Lansoprazole apollo

Transcription

1 Lansoprazole apollo Lansoprazole apollo Lansoprazole CAS Number : Molecular Weight : g/mol Molecular Formula : C16H14F3N3O2S Systematic (IUPAC) : 2-({[3-methyl-4-(2,2,2- trifluoroethoxy)pyridin-2-yl]methane}sulfinyl)-1h-1,3- benzodiazole Type : small molecule

2 Description Lansoprazole is a proton pump inhibitor which prevents the stomach from producing acid. It is manufactured by TAP Pharmaceutical Products. Lansoprazole has been marketed for many years and is one of several PPI s available. Categories Anti-Infective Agents Anti-Infectives Anti-Ulcer Agents Enzyme Inhibitors Proton-pump Inhibitors Taxonomy Kingdom : Organic Classes Benzimidazoles Ethers Substructures Benzimidazoles Pyridines and Derivatives Ethers Halogen Derivatives Benzene and Derivatives Imidazoles Heterocyclic compounds Aromatic compounds Imines

3 Cyanamides Sulfoxides Pharmacology Indication : For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, H. pylori eradication, and prevention of gastroinetestinal bleeds with NSAID use. Pharmacodynamics : Lansoprazole, an acid protonpump inhibitor similar to omeprazole, is used as an untiulcer drug in the treatment and maintenance of healing of duodenal or gastric ulcers, erosive and reflux esophagitis, NSAID-induced ulcer, Zollinger-Ellison syndrome, and Barrett's esophagus. Lansoprozole is active against Helicobacter pylori. The plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion. Thus, the plasma elimination half-life is less than two hours, while the acid inhibitory effect lasts more than 24 hours. Mechanism of action : Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but rather 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

4 leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Absorption : The absorption of lansoprazole is rapid, with mean Cmax occurring approximately 1.7 hours after oral dosing, and relatively complete with absolute bioavailability over 80%. Protein binding : 97% Metabolism : Hepatic. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by (H+,K+)-ATPase within the parietal cell canaliculus, but are not present in the systemic circulation. Route of elimination : Following single-dose oral administration of PREVACID, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites. Half life 1.5 (± 1.0) hours

5 Toxicity : Symptoms of overdose include abdominal pain, nausea and diarrhea. Affected organisms : Humans and other mammals Uses Lansoprazole is used to treat a number of problems. It is a member of a class of drugs called the proton pump inhibitors, sometimes known as PPIs. It is used to reduce the amount of acid produced in the stomach. In general, this drug is used for the treatment of ulcers of the stomach and duodenum (part of the small intestine), in combination with antibiotic drugs to remove the bacteria Helicobacter pylori from the stomach, for the prevention and treatment of other conditions associated with excess production of acid in the stomach, and for the treatment and prevention of ulcers in the stomach or gut caused by non-steroidal anti-inflammatory drugs (NSAIDs). Benefits of being on this drug can include relief from gastrointestinalpain, a reduction in excess acid production in the stomach and healing of gastrointestinal ulcers. Listed below are the typical uses of lansoprazole. Ulcers of the stomach Ulcers of the gut (duodenum) Treatment or prevention of ulcers of the stomach or gut caused by non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, ketoprofen and piroxicam which are used to treat pain and inflammation Treatment of infections caused by the bacteria Helicobacter pylori which is often associated with ulcers

6 of the gut (duodenum) or ulcer-like dyspepsia (indigestion). In this condition lansoprazole is given in combination with antibiotic therapy Gastro-oesophageal reflux disease (a condition associated with the escape of acid from the stomach into the food pipe or oesophagus causing damage and inflammation) Prevention and treatment of inflammation in the food pipe (oesophagus) also known as reflux oesophagitis On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below. Pain caused by indigestion or heart burn (associated with too much acid in the stomach) Zollinger-Ellison syndrome (a condition that occurs when the stomach produces too much acid) How often do I take it? Lansoprazole is available as a tablet or capsule. Lansoprazole capsules should be swallowed whole with a glass of water and not crushed or chewed. Lansoprazole orodispersible tablets should be placed on the tongue and sucked gently, at least 30 minutes before food. The tablet should then dissolve rapidly in the mouth to release small granules which you should swallow without chewing. Alternatively, the orodispersible tablets may be swallowed whole with a glass of water. If you have serious problems swallowing then your doctor may suggest that you to take the orodispersible tablets using an oral syringe. Make sure you carefully follow the administration instructions provided. If you are taking lansoprazole once a day, take it before breakfast. If you are taking lansoprazole twice a day, take the first dose in

7 the morning before breakfast and the second dose in the evening. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day - unless specifically told otherwise by your doctor. It may take some time before the full benefit of this drug takes effect. Certain medical conditions may require different dosage instructions as directed by your doctor. What dose? Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines. Do I need to avoid anything? Lansoprazole may cause dizziness, giddiness (vertigo), problems with your eyesight (vision) and drowsiness (somnolence). If you experience any of these symptoms whilst taking lansoprazole, do not drive or operate machinery. Consult your doctor or pharmacist for more details. When can I stop? It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop. Side Effects Feeling sick (nausea) Being sick (vomiting) Pain in the stomach area (abdomen)

8 Wind (flatulence) Diarrhoea Constipation Headache General feeling of being unwell Tingling, pricking or numbness of the skin or a feeling of pins and needles (paraesthesia) Hair loss Loss of appetite Swelling of the breasts and unable to get an erection (impotence) Low mood (depression) Pain in the joints (arthralgia) Muscle pain (myalgia) Swelling of the legs or arms (peripheral oedema) Changes in number of blood cells (detected on blood testing) Fever Tiredness Restlessness Feeling confused Strange sounds or visions (hallucinations) Feeling dizzy sometimes with a spinning feeling (vertigo) Disturbed sleep Blurred vision (sight) Dry or sore mouth and changes in the way things taste Inflammation of the tongue (glossitis) Skin rash Itchy skin (pruritus) Increased sensitivity of the skin to sunlight Excessive sweating Anaemia Kidney problems

9 Pancreatitis (inflammation of the pancreas) Liver problems Candidiasis (fungal infection) If any of these persist or you consider them severe then you should inform your doctor or pharmacist. Stop taking lansoprazole immediately and tell your doctor or got to a hospital straight away if you develop any of the following symptoms: Swelling of the hands, feet, ankles, face lips or throat which may cause difficulty swallowing or breathing. You may also develop an itchy, lumpy rash (hives) or nettle rash (urticaria). These symptoms may be a sign of an allergic reaction Blistering, peeling or bleeding of the skin around the lips, nose, eyes, mouth and genitals, possibly together with flu-like symptoms and a high temperature. These symptoms may be the sign of a very rare syndrome called Stevens-Johnson syndrome Severe blistering rash possibly with severe skin peeling which leaves large areas of raw exposed skin Yellowing of your skin, whites of your eyes, tiredness and fever. This may be a sign of liver problems Tell your doctor immediately if you develop any of the following symptoms: Diarrhoea and being sick Difficulty passing water (urine) You bruise more easily or get more infections than usual Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms

10 of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Precautions Before taking lansoprazole, tell your doctor or pharmacist if you are allergic to it; or to other proton pump inhibitors (PPIs); or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an allergy to lansoprazole or to other proton pump inhibitors (PPIs), the rare hereditary conditions of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, pregnant or breast feeding Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: liver problems, an intolerance to some sugars, phenylketonuria. Before having surgery, tell your doctor or dentist that you are taking this medication. Does alcohol intake affect this drug? Lansoprazole does not appear to be affected by alcohol The elderly: lansoprazole should be used with caution in the elderly as it may be cleared from (leave) the body more slowly in the elderly than in younger patients. A lower dose may be necessary in elderly patients.

11 Pregnancy and breastfeeding - please ensure you read the detailed information below Pregnancy The safety of lansoprazole has not been established during pregnancy. It is recommended that the use of lansoprazole is avoided during pregnancy. Ask your doctor or pharmacist if you have any doubts or questions about this. It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation. If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist. Breast Feeding It is not known whether lansoprazole passes into breast milk. The manufacturer therefore states that it should not be taken if you are breastfeeding. It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation. If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist. Interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you

12 for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: Atazanavir (used in the treatment of HIV). Clopidogrel (used to prevent heart attacks and strokes). If you are currently using any of these medications, tell your doctor or pharmacist before starting lansoprazole. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: Ketoconazole, itraconazole, rifampicin (used to treat infections) Digoxin (used to treat heart problems) Tracolimus (used to prevent transplant rejection) Fluvoxamine (used to treat depression and other psychiatric disease) The oral contraceptive pill Theophylline (for asthma) Phenytoin or carbamazepine (for epilepsy) Warfarin (for thinning the blood) Other medicines for indigestion or heart burn Sucralfate (used for healing ulcers) Antacids (used for heartburn) St John's wort (used to treat mild depression) This information does not contain all possible interactions. Therefore, before using lansoprazole, tell your doctor or pharmacist of all the products you use. Missed dose If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose

13 and resume your usual dosing schedule. Do not double the dose to catch up. Warning Lansoprazole should be used with caution in patients with liver disease, the elderly, patients with an intolerance to some sugars or phenylketonuria. It should not be used in women who are pregnant or breast feeding, patients with an allergy to lansoprazole or to other proton pump inhibitors (PPIs), children, liver problems, the rare hereditary conditions of galactose intolerance, Lapp lactase deficiency, or glucosegalactose malabsorption Also see list of precautions and interactions Storage Do not store above 25ºC. Do not keep in a fridge. apollo asia Division APOLLO Pharmaceuticals API Manufacturers INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK:

14 Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West,

15 Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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