Wednesday, September 28, 2011

butalbital,acetaminophen and caffeine solution





Rx Only


Code 778Z00                                                                                                            Rev. 10/02



butalbital,acetaminophen and caffeine solution Description


Butalbital, acetaminophen and caffeine are supplied in liquid form for oral administration.


Each 15 mL contains:


Butalbital USP......................................................50 mg


Warning: May be habit forming.


Acetaminophen USP............................................325 mg


Caffeine USP........................................................40 mg


Alcohol ..................................................................7.368%


Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:


C11H16N2O3 MW = 224.26



Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:


C8H9NO2 MW = 151.17



Caffeine (1,3,7‑trimethylxanthine), a bitter, white powder or white‑glistening needles, is a central nervous system stimulant. It has the following structural formula:


C8H10N4O2 MW = 194.19



In addition, this drug product contains the following inactive ingredients: citric acid, ethyl maltol, liquid glucose, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and natural and artificial flavoring.



butalbital,acetaminophen and caffeine solution - Clinical Pharmacology


This combination drug product is intended as a treatment for tension headache.


It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is not completely understood.



Pharmacokinetics


The behavior of the individual components is described below.


Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.


Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.


The in vitro plasma binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.


See OVERDOSAGE for toxicity information.


Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.


See OVERDOSAGE for toxicity information.


Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.


Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.


See OVERDOSAGE for toxicity information.



Indications and Usage for butalbital,acetaminophen and caffeine solution


Butalbital, Acetaminophen and Caffeine Oral Solution is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.


Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit‑forming and potentially abusable.



Contraindications


This product is contraindicated under the following conditions:


  • Hypersensitivity or intolerance to any component of this product.

  • Patients with porphyria.


Warnings


Butalbital is habit‑forming and potentially abusable. Consequently, the extended use of this product is not recommended.



Precautions



General


Butalbital, Acetaminophen and Caffeine Oral Solution should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe renal or hepatic impairment or acute abdominal conditions.



Information for Patients


This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.


Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.


Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.


For information on use in geriatric patients, see PRECAUTIONS / Geriatric Use .



Laboratory Tests


In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.



Drug Interactions


The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.


Butalbital, acetaminophen and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.



Drug/Laboratory Test Interactions


Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.



Pregnancy


Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.


Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.



Nursing Mothers


Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


Clinical studies of butalbital, acetaminophen and caffeine 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing rage, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


Butalbital 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.



Adverse Reactions



Frequently Observed


The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.



Infrequently Observed


All adverse events tabulated below are classified as infrequent.


Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.


Autonomic Nervous System: dry mouth, hyperhidrosis.


Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.


Cardiovascular: tachycardia.


Musculoskeletal: leg pain, muscle fatigue.


Genitourinary: diuresis.


Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.


Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.


The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.


Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.


Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.



Drug Abuse and Dependence



Abuse and Dependence: Butalbital: Barbiturates may be habit-forming


Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.



Overdosage


Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.



Signs and Symptoms


Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.


In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.


Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.



Treatment


A single or multiple overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.


Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. The value of vasopressor agents such as norepinephrine or phenylephrine hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow. However, if prolonged support of blood pressure is required, norepinephrine bitartrate may be given I.V. with the usual precautions and serial blood pressure monitoring. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital.


Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.


If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.


Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.


Toxic Doses (for adults):


Butalbital:                    toxic dose          1 g          (20 tablespoonfuls)


Acetaminophen:        toxic dose          10 g         (30 tablespoonfuls)


Caffeine:                     toxic dose          1 g           (25 tablespoonfuls)


In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physician’s Desk Reference®*. 



butalbital,acetaminophen and caffeine solution Dosage and Administration


One or two tablespoonfuls (15 mL or 30 mL) every four hours. Total daily dosage should not exceed 6 tablespoonfuls.


Extended and repeated use of this product is not recommended because of the potential for physical dependence.



How is butalbital,acetaminophen and caffeine solution Supplied


Butalbital, Acetaminophen and Caffeine Oral Solution is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg (Warning: May be habit-forming), acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied in containers as follows:


16 fl oz          NDC 46672-633-16


128 fl oz        NDC 46672-633-28



Storage


Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP).


Dispense in a tight, light-resistant container with a child-resistant closure.


*Trademark of Medical Economics Company, Inc.


 


Rx only


Manufactured by:


MIKART, INC.


Atlanta, GA 30318


Rev. 10 / 02                                                                                                                     Code 778Z00








BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 
butalbital, acetaminophen and caffeine  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)46672-633
Route of AdministrationORALDEA ScheduleCIII    





















































INGREDIENTS
Name (Active Moiety)TypeStrength
Butalbital (Butalbital)Active50 MILLIGRAM  In 15 MILLILITER
Acetaminophen (Acetaminophen)Active325 MILLIGRAM  In 15 MILLILITER
Caffeine (Caffeine)Active40 MILLIGRAM  In 15 MILLILITER
citric acidInactive 
ethyl maltolInactive 
FD&C yellow #6Inactive 
glycerinInactive 
liquid glucoseInactive 
methylparabenInactive 
natural and artificial flavoringInactive 
propylene glycolInactive 
propylparabenInactive 
waterInactive 
saccharin sodiumInactive 
sorbitol solutionInactive 
sucroseInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
146672-633-283784 mL (MILLILITER) In 1 BOTTLE, PLASTICNone
246672-633-16473 mL (MILLILITER) In 1 BOTTLE, PLASTICNone
346672-633-0130 mL (MILLILITER) In 1 BOTTLE, PLASTICNone

Revised: 01/2008MIKART, INC.

More butalbital,acetaminophen and caffeine solution resources


  • Butalbital,acetaminophen and caffeine solution Side Effects (in more detail)
  • Butalbital,acetaminophen and caffeine solution Use in Pregnancy & Breastfeeding
  • Drug Images
  • Butalbital,acetaminophen and caffeine solution Drug Interactions
  • Butalbital,acetaminophen and caffeine solution Support Group
  • 80 Reviews for Butalbital,acetaminophen and caffeine solution - Add your own review/rating


Compare butalbital,acetaminophen and caffeine solution with other medications


  • Headache

Friday, September 16, 2011

Betalan




Betalan may be available in the countries listed below.


Ingredient matches for Betalan



Betahistine

Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Betalan in the following countries:


  • Poland

International Drug Name Search

Tuesday, September 13, 2011

Ranitidina Ratiopharm




Ranitidina Ratiopharm may be available in the countries listed below.


Ingredient matches for Ranitidina Ratiopharm



Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina Ratiopharm in the following countries:


  • Italy

  • Portugal

  • Spain

International Drug Name Search

Monday, September 12, 2011

Dicel Chewables


Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion


What is Dicel Chewables (chlorpheniramine and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.


Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Dicel Chewables (chlorpheniramine and pseudoephedrine)?


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


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


What should I discuss with my healthcare provider before taking Dicel Chewables (chlorpheniramine and pseudoephedrine)?


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • narrow angle glaucoma;




  • a stomach ulcer;




  • if you are unable to urinate; or




  • if you are having an asthma attack.



Ask a doctor or pharmacist if it is safe for you to take this medication if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • circulation problems;




  • heart disease or high blood pressure;




  • overactive thyroid;




  • a seizure disorder such as epilepsy;




  • asthma, emphysema or chronic bronchitis; or




  • urination problems or an enlarged prostate.




FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take Dicel Chewables (chlorpheniramine and pseudoephedrine)?


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. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.


Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while taking Dicel Chewables (chlorpheniramine and pseudoephedrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Dicel Chewables (chlorpheniramine and pseudoephedrine) 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. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, nervousness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness; or




  • seizure (black-out or convulsions).



Less serious side effects may include:



  • blurred vision;




  • dry nose or mouth;




  • nausea, stomach pain, constipation, loss of appetite;




  • dizziness, drowsiness;




  • problems with memory or concentration;




  • ringing in your ears; or




  • feeling restless or excited (especially in children).



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 Dicel Chewables (chlorpheniramine and pseudoephedrine)?


Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

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



  • mecamylamine (Inversine);




  • methyldopa (Aldomet);




  • reserpine;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or




  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. 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 Dicel Chewables resources


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


  • AccuHist Drops Prescribing Information (FDA)

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

  • Deconamine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Deconamine SR Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duotan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • QDALL 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Dicel Chewables with other medications


  • Hay Fever
  • Sinusitis


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.

See also: Dicel Chewables side effects (in more detail)


Saturday, September 10, 2011

Phos-Ex




Phos-Ex may be available in the countries listed below.


Ingredient matches for Phos-Ex



Calcium Acetate

Calcium Acetate is reported as an ingredient of Phos-Ex in the following countries:


  • Denmark

  • Germany

  • Netherlands

  • Norway

  • Turkey

International Drug Name Search

Friday, September 9, 2011

Lansoprazol Cantabria




Lansoprazol Cantabria may be available in the countries listed below.


Ingredient matches for Lansoprazol Cantabria



Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazol Cantabria in the following countries:


  • Spain

International Drug Name Search

Oratuss Liquid


Pronunciation: kar-bay-ta-PEN-tane/gwye-FEN-e-sin
Generic Name: Carbetapentane/Guaifenesin
Brand Name: Examples include Oratuss and Tusso-ZR


Oratuss Liquid is used for:

Relieving unproductive cough and reducing mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Oratuss Liquid is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex. The expectorant works by thinning mucus (phlegm) in the lungs, making it less sticky and easier to cough up. This makes coughs more productive.


Do NOT use Oratuss Liquid if:


  • you are allergic to any ingredient in Oratuss Liquid

  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) with the last 14 days

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



Before using Oratuss Liquid:


Some medical conditions may interact with Oratuss Liquid. 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 chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces large amounts of mucus

  • if you have a history of heart problems, high blood pressure, prostate problems, an overactive thyroid, diabetes, or glaucoma

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


  • MAOIs (eg, phenelzine) because they may increase the risk of Oratuss Liquid's side effects

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


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


  • Take Oratuss Liquid by mouth with or without food.

  • Drinking extra fluids while you are taking Oratuss Liquid is recommended. Check with your doctor for instructions.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Oratuss Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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



Important safety information:


  • Oratuss Liquid may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Oratuss Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Oratuss Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not use Oratuss Liquid for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.

  • Oratuss Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Oratuss Liquid.

  • Caution is advised when using Oratuss Liquid in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oratuss Liquid while you are pregnant. It is not known if Oratuss Liquid is found in breast milk. If you are or will be breast-feeding while you use Oratuss Liquid, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Oratuss Liquid:


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:



Drowsiness; dry mouth, nose, or throat; upset stomach.



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).



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: Oratuss 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 restlessness; seizures; severe agitation.


Proper storage of Oratuss Liquid:

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


General information:


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

  • Oratuss Liquid 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 Oratuss Liquid. 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 Oratuss resources


  • Oratuss Side Effects (in more detail)
  • Oratuss Use in Pregnancy & Breastfeeding
  • Oratuss Drug Interactions
  • Oratuss Support Group
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