Thursday, September 29, 2016

cyclophosphamide oral/injection


Generic Name: cyclophosphamide (oral/injection) (sye kloe FOSS fah mide)

Brand Names: Cytoxan, Cytoxan Lyophilized, Neosar


What is cyclophosphamide?

Cyclophosphamide is a cancer (chemotherapeutic) medication. Cyclophosphamide interferes with the growth of cancer cells and slows their growth and spread in the body.


Cyclophosphamide is used to treat several types of cancer. Cyclophosphamide is also used to treat certain cases of nephrotic syndrome (kidney disease) in children.


Cyclophosphamide may also be used for purposes other than those listed in this medication guide.


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


Cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.


Serious side effects have been reported with the use of cyclophosphamide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); bladder problems; and others. Talk to your doctor about the possible side effects from treatment with cyclophosphamide.


In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.


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


Before taking cyclophosphamide, tell your doctor if you



  • have an infection or have had recent vaccinations;




  • have a low level of white blood cells or platelets (detected by blood tests);




  • have bone marrow problems;




  • have been previously treated with x-ray therapy;




  • have been previously treated with other chemotherapy medicines (i.e., Alkeran, CeeNU, Leukeran, Myleran, and others);




  • have had your adrenal glands removed;




  • need to have surgery;




  • have any unhealed wounds;




  • have a history of heart disease;



  • have liver disease; or

  • have kidney disease.

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


Cyclophosphamide is in the FDA pregnancy category D. This means that cyclophosphamide is known to be harmful to an unborn baby. Cyclophosphamide may also affect egg production in women and sperm production in men. Do not take cyclophosphamide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of cyclophosphamide by the father prior to conception has also been associated with birth defects. Contraceptive measures are recommended during treatment with cyclophosphamide for both men and women. Cyclophosphamide passes into breast milk and may harm a nursing infant. Do not take cyclophosphamide without first talking to your doctor if you are breast feeding a baby.

How should I take cyclophosphamide?


Take cyclophosphamide exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse or pharmacist to explain them to you.


Take each oral dose with a large glass of water.

To avoid urinary bladder irritation during treatment with either oral or injectable cyclophosphamide, drink plenty of fluid during treatment and for 48 hours following treatment, usually 7 to 12 cups (3 quarts) per day, and empty your bladder frequently, every 2 to 3 hours including once during the night.


Taking oral cyclophosphamide on an empty stomach is preferable. If severe stomach upset occurs, take cyclophosphamide with food. Continue to take cyclophosphamide even if nausea and vomiting occurs. Do not stop taking the medicine without first talking to your doctor. Check with your doctor if vomiting occurs shortly after taking a dose of cyclophosphamide. Your doctor may want you to take another dose, but do not do this without checking with your doctor first.


If you are taking a liquid form of cyclophosphamide by mouth, use a dose measuring spoon or cup to ensure that you get the correct dose.


Injectable cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.


Your doctor will determine the correct amount and frequency of treatment with cyclophosphamide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.


Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with cyclophosphamide to monitor progress and side effects.


Store cyclophosphamide oral tablets at or below 77 degrees Fahrenheit (25 degrees Celsius). Brief exposures to 86 degrees Fahrenheit (30 degrees Celsius) are permitted but the tablets should be protected from temperatures above 86 degrees Fahrenheit. Your healthcare provider will store cyclophosphamide injection as directed by the manufacturer. If you are storing cyclophosphamide injection at home, follow the directions provided by your healthcare provider. Store cyclophosphamide oral liquid in a glass container in the refrigerator for up to 14 days.

See also: Cyclophosphamide dosage (in more detail)

What happens if I miss a dose?


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


Contact your doctor if you miss a dose of cyclophosphamide injection.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a cyclophosphamide overdose may include decreased bone marrow function, infection, and heart problems.


What should I avoid while taking cyclophosphamide?


Cyclophosphamide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.


Cyclophosphamide side effects


If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);




  • blood in the urine;




  • black or tarry stools;




  • painful or difficult urination;




  • signs of infection such as fever; chills, or sore throat;




  • jaundice (yellowing of the skin or eyes);




  • lower back or side pain;




  • chest pain, difficulty breathing, or swelling;




  • unusual bleeding or bruising; or




  • changes in bone marrow function (detected by blood tests).



Other less serious side effects may be more likely to occur. Talk to your doctor if you experience



  • nausea, vomiting, or decreased appetite;




  • mouth sores;




  • abdominal pain;




  • diarrhea;




  • temporary hair loss;




  • temporary or permanent sterility;




  • rash;




  • changes in skin color; or




  • changes in nails.



In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.


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. You may report side effects to FDA at 1-800-FDA-1088.


Cyclophosphamide Dosing Information


Usual Adult Dose for Malignant Disease:

Intravenous: When used alone, the initial dose for patients with no hematologic deficiency is 40 to 50 mg/kg usually in divided doses over 2 to 5 days. Alternatively, 10 to 15 mg/kg may be administered every 7 to 10 days or 3 to 5 mg/kg twice a week.

Oral: Usual Range: 1 to 8 mg/kg/day for initial and maintenance dosing.

Usual Adult Dose for Ovarian Cancer:

For use in the treatment of epithelial ovarian cancer:

600 mg/m2 intravenously on day one in combination with carboplatin or cisplatin
Repeat cycle every 28 days.

Usual Adult Dose for Multiple Myeloma:

(In combination with other chemotherapeutic agents as a part of the M2 protocol)
10 mg/kg IV on day 1

Usual Pediatric Dose for Malignant Disease:

Intravenous: When used alone, the initial dose for patients with no hematologic deficiency is 40 to 50 mg/kg usually in divided doses over 2 to 5 days. Alternatively, 10 to 15 mg/kg may be administered every 7 to 10 days or 3 to 5 mg/kg twice a week.

Oral: Usual Range: 1 to 8 mg/kg/day for initial and maintenance dosing.

Usual Pediatric Dose for Nephrotic Syndrome:

When use for biopsy proven "minimal change" nephrotic syndrome in children, a dose of 2.5 to 3 mg/kg/day orally for 60 to 90 days is recommended.


What other drugs will affect cyclophosphamide?


Before taking cyclophosphamide, tell your doctor if you are taking any other medicines, especially any of the following:



  • phenobarbital (Luminal, Solfoton);




  • allopurinol (Zyloprim);




  • digoxin (Lanoxin);




  • warfarin (Coumadin);




  • a thiazide diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others; or




  • another chemotherapy medicine.



You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.


Do not receive "live" vaccines during treatment with cyclophosphamide. Administration of a live vaccine may be dangerous during treatment with cyclophosphamide.

Other drugs may interact with cyclophosphamide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with cyclophosphamide.



More cyclophosphamide resources


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


Compare cyclophosphamide with other medications


  • Acute Lymphocytic Leukemia
  • Acute Nonlymphocytic Leukemia
  • Bladder Cancer
  • Brain Tumor
  • Breast Cancer
  • Bullous Pemphigoid
  • Cancer
  • Cervical Cancer
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Cogan's Syndrome
  • Dermatomyositis
  • Endometrial Cancer
  • Ewing's Sarcoma
  • Histiocytosis
  • Hodgkin's Lymphoma
  • IgA Nephropathy
  • Multiple Myeloma
  • Multiple Sclerosis
  • Mycosis Fungoides
  • Nephrotic Syndrome
  • Neuroblastoma
  • Non-Hodgkin's Lymphoma
  • Non-Small Cell Lung Cancer
  • Organ Transplant, Rejection Prophylaxis
  • Osteosarcoma
  • Ovarian Cancer
  • Pemphigoid
  • Pemphigus
  • Prostate Cancer
  • Rheumatoid Arthritis
  • Small Cell Lung Cancer
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Testicular Cancer
  • Wegener's Granulomatosus
  • Wilms' Tumor


Where can I get more information?


  • Your pharmacist has additional information about cyclophosphamide written for health professionals that you may read.

See also: cyclophosphamide side effects (in more detail)


Wednesday, September 28, 2016

Omeprazol Mylan




Omeprazol Mylan may be available in the countries listed below.


Ingredient matches for Omeprazol Mylan



Omeprazole

Omeprazole is reported as an ingredient of Omeprazol Mylan in the following countries:


  • Denmark

  • Sweden

International Drug Name Search

cyclandelate


Generic Name: cyclandelate (sye KLAN de late)

Brand Names: Cyclospasmol


What is cyclandelate?

Cyclandelate is in a class of drugs called vasodilators. Cyclandelate relaxes veins and arteries, which makes them wider and allows blood to pass through them more easily.


These actions may help treat the symptoms of conditions such as leg cramps, arteriosclerosis (hardening of the arteries), Raynaud's phenomenon, and other conditions that involve poor blood flow in your veins and arteries.


Cyclandelate is not commercially available in the United States.


Cyclandelate may also be used for purposes other than those listed in this medication guide.


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


Cyclandelate is not commercially available in the United States.


Take cyclandelate with food or an antacid to lessen stomach discomfort.

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


Before taking this medication, tell your doctor if you have



  • serious coronary artery disease;




  • peripheral or cerebral vascular disease;




  • glaucoma, or




  • bleeding or blood problems.




The safety of cyclandelate for use by pregnant or nursing women has not been established. Do not take cyclandelate without first talking to your doctor if you are pregnant or are breast-feeding a baby.

How should I take cyclandelate?


Take cyclandelate exactly as directed by your doctor. 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. Take cyclandelate with food or an antacid to lessen stomach discomfort. Cyclandelate is usually taken two to four times a day, before meals and at bedtime. Follow your doctor's instructions. Store cyclandelate 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 your next dose, skip the missed dose and take only your 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 cyclandelate overdose include lightheadedness, weakness, fainting, headache, and a faint heartbeat.


What should I avoid while taking cyclandelate?


There are no restrictions on foods, beverages, or activities during therapy with cyclandelate. Follow any special instructions you receive from your doctor.


Cyclandelate side effects


Stop taking cyclandelate 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 cyclandelate and talk to your doctor if you experience



  • heartburn, stomach upset, or belching;




  • flushing;




  • headache;




  • a fast heartbeat; or




  • weakness.



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 cyclandelate?


Drugs used to treat high blood pressure and other heart conditions may increase the effects of cyclandelate. Special monitoring may be necessary.


Drugs other than those listed here may also interact with cyclandelate or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More cyclandelate resources


  • Drug Images
  • Cyclandelate Drug Interactions
  • Cyclandelate Support Group
  • 0 Reviews for Cyclandelate - Add your own review/rating


  • cyclandelate Advanced Consumer (Micromedex) - Includes Dosage Information



Compare cyclandelate with other medications


  • Nocturnal Leg Cramps
  • Raynaud's Syndrome
  • Renal Artery Atherosclerosis


Where can I get more information?


  • Your pharmacist has additional information about cyclandelate written for health professionals that you may read.

What does my medication look like?


Cyclandelate was formerly available with a prescription under the brand names Cyclan and Cyclospasmol in 200 mg and 400 mg capsules. Cyclandelate was also formerly available in a generic tablet formulation. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



Cydectin Oral Drench





Dosage Form: FOR ANIMAL USE ONLY
CYDECTIN®

(moxidectin)

Oral Drench for Sheep

Antiparasitic

NADA 141-247, Approved by FDA


Contains 1 mg moxidectin/mL


For Treatment and Control of Infections Due to Internal Parasites of Sheep.


Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.



PRODUCT DESCRIPTION:


Cydectin Oral Drench for Sheep is a ready-to-use solution containing 0.1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite.



INDICATIONS:


Cydectin Oral Drench for Sheep, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep:


Parasites


Haemonchus contortus - Adult and L4


Cooperia oncophora - Adult and L4


Teladorsagia circumcincta - Adult and L4  


Oesophagostomum columbianum - Adult and L4


Teladorsagia trifurcata - Adult and L4  


Oesophagostomum venulosum -Adult and L4


Trichostrongylus axei - Adult and L4  


Nematodirus battus - Adult and L4


Trichostrongylus colubriformis - Adult and L4  


Nematodirus filicollis - Adult and L4


Trichostrongylus vitrinus - Adult and L4


Nematodirus spathiger - Adult and L4


Cooperia curticei - Adult and L4 



ADMINISTRATION:


Cydectin Oral Drench is ready-to-use. Administer 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of the sheep, using any standard drenching equipment. Check dose rates and equipment before drenching. Do not overdose. Do not mix with any other products before administration. Avoid contaminating the drench solution.



DOSAGE:


The recommended rate of administration for Cydectin Oral Drench for Sheep is 1 mL per 11 lb (5 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of drench in 1.0 mL increments and it must be administered based on the weight of animal being treated.























































Body Weight DoseBody WeightDose
11 lb5 kg1 mL99 lb45 kg9 mL
22 lb10 kg2 mL110 lb50 kg10 mL
33 lb15 kg3 mL121 lb55 kg11 mL
44 lb20 kg4 mL132 lb60 kg12 mL
55 lb25 kg5 mL143 lb65 kg13 mL
66 lb30 kg6 mL154 lb70 kg14 mL
77 lb35 kg7 mL165 lb75 kg15 mL
88 lb40 kg8 mL

HUMAN WARNINGS:


Not for use in humans. Keep this and all drugs out of the reach of children. To obtain a copy of the material safety data sheet (MSDS) which provides more detailed occupational safety information or to report adverse reactions attributable to exposure to this product, call 1-866-638-2226.



RESIDUE WARNINGS:


Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.



ENVIRONMENTAL WARNINGS:


Studies indicate that when moxidectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Free moxidectin may adversely affect fish and certain aquatic organisms. Do not contaminate water by direct application or by improper disposal of drug containers.



ANIMAL SAFETY WARNINGS:


Cydectin Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.



ANIMAL SAFETY:


A well-controlled U.S. study has demonstrated an adequate margin of safety to allow treatment of sheep four months of age and older with Cydectin Oral Drench. In this study no signs of toxicity were seen in sheep given up to 5 times the recommended dose. Reproductive safety studies evaluating the use of Cydectin Oral Drench in breeding ewes and rams have not been conducted in the U.S.



STORAGE:


Store product at or below 77°F (25°C). Protect from light.



DISPOSAL:


Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.



U.S. Patent No. 4,916,154 - used under license.


© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.


Cydectin is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.



Manufactured by:


Boehringer Ingelheim Vetmedica, Inc.


St. Joseph, MO 64506 U.S.A.



Liter - Front Label




Liter - Back Label




Liter - Front Label




Liter - Back label










Cydectin Oral Drench FOR SHEEP 
moxidectin  liquid










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)0010-3840
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MOXIDECTIN (MOXIDECTIN)MOXIDECTIN1 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10010-3840-011000 mL In 1 BOTTLE, PLASTICNone
20010-3840-024000 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14124711/30/2005


Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)
Revised: 11/2010Boehringer Ingelheim Vetmedica, Inc.



Gadoxetic Acid




Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V08CA10

CAS registry number (Chemical Abstracts Service)

0135326-11-3

Chemical Formula

C23-H30-Gd-N3-O11

Molecular Weight

681

Therapeutic Categories

Contrast medium

Diagnostic agent

Chemical Names

Dihydrogen [N-[(2S)-2-]bis(carboxymethyl)amino]-3-(p-ethoxyphenyl)propyl]-N-[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]gadolinate(2-) (WHO)

Dihydrogen [N-{(2S)-2-[bis(carboxymethyl)amino]-3-(4-ethoxyphenyl)propyl}-N-{2-[bis(carboxymethyl)amino]ethyl}glycinato(5-)]gadolinat(2-) (IUPAC)

Gadolinium ethoxybenyldiethylenetriaminepentaacetic acid

Foreign Names

  • Acidum gadoxeticum (Latin)
  • Gadoxetsäure (German)
  • Acide gadoxetique (French)
  • Acido gadoxetico (Spanish)

Generic Names

  • Gd-EOB-DTPA (IS)
  • Gadoxetate Disodium (OS: USAN)
  • Eovist (IS)
  • SHL-569B (IS)
  • ZK-139834 (IS)

Brand Names

  • Eovist
    Bayer, United States


  • Primovist
    Bayer, Austria; Bayer, Switzerland; Bayer, Germany; Bayer, Spain; Bayer, United Kingdom; Bayer, Hungary; Bayer, Italy; Bayer, Latvia; Bayer, Sweden; Bayer Animal Health, Luxembourg; Bayer Schering, Australia; Bayer Schering, Finland; Bayer Schering Pharma, Norway; Schering, Czech Republic; Schering, Estonia; Schering, Lithuania; Schering, Malta; Schering, Poland; Schering, Slovenia


  • Primovist EOB
    Bayer Yakuhin, Japan

International Drug Name Search

Glossary

IUPACInternational Union of Pure and Applied Chemistry
ISInofficial Synonym
OSOfficial Synonym
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name
WHOWorld Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Tuesday, September 27, 2016

Doloket




Doloket may be available in the countries listed below.


Ingredient matches for Doloket



Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Doloket in the following countries:


  • Dominican Republic

International Drug Name Search

Cyanocobalamin (B12) Spray



Pronunciation: SYE-an-oh-koe-BAL-a-min
Generic Name: Cyanocobalamin (B12)
Brand Name: Nascobal


Cyanocobalamin (B12) Spray is used for:

Maintaining normal vitamin B12 blood levels in certain patients with pernicious anemia. It is also used to treat or prevent low blood levels of vitamin B12 that may be caused by other conditions.


Cyanocobalamin (B12) Spray is a form of vitamin B12. It works by replacing vitamin B12 in the body.


Do NOT use Cyanocobalamin (B12) Spray if:


  • you are allergic to any ingredient in Cyanocobalamin (B12) Spray, including cobalt

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



Before using Cyanocobalamin (B12) Spray:


Some medical conditions may interact with Cyanocobalamin (B12) Spray. 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 a runny or stuffy nose, or an upper respiratory tract infection

  • if you have any type of anemia, bone marrow problems, certain eye nerve problems (Leber disease), an infection, a buildup of waste in the blood (uremia), or low blood iron or folic acid levels

  • if you are a vegetarian

  • if you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Cyanocobalamin (B12) Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Chloramphenicol, colchicine, or para-aminosalicylic acid because they may decrease Cyanocobalamin (B12) Spray's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin (B12) Spray 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 Cyanocobalamin (B12) Spray:


Use Cyanocobalamin (B12) Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Cyanocobalamin (B12) Spray. Talk to your pharmacist if you have questions about this information.

  • Cyanocobalamin (B12) Spray is used in the nose.

  • Follow the directions provided by your doctor or other health care provider. If you are unsure how to use Cyanocobalamin (B12) Spray, contact your doctor or other health care provider.

  • Do not use Cyanocobalamin (B12) Spray within 1 hour before or after eating or drinking hot foods or liquids.

  • Prime the pump before the first use. Place the nozzle between the first and second finger with the thumb on the bottom. Point the nozzle away from yourself and others. Pump the unit firmly and quickly until the medicine sprays out, then spray two more times.

  • Re-prime the pump before each dose. Point the nozzle away from yourself and others, then spray once.

  • Use Cyanocobalamin (B12) Spray in only 1 nostril each week.

  • To use Cyanocobalamin (B12) Spray, sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breath gently through the open nostril and spray a dose of medicine from the container. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.

  • Cyanocobalamin (B12) Spray is usually used 1 time per week. Do not use it more often than 1 time per week without checking with your doctor.

  • This bottle contains 8 doses. Do not continue to use this bottle after 8 doses have been used. It may not give the correct amount of medicine.

  • Continue to use Cyanocobalamin (B12) Spray even if you feel well. Do not miss any doses.

  • If you miss a dose of Cyanocobalamin (B12) Spray, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyanocobalamin (B12) Spray.



Important safety information:


  • Heavy alcohol intake for more than 2 weeks may decrease the effectiveness of Cyanocobalamin (B12) Spray. Check with your doctor if you drink alcohol on a regular basis.

  • Do not substitute folic acid for Cyanocobalamin (B12) Spray without first checking with your doctor. Folic acid may prevent anemia but may not prevent other serious effects such as spinal cord problems.

  • Certain medicines, including antibiotics, methotrexate, or pyrimethamine, may interfere with lab tests for vitamin B12 and folic acid. Be sure your doctor and lab personnel know all the medicines that you are taking.

  • Do not take large doses of vitamins while taking Cyanocobalamin (B12) Spray unless your doctor tells you to.

  • Lab tests, including complete blood cell counts; platelet counts; blood potassium; and blood vitamin B12, iron, and folic acid levels, may be performed while you use Cyanocobalamin (B12) Spray. These tests may be used to monitor your condition or check for side effects. They may be performed every 3 to 6 months. Be sure to keep all doctor and lab appointments.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyanocobalamin (B12) Spray, check with your doctor. You will need to discuss the benefits and risks of using Cyanocobalamin (B12) Spray while you are pregnant. Cyanocobalamin (B12) Spray is found in breast milk. If you are or will be breast-feeding while you are using Cyanocobalamin (B12) Spray, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Cyanocobalamin (B12) Spray:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); calf swelling or tenderness; chest pain; irregular heartbeat; muscle weakness or cramping; shortness of breath; swelling of the hands, ankles, or feet; unusual bruising.



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: Cyanocobalamin (B12) 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 Cyanocobalamin (B12) Spray:

Store Cyanocobalamin (B12) Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store upright. Do not freeze. Do not store in the bathroom. Keep Cyanocobalamin (B12) Spray out of the reach of children and away from pets.


General information:


  • If you have any questions about Cyanocobalamin (B12) Spray, please talk with your doctor, pharmacist, or other health care provider.

  • Cyanocobalamin (B12) Spray 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 Cyanocobalamin (B12) Spray. 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.

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Monday, September 26, 2016

Sertralina




Sertralina may be available in the countries listed below.


Ingredient matches for Sertralina



Sertraline

Sertraline is reported as an ingredient of Sertralina in the following countries:


  • Chile

  • Colombia

  • Romania

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralina in the following countries:


  • Chile

  • Peru

  • Venezuela

International Drug Name Search

Carboplatin


Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 41575-94-4
Brands: Paraplatin



  • Use only under the supervision of a qualified clinician experienced in the use of cytotoxic therapy.1 Use only when adequate treatment facilities for appropriate management of therapy and complications are available.1




  • Dose-related bone marrow suppression may result in infection and/or bleeding.1 Anemia may be cumulative and may require transfusion support.1




  • Vomiting is a common adverse effect.1 201




  • Anaphylactic-like reactions may occur within minutes of administration.1 Administer epinephrine, corticosteroids, and/or antihistamines to relieve symptoms.1




Introduction

Antineoplastic agent; platinum-containing compound.1 2 3 4 5 6 92 93


Uses for Carboplatin


Carboplatin and cisplatin appear to have similar efficacy in the treatment of platinum-responsive ovarian tumors,1 5 9 10 11 12 60 137 184 185 lung cancers,18 29 121 137 and certain head and neck cancers;17 137 carboplatin is less effective than cisplatin in certain testicular cancers.24 78 137 193


Because carboplatin and cisplatin have different toxicity profiles,1 2 3 4 5 8 9 10 11 12 68 carboplatin may be effective in patients with platinum-responsive tumors who are unable to tolerate cisplatin because of renal impairment, refractory nausea, hearing impairment, or neuropathy;4 40 137 cisplatin may be preferred in patients with decreased bone marrow reserve or high risk of sepsis or those requiring anticoagulation therapy.10 137


Ovarian Cancer


Treatment of ovarian cancer (alone and as combination therapy).1 9 29


Combination therapy with platinum-containing agent (carboplatin or cisplatin) and paclitaxel is the preferred regimen for initial treatment of advanced epithelial ovarian cancer; therapy with platinum-containing agent and paclitaxel is superior to therapy with platinum-containing agent and cyclophosphamide.9 29 60 137 139 147 Carboplatin is as effective as but less toxic than cisplatin when used in combination with paclitaxel184 185 or cyclophosphamide.10 11


Carboplatin in combination with docetaxel has been used for the first-line treatment of ovarian cancer and has demonstrated similar efficacy and a different tolerability profile (i.e., more hematologic toxicity but less neurotoxicity) compared with carboplatin in combination with paclitaxel.196


Has been used as a single agent in the first-line treatment of advanced ovarian cancer.9 29 Role remains to be established, but some clinicians consider single-agent carboplatin a reasonable option.29 137 187


Used alone as second-line therapy for palliative treatment of recurrent ovarian cancer in patients with platinum-sensitive disease;1 2 9 nonplatinum-based regimens generally preferred for retreatment of patients with platinum-refractory disease.2 9 60 72


Being studied for use in combination regimens for second-line treatment of advanced ovarian epithelial cancer.9 188 189


Has been used alone or in combination therapy for adjuvant treatment of early-stage ovarian cancer.9 179 180 Survival benefit may be limited to patients whose disease is associated with poorer prognosis.137 179


Lung Cancer


Treatment of small cell lung cancer as a component of combination regimens.3 4 18 19 20 29 75 76


An active agent in non-small cell lung cancer.29 121 132 133 137 152 177 178 197 198


Cervical Cancer


Role in the treatment of cervical cancer remains to be established.157 166 Current evidence supports use of cisplatin in chemotherapy regimens given concurrently with radiation therapy in patients with locally advanced cervical cancer; similar benefit from carboplatin-containing chemotherapy cannot be assumed.157 166


An active agent in the treatment of metastatic or recurrent cervical cancer.29 163 164 165 May be considered an alternative to cisplatin, particularly in patients with nephrotoxicity or neurotoxicity caused by advanced cervical tumor who are not candidates for cisplatin therapy.163 164 165


Head and Neck Cancer


May be useful in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.3 4 5 15 16 17 29 41 128 135 200


Wilms’ Tumor


Has shown activity in the management of Wilms’ tumor.29 65


Brain Tumors


Has been used for palliative treatment of various primary brain tumors.3 29


Has shown activity in the treatment of progressive or recurrent low-grade gliomas in children;29 56 57 responses observed in adults with recurrent glioma, including those who had received previous chemotherapy with nitrosoureas.29 170 171


Has shown activity in the treatment of recurrent medulloblastoma.56 130


Combination therapy with platinum-containing agent (cisplatin or carboplatin) and etoposide is used for treatment of intracranial germ cell tumors.29 169 176


Neuroblastoma


Used (as combination therapy) fortreatment of neuroblastoma.26 29


Testicular Cancer


Cisplatin-based regimen (i.e., cisplatin/etoposide or cisplatin/etoposide/bleomycin) is more effective than carboplatin-based regimen (i.e., carboplatin/etoposide or carboplatin/etoposide/bleomycin) for initial treatment of good-prognosis metastatic nonseminomatous germ cell tumor; generally reserve use of carboplatin regimen for patients who do not tolerate or who refuse cisplatin.24 78 137 193


Limited data suggest that high-dose carboplatin and etoposide may be effective in some patients with relapsed or refractory germ cell tumors.23 30 59


Bladder Cancer


Has been substituted as a less toxic alternative to cisplatin in the treatment of advanced bladder cancer in some patients receiving combination chemotherapy.143 146


Combination therapy with paclitaxel followed by carboplatin is being studied in patients with advanced bladder cancer, including those with abnormal renal function.97 131 168 190


Retinoblastoma


Has been used in combination with etoposide in a limited number of children with recurrent or progressive retinoblastoma.102 106


Breast Cancer


Has been used in a limited number of patients with metastatic breast cancer.199


Endometrial Cancer


Being studied in the treatment of advanced or recurrent endometrial cancer.195


Carboplatin Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1




  • Carboplatin is considered a moderate antiemetic risk antineoplastic (i.e., 30–90% incidence of emesis without antiemetics).201 Antiemetic therapy (e.g., a 5-HT3 receptor antagonist and dexamethasone) is recommended to prevent nausea and vomiting.201 (See Emetogenic Effects under Cautions.)




  • Pretreatment and posttreatment hydration and/or diuresis are not necessary.1 10 11 24 27 37 (See Renal Effects under Cautions.)



Administration


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer by IV infusion;1 also has been administered intraperitoneally.2 3 4 32 43 47


Needles, syringes, catheters, and IV administration sets that contain aluminum parts which may come in contact with carboplatin should not be used for preparation or administration.1


Reconstitution

Reconstitute vial containing 50, 150, or 450 mg of carboplatin powder for injection with 5, 15, or 45 mL, respectively, of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection to provide a solution containing 10 mg/mL.b


Resulting solutions can be further diluted to concentrations as low as 0.5 mg/mL with 5% dextrose injection or 0.9% sodium chloride injection.b


Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.b


Dilution

May be diluted with 0.9% sodium chloride injection or 5% dextrose injection to a concentration as low as 0.5 mg/mL.1


Rate of Administration

Administer by IV infusion over a period of ≥15 minutes;1 2 4 10 13 25 27 42 also has been administered by continuous IV infusion over 24 hours.1 2 3


Dosage


Base dosage on the clinical, renal, and hematologic response and tolerance of the patient in order to obtain optimum therapeutic response with minimum adverse effects.1 10 11


Initial dosage can be based on body surface area, but dosage may be more accurately calculated using formula dosing methods based on the patient’s renal function.1 81 82 83 84 85 93 107 108 137 (See Methods for Individualization of Dosage under Dosage and Administration.)


When used as a component of a multiple-drug regimen, consult published protocols for the dosage of each chemotherapeutic agent and the method and sequence of administration.


Adults


Ovarian Cancer

Initial Therapy for Advanced (Stage III and IV) Ovarian Carcinoma

IV

Initially, 300 mg/m2 given in combination with cyclophosphamide.1 10 11 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1


Alternatively, calculate dosage using formula dosing methods (see Methods for Individualization of Dosage).1 81 82 83 84 85 93 107 108 137


A course of carboplatin consists of single doses administered once every 4 weeks (or longer if delayed for hematologic toxicity) for a total of 6 cycles.1 10 11 69 70 71


Secondary Treatment of Advanced Ovarian Cancer

IV

Initially, 360 mg/m2 as monotherapy.1 Administer drug once every 4 weeks (or longer if delayed for hematologic toxicity).1 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1 137


Dosage Adjustment in the Treatment of Ovarian Cancer










Dosage Adjustment Based on Hematologic Response to Previous Dose

Hematologic Toxicity



Recommended Dosage Adjustment



No hematologic toxicity (platelet count >100,000/mm3 and neutrophil count >2000/mm3)



Increase dosage by 25%1 10 11



Mild or moderate hematologic toxicity (platelet count 50,000–100,000/mm3 or neutrophil count 500–2000/mm3)



No adjustment in dosage1 10 11



Moderate to severe hematologic toxicity (platelet count <50,000/mm3 or neutrophil count <500/mm3)



Decrease dosage by 25%1 10 11 137


Other Malignant Neoplasms

IV

Consult published protocols for dosages and methods and sequences of administration. In general, escalation of dosages above 400 mg/m2 results in substantial hematologic toxicity, but high-dose carboplatin (900–2000 mg/m2) has been used with colony-stimulating factors,40 67 121 autologous bone marrow rescue, and/or peripheral stem cell rescue.28 30 37 40 59 111 137


Methods for Individualization of Dosage

Alternative methods for calculating initial carboplatin dosage have been suggested based on the patient’s pretreatment renal function or pretreatment renal function and desired platelet nadir.1 38 81 82 83 84 85 93 107 108


Calvert Formula

Calculation is based on the patient’s GFR (in mL/minute) and the target AUC (in mg/mL per minute).1 81 82 83 93 137 Dosage is calculated in mg, not mg/m2.1





Calvert Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × [GFR (in mL/min) + 25]


A target AUC of 5 (range: 4–6) mg/mL per minute appears to provide the most appropriate dosage range for use of carboplatin alone in patients previously treated with chemotherapeutic agents.1 82 83 93












Actual Toxicity in Previously Treated Patients1828393

AUC (mg/mL x min)



Percentage of Patients with Grade 3 or 4 Thrombocytopenia



Percentage of Patients with Grade 3 or 4 Leukopenia



4–5



16%



13%



6–7



33%



34%


For patients who previously did not receive chemotherapy, a target AUC of 7 (range: 6–8) mg/mL per minute has been recommended when carboplatin is used alone.82 83 93 Higher target AUCs (e.g., 7.5 mg/mL) also have been used (e.g., when carboplatin was used as a component of high-intensity dosing with paclitaxel and a hematopoietic agent for non-small cell lung carcinoma).121 Subsequent carboplatin dosage has been adjusted according to hematologic tolerance to the previous dose (e.g., reducing the dose by 25% for moderate to severe hematologic toxicity).121


Formula is not sufficiently accurate to determine dosage for children or for adults with severe renal impairment (i.e., GFR <20 mL/minute); therefore, do not use this formula in such patients.83 Consult specialized references for an alternative pediatric formula.83 93 119 120


Chatelut (French) Formula

Method does not require determination of GFR.84 85 93 Dosage is calculated in mg, not mg/m2.84 93





Chatelut (French) Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × carboplatin clearance (in mL/min)


When carboplatin clearance is calculated as follows:





Carboplatin Clearance:



Carboplatin clearance (mL/min) = (0.134 × wt) + ([218 × wt × (1 - {0.00457 × age})] × [1 - {0.314 × gender}] / serum creatinine (mcmol/L)) (where weight is in kg, age is in years, and gender is 0 for males and 1 for females)


Do not use this formula for calculating dosage in pediatric patients or those undergoing hemodialysis.84


Special Populations


Renal Impairment


Reduce dosage in patients with Clcr <60 mL/minute.3 5 38









Dosage Recommendations for Patients with Impaired Renal Function

Baseline Clcr



Initial Dose



41–59 mL/min



250 mg/m2



16–40 mL/min



200 mg/m2


Incidence of severe leukopenia, neutropenia, or thrombocytopenia at these adjusted initial dosages is about 25%.1 Adjust subsequent dosage according to the patient’s hematologic tolerance to the previous dose.1 Experience in patients with Clcr <15 mL/minute is too limited to make dosage recommendations.1


Geriatric Patients


Use of dosing formulas incorporating estimates of GFR to determine dosage recommended in geriatric patients.1


Cautions for Carboplatin


Contraindications



  • History of sensitivity reactions to carboplatin or other platinum-containing compounds (e.g., cisplatin).1




  • Severe bone marrow depression or significant bleeding.1



Warnings/Precautions


Warnings


Highly toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity.1 10 11


Hematologic Effects

The major and dose-limiting adverse effects are dose-related hematologic toxicity (thrombocytopenia, leukopenia, neutropenia, and/or anemia).1 2 3 4 5 10 11 27 28 53 56 66 67 79 80 93 121


Myelosuppression appears to be most common and more severe in patients who received prior antineoplastic therapy (especially cisplatin-containing regimens), those concurrently receiving or having recently received other myelosuppressive drugs or radiation therapy, and those with renal impairment.1 3 38 53 66 67 82 83 84 85 93 101 121 137 Patients with poor performance status also appear to be at increased risk for severe leukopenia and thrombocytopenia.1 (See Interactions.)


At usual dosages, thrombocytopenia is more common and pronounced than leukopenia.53 82 93 Thrombocytopenia may be cumulative and occasionally require transfusions.121 Potential for infection.1 10 11


Anemia may be severe or symptomatic (e.g., accompanied by asthenia).1 10 11 Incidence appears to be cumulative.1 93 121 Transfusions may be required, particularly in patients receiving prolonged (>6 cycles) therapy.1 121 137


Monitor hematologic status carefully; perform peripheral blood counts at frequent intervals.1 121


Do not administer to patients with severe bone marrow depression or substantial bleeding.1 In patients who experience myelosuppression, withhold subsequent cycles until neutrophil counts are >2000/mm3 and platelet counts are >100,000/mm3.1


Treatment of severe hematologic toxicity may consist of supportive care, anti-infective agents for complicating infections, blood product transfusions, autologous bone marrow rescue, peripheral stem cell transplantation, and hematopoietic agents (colony-stimulating factors).1 30 40 93 121 137


Emetogenic Effects

Carboplatin is classified as an antineoplastic agent of moderate emetic risk (i.e., 30–90% incidence of emesis without antiemetics).201 Acute vomiting episodes are most common in patients who received prior emetogenic antineoplastic regimens (especially cisplatin-containing regimens) and in those receiving other emetogenic agents concurrently.1 201


Possible reduction in the incidence of nausea and vomiting when given as a 24-hour continuous IV infusion or IV in divided doses over 5 consecutive days rather than as a single IV infusion; however, efficacy of these schedules not established.1


Pretreatment with antiemetics may reduce incidence and severity of emesis; rarely, nausea and vomiting may be refractory to antiemetic therapy.1 3 93 103 136 201 For prevention of acute emesis, ASCO recommends a 2-drug antiemetic regimen consisting of a type 3 serotonin (5-HT3) receptor antagonist and dexamethasone given before carboplatin.201


For the prevention of delayed emesis following administration of carboplatin, ASCO recommends single-agent therapy with dexamethasone or a 5-HT3 receptor antagonist.201


Optimal use of antiemetics for prevention of acute and delayed emesis during early courses of therapy is the most important means for preventing anticipatory vomiting; behavioral modification, hypnosis, and drug therapy (e.g., benzodiazepine with or without conventional antiemetics) also may be useful.136 201


Peripheral Neuropathies

Possible peripheral neuropathies, generally sensory (e.g., paresthesia).1 10 11 93 Increased incidence in patients >65 years of age,1 those receiving prolonged therapy, and/or those who have received prior cisplatin therapy.1 93 121


Preexisting cisplatin-induced peripheral neurotoxicity generally does not worsen during carboplatin therapy.1


Otic Effects

Possible ototoxicity in patients receiving usual dosages of carboplatin in conjunction with cyclophosphamide.1


Concomitant use of ototoxic drugs (e.g., aminoglycosides, furosemide, ifosfamide) may increase risk.93 111 (See Interactions.)


Ocular Effects

Loss of vision (sometimes complete for light and colors) reported in patients receiving higher than usually recommended dosages; improvement and/or total recovery of vision has occurred within weeks following drug discontinuance.1 31


Hepatic Effects

Possible substantial abnormalities in liver function test results in patients receiving high doses (>4 times usual recommended dose) and autologous bone marrow transplantation.1


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1


Embryotoxic and teratogenic in rats.1


Sensitivity Reactions


Hypersensitivity Reactions

Prior exposure to other platinum-containing agents increases the risk for carboplatin-induced allergic reactions, including anaphylaxis.1


Exposure (e.g., industrial) to platinum-containing compounds can cause asthma and immediate and delayed hypersensitivity reactions;33 36 93 consider the possibility that patients with a history of such exposure may be cross-sensitive to carboplatin.36


Observe closely for possible hypersensitivity reactions.1 61 Appropriate equipment for maintenance of an adequate airway and other supportive measures and agents for the treatment of such reactions (e.g., antihistamines, epinephrine, oxygen, corticosteroids) should be readily available when carboplatin is administered.1 61


General Precautions


Mutagenicity and Carcinogenicity

Mutagenic in vitro and in vivo.1


Carcinogenic potential not fully studied; however, drugs with similar mechanisms of action and evidence of mutagenic effects have been reported to be carcinogenic.1 Secondary malignancies reported in patients receiving carboplatin in combination with other agents.1


Renal Effects

Nephrotoxicity is less common and severe than that associated with cisplatin; concomitant IV hydration and diuresis generally not necessary.1 10 11 24 27 37 92 93 However, consider the possibility that nephrotoxicity may be potentiated by other nephrotoxic drugs.1 (See Interactions.)


Specific Populations


Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Lactation

Not known whether carboplatin or its platinum-containing products are distributed into milk.1 Discontinue nursing during therapy.1


Pediatric Use

Safety and efficacy not established.1


Limited experience in the treatment of germ cell tumors in adolescents ≥16 years of age,24 various brain tumors or neuroblastoma in children 6 months to 19 years of age,26 27 28 56 62 and Wilms’ tumor in children 2–15 years of age.66 79 80


Adverse effects reported to date in children are similar to those reported in adults and include hematologic toxicity (principally thrombocytopenia),27 28 56 66 79 80 adverse GI effects (e.g., nausea, vomiting),27 28 56 66 hypersensitivity reactions (e.g., urticaria, facial swelling, abdominal pain, coryza, cough),62 and hearing loss (particularly at higher than recommended doses in combination with other ototoxic agents).1


Geriatric Use

In clinical trials evaluating carboplatin as combination therapy for ovarian cancer, age was not found to be a factor for survival in patients ≥65 years of age relative to younger adults.1


Possible increased incidence of severe thrombocytopenia and carboplatin-induced peripheral neuropathy in adults ≥65 years of age compared with younger patients.1


Consider increased incidence of decreased renal function in geriatric population (see Geriatric Patients under Dosage and Administration).137


Renal Impairment

Increased risk of severe bone marrow depression in patients with renal impairment; monitor renal function carefully.1 40 82 83 84 85 93 Clcr appears to most accurately reflect kidney function in patients receiving carboplatin.1 40 82 83 84 85 93


Reduce dosage in patients with renal impairment.3 5 38 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Thrombocytopenia,1 neutropenia,1 leukopenia,1 anemia,1 nausea,1 201 vomiting,1 201 electrolyte abnormalities (hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia),1 alkaline phosphatase elevations.1


Interactions for Carboplatin


Ototoxic Drugs


Hearing loss reported in children receiving carboplatin at higher than recommended doses in combination with other ototoxic drugs.1


Nephrotoxic Drugs


Possible potentiation of renal effects.1


Emetogenic Drugs


Concomitant use with emetogenic drugs or use in individuals who previously received emetogenic therapy is associated with an increased incidence of emesis.1 201


Specific Drugs and Therapies


















Drug or Therapy



Interaction



Comments



Aminoglycosides



Increased risk of nephrotoxicity and/or ototoxicity1



Use with caution1



Antineoplastic agents



Prior antineoplastic therapy may increase risk of bone marrow suppression1



Myelosuppressive agents



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137



Radiation therapy



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137


Carboplatin Pharmacokinetics


Complex pharmacokinetics involve the parent compound as well as total platinum (protein-bound and nonprotein-bound platinum) and ultrafilterable platinum (carboplatin and nonprotein-bound carboplatin metabolites).1 2 3 4 43 44


Absorption


Bioavailability


Following IV infusion, peak plasma concentrations of carboplatin, total platinum, and ultrafilterable platinum occur immediately.3 42 44 46


Following intraperitoneal administration, peak plasma concentrations of total platinum, free platinum, and carboplatin are attained within 2–4 hours following instillation.3 4 43 47


Distribution


Extent


Widely distributed into body tissues and fluids, with highest concentrations in the kidney, liver, skin, and tumor tissue;3 43 44 lower concentrations found in fat and brain.3 43 Also distributed into erythrocytes.43 44


Not known whether carboplatin or its platinum-containing products cross the placenta or are distributed into milk.1


Plasma Protein Binding


Carboplatin is not bound to plasma proteins, but degrades to platinum-containing products which rapidly bind to protein.45 49


<24% of platinum is bound to plasma proteins during the first 4 hours after IV administration of carboplatin; within 24 hours, 87% is protein bound.46


Elimination


Metabolism


Metabolic fate has not been completely elucidated.1 3 4 5 6 7 43 No evidence to date that the drug undergoes enzymatic biotransformation; the bidentate dicarboxylate ligands of carboplatin are believed to be displaced by water, forming positively charged platinum complexes that react with nucleophilic sites on DNA.1 3 4 5 6 7 43


Elimination Route


Carboplatin and its platinum-containing product(s) are excreted principally in urine (predominantly via glomerular filtration).1 3 4 43 44


Carboplatin (as ultrafilterable carboplatin) is removed extensively by hemodialysis.54 86


Half-life


Plasma elimination half-lives (t½β) for carboplatin and ultrafilterable platinum: 2–3 hours.1 43 44


Terminal elimination half-life (t½γ) for total platinum: 4–6 days.43 44


Special Populations


In patients with impaired renal function, renal clearance and total body clearance of platinum are reduced.3 4 38 54 In patients undergoing hemodialysis, t½β values for total and ultrafilterable platinum are increased compared with values in individuals with normal renal function.43 54


Stability


Storage


Parenteral


Injection Concentrate

25°C (may be exposed to 15–30°C).1 Protect from light.1


Discard unused solution 14 days after initial entry into vial.1


Discard diluted solutions 8 hours after preparation.1


Powder for Injection

20–25°C; protect from light.b


Reconstituted solutions are stable for 8 hours at room temperature (25°C).b Reconstituted solutions contain no preservatives; discard after 8 hours.b


Compatibility


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


Parenteral


Solution Compatibilitya







Compatible



Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%



Dextrose 5% in water



Sodium chloride 0.9%



Incompatible



Sodium bica