Karsivan may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Propentofylline is reported as an ingredient of Karsivan in the following countries:
International Drug Name Search
Treating allergy symptoms and chronic hives. It may also be used for other conditions as determined by your doctor.
Desloratadine is an antihistamine. It works by blocking the action of histamine to relieve allergy symptoms, such as sneezing, runny nose, and itchy or watery eyes, and to relieve itching and rash due to chronic hives.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Desloratadine. 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 Desloratadine. 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 Desloratadine 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 Desloratadine 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 Desloratadine.
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:
Dizziness; drowsiness; dry mouth; menstrual pain; muscle pain; nausea; sore throat; tiredness; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); dark urine; fast or irregular heartbeat; pale stools; seizures; yellowing of the skin or eyes.
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: Desloratadine 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. Symptoms may include drowsiness; fast or irregular heartbeat.
Store Desloratadine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid storage at or above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Desloratadine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Desloratadine. 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.
dak-tin-oh-MYE-sin
This drug is highly toxic and both powder and solution must be handled and administered with care. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. If extravasation occurs during intravenous use, severe damage to soft tissues will occur .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic
Dactinomycin belongs to the group of medicines known as antineoplastics. It is used to treat some kinds of cancer of the bones and soft tissue, including muscles and tendons; Wilms' tumor (a cancer of the kidney found primarily in children); tumors in the uterus or womb; and cancer of the testicles.
Dactinomycin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by dactinomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with dactinomycin, you and your doctor should talk about the good dactinomycin will do as well as the risks of using it.
Dactinomycin is to be administered only by or under the immediate 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, dactinomycin 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 dactinomycin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to dactinomycin 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.
Because of increased toxicity, use of dactinomycin in infants less than 6 to 12 months of age is not recommended.
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 or if they cause different side effects or problems in older people. There is no specific information about the use of dactinomycin in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking dactinomycin, 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 dactinomycin 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.
Using dactinomycin 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.
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 dactinomycin. Make sure you tell your doctor if you have any other medical problems, especially:
Dactinomycin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.
dactinomycin often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.
dactinomycin is very toxic and can cause severe damage to your skin, eyes, nose, throat, or lungs. The medicine must NOT come into contact with your skin, eyes, or any other part of your body. Ask your doctor about instructions for handling dactinomycin, especially if you will be receiving dactinomycin at home. The doctor will have specific instructions for protective clothing to be worn and what to do if you inhale dactinomycin, or if it comes into contact with your eyes or skin.
The dose of dactinomycin 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 dactinomycin. 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.
It is very important that your doctor check your progress at regular visits to make sure that dactinomycin is working properly and to check for unwanted effects.
While you are being treated with dactinomycin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Dactinomycin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Dactinomycin can temporarily lower the number of white blood cells in your blood increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
If dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring. Tell the health care professional right away if you notice redness, pain, or swelling at the place of injection.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible 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:
dactinomycin often causes a temporary loss of hair, sometimes including the eyebrows. After treatment with dactinomycin has ended, normal hair growth should return.
After you stop using dactinomycin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
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: dactinomycin Intravenous side effects (in more detail)
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Metoprololsuccinat dura may be available in the countries listed below.
Metoprolol succinate and tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprololsuccinat dura in the following countries:
International Drug Name Search
Arovit may be available in the countries listed below.
Retinol is reported as an ingredient of Arovit in the following countries:
Retinol acetate (a derivative of Retinol) is reported as an ingredient of Arovit in the following countries:
Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Arovit in the following countries:
International Drug Name Search
Rx Only
Each Dyphylline GG ES TABLET for oral administration contains:
| Dyphylline | 200 mg |
| Guaifenesin | 300 mg |
Dyphylline GG ES also contains the following inactive ingredients: Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyvinylpyrrolidone, Silica, Sodium Saccharin, Sodium Starch Glycolate, Stearic Acid and Vanilla Flavor.
Dyphylline is a bronchodilator which occurs as a white, odorless, extremely bitter, amorphous or crystalline solid. It is freely soluble in water; sparingly soluble in alcohol and in chloroform; practically insoluble in ether. The chemical name is 1H Purine-2,6-dione, 7-(2,3- dihydroxypropyl)-3,7-dihydro- 1,3-dimethyl-. Its structural formula is as follows:
Guaifenesin is an expectorant which occurs as a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. The chemical name is 1, 2-Propanediol, 3-(2-methoxyphenoxy)-. Its structural formula is as follows:
Dyphylline is a xanthine derivative with pharmacologic actions similar to those of theophylline and other members of this class of drugs. Its primary action is that of bronchodilation, but it also exhibits peripheral vasodilatory and other smooth muscle relaxant activity to a lesser degree. The bronchodilatory action of dyphylline, as with other xanthines, is thought to be mediated through competitive inhibition of phosphodiesterase with a resulting increase in cyclic AMP producing relaxation of bronchial smooth muscle.
Dyphylline is well tolerated and produces less nausea than aminophylline and other alkaline theophylline compounds when administered orally. Unlike the hydrolyzable salts of theophylline, dyphylline is not converted to free theophylline in vivo. It is absorbed rapidly in therapeutically active form and in healthy volunteers reaches a mean peak plasma concentration of 17.1 mcg/mL in approximately 45 minutes following a single oral dose of 1000 mg of dyphylline.
Dyphylline exerts its bronchodilatory effects directly and, unlike theophylline, is excreted unchanged by the kidneys without being metabolized by the liver. Because of this, dyphylline pharmacokinetics and plasma levels are not influenced by various factors that affect liver function and hepatic enzyme activity, such as smoking, age, or concomitant use of drugs which affect liver function.
The elimination half-life of dyphylline is approximately two hours (1.8-2.1 hr) and approximately 88% of a single oral dose can be recovered from the urine unchanged. The renal clearance would be correspondingly reduced in patients with impaired renal function. In anuric patients, the half-life may be increased 3 to 4 times normal.
Dyphylline plasma levels are dose-related and generally predictable. The therapeutic range of plasma levels within which dyphylline can be expected to produce effective bronchodilation has not been determined.
Guaifenesin is an exportant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.
Dyphylline GG ES is indicated for the temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma. Dyphylline GG ES also helps to loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Hypersensitivity to any of the ingredients or related compounds.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a physician.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by your physician.
Do not use this product unless a diagnosis of asthma has been made by a doctor.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a doctor. Dyphylline GG ES is not indicated in the management of status asthmaticus, which is a serious medical emergency.
Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with an increased risk of adverse effects.
Use Dyphylline GG ES with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury or peptic ulcer. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Synergism between xanthine bronchodilators (e.g., theophylline), ephedrine, and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly.
Concurrent administration of dyphylline and probenecid, which competes for tubular secretion, has been shown to increase the plasma half-life of dyphylline. Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels.
Guaifenesin may produce an increase in urinary 5- hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.
No long-term animal studies have been performed with Dyphylline GG ES.
Animal reproduction studies have not been conducted with Dyphylline GG ES. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyphylline GG ES should be given to a pregnant woman only if the potential benefit to the mother, justifies the potential risk to the fetus.
If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
Dyphylline is present in human milk at approximately twice the maternal plasma concentration. This product should not be given to nursing mothers.
Safety and effectiveness in the pediatric population has not been established. This product is not indicated for use in the pediatric population.
Dyphylline GG ES may cause nausea, headache, cardiac palpitation and CNS stimulation. Postprandial administration may help avoid gastric discomfort.
The following adverse reactions have been reported with other xanthine bronchodilators and have most often related to excessive drug plasma levels. They should be considered as potential adverse effects when dyphylline is administered:
Gastrointestinal: nausea, vomiting, epigastric pain, hematemesis, diarrhea
Central Nervous System: headache, irritability, restlessness, insomnia, hyperexcitability, agitation, muscle twitching, generalized clonic and tonic convulsions.
Cardiovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory failure, ventricular arrhythmias.
Respiratory: tachypnea
Renal: albuminuria, gross and microscopic hematuria, diuresis.
Other: hyperglycemia, inappropriate ADH syndrome.
There have been no reports, in the literature, of overdosage with Dyphylline GG ES. However, the following information based on reports of theophylline overdosage are considered typical of the xanthine class of drugs and should be kept in mind.
Restlessness, anorexia, nausea, vomiting, diarrhea, insomnia, irritability, and headache. Marked overdosage with resulting severe toxicity has produced agitation, severe vomiting, dehydration, excessive thirst, tinnitus, cardiac arrhythmias, hyperthermia, diaphoresis, and generalized clonic and tonic convulsions. Cardiovascular collapse has also occurred, with some fatalities. Seizures have occurred in some cases associated with very high theophylline plasma concentrations, without any premonitory symptoms of toxicity.
There is no specific antidote for overdosage with drugs of the xanthine class. Symptomatic treatment and general supportive measures should be instituted with careful monitoring and maintanence of vital signs, fluids, and electrolytes. The stomach should be emptied by inducing emesis if the patient is conscious and responsive, or by gastric lavage, taking care to protect against aspiration especially in comatose or stuporous patients. Maintenance of an adequate airway is essential in case oxygen or assisted respiration is needed. Sympathomimetic agents should be avoided but sedatives such as short-acting barbiturates may be useful. Dyphylline is dialyzable and, although not recommended as a routine procedure in overdosage cases, hemodialysis may be of some benefit when severe intoxication is present or when the patient has not responded to general supportive and symptomatic treatment.
DO NOT EXCEED RECOMMENDED DOSAGE.
Dyphylline GG ES: Adults and adolescents 18 years of age and over: 1 tablet administered orally 3 or 4 times daily. In severe cases, dosage may be doubled if necessary. Maintenance dosage should be adjusted according to patient response.
Dyphylline GG ES, each tablet of which contains dyphylline 200 mg and guaifenesin 300 mg, are supplied as a white, capsule shaped tablet, embossed "B 536" in bottles of 100, NDC 51991-536-01.
Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°-86°F). See USP Controlled Room Temperature.
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Rx Only
Manufactured By:
Contract Pharmacal Corp.
Hauppauge, NY 11788
Distributed By:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Rev. 06/09
Breckenridge
Pharmaceutical, Inc.
NDC 51991-536-01
Dyphylline GG ES
Dyphylline & Guaifenesin
Tablets
Rx Only
100 TABLETS
| DYPHYLLINE GG ES dyphylline and guaifenesin tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 02/01/2008 | 02/28/2012 | |
| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Contract Pharmacal | 057795122 | MANUFACTURE | |
Molsidomine Teva may be available in the countries listed below.
Molsidomine is reported as an ingredient of Molsidomine Teva in the following countries:
International Drug Name Search
