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Dr Reddy’s Laboratories has purchased the oral penicillin laboratory of GlaxoSmithKline based in USA

In a major buyout at the global pharmaceutical scenario, Dr Reddy’s Laboratories has purchased the oral penicillin laboratory of GlaxoSmithKline based in USA.

The transaction amount is not yet disclosed by Dr Reddy’s, a pharma major.

“This acquisition allows us to enter the US penicillin-containing antibacterial market segment and serve the needs of our customers. This is in line with our strategy to significantly scale up our generics business in North America, while providing an opportunity to explore additional synergy with our other businesses,” said, Abhijit Mukherjee, President (Global Generics Business), Dr Reddy’s Laboratory.

Drug Controller General of India (DCGI) has advised small units to adopt bar coding for their product

In an effort to improve efficiency of small pharma units, the Drug Controller General of India (DCGI) has advised these units to adopt bar coding for their product.

The advisory from the drug controller comes in the wake of Union Health Ministry’s proposal to make bar coding of drug formulations mandatory. The small pharma are asked to make full use of the subsidy granted by the government for the same.

“Bar codes can be very effectively used to track distribution of drugs in the marketplace and recall them if necessary. It also assists in effectively monitoring stock and consumption in hospitals. We will be happy to request all the federation members to impress upon their manufacturing units who have not so far adopted bar coding, to do so at the earliest, because this will be in their interest and in the interest of the industry as a whole,” said, T. S. Jaishankar, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI).

Mumbai Base Pharma PCD Company need Franchise Stockiest from All India

Activa Lifesciences requires PCD and Franchise stockist and distributors from all over India.

We have pharmaceutical tablets, capsules, syrups and Dry Syrups etc.

Most advanced range with world class packing

1. Largest Range of Molecules
2. Monopoly Rights
3. Creative Promotional Inputs
4. Latest Book type Visual Aid
5. Attractive catch covers
6. Gift Articles


We offer promotional inputs and marketing assistance absolutely free!

We Provides


  • Timely Delivery
  • Competitive Prices
  • Attractive Packaging
  • Marketing Backup
  • Wide Range
  • Guaranteed Monopoly
  • AND HUGE MARGINS OF PROFITS


We Need

The Person from pharma Marketing experience ( As MR, ASM, RSM,ZSM etc. in any pharma company) are welcome for sole Marketing and Distribution rights.

If you are really interested to be associated with us and engage your territory initially to enjoy monopoly, then you can Call/e-mail/fax to us.

Interested can contact with postal address and contact number.

To contact us go to Activa

Gujarat State FDCA in collaboration with CII is organising a one-day seminar on November 27

With a view to sensitise the pharma industry on 'Vibrant Gujarat 2011' starting on January 12, the Gujarat State Food and Drug Control Administration (FDCA) in collaboration with CII is organising a one-day seminar on November 27. The seminar is a part of Vibrant Gujarat global investors summit 2011 aimed to attract investors of pharma and boitech industry to the state.

The main aim of the seminar is to sensitise and create awareness about the investment opportunities that Gujarat holds for future investors. According to Hemant Koshia, commissioner, FDCA, "Gujarat has a lot of untapped potential and we plan to bring these into focus so as to provide lots of investment opportunities for companies. With this seminar, we want to inform our potential investors about the opportunity that Gujarat can provide them."

It would be an ideal ground to meet the potential investors who would be interested in entering into memorandum of understanding (MoU) with the Gujarat government. He adds that through this seminar the government plans to sustain and enhance the image of Gujarat as a hub of pharma industry by pro actively informing the industry about the benefits of investment in Gujarat.

In 2009, the Gujarat government had signed 26 MoU's with pharma companies which resulted in about Rs. 27,000 crore to be invested in the state. Koshia informed that out of the 26 MoUs the government has already completed its work on eight plants which are functioning at present, where as for the others work is under progress. "The government is having high expectation from the upcoming event and is hopeful to cross the target of 26 MoUs that was achieved in Vibrant Gujarat 09," he said.

The main hubs of pharma based activities in Gujarat is clustered in and around Ankleshwar, Ahmedabad, Vadodara and the Bharuch-Vapi-Valsad belt and are home to many domestic and international pharma and biotech companies. At present there are 2322 pharma manufacturing units and 115 units manufacturing medical devises that are operational in Gujarat. National share of Gujarat's pharma industry is approximately 42 per cent, I.V. set/BT set manufacturing is approximately 80 per cent, orthopaedic implants is approximately 50 per cent, intraocular lenses is approximately 35 per cent and cardiac stent is approximately 30 per cent. The state also has five AC-GET projects coming up exclusively for pharma industry which is attracting a lot of inquiries from other parts of India for setting up units in Gujarat.

Maharashtra FDA will have 95 new inspectors in the next three months

MUMBAI: The Food and Drug Administration in Maharashtra will have 95 new inspectors in the next three months.

Last 10 years has seen no newdrug inspectors in the state. The latest recruitment drive is to make the department more efficient. Out of 161 posts of drug inspectors, 95 are still vacant. The new recruitment drive is initiated by Seema Vyas, the first women FDA commissioner of the state.

Maharashtra accounts for 40 percent of exported drugs from India. Furthermore nearly 50 percent of India’s drugs are manufactured in the state.

Eight purifiers tested did not conform to USEPA standards - Health News

Despite loud promises that these gadgets suck out disease-causing bugs from drinking water, most purifiers sold across India do not completely eliminate water-borne viruses like Hepatitis E, says Pune-based National Institute of Virology.

A study by the government-funded body that conducts research on communicable diseases and viruses evaluated eight domestic water purifier brands. It found only two - one equipped with a hollow fibre membrane and the other with a gravity-fed filter - could completely remove the viruses.

The study also found no standards existed for virological evaluation of water purification devices in India and called for well-defined parameters.

The NIV relied on the United States Environment Protection Agency's (USEPA) guide, standard and protocol benchmark for testing microbial purifiers.

The study was conducted by senior deputy director and head of the NIV's hepatitis division, Vidya Arankalle, and scientist Vikram Verma. The Indian Council of Medical Research ( ICMR), ministry of health and family welfare, government of India, extended financial suppo rt to the study conducted by the NIV scientists.

The purifiers that were tested included those using activated carbon filters, ceramic candle filters, sediment filters, iodine resin gravity filters, polyster filters, ultraviolet irradiation, reverse osmosis and hollow fibre membrane filters. These features were either employed singly or in a combination.

The purifiers were evaluated using Hepatitis E vir us (HEV) as a model. The viral log reduction value (LRV) - the capacity to eliminate viruses - was calculated for each purifier.

"The log reduction value (LRV) is the difference in the amount of virus particles between raw water (spiked with HEV) and purified water," said Verma. The US EPA criterion for reduction of viruses is 4.0 log. This means that if there are 10,000 particles in the water that is going to be processed, there should be no viral particles in the water after purification.

"We evaluated one purifier of each brand. The batch-to-batch or unit-to-unit variation was not evaluated. However, even with this limitation, the results indicated that six of the eight purifiers tested did not conform to USEPA standards. The purifiers did not remove the viruses completely," said Arankalle.
"We need a national policy for the evaluation of such purifiers by the regulatory authorities and at the factory level. This will ensure availability of quality domestic water purifiers," she said.

According to Arankalle, viruses remain longer than bacteria in water. "In India, the standard to evaluate the microbial performance of a purifier is for the device to provide bacteria-free water from water in which a fixed amount of Escherichia coli bacteria has been added. However, it is unsafe to rely only on bacteriological standards to assess the virological quality of water. Virological standards should be established immediately," she said.

The Bureau of Indian Standards (BIS), which looks into the standardisation, certification and quality of purifiers, has already appointed a commitee to look into the NIV report.

"The first sectional meeting on water purification equipment was held at the BIS on April 28 this year. The committee discussed the nitty-gritties involved in formulating a regulation regarding the quality of water purifiers. We have also formed sub-committees to look into the bacteriological and microbiological aspects of water purifiers," said Pawan Labhshetwar, who is heading the committee formed by the BIS on water purification equipment.

The meeting was attended by representatives from NIV Pune, NEERI, Chennai, Eureka Forbes, Bangalore and Dehradun, Unilever R&D, Bangalore, Ion Exchange and Whirlpool India, Faridabad. The next meeting will be held in October.
When contacted, K V Thomas, Union minister of state for agriculture, consumer affairs, food and public distribution, told TOI that the upgradation of existing standards was on the anvil. "We need to address the upgradation issue urgently. I will ask the BIS to speed up the process," he said.

While NIV did not reveal to TOI brands of the water purifiers it tested, Hindustan Unilever Ltd insisted that their purifier, Pureit, met all standards.

Vikram Surendran, general manager (water), Hindustan Unilever, said, " Pureit meets the germ removal criteria of the Environmental Protection Agency (EPA), the toughest drinking water regulatory agency in the US. The EPA standard requires a 4.0 log reduction value with respect to virus removal and Pureit meets the same. It is pertinent to clarify that Pureit also removes enteric viruses from water, including the Hepatitis A and Hepatitis E viruses." "The study by NIV in fact identifies Pureit as the device which meets US standards," he said.

Eureka Forbes Limited (EFL), which manufactures water purifier Aquaguard, differed on the methods adopted by the NIV for its study. Marzin R Shroff, CEO, (direct sales) and senior vice-president (marketing), EFL, said, "The Real Time-Polymerase Chain Reaction (RT-PCR) method used in this specific study has been declared unreliable in citations by the global research community for measuring the virus inactivation efficacy of UV-based products, because the method is known to give false positives and is also not approved by global regulatory authorities like the USEPA."

Raman Venkatesh, EFL's senior vice-president (technology), said, "The NIV study does not cite whether the flow rates of products tested are in compliance with the design or rated flow rates, as that will have a great impact on the contact time and dosage of UV-based products, which will impact disinfection efficacy."

Commenting on EFL's objection to the method used in the evaluation, Verma said, "The methodology used in the virological evaluation of water purifiers was recently published in UK-based journal, Tropical Medicine and International Health, after a thorough review. This peer-reviewed journal had been in the public domain for the last one year. If the methodology was unreliable, it would not have found a place in such a prestigious journal."

Verma further said, "We have amplified the complete genome of the virus present in the purified water samples and this is sufficient to prove the infectivity of the virus. We have also taken proper measures to rule out any false positive results with the help of the RT- PCR technique."

Repeated attempts to contact Ion Exchange and Whirlpool India Limited were unsuccessful.

Temporarily banned the use of paracetamol injections - Latest Pharmaceutical News,

The state government has "temporarily banned the use of paracetamol injections in all government hospitals across the State till further orders" following the death of two people in Suntikoppa, Kodagu district after they were administered paracetamol injections in the primary health centre, said commissioner, health & family welfare, D.N. Nayak.

Two people - Susheela, 57, from Kedakkal near Suntikoppa, and Moidu 66, from Pumphouse in Suntikoppa town died soon after they were administered paracetamol injections in the PHC, Suntikoppa on Saturday morning.

The third victim, Sarita, 25, from Kushalnagar, died after she was administered dextrose IV fluid and Ranitidine - an antihistamine, said the commissioner.

He added that in the case of paracetamol the victims were given muscular injections. Mr Nayak said that though the post-mortem reports of the deceased are expected to arrive on Tuesday; the decision to temporarily ban the paracetamol injections in government hospitals has been taken as a precautionary measure. According to him deaths could possibly be due to "drug reaction and shock".

Meanwhile the drug controller Dr B.R. Jagashetty has seized the samples of the 'killer' drugs - the paracetamol vials, the dextrose IV fluid and Ranitidine and sent them to the Drug Testing Laboratory, Bengaluru. "The tests will take at least a fortnight," said Dr. Jagashetty.
"The drugs will be put through chemical and later abnormal toxicity and sterility tests on animals to rule out contamination," said Mr Nayak.

The paracetamol injections were acquired by the government from two pharmaceutical firms - SPM Drugs, Bhawani, Tamil Nadu and Nagarjuna Sagar, Hyderabad, the Commissioner said.

Wanted PCD Distributors for Pharma Company from Maharashtra - PCD & Franchise Offer

Dear Sir / Madam
Greetings from Activa Lifesciences - Mumbai!

We would be privileged to be associated with your organization to represent our product range.

Activa Lifesciences - Mumbai is one of the fastest growing pharmaceutical arm of Activa  group specialized in manufacturing ,distribution and marketing of wide range of pharmaceuticals and specialty health care products including tablets and capsules formulations.

Our motto is to give best quality and efficacy pharmaceutical products for the benefit of man kind 

The company currently focuses on following important areas of health care
1 Proton Pump Inhibiters Products
2 Gynaecological products
3 Food supplements
4 Anti-infectives
5 General products

We are pleased to offer you Franchise Marketing Distributorship (Exclusive Marketing Cum Distribution franchise) for your area with monopoly rights.
DETAILS OF ADVANTAGES / FACILITIES OFFERED TO FRANCHISEE

By being our franchise, you will have to market the products in your territory and for the same you shall avail the following:

1. Around 70 range of Pharma Products with wide therapeutic coverage.
2. Pricing of products on competitive NET RATES
3. Products Free from Excise Duty
4. Samples, Call and Visiting cards, Product cards, Visual Aids, M.R. Bags, Literatures, Updates, Abridged Prescribing Guide, Glossaries, Pens, Key Chains, Pads, Drug Manuals, TPLs, Scripto Medical Detailing Story, and Gift Items provided
5. Turnover Incentive Schemes
6. Free Monthly Gift Schemes and Innovative Product Promotion Schemes
7. Exclusive Marketing Rights on monopoly system for allotted area.
8. Maximum support from the end of Company as and when required.
9. Customization of Prices as required for bulk purchases

Awaiting your valuable reply
Many Thanks
--
With Best Regards
Himmat Bhanushali
9870298512
For Activa Lifesciences - Mumbai


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5 Rabeprazole-20mg + Domperidone-10mg Tablets (Alu-Alu Pack)
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8 Lansoprazole-30mg Capsules (Alu-Alu Pack)

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Get Aceclofenac-100mg + Paracetamol-500mg tablet at lowest rate in latest Alu-Alu pack

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A new approach to drug discovery that may eventually yield drugs with fewer side effects.

Researchers at the Stanford University School of Medicine have taken an early step toward identifying a new approach to drug discovery that may eventually yield drugs with fewer side effects.

In a study to be published online Jan. 7 in Nature, investigators led by senior author Brian Kobilka, MD, professor and chair of molecular and cellular physiology, found that largely neglected regions on key cell-surface proteins undergo minute changes in shape in response to drugs and thus could prove useful in drug design. The study's first author is Michael Bokoch, an MD/PhD student in Kobilka's laboratory.

The class of proteins known as G-protein-coupled receptors, or GPCRs, is already immensely important in drug research, accounting for some 40 percent of all currently marketed drugs, said Kobilka. His laboratory focuses on a particular type of GPCR called adrenergic receptors, which are activated by adrenaline and its close cousin noradrenaline. Secreted by the adrenal glands and certain nerve cells, these two "molecules on a mission" regulate key physiological actions in the central nervous system, heart and musculature. They are acclaimed for tripping off the "fight or flight" response, which steels middle-aged mortals' melting muscles for high-stakes activities like fending off saber-tooth tigers or running to catch a bus.

Like all GPCRs, an adrenergic receptor consists of three portions. One is anchored within a cell's outer membrane. The second juts from the cell's outer membrane surface and is exposed to the external environment. And the third extends into the cell's fluid interior, or cytoplasm.

Cell-surface receptors are akin to customized doorbells that ring only if pressed by molecular fingers with precisely the right shape. For an adrenergic receptor, the fingers with the magic touch are adrenaline and noradrenaline. When a molecule of one of these structurally similar substances happens upon an adrenergic receptor, it is drawn to a site on the receptor called a binding pocket with just the right shape and charge for a snug fit. (An adrenergic receptor's binding pocket sits within the portion of the receptor that is anchored in the cell's outer membrane.) The binding event alters the shape (or "conformation") of the receptor's cytoplasm-facing domain, setting off a massive redirection of activity inside the cell.

Other molecules besides adrenaline and noradrenaline can slip into adrenergic receptors' binding pockets. That's the basis for many effective drugs. Cell-surface receptors are great targets for the small molecules that drug developers discover and deliver into our bodies to stimulate or shut down a physiological process. Various drugs can affect the same receptor quite differently. "Agonists" lock their targeted receptor into an active or even hyperactive mode. "Antagonists" force the receptor into a sluggish or inactive posture so that it stalls out, or they simply get in the way of the naturally occurring molecules the receptor was meant to match.

Adrenergic receptors come in nine different varieties, or subtypes, all responsive to adrenaline and noradrenaline but playing different roles in regulating bodily functions. For instance, Kobilka said, the beta-2 adrenergic receptor is the chief regulator of smooth muscle, especially in relaxing air passages such as the lungs (a fight-or-flight necessity). This makes beta-2 agonists, which open airways, good for combating an asthma attack.

It is primarily the beta-1 receptor that accelerates the heartbeat and stimulates the heart to pump more blood per beat. That's also great for a fight-or-flight response. But too much beta-1 stimulation over an extended period can lead to medical problems like heart failure. Thus, beta-1 antagonists (also known as beta-blockers) are often prescribed for patients with coronary artery disease, heart failure or arrhythmias.

The trouble is, drugs that fit in one subtype's binding pocket can often climb into the other's. "The beta-1 and beta-2 receptors largely respond to drugs in the same way. That's one reason we get side effects," said Kobilka. "Say you have a patient with both heart disease and asthma. You want to treat that patient's lung problem with beta-2 agonists. But those may stimulate beta-1 receptors in the heart, potentially causing arrhythmias. So you can't use beta-2 agonists in that patient. Similarly, you may not be able to use a beta-1 antagonist for this patient's heart problem, because it may exacerbate the asthma."

While the binding pockets of various adrenergic-receptor subtypes have to be nearly identical so they can all attract and bind adrenaline and noradrenaline, certain portions of these receptors' exposed outer domains have been freer to diverge over eons of evolution. The extracellular portions of the beta-1 and beta-2 adrenergic receptors, for instance, are quite different. A drug that bound selectively to an extracellular section of one receptor subtype - but not of the second subtype - in a way that altered the receptor's cytoplasmic conformation just as do drugs that target the receptor's binding pocket might be more selective, minimizing side effects.

Kobilka and his colleagues used a sensitive technique called nuclear magnetic resonance spectroscopy to zero in on one specific part of the beta-2 adrenergic receptor's extracellular domain to see if they could detect subtle changes in that area when they applied three different drugs: a beta-2 adrenergic-receptor agonist, an antagonist and a third one with a neutral effect on the receptor's activation status. Even though the drug molecules themselves landed smack-dab in their binding pockets as expected, each drug coaxed this part of the receptor's extracellular domain into a different conformation. This suggests, said Kobilka, that the conformational shifts of this region were coupled to those triggered by the drugs' interactions with the receptor's binding pocket.

If this coupling works in reverse, molecules that bind to the extracellular domain could conceivably modulate receptor function. Thus, the diversity of different receptors' extracellular domains could be exploited to modulate receptor activity, with high subtype selectivity.

Even if the tail-wags-the-dog effect were only slight, Kobilka said, drugs targeting GPCRs' extracellular surfaces would still let natural molecules fit into their binding pockets. "So, instead of simply switching receptor activity on or off they could instead fine-tune that activity, like rheostats. For therapy, it would be nice to control the receptor's activity in this way."

Patients, physicians, pharmacists and other healthcare providers need to know about the potential harm these herbs can have.

Millions of people are thought to use over the counter herbal remedies but doctors have warned that just because they are 'natural' does not mean they are safe.

They added that these substances can interfere with the way conventional medicines work, making them more potent or ineffective.

Researchers writing in the Journal of the American College of Cardiology said patients should inform their doctor if they are taking any herbal preparations.

Experts from the prestigious May Clinic in Arizona, America, said that St John's Wort, typically used for mild depression and sleep problems can reduce the effect of drugs to treat heart rhythm problems and high blood pressure. It may also increase blood cholesterol levels which may contribute to heart problems.

Ginkgo biloba, taken by some to boost their immune system or 'sharpen' their attention and increase energy levels can increase the risk of bleeding in patients taking blood thinners warfarin and aspirin.

Garlic can also have the same effect when taken in large doses.

Patients taking drugs such as warfarin are already wanred to avoid a list of foods and drinks, including grapefruit juice, as it interferes with the blood thinning action of the drug.

Dr Arshad Jahangir, Professor of Medicine and Consultant Cardiologist, at the Mayo Clinic, said: "Many people have a false sense of security about these herbal products because they are seen as 'natural'.

"But 'natural' doesn't always mean they are safe. Every compound we consume has some effect on the body, which is, in essence, why people are taking these products to begin with.

"We can see the effect of some of these herb-drug interactions some of which can be life-threatening—on tests for blood clotting, liver enzymes and, with some medications, on electrocardiogram."

He said a major concern is that patients often do not tell their doctor they are taking herbal remedies as they do not think of them as medicines.

Dr Jahangir said: "These herbs have been used for centuries well before today's cardiovascular medications—and while they may have beneficial effects these need to be studied scientifically to better define their usefulness and, more importantly, identify their potential for harm when taken with medications that have proven benefit for patients with cardiovascular diseases.

"Patients, physicians, pharmacists and other healthcare providers need to know about the potential harm these herbs can have."

Proton pump inhibitors (PPIs) may reduce the benefits of aspirin in patients with coronary artery disease (CAD)

Proton pump inhibitors (PPIs) may reduce the benefits of aspirin in patients with coronary artery disease (CAD), researchers from Denmark report.

Previous research has suggested that concomitant PPI use might be responsible for the reduced aspirin efficacy seen in some patients.

â€Å“Aspirin is the mainstay of secondary antithrombotic treatment; accordingly, low-dose aspirin lowers the risk of vascular events by 32% in high-risk patients,” explain Anne-Mette Hvas (Aarhus University Hospital, Brendstrupgaardsvej) and colleagues in the journal Heart.

â€Å“However, platelet response to aspirin is variable and in some patients platelet aggregation is inhibited less than expected and these patients might be at an increased risk of cardiovascular events.”

PPIs exert their antacid effect by inhibiting an ATPase associated with gastric parietal cells and raising intragastric pH, which can greatly reduce the lipophilicity of aspirin and, therefore, potentially its efficacy.

To better understand the effects of PPIs on aspirin function, the investigators studied 418 patients with stable CAD, all of whom were taking aspirin 75 mg/day and 54 of whom were also taking PPIs.

Analysis revealed that platelet aggregation was significantly greater in patients taking aspirin as well as a PPI (180 units/min) than in those taking aspirin only (152 units/min).

Platelet activation, as assessed by levels of soluble serum P-selectin, was also significantly increased in those taking both aspirin and a PPI (88.5 ng/ml) than those taking aspirin only (75.4 ng/ml).

Importantly, these differences were not explained by differences in age, sex, body mass index, blood pressure, family history of ischemic heart disease, smoking, or diabetes, all of which factors were well balanced between patient groups.

Although the authors did not demonstrate a causal link between PPI use and reduced aspirin function, â€Å“these findings may nevertheless affect the clinical practice of antithrombotic treatment,” conclude the researchers.

â€Å“In view of the widespread use of PPIs, a randomised double-blind crossover study is needed to explore further the inhibitory effect of PPIs on aspirin,” the investigators recommend.

What is the treatment for acid reflux?

Diet

The vast majority of people with acid reflux will get better if they make some changes to their diet. Some foods are safe for heartburn sufferers, while others are major triggers of it.

It would be easy to say that there is a reflux diet. Unfortunately, we all react differently to different foods.

Below is a list of foods/drinks that commonly cause irritation and/or heartburn:
  • Alcohol
  • Black pepper
  • Chili and chili powder
  • Citrus fruit, pineapple
  • Coffee
  • Garlic
  • Spicy food
  • Tea
  • Tomatoes, tomato sauce, tomato juice, ketchup
  • Vinegar
  • Some patients with acid reflux say these gassy foods cause discomfort:
  • Beans
  • Broccoli
  • Brussel Sprouts
  • Cabbage
  • Cauliflower
  • Kale
  • Fizzy drinks (sodas)
  • Medications

Acid suppressant - these have been shown to be effective, such as histamine2-receptor antagonists (blockers). Histamines are good at reducing inflammation. An inflamed stomach produces more acid - blocking this extra production of acid helps prevent the acids from building up and seeping upwards.

Propton pump inhibitors - these reduce the production of acid in the stomach. They act on cells in the stomach wall and produce stomach acids.

Prokinetic agents - these promote the emptying of the stomach, stopping it from becoming overfull.

Antiacids - commonly used to treat mild acid-related symptoms, such as heartburn or indigestion. They neutralize the acids in the stomach. These are not recommended for frequent heartburn for patients with GERD.

What are the symptoms of acid reflux?, What causes acid reflux?

What are the symptoms of acid reflux?

Asthma - gastric juices seep upwards into the throat, mouth and air passages of the lungs
Chest pain - part of the heartburn sensation
Dental erosion
Dysphagia - difficulty swallowing
Heartburn - a burning feeling rising from the stomach or lower chest towards the neck
Hoarseness
Regurgitation - bringing food back up into the mouth
What causes acid reflux?

Acid reflux commonly occurs when the lower esophageal sphincter (LES) does not work properly, and allows acid to seep upwards from the stomach to the esophagus. Although we know that a faulty LES is a common cause, we are not sure why it becomes faulty. One of many reasons could be that pressure in the stomach rises higher than the LES can withstand.

Here are some common causes of acid reflux:

Pregnancy - more commonly found during the third trimester of a pregnancy. As the growing baby presses on the stomach, contents may back up into the esophagus. Doctors say antacids will not relieve acid reflux caused by pregnancy. Patients find that if they eat smaller meals but eat more meals per day, it helps. In the vast majority of cases the acid reflux will disappear soon after the baby is born.

Large meals and eating habits - people who have large meals will usually find that their acid reflux will improve if they cut down portion sizes. Patients who kept a food diary, noting down everything they ate and linking certain foods to incidences of acid reflux, have experienced a reduction in acid reflux.

Bending forward - this movement will not usually cause acid reflux unless there is another underlying trigger or problem.

Hiatus hernia (hiatal hernia) - a condition where the upper part of the stomach protrudes into the chest through a small opening in the diaphragm. Hiatal hernias are commonly caused by severe coughing, vomiting, straining, sudden physical exertion, pregnancy, and obesity.

Peptic ulcers and insufficient digestive enzymes - peptic ulcers and not enough digestive enzymes in the stomach may slow down the digestive process, causing an accumulation of gastric acids that back up into the esophagus.

Asthma - experts still argue about which came first, the asthma or the acid reflux - did the asthma cause the acid reflux or did the acid reflux cause the asthma? Nobody has a definite answer to the relationship between asthma and acid reflux. Some say that the coughing and sneezing brought on by asthmatic attacks can cause changes in the chest which trigger acid reflux. Others blame asthma medications - they are taken to dilate the airways, but might also relax the esophageal sphincter.

Most asthma sufferers say that their asthma is worsened by acid reflux because the acid that seeps into the esophagus from the stomach stimulates the nerves along the neck into the chest, causing bronchial constriction and breathing problems.

Smoking - research has shown that the saliva of smokers contain lower levels of bicarbonates, which neutralize acids. Cigarette smoking also reduces the production of saliva. Smoking also stimulates the production of stomach acid, weakens the esophageal sphincter, promotes the movement of bile salts from the intestine to the stomach (making the acids more harmful), and slows down digestion (making stomach pressure last longer because it takes more time to empty).

Alcohol - patients have commented that quitting alcohol, or cutting down consumption significantly improved their symptoms.

Patients with upper gastrointestinal (GI) complaints visit their general practitioner (GP) more often

Patients with upper gastrointestinal (GI) complaints visit their general practitioner (GP) more often than patients with other conditions. Researchers writing in the open access journal BMC Family Practice found that people with dyspepsia, heartburn, epigastric discomfort and other upper-abdominal complaints had almost twice as many GP contacts, which were ultimately associated with problems in all organ systems. These patients were twice as frequently referred to specialist care and received twice as many prescriptions.

Henk van Weert led a team of researchers from the University of Amsterdam who set out to investigate the connection between psychological conditions and upper-GI symptoms. He said, "Traditionally, psychological factors were held responsible for upper-GI symptoms. With the identification of Helicobacter pylori the etiological paradigm changed dramatically, but eradication therapy has proved to be of only limited value in functional dyspepsia. We aimed to investigate whether psychological and social problems are more frequent in patients with upper GI symptoms".

The researchers found that the prevalence of upper-GI symptoms was actually associated with a broader pattern of illness-related health care use - GI patients' increased health care demands were not restricted to psychosocial problems, but comprised all organ systems. According to van Weert, "Patients with upper-GI symptoms visited their GP twice as often and received up to double the number of prescriptions as control patients. We demonstrated that not psychological and social co-morbidity, but high contact frequency in general is most strongly associated with upper-GI symptoms".

Speculating as to the reason for the increased care-seeking among people with upper-GI symptoms, van Weert said, "Patients who consult their GP frequently because of their coping style and attentiveness to physical symptoms may just have a high chance to be diagnosed in any health domain, including the psychosocial. In other words, upper GI symptoms and psychosocial complaints may both be manifestations of increased health care demands and not etiologically related".

Complications of indigestion

In the vast majority of cases indigestion is mild and does not happen frequently. Severe indigestion can occasionally cause the following complications:

Esophageal stricture - if the indigestion is caused by acid reflux, when stomach acids leak back up into the esophagus and irritate the mucosa, the esophagus can become scarred. The esophagus can eventually become narrow and constricted. Patients with esophageal stricture may have swallowing difficulties; food can get stuck in the throat, causing chest pain. Surgery is sometimes needed to widen the esophagus.

Pyloric stenosis - this is caused by long-term irritation of the lining of the digestive system from stomach acid. The Pylorus - the passage between the stomach and the small intestine - becomes scarred and narrowed. Food is not properly digested. Surgery may be required to widen the pylorus.

Peritonitis - inflammation of the peritoneum (the tissue layer of cells lining the inner wall of the abdomen and pelvis). Surgery can repair damage to the peritoneum, and antibiotics are sometimes prescribed to deal with infection.

Treatment options for indigestion - Proton Pump Inhibitors

Treatment for indigestion depends on what is causing it and how severe symptoms are.
Diet and lifestyle changes - if symptoms are mild and your indigestion is not occurring often, some lifestyle changes will probably ease symptoms. This usually involves consuming less fatty foods, less caffeine, alcohol and chocolates, sleeping at least 7 hours every night, and avoiding spicy foods.

Medications:
Antacids - examples include Alka-Seltzer, Maalox, Rolaids, Riopan, and Mylanta. These are OTC (over-the-counter, no prescription needed) medicines. These are usually the first medications doctors recommend.

H-2-receptor antagonists - examples include Zantac, Tagamet, Pepcid and Axid. Some of these are OTC while others are prescription drugs. They reduce levels of stomach acids and last longer than antacids. However, antacids are effective faster. Some patients may experience nausea, vomiting, constipation, diarrhea, and headaches. Other side-effects may include bruising or bleeding.

PPIs (proton pump inhibitors) - examples include Aciphex, Nexium, Prevacid, Prilosec, Protonix and Zegerid. PPIs are very effective for patients who also have GERD (gastroesophageal reflux disease). They reduce stomach acid and are stronger than H-2-receptor antagonists. Side effects may include cough, headache, dizziness, back pain, abdominal pain, wind, nausea and/or vomiting, constipation and diarrhea. In very rare cases long-term use can lead to bone fractures.

Prokinetics - an example includes Reglan. This medication is helpful if the stomach empties slowly. Side effects may include tiredness, depression, sleepiness, anxiety and muscle spasms.

Antibiotics - if Helicobacter pylori is causing peptic ulcers which result in indigestion an antibiotic will be prescribed. Side effects may include upset stomach, diarrhea and fungal infections.

Antidepressants - if no causes for indigestion are found after a thorough evaluation and the patient has not responded to treatments, the doctor may prescribe antidepressants. Antidepressants sometimes ease the discomfort by reducing the patient's sensation of pain. Side effects may include nausea, headaches, agitation, constipation, and night sweats.
The doctor may also recommend making changes to the patient's current medication if it is thought that it could be contributing to the indigestion. Sometimes aspirin or ibuprofen may be discontinued and alternative medications sought. It is important to change medications under the supervision of your doctor, and not to do this on your own.

How to diagnose indigestion? - Proton Pump Inhibitors

For the majority of patients indigestion is mild and does not occur very often. In such cases no treatment from a doctor is required. People who experience indigestion regularly should see their GP (general practitioner, primary care physician). You should also see your doctor if you experience severe discomfort or pain.

A doctor will ask the patient about symptoms, his/her medical and possibly family history, and examine the chest and stomach. This may involve pressing different areas of the abdomen to find out whether any are sensitive or tender.
Blood test - if the patient has any symptoms of anemia the doctor may order a blood test.

Endoscopy - patients who have not responded to treatment, or those with certain signs and symptoms, may be advised to have their abdomen examined in more detail. An endoscopy takes place in hospital. A long thin tube with a camera at the end - an endoscope - goes through the patient's throat and into the stomach. The surgeon can see images of the inside of the abdomen on an external monitor.

Tests to diagnose Helicobacter pylori infection - this may include a urea breath test, a stool antigen test, and a blood test. Peptic ulcers are often cause by this bacterium.

Liver function test - if the doctor thinks the patient may have a biliary condition, which affects the bile ducts in the liver. This involves a blood test that determines how the liver is working.

X-rays - usually an upper-gastrointestinal and small bowel series. X-rays are taken of the esophagus, stomach and small intestine.

Abdominal ultrasound - high-frequency sound waves make images that show movement, structure and blood flow. A gel is applied to the patient's abdomen and a hand-held device is pressed against the skin. The device emits sound waves and the doctor can see the insides of the abdomen in detail on a monitor.

Abdominal CT (computed tomography) scan - this may involve injecting a dye into the patient's veins. The dye shows up on the monitor. The CT scan takes a series of X-ray images to produce a 3-dimensional image of the inside of the abdomen.

Causes of indigestion - Proton Pump Inhibitors

Indigestion is usually related to lifestyle and what we eat and drink. It may also be caused by infection or some other digestive conditions. Some common causes include:
  • Eating too much
  • Eating too rapidly
  • Consuming fatty or greasy foods
  • Consuming spicy foods
  • Consuming too much caffeine
  • Consuming too much alcohol
  • Consuming too much chocolate
  • Consuming too many fizzy drinks
  • Emotional trauma
  • Gallstones
  • Gastritis (inflammation of the stomach)
  • Hiatus hernia
  • Infection, especially with bacteria known as Helicobacter pylori
  • Nervousness
  • Obesity - caused by more pressure inside the abdomen
  • Pancreatitis (inflammation of the pancreas)
  • Peptic ulcers
  • Smoking
  • Some medications, such as antibiotics and NSAIDs (non-steroidal anti-inflammatory drugs)
  • Stomach cancer
When a doctor cannot find a cause for indigestion the patient may have functional dyspepsia - a type of indigestion that may undermine the stomach's ability to accept and digest food and then pass that food on to the small intestine.

Symptoms of indigestion - Proton Pump Inhibitors

Most people with indigestion feel pain and discomfort in the stomach or chest area. The sensation generally appears soon after consuming food or drink. In some cases symptoms may appear some time after a meal. Some people feel full during a meal, even if they have not eaten much.

Heartburn and indigestion are two separate conditions. Heartburn is a burning feeling behind the breastbone, usually after eating.

The following symptoms are also common:
  • Nausea
  • Belching
  • Feeling bloated (very full)
  • In very rare cases indigestion may be a symptom of stomach cancer.

Mild indigestion is rarely anything to worry about. You should see your doctor if symptoms continue for more than two weeks. See your doctor immediately if pain is severe, and the following also occur:
  • Loss of appetite or weight loss
  • Vomiting
  • Black stools
  • Jaundice (yellow coloring of eyes and skin)
  • Chest pain when your exert yourself
  • Shortness of breath
  • Sweating
  • Chest pain radiation to the jaw, arm or neck

Dyspepsia, indigestion and upset stomach are the same terms

Dyspepsia, also known as indigestion or upset stomach, is a term that describes discomfort or pain in the upper abdomen. It is not a disease. Dyspepsia is a group of symptoms which often include bloating, nausea and burping.

Indigestion is usually caused by stomach acid coming into contact with the mucosa of the digestive system - the sensitive protective lining of the digestive system. Stomach acids break down the mucosa, causing irritation and inflammation, which trigger the symptoms of indigestion.

In the majority of cases indigestion is linked to eating and/or drinking. Sometimes it may be caused by infection or some medications.

H2 Blocker drugs Deemed Safe For Fetuses

H2 Blocker drugs, such as Famotidine, Cimetidine and Ranitidine, approved in the U.S. for acid reflux (heartburn), pose no significant risks for the fetus according to a large collaborative cohort study by researchers at Ben-Gurion University of the Negev.

The study published in the Journal of Clinical Pharmacology provides significant reassurance for the safety of the fetus when H2 blocker drugs are given to women to relieve acid reflux during pregnancy.

H2 blockers are among the most frequently recommended drugs for acid reflux symptoms of heartburn, regurgitation and trouble swallowing, which are common in pregnant women. The findings of a large cohort study examining infants born to mothers who were exposed to H2 blockers, particularly Famotidine, during pregnancy. Usually symptoms of acid reflux are more frequent and more severe in the latter months of gestation. It has been estimated that between 30 percent to 80 percent of pregnant women are affected.

The study was a collaboration between Ben-Gurion University of the Negev, Soroka University Medical Center and Clalit Health Services - all in Beer-Sheva, Israel - along with the Division of Pharmacology, Hospital for Sick Children in Toronto, Canada. It was part of the doctoral thesis of Ilan Matok under the supervision of principal investigators epidemiologist Dr. Amalia Levy and pediatrician and clinical pharmacologist professor emeritus Rafael Gorodischer. The study was conducted by the three Israeli entities as part of the BeMORE collaboration (Ben-Gurion MotheRisk Obstetric Registry of Exposure). The investigation of the safety of other medications commonly used off-label in pregnancy is an ongoing project of BeMORE investigators in large cohorts of women in Southern Israel.

"Of the vast majority of medications approved for use, there is insufficient data from human studies to determine whether the benefits of therapy exceed the risk to the fetus," according to the pediatrician and clinical pharmacologist, principal investigator Dr. Rafael Gorodischer, professor emeritus at Ben-Gurion University of the Negev. "Medicines are approved for use only after there is sufficient scientific evidence demonstrating the drug safety and effectiveness for its intended uses."

The safety of H2 blockers used during the first trimester of pregnancy was investigated by linking a database of medications dispensed over 10 years to all women registered in Clalit Health Services in the Southern District of Israel, with databases containing maternal and infant hospital records, and with therapeutic abortion records of Soroka University Medical Center, during the same period. In the study, 1,148 (or 1.4 percent) were exposed to H2 blockers during the first trimester of pregnancy of the 84,823 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to H2 blockers during the first trimester was 5.7 percent (65 of 1,148 infants), as compared with a rate of 5.3 percent (4,400 of 83,675 infants) in the unexposed group.

According to principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "Exposure to H2 blockers among this group was not associated with significantly increased risks of major congenital malformations. The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. Also, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth".

Drug Interactions of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

Theophylline, non-steroidal anti-inflammatory drugs and corticosteroids enhance the toxicity of fluoroquinolones.

Products containing multivalent cations, such as aluminum- or magnesium-containing antacids and products containing calcium, iron, or zinc, invariably result in marked reduction of oral absorption of fluoroquinolones.

Other drugs that interact with fluoroquinolones include Antacids, Sucralfate, Probenecid, Cimetidine, Warfarin, Antiviral agents, Phenytoin, Cyclosporine, Rifampin, Pyrazinamide, and Cycloserine.

Many fluoroquinolones, especially ciprofloxacin, inhibit the cytochrome P450 isoform CYP1A2.This inhibition causes an increased level of, for example, antidepressants such as amitriptyline and imipramine, Clozapine (an atypical antipsychotic), Caffeine, Olanzapine (an atypical antipsychotic), Ropivacaine (a local anaesthetic), Theophylline (a xanthine) and Zolmitriptan (a Serotonin receptor agonist).

Mechanism of action of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

Quinolones and fluoroquinolones are chemotherapeutic bactericidal drugs, eradicating bacteria by interfering with DNA replication. The other antibiotics used today, (e.g., tetracyclines, lincomycin, erythromycin, and chloramphenicol) do not interact with components of eukaryotic ribosomal particle and thus have proven not to be toxic to eukaryotes, as opposed to the fluoroquinolone class of drugs. Safer drugs used to treat bacterial infections, such as penicillins and cephalosporins, inhibit cell wall biosynthesis, thereby causing bacterial cell death, as opposed to the interference with DNA replication as seen within the fluoroquinolone class of drugs.

Quinolones are synthetic chemotherapeutic agents which have a broad spectrum of antimicrobial activity as well as a unique mechanism of action resulting in inhibition of bacterial DNA gyrase and topoisomerase IV. Quinolones inhibit the bacterial DNA gyrase or the topoisomerase IV enzyme, thereby inhibiting DNA replication and transcription. Quinolones can enter cells easily via porins and therefore are often used to treat intracellular pathogens such as Legionella pneumophila and Mycoplasma pneumoniae. For many gram-negative bacteria DNA gyrase is the target, whereas topoisomerase IV is the target for many gram-positive bacteria. It is believed that eukaryotic cells do not contain DNA gyrase or topoisomerase IV.

However, there is debate concerning whether the quinolones still have such an adverse effect on the DNA of healthy cells, in the manner described above, hence contributing to their adverse safety profile. This class has been shown to damage mitochondrial DNA.

Pharmacology of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

The basic pharmacophore, or active structure, of the fluoroquinolone class is based upon the quinoline ring system. The addition of the fluorine atom at C6 is what distinguishes the successive generations, fluoroquinolones, from the first generation, quinolones. It has since been demonstrated that the addition of the C6 fluorine atom is not a necessary requirement for the antibacterial activity of this class (circa 1997).

Various substitutions made to the quinoline ring resulted in the development of numerous fluoroquinolone drugs that we see today. Each substitution is associated with a number of specific adverse reactions, as well as increased activity against bacterial infections, where as the quinoline ring, in and of itself, has been associated with severe and even fatal adverse reactions.

Contraindications of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

Quinolones are contraindicated if a patient has epilepsy, QT Prolongation, pre-existing CNS lesions, central nervous system inflammation or those who have suffered a stroke. There are safety concerns of fluoroquinolone use during pregnancy and as a result are contraindicated except for when no other safe alternative antibiotic exists.

They are also contraindicated in children due to the risks of damage to the muscoskeletal system.[ Their use in children is not absolutely contraindicated however. For certain severe infections where other antibiotics are not an option their use can be justified. Quinolone should also not be given to people with a known hypersensitivity to the drug.

Adverse effects of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

Fluoroquinolones are generally well tolerated with most side effects being mild to moderate. Occasionally serious adverse effects occur.

Some of the serious adverse effects which occur more commonly with fluoroquinolones than with other antibiotic drug classes include CNS and tendon toxicity.

The currently marketed quinolones have safety profiles similar to that of other antimicrobial classes. Fluoroquinolones are sometimes associated with an QTc interval prolongation and cardiac arrhythmias, convulsions, tendon rupture, torsade de pointes and hypoglycemia.

These adverse reactions are a class effect of all quinolones, however, certain quinolones are more strongly associated with increased toxicity to certain organs. For example, moxifloxacin carries a higher risk of QTc prolongation, and gatofloxacin has been most frequently linked to disturbed blood sugar levels, although all quinolones carry these risks.

Some quinolones were withdrawn from the market because of these adverse events (for example, sparfloxacin was associated with phototoxicity and QTc prolongation, thrombocytopenia and nephritis were seen with tosufloxacin and hepatotoxicity with trovafloxacin).

Simultaneous use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture.The risk of adverse events is further increased if the dosage is not properly adjusted, for example if there is renal insufficiency.

The serious events may occur during therapeutic use at therapeutic dose levels or with acute overdose. At therapeutic doses they include: central nervous system toxicity, cardiovascular toxicity, tendon / articular toxicity, and rarely hepatic toxicity.

Caution is required in patients with liver disease.Events that may occur in acute overdose are rare and include: renal failure and seizure.Susceptible groups of patients such as children and the elderly are at greater risk of adverse reactions during therapeutic use. Adverse reactions may manifest during, as well as after fluoroquinolone therapy has been completed.

Fluoroquinolones are considered high risk antibiotics for the development of C Difficile and MRSA infections. A previoualy rare strain of C Difficile which produces a more severe disease with increased levels of C Difficile toxins is becoming epidemic, may be connected to the use of fluoroquinolones.

Fluoroquinolones are more strongly associated with C difficile infections than other antibiotics including clindamycin, 3rd generation cephalosporins beta lactamase inhibitors. One study found that fluoroquinolones were responsible for 55% of C difficile infections.

The European Center for Disease Prevention and Control recommend that fluoroquinolones and the antibiotic clindamycin are avoided in clinical practice due to their high association with clostridium difficile, a potentially life-threatening super-infection.

The central nervous system is an important target for fluoroquinolone mediated neurotoxicity. Adverse event reporting in Italy by doctors showed fluoroquinolones among the top 3 prescribed drugs for causing adverse neurological and psychiatric adverse effects. These neuropsychiatric effects included tremor, confusion, anxiety, insomnia, agitation and in severe cases psychosis. Moxifloxacin came out worst amongst the quinolones for causing CNS toxicity.

Some support and patient advocacy groups refer to these adverse events as "fluoroquinolone toxicity". Some people from these groups claim to have suffered serious long term harm to their health from using fluoroquinolones. This has led to a class action lawsuit by people harmed by the use of fluoroquinolones as well as action by the consumer advocate group Public Citizen.

Partly as a result of the efforts of Public Citizen the FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons.

Indications of Quinolone ( fluoroquinolones) - Antibiotics and Antibacterials

It continues to be debatable as to whether or not the effectiveness of fluoroquinolones for the treatment of respiratory disorders is similar to other antibiotic classes.

Fluoroquinolone use for pneumonia is increasing and with it so is bacterial resistance to fluoroquinolones. The majority of the prescribing of fluoroquinolones is inappropriate with less than 4 percent of people prescribed quinolones being appropriate according to clinical guidelines. Clinical guidelines in Canada only recommend fluoroquinolones for outpatient treatment of pneumonia in a small number of patients such as those with certain co-morbid conditions such as patients with a history of COPD, or recent use of antibiotics.

For severe forms of community-acquired pneumonia the fluoroquinolones are associated with improved treatment rates, but with no differences found in mortality between other antibiotic classes.

Fluoroquinolones are not recommended as first line antibiotics for acute sinusitis as this condition is usually self-limiting and the risks outweigh the benefits in comparison to other antibiotic classes.

Antibiotics including fluoroquinolones can be effective in some cases of bronchitis. However, only about 5-10% of bronchitis cases are caused by a bacterial infection; most cases of bronchitis are caused by a viral infection and are self-limiting and resolve themselves in a few weeks. It has been recommended that antibiotics are limited in most cases to those whose symptoms fail to resolve on their own.

Fluoroquinolones are often used for genitourinary infections; in general they are recommended only after other antibiotic regimes have failed. However, for serious acute cases of pyelonephritis or bacterial prostatitis where the patient may need to be hospitalised fluoroquinolones are recommended as first line therapy.

Prostatitis has been termed "the waste basket of clinical ignorance" by prominent Stanford University Urologist Dr. Thomas Stamey. Campbell's Urology, the urologist's most authoritative reference text, identifies only about 5% of all patients with prostatitis as having bacterial prostatitis which can be "cured" at least in the short term by antibiotics. In other words, 95% of men with prostatitis have little hope for a cure with antibiotics alone since they don't actually have any identifiable bacterial infection.

The American Thoracic Society recommends that fluoroquinolones are not used as a first line agent, instead recommending macrolide or doxycycline as first line agents. The Drug-Resistant Streptococcus pneumoniae Working Group recommends fluoroquinolones are only used after other antibiotic classes have been tried and failed or in those with demonstrated drug-resistant Streptococcus pneumoniae. The Center for Disease Control are concerned that fluoroquinolones are being used as a "one-size-fits-all" treatment unnecessarily by doctors without considering suitability and differences due to age and other risk factors. Effective interventions have been recommended to reduce the excessive fluoroquinolone prescribing in the United States.

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