Praze

Lansoprazole.

Each vial contains Sterile Lansoprazole 30 mg.

Pharmacology: Pharmacodynamics: Lansoprazole is a substituted benzimidazoles which is anti-secretory compound that suppress gastric acid secretion by specific inhibition of the H⁺, K⁺-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is the "acid (proton) pump" within the gastric mucosa, Lansoprazole has been characterized as a gastric acid pump inhibitor. Lansoprazole blocks the final step of the acid production. This effect is dose related and inhibits basal and stimulated acid secretion regardless of the stimulus.
It has been reported that 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 pepsin 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.
Pharmacokinetics: Lansoprazole can be administered intravenously (IV). The degree of inhibition of gastric acid secretion is similar following oral or IV administration. Lansoprazole is 97% bound to plasma proteins. Lansoprazole is extensively metabolized by the liver via CYP2C19 and CYP3A4 to inactive metabolites. Lansoprazole is metabolized in parietal cells to two active metabolites that are not present in systemic circulation. The plasma elimination half-life is less than 2 hours which does not reflect duration of suppression of gastric acid secretion that last more than 24 hours, apparently because of prolonged binding to the parietal H⁺, K⁺-ATPase enzyme. The metabolites are excreted in feces (67%) and urine (33%).
Lansoprazole is not removed by hemodialysis.

Lansoprazole IV is used in the treatment of following diseases when oral formulation cannot be taken: Gastric ulcer; duodenal ulcer; acute stress ulcer; acute gastric mucosal lesion accompanied by bleeding.

Recommended Dose: Adult: Usually, for adults, one vial of PRAZE (30 MG INJECTION) is mixed with isotonic sodium chloride solution (NSS) or 5% dextrose in water (D5W) and administered by intravenous injection or intravenous drip twice a day.
Pediatric: The safety of Lansoprazole IV in children has not been established.
Geriatric: Since physiological function is generally decreased in elderly patients. Lansoprazole IV should be carefully administered in elderly patients.
Patients with renal impairment: Dosage adjustment is not necessary.
Patients with hepatic impairment: Dosage reduction should be considered in patients with severe hepatic impairment (Child-Pugh class C).
Mode of Administration: Directions for use: 1. Intravenous injection: Use 5 - 10 ml NSS or D5W to mix with PRAZE (30 MG INJECTION) shake the vial gently until getting clear and colorless solution. Then draw all solution back and gently inject intravenously over 2 minutes.
2. Intravenous drip: Use 5 - 10 ml NSS or D5W to mix with PRAZE (30 MG INJECTION) shake the vial gently until getting clear and colorless solution.
Then draw all solution back and mix with NSS or D5W 100 ml and then administer by intravenous drip.
Stability after reconstitution: PRAZE (30 MG INJECTION) should be used immediately after reconstitution in compatible infusion solutions and the dissolved solution should not be stored.
For intravenous drip: Mixing with NSS, drip the solution within 12 hours; mixing with D5W, drip the solution within 5 hours.

There is no specific antidote for Lansoprazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
Hemodialysis is unlikely to be of value because of the high degree of protein binding and large volume of distribution of Lansoprazole.

Hypersensitivity to Lansoprazole or any component of the product.
Concomitant use with atazanavir sulfate or rilpivirine hydrochloride.

Use with caution in patients with history of hypersensitivity reactions to Lansoprazole, hepatic disorders or elderly patients.
Lansoprazole IV 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.
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 the Lansoprazole IV 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.
It has been reported that visual disturbance occurred with use of a similar drug (omeprazole).
The administration of Lansoprazole IV may mask the symptoms of gastric cancer. It is necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of Lansoprazole IV.
Use of proton-pump inhibitors may increase risk of Clostridium difficile-associated disease (CDAD), especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of proton-pump inhibitors therapy appropriate for the condition being treated.
Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g. community-acquired pneumonia).
Therapy with proton-pump inhibitors particularly in high dosages and/or prolonged periods of time (i.e.one year or longer), may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist or spine.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients receiving long-term therapy (at least 3 months, most case more than 1 year of therapy) with proton-pump inhibitors, including lansoprazole. Clinically serious adverse effect associated with hypomagnesemia, which are similar to manifestations of hypocalcemia, include tetany, seizures, tremors, carpopedal spasm, cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia) and abnormal QT interval.

Pregnancy: Pregnancy category B.
Lansoprazole IV should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk.
Lactation: It is not known if lansoprazole is excreted in breast milk. Due to the potential for serious adverse reactions in the breast-feeding infant, a decision should be made whether to discontinue breast-feeding or the drug, taking into account the importance of treatment to the mother.

Undesirable Effects may be founded during treatment with Lansoprazole.
Central nervous system: dizziness, headache.
Endocrine & metabolic: abnormal albumin-globulin ratio, albuminuria, decreased serum cholesterol, hyperlipidemia, increased gamma-glutamyl transferase, increased gastrin, increased lactate dehydrogenase, increased serum glucocorticoids, increased serum potassium.
Gastrointestinal: abdominal pain, constipation, diarrhea, nausea, occult blood in stools.
Genitourinary: crystalluria, hematuria.
Hematologic & oncologic: abnormal erythrocytes, abnormal platelets, leukocyte disorder, leukocytosis.
Hepatic: abnormal hepatic function tests, hyperbilirubinemia, increased serum alkaline phosphatase, increased serum ALT, increased serum AST.
Immunologic: increased serum globulins.
Renal: acute interstitial nephritis, increased blood urea nitrogen, increased serum creatinine.
Rare but important or life-threatening: Abdominal distention, abnormal dream, abnormal stool, abnormality in thinking, acne vulgaris, ageusia, agitation, agranulocytosis, alopecia, altered sense of smell, amblyopia, amnesia, anaphylactoid reaction, anaphylaxis, anemia, angina pectoris, anorexia, anxiety, apathy, aphthous stomatitis, aplastic anemia, arthralgia, arthritis, arthropathy, asthma, back pain, bezoar formation, blepharitis, blepharoptosis, blurred vision, bone disease, bone fracture, bradycardia, breast hypertrophy, breast tenderness, bronchitis, candidiasis, carcinoma, cardiac arrhythmia, cataract, cerebral infarction, cerebrovascular accident, change in platelet count (decreased/increased), chest pain, chills, cholelithiasis, circulatory shock, Clostridium difficile-associated diarrhea, colitis, confusion, conjunctivitis, contact dermatitis, cough, cutaneous lupus erythematous, deafness, decreased libido, dehydration, dementia, depersonalization, depression, dermatological disease, diabetes mellitus, diaphoresis, difficulty in micturition, diplopia, dizziness, drowsiness, dry eye syndrome, dysgeusia, dysmenorrhea, dyspepsia, dysphagia, dyspnea, dysuria, ear disease, edema, electrolyte disturbance (decreased/increased), emotional lability, enteritis, eosinophilia, epistaxis, eructation, erythema multiforme, esophageal ulcer, esophagitis, eye pain, fecal discoloration, fever, fixed drug eruption, flatulence, flu-like symptoms, gastritis, gastroenteritis, gastrointestinal hemorrhage, GI moniliasis, gingival hemorrhage, glaucoma, glossitis, glycosuria, goiter, gout, gynecomastia, hair disease, halitosis, hallucination, hematemesis, hemiplegia, hemolysis, hemolyticanemia, hemoptysis, hepatotoxicity, hiccups, hostility, hyperkinesia, hypermenorrhea, hypersensitivity reaction, hypertension, hypertonia, hypoesthesia, hypoglycemia, hypomagnesemia, hypotension, hypothyroidism, impotence, increase appetite, increased libido, increased thirst, infection, insomnia, interstitial nephritis, leg cramps, leukopenia, leukorrhea, lymphadenopathy, maculopapular rash, malaise, malignant neoplasm of larynx, mastalgia, melena, menstrual disease (includes abnormal menses), migraine, musculoskeletal pain, myalgia, myasthenia, myocardial infarction, myositis, nail disease, neck pain, neck stiffness, nephrolithiasis, nervousness, neutropenia, oral mucosa ulcer, otitis media, pain, palpitations, pancreatitis, pancytopenia, paresthesia, pelvic pain, penile disease, peripheral edema, pharyngitis, photophobia, pleural disease, pneumonia, polyp (gastric nodules and fundic gland polyp), polyuria, pruritus, psychoneurosis, pulmonary fibrosis, rectal disease, rectal hemorrhage, chronic renal disease, renal pain, respiratory tract disease, retinal degeneration, retinopathy, rhinitis, seizure, sialorrhea, sinusitis, skin carcinoma, skin rash, sleep disorder, speech disturbance, Steven-Johnson syndrome, stomatitis, stridor, syncope, synovitis, systemic lupus erythematosus, tachycardia, tenesmus, testicular disease, thrombocytopenia, thrombotic thrombocytopenic purpura, tinnitus, tremor, tongue disease, toxic epidermal necrolysis, ulcerative colitis, upper respiratory tract inflammation, upper respiratory tract infection, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urticaria, vaginitis, vasodilation, vertigo, visual disturbance, visual field defect, vitamin deficiency, vomiting, weakness, weight gain, weight loss, xeroderma, xerostomia.

Concurrent use of Lansoprazole IV and atazanavir may result in decreased in the blood concentration of atazanavir. Avoid combination.
Concurrent use of Lansoprazole IV and rilpivirine may result in decreased in the blood concentration of rilpivirine. Avoid combination.
Concurrent use of Lansoprazole IV and theophylline may result in decreased in the blood concentration of theophylline. Use with caution.
Concurrent use of Lansoprazole IV and tacrolimus may result in increased in the blood concentration of tacrolimus. Use with caution.
Concurrent use of Lansoprazole IV and digoxin/methyldigoxin may result in increased in the blood concentration of digoxin. Use with caution.
Concurrent use of Lansoprazole IV and itraconazole may result in decreased in the blood concentration of itraconazole. Use with caution.
Concurrent use of Lansoprazole IV and gefinitib may result in decreased in the blood concentration of gefinitib. Use with caution.
Concurrent use of Lansoprazole IV and methotrexate may result in increased in the blood concentration of methotrexate. Use with caution.

Storage below 30°C prior to reconstitution.
The reconstituted solutions of PRAZE (30 MG INJECTION) should be used immediately and the dissolved solution should not be stored.
Stability after dissolution of PRAZE (30 MG INJECTION) for intravenous drip mentioned in "Stability after reconstitution" topic.

Antacids, Antireflux Agents & Antiulcerants

A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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