Thursday, 22 September 2016

Cartia XT 24-Hour Sustained-Release Beads Capsules


Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Examples include Cardizem CD and Cartia XT


Cartia XT 24-Hour Sustained-Release Beads Capsules are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Cartia XT 24-Hour Sustained-Release Beads Capsules are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.


Do NOT use Cartia XT 24-Hour Sustained-Release Beads Capsules if:


  • you are allergic to any ingredient in Cartia XT 24-Hour Sustained-Release Beads Capsules

  • you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker, you have very low blood pressure, or you have fluid buildup in the lungs during or soon after a heart attack

  • you are taking erythromycin

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



Before using Cartia XT 24-Hour Sustained-Release Beads Capsules:


Some medical conditions may interact with Cartia XT 24-Hour Sustained-Release Beads Capsules. 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 have heart failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems; low blood pressure; certain stomach or intestine problems (eg, narrowing); liver disease; or kidney problems

  • if you are taking other medicines for high blood pressure or heart conditions

Some MEDICINES MAY INTERACT with Cartia XT 24-Hour Sustained-Release Beads Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cartia XT 24-Hour Sustained-Release Beads Capsules's side effects, such as heart rhythm problems

  • Moricizine or rifamycins (eg, rifampin) because they may decrease Cartia XT 24-Hour Sustained-Release Beads Capsules's effectiveness

  • Benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, simvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressants (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Cartia XT 24-Hour Sustained-Release Beads Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cartia XT 24-Hour Sustained-Release Beads Capsules 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 Cartia XT 24-Hour Sustained-Release Beads Capsules:


Use Cartia XT 24-Hour Sustained-Release Beads Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Cartia XT 24-Hour Sustained-Release Beads Capsules by mouth with or without food.

  • Swallow Cartia XT 24-Hour Sustained-Release Beads Capsules whole. Do not open, break, crush, or chew before swallowing.

  • Taking Cartia XT 24-Hour Sustained-Release Beads Capsules at the same time each day will help you remember to take it.

  • Continue to take Cartia XT 24-Hour Sustained-Release Beads Capsules even if you feel well. Do not miss any doses.

  • If you miss a dose of Cartia XT 24-Hour Sustained-Release Beads Capsules, 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 Cartia XT 24-Hour Sustained-Release Beads Capsules.



Important safety information:


  • Cartia XT 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Cartia XT 24-Hour Sustained-Release Beads Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Cartia XT 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Cartia XT 24-Hour Sustained-Release Beads Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cartia XT 24-Hour Sustained-Release Beads Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Do not suddenly stop taking Cartia XT 24-Hour Sustained-Release Beads Capsules. Your condition may get worse if you suddenly stop taking it. If you need to stop Cartia XT 24-Hour Sustained-Release Beads Capsules or add a new medicine, your doctor will gradually lower your dose.

  • Tell your doctor or dentist that you take Cartia XT 24-Hour Sustained-Release Beads Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Be sure to have your blood pressure checked regularly while taking Cartia XT 24-Hour Sustained-Release Beads Capsules.

  • Lab tests, including blood pressure, electrocardiogram (ECG), and heart rate, may be performed while you use Cartia XT 24-Hour Sustained-Release Beads Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Cartia XT 24-Hour Sustained-Release Beads Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.

  • Cartia XT 24-Hour Sustained-Release Beads Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Cartia XT 24-Hour Sustained-Release Beads Capsules while you are pregnant. Cartia XT 24-Hour Sustained-Release Beads Capsules are found in breast milk. Do not breast-feed while taking Cartia XT 24-Hour Sustained-Release Beads Capsules.


Possible side effects of Cartia XT 24-Hour Sustained-Release Beads Capsules:


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:



Constipation; dizziness; facial flushing; headache; lightheadedness; tiredness; weakness.



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; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.



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: Cartia XT 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. Symptoms may include confusion; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.


Proper storage of Cartia XT 24-Hour Sustained-Release Beads Capsules:

Store Cartia XT 24-Hour Sustained-Release Beads Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cartia XT 24-Hour Sustained-Release Beads Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Cartia XT 24-Hour Sustained-Release Beads Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Cartia XT 24-Hour Sustained-Release Beads Capsules 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 Cartia XT 24-Hour Sustained-Release Beads Capsules. 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 Cartia XT resources


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


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Ceftazidime


Class: Third Generation Cephalosporins
Chemical Name: [6R-[6α,7β(Z)]]-1-[[7-[[(2-Amino-4-thiazolyl) [(1 - carboxy - 1 - methylethoxy)imino]acetyl]amino] - 2 - carboxy - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - en - 3 - yl]methyl] pyridinium hydroxide, inner salt, pentahydrate
CAS Number: 78436-06-2
Brands: Fortaz

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.1 3 7 10 45 50 53 54 56 147 150 203 217


Uses for Ceftazidime


Bone and Joint Infections


Treatment of bone and joint infections caused by susceptible Staphylococcus aureus (oxacillin-susceptible strains only) Klebsiella, or Pseudomonas aeruginosa.1 104 118 136 298


Intra-abdominal and Gynecologic Infections


Treatment of gynecologic infections (including endometritis, pelvic cellulitis, other infections of the female genital tract) caused by susceptible Escherichia coli.1


Treatment of intra-abdominal infections (including peritonitis) caused by susceptible S. aureus (oxacillin-susceptible strains only), E. coli, or Klebsiella.1


Treatment of polymicrobial intra-abdominal infections caused by susceptible aerobic and anaerobic bacteria and Bacteroides.1 136 137 Consider that many strains of B. fragilis are resistant; generally should not be used alone in serious intra-abdominal infections when this organism may be involved.1 a


Meningitis and Other CNS Infections


Treatment of meningitis caused by susceptible H. influenzae, Neisseria meningitidis, Ps. aeruginosa, or Streptococcus pneumoniae in adults or children.1 46 47 50 137 254


Ceftazidime in conjunction with an aminoglycoside considered a regimen of choice for treatment of meningitis caused by susceptible P. aeruginosa13 14 112 147 218 337 354 or susceptible Enterobacteriaceae† (e.g., E. coli, P. mirabilis, Enterobacter, S. marcescens).46 47 218 222 223 224 335


Cefotaxime or ceftriaxone generally preferred when a third generation cephalosporin is indicated for treatment of meningitis caused by H. influenzae, N. meningitidis, or S. pneumoniae.47 150 216 218 335 336 337 338


Respiratory Tract Infections


Treatment of respiratory tract infections (including pneumonia) caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only), S. pneumoniae, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus mirabilis, Pseudomonas (including Ps. aeruginosa), or Serratia.1 103 108 117 118 119 120 137 143 144 146 147 148


For treatment of community-acquired pneumonia (CAP) caused by Ps. aeruginosa, ATS and IDSA recommend a combination regimen that includes an antipseudomonal β-lactam (cefepime, ceftazidime, aztreonam, imipenem, meropenem, piperacillin, ticarcillin) given in conjunction with ciprofloxacin, levofloxacin, or an aminoglycoside.227


Septicemia


Treatment of septicemia caused by susceptible S. aureus (oxacillin-susceptible strains only), S. pneumoniae, Haemophilus influenzae, E. coli, Klebsiella, Ps. aeruginosa, or Serratia.1 115 118 119 120 146


Skin and Skin Structure Infections


Treatment of skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible strains only), S. pyogenes (group A β-hemolytic streptococci), Enterobacter, E. coli, Klebsiella, Proteus (including P. mirabilis), Ps. aeruginosa, or Serratia.1 115 118 119 120 136 146


Urinary Tract Infections (UTIs)


Treatment of uncomplicated and complicated UTIs caused by susceptible Enterobacter, E. coli, Klebsiella, Proteus (including P. mirabilis), Ps. aeruginosa, or Serratia.1 106 113 115 118 119 137 141 145 153


Burkholderia Infections


Treatment of septicemia or pulmonary infections caused by Burkholderia cepacia† (formerly Ps. cepacia);147 208 218 345 alone or in conjunction with an aminoglycoside.147 208 218 345 Co-trimoxazole considered drug of choice; ceftazidime, chloramphenicol, or imipenem are alternatives.218


Treatment of severe melioidosis† caused by B. pseudomallei (formerly Ps. pseudomallei).218 264 266 267 276 277 346 355 356 357 358 Localized or mild disease may be effectively treated with a prolonged regimen of oral anti-infectives (e.g., co-trimoxazole with or without doxycycline).356 Severe illness usually treated with an initial parenteral regimen of ceftazidime, imipenem, or meropenem (some clinicians recommend that co-trimoxazole also be included, especially if the patient is septicemic) followed by prolonged maintenance with oral anti-infectives (e.g., co-trimoxazole with or without doxycycline).261 355 356 357 358 B. pseudomallei is difficult to eradicate (relapse of melioidosis is common).264 266 276 346 355 a


Otitis Externa


Treatment of malignant otitis externa† caused by Ps. aeruginosa.352 353


Acute bacterial otitis externa localized in the external auditory canal may be effectively treated using topical anti-infectives (e.g., otic preparations of ciprofloxacin or ofloxacin), but malignant otitis externa is an invasive, potentially life-threatening infection (especially in immunocompromised patients such as those with diabetes mellitus or HIV infection) and requires prompt diagnosis and long-term treatment with parenteral anti-infectives (e.g., ceftazidime and/or ciprofloxacin).352 353


Pseudomonas aeruginosa Infections


Generally considered a drug of choice for treatment of infections caused by Ps. aeruginosa,50 57 147 186 198 including acute exacerbations of bronchopulmonary Ps. aeruginosa infections in children and adults with cystic fibrosis.28 119 125 126 128 129 130 132 134 147 150 154 208 246 313 332 348


In severe infections, especially in immunocompromised patients, concomitant use of ceftazidime and an aminoglycoside (e.g., amikacin, gentamicin, tobramycin) is recommended.218 Consider that ceftazidime-resistant strains of Ps. aeruginosa can emerge during therapy and superinfection with resistant strains has occurred.50 111 115 147


Anti-infective therapy in patients with cystic fibrosis may result in clinical improvement and Ps. aeruginosa may be temporarily cleared from the sputum, but a bacteriologic cure is rarely obtained and should not be expected.28 119 125 126 132 149 150 208 246 313


Vibrio Infections


Treatment of infections caused by Vibrio vulnificus†.219 256


Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.218 219 256 Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.256 262


Empiric Therapy in Febrile Neutropenic Patients


Empiric treatment of presumed bacterial infections in febrile neutropenic adults or children†.122 123 124 138 139 140 212 228 247 248 249 275 279 280 286 287 288 289 290 291 292 294 295 347 349 Has been used alone or in conjunction with an aminoglycoside (e.g., amikacin, gentamicin, tobramycin).124 138 139 140 212 228 247 248 249 275 290 292 295


Consider that gram-positive bacteria have become a predominant pathogen in febrile neutropenic patients and that ceftazidime is less active against gram-positives than many other cephalosporins and β-lactam antibiotics.122 124 212 222 229 281 282 284 An anti-infective active against staphylococci (e.g., vancomycin) probably should be used concomitantly if ceftazidime is used for empiric therapy.122 124 132 138 139 140 212 222 229 247


Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.282 Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.281 282


Perioperative Prophylaxis


Has been used for perioperative prophylaxis† in patients undergoing vaginal hysterectomy,151 intra-abdominal surgery,167 or transurethral resection of the prostate.142


Other cephalosporins or cephamycins (cefazolin, cefotetan, cefoxitin) are preferred drugs for perioperative prophylaxis.220 Ceftazidime and other third generation cephalosporins usually not used for perioperative prophylaxis since they are expensive, some are less active against staphylococci than cefazolin, they have a spectrum of activity wider than necessary for organisms encountered in elective surgery, and their use for prophylaxis promotes emergence of resistant organisms.147 220 221 222


Ceftazidime Dosage and Administration


Administration


Administer by intermittent IV injection or infusion or by deep IM injection.1 217 Also has been administered by continuous IV infusion†.299 300 301 302 310 332 348


Has been administered intraperitoneally in dialysis solutions.1 27 217 Should not be administered by intra-arterial injection since arteriospasm and necrosis can occur.1 217


IV route preferred for treatment of septicemia, meningitis, peritonitis, or other severe or life-threatening infections and in patients with lowered resistance resulting from malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.1 217


The commercially available frozen ceftazidime injection in dextrose should be used only for IV infusion.1


IV Injection


Reconstitution

For intermittent IV injection, reconstitute vials containing 500 mg, 1 g, or 2 g with 5.3 mL, 10, or 10 mL, respectively, of sterile water for injection to provide solutions containing approximately 100, 100, or 170mg/mL, respectively.1 217


Shake vial after adding the diluent;1 217 carbon dioxide is released as drug dissolves and the solution will become clear within 1–2 minutes.1 217 When withdrawing a dose from reconstituted vials, consider that the solution may contain some carbon dioxide bubbles which should be expelled from the syringe before injection.1 217


Rate of Administration

Inject appropriate dose of reconstituted solution into a vein over a period of 3–5 minutes or slowly into the tubing of a compatible IV solution.1 217


IV Infusion


Reconstitution and Dilution

Reconstitute vials of containing 1 or 2 g of ceftazidime with 100 mL of sterile water for injection or compatible IV solution.1 217 Shake the vial after adding the diluent;1 217 carbon dioxide is released as the drug dissolves and the solution will become clear within 1–2 minutes.1 217 The appropriate dose of the drug should then be added to a compatible IV solution.1 217


Reconsitute pharmacy bulk packages according to the manufacturer's directions and then further dilute in a compatible IV infusion solution prior to administration.1 233


ADD-Vantage vials labeled as containing 1 or 2 g of ceftazidime should be reconstituted according to the manufacturer’s directions.1 217


Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.1 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.1 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.1 231 232 The injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.1 231 232


Rate of Administration

Intermittent IV infusions generally have been infused over 15–30 minutes in adults,8 102 104 105 115 116 118 119 133 137 139 144 neonates,34 and children.108 157


If a Y-type administration set is used, the other solution flowing through the tubing should be discontinued while ceftazidime is being infused.1 217 262


IM Injection


IM injections should be made deeply into a large muscle mass, such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.1 217


Reconstitution

IM injections are prepared by adding 1.5 or 3 mL of sterile or bacteriostatic water for injection or 0.5 or 1% lidocaine hydrochloride injection to vials containing 500 mg or 1 g of ceftazidime, respectively, to provide solutions containing approximately 280 mg/mL.1


Shake the vial after adding the diluent;1 217 carbon dioxide is released as the drug dissolves and the solution will become clear within 1–2 minutes.1 217 When withdrawing a dose from reconstituted vials, consider that the solution may contain some carbon dioxide bubbles which should be expelled from the syringe before injection.1 217


Intraperitoneal Instillation


Reconstitute with sterile water for injection as for IV infusion221 and then further dilute in a compatible peritoneal dialysis solution to provide a solution containing 250 mg of ceftazidime in each 2 L of dialysis solution.1 217


Dosage


Available as ceftazidime pentahydrate and as ceftazidime sodium; dosage expressed as anhydrous ceftazidime.1 3 217


Pediatric Patients


General Pediatric Dosage in Neonates

IV

Neonates ≤4 weeks of age: manufacturer recommends 30 mg/kg every 12 hours.1 217


Neonates <1 week of age: AAP recommends 50 mg/kg every 12 hours in those weighing ≤2 kg and 50 mg/kg every 8 or 12 hours in those weighing >2 kg.261


Neonates 1–4 weeks of age: AAP recommends 50 mg/kg every 12 hours in those weighing <1.2 kg and 50 mg/kg every 8 hours in those weighing ≥1.2 kg.261


General Pediatric Dosage in Children 1 Month to 12 Years of Age

IV

25–50 mg/kg every 8 hours.1 38 103 107 217 254 261 Use 50 mg/kg every 8 hours in immunocompromised children or children with cystic fibrosis.1 28 30 108 126 128 129 149 217


AAP recommends 75–100 mg/kg daily in 3 equally divided doses for the treatment of mild to moderate infections or 125–150 mg/kg daily in 3 equally divided doses for the treatment of severe infections.261


General Pediatric Dosage in Children >12 Years of Age

IV

Use usual adult dosage.1 217 (See Adult Dosage under Dosage and Administration.)


Meningitis

IV

Some clinicians recommend 100–150 mg/kg daily in 2 or 3 equally divided doses for neonates ≤7 days of age and 150 mg/kg daily in 3 divided doses in older neonates and children.354


Because of a high rate of relapse, treatment duration should be ≥3 weeks for meningitis caused by gram-negative bacilli.335 337 354 In neonates, some clinicians recommend that treatment be continued for 2 weeks beyond the first sterile CSF culture or at least 3 weeks, whichever is longer.354


Burkholderia Infections†

Severe Melioidosis Caused by Burkholderia pseudomallei†

IV

60 mg/kg daily in 2 equally divided doses recommended by some clinicians for children <2 months of age or 100 mg/kg daily in 3 equally divided doses for children ≥2 months of age.357 Concomitant co-trimoxazole or doxycycline may be indicated in septicemic or other severe cases.357


Continue initial parenteral regimen for at least 14 days and until there is clinical improvement.355 356 357 When appropriate, switch to an oral maintenance regimen (e.g., oral co-trimoxazole with or without oral doxycycline) and continue for at least 3–6 months to prevent recrudence or relapse.355 356 357 More prolonged oral maintenance therapy (up to 12 months) may be necessary, depending on the response to therapy and severity of initial illness.356 357


Empiric Therapy in Febrile Neutropenic Children†

IV

50 mg/kg (maximum 2 g) every 8 hours has been used in pediatric patients ≥2 years of age.347


Adults


General Adult Dosage

Less Severe Infections

IV or IM

1 g every 8–12 hours.1 217


Severe or Life-threatening Infections

IV

2 g every 8 hours,1 especially in immunocompromised patients.1


Bone and Joint Infections

IV

2 g every 12 hours.1 104 217


Intra-abdominal and Gynecologic Infections

Serious Infections

IV

2 g every 8 hours.1 217


Meningitis

IV

2 g every 8 hours.1 217 354 Duration of treatment is ≥3 weeks for meningitis caused by susceptible gram-negative bacilli.335 337 354


Respiratory Tract Infections

Uncomplicated Pneumonia

IV or IM

0.5–1 g every 8 hours.1 217


Pseudomonas Lung Infections in Cystic Fibrosis Patients

IV

30–50 mg/kg every 8 hours (up to 6 g daily).1 28 30 50 125 126 128 129 149 217 246 348


Clinical improvement may occur, but bacteriologic cures should not be expected in patients with chronic respiratory disease and cystic fibrosis.1 28 119 125 126 132 149 150 208 217


Skin and Skin Structure Infections

Mild Infections

IV or IM

0.5–1 g every 8 hours.1 104 217


Urinary Tract Infections (UTIs)

Uncomplicated Infections

IV or IM

250 mg every 12 hours.1 104 217


Complicated Infections

IV or IM

500 mg every 8–12 hours.1 104 217


Burkholderia Infections†

Severe Melioidosis Caused by Burkholderia pseudomallei†

IV

40 mg/kg every 8 hours recommended by US Army Medical Research Institute of Infectious Diseases (USAMRIID).356 Others recommend 2 g every 8 hours (up to 6 g daily)357 or 50 mg/kg (up to 2 g) every 6 hours.355 358 Concomitant co-trimoxazole or doxycycline may be indicated in septicemic or other severe cases.355 356 357 358


Continue initial parenteral regimen for at least 14 days and until there is clinical improvement.355 356 357 358 When appropriate, switch to an oral maintenance regimen (e.g., oral co-trimoxazole with or without oral doxycycline) and continue for at least 3–6 months to prevent recrudence or relapse.355 356 357 358 More prolonged oral maintenance therapy (up to 12 months) may be necessary, depending on the response to therapy and severity of initial illness.356 357


Prescribing Limits


Pediatric Patients


Maximum 6 g daily.1


Adults


Maximum 6 g daily.1 217 221 225


Special Populations


Hepatic Impairment


Dosage adjustments not required unless renal function also impaired.1 150 217


Renal Impairment


Reduce dosage in patients with Clcr ≤50 mL/minute.1 217


Manufacturers recommend that adults with Clcr ≤50 mL/minute receive an initial loading dose of 1 g and a maintenance dosage based on Clcr.1 217 (See Table.)













Maintenance Dosage for Adults with Renal Impairment1

Clcr (mL/minute)



Dosage



31–50



1 g every 12 h



16–30



1 g every 24 h



6–15



500 mg every 24 h



<5



500 mg every 48 h


Patients with renal impairment and severe infections who would generally receive 6 g daily if renal function were normal: increase dosage in table by 50% or dosing interval may be increased appropriately.1


Patients undergoing hemodialysis: given an initial loading dose of 1 g followed by 1 g after each hemodialysis period.1 217 221


Patients undergoing intraperitoneal dialysis or CAPD: given an initial loading dose of 1 g followed by 500 mg every 24 hours.1 217 221


Geriatric Patients


Cautious dosage selection because of age-related decreases in renal function.1 (See Renal Impairment under Dosage and Administration.)


Cautions for Ceftazidime


Contraindications



  • Known hypersensitivity to ceftazidime or other cephalosporins.1



Warnings/Precautions


Warnings


Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.1 Careful observation of the patient is essential.1 217 Institute appropriate therapy if superinfection occurs.1 217


Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including ceftazidime, and may range in severity from mild diarrhea to fatal colitis.1 217 Hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1


Consider CDAD if diarrhea develops and manage accordingly.1 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1


If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.1 Some mild cases of CDAD may respond to discontinuance alone.1 217 339 340 341 342 343 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 217 339 340 341 342 343


Neurotoxicity

Possibility of seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia if inappropriately high dosage used in patients with renal impairment.1 (See Renal Impairment under Cautions.)


Sensitivity Reactions


Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.1 217 a


If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1 217


Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.1 217 a


Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 217 Cautious use recommended in individuals hypersensitive to penicillins:1 217 a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a


General Precautions


History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.1 217 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)


Prolonged PT

Possibility of prolonged PT.1 217


Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged therapy, or stabilized on anticoagulant therapy.1 217 Administer vitamin K when indicated.1 217


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ceftazidime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1 217


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 217 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 217


Resistance in Gram-negative Bacteria

Resistance caused by inducible type I β-lactamases can develop in some gram-negative bacilli (e.g., Enterobacter, Pseudomonas, Serratia) during treatment, leading to clinical failure in some cases.1


When treating infections caused by these bacteria, perform periodic in vitro susceptibility testing when clinically appropriate.1 If patient fails to respond to monotherapy, an aminoglycoside or similar agent should be considered.1


Risk of Distal Necrosis

Possibility of distal necrosis after inadvertent intra-arterial administration.1


Sodium Content

Vials, pharmacy bulk packages, and ADD-Vantage vials contain ceftazidime admixed with sodium carbonate to facilitate dissolution.1 217 233 These preparations contain approximately 54 mg (2.3 mEq) of sodium per g of ceftazidime.1 217 233


Specific Populations


Pregnancy

Category B.1


Lactation

Distributed into milk in low concentrations; use with caution.1


Geriatric Use

No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.1


Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.1 Select dosage with caution and assess renal function periodically because of age-related decreases in renal function.1 (See Renal Impairment under Dosage and Administration.)


Hepatic Impairment

Pharmacokinetics not affected.1


Renal Impairment

Possible decreased clearance and increased serum half-life.1


Neurotoxicity reported in some patients with renal impairment who received dosage inappropriately high for their renal status.1 (See Neurotoxicity under Cautions.)


Dosage adjustments necessary in patients with Clcr ≤50 mL/minute.1 See Renal Impairment under Dosage and Administration.


Common Adverse Effects


GI effects, hypersensitivity reactions, local reactions at IV injection sites.1


Interactions for Ceftazidime


Specific Drugs and Laboratory Tests


















Drug or Test



Interaction



Comments



Aminoglycosides



Nephrotoxicity reported with concomitant use of some cephalosporins and aminoglycosides1 209 217


In vitro evidence of additive or synergistic antibacterial activity against Pseudomonas and Enterobacteriaceae1 50 63 90 147 186 187 191 217



Carefully monitor renal function, especially if high aminoglycoside dosage is used or if therapy is prolonged1 217



Chloramphenicol



In vitro evidence of antagonism against gram-negative bacilli1 270 271 272 273 274



Avoid concomitant use1 274



Probenecid



No appreciable effect on pharmacokinetics of ceftazidime1 5 10 24 50 130 147 164 217



Tests for glucose



Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1 173 a



Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1 173 a


Ceftazidime Pharmacokinetics


Absorption


Bioavailability


Not absorbed from GI tract; must be given parenterally.3 50


Following IM administration, peak serum concentrations attained in approximately 1 hour.1 6 12 217 May be absorbed more slowly in women than in men following IM injection into the gluteus maximus or vastus lateralis.6 In women, peak serum concentrations may be lower following IM injection into the gluteus maximus than into the vastus lateralis.6


In patients with end-stage chronic renal failure who receive a single dose of the drug via an intraperitoneal catheter, peak serum concentrations attained 2.75 hours after the dose.27


Distribution


Extent


Widely distributed into body tissues and fluids including the gallbladder,24 169 255 bone,1 3 23 147 168 203

Lotyn




Lotyn may be available in the countries listed below.


Ingredient matches for Lotyn



Lovastatin

Lovastatin is reported as an ingredient of Lotyn in the following countries:


  • Indonesia

International Drug Name Search

Concerta



Generic Name: methylphenidate (Oral route)

meth-il-FEN-i-date

Oral route(Tablet;Tablet, Extended Release;Tablet, Chewable;Solution)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, due to abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior including psychotic episodes. Careful supervision during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .



Commonly used brand name(s)

In the U.S.


  • Concerta

  • Metadate CD

  • Metadate ER

  • Methylin

  • Methylin ER

  • Ritalin

  • Ritalin LA

  • Ritalin-SR

Available Dosage Forms:


  • Tablet, Extended Release

  • Capsule, Extended Release

  • Tablet, Chewable

  • Solution

  • Tablet

Therapeutic Class: CNS Stimulant


Chemical Class: Amphetamine Related


Uses For Concerta


Methylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.


Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.


This medicine is available only with a doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:


  • Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines.

Before Using Concerta


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.


Geriatric


Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.


No information is available on the relationship of age to the effects of Ritalin® and Ritalin LA® in geriatric patients.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Brofaromine

  • Clorgyline

  • Furazolidone

  • Iproniazid

  • Isocarboxazid

  • Lazabemide

  • Linezolid

  • Moclobemide

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Rasagiline

  • Selegiline

  • Toloxatone

  • Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Carbamazepine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Agitation, severe or

  • Anxiety, severe or

  • Glaucoma or

  • Motor tics (repeated muscle movements) or

  • Tension, severe or

  • Tourette's syndrome, or family history of—Should not be used in patients with these conditions.

  • Alcohol abuse, history of or

  • Drug abuse or dependence, history of—Dependence may be more likely to develop.

  • Bipolar disorder (manic-depressive illness), history of or

  • Blood vessel problems or

  • Coronary artery disease or

  • Depression, history of or

  • Heart attack, recent or

  • Heart disease (e.g., cardiomyopathy) or

  • Heart failure or

  • Heart rhythm problems (e.g., ventricular arrhythmia), history of or

  • Hypertension (high blood pressure) or

  • Hyperthyroidism (overactive thyroid) or

  • Psychosis (mental illness), history of or

  • Seizures, history of or

  • Stroke, history of or

  • Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

  • Cystic fibrosis or

  • Stomach or bowel problems (e.g., bowel blockage, Meckel's diverticulum, peritonitis, short gut syndrome) or

  • Trouble with swallowing—Concerta® extended release tablets should not be given in patients with these conditions.

Proper Use of methylphenidate

This section provides information on the proper use of a number of products that contain methylphenidate. It may not be specific to Concerta. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.


This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.


To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 p.m., unless your doctor gives you or your child a different time.


If you or your child are taking the long-acting forms of this medicine:


  • The Concerta® extended release tablets, Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.

  • If you or your child are unable to swallow the Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture can not be stored for future use.

  • If you are taking the Concerta® extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body.

  • You may take Concerta® extended release tablets with or without food.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For attention deficit hyperactivity disorder (ADHD):
    • For short-acting oral dosage form (tablets):
      • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.

      • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.

      • Children up to 6 years of age—Use and dose must be determined by the doctor.


    • For long-acting oral dosage form (extended-release tablets):
      • For patients who have not been treated with Concerta®:
        • Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.

        • Teenagers and children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.

        • Children up to 6 years of age—Use and dose must be determined by your doctor.


      • For patients already using Concerta®:
        • Adults, teenagers, and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.

        • Children up to 6 years of age—Use and dose must be determined by your doctor.



    • For long-acting oral dosage form (sustained-release tablets):
      • Adults, teenagers, and children 6 years of age and older—The dose must be determined by the doctor.

      • Children up to 6 years of age—Use and dose must be determined by the doctor.


    • For the long-acting oral dosage form (extended-release capsules):
      • Adults, teenagers, and children 6 years of age and older—10 to 20 milligrams (mg) once a day, taken in the morning before breakfast. If needed, your doctor may increase the dose once a week by 10 mg a day as needed up to 60 mg a day.

      • Children up to 6 years of age—Use and dose must be determined by the doctor.



  • For narcolepsy:
    • For short-acting oral dosage form (tablets):
      • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.

      • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.

      • Children up to 6 years of age—Use and dose must be determined by your doctor.


    • For long-acting oral dosage form (sustained-release tablets):
      • Adults and teenagers and children 6 years of age and older—The dose must be determined by the doctor.

      • Children up to 6 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Concerta


Your doctor should check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.


You or your child will also need to have your blood pressure measured before starting this medicine and while you or your child are using it. If you notice any change to you or your child's recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.


You or your child should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.


Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.


Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while using this medicine.


Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.


This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.


Concerta Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Fast heartbeat

Less common
  • Chest pain

  • fever

  • joint pain

  • skin rash or hives

Rare
  • Black, tarry stools

  • blood in the urine or stools

  • blurred vision or other changes in vision

  • convulsions

  • crusting, dryness, or flaking of the skin

  • muscle cramps

  • pinpoint red spots on the skin

  • scaling, severe redness, soreness, or swelling of the skin

  • uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)

  • unusual bleeding or bruising

Incidence not known
  • Confusion

  • cracks in the skin

  • delusions (false beliefs)

  • depersonalization (feeling like surroundings are not real)

  • depression (severe)

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • hives or welts

  • loss of heat from the body

  • mood changes

  • numbness of the hands

  • painful or difficult urination

  • pale skin

  • red, irritated eyes

  • red, swollen, or scaly skin

  • severe or sudden headache

  • shortness of breath

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • sudden loss of coordination

  • sudden slurring of speech

  • swollen glands

  • troubled breathing with exertion

  • unusual behavior

  • unusual tiredness or weakness

  • weight loss

  • yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Agitation

  • confusion (severe)

  • convulsions

  • dryness of the mouth or mucous membranes

  • false sense of well-being

  • fast, pounding, or irregular heartbeat

  • fever

  • flushing

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • headache (severe)

  • increased sweating

  • large pupils

  • muscle twitching

  • overactive reflexes

  • sweating

  • trembling or shaking

  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Loss of appetite

  • nervousness

  • sleeplessness

  • stuffy nose

  • trouble with sleeping

  • unable to sleep

  • unusually warm skin

Less common
  • Anger

  • dizziness

  • drowsiness

  • fear

  • headache

  • irritability

  • muscle aches

  • nausea

  • nervousness

  • runny nose

  • scalp hair loss

  • stomach pain

  • talking, feeling, and acting with excitement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Concerta side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Concerta resources


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


  • Concerta Consumer Overview

  • Concerta Prescribing Information (FDA)

  • Concerta Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Daytrana Prescribing Information (FDA)

  • Daytrana System MedFacts Consumer Leaflet (Wolters Kluwer)

  • Daytrana Consumer Overview

  • Metadate CD Prescribing Information (FDA)

  • Metadate CD Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Metadate ER Prescribing Information (FDA)

  • Methylin Prescribing Information (FDA)

  • Methylin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Methylin ER Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Methylphenidate Hydrochloride Monograph (AHFS DI)

  • Ritalin Consumer Overview

  • Ritalin Prescribing Information (FDA)

  • Ritalin LA Prescribing Information (FDA)

  • Ritalin LA Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Concerta with other medications


  • ADHD
  • Narcolepsy

Wednesday, 21 September 2016

Carvedilol


Pronunciation: kar-VE-dil-ol
Generic Name: Carvedilol
Brand Name: Coreg


Carvedilol is used for:

Treating high blood pressure or certain types of heart failure. It may also be used after a heart attack to improve survival in certain patients. It may be used along with other medicines. It may also be used for other conditions as determined by your doctor.


Carvedilol is an alpha- and beta-blocker. It works by relaxing the blood vessels, slowing down the heart, and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart.


Do NOT use Carvedilol if:


  • you are allergic to any ingredient in Carvedilol

  • you have certain types of irregular heartbeat (eg, moderate to severe heart block, sick sinus syndrome), very severe heart failure (eg, requires treatment in a hospital), or shock caused by severe heart problems

  • you have a very slow heartbeat and you do not have a permanent pacemaker

  • you have asthma or other severe breathing problems

  • you have severe liver problems

  • you are taking mibefradil

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



Before using Carvedilol:


Some medical conditions may interact with Carvedilol. 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 or are taking medicine for allergies

  • if you have a history of other heart problems (eg, heart failure, slow or irregular heartbeat, angina) or low blood pressure

  • if you have a history of liver or kidney problems, blood vessel disease, blood flow problems (eg, in the legs or feet), lung or breathing problems (eg, chronic bronchitis emphysema, chronic obstructive pulmonary disease), diabetes, low blood sugar, thyroid problems, or glaucoma

  • if you have an adrenal gland tumor (pheochromocytoma)

  • if you will be having surgery

Some MEDICINES MAY INTERACT with Carvedilol. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Mibefradil because the risk of serious heart side effects may be increased

  • Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, cancer, diabetes, depression, mental or mood problems, multiple sclerosis [MS], prostate problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures, thyroid problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Carvedilol, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carvedilol 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 Carvedilol:


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


  • An extra patient leaflet is available with Carvedilol. Talk to your pharmacist if you have questions about this information.

  • Take Carvedilol by mouth with food.

  • Take Carvedilol on a regular schedule to get the most benefit from it. Taking Carvedilol at the same time each day will help you remember to take it.

  • Continue to take Carvedilol even if you feel well. Do not miss any doses.

  • Do not suddenly stop taking Carvedilol. You may have an increased risk of side effects. If you need to stop Carvedilol or add a new medicine, your doctor will gradually lower your dose.

  • If you miss a dose of Carvedilol, 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 Carvedilol.



Important safety information:


  • Carvedilol may cause dizziness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Carvedilol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Carvedilol may cause dizziness, light-headedness, or fainting. These effects may occur within the first hour after you take your dose. They may be more likely when you start taking Carvedilol or if your dose is increased. Alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Tell your doctor if these effects occur.

  • Do NOT take more than the recommended dose without checking with your doctor.

  • Do not suddenly stop taking Carvedilol. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Carvedilol. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Carvedilol for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Carvedilol again.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Tell your doctor or dentist that you take Carvedilol before you receive any medical or dental care, emergency care, or surgery.

  • If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk for an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Carvedilol.

  • Diabetes patients - Carvedilol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Diabetes patients - Carvedilol may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Lab tests, including blood pressure and heart function, may be performed while you use Carvedilol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Carvedilol with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness.

  • Carvedilol should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carvedilol while you are pregnant. It is not known if Carvedilol is found in breast milk. Do not breast-feed while taking Carvedilol.


Possible side effects of Carvedilol:


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:



Diarrhea; dizziness; dry eyes; fatigue; light-headedness; weakness.



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; unusual hoarseness); change in the amount of urine produced; chest pain; cold or numb legs or feet; fainting; irregular or unusually slow heartbeat; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual leg pain; very cold or blue fingers or toes.



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: Carvedilol 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. Symptoms may include chest pain; fainting; seizures; severe dizziness; slow heartbeat; slow, shallow, or difficult breathing.


Proper storage of Carvedilol:

Store Carvedilol below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carvedilol out of the reach of children and away from pets.


General information:


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

  • Carvedilol is 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 Carvedilol. 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 Carvedilol resources


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


  • Carvedilol Prescribing Information (FDA)

  • Carvedilol Monograph (AHFS DI)

  • Carvedilol Professional Patient Advice (Wolters Kluwer)

  • carvedilol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Coreg Consumer Overview

  • Coreg Prescribing Information (FDA)

  • Coreg CR Prescribing Information (FDA)



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