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Personal Information
Patient ID: # 06200601VC
Attending Physician: xxxxxxxxxxxxxMD
Patient Name: XXXXXXXXXXXX
Address: xxxxxxxxxxxxxxxx
City: xxxxxxxxxx
State: LA
Zipcode: xxxxx
Country: USA
Phone: (xxx) xxx-xxxx
____________________________________________________________________________________
Medical Information
____________________________________________________________________________________
General complaints not listed as diagnosis by your doctor:
Family reports patient is over-sedated
June 19, 2006
Letter sent to MD on June 20, 2006
Dear Dr. XXXXX,
First let me thank you for the vote of confidence in me in requesting this consult. As pre your request I have reviewed the records of Mrs. xxxxx xxxxxx due to reports of over-sedation.
Her current medication regimen is:
Lasix 20mg daily Restoril 7.5mg
Danazol 200mg daily Klonopin 0.5mg bid
Prevacid 30mg daily Lortab 10 1 po q 6 hrs
Senokot 1 po daily Cardizem 180mg daily*
Prednisone 20mg daily
Exelon 3mg bid
Calcium with vitamin D
Pepcid 20mg daily *Potentially interacting drugs via CYP 450 pathways
There are of course additive CNS effects from the items above which are in bold. This combination alone may be causing the patient’s over-sedation. Since her history of medication use isn’t available its also possible that a tolerance to CNS sedation had previously been developed if she didn’t display any signs or symptoms of over-sedation in the past on this combination. However, with aging and decreased renal function this may have changed.
Diltiazem (Cardizem) is metabolized via the CYP 450 3A4 pathway and will cause an increase in effects of benzodiazepines in patient with normal hepatic and renal function. Additionally, since this patient’s estimated creatinine clearance (CrCl) which I calculated is 45.5ml/min and some of the CYP 450 pathway is also involved in the kidney this combination may be the cause of the oversedation in this patient as she’s on two benzodiaepines, Restoril and Klonopin.
Recommendations based on current complaint and medication regimen and diagnosis:
- Slowly titrate away both benzodiazepines and add an alternate anti-anxiety drug such as duloxetine (Cymbalta) venlafaxine(Effexor). I prefer, as you are well aware, the venlafaxine. These agents both act at both pre and post receptor sites (norepinephrine and serotonin sites) thus the preference for use of these agents as opposed to benzodiazepines. I prefer the venlafaxine because it has less risk of liver toxicity than does duloxetine.
- D/C Lortab and start APAP 650mg qid for pain.
- Use the Lortab q6hrs prn breakthrough pain
Suggestions:
- Start by decreasing the Restoril to qod hs x 1 week then D/C add Effexor XR 37.5mg hs now increase to 75mg hs when the Restoril is D/C’d in one week.
- Once Restoril titration is complete decrease Klonopin to 0.25mg am & 0.5mg hs x 1 week and increase Effexor to 112.5mg hs then and monitor patient’s BP weekly. (This shouldn’t be a problem until we reach at least 300mg dose which shouldn’t be necessary.)
- Decrease the Klonopin to 0.25mg bid x 3 days then to 0.25mg hs x 3 days then D/C it.
Additional recommendations not related to over-sedation but which may improve current drug benefits your evaluation and consideration are sincerely appreciated.
- Due to patient’s current decreased kidney function and need for conservation of calcium consider changing from furosemide 20mg daily to torsemide 10mg daily. Preservation of diuresis effects without rebound antidiuresis is much better with torsemide than with furosemide and torsemide is also less potassium, magnesium, and caclcium wasting and this patient thas osteoporosis.
- Change the Calcium with Vitamin D to Calcium Citrate 600mg with vitamin D bid. This product is acid independent and has more reliable absorption in the geriatric patient than calcium carbonate which requires an acid stomach for absorption and the patient is on Prevacid 30mg daily and Pepcid.
Consider that: Long term use of proton pump inhibitors (beyond 4-8 weeks of therapy - the duration of treatment recommended by all manufacturers for their PPIs in company monographs and all current drug reference resources for treatment of GERD) may lead to several serious conditions...
- Incidence of C. difficile diarrhea is 3 times higher for patient on long-term PPI therapy and twice as high for patients on H2 antagonist long term than control patients on neither.
- Rebound acidity –from the body’s attempt to regain the low gastric pH through more gastric acid secretions exacerbating the GI condition.
- Aspiration Pneumonia risk are increased (in the geriatric & ICU patient) - raising the pH of the gut for long times produces a basic gut that complicates digestion, increase more gas and discomfort, slows down the breakdown of foods and many drugs and increase potential risk for aspiration of this basic fluid into the lungs.
- D/C Prevacid & Pepcid and start Zantac 75mg po bid x 1 month, use the H2 blocker in a step-down approach to reduce the potential for serious adverse events and implement non drug approaches as follows:
- Prohibit spicy and difficult to digest foods after evening meal around 6 to 7 PM
- Have the patient consume 3 oz buttermilk and saltine crackers or a container of plain yogurt amazingly helps this problem. If these non-drug approaches are successful with this patient then begin tapering the H2 blocker as follows:
decrease Zantac to 75mg hs x 1 month then qod hs x 1 month then D/C
Thank you for this very interesting consult,
________________________________________
Charles S. Feucht, PD,FASCP
____________________________________________________________________________________
Effexor XR
Venlafaxine extended-release capsules
What are venlafaxine extended-release capsules?
VENLAFAXINE (EffexorŽ XR) is an antidepressant, a medicine that helps to lift mental depression. Venlafaxine can help patients whose depression has not responded to other medications. Venlafaxine is also effective for the treatment of anxiety or other nervous conditions. Occasionally it is prescribed for other purposes. Generic venlafaxine tablets are not yet available.
What should my health care professional know before I take venlafaxine?
They need to know if you have any of these conditions:
.anorexia or weight loss
.attempted suicide
.high blood pressure, heart problems or a recent heart attack
.high cholesterol levels or receiving treatment for high cholesterol
.kidney disease
.liver disease
.mania or bipolar disorder
.seizures (convulsions)
.suicidal thoughts or a previous suicide attempt
.thyroid problems
.an unusual or allergic reaction to venlafaxine, other medicines, foods, dyes, or preservatives
.pregnant or trying to get pregnant
.breast-feeding
How should I take this medicine?
Take venlafaxine capsules by mouth. Follow the directions on the prescription label. Do not cut, crush, chew or divide the capsules; swallow them whole with plenty of water. Take venlafaxine capsules with food. Try to take your dose at about the same time each day, in the morning or evening. Do not take your medicine more often than directed. Do not stop taking the capsules except on your prescriber's advice.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is less than two hours to your next dose, take only that dose and skip the missed dose. Do not take double or extra doses.
What drug(s) may interact with venlafaxine?
.alcohol
.amphetamine
.certain migraine headache medicines (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)
.cimetidine
.clozapine
.dextroamphetamine
.furazolidone
.linezolid
.lithium
.medicines for heart rhythm or blood pressure
.medications for weight control or appetite
.medicines called MAO inhibitors-phenelzine (NardilŽ), tranylcypromine (ParnateŽ), isocarboxazid (MarplanŽ)
.other medicines for mental depression, mania, psychosis, or anxiety
.procarbazine
.selegiline
.St. John's wort, Hypericum perforatum
.warfarin
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from taking venlafaxine?
Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare or uncommon:
.abnormal body movements, for example, of your tongue or upper body
.bruising or bleeding
.difficulty breathing
.fainting spells
.mania (over-active behavior)
.problems passing urine (increase or decrease in frequency)
.rapid heartbeat, or palpitations
.seizures (convulsions)
More common:
.agitation, anxiety, or restlessness, especially in the first week of treatment or when doses are changed
.changes in vision (blurred vision)
.sexual difficulties (abnormal ejaculation or orgasm, difficult or painful erections, impotence)
.vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
.dry mouth
.constipation
.dizziness, drowsiness
.increased sweating
.loss of appetite, loss of weight
.nausea
.tremor
.weakness or tiredness
What should I watch for while taking venlafaxine?
Visit your prescriber or health care professional for regular checks on your progress. You may have to take venlafaxine for 4 weeks before you feel better. If you have been taking venlafaxine for some time, do not suddenly stop taking it. You must gradually reduce the dose to avoid side effects. Ask your prescriber or health care professional for advice.
Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.
Venlafaxine can cause an increase in blood pressure or a faster heart beat. Check with your prescriber or health care professional; you may be able to measure your own blood pressure and pulse. Find out what your blood pressure and heart rate should be and when you should contact him or her.
You may get drowsy, dizzy or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how venlafaxine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness or drowsiness; avoid alcoholic drinks.
Venlafaxine can make your mouth dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help.
Do not treat yourself for coughs, colds, or allergies without asking your prescriber or health care professional for advice. Some ingredients may increase possible side effects.
If you are going to have surgery, tell your prescriber or health care professional that you are taking venlafaxine.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at a controlled temperature between 20 degrees and 25 degrees C (68 degrees and 77 degrees F), in a dry place. Throw away any unused medicine after the expiration date.
Classification:
• Gastrointestinal Agents
• Antiulcer Agents
• Proton pump inhibitors (PPIs)
Description, Mechanism of Action, Pharmacokinetics
Description: Lansoprazole is an antiulcer drug similar to omeprazole. Like omeprazole, lansoprazole is an acid proton-pump inhibitor. It is used for the short-term treatment of duodenal or gastric ulcers, gastroesophageal reflux disease (GERD), and erosive esophagitis. It is also indicated to maintain healing of duodenal ulcer and esophagitis, for NSAID-induced ulcer treatment or prophylaxis, and for long-term treatment of Zollinger-Ellison syndrome (pathological hypersecretory condition). In vitro data indicate that lansoprazole is significantly more potent than either omeprazole or pantoprazole against H. pylori.[1723] Clinically, lansoprazole is at least as effective as omeprazole in treating peptic ulcers and reflux esophagitis, and it has been shown to relieve reflux symptoms more quickly than either omeprazole or ranitidine.[757] Over a 4-week period, ulcer healing was greater with lansoprazole than ranitidine or placebo in a double-blind study of the treatment of active duodenal ulcer.[758] A comparative study of omeprazole and lansoprazole in the short-term treatment of reflux esophagitis showed no significant difference in healing after 4 or 8 weeks. Lansoprazole, however, showed greater improvement in heartburn and acid regurgitation symptoms after 4 weeks.[759] Lansoprazole has also been demonstrated to be safe and effective for chronic therapy of Zollinger-Ellison syndrome[760] and for Barrett's esophagus.[761] Lansoprazole is also available in a therapy pack which contains clarithromycin and amoxicillin (see Prevpac® monograph); this triple-drug regimen is indicated for the treatment of patients with duodenal ulcer and Helicobacter pylori infection. Lansoprazole was initially approved by the FDA May 10, 1995. A delayed-release oral suspension formulation of Prevacid® was approved by the FDA on May 3, 2001. Lansoprazole is approved for children >= 1 year and adolescents for short-term treatment of symptomatic GERD and erosive esophagitis. Prevacid® SoluTab™ Delayed-Release Orally Disintegrating Tablets were approved on August 30, 2002. All three oral Prevacid® dosage forms have delayed-release properties and contain lansoprazole within enteric-coated granules. An intravenous formulation of lansoprazole for the short-term treatment of erosive esophagitis was approved by the FDA on May 27, 2004. Oral Prevacid® is currently scheduled to go off patent by July 2005.
Mechanism of Action: Lansoprazole inhibits gastric acid secretion. It belongs to a new class of antisecretory agents, the substituted benzimidazoles, which suppress gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system of gastric parietal cells. An acidic environment in the parietal cell is required for conversion of gastric-acid pump inhibitors, such as lansoprazole, to the active sulfenamide metabolite. The active metabolite then inhibits the ATPase enzyme required for gastric-acid pump activation, thereby blocking the final step of acid output from the parietal cells. A significant increase in gastric pH and decrease in basal acid output follow oral administration of lansoprazole. In hypersecretory conditions, lansoprazole has a marked effect on gastric acid secretion, both basal- and pentagastrin-stimulated. Lansoprazole exerts an inhibitory effect on gastric acid for at least 24 hours, which allows a once-daily dosing schedule. Lansoprazole does not antagonize H2 or cholinergic receptors.
Significant in vitro activity against Helicobacter pylori (H. Pylori) has been demonstrated for lansoprazole. Minimum inhibitory concentrations (MICs) for lansoprazole are lower than that for omeprazole. The clinical significance of this finding has not been established. Lansoprazole monotherapy increases the clearance rate of H. pylori; however, eradication does not occur without antimicrobial therapy.
Serum gastrin levels increase 50—100% from baseline in the fasting state, and these increases are greater during lansoprazole therapy than during ranitidine therapy.[758] Increases reach a plateau within 2 months and return to pretreatment levels within 4 weeks of discontinuation of lansoprazole therapy. Although prolonged hypergastrinemia has been associated with gastric tumors, a long-term study of lansoprazole for the treatment of Zollinger-Ellison syndrome did not reveal evidence to suggest that lansoprazole was implicated in tumor progression noted in two (10% of) patients.[760] Both patients already had extensive metastatic disease.
Short-term (i.e., 8-week) studies showed that lansoprazole had no effect on the endocrine system. Like omeprazole, however, lansoprazole also inhibits the hepatic cytochrome P450 oxidase system (see Drug Interactions).
Pharmacokinetics: Lansoprazole is administered orally and should be taken in the morning at least 30 minutes before a meal on a once-daily schedule, unless large doses must be divided for hypersecretory conditions. All lansoprazole dosage forms (capsules, oral suspension, and disintegrating tablets) contain delayed-release, enteric-coated granules that release drug after they leave the stomach. Absorption of lansoprazole is rapid; mean peak plasma levels occur after about 1.7 hours. The absolute bioavailability is over 80%, which can be reduced by 50% if lansoprazole is given 30 minutes after food. Lansoprazole is about 97% bound to plasma protein. Lansoprazole is excreted into animal breast milk and possibly into human breast milk. Lansoprazole is believed to be transformed into two active inhibitors of acid secretion in the gastric parietal cells.
Hepatic metabolism of lansoprazole is extensive. The two identified hepatic metabolites of lansoprazole have little antisecretory activity. Plasma elimination half-life, which is less than 2 hours, is not related to gastric antisecretory effect, which lasts more than 24 hours. Elimination is believed to occur via biliary excretion. Almost no unchanged lansoprazole is detected in urine after single-dose administration. After administration of a single dose of radio-labeled lansoprazole, one-third of the administered radiation was excreted in urine and two-thirds in the feces.
•Special populations: The pharmacokinetics of lansoprazole are similar for children (1—11 years) and adult subjects. The mean Cmax and AUC values are similar for two weight-adjusted dosage groups: 15 mg/day for weight <= 30 kg versus 30 mg/day for weight > 30 kg; pharmacokinetics are not affected by age or weight within these groups. Lansoprazole serum concentrations are increased in the elderly or patients with hepatic disease; but are not affected by gender, renal dysfunction or hemodialysis. In patients with various degrees of chronic hepatic disease, the mean plasma half-life of the drug was prolonged from 1.5 hours to 3.2—7.2 hours. An increase in the mean AUC of up to 500% was observed at steady-state in patients with hepatic impairment compared to healthy subjects in another study. Elderly patients have a reduced clearance and an increased elimination half-life (up to 2.9 hours) of lansoprazole; but drug accumulation was not observed during once-daily dosing. No clinically significant gender differences in clearance or AUC were determined. Pharmacokinetic parameters are not changed by the presence of renal impairment. Lansoprazole is not removed by hemodialysis.
Description, Mechanism of Action, Pharmacokinetics last revised 7/8/2004 11:22:00 AM
Indications
• duodenal ulcer |
• Helicobacter pylori |
• esophagitis |
• NSAID-induced ulcer prophylaxis |
• gastric ulcer |
• pyrosis (heartburn)† |
• gastroesophageal reflux disease (GERD) |
• Zollinger-Ellison syndrome |
† non-FDA-approved indication
Dosage
For the short-term treatment of frequent pyrosis (heartburn)† that occurs >= 2 times per week:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults and the elderly: 15 mg PO once daily for up to 14 days. Full relief may take 1—4 days. If frequent heartburn returns soon after the initial 14-day treatment regimen, patients should contact their health care provider.
Children: Safe and effective use has not been established.
For the short-term treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD):
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal, for up to 8 weeks. If the patient has symptomatic erosive or recurrent GERD, initially 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks. If healing is incomplete or recurs, a further 8 weeks of therapy can be considered.
Children 1—11 years: The FDA-approved initial dosage is 15—30 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks (15 mg/day for weight <= 30 kg; 30 mg/day for weight > 30 kg); the dosage was increased (up to 30 mg PO twice daily) in some children who were symptomatic after 2 weeks in trials. Based on published literature, initial starting doses of 1.4—1.5 mg/kg/day PO have also been suggested.[3636] [3637] Individualize dosage to attain clinical goals.
For the treatment of symptomatic erosive GERD, such as erosive esophagitis:
•for treatment of active disease:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: Initially, 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks. If healing is incomplete, a further 8 weeks of therapy can be administered. If erosive esophagitis recurs, an additional 8 week course of treatment can be considered.
Children 1—11 years: The FDA-approved initial dosage is 15—30 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks (15 mg/day for weight <= 30 kg; 30 mg/day for weight > 30 kg); the dosage was increased (up to 30 mg PO twice daily) in some children who were symptomatic after 2 weeks in trials. Based on published literature, initial starting doses of 1.4—1.5 mg/kg/day PO have also been suggested.[3636] [3637] Individualize dosage to attain clinical goals.
•for maintenance of remission:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: The recommended dosage is 15 mg PO once daily in the morning at least 30 minutes before a meal. Controlled studies do not extend beyond 12 months. In one clinical study, 173 patients were randomized to placebo, lansoprazole 15 mg, or lansoprazole 30 mg PO once daily before breakfast for 12 months. Lansoprazole was superior to placebo however there was no difference between the 2 lansoprazole doses.[1180]
Children: Safe and effective use has not been established.
•for the short-term treatment of erosive esophagitis in patients unable to take oral therapy:
Intravenous infusion dosage:
Adults and the elderly: 30 mg IV once daily given over 30 minutes for up to 7 days (see Administration for dilution and administration methods). Switch to oral therapy when feasible. Oral and IV lansoprazole equally suppress acid production.[5702]
Adolescents and children: Safe and effective use has not been established.
For the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: Initially, 60 mg PO once daily in the morning at least 30 minutes before a meal. Dosage should be individualized and continued for as long as clinically indicated. Some patients with Z-E syndrome have been treated continuously for more than four years. Doses up to 90 mg PO twice daily have been used for this condition. If dosage is > 120 mg/day, give in divided doses.
Children: Safe and effective use has not been established.
For the treatment of active duodenal ulcer or active benign gastric ulcer:
•for the short-term treatment of active duodenal ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal, for up to 4 weeks.
Children: Safe and effective use has not been established.
•for maintenance of remission following treatment of active duodenal ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal. Controlled studies do not extend beyond 12 months.
Children: Safe and effective use has not been established.
•for the treatment of active benign gastric ulcer:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 30 mg PO once daily in the morning at least 30 minutes before a meal, for up to 8 weeks.
Children: Safe and effective use has not been established.
•for triple therapy of Helicobacter pylori-positive duodenal ulcer in combination with clarithromycin and amoxicillin:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: The FDA-approved dosage is lansoprazole 30 mg PO twice daily, in combination with clarithromycin 500 mg PO twice daily plus amoxicillin 1 g PO twice daily, for 10—14 days. The American College of Gastroenterology (ACG) has previously recommended 14 days for triple regimens based on high H. pylori eradication rates.[2661]
Children: Safe and effective use has not been established.
•for dual therapy of Helicobacter pylori-positive duodenal ulcer in combination with amoxicillin in patients who are intolerant or resistant to clarithromycin:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: NOTE: More effective triple regimens are available.[2661] The FDA-approved dual regimen includes: lanzoprazole 30 mg PO three times daily plus amoxicillin 1 g PO three times daily, given for 14 days. H. pylori eradication rates are lower with this dual regimen (66—77%, per-protocol analysis) relative to the 2-week triple regimen containing clarithromycin (85—92%, per-protocol analysis).
Children: Safe and effective use has not been established.
For NSAID-induced ulcer prophylaxis or healing:
•to treat an NSAID-associated gastric ulcer in patients who continue NSAID use:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 30 mg PO once daily in the morning at least 30 minutes before a meal for up to 8 weeks.
Children: Safe and effective use has not been established.
•to reduce the risk of NSAID-associated ulcers in patients with a prior documented gastric ulcer, who require NSAID therapy:
Oral dosage (capsules, disintegrating tablets, or oral suspension):
Adults, elderly and adolescents: 15 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks. A higher dosage of 30 mg once daily has been evaluated for risk-reduction of NSAID-induced ulcers in a large multicenter trial; the larger dose yielded no additional benefit compared to the 15 mg dose.
Children: Safe and effective use has not been established.
Maximum Dosage Limits:
•Adults: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
•Elderly: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
•Adolescents: 30 mg/day PO for most indications; 90 mg/day PO for eradication of H. pylori; up to 180 mg/day PO for Zollinger-Ellison syndrome.
•Children > 30 kg: 30 mg/day PO for GERD or erosive esophagitis, up to 60 mg/day PO has been used for refractory cases.
•Children <= 30 kg: 15 mg/day PO for GERD or erosive esophagitis; occasionally higher dosages used for refractory cases.
•Infants: Safe and effective use not established.
Patients with hepatic impairment:
Consider dosage reduction in patients with severe hepatic disease; specific recommendations are not available.
Patients with renal impairment:
No dosage adjustments are needed (manufacturer's information).
Intermittent hemodialysis:
Lansoprazole is not removed by hemodialysis.
†non-FDA-approved indication
Indications...Dosage last revised 8/22/2004 2:03:00 PM
Administration Guidelines
Oral Administration
•All dosage forms: Administer dosage 30 minutes prior to meal whenever possible. A once-daily dosage is usually administered prior to breakfast. The presence of a meal in the stomach decreases the bioavailability by about 50%. Antacids were used concomitantly with lansoprazole in clinical trials.
•Delayed-release capsules: Swallow delayed-release capsules intact; do not chew or crush. For patients with difficulty swallowing, the capsules may opened and the contents may be sprinkled on 1 tablespoonful (15 ml) of either applesauce, Ensure® liquid supplement, pudding, yogurt, or cottage cheese. Do not crush the capsule contents into the food. Swallow immediately. Do not chew the medication. Do not prepare doses before the time of administration. Alternatively, the capsule may be emptied into a small volume of either apple juice, orange juice or tomato juice (60 ml, approximately 2 ounces), mixed briefly and swallowed immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately. The granules have been shown in vitro to remain intact when exposed to apple, cranberry, grape, orange, pineapple, prune, tomato, and V-8 vegetable juice and stored for up to 30 minutes.
•Delayed-release oral suspension: Packets containing the enteric-coated granules (15 or 30 mg doses) are mixed with 2 tablespoonfuls (30 ml) of water to form a strawberry-flavored suspension, intended for immediate administration after mixing. Do not use with other liquids or foods. Stir well and drink immediately. Do not crush or chew the granules. If any material remains after drinking, add more water, stir, and drink immediately.
•Delayed-release disintegrating tablets: Place the Prevacid® SoluTab™ on the tongue and allow it to disintegrate until the particles can be swallowed. The tablet will disintegrate rapidly (< 1 minute). Do not chew the tablets. For administration via an oral syringe, the tablet can be dissolved in water (4 ml for 15 mg tablet, 10 ml for 30 mg tablet) and should be administered within 15 minutes.
•Patients with a nasogastric tube: Prevacid® capsules or disintegrating tablets can be administered via a nasogastric tube. Capsules: Open the capsule and mix the intact granules in 40 ml of apple juice and inject through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional apple juice to clear the tube. Nasogastric tube: Dissolve tablet in water (4 ml for 15 mg tablet, 10 ml for 30 mg tablet) and administer within 15 minutes. After administration, the tube should be flushed to clear the tube.
Intravenous Administration
•Lansoprazole is administered as an intravenous (IV) infusion either through a dedicated line or a Y-site. The drug should NOT be given by IV push or other parenteral routes other than IV infusion.
•Administer IV using the in-line filter provided. The filter MUST be used to remove precipitate.
•Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Reconstitution of vial:
•Reconstitute each 30 mg vial with 5 ml of Sterile Water for Injection, USP only. NOTE: Lansoprazole IV must be reconstituted with 5 ml of Sterile Water for Injection, USP. Failure to reconstitute with Sterile Water may result in formation of precipitation/particulates.
•Mix gently by swirling. The resulting solution will contain lansoprazole 6 mg/ml.
•The reconstituted solution can be held for 1 hour when stored at 25 degrees C (77 degrees F) prior to further dilution.
•Reconstituted vials and admixtures do not need to be protected from light. Do not freeze.
Preparation and Administration of IV infusion:
•Dilute the reconstituted vial in either 50 ml of 0.9% Sodium Chloride Injection (NS), Lactated Ringer's Injection (LR), or 5% Dextrose Injection (D5W). The admixture should be stored at 25 degrees C (77 degrees F). No refrigeration is required.
•If reconstituted with NS or LR, solution must be administered within 24 hours. If reconstituted with D5W, solution must be administered within 12 hours.
•Administer IV using the in-line filter provided. The filter MUST be used to remove precipitate.
•Lansoprazole IV infusion is administered either through a dedicated line or a Y-site. A dedicated line is not required; however, the intravenous line should be flushed before and after administration. When administered via a Y-site, immediately stop use if a precipitation or discoloration occurs.
•Infuse IV over 30 minutes.
•Do not administer lansoprazole IV with other drugs or diluents.
Administration last revised 4/15/2005 2:21:00 PM
Contraindications/Precautions
• proton pump inhibitors (PPIs) hypersensitivity |
• hepatic disease |
• breast-feeding |
• infants |
• children |
• phenylketonuria |
• gastric cancer |
• pregnancy |
• Absolute contraindications are in italics.
Lansoprazole is contraindicated in patients with known hypersensitivity to lansoprazole or other substituted benzimidazoles such as omeprazole or esomeprazole (i.e., known proton pump inhibitors (PPIs) hypersensitivity). Although rare, occasionally such reactions can be serious (e.g., result in anaphylaxis or angioedema). There has been evidence of PPI cross-sensitivity in some sensitive individuals in literature reports.
Lansoprazole is classified as pregnancy category B. Animal studies have shown no teratogenic effects. Adequate studies have not been undertaken in humans. Lansoprazole should be used during pregnancy only when clearly needed.
Animal studies have indicated that lansoprazole is excreted into breast milk. Although no studies have been done to determine if lansoprazole is similarly excreted into human milk, lansoprazole use is not recommended during breast-feeding. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from lansoprazole in breast-fed infants, a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Lansoprazole elimination half-life is significantly prolonged in patients with hepatic disease. In patients with severe hepatic disease, dosage reduction of lansoprazole should be considered. Abnormal liver-function tests have been reported infrequently with lansoprazole use. No dosage adjustment is necessary in patients with renal insufficiency or the elderly (manufacturer's information).
Safety and efficacy of lansoprazole have not been established in infants (i.e., age < 1 year). The manufacturer has established safety and efficacy for lansoprazole use in children aged 1—17 years for short-term treatment of symptomatic GERD and erosive esophagitis. Safety and effectiveness in the pediatric population has been determined from adult clinical trials with additional clinical, pharmacokinetic, and pharmacodynamic studies in children.
Antimicrobials, lansoprazole, omeprazole, and bismuth preparations suppress H.pylori. Ingestion of these substances within four (4) weeks prior to performing urease or breath-tests for H. pylori detection may lead to false negative results. In the four weeks prior to performing the test, the patient must avoid the use lansoprazole and other agents which are known to suppress H.pylori.
Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric cancer or other malignancy.
Patients with phenylketonuria should be made aware that lansoprazole disintegrating tablets contain phenylalanine (2.5 mg per 15 mg tablet; 5.1 mg per 30 mg tablet). The capsule and syrup formulations do not contain phenylalanine.
Contraindications last revised 7/6/2005 3:40:00 PM
Drug Interactions
• Ampicillin |
• Iron Salts |
|
Antimuscarinics |
• Itraconazole |
|
• Atazanavir |
• Ketoconazole |
|
• Delavirdine |
• Methylphenidate |
|
• Dexmethylphenidate |
• Misoprostol |
|
• Digoxin |
• Octreotide |
|
• Fluvoxamine |
• Sucralfate |
|
• food |
• Theophylline, Aminophylline |
|
• Gefitinib |
• Voriconazole |
|
H2-blockers |
• Warfarin |
|
NOTE: Lansoprazole is a substrate of the cytochrome P-450 system via the CYP2C19 and CYP3A4 isoenzymes.[4718] [5142]
Sucralfate has been shown to delay the absorption and reduce the bioavailability of oral lansoprazole by about 17%.[5142] Lansoprazole should be taken no less than 30 minutes before sucralfate if these drugs are to be used concomitantly. Concurrent administration of oral lansoprazole and antacids may reduce the bioavailability of lansoprazole; except when the antacids are given at least one hour before lansoprazole administration.[5142] The manufacturer states that antacids were given with lansoprazole in clinical trials, with the interpretation that concurrent antacids did not interfere with lansoprazole's effects.[5142]
Lansoprazole is metabolized by the hepatic cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes.[4718] However, no interactions have been reported between lansoprazole and antipyrine, clarithromycin, diazepam, ibuprofen, indomethacin, oral contraceptives [763], phenytoin, prednisone, propranolol, or terfenadine in healthy subjects.[5142]
In a study of healthy subjects neither the pharmacokinetics of warfarin enantiomers nor prothrombin time were affected following single or multiple 60 mg doses of lansoprazole.[5142] However, there have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including lansoprazole, and warfarin concomitantly.[5142] It is prudent to monitor the INR more closely if a proton pump inhibitor is combined with warfarin.
Concomitant use of theophylline (CYP1A2 and CYP3A substrate) and lansoprazole has led to a small increase (10%) in theophylline clearance.[5142] Theophylline may require dosage adjustment when therapy with lansoprazole is initiated or discontinued.
Lansoprazole has a long-lasting effect on the secretion of gastric acid. For drugs whose bioavailability is influenced by gastric pH, the concomitant administration of lansoprazole can exert a significant effect on their absorption.[5142] Drugs that could be affected by lansoprazole in this way include ampicillin [5142], digoxin [5142], iron salts [5142] [6305], itraconazole [4700], and ketoconazole [4699] [5142]. The bioavailability of polysaccharide-iron complex and other oral iron salts is influenced by gastric pH, and the concomitant administration of a proton pump inhibitor can completely decrease iron absorption.[6924] The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Lansoprazole has been shown to lack a clinically significant interaction with amoxicillin. Gastric acid pump-inhibitors may increase digoxin bioavailability, however, the magnitude of the interaction is small. The potential interaction between lansoprazole and digoxin has not been specifically studied. Omeprazole increases the AUC of digoxin by about 10%. When rabeprazole is co-administered with digoxin, the AUC and Cmax for digoxin increases approximately 19% and 29%, respectively. Patients with digoxin serum levels at the upper end of the therapeutic range may need to be monitored for potential increases in serum digoxin levels when a gastric acid pump-inhibitor is coadministered with digoxin.
Lansoprazole is metabolized by the hepatic cytochrome P450 system, specifically via the CYP3A and CYP2C19 isozymes;[5142] voriconazole is a known inhibitor of these isozymes [4882]. The manufacturer for voriconazole has recommended that higher dosages of a related proton pump inhibitor, omeprazole, be reduced by one-half when initiating voriconazole therapy, due to increased omeprazole serum concentrations produced by this interaction.[4882] Although data are not available, theoretically a similar interaction may occur between lansoprazole and voriconazole. Higher daily doses of lansoprazole may need to be reduced when initiating voriconazole therapy.
Long-term treatment with lansoprazole in conjunction with diazepam therapy has been studied. Plasma elimination half-life, clearance, and volume of distribution of diazepam were not affected by concurrent use of lansoprazole.[762]
Proton pump inhibitors (PPIs), which increase gastric pH, may reduce the absorption of delavirdine. However, since these agents affect gastric pH for an extended period, separation of doses may not eliminate the interaction. Chronic use of proton pump inhibitors (PPIs) with delavirdine is not recommended.[5206]
Drugs that cause a significant sustained elevation in gastric pH [e.g., proton pump inhibitors (PPIs)] may reduce plasma concentrations of gefitinib and thus potentially may reduce gefitinib efficacy.[5012]
The American College of Gastroenterology states that the effectiveness of proton pump inhibitors (PPIs) may be decreased if given with other antisecretory agents (e.g., antimuscarinics, octreotide, H2-blockers, or misoprostol).[1569] Proton pump inhibitors (PPIs) inhibit only actively secreting H+-pumps.
Fluvoxamine is a major inhibitor of the cytochrome P450 enzyme (CYP) 2C19. Several proton pump inhibitors (PPIs), including lansoprazole, are primary substrates of the CYP2C19 enzyme. Reduced metabolism and resulting elevated plasma concentrations of these PPIs may occur if combined with fluvoxamine. A single-dose pharmacokinetic study has shown that the mean AUC of omeprazole 40 mg was increased 2- to 6-fold when given after fluvoxamine 50 mg/day for 6 days.[6481] Monitor patients for PPI toxicity, such as headache or GI distress if these drugs are combined.
A randomized, open-label, multiple-dose drug interaction study of atazanavir (300 mg) with ritonavir (100 mg) coadministered with omeprazole 40 mg, found a reduction in atazanavir AUC and Cmin of 76% and 78%, respectively. Based on these study results, atazanavir, with or without ritonavir, should not be coadministered with omeprazole due to the reduction in atazanavir exposure levels. It is not known whether the over-the-counter dose of omeprazole (20 mg once daily) would produce similar results; therefore, coadministration is not recommended. Increasing the atazanavir and ritonavir doses to 400 and 100 mg, respectively, with omeprazole did not result in atazanavir exposures comparable to those observed with a regimen of atazanavir 300 mg with ritonavir 100 mg without omeprazole. Due to similar mechanisms, other proton pump inhibitors (PPIs) (e.g., esomeprazole, pantoprazole, rabeprazole, and lansoprazole) should not be used with atazanavir. When such substantial reductions in atazanavir serum concentrations are seen, therapeutic failure and resistance development may be expected.[4865]
Administer a lansoprazole oral dosage 30 minutes prior to food whenever possible.[5142] The presence of a meal (food) in the stomach decreases the bioavailability by about 50%.
The effects of gastrointestinal pH alterations on the absorption of methylphenidate extended release capsules (Ritalin® LA) and dexmethylphenidate extended-release tablets (Focalin™ XR) have not been studied. Although the SODAS® system (drug delivery system utilized in Ritalin® LA and Focalin™ XR) is thought to be minimally affected by changes in pH,[8068] per the manufacturer, the modified release characteristics of both extended-release formulations are pH-dependent. It is possible that the administration of proton pump inhibitors (PPIs) or other acid suppressants could alter the release of dexmethylphenidate or methylphenidate.[8067] [8069] Patients receiving these extended-release products (Focalin™ XR or Ritalin® LA) with acid suppressants should be monitored for adverse effects and therapeutic efficacy.
Interactions last revised 6/30/2005 4:19:00 PM
Adverse Reactions
• abdominal pain |
• hyperbilirubinemia |
• agranulocytosis |
• jaundice |
• alopecia |
• leukopenia |
• anaphylactoid reactions |
• nausea/vomiting |
• anemia |
• neutropenia |
• aplastic anemia |
• pancreatitis |
• cholelithiasis |
• pancytopenia |
• constipation |
• pernicious anemia |
• diarrhea |
• pruritus |
• elevated hepatic enzymes |
• rash (unspecified) |
• erythema multiforme |
• Stevens-Johnson syndrome |
• gynecomastia |
• thrombocytopenia |
• headache |
• thrombotic thrombocytopenic purpura (TTP) |
• hemolysis |
• toxic epidermal necrolysis |
• hemolytic anemia |
• urticaria |
• hepatitis |
• vitamin B<SUB>12</SUB> deficiency |
The safety profile of lansoprazole is similar in adults and children 1—11 years old. Adverse reactions reported during lansoprazole clinical trials were mild and primarily related to the GI tract. The most frequent adverse reactions (> 1%) in adults which occurred at a greater frequency than placebo included: diarrhea (3.6% vs 2.6%), abdominal pain (1.8% vs 1.3%), and nausea/vomiting (1.5% vs 1.3%). The incidence of diarrhea was dose-related. At a daily dose of 60 mg of lansoprazole, 7.4% of patients experienced diarrhea compared with 1.4% at 15 mg/day and 4.2% at 15 mg/day (2.9% incidence in the placebo group). In children 1—11 years old, the most frequent side effect was constipation (5%). Other GI adverse events occurring infrequently (< 1%) in lansoprazole-treated patients during clinical trials or post-marketing experience and included: melena, anorexia, bezoar, constipation, xerostomia, dyspepsia, dysphagia, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastroenteritis, gastrointestinal hemorrhage, hematemesis, increased appetite, increased salivation, rectal hemorrhage, stomatitis, tenesmus, and ulcerative colitis.
Headache was reported in > 1% of patients taking lansoprazole, but a higher percentage of patients taking placebo reported headache. During GERD trials with lansoprazole in pediatric patients, the frequency of headache in children 1—11 years old was 3%.
Hepatitis and/or jaundice have been associated with PPIs. Specifically, cholelithiasis (<1%), hepatoxicity (post-marketing data), hyperbilirubinemia, and elevated hepatic enzymes (increased AST and ALT) have been reported during lansoprazole therapy. In controlled clinical trials, 0.4% (1/250) placebo patients and 0.3% (2/795) lansoprazole patients had hepatic enzyme elevations > 3 times the upper limit of the normal range at the end of the study, but without evidence of jaundice. Pancreatitis has been reported post-marketing, but causal association and frequency are unknown.
Infrequent hematological reactions have been associated with lansoprazole therapy (<1%). These reactions have included agranulocytosis, anemia, aplastic anemia, hemolysis, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura (TTP). Generally, long-term (e.g., > 3 years) treatment with acid-suppressing agents can lead to malabsorption of vitamin B12 (cyanocobalamin). In a study of healthy volunteers, it was shown that omeprazole caused a significant reduction in cyanocobalamin absorption (vitamin B12 deficiency).[162] Although clinical data in lansoprazole is lacking, it may be prudent to monitor patients for signs of pernicious anemia. Neurological manifestations of pernicious anemia can occur in the absence of hematologic changes.
Allergic reactions, including rash (unspecified) and anaphylactoid reactions, have been reported infrequently with PPI therapy including lansoprazole (<1%). Specific dermatological reactions reported in < 1% of lansoprazole-treated patients included: acne, alopecia, pruritus, rash, and urticaria. Severe dermatological reactions reported during post-marketing experience include: erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal).
Gynecomastia was reported in < 1% of patients receiving lansoprazole.
Significant elevations in serum gastrin have been reported with lansoprazole and is consistent with the effects of other PPIs; this effect may be dose-related. Although not specifically studied in patients receiving lansoprazole, the risk of carcinoid tumors during therapy with proton pump inhibitors is low based on cumulative safety experience. Monitoring of serum gastrin levels during PPI therapy is generally not necessary.[2859]
Other infrequent (< 1%) or rare adverse experiences reported without regard to causality are detailed in the prescribing information for lansoprazole.
Adverse Reactions last revised 3/12/2004 4:52:00 PM
Patient Education
Lansoprazole capsules
What are lansoprazole capsules?
LANSOPRAZOLE (Prevacid®) prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD) or ulcers. Lansoprazole is also useful in conditions that produce too much stomach acid such as Zollinger-Ellison syndrome. Generic lansoprazole capsules are not yet available.
What should my health care professional know before I take lansoprazole?
They need to know if you have any of these conditions:
•liver disease
•an unusual or allergic reaction to lansoprazole, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I take this medicine?
Take lansoprazole capsules by mouth. Follow the directions on the prescription label. Swallow the capsules whole with a drink of water; do not crush or chew. Lansoprazole works best if taken on an empty stomach. It is best to take the capsules 30 to 60 minutes before food. Take your doses at regular intervals. Do not take your medicine more often than directed.
If you have difficulty swallowing the capsules, you may open the Prevacid® capsule and sprinkle the contents on a tablespoon of any of the following foods: applesauce, pudding, cottage cheese, yogurt, or a spoonful of Ensure® drink. Do not crush the contents of the capsule into the food. Swallow the dose immediately after preparing it; do not chew. Follow with a drink of water.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What drug(s) may interact with lansoprazole?
•ampicillin
•bisacodyl
•delavirdine
•digoxin
•fluvoxamine
•iron salts
•itraconazole
•ketoconazole
•sucralfate
•theophylline
•voriconazole
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from taking lansoprazole?
Side effects that you should report to your prescriber or health care professional as soon as possible.
Rare or uncommon:
•dark yellow or brown urine
•fever or sore throat
•unusual skin rash, blistering, or peeling
•unusual bleeding or bruising
•yellowing of the eyes or skin
•vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•abdominal pain
•diarrhea or constipation
•headache
•nausea
What should I watch for while taking lansoprazole?
It can take several days of therapy with lansoprazole before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of pain unless your prescriber or health care professional tells you otherwise.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.
NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.
[Revised: 10/02/2002]
Lansoprazole disintegrating tablets
What are Lansoprazole disintegrating tablets?
LANSOPRAZOLE (Prevacid® SoluTab™) prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD) or ulcers. Lansoprazole is also useful in conditions that produce too much stomach acid such as Zollinger-Ellison syndrome. Generic lansoprazole disintegrating tablets are not yet available.
What should my health care professional know before I receive Lansoprazole?
They need to know if you have any of these conditions:
•liver disease
•phenylketonuria
•an unusual reaction to lansoprazole, medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should this medicine be used?
Take lansoprazole disintegrating tablets by mouth. Follow the directions on the prescription label. Place the tablet on your tongue and allow it to dissolve in your mouth. The tablet will dissolve rapidly, usually in less than one minute. Swallow the medicine once completely dissolved. Do not chew the tablets. Take your doses at regular intervals. Do not take your medicine more often than directed.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What drug(s) may interact with Lansoprazole?
•ampicillin
•bisacodyl
•delavirdine
•digoxin
•fluvoxamine
•iron salts
•itraconazole
•ketoconazole
•sucralfate
•theophylline
•voriconazole
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from receiving Lansoprazole?
Side effects that you should report to your prescriber or health care professional as soon as possible.
Rare or uncommon:
•dark yellow or brown urine
•fever or sore throat
•unusual skin rash, blistering, or peeling
•unusual bleeding or bruising
•yellowing of the eyes or skin
•vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•abdominal pain
•diarrhea or constipation
•headache
•nausea
What should I watch for while taking Lansoprazole?
It can take several days of therapy with lansoprazole before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of pain unless your prescriber or health care professional tells you otherwise.
If you have phenylketonuria, you should avoid taking the lansoprazole disintegrating tablets which contain phenylalanine. The capsules and syrup forms of lansoprazole are preferred because they do not contain phenylalanine.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.
NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.
[Revised: 10/03/2002]
Lansoprazole Injection
What is lansoprazole Injection?
LANSOPRAZOLE (Prevacid® IV) prevents the production of acid in the stomach. It reduces symptoms and helps to heal injury to the esophagus in patients with erosive esophagitis (a severe reflux of stomach acid that damages the lining of the esophagitis). Generic lansoprazole injection is not yet available.
What should my health care professional know before I receive lansoprazole?
They need to know if you have any of these conditions:
•liver disease
•an unusual or allergic reaction to lansoprazole, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I take this medicine?
Lansoprazole injection is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
This does not apply.
What drug(s) may interact with lansoprazole?
•ampicillin
•bisacodyl
•delavirdine
•digoxin
•fluvoxamine
•iron salts
•itraconazole
•ketoconazole
•theophylline
•voriconazole
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from taking lansoprazole?
Side effects that you should report to your prescriber or health care professional as soon as possible.
Rare or uncommon:
•dark yellow or brown urine
•fever or sore throat
•unusual skin rash, blistering, or peeling
•unusual bleeding or bruising
•yellowing of the eyes or skin
•vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•abdominal pain
•diarrhea or constipation
•headache
•nausea
What should I watch for while taking lansoprazole?
It can take several days of therapy with lansoprazole before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of pain unless your prescriber or health care professional tells you otherwise.
Where can I keep my medicine?
This does not apply. You will not be given lansoprazole injection to use at home.
NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.
[Revised: 08/04/2004]
Lansoprazole oral suspension
What is lansoprazole oral suspension?
LANSOPRAZOLE (Prevacid® Oral Suspension) prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD) or ulcers. Lansoprazole is also useful in conditions that produce too much stomach acid such as Zollinger-Ellison syndrome. Generic lansoprazole oral suspension is not yet available.
What should my health care professional know before I take lansoprazole?
They need to know if you have any of these conditions:
•liver disease
•an unusual or allergic reaction to lansoprazole, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I take this medicine?
Take lansoprazole oral suspension by mouth. Follow the directions on the prescription label. First, mix the contents (granules) of the packets with 2 tablespoonfuls (30 ml) of water to form a strawberry-flavored suspension. Do not crush or chew the granules before mixing. Stir well and drink the liquid mixture immediately. If any material from the suspension remains after drinking, add more water, stir, and drink immediately. Do not take lansoprazole suspension with other liquids or foods. It is best to take the oral suspension at least 30 to 60 minutes before you eat any food. Take your doses at regular intervals. Do not take your medicine more often than directed.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What drug(s) may interact with lansoprazole?
•ampicillin
•bisacodyl
•delavirdine
•digoxin
•fluvoxamine
•iron salts
•itraconazole
•ketoconazole
•sucralfate
•theophylline
•voriconazole
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What side effects may I notice from taking lansoprazole?
Side effects that you should report to your prescriber or health care professional as soon as possible.
Rare or uncommon:
•dark yellow or brown urine
•fever or sore throat
•unusual skin rash, blistering, or peeling
•unusual bleeding or bruising
•yellowing of the eyes or skin
•vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
•abdominal pain
•diarrhea or constipation
•headache
•nausea
What should I watch for while taking lansoprazole?
It can take several days of therapy with lansoprazole before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. You can take antacids for the occasional relief of pain unless your prescriber or health care professional tells you otherwise.
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.
NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.
[Revised: 10/02/2002]
Prednisone
Deltasone® | Predone™ | Sterapred® | Sterapred® DS
Classification:
• Biologic Response Modifiers
• Immunosuppressives
• Corticosteroids
• Hormones and Hormone Modifiers
• Adrenal Agents
• Corticosteroids
• Musculoskeletal Agents
• Antiinflammatory Agents
• Corticosteroids
• Respiratory Agents
• Respiratory Antiinflammatory Agents
• Corticosteroids
Description, Mechanism of Action, Pharmacokinetics
Description: Prednisone is the most commonly-prescribed oral corticosteroid. The drug is metabolized in the liver to its active form, prednisolone. Relative to hydrocortisone, prednisone is roughly 4 times as potent as a glucocorticoid. Prednisone is intermediate between hydrocortisone and dexamethasone in duration of action. Prednisone is used in many conditions, including allograft rejection, asthma, systemic lupus erythematosus, and many other inflammatory states. Prednisone has very little mineralocorticoid activity, so it is not used in the management of adrenal insufficiency unless a more potent mineralocorticoid is administered concomitantly. Prednisone was first approved by the FDA in 1955.
Mechanism of Action: Glucocorticoids are naturally occurring hormones that prevent or suppress inflammation and immune responses when administered at pharmacological doses. At a molecular level, unbound glucocorticoids readily cross cell membranes and bind with high affinity to specific cytoplasmic receptors. This binding induces a response by modifying transcription and, ultimately protein synthesis to achieve the steroid's intended action. Such actions may include: inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. Some of the net effects include reduction in edema or scar tissue, as well as a general suppression in immune response. The degree of clinical effect is normally related to the dose administered. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Likewise, the numerous adverse effects related to corticosteroid use are usually related to the dose administered and the duration of therapy.
Pharmacokinetics: Prednisone is rapidly absorbed across the GI membrane following oral administration. Peak effects can be observed after 1—2 hours. The circulating drug binds extensively to the plasma proteins albumin and transcortin, with only the unbound portion of a dose active. Systemic prednisone is quickly distributed into the kidneys, intestines, skin, liver and muscle. Corticosteroids distribute into the breast milk and cross the placenta. Prednisone is metabolized by the liver to the active metabolite prednisolone, which is then further metabolized to inactive compounds. These inactive metabolites, as well as a small portion of unchanged drug, are excreted in the urine. The plasma elimination half-life is 1 hour whereas the biological half-life of prednisone is 18—36 hours.
Description, Mechanism of Action, Pharmacokinetics last revised 5/22/2002
Indications
• acute lymphocytic leukemia (ALL) |
• idiopathic thrombocytopenic purpura (ITP) |
• acute respiratory distress syndrome (ARDS) |
• iritis |
• Addison's disease |
• juvenile rheumatoid arthritis (JRA) |
• adrenal hyperplasia |
• keratitis |
• adrenocortical insufficiency |
• kidney transplant rejection prophylaxis |
• allergic conjunctivitis |
• Loeffler's syndrome |
• amyloidosis† |
• lupus nephritis |
• angioedema |
• mixed connective tissue disease† |
• ankylosing spondylitis |
• multiple myeloma |
• anterior segment inflammation |
• myasthenia gravis |
• asthma |
• mycosis fungoides |
• atopic dermatitis |
• nephrotic syndrome |
• autoimmune hepatitis† |
• optic neuritis |
• Behcet's syndrome† |
• osteoarthritis |
• Bell's palsy† |
• pemphigus |
• berylliosis |
• pericarditis† |
• bone pain† |
• pneumonia† |
• bursitis |
• pneumonitis |
• carpal tunnel syndrome† |
• polyarteritis nodosa† |
• chorioretinitis |
• polychondritis† |
• chronic lymphocytic leukemia (CLL) |
• polymyositis |
• Churg-Strauss syndrome† |
• psoriasis |
• corneal ulcer |
• pulmonary fibrosis† |
• Crohn's disease |
• rheumatic carditis |
• dermatitis |
• rheumatoid arthritis |
• dermatomyositis† |
• sarcoidosis |
• Duchenne muscular dystrophy† |
• severe pain |
• endophthalmitis† |
• Stevens-Johnson syndrome |
• epicondylitis |
• systemic lupus erythematosus (SLE) |
• erythroblastopenia |
• temporal arteritis† |
• gout |
• tenosynovitis |
• gouty arthritis |
• thrombocytopenia |
• graft-versus-host disease (GVHD) |
• thyroiditis |
• headache |
• tuberculosis |
• hemolytic anemia |
• ulcerative colitis |
• Hodgkin's disease |
• urticaria |
• hypercalcemia |
• uveitis |
• hypoplastic anemia |
• Wegener's granulomatosis† |