sotalol Intravenous

SOE-ta-lol

Intravenous route(Solution)

To minimize the risk of induced arrhythmia, patients initiated or reinitiated on sotalol should be placed in a facility that can provide continuous cardiac monitoring. Do not initiate sotalol therapy if the baseline QTc is longer than 450 msec. If the QT interval prolongs to 500 msec or greater, reduce dose, reduce rate of infusion, or discontinue drug. Adjust dosing interval based on creatinine clearance .

Available Dosage Forms:

• Solution

Therapeutic Class: Antiarrhythmic, Group III

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For sotalol

Sotalol injection is used to control rapid heartbeats and abnormal heart rhythms that are serious or life-threatening. The injection may also be used when patients are not able to take the oral form.

Sotalol is a beta-blocker and antiarrhythmic. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and at a regular rhythm.

sotalol is available only with your doctor's prescription.

Before Using sotalol

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 sotalol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sotalol 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 sotalol injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of sotalol injection in elderly patients. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving sotalol injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 receiving sotalol, 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 sotalol 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


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

Using sotalol 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


• Acetazolamide


• Albuterol


• Amiloride


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Apomorphine


• Aprindine


• Arformoterol


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Azosemide


• Bambuterol


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bitolterol


• Bretylium


• Broxaterol


• Bumetanide


• Canrenoate


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Chlorthalidone


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clenbuterol


• Clomipramine


• Clonidine


• Clopamide


• Clozapine


• Colterol


• Crizotinib


• Cyclothiazide


• Dasatinib


• Desipramine


• Dibenzepin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Dronedarone


• Droperidol


• Enflurane


• Epinephrine


• Erythromycin


• Ethacrynic Acid


• Etozolin


• Fenoldopam


• Fenoterol


• Fenquizone


• Fingolimod


• Flecainide


• Fluconazole


• Fluoxetine


• Formoterol


• Foscarnet


• Furosemide


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hexoprenaline


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibutilide


• Iloperidone


• Imipramine


• Indacaterol


• Indapamide


• Isoetharine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lapatinib


• Levalbuterol


• Levofloxacin


• Lidocaine


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mannitol


• Mefloquine


• Metaproterenol


• Methadone


• Metolazone


• Moricizine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirbuterol


• Piretanide


• Polythiazide


• Posaconazole


• Prilocaine


• Probucol


• Procainamide


• Procaterol


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinethazone


• Quinidine


• Quinine


• Ranolazine


• Reproterol


• Rimiterol


• Risperidone


• Ritodrine


• Salmeterol


• Saquinavir


• Sematilide


• Sertindole


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Spironolactone


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terbutaline


• Tetrabenazine


• Ticrynafen


• Toremifene


• Torsemide


• Trazodone


• Tretoquinol


• Triamterene


• Trichlormethiazide


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Tulobuterol


• Vandetanib


• Vardenafil


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Xipamide


• Zolmitriptan


• Zotepine

Using sotalol 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.

• Abarelix


• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Carprofen


• Chlorpropamide


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dipyrone


• Doxazosin


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Methyldopa


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Repaglinide


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Zomepirac

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

• Angina (severe chest pain) or


• Heart attack, recent or


• Heart disease or


• Heart failure, history of or


• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Asthma or


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


• Bradycardia (slow heartbeat) or


• Breathing problems or


• Cardiogenic shock or


• Heart failure, uncontrolled or


• Heart rhythm problems (e.g., congenital long QT interval) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Kidney disease, severe or


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

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)—Use with caution. May cover up some of the symptoms of these diseases, such as a fast heartbeat.

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

Proper Use of sotalol

A nurse or other trained health professional will give you sotalol in a hospital. sotalol is given through a needle placed in one of your veins.

Tell your doctor or nurse right away if you develop pain or swelling at the site where the needle is placed.

Your doctor will give you a few doses of sotalol until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using sotalol

It is very important that your doctor check your progress while you are receiving sotalol to make sure the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using sotalol, or when the dose is increased. Getting up slowly may help.

Sotalol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.

sotalol may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving sotalol.

sotalol may cause changes in your blood sugar levels. Also, sotalol may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

sotalol 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 or nurse immediately if any of the following side effects occur:

More common

• Blurred vision


• chest pain or discomfort


• confusion


• difficult or labored breathing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fast, irregular, pounding, or racing heartbeat or pulse


• increased sweating


• shortness of breath


• slow or irregular heartbeat


• sweating


• swelling


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Less common

• Arm, back, or jaw pain


• body aches or pain


• chest tightness or heaviness


• chills


• cold hands and feet


• cough


• decreased urine output


• diarrhea


• difficulty with breathing


• difficulty with speaking


• dilated neck veins


• dizziness


• double vision


• ear congestion


• extreme fatigue


• fainting


• fever


• general feeling of discomfort or illness


• headache


• inability to move the arms, legs, or facial muscles


• inability to speak


• irregular breathing


• joint pain


• loss of appetite


• loss of voice


• muscle aches and pains


• nasal congestion


• nausea


• nervousness


• noisy breathing


• pounding in the ears


• runny nose


• shivering


• slow speech


• sneezing


• sore throat


• swelling of the face, fingers, feet, or lower legs


• trouble sleeping


• troubled breathing


• vomiting


• weight gain

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• blue lips and fingernails


• coughing that sometimes produces a pink frothy sputum


• difficult, fast, or noisy breathing, sometimes with wheezing


• increased sweating


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• swelling in the legs and ankles


• swollen glands


• unusual bleeding or bruising

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

• Acid or sour stomach


• belching


• heartburn


• indigestion


• lack or loss of strength


• sleeplessness


• stomach discomfort, upset, or pain


• unable to sleep

Less common

• Abdominal or stomach distension


• abnormal ejaculation


• back pain


• bloated feeling


• blurred or loss of vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• decreased appetite


• decreased sexual performance or desire


• depression


• disturbed color perception


• double vision


• excess air or gas in the stomach or intestines


• full feeling


• halos around lights


• mood changes


• muscle or bone pain


• night blindness


• overbright appearance of lights


• passing gas


• rash


• tunnel vision

Incidence not known

• Crying


• depersonalization


• difficulty with moving


• dysphoria


• euphoria


• feeling of constant movement of self or surroundings


• hair loss


• increased sensitivity of the skin to sunlight


• itching skin


• lack of coordination


• mental depression


• muscle aching or cramping


• muscle pains or stiffness


• pain, itching, burning, swelling, or a lump under your skin where the needle is placed


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of the skin


• sensation of spinning


• severe sunburn


• swollen joints


• thinning of the hair

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: sotalol Intravenous side effects (in more detail)

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

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

More sotalol Intravenous resources

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

Compare sotalol Intravenous with other medications

• Atrial Fibrillation
• Atrial Flutter
• Ventricular Arrhythmia

Allfen

Generic Name: guaifenesin (Oral route)

gwye-FEN-e-sin

Commonly used brand name(s)

In the U.S.

• Allfen


• Altarussin


• Amibid LA


• Antitussin


• Bidex 400


• Diabetic Siltussin DAS-Na


• Diabetic Tussin EX


• Drituss G


• Guaifenex G


• Guaifenex LA


• Mucinex


• Robitussin

In Canada

• Benylin-E


• Benylin E Extra Strength Chest Congestion


• Broncho-Grippex Expectorant


• Robitussin Extra Strength

Available Dosage Forms:

• Tablet, Extended Release


• Solution


• Capsule, Extended Release


• Packet


• Liquid


• Tablet


• Capsule


• Elixir


• Syrup

Therapeutic Class: Expectorant

Uses For Allfen

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Allfen

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

Allergies

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

Pediatric

Although there is no specific information comparing use of guaifenesin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using this medicine in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of guaifenesin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of guaifenesin

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

Drinking plenty of water while taking guaifenesin may help loosen mucus or phlegm in the lungs.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole, or open the capsule and sprinkle the contents on soft food such as applesauce, jelly, or pudding and swallow without crushing or chewing.

For patients taking the extended-release tablet form of this medicine:

• If the tablet has a groove in it, you may carefully break it into two pieces along the groove. Then swallow the pieces whole, without crushing or chewing them.


• If the tablet does not have a groove, it must be swallowed whole. Do not break, crush, or chew it before swallowing.

Dosing

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

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

• For regular (short-acting) oral dosage forms (capsules, oral solution, syrup, or tablets):
  
  • For cough:
    
    • Adults—200 to 400 milligrams (mg) every four hours.
    
    
    • Children 6 to 12 years of age—100 to 200 mg every four hours.
    
    
    • Children 4 to 6 years of age—50 to 100 mg every four hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For long-acting oral dosage forms (extended-release capsules or tablets):
  
  • For cough:
    
    • Adults—600 to 1200 mg every twelve hours.
    
    
    • Children 6 to 12 years of age—600 mg every twelve hours.
    
    
    • Children 4 to 6 years of age—300 mg every twelve hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Allfen

If your cough has not improved after 7 days or if you have a fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

Allfen 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.

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:

Less common or rare

• Diarrhea


• dizziness


• headache


• hives


• nausea or vomiting


• skin rash


• stomach pain

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: Allfen side effects (in more detail)

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

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

More Allfen resources

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

• Allfen MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin Monograph (AHFS DI)


• Guaifenesin Granules MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin NR Prescribing Information (FDA)


• Hytuss Immediate-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex Prescribing Information (FDA)


• Mucinex Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex Consumer Overview


• Organidin NR Prescribing Information (FDA)


• Tussin Consumer Overview

Compare Allfen with other medications

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• Cough
• Fibromyalgia

Froben 50mg Tablets

1. Name Of The Medicinal Product

Froben Tablets 50 mg

2. Qualitative And Quantitative Composition

Froben Tablets 50mg contain 50 mg Flurbiprofen BP.

3. Pharmaceutical Form

The tablets are sugar-coated and yellow in colour. They may be either unprinted or printed in black with an identifying motif.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains.

Froben is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine.

4.2 Posology And Method Of Administration

For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4).

Adults:

150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses.

For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg.

Children:

Not recommended for use in children under 12 years.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

4.3 Contraindications

Froben is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients.

Froben is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to flurbiprofen, aspirin or other NSAIDs.

Froben is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Froben should not be used in patients with active, or history of, ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).

Froben is contraindicated in patients with severe heart failure, hepatic failure and renal failure (see section 4.4).

Froben is contraindicated during the last trimester of pregnancy (see section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.2 and GI and cardiovascular risks below).

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactose deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medication.

The use of Froben with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive effects (see section 4.5).

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2).

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and may occur with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Froben, the treatment should be withdrawn.

Respiratory disorders

Caution is required if Froben is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, renal and hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3).

Froben should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with flurbiprofen administration.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with flurbiprofen administration and NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration.Similar consideration should be made before initating longer-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Renal effects

Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy. In the majority of cases, the onset of the reaction occurs within the first month of treatment. Froben should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Haematological effects

Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Froben should be used with caution in patients with a potential for abnormal bleeding.

Impaired female fertility

The use of Froben may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Froben should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients.

Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.

Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4).

Aspirin: As with other products containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended because of the potential of increased adverse effects.

Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).

Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding with NSAIDs (see section 4.4).

Lithium salts: Decreased elimination of lithium.

Methotrexate: Caution is advised in the concomitant administration of flurbiprofen and methotrexate since NSAIDs may increase methotrexate levels.

Ciclosporin: Increased risk of nephrotoxicity.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4).

Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects (see section 4.4).

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and other NSAIDs.

Studies have failed to show any interaction between flurbiprofen and tolbutamide or antacids. There is no evidence so far that flurbiprofen interferes with standard laboratory tests.

4.6 Pregnancy And Lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, flurbiprofen should not be given unless clearly necessary. If flurbiprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.

Lactation

In the limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

See section 4.4 Special warnings and precautions for use, regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.3 and 4.4) have been reported following flurbiprofen administration. Less frequently, gastritis, has been observed. Pancreatitis has been reported very rarely.

Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).

Cardiac disorders and Vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Respiratory, thoracic and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, dyspnoea).

Other adverse events reported less commonly and for which causality has not necessarily been established include:

Blood and lymphatic system disorders: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Psychiatric disorders: Depression, confusional state, hallucination

Nervous system disorders: Cerebrovascular accident, optic neuritis, headache, paraesthesia, dizziness, and somnolence.

Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation) (see section 4.4).

Eye disorders: Visual disturbance

Ear and labyrinth disorders: Tinnitus, vertigo

Hepatobiliary disorders: Abnormal liver function, hepatitis and jaundice.

Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritis, urticaria, purpura and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme) and photosensitivity reaction.

Renal and urinary disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

General disorders and administration site conditions: Malaise, fatigue

4.9 Overdose

Symptoms

Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Flurbiprofen has analgesic, anti-inflammatory and antipyretic properties. These are thought to result from the drug's ability to inhibit prostaglandin synthesis.

5.2 Pharmacokinetic Properties

Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life of about three to four hours.

The rate of urinary excretion of flurbiprofen and its two major metabolites ([2-(2-fluoro-4′-hydroxy-4-biphenylyl) propionic acid] and [2-(2-fluoro-3′-hydroxy-4′-methoxy-4-biphenylyl) propionic acid]) in both free and conjugated states is similar for both the oral and rectal routes of administration. Metabolic patterns are quantitatively similar for both routes of administration.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch powder EP, lactose NF anhydrous, povidone BPC, industrial alcohol FRP, magnesium stearate EP, stearic acid PDR BPC, *sandarac BPC 49 tablet varnish WMR, isopropyl alcohol, sucrose, purified water

Coat

Liquid glucose BPC 63, French chalk for tablets HSE, titanium dioxide BP, colloidal silicon dioxide NF, opalux yellow ASF 2230 HSE, carnauba wax PDR BP, **opacode S-1-8152HV black HSE

* Alternatively sandarac tablet varnish BPC 49

** Alternatively fine black ink markem

6.2 Incompatibilities

None known.

6.3 Shelf Life

Blister pack: 36 months (unopened)

Bulk pack: 12 months (unopened)

6.4 Special Precautions For Storage

None for the blister pack.

Store in a cool, dry place for the bulk pack.

6.5 Nature And Contents Of Container

A blister pack consisting of a PVC blister heat sealed to hard temper aluminium foil packed in a cardboard carton. Each blister contains 10 tablets.

Pack sizes: 10, 20, 30, 100 and 500 tablets. Also a sample pack of 5 tablets in a blister.

A bulk pack of a low density polyethylene bag in a rectangular white plastic tub having a snap-on lid.

Pack sizes: Approx. 25,000 or 50,000 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Abbott Laboratories Limited

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UK.

8. Marketing Authorisation Number(S)

Froben Tablets 50 mg: PL 00037/0349

9. Date Of First Authorisation/Renewal Of The Authorisation

31 December 2001

10. Date Of Revision Of The Text

02 January 2010

Gyne Sulf

Generic Name: triple sulfa vaginal (TRIH pull SUL fa)

Brand Names: Gyne Sulf, Sultrin Triple Sulfa, Trysul, V.V.S.

What is Gyne Sulf (triple sulfa vaginal)?

Triple sulfa is an antibacterial medication. It fights bacteria in the body.

Triple sulfa vaginal is used to treat vaginal infections caused by the bacteria Gardnerella vaginalis.

Triple sulfa vaginal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Gyne Sulf (triple sulfa vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (such as pantyhose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Gyne Sulf (triple sulfa vaginal)?

Do not use triple sulfa vaginal if you have ever had an allergic reaction to it or to another sulfa-based medicine.

Triple sulfa vaginal is in the FDA pregnancy category C. This means that it is not known whether triple sulfa vaginal will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. Triple sulfa passes into breast milk and may affect a nursing baby. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use Gyne Sulf (triple sulfa vaginal)?

Use triple sulfa vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Insert the tablet or cream into the vagina using the applicator as directed. Triple sulfa vaginal is usually used twice a day, in the morning and evening.

Use this medication continuously for the prescribed amount of time, even during your menstrual period.

A sanitary napkin can be worn to prevent the medication from staining clothing but do not use a tampon.

If the infection does not clear up after one course of therapy has been finished, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store triple sulfa vaginal at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose.

What happens if I overdose?

An overdose of triple sulfa vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that triple sulfa vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Gyne Sulf (triple sulfa vaginal)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent spreading the infection to a sexual partner.

Gyne Sulf (triple sulfa vaginal) side effects

Stop using triple sulfa vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

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

What other drugs will affect Gyne Sulf (triple sulfa vaginal)?

Avoid using other vaginal creams or douches during treatment with triple sulfa, unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with triple sulfa vaginal. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines, including herbal products.

More Gyne Sulf resources

• Gyne Sulf Support Group
• 0 Reviews for Gyne Sulf - Add your own review/rating

Compare Gyne Sulf with other medications

• Bacterial Vaginitis

Where can I get more information?

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

What does my medication look like?

Triple sulfa vaginal is available with a prescription under several brand names. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Sultrin Triple Sulfa vaginal tablets

  
  


• 
  

  Sultrin Triple Sulfa vaginal cream

  
  


• 
  

  Dayto Sulfa vaginal cream

  
  


• 
  

  Gyne-Sulf vaginal cream

  
  


• 
  

  Trysul vaginal cream

  
  


• 
  

  V.V.S. vaginal cream

  
  

NegGram

nalidixic acid

Dosage Form: tablet

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NegGram (nalidixic acid, USP) and other antibacterial drugs, NegGram should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

NegGram Description

NegGram, brand of nalidixic acid, is a quinolone antibacterial agent for oral administration. Nalidixic acid is 1-ethyl-1,4-dihydro-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acid. It is a pale yellow, crystalline substance and a very weak organic acid.

Nalidixic acid has the following structural formula:

Inactive Ingredients - Hydrogenated Vegetable Oil, Methylcellulose, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Yellow Ferric Oxide.

NegGram - Clinical Pharmacology

Following oral administration, NegGram is rapidly absorbed from the gastrointestinal tract, partially metabolized in the liver, and rapidly excreted through the kidneys. Unchanged nalidixic acid appears in the urine along with an active metabolite, hydroxynalidixic acid, which has antibacterial activity similar to that of nalidixic acid. Other metabolites include glucuronic acid conjugates of nalidixic acid and hydroxy nalidixic acid, and the dicarboxylic acid derivative. The hydroxy metabolite represents 30 percent of the biologically active drug in the blood and 85 percent in the urine. Peak serum levels of active drug average approximately 20 mcg to 40 mcg per mL (90 percent protein bound), one to two hours after administration of a 1 g dose to a fasting normal individual, with a half-life of about 90 minutes. Peak urine levels of active drug average approximately 150 mcg to 200 mcg per mL, three to four hours after administration, with a half-life of about six hours. Approximately four percent of NegGram is excreted in the feces. Traces of nalidixic acid were found in blood and urine of an infant whose mother had received the drug during the last trimester of pregnancy. (See PRECAUTIONS—Drug Interactions.)

Microbiology

NegGram has marked antibacterial activity against gram-negative bacteria including Enterobacter species, Escherichia coli, Morganella Morganii; Proteus Mirabilis, Proteus vulgaris, and Providencia rettgeri. Pseudomonas species are generally resistant to the drug. NegGram is bactericidal and is effective over the entire urinary pH range. Conventional chromosomal resistance to NegGram taken in full dosage has been reported to emerge in approximately 2 to 14 percent of patients during treatment; however, bacterial resistance to NegGram has not been shown to be transferable via R factor.

Susceptibility Test

Diffusion Techniques

Quantitative methods that require measurement of zone diameters give the most precise estimates of antibacterial susceptibility. One such procedure recommended for use with a disc containing 30 mcg of nalidixic acid is the National Committee for Clinical Laboratory Standards (NCCLS) approved procedure. Only organisms from urinary tract infections should be tested. Results of laboratory tests using 30 mcg nalidixic acid discs should be interpreted using the following criteria:

Zone Diameter (mm)	Interpretation
≥ 19	(S) Susceptible
14–18	(I) Intermediate
≤13	(R) Resistant

Dilution Techniques

Broth and agar dilution methods, such as those recommended by the NCCLS, may be used to determine the minimum inhibitory concentration (MIC) of nalidixic acid. MIC test results should be interpreted according to the following criteria:

MIC (mcg/mL)	Interpretation
≤16	(S) Susceptible
≥32	(R) Resistant

For any susceptibility test, a report of "susceptible" indicates that the pathogen is likely to respond to nalidixic acid therapy. A report of "resistant" indicates that the pathogen is not likely to respond. A report of "intermediate" generally indicates that the test result is equivocal.

The Quality Control strains should have the following assigned daily ranges for nalidixic acid:

QC Strains

E. Coli

(ATCC 25922)

Disc Zone Diameter

22–28

MIC (mcg/mL)

1.0–4.0

Indications and Usage for NegGram

NegGram (nalidixic acid, USP) is indicated for the treatment of urinary tract infections caused by susceptible gram-negative microorganisms, including the majority of E. Coli, Enterobacter species, Klebsiella species, and Proteus species. Disc susceptibility testing with the 30 mcg disc should be performed prior to administration of the drug, and during treatment if clinical response warrants.

To reduce the development of drug-resistant bacteria and maintain effectiveness of NegGram and other antibacterial drugs, NegGram should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered when selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

NegGram is contraindicated in patients with known hypersensitivity to nalidixic acid or to related compounds, infants less than three months of age, and in patients with porphyria or a history of convulsive disorders. NegGram is contraindicated in patients undergoing concomitant therapy with melphalan or other related cancer chemotherapeutic alkylating agents because of serious gastrointestinal toxicity such as hemorrhagic ulcerative colitis or intestinal necrosis.

Warnings

Central Nervous System (CNS) effects including convulsions, increased intracranial pressure, and toxic psychosis have been reported with nalidixic acid therapy. Convulsive seizures have been reported with other drugs in this class. Quinolones may also cause CNS stimulation which may lead to tremor, restlessness, lightheadedness, confusion, and hallucinations. Therefore, nalidixic acid should be used with caution in patients with known or suspected CNS disorders, such as, cerebral arteriosclerosis or epilepsy, or other factors which predispose seizures. (See ADVERSE REACTIONS.) If these reactions occur in patients receiving nalidixic acid, the drug should be discontinued and appropriate measures instituted.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactoid reactions required immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.

Nalidixic acid and other members of the quinolone drug class have been shown to cause arthropathy in juvenile animals. (See PRECAUTIONS and ANIMAL PHARMACOLOGY.)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Peripheral neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including nalidixic acid. Nalidixic acid should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Tendon Effects

Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including nalidixic acid. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Nalidixic acid should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including nalidixic acid.

Precautions

General

Blood counts and renal and liver function tests should be performed periodically if treatment is continued for more than two weeks. NegGram should be used with caution in patients with liver disease, epilepsy, or severe cerebral arteriosclerosis. (See WARNINGS.) Caution should be used in patients with renal insufficiency. (See DOSAGE AND ADMINISTRATION.)

Moderate to severe phototoxicity reactions have been observed in patients who are exposed to direct sunlight while receiving NegGram or other members of this drug class. Excessive sunlight should be avoided. Therapy should be discontinued if phototoxicity occurs.

If bacterial resistance to NegGram emerges during treatment, it usually does so within 48 hours, permitting rapid change to another antimicrobial. Therefore, if the clinical response is unsatisfactory or if relapse occurs, cultures and sensitivity tests should be repeated. Underdosage with NegGram during initial treatment (with less than 4 g per day for adults) may predispose to emergence of bacterial resistance. (See DOSAGE AND ADMINISTRATION.)

Cross-resistance between nalidixic acid and other quinolone derivatives such as oxolinic acid and cinoxacin has been observed.

Caution should be observed in patients with glucose-6-phosphate dehydrogenase deficiency. (See ADVERSE REACTIONS).

Prescribing NegGram in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be advised NegGram may be taken with or without meals. Patients should be advised to drink fluids liberally and not take antacids.

Patients should be advised that quinolones may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reactions.

Quinolones may cause dizziness and light-headedness, therefore, patients should know how they react to NegGram before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.

Patients should be advised that quinolones may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones. Patients should be advised to avoid excessive sunlight or artificial ultraviolet light while receiving nalidixic acid and to discontinue therapy if phototoxicity occurs.

Patients should be advised that convulsions have been reported in patients taking quinolones, including nalidixic acid, and to notify their physician before taking this drug if there is a history of this condition. Patients should be advised that mineral supplements, vitamins with iron or minerals, calcium-, aluminum-, magnesium-based antacids, sucralfate or Videx®, (didanosine), chewable/buffered tablets of the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking nalidixic acid (see Drug Interactions).

Patients should be advised:

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that nalidixic acid may cause changes in the electrocardiogram (QTc interval prolongation)

-

that nalidixic acid should be avoided in patients receiving class IA (e.g. quinidine, Procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents

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that nalidixic acid should be used with caution in subjects receiving drugs that affect the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants

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to inform their physicians of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia or recent myocardial ischemia

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that peripheral neuropathies have been associated with nalidixic acid use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, they should discontinue treatment and contact their physicians.

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that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs including NegGram should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When NegGram is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by NegGram or other antibacterial drugs in the future.

Drug Interactions

Elevated plasma levels of theophylline have been reported with concomitant quinolone use. There have been reports of theophylline-related side effects in patients on concomitant therapy with quinolones and theophylline. Therefore, monitoring of theophylline plasma levels should be considered and dosage of theophylline adjusted, as required.

Quinolones have been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and the prolongation of its plasma half-life.

Quinolones, including nalidixic acid, may enhance the effects of the oral anticoagulant warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation test should be closely monitored.

Since active proliferation of organisms is a necessary condition for its antibacterial activity, the action of nalidixic acid may be inhibited by the presence of other antibacterial substances, especially bacteriostatic agents such as tetracycline, chloramphenicol, or nitrofurantoin, which is antagonistic to nalidixic acid in vitro.

Probenecid inhibits the tubular secretion of nalidixic acid and may reduce its efficacy in the treatment of urinary tract infections while increasing the risk of systemic side effects.

Serious gastrointestinal toxicity has been associated with the concomitant use of nalidixic acid and the anti-cancer drug melphalan. (see CONTRAINDICATIONS)

Antacids containing magnesium, aluminum, or calcium; sucralfate or divalent or trivalent cations such as iron; multivitamins containing zinc; and Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution may substantially interfere with the absorption of quinolones, resulting in systemic levels considerably lower than desired. These agents should not be taken within the two-hour period before or within the two-hour period after nalidixic acid administration.

Elevated serum levels of cyclosporine have been reported with the concomitant use of some quinolones and cyclosporine. Therefore, cyclosporine serum levels should be monitored and appropriate cyclosporine dosage adjustments made when these drugs are used concomitantly.

Drug Laboratory Test Interactions

When Benedict's or Fehling's solution or Clinitest® Reagent Tablets are used to test the urine of patients taking NegGram, a false-positive reaction for glucose may be obtained, due to the liberation of glucuronic acid from the metabolites excreted. However, a colorimetric test for glucose based on an enzyme reaction (e.g., with Clinistix® Reagent Strips or Tes-Tape®) does not give a false-positive reaction to the liberated glucuronic acid.

Incorrect values may be obtained for urinary 17-keto and ketogenic steroids in patients receiving NegGram, because of an interaction between the drug and the m-dinitrobenzene used in the usual assay method. In such cases, the Porter-Silber test for 17-hydroxycorticoids may be used.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In lifetime studies in the rat given nalidixic acid in the diet, there was an increased incidence of preputial gland neoplasms in the treated males and clitoral gland neoplasms in the treated females. Studies in mice in which nalidixic acid was administered in the feed for two years, or was given in the feed for 76 weeks followed by no treatment for 9 weeks, gave equivocal evidence of carcinogenic activity.

Nalidixic acid was tested in the Ames bacterial mutagenicity test (maximum dose 33 mcg/plate) and the mouse lymphoma assay (L5178Y/TK; maximum dose 100 mcg/mL) with and without metabolic activation, and results were negative.

Pregnancy

Teratogenic Effects

Pregnancy Category C

NegGram has been shown to be teratogenic and embryocidal in rats when given in oral doses six times the human dose. NegGram also prolonged the duration of pregnancy especially at four times the clinical dose. There are no adequate and well-controlled studies in pregnant women. Since nalidixic acid, like other drugs in this class, causes arthropathy in immature animals, NegGram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (See WARNINGS and ANIMAL PHARMACOLOGY.)

Nursing Mothers

Since nalidixic acid is excreted in breast milk, it is contraindicated during lactation.

Pediatric Use

Safety and effectiveness in infants below the age of three months have not been established.

Usage in Patients Under 18 Years of Age

Toxicological studies have shown that nalidixic acid and related drugs can produce erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of most species tested. No such joint lesions have been reported in humans to date. Nevertheless, until the significance of this finding is clarified, this drug should only be used in patients under 18 years of age when the potential benefit justifies the potential risk. If arthralgia occurs, treatment with nalidixic acid should be stopped. (See WARNINGS and ANIMAL PHARMACOLOGY.)

Geriatric Use

Clinical studies of NegGram did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution should therefore be observed in using nalidixic acid in elderly patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General.)

Adverse Reactions

Reactions reported after oral administration of NegGram include the following.

CNS effects:


drowsiness, weakness, headache, dizziness and vertigo. Reversible subjective visual disturbances without objective findings have occurred infrequently (generally with each dose during the first few days of treatment). These reactions include overbrightness of lights, change in color perception, difficulty in focusing, decrease in visual acuity, and double vision. They usually disappeared promptly when dosage was reduced or therapy was discontinued. Toxic psychosis or brief convulsions have been reported rarely, usually following excessive doses. In general, the convulsions have occurred in patients with predisposing factors such as epilepsy or cerebral arteriosclerosis. In infants and children receiving therapeutic doses of NegGram, increased intracranial pressure with bulging anterior fontanel, papilledema, and headache has occasionally been observed. A few cases of 6th cranial nerve palsy have been reported. Although the mechanisms of these reactions are unknown, the signs and symptoms usually disappeared rapidly with no sequelae when treatment was discontinued.

Gastrointestinal:


abdominal pain, nausea, vomiting, and diarrhea.

Allergic:


rash, pruritus, urticaria, angioedema, eosinophilia, arthralgia with joint stiffness and swelling, and anaphylactoid reaction, including anaphylactic shock. Erythema Multiforme and Stevens-Johnson syndrome have been reported with nalidixic acid and other drugs in this class. Rash was the most frequently reported adverse reaction. Photosensitivity reactions consisting of erythema and bullae on exposed skin surfaces usually resolve completely in 2 weeks to 2 months after NegGram is discontinued; however, bullae may continue to appear with successive exposures to sunlight or with mild skin trauma for up to 3 months after discontinuation of drug. (See PRECAUTIONS.)

Other:


rarely, cholestasis, paresthesia, metabolic acidosis, thrombocytopenia, leukopenia, or hemolytic anemia, sometimes associated with glucose 6-phosphate dehydrogenase deficiency and peripheral neuropathy.

Overdosage

Manifestations

Toxic psychosis, convulsions, increased intracranial pressure, or metabolic acidosis may occur in patients taking more than the recommended dosage. Vomiting, nausea, and lethargy may also occur following overdosage.

Treatment

Reactions are short-lived (two to three hours) because the drug is rapidly excreted. If absorption has occurred, increased fluid administration is advisable and supportive measures such as oxygen and means of artificial respiration should be available. Although anticonvulsant therapy has not been used in the few instances of overdosage reported, it may be indicated in a severe case.

NegGram Dosage and Administration

Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; multivitamins containing zinc; or Videx® (Didanosine), chewable/buffered tablets of the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking nalidixic acid.

Adults

The recommended dosage for initial therapy in adults is 1 g administered four times daily for one or two weeks (total daily dose, 4 g). For prolonged therapy, the total daily dose may be reduced to 2 g after the initial treatment period. Underdosage during initial treatment may predispose to emergence of bacterial resistance.

Renal Insufficiency

The normal dosage of nalidixic acid may be employed in patients with plasma creatinine of less than 300 µmol/L (creatinine clearance more than 20 mL/minute). Dosage should be halved in patients with plasma creatinine of more than 300 µmol/L (creatinine clearance 20 mL/minute or less).

Pediatric Patients

Until further experience is gained, NegGram should not be administered to infants younger than three months. Dosage in pediatric patients 12 years of age and under should be calculated on the basis of body weight. The recommended total daily dosage for initial therapy is 25 mg/lb/day (55 mg/kg/day), administered in four equally divided doses. For prolonged therapy, the total daily dose may be reduced to 15 mg/lb/day (33 mg/kg/day). NegGram Caplets of 250 mg may be used.

How is NegGram Supplied

NegGram (nalidixic acid, USP) is supplied as:

Caplets of 500 mg, light buff-colored capsule-shaped tablets, bottles of 56 (NDC 0024-1322-03)

Store at room temperature, up to 30° C (86° F).

Animal Pharmacology

NegGram (nalidixic acid) and related drugs have been shown to cause arthropathy in juvenile animals of most species tested. (See WARNINGS.)

Long-term administration of nalidixic acid to rats resulted in retinal degeneration and cataracts.

Hydroxynalidixic acid, the principal metabolite of NegGram, did not produce any oculotoxic effects at any dosage level in seven species of animals including three primate species. However, oral administration of this metabolite in high doses has been shown to have oculotoxic potential, namely in dogs and cats where it produced retinal degeneration upon prolonged administration leading, in some cases, to blindness.

In experiments with NegGram itself, little if any such activity could be elicited in either dogs or cats. Sensitivity to CNS side effects in these species limited the doses of NegGram that could be used; this factor, together with a low conversion rate to the hydroxy metabolite in these species, may explain the absence of these effects.

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

Revised September 2008

© 2008 sanofi-aventis U.S. LLC

NegGram  nalidixic acid  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-1322 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength nalidixic acid (nalidixic acid) Active 500 MILLIGRAM  In 1 TABLET Hydrogenated Vegetable Oil Inactive   Methylcellulose Inactive   Microcrystalline Cellulose Inactive   Sodium Lauryl Sulfate Inactive   Yellow Ferric Oxide Inactive

Product Characteristics Color yellow (light buff-colored) Score no score Shape OVAL (capsule shaped) Size 18mm Flavor Imprint Code Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0024-1322-03 56 TABLET In 1 BOTTLE None

Revised: 04/2009sanofi-aventis U.S. LLC

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