Prazotec Injection

Prazotec Injection

lansoprazole

Manufacturer:

Fahrenheit
Full Prescribing Info
Contents
Lansoprazole.
Description
Each vial contains lansoprazole 30 mg.
Action
Pharmacology: Pharmacodynamics: Lansoprazole is firstly transferred to the acid-producing region of the gastric mucosal parietal cells, and transformed into an activated form through conversion reaction by acid. This reaction product is considered to combine with the SH-groups of (H+, K+)-ATPase which is locally located in the acid-producing region and playing a role of the proton pump, suppressing the enzyme activity to inhibit the acid secretion.
Blood coagulation and platelet aggregation capacities are severely impaired under acidic conditions, and that fibrin formed as a result of blood coagulation is dissolved by pepsin under acidic conditions.
Lansoprazole is considered to increase gastric pH, thereby improving blood coagulation and platelet aggregation capacities and inhibiting peptic activity, resulting in suppression of bleeding. Also, lansoprazole is considered to increase gastric pH by inhibiting acid secretion, thereby promoting repair of injured mucosa, which is inhibited under acidic conditions.
Inhibiting activity on gastric bleeding: Lansoprazole shows an inhibiting activity on gastric bleeding due to hemorrhagic shock.
Inhibiting activity on formation of gastric mucosal injury: Lansoprazole inhibits gastric mucosal injury due to aspirin or indometacin.
Inhibiting activity on gastric acid secretion (24-hour gastric pH monitoring): By intravenous administration of lansoprazole at a dose of 30 mg twice a day, continuous inhibition of gastric acid secretion is observed.
Pharmacokinetics: Blood concentrations: The serum concentration of lansoprazole after intravenous administration of Prazotec injection 30 mg varies among individuals.
Protein binding rate: The human serum protein binding rate of lansoprazole at the concentration range of 0.05 to 5 μg/mL is approximately 98%.
Metabolism: Lansoprazole is mainly metabolized by CYP2C19 and CYP3A4.
Urinary excretion: After single intravenous administration of 30 mg of lansoprazole, no unchanged compound was detected in the urine; all detected were metabolites.
Indications/Uses
Patients with the following disease who are unable to take the oral formulations: Gastric ulcer, duodenal ulcer, acute stress ulcer, and acute gastric mucosal lesion accompanied by bleeding.
Dosage/Direction for Use
Usually, for adults, Prazotec Injection 30 mg is mixed with isotonic sodium chloride solution or 5% glucose injection and administered by intravenous drip twice a day.
Contraindications
Prazotec Injection 30 mg is contraindicated in the following patients: Patients with a history of hypersensitivity to any of the ingredients of this drug.
Patients who are receiving atazanavir sulfate.
Contraindications for coadministration: Prazotec Injection 30 mg should not be coadministered with the following drug: See Table 1.


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Special Precautions
As Prazotec Injection 30 mg was shown to have high hemostatic effect based on the data up to 3 days after starting treatment, once the patient is able to take medications orally. Therapy should be switched to an oral formulation and this drug should not be administered aimlessly for a long period.
There is no clinical experience of treatment over 7 days in Japanese clinical trials.
Careful Administration: Prazotec Injection 30 mg should be administered with care in the following patients: Patients with a history of drug hypersensitivity.
Patients with hepatic disorders. (A delay in the metabolism and excretion of Prazotec Injection 30 mg may occur).
Elderly patients (see Use in Elderly as follows).
Important Precautions: At the treatment, the course of the disease should be closely observed and the minimum therapeutic necessity should be used according to the disease condition. If Prazotec Injection 30 mg is ineffective, it should be switched to another treatment.
If the patient has projectile bleeding or oozing bleeding, or is considered at risk for rapid bleeding such as the case of presence of exposed blood vessels, the patient should undergo endoscopic hemostasis such as heater probe or clipping.
Precautions for coadministration: Prazotec Injection 30 mg should be administered with care when coadministered with the following drugs: See Table 2.


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Other Precautions: It has been reported from abroad that visual disturbance occurred with use of a similar drug (omeprazole).
The administration of Prazotec Injection 30 mg may mask the symptoms of gastric cancer. It is, therefore, necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of this drug.
Use in Children: The safety of Prazotec Injection 30 mg in children has not been established (no clinical experience).
Use in Elderly: Since physiological function generally decreased in elderly patients, Prazotec Injection 30 mg should be carefully administered.
Use In Pregnancy & Lactation
Prazotec Injection 30 mg should be used in pregnant women or woman having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk.
It is advisable to avoid the administration of Prazotec Injection 30 mg to nursing mothers. However, when the administration is indispensable, nursing should be discontinued.
Adverse Reactions
Main adverse reactions included abnormal changes in laboratory data such as increase ALT (GPT) (6.2%), AST (GOT) (5.7%), LDH (2.0%), and -GTP (1.5%).
Since the following adverse reactions were observed with use of the oral formulations of lansoprazole, caution should be exercised when the intravenous formulation of this drug is administered.
Clinically significant adverse reactions: Anaphylactic reactions (generalized rash, facial edema, dyspnea, etc.) may occur (<0.1%), and shock has consequently occurred in certain cases (<0.1%). Therefore, close observation should be made, and if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Pancytopenia, agranulocytosis or hemolytic anemia may occur (<0.1%). Granulocytopenia, thrombocytopenia or anemia may occur (0.1%-<5%). Therefore, close observation should be made, and if any abnormality is observed, such appropriate measures as discontinuation of Prazotec Injection 30 mg should be taken.
Severe hepatic dysfunction with jaundice, increased AST (GOT), ALT (GPT), etc., may occur (0.1%). Therefore, close observation should be made. If any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Toxic epidermal necrolysis (Lyell syndrome) and oculomucocutaneous syndrome (Stevens-Johnson syndrome) (<0.1%) may occur. Therefore, close observation should be made, if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Interstitial pneumonia (<0.1%) may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, such examinations as chest X-ray should immediately be performed, and Prazotec Injection 30 mg should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken.
Interstitial nephritis (frequency unknown) may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increases in BUN, creatinine, etc), and if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Other adverse reactions: If any of the following adverse reactions is observed, appropriate measures such as discontinuation of Prazotec Injection 30 mg should be taken. (See Table 3.)


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Drug Interactions
Prazotec Injection 30 mg is metabolized mainly by hepatic drug-metabolizing enzyme CYP2C19 and CYP3A4.
Gastric antisecretory effect of Prazotec Injection 30 mg may promote or inhibit absorption of concomitant drugs.
Caution For Usage
Precautions Concerning Use: Route of administration: Prazotec Injection 30 mg should be used only by intravenous route.
After dissolution: Prazotect Injection 30 mg should be used immediately after dissolution and the dissolved solution should not be stored since the solution may deteriorate over time.
Method of administration: A dedicated infusion line should be used for the administration of Prazotec Injection 30 mg. The infusion line should not be shared with other drugs. If it is inevitable to administer Prazotec Injection 30 mg using the infusion line for other drugs via Y-site, the infusion of other drugs should be stopped and the line should be flushed by isotonic sodium chloride solution or 5% glucose injection before and after administration of Prazotec Injection 30 mg.
Incompatibility: Prazotec Injection 30 mg should not be mixed with solutions, infusion fluid, replacement fluid, and other medicinal products except isotonic sodium chloride solution or 5% glucose injection since discoloration and precipitation may occur in the mixed solution.
Storage
Store below 30°C.
ATC Classification
A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Powd for inj (vial) 30 mg (white to yellowish white) x 1's.
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