Brands Of Lansoprazole in Kenya
Degastrol, Pharmaco Healthcare Limited
Lan 30mg ,Intas Pharmaceuticals Ltd
Lancid , Micro Labs Ltd
Lanop-30, Biodeal
Lanpro , Unichem Laboratories Ltd.
Lanzol-30 , Cipla Ltd
Lanzol DT Junior 15 mg Tablets, Cipla Ltd
Lasoprol, Delorbis Pharmaceuticals Limited
Lazope,Unicure RemediesPvt for Metro Pharmaceuticals Limited
Lazoton 30, Cosmos Limited
Selanz SR, The Searle Company Limited
Ulsacure , Gujarat Liqui Pharmacaps Limited
Zapacid , Win Medicare Private Limited
Lansoprazole Chemical Structure
Mechanism of Action
Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, 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 regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.
INDICATIONS
1.Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer
Short-Term Treatment 15 mg Once daily for 4 weeks
Maintenance of Healed 15 mg Once daily
2. Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence
a)Triple Therapy: Lansoprazole/amoxicillin/clarithromycin
Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
Lansoprazole 30 mg Twice daily for 10 or 14 days
Amoxicillin 1 gram Twice daily for 10 or 14 days
Clarithromycin 500 mg Twice daily for 10 or 14 days
b) Dual Therapy: Lansoprazole/amoxicillin
Lansoprazole in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
Lansoprazole 30 mg Three times daily for 14 days
Amoxicillin 1 gram Three times daily for 14 days
3.Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months
4.Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer
Short-Term Treatment 30 mg Once daily for up to 8 weeks
5.Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks
Healing 30 mg Once daily for 8 weeks
6.Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole is indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID
Lansoprazole 15 mg Once daily for up to 12 weeks
7.Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD
8.Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules are indicated for short-term treatment for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.
Lansoprazole 30 mg Once daily for up to 8 weeks
9. Maintenance of Healing of EE
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months
Lansoprazole 15 mg Once daily
10.Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome(ZES)
Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome
Lansoprazole 60 mg Once daily
CONTRAINDICATIONS
Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria
Proton Pump Inhibitors (PPIs), including lansoprazole , are contraindicated with rilpivirine-containing products
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the Contraindications section of their prescribing information.
DRUG INTERACTIONS
Effects of lansoprazole on other drugs
Medicinal products with pH dependent absorption
Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavailability.
Atazanavir:
A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax). Lansoprazole should not be co-administered with atazanavir (see section 4.3).
Ketoconazole and itraconazole:
The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid. Administration of lansoprazole may result in sub-therapeutic concentrations of ketoconazole and itraconazole and the combination should be avoided.
Digoxin:
Co-administration of lansoprazole and digoxin may lead to increased digoxin plasma levels. The plasma levels of digoxin should therefore be monitored and the dose of digoxin adjusted if necessary when initiating and ending lansoprazole treatment.
Medicinal products metabolised by P450 enzymes
Lansoprazole may increase plasma concentrations of drugs that are metabolised by CYP3A4. Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme and have a narrow therapeutic window.
Theophylline:
Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose. Caution is advised when combining the two drugs.
Tacrolimus:
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P-gp substrate). Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%. Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lanzoprazole is initiated or ended.
Medicinal products transported by P-glycoprotein
Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro. The clinical relevance of this is unknown.
Effects of other drugs on lansoprazole
Drugs which inhibit CYP2C19
Fluvoxamine:
A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine. A study shows that the plasma concentrations of lansoprazole increase up to 4-fold.
Drugs which induces CYP2C19 and CYP3A4
Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Others
Sucralfate/Antacids:
Sucralfate/Antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least 1 hour after taking these drugs.
No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.
ADVERSE REACTIONS
Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain
Cardiovascular System: angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation
Digestive System: abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis
Endocrine System: diabetes mellitus, goiter, hypothyroidism
Hemic and Lymphatic System: anemia, hemolysis, lymphadenopathy
Metabolism and Nutritional Disorders: avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss
Musculoskeletal System: arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis
Nervous System: abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo
Respiratory System: asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor
Skin and Appendages: acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria
Special Senses: abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect
Urogenital System: abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Lansoprazole in Kenya
Lansoprazole in Kenya
Lansoprazole in Kenya
Lansoprazole in Kenya
Lansoprazole in Kenya
Lansoprazole in Kenya
Lansoprazole in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: By mouth, IV
Bioavailability: 80% or more
Protein Binding: 97%
Metabolosim: Liver (CYP3A4- and CYP2C19-mediated)
Onset of Action: N/A
Elimination Half life: 1.0–1.5 hours
Excretion: Fecal and Kidney
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
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Drug Images
References/ Citation:
- PPB Drugs Retention Register
- Barradell, Lee B., Diana Faulds, and Donna McTavish. “Lansoprazole.” Drugs 44.2 (1992): 225-250.
- Landes, B. Delhotal, J. P. Petite, and B. Flouvat. “Clinical pharmacokinetics of lansoprazole.” Clinical pharmacokinetics 28.6 (1995): 458-470.
- Iwahi, T., et al. “Lansoprazole, a novel benzimidazole proton pump inhibitor, and its related compounds have selective activity against Helicobacter pylori.” Antimicrobial Agents and Chemotherapy 35.3 (1991): 490-496.