Molecule Info

Content

Each combo formulation contains One Lansoprazole USP 30 mg capsule, Two Amoxycillin BP 500 mg capsules and One Clarithromycin USP 500 mg tablet.

Indication & dosage

This is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers. Twice daily for 7-14 days or as per the physician's advice.

Contraindication

Contraindicated in patients with known hypersensitivity to any of its component. 

Precaution

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been, reported in patients on Amoxycillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. 

Drug Interaction

Lansoprazole is metabolized through the cytochrome P450 system, specially through the CYP3A and CYP2C19 isozymes. Studies have shown that Lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin or terfenadine in healthy subjects.

Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfetanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide & astemizole. 

Use in pregnancy/ lactation & geriatrics

There were no adequate and well-controlled studies of This product in pregnant women. This product should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Amoxicillin is excreted in human milk in very small amounts. Because of the potential for serious adverse reactions in nursing infants from This product a decision should be made Whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother.

Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to these patients. 

Side effects

Side effects which were reported as possibly or probably related to treatment (>3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body systems.

Digestive system: Nausea, vomiting, diarrhoea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration ;

Musculoskeletal System - myalgia;

Nervous System - confusion, headache, dizziness;

Skin - allergic reactions;

Urogenital System - vaginitis, vaginal moniliasis.

Brand/Product Info


Total Products : 2  
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
HELICON KIT General Pharmaceuticals Ltd 1 lansoprazole INN 30mg+ 2 Amoxycillin BP 500mg+ 1 Clarithromycin USP 500mg Combo 14's: 772.94 MRP
PYLOTRIP Square Pharmaceuticals Ltd. Lansoprazole 30mg+ Clarithromycin 500mg+ Amoxicillin 1gm 0 7's: 386.12 MRP

Gen. MedInfo

WHY THIS MEDICATION IS USED

This combination preparation is used to treat HELICOBACTER PYLORI (H. Pylori) infection. People with a history of peptic ulcer disease, active gastric ulcer, or active duodenal ulcer associated with H. pylori infection should be treated. Successful treatment of H. pylori can help the ulcer to heal, prevent ulcers from coming back, and reduce the risk of ulcer complications (like bleeding).

Medications — No single drug cures H. pylori infection. Treatment involves taking several medications for 7 to 14 days.

  • Most of the treatment regimens include a medication called a proton pump inhibitor. This medication decreases the stomach's production of acid, which allows the tissues damaged by the infection to heal. Examples of proton pump inhibitors include lansoprazole, omeprazole, pantoprazole, rabeprazole, dexlansoprazole, and esomeprazole.
  • Two antibiotics are also generally recommended; this reduces the risk of treatment failure and antibiotic resistance.
  • There are increasing numbers of patients with H. pylori infection that is resistant to antibiotics so it is important to take all the medications prescribed and to have a test that confirms that the infection has been cleared.

Although the optimal H. pylori treatment regimen continues to be investigated, the American College of Gastroenterology has recommended four specific drug regimens that use a combination of at least three medications. These regimens successfully cure infection in up to 90 percent of people. For the H. pylori treatment to be effective, it is important to take the entire course of all medications.

Side effects — Up to 50 percent of patients have side effects while taking H. pylori treatment. Side effects are usually mild, and fewer than 10 percent of patients stop treatment because of side effects. For those who do experience side effects, it may be possible to make adjustments in the dose or timing of medication. Some of the most common side effects are described below.

  • Some of the treatment regimens use a medication called metronidazole (Flagyl) or clarithromycin. These medications can cause a metallic taste in the mouth.
  • Alcoholic beverages should be avoided while taking metronidazole; the combination can cause skin flushing, headache, nausea, vomiting, sweating and a rapid heart rate.
  • Bismuth, which is contained in some of the regimens, causes the stool to become black and may cause constipation.
  • Many of the regimens cause diarrhea and stomach cramps.

Treatment failure — Up to 20 percent of patients with H. pylori infection are not cured after completing their first course of treatment. A second treatment regimen is usually recommended in this case. Re-treatment usually requires that the patient take 14 days of a proton pump inhibitor and two antibiotics. At least one of the antibiotics is different from those used in the first treatment course.

Follow-up — After completing H. pylori treatment, repeat testing is usually performed to ensure that the infection has resolved. This is typically done with a breath or stool test. Blood tests are not recommended for follow up testing; the antibody detected by the blood test often remains in the blood for four or more months after treatment, even after the infection is eliminated.

HELICOBACTER PYLORI OVERVIEW

Helicobacter pylori, also known as H. pylori, is a bacterium that is commonly found in the stomach. It is present in approximately one-half of the world's population.

The vast majority of people infected with H. pylori infection have no symptoms and will never develop problems. However, H. pylori is capable of causing a number of digestive problems, including ulcers, and, much less commonly, stomach cancer. It is not clear why some people with H. pylori get these conditions and others do not.

H. PYLORI RISK FACTORS

H. pylori is probably spread by consuming food or water contaminated with fecal matter. H. pylori causes changes to the stomach and duodenum (the first part of the small intestine). The bacteria infect the protective tissue that lines the stomach. This leads to the release of certain enzymes and toxins and activation of the immune system. Together, these factors may directly or indirectly injure the cells of the stomach or duodenum. This causes chronic inflammation in the walls of the stomach (gastritis) or duodenum (duodenitis).

As a result of these changes, the stomach and duodenum are more vulnerable to damage from digestive juices, such as stomach acid.

In the United States and other developed countries, infection with H. pylori is unusual during childhood but becomes more common during adulthood. However, in developing countries, most children are infected with H. pylori before age 10.

H. PYLORI SYMPTOMS

Most individuals with chronic gastritis or duodenitis have no symptoms. However, some people develop more serious problems, including stomach or duodenal ulcers.

Ulcers can cause a variety of symptoms or no symptoms at all, with the most common ulcer symptoms including:

  • Pain or discomfort (usually in the upper abdomen)
  • Bloating
  • Feeling full after eating a small amount of food
  • Lack of appetite
  • Nausea or vomiting
  • Dark or tar-colored stools
  • Ulcers that bleed can cause a low blood count and fatigue

Less commonly, chronic gastritis causes abnormal changes in the stomach lining, which can lead to certain forms of cancer. It is uncommon to develop cancer as a result of H. pylori infection. Nevertheless, because so many people in the world are infected with H. pylori, it is considered to be an important cause of stomach cancer. People who live in countries in which H. pylori infection occurs at an early age are at greatest risk of stomach cancer.

WHO SHOULD BE TESTED FOR H. PYLORI?

If you have symptoms — Diagnostic testing for H. pylori infection is recommended if you have active gastric or duodenal ulcers or if you have a past history of ulcers.

Although H. pylori infection is the most common cause of ulcers, not all patients with ulcers have H. pylori. Certain medications (eg, aspirin, ibuprofen, naproxen) can also cause peptic ulcers. 

If you do not have symptoms — H. pylori testing is usually not recommended if you have no symptoms and no past history of peptic ulcer disease. However, it may be considered for selected people, such as those with a family history or concern about stomach cancer, particularly individuals of Chinese, Korean, Japanese, or Central American descent; these groups have a higher incidence of stomach cancer.

Consult your healthcare provider for questions and concerns related to your medical problem.

 


 

This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.