Perivax may be available in the countries listed below.
Ingredient matches for Perivax
Pentoxifylline
Pentoxifylline is reported as an ingredient of Perivax in the following countries:
- Peru
International Drug Name Search
Tuesday, 26 April 2011
Monday, 25 April 2011
Promezin
Promezin may be available in the countries listed below.
Ingredient matches for Promezin
Promethazine
Promethazine hydrochloride (a derivative of Promethazine) is reported as an ingredient of Promezin in the following countries:
- Bangladesh
International Drug Name Search
Friday, 22 April 2011
Haloperidol Prodes
Haloperidol Prodes may be available in the countries listed below.
Ingredient matches for Haloperidol Prodes
Haloperidol
Haloperidol is reported as an ingredient of Haloperidol Prodes in the following countries:
- Spain
International Drug Name Search
Saturday, 16 April 2011
DocuSol
Generic Name: docusate (DOK ue sate)
Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax
What is DocuSol (docusate)?
Docusate is a stool softener. It makes bowel movements softer and easier to pass.
Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.
Docusate may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about DocuSol (docusate)?
You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.
Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.
What should I discuss with my healthcare provider before using DocuSol (docusate)?
You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.
Ask a doctor or pharmacist if it is safe for you to take docusate:
if you are on a low-salt diet; or
if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.
It is not known whether docusate 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 docusate 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. Do not give this medication to a child younger than 2 years old without the advice of a doctor.
How should I use DocuSol (docusate)?
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.
Take docusate tablets or capsules with a full glass of water. Drink plenty of liquids while you are taking docusate. Do not crush, chew, or break a docusate capsule. Swallow it whole.
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. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.
Do not take docusate rectal enema by mouth. It is for use only in your rectum. Wash your hands before and after using docusate rectal enema.
Try to empty your bowel and bladder just before using the enema.
Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.
After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.
Do not use docusate for longer than 7 days unless your doctor has told you to. Overuse of a stool softener can lead to serious medical problems. Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Since docusate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting or stomach pain.
What should I avoid while using DocuSol (docusate)?
Avoid using laxatives or other stool softeners unless your doctor has told you to.
Avoid using the bathroom just after using docusate enema.
DocuSol (docusate) 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 docusate and call your doctor at once if you have a serious side effect such as:
rectal bleeding or irritation;
numbness or a rash around your rectum;
severe diarrhea or stomach cramps; or
continued constipation.
Less serious side effects may include:
mild diarrhea; or
mild nausea.
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 DocuSol (docusate)?
There may be other drugs that can interact with docusate. 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 DocuSol resources
- DocuSol Side Effects (in more detail)
- DocuSol Use in Pregnancy & Breastfeeding
- DocuSol Drug Interactions
- DocuSol Support Group
- 0 Reviews for DocuSol - Add your own review/rating
- Docusate Professional Patient Advice (Wolters Kluwer)
- Colace MedFacts Consumer Leaflet (Wolters Kluwer)
- Diocto Liquid MedFacts Consumer Leaflet (Wolters Kluwer)
- Docusate Salts Monograph (AHFS DI)
- Dostinex Monograph (AHFS DI)
- Enemeez Mini Enema MedFacts Consumer Leaflet (Wolters Kluwer)
Compare DocuSol with other medications
- Constipation
Where can I get more information?
- Your pharmacist can provide more information about docusate.
See also: DocuSol side effects (in more detail)
Saturday, 9 April 2011
Selipran
Selipran may be available in the countries listed below.
Ingredient matches for Selipran
Pravastatin
Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Selipran in the following countries:
- Switzerland
International Drug Name Search
Sunday, 3 April 2011
Amoxicilline Merck
Amoxicilline Merck may be available in the countries listed below.
Ingredient matches for Amoxicilline Merck
Amoxicillin
Amoxicillin is reported as an ingredient of Amoxicilline Merck in the following countries:
- Luxembourg
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline Merck in the following countries:
- Netherlands
International Drug Name Search
Saturday, 2 April 2011
Pakadel
Pakadel may be available in the countries listed below.
Ingredient matches for Pakadel
Atorvastatin
Atorvastatin is reported as an ingredient of Pakadel in the following countries:
- Colombia
International Drug Name Search
Friday, 1 April 2011
Demser
Demser1 (Metyrosine) is (–)-α-methyl-L-tyrosine or (α-MPT). It has the following structural formula:
Metyrosine is a white, crystalline compound of molecular weight 195. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene. It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions, but is subject to oxidative degradation under these conditions.
Demser is supplied as capsules, for oral administration. Each capsule contains 250 mg metyrosine. Inactive ingredients are colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, magnesium stearate, titanium dioxide, and FD&C Blue 2.
- 1
- Registered trademark of ATON PHARMA, INC.
COPYRIGHT © 2007 ATON PHARMA, INC.
All rights reserved
Demser - Clinical Pharmacology
Demser inhibits tyrosine hydroxylase, which catalyzes the first transformation in catecholamine biosynthesis, i.e., the conversion of tyrosine to dihydroxyphenylalanine (DOPA). Because the first step is also the rate-limiting step, blockade of tyrosine hydroxylase activity results in decreased endogenous levels of catecholamines, usually measured as decreased urinary excretion of catecholamines and their metabolites.
In patients with pheochromocytoma, who produce excessive amounts of norepinephrine and epinephrine, administration of one to four grams of Demser per day has reduced catecholamine biosynthesis from about 35 to 80 percent as measured by the total excretion of catecholamines and their metabolites (metanephrine and vanillylmandelic acid). The maximum biochemical effect usually occurs within two to three days, and the urinary concentration of catecholamines and their metabolites usually returns to pretreatment levels within three to four days after Demser is discontinued. In some patients the total excretion of catecholamines and catecholamine metabolites may be lowered to normal or near normal levels (less than 10 mg/24 hours). In most patients the duration of treatment has been two to eight weeks, but several patients have received Demser for periods of one to 10 years. Most patients with pheochromocytoma treated with Demser experience decreased frequency and severity of hypertensive attacks with their associated headache, nausea, sweating, and tachycardia. In patients who respond, blood pressure decreases progressively during the first two days of therapy with Demser; after withdrawal, blood pressure usually increases gradually to pretreatment values within two to three days.
Metyrosine is well absorbed from the gastrointestinal tract. From 53 to 88 percent (mean 69 percent) was recovered in the urine as unchanged drug following maintenance oral doses of 600 to 4000 mg/24 hours in patients with pheochromocytoma or essential hypertension. Less than 1% of the dose was recovered as catechol metabolites. These metabolites are probably not present in sufficient amounts to contribute to the biochemical effects of metyrosine. The quantities excreted, however, are sufficient to interfere with accurate determination of urinary catecholamines determined by routine techniques.
Plasma half-life of metyrosine determined over an 8-hour period after single oral doses was 3-3.7 hours in three patients.
For further information, refer to: Sjoerdsma, A.; Engelman, K.; Waldman, T.A.; Cooperman, L.H.; Hammond, W.G.: Pheochromocytoma: Current concepts of diagnosis and treatment, Ann. Intern. Med. 65: 1302-1326, Dec. 1966.
Indications and Usage for Demser
Demser is indicated in the treatment of patients with pheochromocytoma for:
1. Preoperative preparation of patients for surgery
2. Management of patients when surgery is contraindicated
3. Chronic treatment of patients with malignant pheochromocytoma.
Demser is not recommended for the control of essential hypertension.
Contraindications
Demser is contraindicated in persons known to be hypersensitive to this compound.
Warnings
Maintain Fluid Volume During and After Surgery
When Demser is used preoperatively, alone or especially in combination with alpha-adrenergic blocking drugs, adequate intravascular volume must be maintained intraoperatively (especially after tumor removal) and postoperatively to avoid hypotension and decreased perfusion of vital organs resulting from vasodilatation and expanded volume capacity. Following tumor removal, large volumes of plasma may be needed to maintain blood pressure and central venous pressure within the normal range.
In addition, life-threatening arrhythmias may occur during anesthesia and surgery, and may require treatment with a beta-blocker or lidocaine. During surgery, patients should have continuous monitoring of blood pressure and electrocardiogram.
Intraoperative Effects
While the preoperative use of Demser in patients with pheochromocytoma is thought to decrease intraoperative problems with blood pressure control, Demser does not eliminate the danger of hypertensive crises or arrhythmias during manipulation of the tumor, and the alpha-adrenergic blocking drug, phentolamine, may be needed.
Interaction with Alcohol
Demser may add to the sedative effects of alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. (See PRECAUTIONS, Information for Patients and Drug Interactions.)
Precautions
General
Metyrosine Crystalluria
Crystalluria and urolithiasis have been found in dogs treated with Demser (Metyrosine) at doses similar to those used in humans, and crystalluria has also been observed in a few patients. To minimize the risk of crystalluria, patients should be urged to maintain water intake sufficient to achieve a daily urine volume of 2000 mL or more, particularly when doses greater than 2 g per day are given. Routine examination of the urine should be carried out. Metyrosine will crystallize as needles or rods. If metyrosine crystalluria occurs, fluid intake should be increased further. If crystalluria persists, the dosage should be reduced or the drug discontinued.
Relatively Little Data Regarding Long-term Use
The total human experience with the drug is quite limited and few patients have been studied long-term. Chronic animal studies have not been carried out. Therefore, suitable laboratory tests should be carried out periodically in patients requiring prolonged use of Demser and caution should be observed in patients with impaired hepatic or renal function.
Information for Patients
When receiving Demser, patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a motor vehicle or operating machinery. Demser may have additive sedative effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers.
Patients should be advised to maintain a liberal fluid intake. (See PRECAUTIONS, General.)
Drug Interactions
Caution should be observed in administering Demser to patients receiving phenothiazines or haloperidol because the extrapyramidal effects of these drugs can be expected to be potentiated by inhibition of catecholamine synthesis.
Concurrent use of Demser with alcohol or other CNS depressants can increase their sedative effects. (See WARNINGS and PRECAUTIONS, Information for Patients.)
Laboratory Test Interference
Spurious increases in urinary catecholamines may be observed in patients receiving Demser due to the presence of metabolites of the drug.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenic studies in animals and studies on mutagenesis and impairment of fertility have not been performed with metyrosine.
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Demser. It is also not known whether Demser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Demser should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether Demser is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Demser is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Geriatric Use
Clinical studies of Demser 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 range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse Reactions
Central Nervous System
Sedation:
The most common adverse reaction to Demser is moderate to severe sedation, which has been observed in almost all patients. It occurs at both low and high dosages. Sedative effects begin within the first 24 hours of therapy, are maximal after two to three days, and tend to wane during the next few days. Sedation usually is not obvious after one week unless the dosage is increased, but at dosages greater than 2000 mg/day some degree of sedation or fatigue may persist.
In most patients who experience sedation, temporary changes in sleep pattern occur following withdrawal of the drug. Changes consist of insomnia that may last for two or three days and feelings of increased alertness and ambition. Even patients who do not experience sedation while on Demser may report symptoms of psychic stimulation when the drug is discontinued.
Extrapyramidal Signs:
Extrapyramidal signs such as drooling, speech difficulty, and tremor have been reported in approximately 10 percent of patients. These occasionally have been accompanied by trismus and frank parkinsonism.
Anxiety and Psychic Disturbances:
Anxiety and psychic disturbances such as depression, hallucinations, disorientation, and confusion may occur. These effects seem to be dose-dependent and may disappear with reduction of dosage.
Diarrhea
Diarrhea occurs in about 10 percent of patients and may be severe. Anti-diarrheal agents may be required if continuation of Demser is necessary.
Miscellaneous
Infrequently, slight swelling of the breast, galactorrhea, nasal stuffiness, decreased salivation, dry mouth, headache, nausea, vomiting, abdominal pain, and impotence or failure of ejaculation may occur. Crystalluria (see PRECAUTIONS) and transient dysuria and hematuria have been observed in a few patients. Hematologic disorders (including eosinophilia, anemia, thrombocytopenia, and thrombocytosis), increased SGOT levels, peripheral edema, and hypersensitivity reactions such as urticaria and pharyngeal edema have been reported rarely.
Overdosage
Signs of metyrosine overdosage include those central nervous system effects observed in some patients even at low dosages.
At doses exceeding 2000 mg/day, some degree of sedation or feeling of fatigue may persist. Doses of 2000-4000 mg/day can result in anxiety or agitated depression, neuromuscular effects (including fine tremor of the hands, gross tremor of the trunk, tightening of the jaw with trismus), diarrhea, and decreased salivation with dry mouth.
Reduction of drug dose or cessation of treatment results in the disappearance of these symptoms.
The acute toxicity of metyrosine was 442 mg/kg and 752 mg/kg in the female mouse and rat respectively.
Demser Dosage and Administration
The recommended initial dosage of Demser for adults and children 12 years of age and older is 250 mg orally four times daily. This may be increased by 250 mg to 500 mg every day to a maximum of 4.0 g/day in divided doses. When used for preoperative preparation, the optimally effective dosage of Demser should be given for at least five to seven days.
Optimally effective dosages of Demser usually are between 2.0 and 3.0 g/day, and the dose should be titrated by monitoring clinical symptoms and catecholamine excretion. In patients who are hypertensive, dosage should be titrated to achieve normalization of blood pressure and control of clinical symptoms. In patients who are usually normotensive, dosage should be titrated to the amount that will reduce urinary metanephrines and/or vanillylmandelic acid by 50 percent or more.
If patients are not adequately controlled by the use of Demser, an alpha-adrenergic blocking agent (phenoxybenzamine) should be added.
Use of Demser in children under 12 years of age has been limited and a dosage schedule for this age group cannot be given.
How is Demser Supplied
Capsules Demser, 250 mg, are opaque, two-toned blue capsules coded Aton 305 on one side and Demser on the other. They are supplied as follows:
- NDC 25010-305-15 bottles of 100.
Distributed by:
ATON PHARMA
Lawrenceville
NJ 08648
USA
Manufactured by:
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031 USA
Issued February 2010
8834-00
PRINCIPAL DISPLAY PANEL - 250 mg Capsule Label
Demser® 250 mg
(Metyrosine)
NDC 25010-305-15
Distributed by:
ATON PHARMA, INC.
LAWRENCEVILLE, NJ 08648, USA
Rx only
USUAL ADULT DOSAGE:
See accompanying circular.
This is a bulk package and not intended
for dispensing.
Package not child resistant.
Dispense in a well-closed container.
100 Capsules
| Demser metyrosine capsule | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017871 | 10/03/1979 | |
| Labeler - Aton Pharma, Inc. (795419675) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pharmaceutics International, Inc. | 878265586 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Draxis Pharma, Inc. (Produits Pharmaceutiques Specialises Draxis Inc.) | 243604761 | PACK | |
More Demser resources
- Demser Side Effects (in more detail)
- Demser Dosage
- Demser Use in Pregnancy & Breastfeeding
- Drug Images
- Demser Drug Interactions
- Demser Support Group
- 0 Reviews for Demser - Add your own review/rating
- Demser Concise Consumer Information (Cerner Multum)
- Demser Advanced Consumer (Micromedex) - Includes Dosage Information
- Demser MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Demser with other medications
- Pheochromocytoma
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