Medications Complete

8/2/2019 Medications Complete

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MEDICATIONS

A step-wise approach may be taken. With this approach, the most benign (or

temporary) drugs are used first. As they fail to provide relief, drugs from a higher step

are used.

The step-wise approach is as follows:

1. The aminosalicylates and symptomatic agents are step I drugs; antibiotics are

step IA drugs, given the limited situations in which they are used.

2. The corticosteroids constitute the step II drugs to be used if the step I drugs fail

to adequately control the IBD.

3. The immune-modifying agents are step III drugs and are used if corticosteroids

fail or are required for prolonged periods. Infliximab and adalimumab are also

step III drugs that can be used in some situations in patients with Crohn disease

and ulcerative colitis.4. The experimental agents are step IV drugs and are used only after the previous

steps fail and, then, are administered only by physicians familiar with their use.

Note: that drugs from all steps may be used additively; in general, the goal is to wean

the patient off steroids as soon as possible to prevent long-term adverse effects from

these agents. Opinions differ regarding the use of certain agents in this step-wise

approach.

A. Aminosalicylates

These agents are effective in reducing inflammatory reactions. All of theaminosalicylates are useful for treating flares of IBD and for maintaining remission.

Sulfasalazine (Azulfidine, Azulfidine EN-tabs)

This agent is considered best for colonic disease, although it is also

considered first-line therapy for Crohn disease. It is used for acute disease and

for maintenance of remission.

Mesalamine (Asacol, Pentasa, Canasa, Rowasa, Lialda, Apriso)

Mesalamine is a 5-ASA and acts systemically. It also has activity as atopical anti-inflammatory.

Balsalazide (Colazal)

Balsalazide is a prodrug 5-ASA connected to a 4-aminobenzoyl-(beta)-

alanine carrier by an azo bond; colonic bacteria break the azo bond, releasing
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the active 5-ASA. Metabolites of the drug may decrease inflammation by blocking

the production of arachidonic acid metabolites in colonic mucosa.

Olsalazine (Dipentum)

This aminosalicylate is useful for active disease and maintenance ofremission in ulcerative colitis. Dipentum is 5-ASA connected to a 5-ASA by an

azo bond; colonic bacteria break the azo bond, releasing the active 5-ASA.

B. Antibiotics

Antimicrobial therapy must cover all likely pathogens in the context of the clinical

setting. Metronidazole (Flagyl) and ciprofloxacin (Cipro) are the most commonly used

antibiotics in persons with IBD. Antibiotics are used sparingly in persons with ulcerative

colitis, because ulcerative colitis increases the risk of developing antibiotic-associated

pseudomembranous colitis. Rifaximin (Xifaxan) is a newly approved broad-spectrum

antibiotic that may also help treat patients with IBD.

Metronidazole (Flagyl)

Metronidazole is a widely available, inexpensive antibiotic and

antiprotozoal agent.

Ciprofloxacin (Cipro)

Ciprofloxacin is a fluoroquinolone antibiotic commonly used for the

treatment of urinary, skin, and respiratory tract infections.

Rifaximin (Xifaxan)

Rifaximin is a nonabsorbed (< 0.4%), broad-spectrum antibiotic specific for

enteric pathogens of the gastrointestinal tract (ie, gram-positive, gram-negative,

aerobic, anaerobic). It is a rifampin structural analog and it binds to the beta-

subunit of bacterial DNA-dependent RNA polymerase, thereby inhibiting RNA

synthesis.

C. Corticosteroids

These agents are the treatments of choice for an acute inflammatory bowel

disease (IBD) attack; administer IV in severe disease. Administer increased or stress

doses to patients already on steroids. Do not use steroids for maintaining remission

because of their lack of efficacy and potential complications, including avascular

necrosis, osteoporosis, cataracts, emotional lability, hypertension, diabetes mellitus,

cushingoid features, acne, and facial hair. Cortenema, Cortifoam, and Anusol-HC

suppositories are useful in treating distal disease (proctitis and proctosigmoiditis).
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Hydrocortisone (Solu-Cortef, Cortenema, Cortifoam, Anusol-HC)

Adrenocortical steroids act as potent inhibitors of inflammation. It may

cause profound and varied metabolic effects, particularly in relation to salt, water,

and glucose tolerance, in addition to their modification of the immune response of

the body. Alternative adrenocortical steroids may be used in equivalent dosage.

Prednisone (Deltasone, Orasone, Sterapred)

Prednisone acts as a potent inhibitor of inflammation. It may cause

profound and varied metabolic effects, particularly in relation to salt, water, and

glucose tolerance, in addition to their modification of the immune response of the

body. Alternative corticosteroids may be used in equivalent dosage.

Methylprednisolone (Solu-Medrol, Depo-Medrol)

Adrenocortical steroids act as potent inhibitors of inflammation. They may cause



body. Alternative adrenocortical steroids may be used in equivalent dosage

Prednisolone (AK-Pred, Pred Forte)

Corticosteroids act as potent inhibitors of inflammation. They may cause



body. Alternative corticosteroids may be used in equivalent dosage.

Budesonide (Entocort)

Budesonide alters the level of inflammation in tissues by inhibiting multiple

types of inflammatory cells and decreasing the production of cytokines and other

mediators involved in inflammatory reactions.

Dexamethasone (Baycadron)

Dexamethasone has many pharmacologic benefits, but also significant

adverse effects. It stabilizes cell and lysosomal membranes, increases surfactant

synthesis, increases serum vitamin A concentrations, and inhibits prostaglandin

and proinflammatory cytokines.

D. Immunosuppressants
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These agents are useful as steroid-sparing agents, in healing fistulas, or when

the patient has serious contraindications to surgery. They are used in patients refractory

to or unable to tolerate steroids and in patients in whom remission is difficult to maintain

with the aminosalicylates alone. Some agents, including azathioprine and its metabolite,

6-MP, have been useful in Crohn disease complicated by recurrent rectal fistulas or

perianal disease; response can take up to 6 months. Methotrexate has also been tried.

Azathioprine (Imuran)

Azathioprine inhibits mitosis and cellular metabolism by antagonizing

purine metabolism and inhibiting synthesis of DNA, RNA, and proteins; these

effects may decrease proliferation of immune cells and result in lower

autoimmune activity.

6-Mercaptopurine (Purinethol)

6-Mercaptopurine is a purine analog that inhibits DNA and RNA synthesis,

causing cell proliferation to arrest.

Methotrexate (Rheumatrex, Trexail)

Methotrexate impairs DNA synthesis and induces the apoptosis and reduction in

interleukin 1 production. It is indicated for moderate-to-severe disease and

maintenance of remission. The onset of action is delayed.

E. Tumor Necrosis Factor Inhibitors

Infliximab (Remicade), given intravenously, consists of monoclonal antibodies to

TNF-alpha. Infliximab is approved by the FDA for use in IBD, in both Crohn disease and

ulcerative colitis. Infliximab is somewhat more effective against CD than UC. The drug

appears to promote mucosal healing, which not even prednisone does. Furthermore, it

heals perianal and enterocutaneous fistulae and has been shown to reduce signs and

symptoms, achieve clinical remission and mucosal healing, and eliminate corticosteroid

use. Infliximab is indicated for patients who have experienced inadequate response to

conventional therapy.

Certolizumab pegol (Cimzia) is a pegylated antitumor necrosis factor (TNF)

alpha blocker, which results in disruption of the inflammatory process. Certolizumab

pegol (Cimzia) is indicated for moderate-to-severe Crohn disease in individuals who

have not responded to conventional therapies.
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Adalimumab (Humira) and certolizumab (Cimzia) are TNF blocking agents that

have been FDA approved for the treatment of Crohn disease. They are administered by

subcutaneous injection. They are not FDA approved for ulcerative colitis.

Infliximab (Remicade)

Infliximab neutralizes cytokine TNF-alpha and inhibits its binding to the

TNF-alpha receptor. Mix in 250 mL normal saline for infusion over 2 hours.

Adalimumab (Humira)

Adalimumab is recombinant human IgG1 monoclonal antibody specific for

human TNF. It binds specifically to TNF-alpha and blocks the interaction with p55

and p75 cell-surface TNF receptors.

Certolizumab pegol (Cimzia)

Certolizumab pegol is a pegylated antitumor necrosis factor (TNF)alpha

blocker, which results in disruption of the inflammatory process. It is indicated for

moderate-to-severe Crohn disease in individuals who have not responded to

conventional therapies.

F. Integrin Receptor Antagonist

Natalizumab (Tysabri) is a recombinant humanized IgG4-1C monoclonal

antibody that works by preventing the accumulation of lymphocytes in the diseased

bowel by blocking the effects of integrin. It has been approved by the FDA, but is only

available through a restricted distribution program. Natalizumab is an IV medication that

has shown efficacy in Crohn disease, but it is not as effective as anti-TNF agents.

Natalizumab has been linked to reports of progressive multifocal leukoencephalopathy

Natalizumab (Tysabri)

This is a recombinant humanized IgG4-1C monoclonal antibody produced in

murine myeloma cells. It binds to alpha-4 subunits of alpha-4-beta-1 and alpha-4-

beta-7 integrins expressed on the leukocyte surface, which inhibits alpha-4-

mediated leukocyte adhesion to their receptors. In Crohn disease, the interactionof the alpha-4-beta-7 integrin with the endothelial receptor MAdCAM-1 has been

implicated as an important contributor to the chronic inflammation that is a

hallmark of the disease.

G. Histamine2-Receptor Antagonists
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H2-receptor antagonists are reversible competitive blockers of histamines at the

H2 receptors, particularly those in the gastric parietal cells, where they inhibit acid

secretion. The H2 antagonists are highly selective, do not affect the H1 receptors, and

are not anticholinergic agents.

Cimetidine (Tagamet)

Cimetidine inhibits histamine at H2 receptors of gastric parietal cells,

which results in reduced gastric acid secretion, gastric volume, and hydrogen

concentrations.

Ranitidine (Zantac)

Ranitidine inhibits histamine stimulation of the H2 receptor in gastric

parietal cells, which, in turn, reduces gastric acid secretion, gastric volume, and

hydrogen ion concentrations.

Famotidine (Pepcid)

Famotidine competitively inhibits histamine at H2 receptor of gastric

parietal cells, resulting in reduced gastric acid secretion, gastric volume, and

hydrogen ion concentrations.

Nizatidine (Axid)

Nizatidine competitively inhibits histamine at the H2 receptor of the gastric

parietal cells, resulting in reduced gastric acid secretion, gastric volume, and

reduced hydrogen concentrations.

Proton Pump Inhibitors

Proton pump inhibitors inhibit gastric acid secretion by inhibition of the H+ -K+ -

ATPase enzyme system in the gastric parietal cells. Used in cases of severe

esophagitis and in patients whose disease is not responsive to H2-antagonist therapy.

Omeprazole (Prilosec)

Omeprazole decreases gastric acid secretion by inhibiting the parietal cell

H+/K+-ATPase pump.

Lansoprazole (Prevacid)

Lansoprazole suppresses gastric acid secretion by specific inhibition of the

H+/K+-ATPase enzyme system (ie, proton pump) at the secretory surface of the

gastric parietal cell. It blocks the final step of acid production. The effect is dose-
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related and inhibits both basal and stimulated gastric acid secretion, thus

increasing gastric pH.

Esomeprazole Magnesium (Nexium)

Esomeprazole magnesium is an S-isomer of omeprazole. It inhibits gastric acidsecretion by inhibiting the H+/K+-ATPase enzyme system at secretory surface of

gastric parietal cells. It is used in severe cases and in patients not responding to

H2 antagonist therapy. It is used for up to 4 weeks to treat and relieve symptoms

of active duodenal ulcers; it may be used for up to 8 weeks to treat all grades of

erosive esophagitis.

Rabeprazole sodium (Aciphex)

Rabeprazole sodium decreases gastric acid secretion by inhibiting the parietal

cell H+/K+ ATP pump.

Pantoprazole (Pantoloc, Protonix)

Pantoprazole suppresses gastric acid secretion by specifically inhibiting the

H+/K+-ATPase enzyme system at the secretory surface of gastric parietal cells.

Antidiarrheal Agents

These agents provide symptomatic relief when patients report symptoms of diarrhea.

Diphenoxylate and atropine (Lomotil)

This is an antidiarrheal agent chemically related to the narcotic analgesic

meperidine. It acts on intestinal muscles to inhibit peristalsis and slow intestinal

motility. It prolongs the movement of electrolytes and fluid through the bowel and

increases viscosity and loss of fluids and electrolytes. Also, diphenoxylate and

atropine is a drug combination. A subtherapeutic dose of anticholinergic atropine

sulfate is added to discourage overdosage, in which case diphenoxylate may

clinically mimic the effects of codeine.

Loperamide (Imodium)

Loperamide acts on intestinal muscles to inhibit peristalsis and slow

intestinal motility. It prolongs the movement of electrolytes and fluid through the

bowel and increases viscosity and loss of fluids and electrolytes.

Cholestyramine (Questran)
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It binds bile acids, thus reducing damage to the intestinal mucosa. It also reduces

the induction of colonic fluid secretion. It forms a nonabsorbable complex with

bile acids in the intestine, which, in turn, inhibits enterohepatic reuptake of

intestinal bile salts.

Antispasmodic Agents

These agents are used to treat spastic disorders of the GI tract.

Dicyclomine (Bentyl)

This agent treats gastrointestinal motility disturbances. It blocks the action of

acetylcholine at parasympathetic sites in secretory glands, smooth muscle, and

the CNS.

Hyoscyamine (Levbid, Levsin, Levsin-SL)

Hyoscyamine blocks the action of acetylcholine at parasympathetic sites

in smooth muscle, secretory glands, and the CNS, which, in turn, has

antispasmodic effects. SL tablets may be administered orally, sublingually, or

chewed.

LATEST DRUGS

In recent years, the medical treatment ofinflammatory bowel disease (IBD)has

gotten more attention from pharmaceutical companies and researchers. The future for

people with IBD is brighter than ever, as more drugs are in the pipeline to treat these

debilitating diseases and their associated complications.

Alicaforsen

Alicaforsen is currently under license by Atlantic Pharmaceuticals Limited.

The drug is administered byenemaand is being tested for use inulcerative

colitisandpouchitis. Alicaforsen has been grantedorphan drug statusin the

United States and the European Union.

Alequel

Enzo Biochem has completed a study of Alequel in patients with moderate

to severeCrohns disease. The drug is a personalized treatment of a protein-

containing extract that is created from tissue from the patientscolonand
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administered orally. Remission was achieved by 50 percent of patients on the

drug, versus 33 percent with a placebo. The drug was well tolerated, with no

adverse effects.

Teduglutide

This new compound is being studied for use in both IBD andshort bowel

syndrome (SBS). SBS is a condition that causes diarrhea, cramping, bloating,

and heartburn that occurs in people who have had half (or more) of theirsmall

intestineremoved. The most common cause of SBS is repeatedresection

surgeriesused to treat Crohns disease.

Side effects of teduglutide appear to be minimal, as the effects occur mainly inthe intestinal tract. People with SBS who participated in a trial of teduglutide

showed both increased nutrient intake and body weight. Commonly reportedadverse effects included abdominal pain, headache, stoma changes, andswelling.

NPS Pharmaceuticals, the developer of teduglutide, completed a proof-of-concept study in patients with Crohn's disease. Of the patients with Crohn's, 55percent had achieved remission after 8 weeks of using the drug, compared to 33percent of the patients receiving a placebo. The most reported adverse effectwas redness at the location of the injection. Another study is being conducted onpatients with SBS.

Teduglutide has been granted orphan drug status in both the United States andEurope for its use in SBS. NPS is currently looking for a development partner tocontinue testing the drug for use in Crohns disease.

Traficet-EN (CCX282)

Traficet-EN is an anti-inflammatory small molecule therapeutic which is currently

being tested for use in Crohn's disease by it's manufacturer, ChemoCentryx. In

the latest trial (PROTECT-1), a greater percentage of patients receiving the drug

achieved remission after 36 weeks than those that received theplacebo. The

drug was well tolerated among the study participants over the course of the 12

month trial.

VGX-1027
http://ibdcrohns.about.com/library/glossary/bldef-sbs.htmhttp://ibdcrohns.about.com/library/glossary/bldef-sbs.htmhttp://ibdcrohns.about.com/library/glossary/bldef-sbs.htmhttp://ibdcrohns.about.com/library/glossary/bldef-sbs.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/od/treatments/f/placebo.htmhttp://ibdcrohns.about.com/od/treatments/f/placebo.htmhttp://ibdcrohns.about.com/od/treatments/f/placebo.htmhttp://ibdcrohns.about.com/od/treatments/f/placebo.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/od/surgeryprocedures/a/resectioncrohns.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/library/glossary/bldef-smallintestine.htmhttp://ibdcrohns.about.com/library/glossary/bldef-sbs.htmhttp://ibdcrohns.about.com/library/glossary/bldef-sbs.htm


10/10

This drug is a pro-inflammatory response inhibitor that is being researched by

Invio Pharmaceuticals for use in treating IBD as well as other inflammatory

conditions. The drug is still in the very early stages of study, and has so far only

been tested on healthy volunteers.

Medications Complete

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