Carbocaine

Generic Name: mepivacaine (me PIV a kane)

Brand Names: Carbocaine, Carbocaine HCl, Polocaine, Polocaine-MPF

What is Carbocaine (mepivacaine)?

Mepivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain.

Mepivacaine is used as a local (in only one area) anesthetic for an epidural or spinal block. It is also used as an anesthetic for dental procedures.

Mepivacaine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Carbocaine (mepivacaine)?

You should not receive mepivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving this medication, tell your doctor if you have liver disease, kidney disease, high or low blood pressure, asthma or a sulfite allergy, a history of heart disease or stroke, heart block or coronary artery disease, a heart rhythm disorder, or a thyroid disorder.

This medication can cause numbness for an extended period of time. Avoid eating, chewing gum, or drinking hot liquids until the feeling in your mouth has returned completely. Chewing while your mouth is numb could result in a bite injury to your tongue, lips, or inside of your cheek.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from mepivacaine.

What should I discuss with my health care provider before receiving Carbocaine (mepivacaine)?

You should not receive mepivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving mepivacaine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;


• kidney disease;


• 
  

  low or high blood pressure;

  
  


• 
  

  asthma or a sulfite allergy;

  
  


• 
  

  a history of heart disease or stroke;

  
  


• 
  

  heart block or coronary artery disease;

  
  


• 
  

  a heart rhythm disorder; or

  
  


• 
  

  a thyroid disorder.

  
  

If you have any of these conditions, you may need a dose adjustment or special precautions to safely receive mepivacaine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive mepivacaine, tell your doctor if you are pregnant. It is not known whether mepivacaine passes into breast or if it could harm a nursing baby. Before you receive mepivacaine, tell your doctor if you are breast-feeding a baby.

How is mepivacaine given?

Mepivacaine is given as an injection placed into an area of your lower back near your spine. You will receive this injection in a hospital or surgical setting.

When used for a dental procedure, mepivacaine is given as an injection that is usually placed into the gum area inside your mouth. You will receive this injection in a dentist's office or oral surgical setting.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from mepivacaine. Your breathing, blood pressure, oxygen levels, and other vital signs may be watched closely while you are receiving mepivacaine.

What happens if I miss a dose?

Since mepivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include extreme drowsiness, fainting, seizure (convulsions), shallow breathing, or slow heart rate.

What should I avoid after receiving Carbocaine (mepivacaine)?

This medication can cause numbness for an extended period of time. Avoid eating, chewing gum, or drinking hot liquids until the feeling in your mouth has returned completely. Chewing while your mouth is numb could result in a bite injury to your tongue, lips, or inside of your cheek.

Carbocaine (mepivacaine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling or puffiness of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  weak or shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  sweating, anxiety, confusion;

  
  


• 
  

  blurred vision, ringing in your ears;

  
  


• 
  

  numbness or tingling around your mouth;

  
  


• 
  

  slow heart rate, weak pulse;

  
  


• 
  

  metallic taste in your mouth;

  
  


• 
  

  tremors, muscle twitching; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting;

  
  


• 
  

  nervousness;

  
  


• 
  

  dizziness; or

  
  


• 
  

  drowsiness.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Carbocaine (mepivacaine)?

Before receiving mepivacaine, tell your doctor if you are using any of the following drugs:

• 
  

  cold medicine, diet pills, stimulants, or medication to treat ADHD;

  
  


• 
  

  medicine to treat a psychiatric disorder (Haldol, Inapsine, Thorazine, Prolixin, Serentil, Mellaril, and others);

  
  


• 
  

  medication to treat nausea and vomiting, such as Compazine or Motillium;

  
  


• 
  

  ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and there may be other drugs that can interact with mepivacaine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More Carbocaine resources

• Carbocaine Side Effects (in more detail)
• Carbocaine Use in Pregnancy & Breastfeeding
• Carbocaine Drug Interactions
• Carbocaine Support Group
• 0 Reviews for Carbocaine - Add your own review/rating

• Carbocaine MedFacts Consumer Leaflet (Wolters Kluwer)


• Carbocaine Prescribing Information (FDA)


• Mepivacaine Prescribing Information (FDA)

Compare Carbocaine with other medications

• Local Anesthesia

Where can I get more information?

• Your doctor or pharmacist can provide more information about mepivacaine.

See also: Carbocaine side effects (in more detail)

Lexiscan

Generic Name: regadenoson (re ga DEN oh son)

Brand Names: Lexiscan

What is regadenoson?

Regadenoson is a stress agent that works by increasing blood flow in the arteries of the heart.

Regadenoson is given in preparation for a radiologic (x-ray) examination of blood flow through the heart to test for coronary artery disease.

Regadenoson may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about regadenoson?

You should not use this medication if you are allergic to regadenoson, or if you have a serious heart condition such as AV block or "sick sinus syndrome" (unless you have a pacemaker).

Before you receive regadenoson, tell your doctor if you have asthma or COPD, a history of heart disease or high blood pressure, or if you have had an illness causing vomiting or diarrhea.

Avoid drinking coffee or other beverages with caffeine for at least 12 hours before your stress test. Tell your caregivers if you have a serious side effect such as chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling, wheezing or trouble breathing, slow heart rate, severe headache, seizure (convulsions), weak pulse, slow breathing, or fainting.

What should I discuss with my health care provider before receiving regadenoson?

You should not use this medication if you are allergic to regadenoson, or if you have a serious heart condition such as AV block or "sick sinus syndrome" (unless you have a pacemaker).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  asthma or COPD (chronic obstructive pulmonary disease);

  
  


• 
  

  a history of heart disease or high blood pressure; or

  
  


• 
  

  if you have had a prolonged illness that caused vomiting or diarrhea.

  
  

FDA pregnancy category C. It is not known whether regadenoson is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant. It is not known whether regadenoson passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is regadenoson given?

Regadenoson is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

After regadenoson is injected, you will be given other intravenous (IV) medications that allow blood vessels to be seen more clearly on the radiologic examination.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during your stress test.

What happens if I miss a dose?

Since regadenoson is given by a healthcare professional in preparation for medical testing, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include severe dizziness, increased heart rate, and warmth or tingly feeling.

What should I avoid while receiving regadenoson?

Avoid drinking coffee or other beverages with caffeine for at least 12 hours before your stress test.

Regadenoson side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heart rate);

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  wheezing, trouble breathing; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  nausea, stomach discomfort, decreased sense of taste;

  
  


• 
  

  mild chest discomfort; or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect regadenoson?

Tell your doctor about all other medications you use, especially:

• 
  

  dipyridamole (Persantine); or

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl).

  
  

This list is not complete and other drugs may interact with regadenoson. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lexiscan resources

• Lexiscan Side Effects (in more detail)
• Lexiscan Dosage
• Lexiscan Use in Pregnancy & Breastfeeding
• Lexiscan Drug Interactions
• Lexiscan Support Group
• 3 Reviews for Lexiscan - Add your own review/rating

• Lexiscan Prescribing Information (FDA)


• Lexiscan Advanced Consumer (Micromedex) - Includes Dosage Information


• Lexiscan Consumer Overview


• Regadenoson Professional Patient Advice (Wolters Kluwer)

Compare Lexiscan with other medications

• Diagnosis and Investigation
• Radionuclide Myocardial Perfusion Study

Where can I get more information?

• Your doctor or pharmacist can provide more information about regadenoson.

See also: Lexiscan side effects (in more detail)

Lansoprazole

Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
Molecular Formula: C₁₆H₁₄F₃N₃O₂S
CAS Number: 103577-45-3
Brands: Prevacid, Prevacid NapraPAC, Prevpac

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.^{1 3 4 5 6 8 9 10 12 13 15 17 19 21 22 23 24 36 103 104 125}

Uses for Lansoprazole

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn).¹

Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.^{1 2 3 5 18 19 20 22 23}

Maintain healing and decrease recurrence of erosive esophagitis.^{1 126}

IV as short-term (up to 7 days) alternative to oral therapy for the treatment of erosive esophagitis in adults unable to continue taking the drug orally; safety and efficacy of IV lansoprazole not established for initial treatment.¹⁷⁰

Short-term self-medication for symptomatic relief of frequent (e.g., ≥2 days per week) heartburn in adults ≥18 years of age.^{191 192 194}

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).^{1 2 3 4 5 6 7 12 13 14}

Treatment of Helicobacter pylori infection and duodenal ulcer disease.^{1 134} Used in conjunction with amoxicillin and clarithromycin (triple therapy) or clarithromycin (dual therapy);^{1 134} has been used in other multidrug regimens†.^{126 129 131 135}

Maintenance therapy following duodenal ulcer healing.¹

Gastric Ulcer

Short-term treatment and symptomatic relief of active benign gastric ulcer.¹

NSAIA-induced Gastric Ulcer

Short-term treatment of NSAIA-induced gastric ulcer in patients continuing NSAIA use.^{1 151 153 169}

Risk reduction in patients with history of gastric ulcer who require NSAIA treatment.^{1 171}

Crohn's Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal, gastroduodenal, and jejunoileal disease.^{162 163 164 166 167}

Pathologic GI Hypersecretory Conditions

Long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome with or without multiple endocrine adenoma).¹

Lansoprazole Dosage and Administration

Administration

Oral Administration

Administer orally before a meal.^{1 3 43 171 191}

Antacids may be used concomitantly as needed for pain relief.^{1 2 3 4}

Capsules

Swallow capsules intact; do not chew or crush.^{1 171 191}

Alternatively, open capsule and sprinkle contents on 1 tablespoonful of compatible foods (e.g., applesauce, Ensure pudding, cottage cheese, yogurt, strained pears) or mix with about 60 mL of appropriate juice (e.g., apple juice, orange juice, tomato juice); swallow immediately without chewing.¹ If mixed with juice, rinse glass with ≥120 mL juice and swallow immediately to ensure complete dose ingestion.¹ Do not mix with other foods or liquids.¹

Manufacturer recommends swallowing capsules for self-medication with a glass of water.¹⁹¹

Orally Disintegrating Tablets

Place orally disintegrating tablets on the tongue and allow to disintegrate (usually in <1 minute) with or without water; swallow particles without chewing.¹

To administer using an oral syringe, place 15- or 30-mg tablet in oral syringe, draw up about 4 or 10 mL, respectively, of water in the syringe, gently shake syringe to ensure rapid dispersal of particles, and administer within 15 minutes.¹ To ensure complete consumption of dose, draw up an additional 2 mL (15-mg dose) or 5 mL (30-mg dose) of water in syringe, mix gently, and administer remaining contents.¹

NG Tube

Open capsule and mix contents with about 40 mL apple juice and administer immediately (within 3–5 minutes) through NG tube; flush tube with additional apple juice.^{1 127} Do not mix with other liquids.¹

Place 15- or 30-mg orally disintegrating tablet in syringe, draw up about 4 or 10 mL, respectively, of water in the syringe, gently shake syringe to ensure rapid dispersal of particles, and administer within 15 minutes through NG tube (8 French or larger).¹ Draw up an additional 5 mL of water in syringe, mix gently, and flush NG tube with syringe contents.¹

IV Administration

For solution compatibility and storage information, see Stability.

Administer by IV infusion over 30 minutes.¹⁷⁰

Use inline filter provided by manufacturer to remove precipitates that may form when lansoprazole is mixed with IV solutions; follow manufacturer's instructions for priming the filter and precautions regarding its use.¹⁷⁰

Flush the IV line with ≥5 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection before administration; then attach the administration set and inline filter to the IV port and infuse the drug.¹⁷⁰ After administering the dose, remove and discard the administration set, including filter, and flush the IV line with ≥5 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection.¹⁷⁰

Failure to flush the IV line or discard the administration set may result in degradation of lansoprazole and formation of black or brown precipitate in the IV tubing or inline filter.¹⁷⁰

Do not administer with any other drugs or diluents because of potential incompatibilities.¹⁷⁰

Reconstitution and Dilution

Reconstitute vial containing 30 mg of lansoprazole with 5 mL of sterile water for injection to provide a solution containing 6 mg/mL.¹⁷⁰ Dilute reconstituted solution in 50 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection prior to administration.¹⁷⁰

Alternatively, connect vial containing 30 mg of lansoprazole powder for injection to a Mini-Bag Plus Container containing 50 mL of 5% dextrose or 0.9% sodium chloride injection and reconstitute according to manufacturer's directions.^{170 181}

Dosage

Pediatric Patients

Gastroesophageal Reflux

GERD

Oral

Children 1–11 years of age: In those weighing ≤30 kg, 15 mg once daily for up to 12 weeks.¹ In those weighing >30 kg, 30 mg once daily for up to 12 weeks.¹ Dosage has been increased up to 30 mg twice daily after ≥2 weeks in patients remaining symptomatic.¹

Children 12–17 years of age: 15 mg daily for up to 8 weeks.¹

Treatment of Erosive Esophagitis

Oral

Children 1–11 years of age: In those weighing ≤30 kg, 15 mg once daily for up to 12 weeks.¹ In those weighing >30 kg, 30 mg once daily for up to 12 weeks.¹ Dosage has been increased up to 30 mg twice daily after ≥2 weeks in patients remaining symptomatic.¹

Children 12–17 years of age: 30 mg daily for up to 8 weeks.¹

Adults

Gastroesophageal Reflux

Chronic, lifelong therapy with proton-pump inhibitor is appropriate for many GERD patients.¹⁵⁶

GERD

Oral

15 mg once daily for up to 8 weeks.¹

Treatment of Erosive Esophagitis

Oral

30 mg once daily for up to 8 weeks.^{1 2 3 5 22} May give additional 8 weeks of therapy (up to 16 weeks for a single course) if not healed.¹ If recurs, consider additional 8 weeks of therapy.¹

IV

30 mg once daily for up to 7 days.¹⁷⁰ Discontinue IV administration as soon as patient can resume oral lansoprazole therapy.¹⁷⁰

Maintenance of Healing of Erosive Esophagitis

Oral

15 mg once daily.¹ Not studied >1 year.¹

Self-medication for Frequent Heartburn

Oral

15 mg once daily in the morning for 14 days.¹⁹¹ Do not exceed recommended dosage or duration; do not administer more than 1 course every 4 months.¹⁹¹ May relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.¹⁹¹

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

15 mg once daily for 4 weeks.^{1 2 3 4 5 6 12 13 14}

Treatment of Helicobacter pylori Infection and Duodenal Ulcer

Oral

Triple therapy: 30 mg every 12 hours for 10 or 14 days in conjunction with amoxicillin and clarithromycin.^{1 134}

Dual therapy: 30 mg every 8 hours for 14 days in conjunction with amoxicillin.¹

Maintenance of Duodenal Ulcer Healing

Oral

15 mg daily.¹ Safety and efficacy beyond 1 year not established.¹

Gastric Ulcer

Benign Gastric Ulcer

Oral

30 mg once daily for up to 8 weeks.^{1 2}

NSAIA-induced Gastric Ulcer

Treatment

Oral

30 mg once daily for 8 weeks.¹

Risk Reduction

Oral

15 mg once daily for up to 12 weeks.^{1 171}

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)

Oral

60 mg once daily initially.^{1 2 24 25 28} Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.^{1 2 3 5} May require dosages of up to 90 mg twice daily.^{1 3 5 10 24 25 26 27 43} Administer daily dosages >120 mg in divided doses.^{1 7 43} Patients with Zollinger-Ellison syndrome have been treated for up to 4 years.¹

Special Populations

Hepatic Impairment

Consider dosage reduction in patients with severe hepatic impairment.^{1 22 24 36 134 170 171}

Renal Impairment

Lansoprazole dosage adjustment not necessary.^{1 24 36 170 171} Kit containing lansoprazole, amoxicillin, and clarithromycin (Prevpac) or lansoprazole and naproxen (PrevacidNapraPAC) not recommended for use in patients with Cl_cr <30 mL/minute.^{134 171}

Geriatric Patients

Lansoprazole dosage adjustment not necessary.^{1 33 34 170 171}

Cautions for Lansoprazole

Contraindications

• 
  

  Known severe hypersensitivity to lansoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, omeprazole, pantoprazole, rabeprazole).^{1 170 171 191 b}

  
  

Warnings/Precautions

GI Effects

Response to lansoprazole therapy does not preclude presence of occult gastric neoplasm.^{1 134 170 171}

Phenylketonuria

Each 15- or 30-mg Prevacid Solu-Tab™ orally disintegrating tablet contains aspartame, which is metabolized in the GI tract to provide 2.5 or 5.1 mg of phenylalanine, respectively.¹

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).^{176 177}

Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.^{178 300 301 302 303 304 305 309} Magnitude of risk is unclear;^{178 300 301 302 303 304 305 310} causality not established.³⁰⁵ FDA is continuing to evaluate this safety concern.³⁰⁵

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.^{178 301 303 305 307 309}

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.^{178 303 305 307 309}

Use of Combination Preparations

When kits containing lansoprazole and other agents (NSAIAs, anti-infectives) are used, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).^{134 171}

Specific Populations

Pregnancy

Category B.^{1 170}

Lactation

Distributed into milk in rats; not known whether distributed into human milk.^{1 134 170 171} Discontinue nursing or the drug.^{1 134 170 171}

Pediatric Use

Safety and efficacy of oral lansoprazole established for short-term treatment of symptomatic GERD and erosive esophagitis in patients 1–17 years of age.¹

Oral lansoprazole is not recommended in infants <1 year of age; the drug was no more effective than placebo in a controlled study in infants 1 month to <1 year of age with symptomatic GERD.¹

Safety and efficacy for self-medication of frequent heartburn not established in children <18 years of age.¹⁹¹

Safety and efficacy of IV lansoprazole not established in pediatric patients.¹⁷⁰

Geriatric Use

No substantial differences in efficacy and safety of oral lansoprazole in geriatric patients relative to younger adults.^{1 170 171} Clinical data regarding use of IV lansoprazole in geriatric patients are limited.¹⁷⁰

Hepatic Impairment

Increased systemic exposure (AUC) and decreased clearance.^{1 134 170 171} Consider dosage reduction in patients with severe hepatic impairment.^{1 22 24 36 134 170 171}

Common Adverse Effects

In children 1–11 years of age, constipation and headache.¹ In children 12–17 years of age, headache, abdominal pain, nausea, dizziness.¹ Pediatric adverse effect profile similar to that in adults.¹

In adults receiving oral lansoprazole, diarrhea, abdominal pain, nausea, constipation.^{1 134 170 171} In adults receiving IV lansoprazole, headache, injection site pain, injection site reaction, nausea.¹⁷⁰

Interactions for Lansoprazole

Metabolized by CYP2C19 and CYP3A.^{1 134 170 171 189 190}

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP3A, 1A2, 2C9, 2C19, 2D6.^{1 134 170 171}

Specific Drugs

Drug	Interaction	Comments
Amoxicillin	No evidence of clinically important interaction 1 134 171
Antacids	Administered concomitantly with lansoprazole in clinical studies1 134 171
Antipyrine	No evidence of clinically important interaction 1 134 170 171
Atazanavir	Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations;1 134 171 possible loss of virologic response180	Manufacturer of lansoprazole states that concomitant administration with atazanavir is not recommended1 134 171 Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir179 180 For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)179 180 Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended179 180
Clarithromycin	No evidence of clinically important interaction 1 134 170 171
Clopidogrel	Certain CYP2C19 inhibitors (e.g., omeprazole) reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel's clinical efficacy.186 224 225 228 232 233 236 311 Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown182 183 184 224 232 317	Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250 American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs); H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311
Diazepam	No evidence of clinically important interaction 1 134 170 171
Gastric pH-dependent drugs (e.g., ampicillin esters, digoxin, iron salts, ketoconazole)	Lansoprazole may alter drug absorption1 134 170 171
Ibuprofen	No evidence of clinically important interaction 1 134 170 171
Indomethacin	No evidence of clinically important interaction 1 134 170 171
Phenytoin	No evidence of clinically important interaction 1 134 170 171
Prednisone	No evidence of clinically important interaction 1 134 170 171
Propranolol	No evidence of clinically important interaction 1 134 170 171
Sucralfate	Lansoprazole absorption delayed, bioavailability decreased1 134 171	Administer at least 30 minutes before sucralfate1 134 171
Theophylline	Minor increase in theophylline clearance1 134 170 171	Usually not clinically important; may require theophylline dosage adjustment when lansoprazole is initiated or discontinued1 134 170 171
Warfarin	May increase PT and INR1 134 170 171	May need to monitor PT and INR1 134 170 171

Lansoprazole Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract (absolute bioavailability >80%).^{1 134 171} Peak plasma concentrations attained about 1.7 hours after oral administration.^{1 134 171}

Onset

Increased gastric pH occurred within 1–2 or 2–3 hours after a single 30- or 15-mg oral dose, respectively.^{1 134 171}

Duration

Gastric acid secretion normalized over 2–4 days after discontinuance; no apparent rebound.^{1 134 171}

Food

Absorption (peak plasma concentration, AUC) decreased by 50–70% when administered 30 minutes after food.^{1 134 171} No substantial food effect when administered before meals.^{1 134 171}

Special Populations

Peak plasma concentration and time to peak plasma concentration in patients with renal impairment similar to healthy individuals.^{1 134 171}

Peak plasma concentrations were comparable in patients in Asian and US studies.^{1 134 171}

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.^{1 134 171}

Prolonged binding to gastric parietal proton pump enzyme.¹

Plasma Protein Binding

97%.^{1 170 171}

Special Populations

Severe renal impairment decreased plasma protein binding by 1–1.5% after administration of 60 mg dose.^{1 134 170 171}

Elimination

Metabolism

In parietal cell secretory canaliculi, thought to be transformed into 2 active sulfenamide metabolites not present in systemic circulation.^{1 2 4 9 19 33 134 170 171} Also metabolized in the liver by CYP3A and CYP2C19.^{1 134 170 171 189 190} Metabolites found in plasma are inactive.^{1 134 170 171}

Lansoprazole is a racemic mixture of R- and S-isomers.^{188 189} Plasma clearance of the R-isomer (dexlansoprazole) is slower than that of the S-isomer; plasma concentrations of the R-isomer are markedly higher than those of the S-isomer.^{188 189}

Elimination Route

Excreted principally in feces (about 67%) with remainder in urine; no unchanged drug excreted in urine.^{1 134 170 171}

Half-life

<2 hours.^{1 134 170 171}

Special Populations

Hepatic impairment increased plasma half-life to 3.2–7.2 hours.^{1 134 170 171}

Renal impairment decreased elimination half-life.^{1 134 170 171}

Stability

Storage

Oral

Capsules and Orally Disintegrating Tablets

25°C (may be exposed to 15–30°C).¹

Capsules for Self-medication

20–25°C; protect from high heat, humidity, and moisture.¹⁹¹

Prevacid NapraPAC Kit

25°C (may be exposed to 15–30°C).¹⁷¹ Protect from light and moisture.¹⁷¹ Store and dispense in original container.¹⁷¹

Prevpac Kit

20–25°C.¹³⁴ Protect from light and moisture.¹³⁴

Parenteral

Powder for IV Infusion

Powder: 25°C (may be exposed to 15–30°C).¹⁷⁰ Protect from light.¹⁷⁰

Reconstituted 6-mg/mL solution: 25°C for up to 1 hour before further dilution.¹⁷⁰ Following dilution, 25°C for up to 12 hours (in 50 mL of 5% dextrose injection) or 24 hours (in 50 mL of lactated Ringer's or 0.9% sodium chloride injection).¹⁷⁰

In Mini-Bag Plus Container: 25°C for up to 8 hours (in 50 mL of 5% dextrose injection) or 24 hours (in 50 mL of 0.9% sodium chloride injection).¹⁷⁰

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Capsules

Immediately use extemporaneous mixtures of capsule contents and food or juice.¹ (See Oral Administration under Dosage and Administration.)

Parenteral

Solution Compatibility

Reconstitute powder with sterile water for injection; use of other diluents may result in precipitate or particulate formation.¹⁷⁰ Further dilution in 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection recommended by manufacturer.¹⁷⁰

Actions

• 
  

  Inhibits basal and stimulated gastric acid secretion.^{1 2 3 4}

  
  


• 
  

  Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton or acid pump), blocking final step in secretion of hydrochloric acid.^{1 2 4 9 18 19 33}

  
  


• 
  

  Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.^{9 21 24 25 33 43 125}

  
  


• 
  

  Lansoprazole is a racemic mixture of R- and S-isomers.^{188 189} Both isomers inhibit hydrogen-potassium ATPase.^{188 189}

  
  


• 
  

  Combined therapy with lansoprazole and appropriate anti-infectives (i.e., amoxicillin, clarithromycin) can effectively eradicate H. pylori infection.^{1 3 16 103 104 134}

  
  

Advice to Patients

• 
  

  Importance of taking before a meal.^{1 191}

  
  


• 
  

  Importance of swallowing capsule intact, without crushing or chewing.^{1 171 191}

  
  


• 
  

  For orally disintegrating tablets, importance of allowing tablet to dissolve on tongue with or without water, then swallowing particles without chewing.¹

  
  


• 
  

  If capsule contents are mixed with food or juice, importance of immediately swallowing mixture without crushing or chewing.¹

  
  


• 
  

  Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.^{305 309}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 134 170 171 191} Antacids may be used concomitantly as needed for pain relief.^{1 2 3 4}

  
  


• 
  

  Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 134 170 171 191}

  
  


• 
  

  Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.¹

  
  


• 
  

  Importance of following dosage instructions when lansoprazole is used for self-medication.¹⁹¹ Advise patients that they should use the drug for self-medication only as directed for no longer than 14 days of continuous use and that they should not exceed one course of therapy every 4 months.³⁰⁵

  
  

  Importance of discontinuing use as self-medication and consulting a clinician if heartburn persists or worsens, use of the drug for >14 days is needed, or >1 course of therapy is required every 4 months.¹⁹¹

  
  


• 
  

  Importance of discontinuing use as self-medication and consulting a clinician if heartburn persists or worsens, use of the drug for >14 days is needed, or >1 course of therapy is required every 4 months.¹⁹¹

  
  


• 
  

  Self-medication with lansoprazole is not intended for immediate relief of heartburn; may relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.¹⁹¹

  
  


• 
  

  Advise patients to consult their clinician before using lansoprazole for self-medication if they have liver disease, have had heartburn for >3 months, or are experiencing heartburn with lightheadedness, dizziness, or sweating; chest or shoulder pain with shortness of breath, sweating, lightheadedness, or pain spreading to the arms, neck, or shoulders; frequent chest pain; frequent wheezing (especially with heartburn); unexplained weight loss; nausea or vomiting; or stomach pain.¹⁹¹

  
  


• 
  

  Advise patients not to use lansoprazole for self-medication and to consult a clinician if they have difficulty or pain with swallowing, are vomiting blood, or have bloody or blackened stools.¹⁹¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 134 170 171} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Lansoprazole

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, delayed-release (containing enteric-coated granules)	15 mg*	Lansoprazole Delayed-Release Capsules
			Prevacid	Takeda
			Prevacid 24HR	Novartis

Latuda

Generic Name: lurasidone (loo RAS i done)

Brand Names: Latuda

What is lurasidone?

Lurasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Lurasidone is used to treat schizophrenia in adults.

Lurasidone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about lurasidone?

Lurasidone is not for use in psychotic conditions related to dementia. Lurasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to lurasidone, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or rifampin (Rifater, Rifadin, Rifamate).

Before you take lurasidone, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson's disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

While you are taking lurasidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking lurasidone. Lurasidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of lurasidone. Stop using lurasidone and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

There are many other drugs that can interact with lurasidone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I discuss with my healthcare provider before taking lurasidone?

Lurasidone is not for use in psychotic conditions related to dementia. Lurasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to lurasidone, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or rifampin (Rifater, Rifadin, Rifamate).

To make sure you can safely take lurasidone, tell your doctor if you have any of these other conditions:

• liver disease;


• 
  

  kidney disease;

  
  


• 
  

  heart disease, high blood pressure, heart rhythm problems;

  
  


• 
  

  a history of heart attack or stroke;

  
  


• 
  

  high cholesterol or triglycerides (a type of fat in the blood);

  
  


• 
  

  low white blood cell (WBC) counts;

  
  


• 
  

  a history of breast cancer;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  personal or family history of diabetes (lurasidone may raise your blood sugar);

  
  


• 
  

  a history of suicidal thoughts or actions;

  
  


• 
  

  Parkinson's disease; or

  
  


• 
  

  trouble swallowing.

  
  

Lurasidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking lurasidone.

FDA pregnancy category B. Lurasidone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lurasidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using lurasidone.

Do not give this medication to a child without medical advice.

How should I take lurasidone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Lurasidone should be taken with food (at least 350 calories).

Use lurasidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking lurasidone?

While you are taking lurasidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking lurasidone. Lurasidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of lurasidone.

Lurasidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking lurasidone and call your doctor at once if you have a serious side effect such as:

• 
  

  dizziness, fainting, fast or pounding heartbeats;

  
  


• 
  

  agitation, hostility, confusion, thoughts about hurting yourself;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  
  


• 
  

  very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  
  


• 
  

  trouble swallowing; or

  
  


• 
  

  twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

  
  

Less serious side effects may include:

• 
  

  drowsiness;

  
  


• 
  

  feeling restless;

  
  


• 
  

  nausea, diarrhea, stomach pain, loss of appetite;

  
  


• 
  

  blurred vision;

  
  


• 
  

  weight gain;

  
  


• 
  

  breast swelling or discharge;

  
  


• 
  

  missed menstrual periods; or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lurasidone?

Before you take lurasidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by lurasidone.

Many drugs can interact with lurasidone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  dexamethasone (Decadron, Hexadrol);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifapentine (Priftin), or telithromycin (Ketek);

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

  
  


• 
  

  medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and other drugs may interact with lurasidone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Latuda resources

• Latuda Side Effects (in more detail)
• Latuda Use in Pregnancy & Breastfeeding
• Latuda Drug Interactions
• Latuda Support Group
• 33 Reviews for Latuda - Add your own review/rating

• Latuda Prescribing Information (FDA)


• Latuda Monograph (AHFS DI)


• Latuda Advanced Consumer (Micromedex) - Includes Dosage Information


• Latuda MedFacts Consumer Leaflet (Wolters Kluwer)


• Latuda Consumer Overview

Compare Latuda with other medications

• Bipolar Disorder
• Borderline Personality Disorder
• Schizoaffective Disorder
• Schizophrenia

Where can I get more information?

• Your pharmacist can provide more information about lurasidone.

See also: Latuda side effects (in more detail)

Liqui-Minic Infant

Generic Name: pheniramine/pyrilamine/phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill proe pa NOLE a meen)

Brand Names: Liqui-Minic Infant, Triactin, Triaminic Infant, Triaminic Pediatric

What is Liqui-Minic Infant (pheniramine/pyrilamine/phenylpropanolamine)?

Pheniramine and pyrilamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine and pyrilamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Pheniramine/pyrilamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Liqui-Minic Infant (pheniramine/pyrilamine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may cause dizziness or drowsiness. Avoid climbing and other hazardous activities while taking this medication. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Liqui-Minic Infant (pheniramine/pyrilamine/phenylpropanolamine)?

Do not take pheniramine/pyrilamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take pheniramine/pyrilamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pheniramine/pyrilamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Liqui-Minic Infant (pheniramine/pyrilamine/phenylpropanolamine)?

Take pheniramine/pyrilamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of the medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of pheniramine/pyrilamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take pheniramine/pyrilamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store pheniramine/pyrilamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking pheniramine/pyrilamine/ phenylpropanolamine?

Pheniramine/pyrilamine/phenylpropanolamine may cause dizziness or drowsiness. Avoid climbing and other hazardous activities while taking this medication. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenylpropanolamine is taken with any of these medications.

Pheniramine/ pyrilamine/phenylpropanolamine side effects

Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/ phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect pheniramine/ pyrilamine/phenylpropanolamine?

Do not take pheniramine/pyrilamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Pheniramine/pyrilamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Liqui-Minic Infant resources

• Liqui-Minic Infant Drug Interactions
• Liqui-Minic Infant Support Group
• 0 Reviews for Liqui-Minic Infant - Add your own review/rating

• Triactin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Liqui-Minic Infant with other medications

• Allergies
• Eye Redness/Itching
• Hay Fever
• Nasal Congestion
• Pruritus
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about pheniramine/pyrilamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Pheniramine/pyrilamine/phenylpropanolamine is available over the counter under the brand name Triaminic Oral Infant Drops. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Cataflam Dispersible

Cataflam Dispersible may be available in the countries listed below.

Ingredient matches for Cataflam Dispersible

Diclofenac

Diclofenac is reported as an ingredient of Cataflam Dispersible in the following countries:

• Luxembourg

International Drug Name Search

Loteprednol Drops

Pronunciation: low-TEH-PRED-nole
Generic Name: Loteprednol
Brand Name: Lotemax

Loteprednol Drops are used for:

Treating swelling, itching, redness, or irritation of the eye caused by bacterial or viral infections, surgery, or certain allergies.

Loteprednol is an ophthalmic corticosteroid. It decreases inflammation (eg, redness, swelling, warmth, pain) of the eye.

Do NOT use Loteprednol Drops if:

• you are allergic to any ingredient in Loteprednol Drops


• you have a bacterial, viral, or mycobacterial infection of the eye

Contact your doctor or health care provider right away if any of these apply to you.

Before using Loteprednol Drops:

Some medical conditions may interact with Loteprednol Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you wear soft contact lenses


• if you have cataract surgery, diabetes, eye discharge, thinning of the cornea or sclera, or glaucoma


• if you have a history of herpes simplex of the eye

Some MEDICINES MAY INTERACT with Loteprednol Drops. However, no specific interactions with Loteprednol Drops are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Loteprednol Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Loteprednol Drops:

Use Loteprednol Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Loteprednol Drops are only for the eye. Do not get it in your nose or mouth.


• Shake well before each use.


• To use Loteprednol Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• If you miss a dose of Loteprednol Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Loteprednol Drops.

Important safety information:

• Loteprednol Drops may cause blurred vision. Use Loteprednol Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Soft contact lenses may absorb a chemical in Loteprednol Drops; do not wear soft contact lenses while you use Loteprednol Drops.


• If Loteprednol Drops are used for more than 10 days, your eyes will need to be re-evaluated by your eye care provider.


• If your symptoms do not get better within 2 days or if they get worse, check with your eye doctor.


• Loteprednol Drops should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Loteprednol Drops can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loteprednol Drops while you are pregnant. It is not known if Loteprednol Drops are found in breast milk. If you are or will be breast-feeding while you use Loteprednol Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Loteprednol Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; discharge; dry eyes; eye redness; eye/eyelid swelling; foreign body sensation; headache; increased tearing; itching; runny nose; sensitivity to light; sore throat; stinging when placed in the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continued or worsening itching; delayed healing after surgery; eye pain; severe redness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Loteprednol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Loteprednol Drops:

Store Loteprednol Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in an upright position. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Loteprednol Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Loteprednol Drops, please talk with your doctor, pharmacist, or other health care provider.


• Loteprednol Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Loteprednol Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Loteprednol resources

• Loteprednol Side Effects (in more detail)
• Loteprednol Use in Pregnancy & Breastfeeding
• Loteprednol Drug Interactions
• Loteprednol Support Group
• 0 Reviews for Loteprednol - Add your own review/rating

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