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Vomiren
Palonosetron
Vomiren
Palonosetron
Indications
Vomiting
Indication detailsView
Palonosetron indicated in-
- Acute and delayed nausea and vomiting
- Uncontrolled nausea and vomiting
- Chemotherapy-induced nausea and vomiting (CINV): Acute CINV resulting in on the day of treatment with certain types of chemotherapy
- Delayed CINV resulting in on days later with certain types of chemotherapy
- Radiotherapy-induced nausea and vomiting (RINV)
- Post-operative & Post-discharge nausea and vomiting (PONV & PDNV).
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors that are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema, to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factorcs and is triggered by release of 5-HT3 in a cascade of neuronal event involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palonosetron works by blocking the actions of Serotonin, associated with nausea and vomiting, at 5-HTs receptor. It is likely that Palonosetron works in the small intestine but it may also work in the brain.
Pharmacokinetics: Palonosetron exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palonosetron in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palonosetron has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palonosetron is metabolized into two inactive metabolites that exhibit <1% of the 5-HT3 receptor antagonist activity. Approximately 40% of the drug is metabolised via kidney, 50% by liver CYP2D6 (mainly), CYP3A4 and CYP1A2 isoenzymes. About 50% of the drug goes under metabolism. After a single intravenous dose, approximately 40% is excreted as unchanged drug in the urine after 144 hours. Total body clearance of Palonosetron is 160±35 ml/h/kg, and renal clearance is 66.5±18.2 ml/h/kg in healthy subjects. Palonosetron exhibits a longer half-life (40 hours) and has a greater 5-HT3 receptor binding affinity.
Pharmacokinetics: Palonosetron exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palonosetron in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palonosetron has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palonosetron is metabolized into two inactive metabolites that exhibit <1% of the 5-HT3 receptor antagonist activity. Approximately 40% of the drug is metabolised via kidney, 50% by liver CYP2D6 (mainly), CYP3A4 and CYP1A2 isoenzymes. About 50% of the drug goes under metabolism. After a single intravenous dose, approximately 40% is excreted as unchanged drug in the urine after 144 hours. Total body clearance of Palonosetron is 160±35 ml/h/kg, and renal clearance is 66.5±18.2 ml/h/kg in healthy subjects. Palonosetron exhibits a longer half-life (40 hours) and has a greater 5-HT3 receptor binding affinity.
DosageView
Usual dosage: Adult tablet dosage: 0.5 mg daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.
Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.
Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.
Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.
Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.
Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.
Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.
Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
Side effectsView
The most common adverse reactions are headaches and constipation.
ContraindicationsView
Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
InteractionsView
In controlled clinical trials, Palonosetron injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palonosetron did not inhibit the antitumor activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C in murine tumor models. Concomitant administration of Palonosetron and metoclopramide has no significant pharmacokinetic interactions. In vitro studies indicated that palonosetron is not inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 & CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6 or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with Palonosetron appears to be low.
Pregnancy & lactationView
Pregnancy category 'B'. It is not known whether Palonosetron is excreted in breast milk.
Pediatric usageView
Use in elderly patients: No dosage adjustment is recommended in elderly patients >65 years of age.
Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.
Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.
Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.
Overdose effectsView
There is no known antidote to Palonosetron. Overdose should be managed with supportive care.
StorageView
Store in a cool & dry place, protected from light.
Vomiset
Ondansetron
Vomiset
Ondansetron
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):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
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.
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.
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: 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.
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.
- 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.
- 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.
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.
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.
VomitOF
Ondansetron
VomitOF
Ondansetron
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):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
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.
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.
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: 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.
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.
- 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.
- 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.
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.
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.
Vomitop
Domperidone Maleate
Vomitop
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Vomitop
Domperidone Maleate
Vomitop
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Vomitop
Domperidone Maleate
Vomitop
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Vomix DR
Pyridoxine Hydrochloride + Doxylamine Succinate
Vomix DR
Pyridoxine Hydrochloride + Doxylamine Succinate
Indications
Pregnancy-associated nausea and vomiting
Indication detailsView
This is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has a high affinity for H1 receptors in the brain that blocks H1 receptors. It also decreases the action of histamine at the H1 receptor by inhibiting both vestibular system & Muscarinic receptor. It affects the vestibular system & decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine Hydrochloride is a vitamin B6 analog. It is used to prevent nausea and vomiting due to its antiemetic properties.
DosageView
Initially, take one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split this tablets. Take daily and not on an as needed basis.
Side effectsView
Somnolence or other accidents resulting from the effect of the combined use of Doxylamine Succinate & Pyridoxine Hydrochloride with CNS depressants.
ContraindicationsView
Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women with any of the following conditions:
- Known hypersensitivity to Doxylamine Succinate, other ethanolamine derivative antihistamines, Pyridoxine Hydrochloride or any inactive ingredient in the formulation
- Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of Doxylamine Succinate & Pyridoxine Hydrochloride
PrecautionsView
Doxylamine Succinate & Pyridoxine Hydrochloride may cause somnolence due to the anticholinergic properties of Doxylamine Succinate, an antihistamine. Women should avoid engaging in activities, such as driving or operating heavy machinery, while using Doxylamine Succinate & Pyridoxine Hydrochloride. Doxylamine Succinate & Pyridoxine Hydrochloride use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol.
Doxylamine Succinate & Pyridoxine Hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.
Doxylamine Succinate & Pyridoxine Hydrochloride has anticholinergic properties and, therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.
InteractionsView
Use of Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Doxylamine Succinate & Pyridoxine Hydrochloride is not recommended.
Pregnancy & lactationView
Pregnancy category A. This is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Both Doxylamine Succinate & Pyridoxine Hydrochloride are excreted into breast milk. Therefore, caution should be exercised while breastfeeding.
Overdose effectsView
Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, Doxylamine Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment.
StorageView
Store at below 30°C in a dry place protected from light. Keep out of reach of children.
Vonazol
Voriconazole
Vonazol
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vonazol
Voriconazole
Vonazol
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vori
Voriconazole
Vori
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vori
Voriconazole
Vori
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voricon
Voriconazole
Voricon
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voricon
Voriconazole
Voricon
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voricon
Voriconazole
Voricon
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voriderm
Voriconazole
Voriderm
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voriderm
Voriconazole
Voriderm
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Voriderm
Voriconazole
Voriderm
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vorifast
Voriconazole
Vorifast
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vorifast
Voriconazole
Vorifast
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.
Vorifast
Voriconazole
Vorifast
Voriconazole
Indications
Scedosporiosis and fusariosis
Indication detailsView
Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-
- Invasive aspergillosis
- Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
- Esophageal candidiasis
- Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
- Patients intolerant of, or refractory to other therapy.
Therapeutic classView
Other Antifungal preparations
PharmacologyView
Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.
DosageView
Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
Injection-
Invasive Aspergillosisd :
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal
- At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
- Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.
Injection-
Invasive Aspergillosisd :
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 3-4 mg/kg 12 hourly.
- Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
- Maintenance Dose: 4 mg/kg 12 hourly.
Side effectsView
The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.
ContraindicationsView
Known hypersensitivity to Voriconazole or any other components of this drug-
- Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
- Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy
PrecautionsView
Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.
InteractionsView
- CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
- Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
- Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric usageView
The efficacy to the children under 12 years of age is not established.
Overdose effectsView
There is no data found about overdose of Voriconazole.
ReconstitutionView
Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.
StorageView
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.