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Razo: A Powerful Experience
For over 20 years, Razo Franchise is the trusted partner in managing a range of GI disorders like Gastroesophageal Reflux Disease (GERD), Dyspepsia, Nocturnal Acid Breakthrough (NAB), Reflux with Nausea & Vomiting & Stress-Induced GERD.
1. Eur J Gastroenterol Hepatol 2001; Aliment Pharmacol Ther 1999; Pharmacogenomics 2011.
2. Besancon M, Simon A, Sachs G, Shin JM. Sites of reaction of the gastric H,K-ATPase with extracytoplasmic thiol reagents. J Biol Chem. 1997;272(36):22438-22446. doi:10.1074/jbc.272.36.22438.
3. Alia D et al.Rabeprazole: a pharmacologic and clinical review for acid-related disorders. Expert Opin Drug Saf. 2009 Jan;8(1):119-26.
4. Katz et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease, The American Journal of Gastroenterology: January 2022 - Volume 117 - Issue 1 - p 27-56.
5. T Jaworski. Restorative impact of rabeprazole on gastric mucus and mucin production impairment during naproxen administration: its potential clinical significance. Dig Dis Sci. 2005 Feb;50(2):357-65.
6. Swan SK, Hoyumpa AM, Merritt GJ. Review article: the pharmacokinetics of rabeprazole in health and disease. Aliment Pharmacol Ther. 1999;13 Suppl 3:11-17. doi:10.1046/j.1365-2036.1999.00020.
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Abridged Prescribing Information
RAZO TM (Rabeprazole sodium Tablets) 10 mg, 20 mg
RAZO EASY (Rabeprazole sodium Sachet) 20 mg
Composition: Each enteric coated tablet contains: Rabeprazole Sodium IP 10 mg With Sodium Bicarbonate as buffer, Colours: Titanium Oxide & Iron Oxide Yellow. Each enteric coated tablet contains: Rabeprazole Sodium IP 20 mg With Sodium Bicarbonate as buffer, Colours: Titanium Oxide & Iron Oxide Red.Rabeprazole Sodium powder for oral suspension 20 mg, each single dose Sachet Contains: Rabeprazole Sodium IP 20 mg With Sodium Bicarbonate as buffer Excipients q.s. Indications: Rabeprazole is indicated for the treatment of Gastric ulcer, duodenal ulcer, Zollinger-Ellison Syndrome and GERD. Dosage & administration: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg to be taken once daily for four-eight weeks. Maintenance of Healing of Erosive or Ulcerative gastroesophageal Reflux Disease (GERD). The recommended adult oral dose is one RAZO-IR 20 mg tablet to be taken once daily. Healing of Duodenal ulcers and Gastric ulcers: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily after morning meal. Treatment of Pathological Hypersecretory Conditions, Including Zollinger Ellison Syndrome: The recommended adult oral starting dose is 60 mg once daily. Contraindications: It is contraindicated in patients with known hypersensitivity to Rabeprazole, or to any of its component or to substituted benzimidazoles. Special Warnings and Precautions for use: Patients on long-term treatment (> 1 year) should be kept under regular surveillance. Co-administration of Atazanavir with Rabeprazole is not recommended. Severe hypomagnesaemia has been reported in patients treated with PPIs like Rabeprazole for at least three months, and in most cases for a year. Concomitant use of PPIs with methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. It may reduce the absorption of vitamin B12 due to hypo- or a- chlorhydria. Use in specific populations: Use in pregnancy: There is no adequate data to establish the safety of Rabeprazole in pregnant women. It is contraindicated during pregnancy. Breast-feeding: It is not known whether Rabeprazole sodium is excreted in human breast milk. Therefore it must not be used during breast feeding. Use in Children: Rabeprazole tablets are not recommended for use in children due to a lack of data on safety and efficacy. Adverse Reactions: The most commonly reported adverse drug reactions, during controlled clinical trials with Rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. Over dosage: Experience to date with deliberate or accidental overdose is limited. No specific antidote for Rabeprazole is known. In the event of over dosage, treatment should be symptomatic and supportive.
Dated: 7th September, 2021
Further information is available on request.
Razo D (Rabeprazole and Domperidone) SR tablets 20 mg and 30 mg
Composition: Each capsule contains Rabeprazole Sodium 20 mg (as enteric coated pellets) Domperidone BP 30 mg (as sustained release pellets),Excipients q.s. Colours: Red Oxide of Iron, Yellow Oxide of Iron, Black Oxide of Iron & Titanium Dioxide IP Approved colours used in capsule shell. Indications: Gastroesophageal reflux disease (GERD) not responding to Rabeprazole alone. Dosage & administration: For Adults and Children over 16 years of age: One Razo-D Capsule is to be taken once daily for 4 to 8 weeks. Razo-D Capsule should be swallowed whole but should not be chewed or crushed, before breakfast in the morning. Contraindications: Hypersensitivity to Rabeprazole, domperidone or substituted benzimidazoles or to any excipient used in the formulation. It is contraindicated in patients with hepatic and/or renal impairment, prolactin-releasing pituitary tumour (prolactinoma), in pregnancy and during breast feeding. It should not be used when stimulation of the gastric motility could be harmful, like gastrointestinal haemorrhage, mechanical obstruction or perforation. Special Warnings and Precautions for use: Co-administration of Razo-D with Atazanavir, Ketoconazole, Erythromycin or other potent CYP3A4 inhibitors are not recommended. Patients with Severe Hepatic Dysfunction: Although no evidence of significant drug related safety problems, caution should be exercised when treatment with Rabeprazole sodium is first initiated in patients with severe hepatic dysfunction. Pediatrics: It is not recommended for use in children under 16 years of age, as there is no experience of its use in this group. Geriatrics: No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects in the clinical studies with Rabeprazole. Use in specific populations: Pregnancy and Lactation: It is contraindicated during pregnancy and should not be used during breast feeding. Effects on Ability to Drive and Use Machines: Razo-D has no or negligible effect. Adverse Reactions: In general, both the drugs are well tolerated separately. Following adverse drug reactions may occur with this fixed drug combination-headache, abdominal pain, dizziness, peripheral edema, asthenia, skin rash, diarrhea, flatulence, constipation, dry mouth, hepatic enzyme increase. Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. Rare reports of thrombocytopenia, neutropenia, leukopenia, bullous or urticarial skin eruptions, and acute systemic allergic reactions, hepatitis, jaundice, myalgia, arthralgia, acute kidney injury, increased prolactin levels, QTc prolongation (frequency not known), galactorrhea, gynecomastia and amenorrhea are seen. Over dosage: Symptoms of overdose may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic, anti-Parkinson medicines or antihistamines with anticholinergic properties may be helpful. There is no specific antidote to either drug and hence overdose treatment should be symptomatic and supportive, gastric lavage & the administration of activated charcoal may be useful.
Dated: 7th September, 2021
Further information is available on request.
Razo - L (Rabeprazole sodium EC & Levosulpride) SR capsule 20 mg & 75 mg
Composition: Each Hard gelatin capsule contains Rabeprazole Sodium IP (As enteric coated pellets) 20 mg, Levosulpiride (As sustained release tablet) 75 mg, Colours: Titanium Dioxide IP, Red oxide of Iron and Black Oxide of Iron. Approved colours used in the capsule shell. Indications: Rabeprazole sodium EC & Levosulpiride SR capsule is indicated in management of GERD. Dosage & administration: Rabeprazole (20 mg) + Levosulpiride SR (75 mg) to be taken once daily before meal. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Epilepsy, Pheochromocytoma, manic states, Hyperprolactinaemias, Porphyria, Mammary dysplasia, malignant mastopathies, Cardiac impairment, Pregnancy and lactation. Special Warnings and Precautions for use: Patients treated with a proton pump inhibitor and warfarin may need to be monitored for increase in INR and prothrombin time due to risk of abnormal bleeding. Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Patient may experience drowsiness, dizziness and dyskinesia with the use of Levosulpiride; hence patients under treatment should be advised to avoid driving vehicles or operation machinery. Levosulpiride should not be used when stimulation of gastrointestinal motility could be harmful, e.g., in the presence of gastrointestinal bleeding, mechanical obstruction or perforation. Cautious use is advised in patients with cardiovascular disease or a family history of QT prolongation. Concomitant use of alcohol should be avoided. Levosulpiride should be used with caution in patients with risk factors for stroke. During treatment with antipsychotic drugs, potentially fatal complex symptoms called “Neuroleptic Malignant Syndrome” (NMS) have been reported. Avoid concomitant therapy with other neuroleptics. Use in specific populations: Pregnancy & Lactation: contraindicated. Adverse Reactions: Rabeprazole like other PPIs has few side effects. The most common side effects are diarrhea, nausea, vomiting, constipation, rash and headaches. Dizziness, nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, water retention and Acute Kidney Injury rarely occur. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated. Adverse effects reported with Levosulpiride include drowsiness, amenorrhoea, gynaecomastia, galactorrhoea, and change in libido. Serious side effects include neuroleptic malignant syndrome, drug-induced movement disorders. Over dosage: There has been no experience with large overdose of Rabeprazole sodium EC & Levosulpride SR capsule. No specific antidote is known. In the event of overdose, treatment should be symptomatic and supportive. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful.
Dated: 7th September, 2021
Further information is available on request.
Razo Easy (Rabeprazole sodium Sachet)
Composition: Each single dose Sachet Contains: Rabeprazole Sodium IP 20 mg With Sodium Bicarbonate as buffer Excipients q.s. Indications: Rabeprazole is indicated for the treatment of Gastric ulcer, Duodenal ulcer, Zollinger-Ellison Syndrome and GERD. Dosage & administration: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg to be taken once daily for four-eight weeks. For patients who have not healed after 8 weeks of treatment, an additional 8 weeks course may be considered. Maintenance of Healing of Erosive or Ulcerative gastroesophageal Reflux Disease (GERD). The recommended adult oral dose is one RAZO-IR 20 mg tablet to be taken once daily. Healing of Duodenal ulcers and Gastric ulcers: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily after morning meal. Treatment of Pathological Hypersecretory Conditions, Including Zollinger Ellison Syndrome: The recommended adult oral starting dose is 60 mg once daily. Contraindications: It is contraindicated in patients with known hypersensitivity to Rabeprazole, or to any of its component or to substituted benzimidazoles. Rabeprazole is contra-indicated in pregnancy and during breast feeding. Special Warnings and Precautions for use: Patients on long-term treatment (> 1 year) should be kept under regular surveillance. Co-administration of Atazanavir with Rabeprazole is not recommended. Severe hypomagnesaemia has been reported in patients treated with PPIs like Rabeprazole for at least three months, and in most cases for a year. Concomitant use of PPIs with methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. It may reduce the absorption of vitamin B12 due to hypo- or a- chlorhydria. Use in specific populations: Effect on driving or handling machinery: It is unlikely that Rabeprazole would cause an impairment of driving performance or compromise the ability to use machinery. Use in Children: Rabeprazole tablets are not recommended for use in children due to a lack of data on safety and efficacy. Adverse Reactions: The most commonly reported adverse drug reactions, during controlled clinical trials with Rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. Over dosage: No specific antidote for Rabeprazole is known. Experience to date with deliberate or accidental overdose is limited. In the event of over dosage, treatment should be symptomatic and supportive.
Dated: 7th September, 2021
Further information is available on request.
RAZO IV Lyophilised (Rabeprazole Sodium for Injection)
Composition: No preservative added. Each twin pack contains: a) One vial of Rabeprazole Sodium for injection containing Rabeprazole Sodium IP 20 mg Excipients q.s. b) One ampoule (FFS) of Sterile water for injection IP 10 ml. Indications: For short term treatment of gastric and duodenal ulcer, Gastroesphageal Reflux Disease (GERD), as an alternative to oral therapy in patients who are unable to take proton-pump inhibitor. Dosage & administration: Parenteral routes of administration other than intravenous are not recommended. The recommended dose of Razo IV is 20 mg once daily by intravenous bolus over 15 minutes or by intravenous infusion for 7 to 10 days. No dosage adjustment is necessary in elderly patients, in renal diseases or in mild to moderate hepatic impairment. Contraindications: Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, substituted benzimidazoles or to any component of the formulation. Caution in severe hepatic impairment. No differences in safety or effectiveness were observed between elderly and younger subjects. Special Warnings and Precautions for use: Published observational studies suggest that proton pump inhibitor (PPI) therapy like omeprazole associated with an increased risk of clostridium difficile associated diarrhoea (CDAD), especially in hospitalized patients. The lowest dose and shortest duration of PPI therapy appropriate to the condition should be used. PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Use in specific populations: No adequate and well controlled studies with the drug in pregnant women are available, hence should be used in pregnancy only if clearly needed. Excretion in human breast milk not known. The safety and effectiveness of Rabeprazole in paediatric patients have not been established. Adverse Reactions: The most commonly reported adverse events with the drug include the following: headache, diarrhoea, abdominal pain, asthenia, flatulence, dry mouth, skin rash, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, arthralgia and bone fracture, and dizziness. The Uncommon are Nervousness, Somnolence, Bronchitis, Sinusitis, Dyspepsia, Dry mouth, Eructation, Rash, Erythema. Myalgia, Leg cramps, Arthralgia, Urinary tract infection, Chest Pain, Chills, Pyrexia, Increased hepatic enzymes. Leukopenia, Thrombocytopenia, Leucocytosis, Hypersensitivity, Anorexia, Depression, Visual disturbance, Gastritis, Stomatitis, Taste disturbance, Hepatitis, Jaundice, Hepatic encephalopathy, Pruritus, Sweating, Bullous reactions, Interstitial nephritis, Weight increased and acute kidney injury may occur. Erythema multiform, toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome (SJS) are very rare. Over dosage: No specific antidote for Rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In over dosage, treatment should be symptomatic and supportive.
Dated: 7th September, 2021
Further information is available on request.
LMRC CODE: GGI-CO-RE-RTS-300021212-300021212-WM-B22-514