Atropine Sulfate Injection BP may be available in the countries listed below.
Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Atropine Sulfate Injection BP in the following countries:
International Drug Name Search
Onelaxant may be available in the countries listed below.
Baclofen is reported as an ingredient of Onelaxant in the following countries:
International Drug Name Search
Lexapro is a brand name of escitalopram, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Lexapro available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lexapro. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Disodium Edetate may be available in the countries listed below.
Disodium Edetate (BAN, JAN) is also known as Edetic Acid (Rec.INN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Treating acne.
BenzaClin Care Kit Gel is an antibiotic and drying agent combination. It works by stopping the bacterial infection that causes acne. The moisturizing serum works by providing moisture to the skin.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with BenzaClin Care Kit Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with BenzaClin Care Kit Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if BenzaClin Care Kit Gel 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.
Use BenzaClin Care Kit Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use BenzaClin Care Kit Gel.
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:
Dry skin; flushing; itching; redness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; burning, peeling, or irritation at the application site; severe diarrhea; stomach cramps or pain.
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: BenzaClin Care side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. BenzaClin Care Kit Gel may be harmful if swallowed.
Store BenzaClin Care Kit Gel at room temperature, below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Throw away any unused portion after 3 months. Keep BenzaClin Care Kit Gel out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about BenzaClin Care Kit Gel. 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.
Zyprexa Adhera may be available in the countries listed below.
Olanzapine pamoate (a derivative of Olanzapine) is reported as an ingredient of Zyprexa Adhera in the following countries:
International Drug Name Search
Lanso TAD may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lanso TAD in the following countries:
International Drug Name Search
Generic Name: benzoyl peroxide topical (BEN zoyl per OX ide)
Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, Benziq, Benziq Wash, BPO Foaming Cloths, Brevoxyl, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-8, Loroxide, NeoBenz Micro, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Zaclir
Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.
Benzoyl peroxide topical (for the skin) is used to treat acne.
Benzoyl peroxide topical may also be used for purposes not listed in this medication guide.
There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.
Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.
It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
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.
Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.
Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.
Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.
It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.
Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.
Less serious side effects may include:
mild stinging or burning;
itching or tingly feeling;
skin dryness, peeling, or flaking; or
redness or other irritation.
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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. 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.
See also: Benzac AC side effects (in more detail)
Betaphlem may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Betaphlem in the following countries:
International Drug Name Search
Rocipro may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Rocipro in the following countries:
International Drug Name Search
Amoxi-Sleecol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxi-Sleecol in the following countries:
International Drug Name Search
Di-Flu may be available in the countries listed below.
Diflunisal is reported as an ingredient of Di-Flu in the following countries:
International Drug Name Search
Bisacodyl, 10 mg
Stimulant Laxative
For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.
If swallowed, get medical help or contact a Poison Control Center right away.
| Adults and children 12 years of age and older | Children 6 to 12 years | Children under 6 |
| One suppository once daily | 1/2 suppository once daily | Ask a doctor. |
CVS pharmacy
NDC 50730-1016-0
Compare to the active
ingredient in Dulcolax®
NEW!
Gentle
LAXATIVE
SUPPOSITORIES
Bisacodyl USP
GUARANTEED RELIEF
Gentle Yet Effective
16 Suppositories (10mg each)
Comfort Shaped
Distributed by CVS Pharmacy, Inc. One CVS Drive
Woonsocket, RI 02895 ©CVS/pharmacy
www.cvs.com 1-800-shop-CVS
This product is not manufactured or distributed by Boehringer Ingelhem
Consumer Healthcare, owner of the registered trademark Dulcolax®.
| BISACODYL bisacodyl suppository | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part334 | 01/01/2009 | |
| Labeler - H and P Industries, Inc. dba Triad Group (050259597) |
Amelior may be available in the countries listed below.
Amlodipine is reported as an ingredient of Amelior in the following countries:
Olmesartan Medoxomil is reported as an ingredient of Amelior in the following countries:
International Drug Name Search
Zycalcit may be available in the countries listed below.
Calcitonin is reported as an ingredient of Zycalcit in the following countries:
International Drug Name Search
Noperten may be available in the countries listed below.
Lisinopril is reported as an ingredient of Noperten in the following countries:
International Drug Name Search
Cofamix Sulfadiméthoxine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimethoxine is reported as an ingredient of Cofamix Sulfadiméthoxine in the following countries:
International Drug Name Search
Cefaclor Labesfal may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Cefaclor Labesfal in the following countries:
International Drug Name Search
Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)
i-MUNE GLOB-ue-lin
Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .
Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. Gammagard(R) does not contain sucrose .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Serum
Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).
This medicine is to be administered only by or under the supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.
| 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. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Baygam. Please read with care.
A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.
The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.
Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.
If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.
Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.
To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.
Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.
Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.
You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.
It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.
Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).
This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.
This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.
Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).
This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.
Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.
This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .
Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
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:
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:
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.
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.
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.
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.
The behavior of the individual components is described below.
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 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.
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.
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.
This product is contraindicated under the following conditions:
Butalbital is habit‑forming and potentially abusable. Consequently, the extended use of this product is not recommended.
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.
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 .
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
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.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
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.
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.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
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.
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.
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.
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.
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®*.
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.
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
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
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Betalan may be available in the countries listed below.
Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Betalan in the following countries:
International Drug Name Search
Ranitidina Ratiopharm may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina Ratiopharm in the following countries:
International Drug Name Search
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
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.
There are many brands and forms of this medication available and not all brands are listed on this leaflet.
Do not use this medication during an asthma attack.
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.
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:
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.
Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
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.
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.
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.
Overdose symptoms may include some of the serious side effects listed in this medication guide.
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.
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.
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.
See also: Dicel Chewables side effects (in more detail)
