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Apulset

Ondansetron

Oral Solution 4 mg/5 ml Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Apulset

Ondansetron

Tablet 8 mg Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Apulset

Ondansetron

IM/IV Injection 8 mg/4 ml Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Aqua

Carboxymethylcellulose Sodium + Hypromellose

Ophthalmic Gel 0.25%+0.3% Allopathic Drugs for Dry eyes

Indications

Dry eye

Indication detailsView

This medication is used to relieve the dryness and pain associated with reduced or abnormal tear production.

Therapeutic classView

Drugs for Dry eyes

PharmacologyView

Carboxymethylcellulose Sodium & Hypromellose both of them are polymer in nature. It is a clear and colorless aqueous solution. This medication lubricates the surface of the eye in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production.

DosageView

For Adults and Children: Instill 1 or 2 drops in the affected eye(s) as needed.

Side effectsView

Common side effects are blurred vision, matting or stickiness of eyelashes.

ContraindicationsView

Known sensitivity or allergy to any ingredient of the formulation.

PrecautionsView

If you experience eye pain, changes in vision, continued redness or irritation of the eye or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Pregnancy & lactationView

Carboxymethylcellulose Sodium & Hypromellose have not been shown to cause birth defects or other problems during pregnancy and breastfeeding.

Pediatric usageView

This drug does not cause different side effects or problems in children than it does in adults.

StorageView

Store in a cool, dry place and protected from light, Keep out of the reach of children, Do not use more than 4 weeks after opening.

Aqua Care

Urea (10%)

Cream 10% w/w Allopathic Topical urea preparations

Indications

Psoriasis

Indication detailsView

Urea 10% cream is indicated for-

Ichthyosis and dry skin conditions
Management of eczemas
Management of psoriasis

Therapeutic classView

Topical urea preparations

PharmacologyView

Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.

DosageView

Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.

Use in children: Urea 10% cream can be used in all age groups.

Side effectsView

No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.

ContraindicationsView

This is contraindicated in any other ingredient of this preaparation.

PrecautionsView

In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.

InteractionsView

No hazardous drug interaction has been reported.

Pregnancy & lactationView

Urea cream can be used during pregnancy and lactation.

StorageView

Keep out of the reach of children. Do not freeze. Keep at cool and dry place.

Aquafresh

Carboxymethylcellulose Sodium

Ophthalmic Solution 1% Allopathic

Indication detailsView

It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

PharmacologyView

Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.

This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.

DosageView

Instill 1 drop in the affected eye(s) 4 times a day or as needed.

Side effectsView

Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.

ContraindicationsView

This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.

PrecautionsView

Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.

InteractionsView

Not known.

Pregnancy & lactationView

Safe use during pregnancy and lactation has not been established.

Pediatric usageView

Pediatric use: This eye drop should not be used in infants and small children under 3 years.

Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

StorageView

The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.

Aqualax

Polyethylene Glycol

Powder for Solution 85 gm Allopathic Osmotic purgatives

Indications

Osmotic laxative

Indication detailsView

Polyethylene Glycol is indicated in the treatment of constipation. This should be used for 2 weeks or less or as directed by physician. Polyethylene Glycol 3350 is a prescription only laxative that has been prescribed by physician to treat constipation. This product should only be used by the person for whom it is prescribed.

Therapeutic classView

Osmotic purgatives

PharmacologyView

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool. Polyethylene Glycol induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

DosageView

The usual dose of Polyethylene Glycol is 17 gm of powder per day (or as directed by physician) in a glass of water, juice, coke, coffee or tea. Each bottle of Polyethylene Glycol is supplied with a cup that is used to measure 17 gm or 8.5 gm of laxative powder when filled upto the marked line.

AdministrationView

It should always be taken by mouth. Measure the dose using the supplied cup, stir and dissolve in a glass of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.

Side effectsView

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

ContraindicationsView

Polyethylene glycol is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

PrecautionsView

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol therapy. Polyethylene Glycol should be administered after being dissolved in water, juice, coke, coffee or tea.

InteractionsView

No specific drug interactions have been demonstrated.

Pregnancy & lactationView

Pregnancy: It is not known whether Polyethylene glycol can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. Polyethylene glycol should only be administered to a pregnant woman if clearly needed.

Lactation: There is no information on the use of Polyethylene glycol while nursing. Consultation with a physician is necessary in case of breastfeeding.

Overdose effectsView

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

Duration of treatmentView

Polyethylene Glycol achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consultation with physician is needed. Polyethylene Glycol is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the Polyethylene Glycol therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).

Aquaphen

Pseudoephedrine + Guaiphenasine + Triprolidine

Syrup (30 mg+100 mg+1.25 mg)/5 ml Allopathic Combined cough expectorants

Indications

Sneezing

Indication detailsView

This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Therapeutic classView

Combined cough expectorants

PharmacologyView

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

DosageView

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

Side effectsView

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

ContraindicationsView

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

PrecautionsView

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

InteractionsView

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Pregnancy & lactationView

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

Overdose effectsView

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

StorageView

Store below 25° C. Protect from light. Do not refrigerate.

Aquatear

Povidone Iodine

Ophthalmic Solution 5% v/v Allopathic Iodine compounds (Anti-septic Preparations)

Indications

Secondarily infected dermatoses

Indication detailsView

Cream or ointment:
Therapeutically: As an adjunct to systemic therapy in the following indications-

Primary or secondary topical infections
Infected surgical incisions
Infected decubitus or stasis ulcers
Pyodermas
Secondarily infected dermatoses
Infected traumatic lesions

Prophylactically:

To prevent microbial contaminations in burns, incisions and other topical lesions
For degerming skin in hyperalimentation, the umbilical area or circumcision
Its use for abrasions, minor cuts, and wounds prevents the development of infections and permits wound healing.

Solution:

For the prevention and treatment of surface infections as well as to degerm the skin, mucous membrane and hyperalimentation procedures
For seborrhea
For preoperative and postoperative scrubbing and washing of hospital operating room and equipments
For preoperative prepping of operative site, including the vagina
For disinfection of wounds, burns, lacerations and abrasions
As a prophylactic anti-infective agent in house, hospital & office procedures
Postoperative application to incisions to help prevent infection
In oral moniliasis (thrush); bacterial and mycotic skin infections, decubitus & stasis ulcers
As a preoperative swab in the mouth & throat

Gargle & Mouthwash: It is a pleasantly flavoured solution which is used:

For the treatment of acute mucosal infections of the mouth and pharynx.
For oral hygiene prior to, during and after dental and oral surgery.

Surgical Scrub: It is a golden surfactant solution, forms rich, golden lather which is used: As an antiseptic skin cleanser for preoperative and postoperative scrubbing and washing by surgeons and operation theatre staff and preoperative preparation of patients' skin

Powder: It is used for topical application in the following indications: Superficial wounds, Minor cuts, Burns, Abrasions, Lacerations, In the treatment and prevention of infections.

Ophthalmic Solution: Povidone is used for the symptomatic treatment of dry eye conditions including keratoconjunctivitis sicca. It is also given as a substitute for tear fluid in case of the unstable tear film or insufficient moistening of the eye surface.

Therapeutic classView

Iodine compounds (Anti-septic Preparations)

PharmacologyView

Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.

DosageView

Cream or ointment:

For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.

Solution: Apply full strength as often as needed as paint, spray, or wet soak. Maybe bandaged (where necessary).

Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.

Surgical Scrub:

For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
For use in the Physician's Office: Use for washing whenever a germicidal soap is required.

Powder: Apply a light dusting of powder to the affected area. When dry, this forms a protective antiseptic layer over the area treated. Or use as advised by the Registered Physician. There are no special dosage recommendations for children or elderly patients.

Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.

Side effectsView

Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.

ContraindicationsView

It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.

PrecautionsView

Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.

Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.

Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.

Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.

InteractionsView

It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.

Pregnancy & lactationView

Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.

There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

StorageView

Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.

Aquavit

Multivitamin & Cod Liver Oil

Syrup Allopathic Specific combined vitamin preparations

Indications

Vitamin deficiency

Indication detailsView

Multivitamin syrup with cod-liver oil is indicated for growing children-

It helps in the development and proper functioning of their vital organs.
It helps to prevent vitamin deficiency and restore lost vitality after illness, in case of lack of appetite or tiredness of growing children.
It also increases immunity and helps to maintain healthy skin, hair, nail, teeth, bone, eye and nervous system.
Increases the resistance against cough, cold, chest and bronchial troubles.
Helps to optimize brain development.
In adults it helps to treat and prevent chronic diseases like heart diseases, rheumatoid arthritis, COPD, cancer etc.
In pregnant and nursing mother it helps in proper development of the baby.

Therapeutic classView

Specific combined vitamin preparations

PharmacologyView

This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.

DosageView

1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.

This syrup can be taken with water or milk.

Side effectsView

Generally well tolerated. However, a few allergic reactions may be seen.

ContraindicationsView

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PrecautionsView

This medicine may accumulate in the body. So, should not be taken in overdose.

InteractionsView

Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.

Pregnancy & lactationView

Should be taken on physician's advice.

StorageView

Keep in cool and dry place and away from light. Keep away from children

Aquisol

Chlorhexidine Gluconate + Isopropyl alcohol

Hand Rub 0.5%+70% Allopathic Chlorhexidine & Chloroxylenol preparations

Indications

Preoperative hand disinfection

Indication detailsView

For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures

Therapeutic classView

Chlorhexidine & Chloroxylenol preparations

PharmacologyView

Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.

DosageView

Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.

Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.

Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.

Side effectsView

Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare

ContraindicationsView

Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.

PrecautionsView

Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.

InteractionsView

Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.

Pregnancy & lactationView

No untoward effects are known

Overdose effectsView

Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.

Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.

StorageView

Do not store above 25° C.

Arafa

Ibuprofen

Tablet 400 mg Allopathic Drugs for Osteoarthritis

Indications

Yellow fever infection

Indication detailsView

Ibuprofen is indicated in the following indications-

Rheumatoid arthritis
Osteoarthritis
Gouty arthritis
Juvenile polyarthritis
Ankylosing spondylitis
Synovitis
Low back pain
Dysmenorrhoea
Fever
Migraine
Soft tissue injuries
Pain & Inflammation in dental and musculoskeletal origin.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

DosageView

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Side effectsView

Upset stomach, vomiting, heartburn, nausea may occur.

ContraindicationsView

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

PrecautionsView

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Pregnancy & lactationView

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

StorageView

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Arain

Tolfenamic acid

Tablet 200 mg Allopathic Other drugs for migraine

Indications

Pain

Indication detailsView

Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.

Therapeutic classView

Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine

PharmacologyView

Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.

Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.

DosageView

Adult:

Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
Mild to moderate pain: 100-200 mg tid
Renal impairment: Dose adjustments may be needed.
Severe renal impairment: Avoid.

Children: A pediatric dosage regimen has not yet been established.

Tolfenamic acid should be taken with food. Take water during or immediately after meals.

Side effectsView

Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.

ContraindicationsView

Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.

PrecautionsView

Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.

InteractionsView

The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics

Pregnancy & lactationView

This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.

Overdose effectsView

Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.

StorageView

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

Araten

Losartan Potassium

Tablet 50 mg Allopathic Angiotensin-ll receptor blocker

Indications

Stroke

Indication detailsView

Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).

Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.

Therapeutic classView

Angiotensin-ll receptor blocker

PharmacologyView

Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.

DosageView

The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.

Side effectsView

The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.

ContraindicationsView

Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.

PrecautionsView

Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.

InteractionsView

Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.

Pregnancy & lactationView

Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

StorageView

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

Araten Plus

Losartan Potassium + Hydrochlorothiazide

Tablet 50 mg+12.5 mg Allopathic Combined antihypertensive preparations

Indications

Stroke

Indication detailsView

This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.

Therapeutic classView

Combined antihypertensive preparations

PharmacologyView

Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT₁receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT₁receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.

DosageView

Hypertension-

The usual starting dose of 50/12.5 is one tablet once daily.
For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.

Severe Hypertension:

The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.

AdministrationView

This preparation may be administered with other antihypertensive agents. This may be administered with or without food.

Side effectsView

Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)

ContraindicationsView

The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

PrecautionsView

Hypersensitivity: Angiooedema
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
Impaired renal function and
Symptomatic hypotension

InteractionsView

Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.

Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.

Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs: additive effect or potentiation.

Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins

Pregnancy & lactationView

Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.

Pediatric usageView

Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.

Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.

Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.

Overdose effectsView

Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.

Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.

StorageView

Do not store above 30°C. Keep out of the reach of children.

Arbecin

Carbetocin

IV Injection 100 mcg/ml Allopathic Drugs acting on the Uterus

Indications

Uterine atony

Indication detailsView

Carbetocin is indicated for the prevention of uterine atony and postpartum haemorrhage (excessive bleeding) following delivery of the infant by elective caesarean section under epidural or spinal anaesthesia.

Therapeutic classView

Drugs acting on the Uterus

PharmacologyView

Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin; it causes contraction of the uterus. Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state, and increases during pregnancy, reaching a peak at the time of delivery.

DosageView

A single intravenous dose of 100 mcg of carbetocin injection is administered by bolus injection, slowly over 1 minute, only when infant delivery has been completed by caesarean section under epidural or spinal anaesthesia. carbetocin is to be used as a single dose only.

Side effectsView

10-40% of patients experienced nausea, vomiting, abdominal pain, itching skin, increased body temperature, trembling and weakness. Infrequent adverse events (1-5% of patients) included back pain, dizziness, metallic taste, anaemia, sweating, chest pain, dyspnoea, chills, tachycardia and anxiety.

ContraindicationsView

Because of its long duration of action relative to oxytocin, uterine contractions produced by carbetocin cannot be stopped by simply discontinuing the medication. Therefore, carbetocin should not be administered prior to delivery of the infant for any reason, including elective or medical induction of labour. Inappropriate use of carbetocin during pregnancy could theoretically mimic the symptoms of oxytocin overdosage, including hyperstimulation of the uterus with strong (hypertonic) or prolonged (tetanic) contractions, tumultuous labour, uterine rupture, cervical and vaginal lacerations, postpartum haemorrhage, utero-placental hypoperfusion and variable deceleration of foetal heart, foetal hypoxia, hypercapnia, or death. Carbetocin should not be used in patients with a history of hypersensitivity to oxytocin or carbetocin. Carbetocin should not be used in patients with cardio vascular disease, especially coronary artery disease, valvular heart disease, cardiomyopathy and heart failure. Carbetocin is not intended for use in children.

PrecautionsView

In patients who may not have an adequate uterine contraction after a single injection of carbetocin, more aggressive treatment with additional doses of oxytocin or ergometrine is warranted.
As carbetocin is closely related in structure to oxytocin, hyponatraemia may occur.
Carbetocin should be used cautiously in the presence of epilepsy, migraine, asthma or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system.
Patients with eclampsia and pre-eclampsia should be monitored for changes in blood pressure.
Carbetocin is not recommended for use in elderly patients.

InteractionsView

No specific drug interactions have been reported with carbetocin.

Pregnancy & lactationView

Use of carbetocin injection is contraindicated during pregnancy. Small amounts of carbetocin has been shown to cross over from plasma into the breast milk of nursing women. The small amount of carbetocin ingested by infant would not be expected to present a significant safety concern.

Overdose effectsView

Overdosage of carbetocin can be expected to produce enhanced pharmacological effects associated with uterine hyperactivity and pain. Treatment consists of symptomatic and supportive management.

StorageView

Store at 2-8°C. Do not freeze. Keep away from light. Once the ampoule has been opened, the product should be used immediately.

Arbitan

Irbesartan

Tablet 150 mg Allopathic Angiotensin-ll receptor blocker

Indications

Hypertension

Indication detailsView

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.

Therapeutic classView

Angiotensin-ll receptor blocker

PharmacologyView

Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.

DosageView

Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.

Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly

Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.

Side effectsView

Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.

ContraindicationsView

Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.

PrecautionsView

Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.

InteractionsView

Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.

Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.

Pregnancy & lactationView

Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.

Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.

Pediatric usageView

Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.

Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.

Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

Overdose effectsView

Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.

StorageView

Store in a cool and dry place, protected from light.

Arbitan

Irbesartan

Tablet 75 mg Allopathic Angiotensin-ll receptor blocker

Indications

Hypertension

Indication detailsView

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen.

Therapeutic classView

Angiotensin-ll receptor blocker

PharmacologyView

Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.

DosageView

Adult: The usual recommended initial and maintenance dose is Irbesartan 150 mg once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with Irbesartan 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with Irbesartan 150 mg once daily, the dose of Irbesartan can be increased to Irbesartan 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan. In hypertensive type 2 diabetic patients, therapy should be initiated at Irbesartan 150 mg once daily and titrated up to Irbesartan 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.

Elderly: although consideration should be given to initiating therapy with Irbesartan 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly

Paediatric: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.

Side effectsView

Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.

ContraindicationsView

Concomitant use with aliskiren in patients with diabetes and renal impairment (GFR <60 ml/min). Pregnancy.

PrecautionsView

Patients with unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.

InteractionsView

Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan.

Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended.

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Non-steroidal anti-inflammatory drugs: When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a drug metabolised by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.

Pregnancy & lactationView

Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.

Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Precautions: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Irbesartan.

Pediatric usageView

Renal impairment: no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose of Irbesartan 75 mg should be considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Irbesartan.

Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.

Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.

General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

Overdose effectsView

Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.

StorageView

Store in a cool and dry place, protected from light.

Arbitan Plus

Irbesartan + Hydrochlorothiazide

Tablet 75 mg+12.5 mg Allopathic Combined antihypertensive preparations

Indications

Hypertension

Indication detailsView

Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan & Hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.

Therapeutic classView

Combined antihypertensive preparations

PharmacologyView

Irbesartan: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.

Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.

Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.

Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

DosageView

Initial therapy: Irbesartan 150 mg & Hydrochlorothiazide 12.5 mg orally once a day; may increase after 1 to 2 weeks.

Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day

Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day

Side effectsView

Irbesartan: Hyperkalemia (19%), Chest pain (2%), Tachycardia (1%), Abnormal urination (2%), Musculoskeletal pain (6%), Flu-like syndrome (3%), Edema (3%), Tachycardia (1%), Chest pain (2%), Creatinine increased (1%), Increased BUN (2%), Dizziness (10%), URI (9%), Orthostatic hypotension (5%), Fatigue (4%), Diarrhea (3%), Dyspepsia (2%)

Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache

ContraindicationsView

Irbesartan and Hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Irbesartan and Hydrochlorothiazide tablets in patients with diabetes

PrecautionsView

Child: Do not nurse
Lactation: Discontinue drug or do not nurse

InteractionsView

Other antihypertensives, lithium, K-sparing diuretics, K supplements, salt substitutes containing K. CNS depressants, antidiabetics, cholestyramine & colestipol resins, corticosteroids, ACTH, digitalis glycosides, antiarrhythmics, NSAIDs, tubocurarine, antigout medications, Ca salts. Alcohol; diazoxide, atropine, beperiden, amantadine, cyclophosphamide, methotrexate.

Pregnancy & lactationView

Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Irbesartan and Hydrochlorothiazide as soon as possible.

Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.

Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Renal Dose Adjustments:

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended

Liver Dose Adjustments: Caution recommended

Overdose effectsView

Irbesartan: No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.

To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.

Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.

Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.

Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

StorageView

Should be stored in cool and dry place

Arbitan Plus

Irbesartan + Hydrochlorothiazide

Tablet 150 mg+12.5 mg Allopathic Combined antihypertensive preparations

Indications

Hypertension

Indication detailsView

Irbesartan & Hydrochlorothiazide tablet are indicated for the treatment of hypertension. This tablet may be used in patients whose blood pressure is not adequately controlled on monotherapy. This tablet may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan & Hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.

Therapeutic classView

Combined antihypertensive preparations

PharmacologyView

Irbesartan: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the RAS and also stimulates aldosterone synthesis and secretion by adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 angiotensin II receptor. There is also an AT2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

Irbesartan is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor, and no agonist activity.

Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.

Irbesartan does not inhibit ACE or renin or affect other hormone receptors or ion channels known to be involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it does not affect the response to bradykinin; whether this has clinical relevance is not known.

Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

DosageView

Initial therapy: Irbesartan 150 mg & Hydrochlorothiazide 12.5 mg orally once a day; may increase after 1 to 2 weeks.

Add-on/Replacement therapy: Irbesartan 150 to 300 mg & Hydrochlorothiazide 12.5 to 25 mg orally once a day

Maximum dose: Irbesartan 300 mg & Hydrochlorothiazide 25 mg orally once a day

Side effectsView

Irbesartan: Hyperkalemia (19%), Chest pain (2%), Tachycardia (1%), Abnormal urination (2%), Musculoskeletal pain (6%), Flu-like syndrome (3%), Edema (3%), Tachycardia (1%), Chest pain (2%), Creatinine increased (1%), Increased BUN (2%), Dizziness (10%), URI (9%), Orthostatic hypotension (5%), Fatigue (4%), Diarrhea (3%), Dyspepsia (2%)

Hydrochlorothiazide: Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia, Headache

ContraindicationsView

Irbesartan and Hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Irbesartan and Hydrochlorothiazide tablets in patients with diabetes

PrecautionsView

Child: Do not nurse
Lactation: Discontinue drug or do not nurse

InteractionsView

Other antihypertensives, lithium, K-sparing diuretics, K supplements, salt substitutes containing K. CNS depressants, antidiabetics, cholestyramine & colestipol resins, corticosteroids, ACTH, digitalis glycosides, antiarrhythmics, NSAIDs, tubocurarine, antigout medications, Ca salts. Alcohol; diazoxide, atropine, beperiden, amantadine, cyclophosphamide, methotrexate.

Pregnancy & lactationView

Pregnancy Category D. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Irbesartan and Hydrochlorothiazide as soon as possible.

Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers: It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.

Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Renal Dose Adjustments:

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended

Liver Dose Adjustments: Caution recommended

Overdose effectsView

Irbesartan: No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.

To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.

Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no established role in the management of irbesartan overdose.

Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.

Hydrochlorothiazide: The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

StorageView

Should be stored in cool and dry place