Saturday, 6 October 2012

Thiamine Hydrochloride



Class: Vitamin B Complex
VA Class: VT105
Chemical Name: thiazolium,3- [(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-chloride, monochloride
CAS Number: 67-03-8

Introduction

Water-soluble, B complex vitamin.a


Uses for Thiamine Hydrochloride


Thiamine Deficiency


Treatment of thiamine deficiency syndromes (e.g., beriberi, Wernicke’s encephalopathy syndrome). b


Dietary Requirements


Adequate intake needed to prevent thiamine deficiency (beriberi).109


Adequate thiamine intake can be accomplished through consumption of foodstuffs.109 Enriched, fortified, or whole grain products; bread and bread products; mixed foods with grain as a main ingredient; and ready-to-eat cereals are the major contributors of thiamine in the diet of US adults and children.109


Recommended Dietary Allowance (RDA) in adults based on erythrocyte transketolase activity, urinary thiamine excretion, and other findings.109


Requirements slightly lower in women than men based on women's size and average energy utilization.109


Adequate intake (AI) established for infants ≤6 months of age based on observed mean thiamine intake of infants fed principally human milk; AI for infants 7–12 months of age based on AI for younger infants and data in adults.109


RDA for children 1–18 years of age based on data in adults.109


Metabolic Disorder


Has been used in thiamine-responsive maple syrup urine disease† and subacute necrotizing encephalomyelopathy† (Leigh's disease).a


Thiamine Hydrochloride Dosage and Administration


Administration


Usually administered orally.a May be administered by IV or IM injection when indicated or when oral administration is not feasible.b


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


Dosage


Available as thiamine hydrochloride; dosage expressed in terms of the salt.a b


Pediatric Patients


Thiamine Deficiency

Oral

Noncritically ill children: 10–50 mg daily, given in divided doses.a


IM or IV

Critically ill children (e.g., infantile beriberi): 10–25 mg.a b


Dietary and Replacement Requirements

Oral

Infants ≤6 months of age: Recommended AI is 0.2 mg (0.03 mg/kg) daily.109


Infants 7–12 months of age: Recommended AI is 0.3 mg (0.03 mg/kg) daily.109


Children 1–3 years of age: RDA is 0.5 mg daily.109


Children 4–8 years of age: RDA is 0.6 mg daily.109


Children 9–13 years of age: RDA is 0.9 mg daily.109


Boys 14–18 years of age: RDA is 1.2 mg daily.109


Girls 14–18 years of age: RDA is 1 mg daily.109


RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.109


Adults


Thiamine Deficiency

Oral

Noncritically ill adults: 5–30 mg daily, as a single dose or 3 divided doses, for 1 month.a


IV followed by IM

Wernicke's syndrome: Initially 100 mg IV, followed by 50–100 mg IM daily until patient can consume a balanced diet.b


IV or IM

Critically ill thiamine-deficient adult or patient with malabsorption syndrome: 5–100 mg 3 times daily.a


IM

Beriberi: 10–20 mg 3 times daily for up to 2 weeks.b


Dietary and Replacement Requirements

Oral

Men ≥19 years of age: RDA is 1.2 mg daily.109


Women ≥19 years of age: RDA is 1.1 mg daily.109


RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.109


Prescribing Limits


Single doses >30 mg not likely to be utilized.a


Special Populations


Pregnant Women


RDA for pregnant women is 1.4 mg daily.109


Thiamine intake >1.4 mg daily needed by women who are pregnant with >1 fetus.109


Requirements increased in pregnant women to cover increased energy utilization and growth in the maternal and fetal compartments.109


Lactating Women


RDA for lactating women is 1.5 mg daily.109


Thiamine intake >1.5 mg daily needed by women who are nursing >1 infant.109


Requirements increased in lactating women to ensure adequate concentration of the vitamin in milk.109


Cautions for Thiamine Hydrochloride


Contraindications


Known sensitivity to thiamine or any ingredient in formulation.a b


Warnings/Precautions


Sensitivity Reactions


Hypersensitivity Reactions

Possible severe hypersensitivity reactions/anaphylaxis, especially following repeated parenteral administration.b


Skin Test

Administer an intradermal test dose prior to parenteral administration of therapeutic doses of thiamine in patients who may be sensitive to the drug.b


General Precautions


Aluminum Content

Some thiamine hydrochloride injection preparations contain aluminum, which may be toxic.b Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.b Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.b


Research indicates that patients with impaired kidney function, including premature neonates, who receive aluminum parenterally in quantities of >4–5 mcg/kg daily accumulate aluminum at levels associated with CNS and bone toxicity.b Tissue loading may occur at even lower rates of administration.b


Specific Populations


Pregnancy

Category A.b


Lactation

Distributed into milk.a Caution if parenteral preparation is used in nursing women.b


Common Adverse Effects


Relatively nontoxic; feelings of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, angioedema, tightness in the throat, cyanosis, pulmonary edema, GI bleeding reported with parenteral administration.a b


Interactions for Thiamine Hydrochloride


Specific Drugs and Laboratory Tests


















Drug



Interaction



Comments



Neuromuscular blocking agents



Possible enhanced neuromuscular blocking actiona



Clinical importance unknowna



Schack and Waxler determination of serum theophylline concentrations



Large doses of thiamine may interfere with this testa



Test for uric acid



Possible false-positive result with the phosphotungstate methoda



Test for urobilinogen using Ehrlich's reagent



Possible false-positive resulta


Thiamine Hydrochloride Pharmacokinetics


Absorption


Bioavailability


Small doses are readily absorbed from the GI tract.a


Completely absorbed following IM administration.b


Food


Rate, but not extent, of GI absorption is decreased when administered with meals.a


Distribution


Extent


Distributed into all tissues; highest concentrations in liver, brain, kidney, and heart.b


Elimination


Elimination Route


Excreted in urine as unchanged drug and metabolites.a


Stability


Storage


Oral


Tablets

Tight, light-resistant container at <40°C; preferably between 15–30°C.a


Parenteral


Injection

20–25°C.b Protect from light.b


Compatibility


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


Parenteral


Solution CompatibilityHID



















Compatible



Dextran 6% in dextrose 5%



Dextran 6% in sodium chloride 0.9%



Dextrose–Ringer's injection combinations



Dextrose-Ringer’s injection, lactated, combinations



Dextrose-saline combinations



Dextrose 2½, 5, or 10% in water



Fat emulsion 10%, IV



Fructose 10% in sodium chloride 0.9%



Fructose 10% in water



Invert sugar 5 and 10% in sodium chloride 0.9%



Invert sugar 5 and 10% in water



Ionosol products



Ringer's injection



Ringer's injection, lactated



Sodium chloride 0.45 or 0.9%



Sodium lactate (1/6) M


Drug Compatibility




Y-Site CompatibilityHID

Compatible



Famotidine


ActionsActions



  • An exogenous source of thiamine is required for carbohydrate metabolism. a




  • Functions as a coenzyme in the metabolism of carbohydrates and branched-chain amino acids.109



Advice to Patients



  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a




  • Importance of proper dietary habits, including taking appropriate AI or RDA of thiamine.109




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information.a (See Cautions.)



Preparations


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


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











































Thiamine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder*



Oral



Tablets



25 mg*



50 mg*



100 mg*



250 mg*



500 mg*



Parenteral



Injection



100 mg/mL*


Thiamine salts are also commercially available for oral use in combination with other vitamins, minerals, amino acids, protein supplements, and infant formulas. For IV infusion, thiamine hydrochloride is commercially available in combination with other vitamins in caloric and electrolyte solutions.a



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



100. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1985; 50:25170-1.



101. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1982; 47:424-7.



102. Food and Drug Administration and American Society for Parenteral and Enteral Nutrition. Deaths associated with thiamine-deficient total parenteral nutrition. MMWR Morb Mortal Wkly Rep. 1989; 38:43-6. [IDIS 250221] [PubMed 2492074]



103. Velez RJ, Myers B, Guber MS. Severe acute metabolic acidosis (acute beriberi): an avoidable complication of total parenteral nutrition. J Parenter Enteral Nutr. 1985; 9:216-9.



104. Mattioli S, Miglioli M, Montagna P et al. Wernicke’s encephalopathy during total parenteral nutrition: observation in one case. J Parenter Enteral Nutr. 1988; 12:626-7.



105. Reuler JB, Girard DE, Cooney TG. Wernicke’s encephalopathy. N Engl J Med. 1985; 312:1035-8. [IDIS 198729] [PubMed 3885034]



106. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:125-32.



107. Lactic acidosis traced to thiamine deficiency related to nationwide shortage of multivitamins for total parenteral nutrition–United States, 1997. MMWR. 1997; 46:523-8. (Also published in JAMA. 1997; 278:109-11.)



108. American Society for Parenteral and Enteral Nutrition (ASPEN). Multivitamin shortage–Update #17: fatality reported. Press release. 1997 Jul 21.



109. Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)



110. American Psychiatric Association. Practice guidelines for the treatment of patients with delirium. Am J Psychiatry. 1999; 156(Suppl 5):1-20.



a. AHFS drug information 2007. McEvoy GK, ed. Thiamine. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 3626-7.



b. Abraxis Pharmaceuticals. Thiamine injection prescribing information. Schaumburg, IL; 2005 Jun.



HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1538-40.



More Thiamine Hydrochloride resources


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


  • thiamine Concise Consumer Information (Cerner Multum)

  • thiamine Oral, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

  • Thiamine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Thiamine Hydrochloride with other medications


  • Beriberi
  • Vitamin B1 Deficiency
  • Vitamin/Mineral Supplementation and Deficiency
  • Wernicke's Encephalopathy

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Wednesday, 3 October 2012

propafenone



proe-PA-fen-one hye-droe-KLOR-ide


Oral route(Tablet;Capsule, Extended Release)

It is prudent to consider any Class 1C antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs .



Commonly used brand name(s)

In the U.S.


  • Rythmol

  • Rythmol SR

Available Dosage Forms:


  • Capsule, Extended Release

  • Tablet

Therapeutic Class: Antiarrhythmic, Group IC


Chemical Class: Propafenone


Uses For propafenone


Propafenone is used to prevent irregular heartbeats such as atrial fibrillation (AF) from occurring again in patients who do not have structural heart disease.


Propafenone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.


There is a chance that propafenone may cause new or make worse existing heart rhythm problems when it is used. Since it has been shown to cause severe problems in some patients, propafenone is only used to treat serious heart rhythm problems. Discuss this possible effect with your doctor.


propafenone is available only with your doctor's prescription.


Before Using propafenone


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 propafenone, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to propafenone 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 have not been performed on the relationship of age to the effects of propafenone in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propafenone in the elderly.


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 propafenone, 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 propafenone 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.


  • Bepridil

  • Cisapride

  • Dronedarone

  • Levomethadyl

  • Mesoridazine

  • Pimozide

  • Posaconazole

  • Ritonavir

  • Saquinavir

  • Sparfloxacin

  • Terfenadine

  • Thioridazine

  • Tipranavir

  • Ziprasidone

Using propafenone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acecainide

  • Ajmaline

  • Alfuzosin

  • Amiodarone

  • Amisulpride

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Aprindine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Azimilide

  • Azithromycin

  • Boceprevir

  • Bretylium

  • Chloral Hydrate

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Crizotinib

  • Darunavir

  • Dasatinib

  • Delavirdine

  • Desipramine

  • Dibenzepin

  • Digoxin

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Duloxetine

  • Eltrombopag

  • Enflurane

  • Erythromycin

  • Etravirine

  • Flecainide

  • Fluconazole

  • Fluoxetine

  • Foscarnet

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Halothane

  • Hydroquinidine

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Isoflurane

  • Isradipine

  • Lapatinib

  • Levofloxacin

  • Lidocaine

  • Lidoflazine

  • Lopinavir

  • Lorcainide

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Moxifloxacin

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Pentamidine

  • Perflutren Lipid Microsphere

  • Pirmenol

  • Prajmaline

  • Prilocaine

  • Probucol

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Risperidone

  • Salmeterol

  • Sematilide

  • Sertindole

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Spiramycin

  • Sulfamethoxazole

  • Sultopride

  • Sunitinib

  • Tedisamil

  • Telaprevir

  • Telithromycin

  • Tetrabenazine

  • Tizanidine

  • Toremifene

  • Trazodone

  • Trifluoperazine

  • Trimethoprim

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vasopressin

  • Vemurafenib

  • Voriconazole

  • Zolmitriptan

  • Zotepine

Using propafenone 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.


  • Bupropion

  • Clozapine

  • Cyclosporine

  • Metoprolol

  • Paroxetine

  • Rifampin

  • Rifapentine

  • Sertraline

  • Theophylline

  • Tolterodine

  • Warfarin

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 propafenone. Make sure you tell your doctor if you have any other medical problems, especially:


  • Asthma or

  • Bronchitis or

  • Emphysema—Propafenone can increase trouble in breathing.

  • AV block (type of abnormal heart rhythm), with no pacemaker or

  • Bradycardia (slow heartbeat) or

  • Breathing problems or lung disease (e.g., bronchospasm, severe obstructive pulmonary disease) or

  • Cardiogenic shock (shock caused by heart attack) or

  • Heart failure or

  • Hypotension (low blood pressure) or

  • Mineral imbalance or

  • Sick sinus node syndrome (type of abnormal heart rhythm) with no pacemaker—Should not be used in patients with these conditions.

  • Blood or bone marrow problems (e.g., agranulocytosis, granulocytopenia) or

  • Coronary artery disease or

  • Heart rhythm problems (e.g., QT prolongation) or

  • Myasthenia gravis (severe muscle weakness) or

  • Torsade de pointes or

  • Ventricular fibrillation or tachycardia—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • If you have a permanent pacemaker—Use with caution. Propafenone may interfere with the pacemaker and require more careful follow-up by the doctor.

Proper Use of propafenone


Take propafenone exactly as directed by your doctor. Do not take more or less of propafenone, and do not take it more often than your doctor ordered.


For patients taking the extended-release capsules:


  • Swallow the capsules whole. Do not crush, break, or chew them.

  • propafenone may be taken with or without food.

propafenone works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at evenly spaced times day and night. For example, if you are to take 3 doses a day, doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.


Your doctor may want you to carry a medical identification card or bracelet stating that you are using propafenone.


Dosing


The dose of propafenone 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 propafenone. 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.


  • The number of extended-release capsules or tablets that you take depends on the strength of the medicine.

  • For atrial fibrillation (AF):
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 225 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed. However, the dose is usually not more than 425 mg every 12 hours.

      • Children—Use and dose must be determined by your doctor.


    • For oral dosage forms (tablets):
      • Adults—150 milligrams (mg) every 8 hours. Your doctor may increase your dose if needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of propafenone, 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 propafenone


It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow for changes to be made in the amount of medicine you are taking, if necessary.


propafenone can cause changes in your heart rhythm, such as conditions called PR, QRS, or QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if your symptoms do not improve or if they get worse.


Check with your doctor right away if you develop any of the following: chest pain; shortness of breath; swelling of your hands, ankles, or feet; or weight gain. These may be symptoms of heart failure.


propafenone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


Make sure any doctor or dentist who treats you knows that you are using propafenone. propafenone may affect the results of certain medical tests.


Propafenone may cause some people to become dizzy or lightheaded. Make sure you know how you react to propafenone before you drive, use machines, or do anything else that could be dangerous if you are dizzy.


If you have been using propafenone regularly for several weeks, do not suddenly stop using it. Check with your doctor for the best way to gradually reduce the amount you are taking before stopping completely.


propafenone may decrease the amount of sperm men make. Talk to your doctor if you have concerns about this.


Grapefruits and grapefruit juice may increase the effects of propafenone by increasing the amount of propafenone in your body. You should not eat grapefruit or drink grapefruit juice while you taking propafenone.


Tell your doctor if you are smoking tobacco.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


propafenone 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:


Less common
  • Chest pain

  • fast, irregular, or slow heartbeat

  • lightheadedness, dizziness, or fainting

  • shortness of breath

  • swelling of the feet or lower legs

  • weight gain

Rare
  • Chills

  • fever

  • joint pain

  • trembling or shaking

  • weakness

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
  • Change in taste or bitter or metallic taste

Less common
  • Blurred vision

  • constipation

  • diarrhea

  • dryness of the mouth

  • headache

  • nausea or vomiting

  • skin rash

  • unusual tiredness or weakness

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: propafenone side effects (in more detail)



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More propafenone resources


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


  • propafenone Concise Consumer Information (Cerner Multum)

  • Propafenone Prescribing Information (FDA)

  • Propafenone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Propafenone Professional Patient Advice (Wolters Kluwer)

  • Propafenone Hydrochloride Monograph (AHFS DI)

  • Rythmol Prescribing Information (FDA)

  • Rythmol SR Prescribing Information (FDA)

  • Rythmol SR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare propafenone with other medications


  • Atrial Fibrillation
  • Atrial Flutter
  • Ventricular Tachycardia
  • Wolff-Parkinson-White Syndrome

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Monday, 1 October 2012

atovaquone and proguanil


Generic Name: atovaquone and proguanil (a TOE va kwone and pro GWAHN il)

Brand Names: Malarone, Malarone Pediatric


What is atovaquone and proguanil?

Atovaquone and proguanil are medications to treat malaria, a disease caused by parasites. These medicines work by interfering with the growth of parasites in the red blood cells of the human body.


Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.


The combination of atovaquone and proguanil is used to treat or prevent malaria.


Atovaquone and proguanil may also be used for purposes not listed in this medication guide.


What is the most important information I should know about atovaquone and proguanil?


You should not use this medication if you are allergic to atovaquone or proguanil. You should not use this medication to prevent malaria if you have severe kidney disease.

Before using this medication, tell your doctor if you have liver or kidney disease, severe complications from infection with malaria, or uncontrolled vomiting or diarrhea.


Take atovaquone and proguanil at the same time each day with food or a milky drink. If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for at least 7 days after you leave. If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.


If you are taking this medicine to treat malaria, take the medication every day for 3 days in a row.


Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

In addition to taking atovaquone and proguanil, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.


Contact your doctor as soon as possible if you have been exposed to malaria, or if you have a fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.


What should I discuss with my healthcare provider before taking atovaquone and proguanil?


You should not use this medication if you are allergic to atovaquone or proguanil. You should not use this medication to prevent malaria if you have severe kidney disease.

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



  • kidney disease;




  • liver disease;




  • severe complications from malaria; or




  • uncontrolled vomiting or diarrhea.




FDA pregnancy category C. It is not known whether atovaquone and proguanil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common. Atovaquone and proguanil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Atovaquone and proguanil should not be used to treat malaria in a child who weighs less than 11 pounds, and should not be used to prevent malaria in a child who weighs less than 24 pounds.

How should I take atovaquone and proguanil?


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


Use atovaquone and proguanil regularly to best prevent malaria. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.


Take atovaquone and proguanil at the same time each day with food or a milky drink. If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria:



  • Start taking the medicine 1 or 2 days before entering an area where malaria is common. Continue taking the medicine every day during your stay and for at least 7 days after you leave the area.




  • If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.



If you are taking this medicine to treat malaria:



  • Take the medicine every day for 3 days in a row.




  • Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.



In addition to taking atovaquone and proguanil, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.


To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.


Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.


Store at room temperature away from moisture and heat.

See also: Atovaquone and proguanil dosage (in more detail)

What happens if I miss a dose?


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


What happens if I overdose?


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

Overdose symptoms may include stomach discomfort, vomiting, mouth sores, hair loss, easy bruising or bleeding, and peeling of the skin on your hands or feet.


What should I avoid while taking atovaquone and proguanil?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Atovaquone and proguanil side effects


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

  • severe or uncontrolled vomiting or diarrhea;




  • fever, mouth sores;




  • problems with speech, balance, or walking;




  • severe skin rash;




  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); o




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.



Less serious side effects may include:



  • mild stomach pain or upset stomach;




  • mild diarrhea;




  • headache;




  • mild itching;




  • weakness; or




  • dizziness.



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


Atovaquone and proguanil Dosing Information


Usual Adult Dose for Malaria:

1 g atovaquone/400 mg proguanil (four adult strength tablets as a single dose) orally once a day for 3 consecutive days

Usual Adult Dose for Malaria Prophylaxis:

Prophylactic therapy should start 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.

250 mg atovaquone/100 mg proguanil (one adult strength tablet) orally once a day

Usual Pediatric Dose for Malaria:

Less than 5 kg ABW (actual body weight): Safety and efficacy has not been established.

5 to 8 kg ABW: 125 mg atovaquone/50 mg proguanil (2 pediatric tablets) once daily for 3 consecutive days.

9 to 10 kg ABW: 187.5 mg atovaquone/75 mg proguanil (3 pediatric tablets) once daily for 3 consecutive days.

11 to 20 kg ABW: 250 mg atovaquone/100 mg proguanil (one adult strength or four pediatric tablets as a single dose) orally once a day for 3 consecutive days

21 to 30 kg ABW: 500 mg atovaquone/200 mg proguanil (two adult strength tablets as a single dose) orally once a day for 3 consecutive days

31 to 40 kg ABW: 750 mg atovaquone/300 mg proguanil (three adult strength tablets as a single dose) orally once a day for 3 consecutive days

Greater than 40 kg ABW: 1 g atovaquone/400 mg proguanil (four adult strength tablets as a single dose) orally once a day for 3 consecutive days

Usual Pediatric Dose for Malaria Prophylaxis:

Prophylactic treatment should start 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.

11 to 20 kg ABW (actual body weight): 62.5 mg atovaquone/25 mg proguanil (one pediatric tablet) orally once a day

21 to 30 kg ABW: 125 mg atovaquone/50 mg proguanil (two pediatric tablets as a single dose) orally once a day

31 to 40 kg ABW: 187.5 mg atovaquone/75 mg proguanil (three pediatric tablets as a single dose) orally once a day

Greater than 40 kg ABW: 250 mg atovaquone/100 mg proguanil (one adult strength tablet) orally once a day


What other drugs will affect atovaquone and proguanil?


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



  • a blood thinner such as warfarin (Coumadin);




  • rifabutin (Mycobutin);




  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);




  • tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or




  • metoclopramide (Reglan).



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



More atovaquone and proguanil resources


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


Compare atovaquone and proguanil with other medications


  • Malaria
  • Malaria Prevention


Where can I get more information?


  • Your pharmacist can provide more information about atovaquone and proguanil.

See also: atovaquone and proguanil side effects (in more detail)


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