 2 weeks.

Side effectsView

Perampanel may cause Serious Psychiatric and Behavioral Reactions, Suicidal Behavior and Ideation, Dizziness, Somnolence, Fatigue, Irritability, Falls, Nausea, Ataxia, Balance Disorder etc.

ContraindicationsView

None.

PrecautionsView

Suicidal Behavior and Ideation: Monitor for suicidal thoughts or Behaviour.
Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence and fatigue.
Falls: Monitor for falls and injuries.
Drug Reaction with Eosinophilia and Systemic Symptoms/Multi-organ Hypersensitivity: Discontinue if no alternate etiology.
Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency.

InteractionsView

Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel.
Moderate and Strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin): increase the clearance of Perampanel and decrease Perampanel plasma concentrations.

Pregnancy & lactationView

Based on animal data, may cause fetal harm. There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.

StorageView

Protect from light and moisture, store below 30°C. Keep out of the reach of children.

Peranel

Perampanel

Tablet 2 mg Allopathic Adjunct anti-epileptic drugs

Indications

Partial seizures

Indication detailsView

Perampanel an anti-epileptic drug is indicated for:

Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy from 4 years of age and older.
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy from 12 years of age and older.

Therapeutic classView

Adjunct anti-epileptic drugs

PharmacologyView

Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which Perampanel exerts its antiepileptic effects in humans is unknown.

DosageView

Perampanel can be taken without regard to food. The dosage of Perampanel is as follows-

Starting dose: 2 mg once daily at bedtime. May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals.
Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime.
Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime.

Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime.

Severe Hepatic Impairment: Not recommended.

Severe Renal Impairment: Not recommended.

Elderly: Increase dose no more frequently than every 2 weeks.

Side effectsView

Perampanel may cause Serious Psychiatric and Behavioral Reactions, Suicidal Behavior and Ideation, Dizziness, Somnolence, Fatigue, Irritability, Falls, Nausea, Ataxia, Balance Disorder etc.

ContraindicationsView

None.

PrecautionsView

Suicidal Behavior and Ideation: Monitor for suicidal thoughts or Behaviour.
Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence and fatigue.
Falls: Monitor for falls and injuries.
Drug Reaction with Eosinophilia and Systemic Symptoms/Multi-organ Hypersensitivity: Discontinue if no alternate etiology.
Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency.

InteractionsView

Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel.
Moderate and Strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin): increase the clearance of Perampanel and decrease Perampanel plasma concentrations.

Pregnancy & lactationView

Based on animal data, may cause fetal harm. There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.

StorageView

Protect from light and moisture, store below 30°C. Keep out of the reach of children.

Perclear

Permethrin

Cream 5% w/w Allopathic Parasiticidal preparations

Indications

Scabies

Indication detailsView

Permethrin cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.

Therapeutic classView

Parasiticidal preparations

PharmacologyView

Permethrin cream contains Permethrin, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.

Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.

DosageView

Recommended duration of Treatment:

Adults and children over 12 years: a full tube
Children aged 6-12 years: up to 1⁄2 of a tube
Children aged 1-5 years: up to ¼ of a tube
Children aged 2 months to 1 year: up to ⅛ of a tube
Children Less then 2 month: dose is not established

AdministrationView

Before application of Permethrin cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying.

For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.

For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.

Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.

Side effectsView

In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.

ContraindicationsView

Permethrin is contraindicated in patients with known hypersensitivity to any component of pyrethroids or permethrin. Nursing staff who routinely apply permethrin may wear globes to avoid any possible irritation to the hands.

PrecautionsView

Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with permethrin may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.

InteractionsView

The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.

Pregnancy & lactationView

In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether permethrin is excreted in human milk so it should not be used in nursing mothers.

StorageView

Store in a cool, dry place, away from light & keep out of the reach of children...

Perex

Betacarotene + Vitamin C + Vitamin E

Tablet 6 mg+200 mg+50 mg Allopathic Anti-oxidant Multivitamin preparations

Indications

Vitamin deficiency

Indication detailsView

Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:

β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.

Therapeutic classView

Anti-oxidant Multivitamin preparations

PharmacologyView

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

DosageView

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

Side effectsView

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

ContraindicationsView

Carocet is contraindicated in patients with hypersensitivity to any of its components.

PrecautionsView

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

InteractionsView

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

Pregnancy & lactationView

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

StorageView

Should be stored in a dry place below 30˚C.

Perfex

Fexofenadine Hydrochloride

Tablet 60 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

DosageView

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Side effectsView

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

PrecautionsView

Caution should be exercised in elderly patient and patient with decreased renal function.

InteractionsView

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

Pregnancy & lactationView

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Overdose effectsView

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Perfex

Fexofenadine Hydrochloride

Tablet 180 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

DosageView

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Side effectsView

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

PrecautionsView

Caution should be exercised in elderly patient and patient with decreased renal function.

InteractionsView

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

Pregnancy & lactationView

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Overdose effectsView

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Perfex

Fexofenadine Hydrochloride

Tablet 120 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

DosageView

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Side effectsView

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

PrecautionsView

Caution should be exercised in elderly patient and patient with decreased renal function.

InteractionsView

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

Pregnancy & lactationView

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Overdose effectsView

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.