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Odatrix

Ceftriaxone Sodium

IV Injection 2 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftriaxone is indicated for the treatment of the following major infections:

Lower respiratory tract infections
Acute Bacterial Otitis Media
Skin and skin structure infections
Urinary tract infections
Gonorrhea
Bacterial Septicemia
Bone and joint infections
Meningitis
Prevention of postoperative infections
Perioperative prophylaxis of infections associated with surgery

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

DosageView

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Uncomplicated gonococcal infections: 250 mg IM as a single dose
Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

AdministrationView

Preparation of Solutions for Intramuscular / Intravenous Injections:

For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Side effectsView

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

ContraindicationsView

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

PrecautionsView

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

InteractionsView

No drug interactions have been reported.

Pregnancy & lactationView

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Pediatric usageView

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

Overdose effectsView

There is no specific antidote. Treatment of overdosage should be symptomatic.

StorageView

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Odatrix

Ceftriaxone Sodium

IV Injection 1 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftriaxone is indicated for the treatment of the following major infections:

Lower respiratory tract infections
Acute Bacterial Otitis Media
Skin and skin structure infections
Urinary tract infections
Gonorrhea
Bacterial Septicemia
Bone and joint infections
Meningitis
Prevention of postoperative infections
Perioperative prophylaxis of infections associated with surgery

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

DosageView

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Uncomplicated gonococcal infections: 250 mg IM as a single dose
Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

AdministrationView

Preparation of Solutions for Intramuscular / Intravenous Injections:

For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Side effectsView

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

ContraindicationsView

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

PrecautionsView

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

InteractionsView

No drug interactions have been reported.

Pregnancy & lactationView

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Pediatric usageView

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

Overdose effectsView

There is no specific antidote. Treatment of overdosage should be symptomatic.

StorageView

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Odatrix

Ceftriaxone Sodium

IM Injection 500 mg/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftriaxone is indicated for the treatment of the following major infections:

Lower respiratory tract infections
Acute Bacterial Otitis Media
Skin and skin structure infections
Urinary tract infections
Gonorrhea
Bacterial Septicemia
Bone and joint infections
Meningitis
Prevention of postoperative infections
Perioperative prophylaxis of infections associated with surgery

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

DosageView

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Uncomplicated gonococcal infections: 250 mg IM as a single dose
Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

AdministrationView

Preparation of Solutions for Intramuscular / Intravenous Injections:

For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Side effectsView

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

ContraindicationsView

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

PrecautionsView

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

InteractionsView

No drug interactions have been reported.

Pregnancy & lactationView

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Pediatric usageView

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

Overdose effectsView

There is no specific antidote. Treatment of overdosage should be symptomatic.

StorageView

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Odatron

Ondansetron

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

Indications

Post-operative nausea and vomiting

Indication detailsView

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

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

Therapeutic classView

Anti-emetic drugs

PharmacologyView

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

DosageView

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

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

Radiotherapy-Induced Nausea and Vomiting-
Adults:

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

Postoperative Nausea and Vomiting-
Adults:

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

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

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

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

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

Oral solution:

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

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

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

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

Oral Soluble Film:

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

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

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

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

AdministrationView

Administration of Oral Soluble Film:

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

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

Pediatric usageView

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

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

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

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

StorageView

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

Odatron

Ondansetron

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

Indications

Post-operative nausea and vomiting

Indication detailsView

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

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

Therapeutic classView

Anti-emetic drugs

PharmacologyView

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

DosageView

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

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

Radiotherapy-Induced Nausea and Vomiting-
Adults:

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

Postoperative Nausea and Vomiting-
Adults:

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

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

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

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

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

Oral solution:

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

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

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

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

Oral Soluble Film:

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

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

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

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

AdministrationView

Administration of Oral Soluble Film:

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

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

Pediatric usageView

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

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

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

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

StorageView

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

Odatron

Ondansetron

IM/IV Injection 2 mg/ml Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

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

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

Therapeutic classView

Anti-emetic drugs

PharmacologyView

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

DosageView

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

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

Radiotherapy-Induced Nausea and Vomiting-
Adults:

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

Postoperative Nausea and Vomiting-
Adults:

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

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

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

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

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

Oral solution:

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

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

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

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

Oral Soluble Film:

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

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

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

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

AdministrationView

Administration of Oral Soluble Film:

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

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

Pediatric usageView

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

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

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

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

StorageView

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

Odatron

Ondansetron

Tablet 8 mg Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

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

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

Therapeutic classView

Anti-emetic drugs

PharmacologyView

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

DosageView

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

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

Radiotherapy-Induced Nausea and Vomiting-
Adults:

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

Postoperative Nausea and Vomiting-
Adults:

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

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

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

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

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

Oral solution:

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

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

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

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

Oral Soluble Film:

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

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

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

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

AdministrationView

Administration of Oral Soluble Film:

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

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

Pediatric usageView

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

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

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

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

StorageView

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

Odatron

Ondansetron

Tablet 4 mg Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

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

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

Therapeutic classView

Anti-emetic drugs

PharmacologyView

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

DosageView

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

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

Radiotherapy-Induced Nausea and Vomiting-
Adults:

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

Postoperative Nausea and Vomiting-
Adults:

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

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

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

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

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

Oral solution:

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

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

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

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

Oral Soluble Film:

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

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

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

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

AdministrationView

Administration of Oral Soluble Film:

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

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

Pediatric usageView

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

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

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

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

StorageView

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

Odaz

Azithromycin Dihydrate

Powder for Suspension 200 mg/5 ml Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odaz

Azithromycin Dihydrate

Tablet 500 mg Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odazin

Azithromycin Dihydrate

Tablet 500 mg Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odazyth

Azithromycin Dihydrate

Capsule 250 mg Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odazyth

Azithromycin Dihydrate

Powder for Suspension 200 mg/5 ml Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odazyth

Azithromycin Dihydrate

Tablet 500 mg Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

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

Odeson

Dexamethasone

Tablet 0.5 mg Allopathic

Indication detailsView

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

For tablet:

In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.

For injection:

Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
Intravenous injections of massive doses should be given slowly, over a period of several minutes.
Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.

For local therapy, the following doses are recommended:

Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
The frequency of these injections may vary from every 3-5 days to every 2-3 weeks

Side effectsView

The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.

ContraindicationsView

Gastric and duodenal ulcers.
Systemic and ophthalmic fungal infections.
Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
Glaucoma.
Hypersensitivity to corticosteroids

PrecautionsView

General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.

InteractionsView

Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.

Pregnancy & lactationView

Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed

Pediatric usageView

In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Overdose effectsView

Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy

StorageView

Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

Odeson

Dexamethasone

IM/IV Injection 4 mg/ml Allopathic

Indication detailsView

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

For tablet:

In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.

For injection:

Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
Intravenous injections of massive doses should be given slowly, over a period of several minutes.
Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.

For local therapy, the following doses are recommended:

Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
The frequency of these injections may vary from every 3-5 days to every 2-3 weeks

Side effectsView

The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.

ContraindicationsView

Gastric and duodenal ulcers.
Systemic and ophthalmic fungal infections.
Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
Glaucoma.
Hypersensitivity to corticosteroids

PrecautionsView

General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.

InteractionsView

Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.

Pregnancy & lactationView

Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed

Pediatric usageView

In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Overdose effectsView

Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy

StorageView

Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

Odessy

Ketoconazole (Shampoo)

Shampoo 2% Allopathic Drugs for subcutaneous and mycoses

Indications

Seborrhoeic dermatitis

Indication detailsView

ketoconazole 2% shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).

Therapeutic classView

Drugs for subcutaneous and mycoses

PharmacologyView

Ketoconazole 2% shampoo is a broad spectrum imidazole-dioxolane, synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).

DosageView

The affected areas of the skin or the scalp should be washed with ketoconazole 2% shampoo, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
Treatment:

Pityriasis versicolor: Once daily for 5 days.
Seborrhoeic dermatitis and pityriasis capitis: Twice weekly for 2 to 4 weeks.

Prophylaxis:

Pityriasis versicolor: Once daily for 3 days during a single treatment course before the summer.
Seborrhoeic dermatitis and pityriasis capitis: Once every 1 or 2 weeks

Side effectsView

Topical treatment with ketoconazole shampoo 2% is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of ketoconazole shampoo 2%.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to ketoconazole.

PrecautionsView

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole shampoo 2%. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.

InteractionsView

No information was found for the Shampoo form of Ketoconazole.

Pregnancy & lactationView

Since ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of ketoconazole shampoo 2%.

Overdose effectsView

Not expected as ketoconazole shampoo 2% is intended for external use only. In the event of accidental ingestion, only supportive measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.

StorageView

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

Oditen

Ceftibuten Dihydrate

Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.
Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

DosageView

Otitis Media-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

Adult Dosage: 400 mg orally every 24 hours for 7 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Side effectsView

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

ContraindicationsView

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

PrecautionsView

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

InteractionsView

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy & lactationView

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Pediatric usageView

Renal Impairment-

CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

ReconstitutionView

The small bottle contains purified water and large bottle contains granules
Pour the purified water completely into large bottle
Tighten the cap of large bottle and shake the bottle for at least one minute
Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

StorageView

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Oditen

Ceftibuten Dihydrate

Capsule 400 mg Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.
Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

DosageView

Otitis Media-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

Adult Dosage: 400 mg orally every 24 hours for 7 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Side effectsView

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

ContraindicationsView

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

PrecautionsView

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

InteractionsView

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy & lactationView

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Pediatric usageView

Renal Impairment-

CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

ReconstitutionView

The small bottle contains purified water and large bottle contains granules
Pour the purified water completely into large bottle
Tighten the cap of large bottle and shake the bottle for at least one minute
Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

StorageView

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.

Oditen

Ceftibuten Dihydrate

Powder for Suspension 90 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.
Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

DosageView

Otitis Media-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

Adult Dosage: 400 mg orally every 24 hours for 7 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Side effectsView

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

ContraindicationsView

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

PrecautionsView

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

InteractionsView

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Pregnancy & lactationView

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Pediatric usageView

Renal Impairment-

CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

ReconstitutionView

The small bottle contains purified water and large bottle contains granules
Pour the purified water completely into large bottle
Tighten the cap of large bottle and shake the bottle for at least one minute
Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

StorageView

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.