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					OTC
Antacid Products
10/8/07


How drugs affect patients directly and what are the clinical drug informations that impact
patients directly. Need to make sure they are safe for consumers.
California board of Pharmacy feels the same way, they are there to protect the consumers.
All the proper information is there for patient to utilize.

Generic and brand contain same main ingredient
Nowadays there is more variety of antacids. Few years back there were less antacids
available and they had the same main ingredients.
The antacids that our parents or grandparents used years ago like Maalox or Mylanta
don’t have the same main ingredient anymore.

Some have different active ingredients and some of them don’t even have things that you
would consider antacids anymore for example Pepto Bismol.
That’s why we need to focus on what the active ingredient is and not on the brand name.
Need to know the background why would we recommend one product over the other.


Make sure whatever we recommend to patient we know what the active ingredients are.
Some of the products have more than one active ingredient like Mylanta, Maalox or
Rolaids and these active ingredients act differently. That is why we need to really now
the main active ingredients of the products.

We also need to know the clinical significance of OTC H2 blockers vs. the prescription
ones.

      20% of adult Americans may suffer from heartburn or acid regurgitation at least
       once a week.
      Heartburn more than twice weekly may indicate serious medical condition.
      If someone asks for recommendation of OTC antacid depending on the person, he
       or she may have a serious underlying problem. Especially if they are suffering
       from regurgitation more than 2 times a week.
      If have person asking for medication that can help with their really bad heartburn
       we need to ask them the proper questions like how often have you had the
       heartburn, how many times have you had it, what have you taken to help with it
      If have symptoms like hard time swallowing need to refer patient to MD because
       may indicate a severe underlying problem.
      Severe gastrointestinal complications may occur without little or no heartburn and
       unfortunately many of the older individuals who may experience peptic ulcer
       disease won’t even know it.
      Most of the time they would be on a pain med and won’t even feel the peptic
       ulcer disease, the first symptom they would feel is hypotension or tachycardia and
       they would be rushed over to the hospital.
      OTC self-treatment or on-demand treatment may be a better identifier of a
       significant gastrointestinal condition so we need to ask the right questions.


Anatomy

Classic heartburn symptoms are due to all the content in the stomach coming back up.
Stomach has a mucosal lining that is protecting the stomach from the acidic content.
The esophagus doesn’t have that and so the acidic content irritates the area, and if this
problem is not addressed quickly the patients end up having more severe problems. pH is
about 1-2 so very acidic. Over time can cause significant problems.

Acid being pumped out and the receptors are being stimulated and the proton pump is
secreting the acid out. PPI’s are drugs that directly act on the proton pump to inhibit acid
secretion.

2 types of acid indigestion: heartburn and dyspepsia

Heartburn
        comes with age and gets worse as get older
        symptoms associated with the reflux of gastric contents into the esophagus

GERD
   if anyone is diagnosed with GERD they have no business taking antacids
   they need to be followed by an MD
   OTC products may be used as an adjunct but should not be one of those things
     that should be self treated.
   Those are the people whose heartburn affects their quality of life more than twice
     a week for more than 3 consecutive weeks.
   Usually by time they see an MD they have tried all sorts of the OTC heartburn
     medications that are available and they realize that the medications don’t really
     work well enough or they start off working well and then after a while didn’t
     work well enough.
   Up to 50% of the US population experiences occasional reflux symptoms usually
     because ate late or had too much to drink and lie down watch tv and that’s when it
     happens.
   GERD happens over long period of time and the lining of the esophagus starts to
     change at a cellular basis and can progress to cancer in the esophagus.

Lifestyle or food can be the cause for experiencing the symptoms.

Dietary risk factors for GERD:
    Alcohol (biggest one)
      Caffeinated beverages and spicy food especially if eat at night and lie down and
       so may experience reflux and get the acidic taste.
      Chocolate
      Citrus fruits or juice
      Garlic or onions
      High-fat food
      Mint
      Tomatoes/juice

Lifestyle risk factors for GERD
     Not a good idea to exercise 2-3 hours after eating a meal
     Obesity (big one)  one of the lifestyle changes that you can do to alleviate the
        symptoms.
     Pregnancy  will have GERD symptoms because the esophageal sphincter tone
        decreases because of all that weight that they are carrying. Not too many things
        that you can use when pregnant. Magnesium or calcium containing antacids are
        supposed to be okay. H2 blockers are also supposed to be okay. One of the few
        Pregnancy category A drugs is Tylenol. Most of them are Pregnancy category B.
     Smoking
     Stress  causes more of dyspepsia symptoms than GERD symptoms
     Supine body position
     Tight-fitting clothing


Medications
   Anticholinergics  ie. Benadryl
   Aspirin
   Benzodiazepines  ie. Valium, Xanax, sedatives and hypnotics
   Bisphosphonates
   Calcium channel blockers  ie. Norvasc, Felodipine
   Iron
   Narcotics
   NSAIDS  Advil, Motrin
   Potassium
   Progesterone
   Tetracycline
   Tricyclic antidepressants


Important thing to remember is that can have a person who is older and is doing fine and
all of a sudden started having GERD symptoms. It could be that the patient was started
on a new drug like a calcium channel blocker that they weren’t on before and that could
cause the patient to have GERD symptoms.
There are a lot of medications that could do that. Most of the gastrointestinal side effects
due to medications go away in time (so not a good idea to recommend an antacid because
the symptoms will go away in time). Most medications will cause some kind of
gastrointestinal side effect such as nausea and vomiting. The only medication that would
not cause that would be the anti-nausea medications, the anti-emetics. Everything else
has the potential to cause some kind of nausea and vomiting, or some kind of dyspepsia
or heartburn symptoms.


Common symptoms associated with GERD symptoms are heartburn and regurgitation.
Some of these in older people can have age associated GERD symptoms. They will have
the atypical symptoms such as chest pain, wheezing, cough and dental erosions. When
someone comes with complaints of chest pain the first thing we would do is call 911, but
may be GERD symptoms. If a patient is experiencing severe nausea and vomiting you
won’t offer an anti-emetic because could be masking a severe problem.
     Example of patient who had an MI but the only symptoms she had was severe
        nausea and vomiting.
     Need to assess patient to see what it is

Complications of GERD  occurs over a period of time
   Erosion, ulceration and bleeding of esophagus
   Esophageal stricture
   Barrett’s esophagus
   Esophageal cancer  if person decides to self-treat and not see an MD can lead to
      this.


Dyspepsia and Peptic Ulcer Disease
    Dyspepsia  uncomfortable feeling where taking a medication or stressed about a
      situation
    Affects 1 out of 8 people in US
    Up to 90% recurrence  will happen again before stressful situations
    15% perforate and cause active gushing and bleeding leads to hypotension and
      tachycardia, will be rushed to the ER and get a blood transfusion
    Gastric ulcer for ages > 50 and secondary gastric ulcer
    Duodenal ulcer  more common than gastric ulcer, and in Peptic Ulcer Disease
      there is a higher than normal acid secretion. In GERD no increased secretion of
      acid

Pathophysiology

A lot of the medications can cause the uncomfortable feeling of indigestion and make the
stomach feel a little weird. So we can tell the patients that when they get that weird
feeling instead of taking antacids, they can take the medication with a little food.
Dyspepsia risk factors
    NSAIDs
    Bisphosphonates
    Potassium, Iron
    Digoxin
    Macrolides
    Other antibiotics
    Alcohol
    Tobacco
    Caffeine
    Stress

Peptic Ulcer Disease risk factors
    NSAIDs  most important risk factor, if over the age of 40 need to be on ASA,
       especially when the CV risk factors are there.
    H. pylori  lives in stomach and causes ulcers
    Stress
    Smoking
    Alcohol
    Coffee
    Glucocorticoids
    Heredity

Ask questions such as how often have you had it, or what else are you taking. And if the
patient is on an NSAID then you know that it might be the reason that the patient is
having the symptoms. If the patient has an ulcer due to the NSAID then that is something
that should not be treated with an OTC antacid. He/she needs to be referred to an MD.

Epigastric pain is the most common symptom. Dyspepsia is an upset stomach with a
burning sensation and nausea. In a lot of older people the epigastric pain would not be
there because they are already on some kind of pain medication.

Gastric ulcer is the one that is precipitated by food. When start eating start to have a pain
in the stomach, especially when your stomach is growling and at the same time you feel
pain in the stomach. You really shouldn’t have pain in your stomach when you are
hungry.

If have sharp pain in the stomach when you are hungry it is usually a Duodenal ulcer.
The pain is relieved by food or antacids.


GI bleeding is the most common complication. Can have an older patient who may or
may not be on an NSAID or ASA. If have a patient who had an MI he/she will be on
ASA and if at the same time that patient has complications of peptic ulcer disease and has
severe pain the patient won’t even know that he/she has a severe case of peptic ulcers.
NSAID induced peptic ulcers are associated with over 100,000 hospitalizations and over
16,000 deaths each year. And of course gastric cancer is a big risk factor especially if
you are infected with H. pylori.


Management of heartburn and dyspepsia
   Dietary and lifestyle modifications, unfortunately people don’t listen and
      compliance is very poor thinking that OTC antacids will help them.
   Self-treatment only for mild, infrequent heartburn or dyspepsia.
   OTC antacid products such as antacids, H2 receptor antagonists, Prilosec OTC

Exclusions to the Self-treatment (before recommend any type of OTC antacid need to
make these exclusions)
    Severe symptoms
    Frequent symptoms  those that are present 3 or more times a week
    Symptoms while taking PPI’s or OTC Prilosec for 14 straight days  need to be
       referred to MD
    Difficulty or pain swallowing solid foods
    Vomiting blood
    Black tarry stools
    Chronic hoarseness, wheezing, coughing  signs of serious problem (cancer)
    Chest pain
    Unexplained weight loss
    Stomach pain


Antacids

Neutralizes gastric acid and increases pH of gastric contents, it also protects the stomach
better. Works great because works really fast and coats the stomach. But it only lasts
about an hour or two and if take with food lasts a little bit more.

Used for temporary relief of heartburn, GERD symptoms and dyspepsia.
It should only be used for 14 days of consecutive use. If find that patient is taking on a
consecutive basis is a good sign that need to see MD for complications. There are 4
primary compounds, but we have so many different products. The compounds are:
      Sodium bicarbonate
      Calcium carbonate
      Aluminum
      Magnesium
Potency

Acid neutralizing capacity, if pick up a product like Maalox you would not see anything
about the ANC. As long as follow what it says on the dosage indication you will be fine.
As far as the ANC goes in general the regular strength Maalox have an ANC with the
regular strength and the maximum strength ones have double the amount of the ANC
(double the active ingredient). But take into account that you will have double the
amount of the active ingredient like magnesium in your body.

If it’s a healthy person taking it it’s probably ok because your kidneys are functioning but
if it’s someone who has some kind of kidney issue they may not be able to excrete the
extra amount of the aluminum or magnesium.

All antacids are interchangeable if used in the recommended dosage. In patients with
kidney disease can be a problem because the aluminum or what not is being absorbed.

Sodium bicarbonate and magnesium hydroxide work really well and very rapidly, even
better than aluminum hydroxide and calcium carbonate. They have a rapid buffering
effect but their duration of action is short. Aluminum and calcium take a little bit longer
to work but their duration of action is longer.

Duration of action

If have patient who has hunger pain soon as they eat the pain goes away and can’t take an
antacid because if they take it on an empty stomach then it will only last about an hour
and you would have to take another one. But if take it after a meal it could last up to 3
hours.

Dosage formulations  all depend on the convenience for the patient
    Liquid, tablet/capsule, powder, gum
    Liquid antacids have a more rapid onset of action and a greater activity than
      tablets, has quick release but is hard to carry around
    Chewable tablets are better than swallowed tablets for heartburn symptoms
    Tablets are more convenient to carry than liquids
    All formulations require frequent dosing because those antacids don’t last that
      long
    The initial dose is about 40-80 mEq 4 times a day which is equal to about 1-2
      tablespoons of Maalox or Mylanta.
    For your patients need to go by the directions on the box which is usually around
      5-10 mLs every 6 hours
    So tell patient to follow the directions that is on the box
Magnesium

Magnesium hydroxide or magnesium isn’t used by itself as an antacid anymore. Use
magnesium (Milk of Magnesia) as laxatives, will have diarrhea. Usually combined with
calcium or aluminum so it neutralizes the diarrhea effect. Also need to remember that it
needs to be used in caution with patients who have renal failure. You would know that
the patient has renal failure or kidney disease by seeing what kind of medication that the
patient is picking up. By law we are required to review the patient’s profile. So we
would spot the interactions and let the patient know. Hypermagnesemia is associated
with muscle weakness, hypotension and arrhythmias. A lot of doctors would specify that
the patient has kidney problems and so should not be taking Milk of Magnesia because of
risks for hypermagnesemia.


Aluminum
    Not used as much as an antacid because of the complications that it causes
    It is used more for hyperphosphatemia
    Also combined with magnesium
    Can cause problems for people with renal failure
    Can cause accumulation of aluminum in the tissues in patients who have renal
      failure
    Build up of aluminum in tissues won’t happen in a few days it occurs over time.


Calcium Carbonate
    Provides good acid neutralization
    Works for a long time
    It does have systemic absorption that’s why Tums is used as a calcium
      supplement
    Whether it causes Acid rebound is questionable (acid rebound  symptoms may
      get worse once stop using)

Combination Products
   Maalox, Mylanta no more products that say just Maalox, its because have so
     many other things in them
   ie. Maalox, Mylanta, Rioan
   combination products are the most frequently used products
   there are side effects such as diarrhea
   again need to use with caution in patients who have renal failure
   increased magnesium
   increased aluminum
   several products that contain magnesium and calcium such as Rolaids
   study that said aluminum was associated with Alzheimer’s and so people stopped
     using them
Sodium Bicarbonate
    found in Alka-Seltzer
    works great
    potent and has rapid neutralizing agent
    works really fast
    has a high systemic absorption
    because the bicarbonate is an alkanizing agent it can cause systemic alkylosis if
      the kidney is not able to excrete the extra bicarbonate .
    some of the older patients who have HTN, diabetes and HF may not be able to
      excrete the extra bicarbonate and that would be a problem for them.
    If have severe kidney disease or in older patients there is a chance of Milk-alkali
      syndrome occurring
    The patients can die from this, it occurs with a high calcium intake
    Use with caution in heart failure, high blood pressure and liver disease patients
      because of the sodium content
    Some products contain acetaminophen or aspirin (original Alka-Seltzer)
    There are people who should not be on ASA and you won’t know unless you ask
      the patient
    Especially if they are allergic, asthmatic or people who are allergic to aspirin.
    Chronic use is contraindicated because don’t want the patient to be getting sodium
      for such a long time

The ingredients are simethicone, alginic acid or bismuth subsalicylate
Only issue is that when pick up product some won’t even have all 3 just one
Make sure they get the right active ingredients.

Patients who are diabetic and on medications some of the patients should not be taking
the antacids because of the high sugar content.


Drug interactions
    2 diff type of interactions with antacids
    Focus on ones that can harm the patients such as interactions with blood thinning
      medications or seizure medications which can be toxic
    Can get subtherapuetic levels of drug and not get the results that you want
    Interaction with antibiotics
    Resistance or other problems
    Increase the pH of the stomach and certain medications require an acidic
      environment to work well and don’t get absorbed
    Tetracyclines and quinolones are a good example of this type of interaction
    Quinolones  Cipro, levaquin
    Make sure they are separated from the time you take the antacid so that you don’t
      have interaction problems
    Ketoconazole is an antifungal medication
      If have an anemic patient and are told that they should take iron and are taking an
       antacid the iron is not going to be absorbed well.
      And iron absorption is a huge problem because the pH is too high and is not being
       absorbed.
      A lot of iron products are combined with the vitamin C so that the acidic
       environment around the drug is lowered.


Question 1

Has to take iron 3 times a day and needs Maalox  take iron first then take Maalox 2
hours later. This is because the iron can be absorbed and then you are taking the Maalox.
Just like with the antibiotic it is good to take the antibiotic first and then take the antacid

Antacids-Selection

Potency is good and most products are interchangeable but just remember to look at the
content. Make sure that the sugar level is low for diabetic patients the lactose is
important for lactose intolerant patients so they would need a product that is low in
lactose.

Also keep in mind the patients who have renal failure as well as the elderly who
shouldn’t be taking long term antacids.

Depending on what they want you can recommend different dosage forms and also keep
in mind the cost.

Question 2

Advise patient to take another antacid that doesn’t have such a high sodium content
because of the HTN


H2 blockers
    Binds to H2 receptors of the parietal cells and inhibits gastric acid secretion
    Inhibits the proton pump
    Treat or prevent heartburn, acid indigestion, and sour stomach
    Only thing about H2 blocker if you are using OTC is that you shouldn’t be using
      it for more than 14 days although Pepcid is available in prescription strength.
    Want to make sure that the patient is informed and is asking the right questions so
      that is why OTC pepcid is behind the counter
    Available OTC are Cimetidine, Ranitidine, Famotidine, and Nizatidine
    Potency: Famotidine > Nizatidine > Ranitidine > Cimetidine
    This means you can use less of Famotidine because it has the highest potency
    Max dose of pepcid OTC is 20mg bid used to be prescription strength
      If a person came into the pharmacy and had ate a lot and needed something to
       relieve his symptoms you would give him something that would act really quickly
      Can use up to twice daily for 2 weeks
      Important are the ones that are renally eliminated but we don’t need to do a dose
       adjustment in renal failure
      Patients don’t have a problem with no side effects and can get away with using
       pepcid once a day
      That is not the case with other medications the patients can become toxic
      Compared to a lot of other side effects these aren’t that bad
      The side effects are headaches, diarrhea, constipation, nausea
      The side effects are usually very well tolerated and go away in time
      Cimetidine has a weak androgenic effect
      Drug interactions can be severe or cause therapy failure
      Cimetidine drug interactions can be one of those that can cause death


Drug interactions  Cimetidine with several clinically significant drug interactions
    Warfarin (blood thinning medication) increases risk of bleeding
    Phenytoin (seizure medication) increases Phenytoin toxicity
    Both Warfarin and Phenytoin have a narrow therapeutic index so a little bit more
       or less can effect the patient.
    Theophylline increase Theophylline toxicity


Question 3
    It’s anticipated, so avoid spicy food
    Can take an H2 blocker 1 hour before the meal
    Take Pepcid complete, which has a fast acting tablet and would last longer
    If take antacid by itself would only last about 3 hours


H2 receptor antagonist – selection
    Best to avoid cimetidine
    It does not offer an adavantage over the other H2 blockers
    Both Pepcid and Zantac are safe and effective
    Both are available in prescription strength
    And should be used only up to 14 days


Question 4
    Don’t take it because by law you cannot recommend prescription strength for
       OTC medications
    Advise not to take Tagamet because of the drug interactions
    Tagamet has a severe drug interaction and so recommend Pepcid or Zantac
Prilosec OTC
     Same as slide

Prilosec OTC side effects
     Same as slide
     Well tolerated
     When taking antibiotics the normal flora of the intestines is disrupted leading to
       diarrhea, this is also seen with PPI’s

Prilosec OTC Drug interactions
     Same as slide

Question 5
    Adivise it is under MD supervision
    Need to see MD on regular basis

Special Populations and Patient Counseling
    Same as slides


Question 6
    Advise to see physician
    None of the OTC medications are working so there might be something more
       severe

				
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