RE OB 90 Plus DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are RE OB 90 Plus DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

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

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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 if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. 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 RE OB 90 Plus DHA resources

• RE OB 90 Plus DHA Use in Pregnancy & Breastfeeding
• RE OB 90 Plus DHA Drug Interactions
• 0 Reviews for RE OB 90 Plus DHA - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare RE OB 90 Plus DHA with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

RE Benzotic Otic Drops

benzocaine

Dosage Form: otic liquid
RE Benzotic Otic Drops

INGREDIENTS:

ACTIVE INGREDIENT:

Benzocaine.....................20% in an aqueous base.

INACTIVE INGREDIENTS:

Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water.

DESCRIPTION:

Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C9H11NO2, with a molecular weight of 165.19.

CLINICAL PHARMACOLOGY:

Benzocaine acts by blocking conduction in nerve fibers as a result of decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites.

INDICATIONS AND USAGE:

RE Benzotic Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used in the treatment of acute otitis media, acute swimmer’s ear and other forms of otitis externa.

CONTRAINDICATIONS:

RE Benzotic Otic Drops is contraindicated in patients sensitive to benzocaine. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge.

WARNINGS:

KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE.

Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear.

PRECAUTIONS:

General: Medication should be discontinued if sensitivity or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women.

Pediatric Use: Do not use in infants under 1 year of age.

ADVERSE REACTIONS:

Benzocaine can cause a hypersensitvity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis which can be treated by intravenous methylene blue.

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

OVERDOSAGE:

Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Treatment is symptomatic. Please call your local Poison Control Center or your doctor if you suspect an overdosage of this product.

DOSAGE AND ADMINISTRATION:

Administer 4-5 drops of RE Benzotic Otic Drops in the external ear canal and then insert a cotton pledget into the meatus. Can be repeated every 1 to 2 hours, if necessary.

STORAGE:

Store at 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Store in a tight, light-resistant container. [See USP.] Keep bottle tightly closed.

HOW SUPPLIED:

RE Benzotic Otic Drops are supplied as a pale yellow liquid in a 15 mL vial, NDC 68032-378-15, and include a wrapped dropper.

PACKAGING:

RE BENZOTIC  benzocaine  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-378 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   POLYETHYLENE GLYCOL   BENZETHONIUM CHLORIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-378-15 15 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2009	08/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC

More RE Benzotic Otic Drops resources

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

Compare RE Benzotic Otic Drops with other medications

• Acute Otitis Externa
• Ear Conditions
• Otitis Externa

Reclast

Pronunciation: ZOE-le-DRON-ik AS-id
Generic Name: Zoledronic Acid
Brand Name: Reclast

Reclast is used for:

Treating and preventing osteoporosis (weak bones) in women who are past menopause. It is also used to help build bone in men with osteoporosis. It is also used to treat and prevent osteoporosis in certain patients treated with corticosteroids (eg, prednisone). It may also be used to treat Paget disease or for other conditions as determined by your doctor.

Reclast is a bisphosphonate. It works by decreasing the breakdown of bone. This reduces the amount of calcium that is released into the blood from bones and helps to lower your blood calcium level.

Do NOT use Reclast if:

• you are allergic to any ingredient in Reclast or to any other bisphosphonate (eg, alendronate)


• you have severe kidney problems or recent worsening of kidney function


• you have low blood calcium levels


• you are using another medicine that contains zoledronic acid

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

Before using Reclast:

Some medical conditions may interact with Reclast. 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 able to become pregnant


• 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 had asthma or other breathing problems from taking aspirin


• if you have a history of kidney problems, low blood calcium levels, blood clotting problems, anemia, or bone infection


• if you have a history of thyroid or parathyroid problems or if you have had thyroid or parathyroid surgery


• if you have poor nutrition, nutrient absorption problems (eg, malabsorption syndrome), have had sections of your intestines removed, or are unable to take calcium or vitamin D supplements


• if you have low blood volume, recent vomiting or diarrhea, decreased appetite, or if you are dehydrated


• if you have cancer or have had or will be receiving radiation or chemotherapy


• if you have poor dental hygiene or other dental problems, or have planned dental surgery (eg, tooth extraction)

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

• Aminoglycoside antibiotics (eg, gentamicin) or diuretics (eg, furosemide) because the risk of low blood calcium levels or kidney problems may be increased


• Corticosteroids (eg, prednisone) because the risk of jawbone problems may be increased


• Medicines that may harm the kidney (eg, amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) or thalidomide because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

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

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

• Reclast comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Reclast refilled.


• Reclast is usually given as an injection at your doctor's office, hospital, or clinic.


• Drink at least 2 full glasses (16 oz/480 mL) of fluid (eg, water) within a few hours before you receive Reclast, as directed by your doctor.


• Do not use Reclast if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of Reclast, contact your doctor right away.

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

Important safety information:

• Reclast may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Reclast with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about taking a calcium and vitamin D supplement while you use Reclast.


• Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.


• It is important to avoid becoming dehydrated while you are using Reclast. Check with your doctor for instructions.


• Certain fractures of the thigh bone (femur) have been reported in patients using bisphosphonates. It is unknown if bisphosphonates contributed to the fractures. Contact your doctor right away if you experience hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.


• You may develop flu-like symptoms, mild fever, muscle or joint aches, or headache after you receive Reclast. If this occurs, a mild pain reliever (eg, acetaminophen) may help to relieve these symptoms.


• Reclast may cause jawbone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infections). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use Reclast. Ask your doctor any questions you may have about dental treatment while you use Reclast.


• Proper dental care is important while you are using Reclast. Brush and floss your teeth and visit the dentist regularly.


• Certain dental procedures should be avoided if possible while you are using Reclast. Check with your doctor and dentist before having any dental treatments while using Reclast.


• Lab tests, including kidney function, complete blood cell counts, and blood electrolyte levels (eg, calcium, magnesium, phosphate), may be performed while you use Reclast. These tests may be used to monitor your condition or check for side effects. Your doctor may also want to evaluate you periodically while you use Reclast to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.


• Use Reclast with caution in the ELDERLY, especially those with kidney problems; they may be more sensitive its effects.


• Reclast should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Reclast if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if Reclast is found in breast milk. Do not breast-feed while you are using Reclast.

Possible side effects of Reclast:

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

Diarrhea; dizziness; headache; mild back, joint, or muscle pain; mild flu-like symptoms (eg, mild fever, muscle aches); mild itching, pain, or redness at the injection site; nausea; stomach pain or upset; tiredness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; eye pain, redness, or swelling; fever, chills, or persistent sore throat; irregular heartbeat; jaw pain or swelling; mental or mood changes (eg, depression); muscle cramps or spasms; numbness or tingling (especially around the mouth); severe bone, joint, or muscle pain (especially in the hip, groin, or thigh); severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet.

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: Reclast side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; irregular heartbeat; mental or mood changes; muscle cramps; numbness or tingling (especially around the mouth).

Proper storage of Reclast:

Reclast is usually handled and stored by a health care provider. If you are using Reclast at home, store Reclast as directed by your pharmacist or health care provider. Keep Reclast out of the reach of children and away from pets.

General information:

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


• Reclast 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 Reclast. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Reclast resources

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

• Reclast Prescribing Information (FDA)


• Reclast Advanced Consumer (Micromedex) - Includes Dosage Information


• Reclast Consumer Overview


• Zoledronic Acid Professional Patient Advice (Wolters Kluwer)


• Zoledronic Acid Monograph (AHFS DI)


• Aclasta Consumer Overview


• Zometa Prescribing Information (FDA)


• Zometa Consumer Overview

Compare Reclast with other medications

• Hypercalcemia of Malignancy
• Osteolytic Bone Lesions of Multiple Myeloma
• Osteolytic Bone Metastases of Solid Tumors
• Osteoporosis
• Paget's Disease
• Prevention of Osteoporosis

Rythmol SR Sustained-Release Capsules

Pronunciation: proe-PA-fen-one
Generic Name: Propafenone
Brand Name: Rythmol SR

Rythmol SR Sustained-Release Capsules has not been shown to improve the rate of survival in patients with an abnormal heart rhythm. For this reason, Rythmol SR Sustained-Release Capsules should only be used for certain life-threatening abnormal heart rhythms. Talk with your doctor about the risks and benefits of using Rythmol SR Sustained-Release Capsules.

Rythmol SR Sustained-Release Capsules are used for:

Helping to maintain a normal heart rhythm in certain patients who have atrial fibrillation.

Rythmol SR Sustained-Release Capsules are a class 1C antiarrhythmic medicine. It works in the heart to stabilize its action and regulate heartbeat.

Do NOT use Rythmol SR Sustained-Release Capsules if:

• you are allergic to any ingredient in Rythmol SR Sustained-Release Capsules


• you have congestive heart failure, shock caused by severe heart problems, slow heartbeat, very low blood pressure, abnormal electrolyte levels, or certain breathing problems that make you short of breath or wheeze


• you have certain types of irregular heartbeat (eg, sick sinus syndrome, heart block) and you do not have a permanent pacemaker


• you are taking another antiarrhythmic (eg, amiodarone, quinidine), cisapride, halofantrine, an HIV protease inhibitor (eg, ritonavir), a ketolide (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), nilotinib, pimozide, a quinolone antibiotic (eg, ciprofloxacin), tetrabenazine, toremifene, vandetanib, or ziprasidone

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

Before using Rythmol SR Sustained-Release Capsules:

Some medical conditions may interact with Rythmol SR Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have kidney or liver problems, lung or breathing problems, lupus, or myasthenia gravis (muscle weakness)


• if you have a certain abnormal blood test (antinuclear antibody [ANA] test)


• if you use an artificial pacemaker or if you smoke tobacco


• if you have low blood pressure or a history of an irregular heartbeat (eg, widening of the QRS complex, atrioventricular [AV] block, ventricular tachycardia or fibrillation), a heart attack, or other heart problems (eg, coronary artery disease)

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

• Antiarrhythmics (eg, amiodarone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, domperidone, droperidol, halofantrine, haloperidol, iloperidone, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, nilotinib, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, serotonin receptor antagonist antiemetics (eg, dolasetron), tacrolimus, terfenadine, tetrabenazine, tricyclic antidepressants (eg, desipramine, imipramine), tyrosine kinase receptor inhibitors (eg, dasatinib), vandetanib, or ziprasidone because the risk of serious side effects, such as abnormal heart rhythms, may be increased


• Abiraterone, azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir, saquinavir), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine, sertraline), or serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine) because they may increase the risk of Rythmol SR Sustained-Release Capsules's side effects


• Orlistat or rifamycins (eg, rifampin) because they may decrease Rythmol SR Sustained-Release Capsules's effectiveness


• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), digoxin, or lidocaine because the risk of their side effects may be increased by Rythmol SR Sustained-Release Capsules

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

How to use Rythmol SR Sustained-Release Capsules:

Use Rythmol SR Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Rythmol SR Sustained-Release Capsules. Talk to your pharmacist if you have questions about this information.


• Take Rythmol SR Sustained-Release Capsules by mouth with or without food.


• Swallow Rythmol SR Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.


• Take each dose at the same time with respect to meals.


• Take Rythmol SR Sustained-Release Capsules on a regular schedule to get the most benefit from it. Do not miss any doses.


• Do not eat grapefruit or drink grapefruit juice while you use Rythmol SR Sustained-Release Capsules.


• If you miss a dose of Rythmol SR Sustained-Release Capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rythmol SR Sustained-Release Capsules.

Important safety information:

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


• Rythmol SR Sustained-Release Capsules may affect how artificial pacemakers work. Pacemakers should be monitored and programmed accordingly during therapy.


• If severe or persistent vomiting, sweating, loss of appetite or thirst, or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Rythmol SR Sustained-Release Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Tell your doctor or dentist that you take Rythmol SR Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Rythmol SR Sustained-Release Capsules may decrease sperm counts in men. This could affect the ability to father a child. Discuss any questions or concerns with your doctor.


• Rythmol SR Sustained-Release Capsules may interfere with certain lab tests, including ANA titers. Be sure your doctor and lab personnel know you are taking Rythmol SR Sustained-Release Capsules.


• Lab tests, including electrocardiographic tests, white blood cell counts, and electrolyte levels, may be performed while you use Rythmol SR Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Rythmol SR Sustained-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Rythmol SR Sustained-Release Capsules:

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

Change in taste; constipation; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; light-headedness; nausea; tiredness.

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); black, tarry stools; blood in the urine; burning, numbness, or tingling; change in the amount of urine produced or painful urination; chest pain; confusion; fainting; fast or slow heartbeat; fever, chills, or sore throat; hearing problems; mental or mood problems (eg, anxiety, depression); muscle weakness; new or worsened irregular heartbeat; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness of the calf or legs; ringing in the ears; severe or persistent dizziness, tiredness, or weakness; severe stomach or back pain; shortness of breath; slurred speech; sudden, severe headache; sudden weight gain; swelling of the hands or feet; tremor; trouble sleeping; unusual bruising or bleeding; vomiting; vision problems (eg, blurred vision); wheezing.

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: Rythmol SR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular or slow heartbeat; seizures; severe dizziness or drowsiness.

Proper storage of Rythmol SR Sustained-Release Capsules:

Store Rythmol SR Sustained-Release Capsules at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rythmol SR Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Rythmol SR Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Rythmol SR Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Rythmol SR resources

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

Compare Rythmol SR with other medications

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

Rythmol

Generic Name: Propafenone Hydrochloride
Class: Class Ic Antiarrhythmics
VA Class: CV300
Chemical Name: 1-Propanone,1-[2-[2-hydroxy-3-(propylamino)propoxy]phenyl]-3- phenylpropan-1-one hydrochloride
Molecular Formula: C₂₁H₂₇NO₃
CAS Number: 34183-22-7

Introduction

Local anesthetic-type class IC antiarrhythmic agent.^{3 10 38 134 289 310}

Uses for Rythmol

Paroxysmal Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachyarrhythmias

Used (as conventional [immediate-release] tablets) to prolong the time to recurrence of symptomatic, disabling paroxysmal supraventricular tachycardia (PSVT) (e.g., AV nodal reentrant tachycardia or AV reentrant tachycardia [Wolff-Parkinson-White syndrome, WPW syndrome]) and symptomatic, disabling paroxysmal atrial fibrillation/flutter (PAF) in patients without structural heart disease.^{1 3 67 68 90 91 92 93 94 99 101 102 105 107 108 109 110 132 133 173 187 206 211}

Comparably effective to quinidine, disopyramide, flecainide, procainamide, sotalol in preventing recurrences of PAF and maintaining sinus rhythm following successful cardioversion of atrial fibrillation.^{3 68 89 129 133 183 200 201 202 204 205}

Used (as extended-release capsules) to prolong the time to recurrence of symptomatic PAF in patients without structural heart disease.²⁸⁹

Safety and efficacy of extended-release capsules not established in patients with exclusively PSVT or atrial flutter.²⁸⁹

Safety and efficacy not established in patients with chronic atrial fibrillation.^{1 289} Generally, do not use to control ventricular rate in patients with atrial fibrillation, but conventional (immediate-release) tablets may be useful in controlling ventricular response rate in patients with stable but rapid atrial fibrillation/flutter and ventricular preexcitation via an accessory pathway (e.g., WPW syndrome).^{269 272 288}

Treatment of PSVT (using IV† propafenone [IV dosage form not commercially available in the US]) in patients with preserved ventricular function refractory to vagal maneuvers, IV adenosine (the drug of choice), AV nodal blocking agents (e.g., calcium-channel blocking agents), and electrical cardioversion therapy or in whom such therapy is not feasible or desirable.²⁸⁸

Conversion of Atrial Fibrillation to Normal Sinus Rhythm

Used (as conventional [immediate-release] tablets and IV†) in the conversion of recent-onset (≤48 hours duration)³¹⁰ atrial fibrillation (e.g., after open-heart surgery) to normal sinus rhythm†; some consider propafenone first-line therapy.^{15 68 88 89 90 101 103 104 109 110 111 195 196 197 198 199 207 208 211 272}

Self-administration for Conversion of PAF

Used for out-of-hospital self-administration (“pill-in-the-pocket” approach) as a single oral loading dose† (conventional (immediate-release) tablets) to terminate recent-onset PAF†; may result in reduced hospitalizations and emergency room visits of patients with mild or no heart disease.^{158 160 211 272 290 294 309}

Ventricular Arrhythmias

As conventional (immediate-release) tablets, suppresses and prevents recurrence of documented life-threatening ventricular arrhythmias (e.g., sustained VT, VF).^{1 3} (See Mortality under Cautions.)

Rythmol Dosage and Administration

General

• 
  

  Individualize dosage according to individual requirements, response, tolerance, general condition, and cardiovascular status.^{1 2 3 9 15 28 47 68}

  
  


• 
  

  Initiate therapy (conventional [immediate-release] tablets) for life-threatening ventricular arrhythmias in a hospital.^{1 273}

  
  


• 
  

  Clinical and ECG evaluation (e.g., Holter monitoring) is recommended during propafenone therapy.^{1 3 289}

  
  

Administration

Administer orally.

Has been administered IV†.^{3 17 31 76 88 89 90 95 96 97 98 100 102 104 106 110 119 122 133 183}

Oral Administration

Administer conventional (immediate-release) tablets in a consistent manner relative to food intake.^{6 9 128 256 272 273}

Administer conventional (immediate-release) tablets in 3 equally divided doses daily at 8-hour intervals.¹

Administer extended-release capsules in equally divided doses every 12 hours without regard to meals.²⁸⁹

Swallow extended-release capsules whole; do not crush.²⁸⁹

Avoid grapefruit juice.^{272 273} (See Drugs, Foods, and Herbal Supplements under Interactions.)

Dosage

Adjust dosage carefully according to individual requirements and response, patient tolerance, and the general condition and cardiovascular status of the patient.^{1 2 3 9 15 28 47 68 289}

Consider dosage reduction in patients who develop excessive prolongation of the PR interval, excessive QRS widening, or second- or third-degree AV block.^{1 2 3 15 90}

Usually do not use oral loading doses (conventional [immediate-release] tablets) since acute toxicity may occur.^{3 6 272 273} However, oral loading doses (e.g., 450–750 mg as conventional [immediate-release] tablets) have been used with apparent safety for conversion of recent-onset atrial fibrillation to normal sinus rhythm† in individuals without heart failure.^{68 89 90 101 109 160 195 196 208 272}

Pediatric Patients

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage 600 mg/m².²⁷²

Adults

Paroxysmal Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachyarrhythmias

Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.^{1 2 68}

Increase dosage after 3–4 days to 225 mg 3 times daily (every 8 hours) if necessary.^{1 68 90}

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily (every 8 hours).^{1 68 90}

Oral (extended-release capsules)

Initially, 225 mg every 12 hours.²⁸⁹

Increase dosage after ≥5 days to 325 mg every 12 hours if necessary.²⁸⁹

If desired therapeutic response is not attained after an additional 5 days, increase dosage to 425 mg every 12 hours.²⁸⁹

If a dose is missed, only administer the next scheduled dose; do not double next dose.²⁸⁹

When switching from conventional (immediate-release) tablets to extended-release capsules, the dosage conversion ratio is not a 1:1 substitution (e.g., a patient who currently is receiving 150 mg every 8 hours of conventional (immediate-release) tablets may be switched to 325 mg of extended-release capsules every 12 hours).^{289 308}

Conversion of Atrial Fibrillation to Normal Sinus Rhythm†

Oral (conventional [immediate-release] tablets)

150–600 mg, as a single dose.^{158 211}

IV†

2 mg/kg (over 10 minutes) as a single dose.^{158 211}

Self-administration for Conversion of PAF†

Oral (conventional [immediate-release] tablets)

Adults weighing 70 kg or more: May use a single oral loading dose of 600 mg 5 minutes after noting the onset of palpitations.^{290 309}

Adults weighing < 70 kg: May use a single oral loading dose of 450 mg 5 minutes after noting the onset of palpitations.^{290 309}

Do not take more than a single oral dose during a 24-hour period.²⁹⁰

Ventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.^{1 2 68}

Increase dosage after 3–4 days to 225 mg 3 times daily if necessary.^{1 68 90}

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily.^{1 68 90}

Prescribing Limits

Pediatric Patients

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 600 mg/m².²⁷²

Adults

Supraventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.^{1 9 90 272 273}

Life-threatening Ventricular Arrhythmias

Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.^{1 9 90 272 273}

Special Populations

Hepatic Impairment

When conventional (immediate-release) tablets are used, reduce dosage by approximately 70–80%; monitor patients for signs of toxicity, including hypotension, somnolence, bradycardia, conduction disturbances, seizures, and/or ventricular arrhythmias.^{1 115 193}

Geriatric Patients and Those with Myocardial Damage

During initiation of therapy (conventional [immediate-release] tablets), gradual dosage escalation should be performed in geriatric patients and those with marked previous myocardial ischemia.^{1 3}

Cautions for Rythmol

Contraindications

• 
  

  Patients with uncontrolled CHF (conventional [immediate-release] tablets),¹ CHF (extended-release capsules).²⁸⁹

  
  


• 
  

  Cardiogenic shock.^{1 3 289}

  
  


• 
  

  Sinoatrial, AV, or intraventricular disorders of impulse generation and/or conduction (e.g., sick sinus node syndrome, AV block) unless an artificial pacemaker is present.^{1 3 6 234 289}

  
  


• 
  

  Bradycardia.^{1 3 289}

  
  


• 
  

  Severe hypotension.^{1 3 289}

  
  


• 
  

  Bronchospastic disorders.^{1 289}

  
  


• 
  

  Marked electrolyte imbalance.^{1 3 289}

  
  


• 
  

  Known hypersensitivity to propafenone.^{1 289}

  
  

Warnings/Precautions

Warnings

Mortality

In CAST study, excessive rate of mortality and nonfatal cardiac arrest reported in patients with asymptomatic or mildly symptomatic non-life-threatening ventricular arrhythmias and recent MI (>6 days but <2 years previously) who were receiving encainide or flecainide compared with placebo.^{1 116 117 149 155 234 235 289} The applicability of these results to other populations (e.g., those without recent MI) or to other antiarrhythmic drugs is uncertain.^{1 6 48 62 118 168 234 235}

Limit use of propafenone or other class I agents in patients with ventricular arrhythmias to those with life-threatening arrhythmias;^{1 116 117} use in patients with less severe ventricular arrhythmias, even when symptomatic, is not recommended.¹

Arrhythmogenic and Cardiac Conduction Effects

Potential for new and/or more severe arrhythmias,^{1 2 3 4 6 9 15 16 17 18 47 58 67 68 75 113 116 168 230 232 233 234 235} especially in those with CHF (NYHA class III or IV]) or myocardial ischemia.²⁸⁹

Risk of clinically important conduction disturbances;^{1 6 75 136 151 310} degree of lengthening of PR and QRS intervals may increase progressively with increasing dosage and plasma propafenone concentrations.^{1 2 47 233 289 1 2 6 9 47 68 168 233 289}

Reduce dosage or discontinue the drug if 2nd- or 3rd-degree AV block occurs.¹ (See Contraindications under Cautions.)

Evaluate clinical status and ECG prior to and during propafenone therapy to monitor for appearance of arrhythmias and to determine the need for continued therapy.^{1 2 168}

Monitor patients with permanent artificial pacemakers and, if necessary, reprogram pacemakers.^{1 2 3 225 229 289}

Cardiovascular Effects

Potential for new or worsened CHF, particularly in patients with preexisting heart failure or ejection fraction <30%.^{1 2 3 4 9 13 17 47 68 75 117 289}

Use with caution (conventional [immediate-release] tablets) in patients with a history of CHF or myocardial dysfunction.^{1 117 168 235 236}

Discontinue therapy if CHF worsens (unless caused by the cardiac arrhythmia); fully compensate CHF before therapy is reinitiated.¹

Hematologic Effects

Possible reversible granulocytopenia^{3 47} and agranulocytosis.^{1 47}

Carefully evaluate patients in whom unexplained fever and/or decreased WBC counts occur (especially during the initial 3 months of therapy).^{1 289} WBC counts generally return to normal within 2 weeks following discontinuance.^{1 289}

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines; use generally not recommended in patients with asthma/bronchospastic disease or nonallergic bronchospastic disease (e.g., chronic bronchitis, emphysema).^{1 3 15 40 67 68 173 215 289} (See Contraindications under Cautions.)

General Precautions

Hepatic Impairment

Extensively metabolized in liver; use with caution in those with hepatic impairment.^{1 3 8 11 15 33 68 178 289}

Renal Impairment

Several metabolites excreted by kidneys; use with caution in those with renal impairment.^{1 13 289}

Antinuclear Antibodies.

Possible positive antinuclear antibody (ANA) titers.^{1 289}

Monitor carefully patients who develop an abnormal ANA test following initiation of therapy; consider discontinuation of therapy if titers remain elevated or increase further.^{1 289}

Impaired Spermatogenesis

Transient, reversible decreases (within normal range) in sperm count may occur.^{1 289}

Myasthenia Gravis

Possible exacerbation of myasthenia gravis.^{1 52 289} Avoid use in patients with this condition.³

Specific Populations

Pregnancy

Category C.^{1 289}

Lactation

Distributed into milk.^{3 289} Caution if used in nursing women.²⁸⁹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 273 289}

Has been used successfully and without unusual adverse effects in a limited number of infants and children† for the management of various refractory supraventricular (e.g., PSVT, junctional ectopic tachycardia, atrial fibrillation or flutter) and ventricular (e.g., VPCs, VT) arrhythmias.^{3 68 146 212 213 214 216 217 218 220 272} However, adenosine is the drug of choice for treatment of supraventricular tachycardia in children.^{288 310}

Geriatric Use

Conventional (immediate-release) tablets: Insufficient experience to determine whether geriatric patients ≥65 years of age respond differently than younger adults.¹ Select dosage with caution; start at the lower end of dosing range due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.¹

Extended-release capsules: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.²⁸⁹

Hepatic Impairment

Extensively metabolized in liver; use with caution.^{1 3 8 11 15 33 68 178 289} Careful monitoring for excessive pharmacological effects recommended.¹ Reduce dosage.^{1 3 8 11 15 33 68 178 289} (See Special Populations under Dosage and Administration.)

Renal Impairment

Use with caution.¹ Careful monitoring for excessive pharmacological effects recommended.¹

Common Adverse Effects

Conventional (immediate-release) tablets: Unusual taste, nausea and/or vomiting, dizziness, constipation, headache, fatigue, blurred vision, and weakness.¹ First-degree AV block and intraventricular conduction delay in patients with ventricular arrhythmia.¹

Extended-release capsules: Constipation, diarrhea, dry mouth, nausea, vomiting, unusual taste, fatigue, weakness, dizziness, headache, somnolence, anxiety, dyspnea, ecchymosis, upper respiratory infection, abnormalities in liver function tests (e.g., increased serum concentrations of alkaline phosphatase), hematuria.²⁸⁹

Interactions for Rythmol

Metabolized by CYP2D6 and to a lesser extent by CYP1A2, CYP3A4.^{1 131 190 285 286 289}

Inhibits CYP2D6.^{1 289}

Drugs and Foods Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP2D6, CYP1A2, or CYP3A4 with possible alteration in metabolism of propafenone and/or other drugs.^{1 131 190 285 286 289} Monitor patients.¹

Drugs Metabolized by p-Glycoprotein Transporter

Effect of propafenone on the p-glycoprotein transport system not evaluated.^{1 289}

Drugs Affecting QT Interval

Do not use with drugs that prolong the QT interval.²⁸⁹

Antiarrhythmic Agents

Use extreme caution when propafenone is administered with 1 or more antiarrhythmic agents.^{3 68 288}

Reserve concomitant use for management of life-threatening arrhythmias unresponsive to monotherapy with propafenone (immediate-release tablets) or another antiarrhythmic agent.^{3 68 288}

Do not use propafenone (extended-release capsules) with class Ia or III antiarrhythmic agents.²⁸⁹

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Amiodarone	Possible increased incidence of cardiovascular effects1 13 287 288 289 Increased propafenone concentrations1 289	Concomitant use not recommended 1 289
β-adrenergic blocking agents (e.g., metoprolol, propranolol)	Increased β-adrenergic blocking agent concentrations and terminal elimination half-life1 246 247 289	Use concomitantly with caution; consider β-adrenergic blocking agent dosage reduction1 6 9 13 247 289
Calcium channel-blocking agents	No evidence of clinically important adverse interactions1 289
Cimetidine	Increased propafenone steady-state plasma concentrations1 289
Cyclosporine	Increased cyclosporine concentrations1 250 289
Desipramine	Increased propafenone concentrations1 289 Increased desipramine serum concentrations1	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289 Consider desipramine dosage reduction1
Digoxin	Increased serum or plasma digoxin concentrations1 3 9 85 124 125 245 279 280 281 282 283 289	Carefully monitor serum digoxin concentrations and adjust digoxin dosage 1 3 9 85 124 125 245 283 289
Diuretics	No evidence of clinically important adverse interactions1 289
Erythromycin	Increased propafenone concentrations1 289 1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Fluoxetine	In extensive-metabolizer phenotypes, increased peak plasma concentrations and AUC of propafenone1 289
Grapefruit juice	Possible increased plasma concentrations of unchanged propafenone and potential adverse effects1 257 258 259 260 261 262 289	Avoid concomitant use272 273
Haloperidol	Increased haloperidol concentrations1 289	Use concomitantly with caution; consider haloperidol dosage reduction1 289
Imipramine	Increased imipramine concentrations1 289	Use concomitantly with caution; consider imipramine dosage reduction1 289
Ketoconazole	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Lidocaine	Possible pharmacologic interaction (additive or antagonistic cardiac effects and additive toxicity) 1 2 9 13 122 289
Orlistat	Possible limited absorption of propafenone1 289 Possibility of severe adverse effects with abrupt discontinuance of orlistat1 289
Paroxetine	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Phenobarbital	Decreased plasma propafenone concentrations3
Quinidine	Increased plasma propafenone concentrations1 3 123 289 Possible increased incidence of cardiovascular effects288	Concomitant use not recommended 1 289
Rifampin	Increased metabolism of propafenone resulting in decreased plasma propafenone concentrations and antiarrhythmic activity1
Ritonavir	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Saquinavir	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Sertraline	Increased propafenone concentrations1 131 190 285 286 289	Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289
Theophylline	Increased serum theophylline concentrations and toxicity1 289
Venlafaxine	Increased venlafaxine concentrations1 289	Use concomitantly with caution; consider venlafaxine dosage reduction1 289
Warfarin	Increased plasma warfarin concentrations and corresponding PTs1 3 6 9 13 15 248 289	Monitor PTs or INRs;275 adjust warfarin dosage 1 3 9 13 248 289

Rythmol Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration of conventional (immediate-release) tablets.^{1 3 15 17 33 40 67 68 133 136}

Absolute bioavailability of conventional (immediate-release) tablets is 5–50%.^{33 174 180}

Bioavailability of 325-mg extended-release capsules (given twice daily) similar to 150-mg conventional (immediate-release) tablets (given 3 times daily).²⁸⁹

Food

Food does not appear to affect bioavailability of conventional (immediate-release) tablets or extended-release capsules during multiple-dose administration.^{2 289}

Special Populations

In patients with marked hepatic impairment, bioavailability of conventional (immediate-release) tablets is about 60–70%.^{1 2 178 289}

Distribution

Extent

Rapidly distributed into lung, liver, and heart tissue.^{3 4 15}

Propafenone crosses the placenta and is distributed into milk.^{3 64 72}

Plasma or Serum Protein Binding

81–97% (mainly α₁ acid glycoprotein).^{3 138 187 188 289}

Special Populations

In patients with severe hepatic dysfunction, approximately 88% of propafenone is bound to plasma proteins.²⁸⁹

Elimination

Metabolism

Extensively metabolized by first-pass metabolism (hydroxylation) in the liver,^{1 33 132 133 136} via CYP2D6 to an active metabolite (5-hydroxypropafenone [5-OHP])^{1 131 190 289} and dealkylation via CYP1A2 and CYP3A4 to another active metabolite (N-depropylpropafenone [NDPP]).^{1 131 289}

Elimination Route

Eliminated principally in feces via biliary excretion as metabolites and in urine or feces as unchanged drug (<1%).^{2 3 4 33 67 68 136}

Half-life

Immediate-release tablets: Averages 1–3 hours (range: 2–10 hours).^{1 2 4 6 7 10 11 12 14 15 16 28 33 37 39 67 68 71 129 133 138 181 187}

Special Populations

In patients with poor metabolizer phenotypes (approximately 5–10% of Caucasians), propafenone is metabolized principally via CYP3A4 and CYP1A2;^{1 131} CYP2D6 is subject to genetic polymorphism.^{1 131 190}

Extensive metabolizers convert propafenone rapidly into 5-OHPand NDPP,^{1 15}