Udofen Atomizer may be available in the countries listed below.
Cetylpyridinium chloride (a derivative of Cetylpyridinium) is reported as an ingredient of Udofen Atomizer in the following countries:
Undecylenic Acid is reported as an ingredient of Udofen Atomizer in the following countries:
International Drug Name Search
meth-il-FEN-i-date
Give cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur .
In the U.S.
Available Dosage Forms:
Therapeutic Class: CNS Stimulant
Chemical Class: Amphetamine Related
Methylphenidate transdermal belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD).
Methylphenidate transdermal works by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. methylphenidate is used as part of a total treatment program that also includes social, educational, and psychological treatment.
methylphenidate is available only with a doctor's prescription.
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 methylphenidate, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to methylphenidate 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 methylphenidate transdermal in the pediatric population. However, safety and efficacy have not been established in children younger than 6 years of age.
Appropriate studies on the relationship of age to the effects of methylphenidate transdermal have not been performed in geriatric patients.
| 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. |
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 methylphenidate, 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 methylphenidate 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 methylphenidate with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 methylphenidate. Make sure you tell your doctor if you have any other medical problems, especially:
methylphenidate should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use the skin patch:
The dose of methylphenidate 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 methylphenidate. 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.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
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.
Throw any used patch away so that children or pets cannot get to it. There is still enough medicine in a used patch to make a child or pet very sick. When throwing away a patch, fold it in half with the sticky sides together and flush it down the toilet, and then wash your hands thoroughly with soap and water. When you stop treatment with methylphenidate, take all of the leftover patches out of the pouches and flush them down the toilet. Do not flush the pouches or the protective liners down the toilet. Put them in a trash can with a cover. You will also need to throw away old patches after the expiration date has passed.
It is very important that your doctor should check the progress of your or your child at regular visits to make sure methylphenidate is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.
You should not use methylphenidate if you or your child have used a medicine for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while using methylphenidate.
If you or your child have any redness, itching, swelling, or blistering where the patch has been, call your doctor right away.
Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
methylphenidate may cause slow growth. If your child is using methylphenidate, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
Methylphenidate transdermal may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how methylphenidate affects you.
Avoid putting methylphenidate near external sources of direct heat, such as hair dyers, heating pads, electric blankets, heated water beds, or hot tubs.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.
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:
Get emergency help immediately if any of the following symptoms of overdose 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.
See also: methylphenidate Transdermal side effects (in more detail)
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Aspirinetas may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Aspirinetas in the following countries:
International Drug Name Search
This drug can cause serious fetal harm and possibly fetal death if used during pregnancy. If you become pregnant, contact your doctor right away.
Lowering high blood pressure.
Moexipril/Hydrochlorothiazide is an angiotensin-converting enzyme (ACE) inhibitor and thiazide diuretic combination. It works to lower your blood pressure by removing excess fluid from the body and causing blood vessels to relax or widen.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Moexipril/Hydrochlorothiazide. 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 Moexipril/Hydrochlorothiazide. 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 Moexipril/Hydrochlorothiazide 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 Moexipril/Hydrochlorothiazide 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 Moexipril/Hydrochlorothiazide.
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:
Diarrhea; dizziness; dry cough; headache; nausea; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount or urine produced; chest pain; difficult or painful urination; drowsiness; dry mouth; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, weakness, or cramps; numbness or tingling; one-sided weakness; red, swollen, blistered, or peeling skin; restlessness; severe or persistent dizziness or light-headedness; severe or persistent nausea or vomiting; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); sudden, severe headache or vomiting; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine; pale stools; unusual loss of appetite, tiredness, or stomach pain; yellowing of the skin or eyes); symptoms of low blood sodium (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness).
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: Moexipril/Hydrochlorothiazide 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 fainting; severe or persistent dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, drowsiness; dry eyes; fast heartbeat; nausea; restlessness; unusual thirst, tiredness, or weakness; vomiting).
Store Moexipril/Hydrochlorothiazide between 68 and 77 degrees F (20 and 25 degrees C). Keep in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Moexipril/Hydrochlorothiazide out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Moexipril/Hydrochlorothiazide. 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.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Moban is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Moban (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes.
Moban is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4 (5H)-one hydrochloride. It is a white to off-white crystalline powder, freely soluble in water and alcohol.
Moban Tablets contain the following inactive ingredients:
Calcium sulfate, lactose, magnesium stearate, microcrystalline cellulose and povidone.
The 5 mg strength also contains alginic acid, colloidal silicon dioxide and FD&C Yellow 6. The 10 mg strength also contains alginic acid, colloidal silicon dioxide, FD&C Blue 2 and FD&C Red 40. The 25 mg strength also contains alginic acid, colloidal silicon dioxide, D&C Yellow 10, FD&C Blue 2, and FD&C Yellow 6. The 50 mg strength also contains FD&C Blue 2 and sodium starch glycolate.
Molindone Hydrochloride is represented by the following structural formula:
The empirical formula is C16H24N2O2• HCl representing a molecular weight of 312.83.
Moban has a pharmacological profile in laboratory animals which predominantly resembles that of other antipsychotic agents causing reduction of spontaneous locomotion and aggressiveness, suppression of a conditioned response and antagonism of the bizarre stereotyped behavior and hyperactivity induced by amphetamines. In addition, Moban antagonizes the depression caused by the tranquilizing agent tetrabenazine.
In human clinical studies an antipsychotic effect is achieved in the absence of muscle relaxing or incoordinating effects. Based on EEG studies, Moban exerts its effect on the ascending reticular activating system.
Human metabolic studies show Moban to be rapidly absorbed and metabolized when given orally. Unmetabolized drug reached a peak blood level at 1.5 hours.
Pharmacological effect from a single oral dose persists for 24-36 hours. There are 36 recognized metabolites with less than 2-3% unmetabolized Moban being excreted in urine and feces.
Moban is indicated for the management of schizophrenia. The efficacy of Moban in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.
Moban is contraindicated in severe central nervous system depression (alcohol, barbiturates, narcotics, etc.) or comatose states, and in patients with known hypersensitivity to the drug.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Moban is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
(For further information about the description of tardive dyskinesia and its clinical detection, please refer to the section on Adverse Reactions.)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include, 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
Some patients receiving Moban (molindone hydrochloride) may note drowsiness initially and they should be advised against activities requiring mental alertness until their response to the drug has been established.
Increased activity has been noted in patients receiving Moban. Caution should be exercised where increased activity may be harmful.
Moban does not lower the seizure threshold in experimental animals to the degree noted with more sedating antipsychotic drugs. However, in humans convulsive seizures have been reported in a few instances.
The physician should be aware that this tablet preparation contains calcium sulfate as an excipient and that calcium ions may interfere with the absorption of preparations containing phenytoin sodium and tetracyclines.
Moban has an antiemetic effect in animals. A similar effect may occur in humans and may obscure signs of intestinal obstruction or brain tumor.
Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.
Moban has not been shown effective in the management of behavioral complications in patients with mental retardation
Class Effect: In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.
Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Moban should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue Moban and have their WBC followed until recovery.
Potentiation of drugs administered concurrently with Moban has not been reported. Additionally, animal studies have not shown increased toxicity when Moban is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs).
Studies in pregnant patients have not been carried out. Reproduction studies have been performed in the following animals:
no adverse effect 20 mg/kg/day - 10 days
no adverse effect 40 mg/kg/day - 10 days
slight increase resorptions 20 mg/kg/day - 10 days
slight increase resorptions 40 mg/kg/day - 10 days
no adverse effect 5 mg/kg/day - 12 days
no adverse effect 10 mg/kg/day - 12 days
no adverse effect 20 mg/kg/day - 12 days
Animal reproductive studies have not demonstrated a teratogenic potential. The anticipated benefits must be weighed against the unknown risks to the fetus if used in pregnant patients.
Data are not available on the content of Moban (molindone hydrochloride) in the milk of nursing mothers.
Use of Moban in pediatric patients below the age of twelve years is not recommended because safe and effective conditions for its usage have not been established.
The most frequently occurring effect is initial drowsiness that generally subsides with continued usage of the drug or lowering of the dose.
Noted less frequently were depression, hyperactivity and euphoria.
Extrapyramidal symptoms noted below may occur in susceptible individuals and are usually reversible with appropriate management.
Motor restlessness may occur early.
Akinesia, characterized by rigidity, immobility and reduction of voluntary movements and tremor, have been observed. Occurrence is less frequent than akathisia.
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Antipsychotic drugs are known to cause a syndrome of dyskinetic movements commonly referred to as tardive dyskinesia. The movements may appear during treatment or upon withdrawal of treatment and may be either reversible or irreversible (i.e., persistent) upon cessation of further antipsychotic administration.
The syndrome is known to have a variable latency for development and the duration of the latency cannot be determined reliably. It is thus wise to assume that any antipsychotic agent has the capacity to induce the syndrome and act accordingly until sufficient data has been collected to settle the issue definitively for a specific drug product. In the case of antipsychotics known to produce the irreversible syndrome, the following has been observed.
Tardive dyskinesia has appeared in some patients on long-term therapy and has also appeared after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). There may be involuntary movements of extremities.
There is no known effective treatment of tardive dyskinesia; antiparkinsonism agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop (See WARNINGS).
Occasionally blurring of vision, tachycardia, nausea, dry mouth and salivation have been reported. Urinary retention and constipation may occur particularly if anticholinergic drugs are used to treat extrapyramidal symptoms. One patient being treated with Moban experienced priapism which required surgical intervention, apparently resulting in residual impairment of erectile function.
There have been rare reports of leucopenia and leucocytosis. If such reactions occur, treatment with Moban may continue if clinical symptoms are absent. Alterations of blood glucose, B.U.N., and red blood cells have not been considered clinically significant.
Alteration of thyroid function has not been significant. Amenorrhea has been reported infrequently. Resumption of menses in previously amenorrheic women has been reported. Initially heavy menses may occur. Galactorrhea and gynecomastia have been reported infrequently. Increase in libido has been noted in some patients. Impotence has not been reported. Although both weight gain and weight loss have been in the direction of normal or ideal weight, excessive weight gain has not occurred with Moban.
There have been rare reports of clinically significant alterations in liver function in association with Moban use.
Rare, transient, non-specific T wave changes have been reported on E.K.G. Association with a clinical syndrome has not been established. Rarely has significant hypotension been reported.
Lens opacities and pigmentary retinopathy have not been reported where patients have received Moban. In some patients, phenothiazine induced lenticular opacities have resolved following discontinuation of the phenothiazine while continuing therapy with Moban.
Early, non-specific skin rash, probably of allergic origin, has occasionally been reported. Skin pigmentation has not been seen with Moban usage alone.
Moban has certain pharmacological similarities to other antipsychotic agents. Because adverse reactions are often extensions of the pharmacological activity of a drug, all of the known pharmacological effects associated with other antipsychotic drugs should be kept in mind when Moban is used. Upon abrupt withdrawal after prolonged high dosage an abstinence syndrome has not been noted.
Symptomatic, supportive therapy should be the rule.
Gastric lavage is indicated for the reduction of absorption of Moban which is freely soluble in water.
Since the adsorption of Moban by activated charcoal has not been determined, the use of this antidote must be considered of theoretical value.
Emesis in a comatose patient is contraindicated. Additionally, while the emetic effect of apomorphine is blocked by Moban in animals, this blocking effect has not been determined in humans.
A significant increase in the rate of removal of unmetabolized Moban from the body by forced diuresis, peritoneal or renal dialysis would not be expected. (Only 2% of a single ingested dose of Moban is excreted unmetabolized in the urine). However, poor response of the patient may justify use of these procedures.
While the use of laxatives or enemas might be based on general principles, the amount of unmetabolized Moban in feces is less than 1%. Extrapyramidal symptoms have responded to the use of Diphenhydramine (Benadryl®)*, Amantadine HCl (Symmetrel®)† and the synthetic anticholinergic antiparkinson agents, (i.e., Artane®‡, Cogentin®§, Akineton®¶).
Initial and maintenance doses of Moban should be individualized.
The usual starting dosage is 50-75 mg/day.
—Increase to 100 mg/day in 3 or 4 days.
—Based on severity of symptomatology, dosage may be titrated up or down depending on individual patient response.
—An increase to 225 mg/day may be required in patients with severe symptomatology.
Elderly and debilitated patients should be started on lower dosage.
1. Mild-5 mg-15 mg three or four times a day.
2. Moderate-10 mg-25 mg three or four times a day.
3. Severe-225 mg/day may be required.
Moban (molindone hydrochloride) tablets are supplied in bottles of 100 tablets as follows:
5 mg Orange, round, biconvex tablet, one face debossed with “Moban 5”, and the
other face plain. NDC 63481-072-70
10 mg Lavender, round, biconvex tablet, one face debossed with “Moban 10”, and
the other face plain. NDC 63481-073-70
25 mg Green, round, biconvex tablet, one face debossed with “Moban 25”, and the
other face plain with partial bisect. NDC 63481-074-70
50 mg Blue, round, biconvex tablet, one face with partial bisect and debossed with
“Moban 50”, and the other face plain. NDC 63481-076-70
Store at 25°C (77°F); excursions permitted to 15°-30°C (59º-86ºF).
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP TIGHTLY CLOSED
* Benadryl is a registered trademark of Warner-Lambert.
†Symmetrel is a registered trademark of Endo Pharmaceuticals Inc.
‡Artane is a registered trademark of Lederle Laboratories.
§Cogentin is a registered trademark of Merck & Co., Inc.
¶ Akineton is a registered trademark of Knoll Laboratories.
Moban is a registered trademark of Endo Pharmaceuticals Inc.
Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317
© 2009 Endo Pharmaceuticals
Printed in U.S.A. 2005295 / June, 2009
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017111 | 07/03/1974 | |
| Labeler - Endo Pharmaceuticals Inc. (178074951) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Novartis Consumer Health, Inc. | 129836151 | MANUFACTURE | |
Zenith may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Diflubenzuron is reported as an ingredient of Zenith in the following countries:
International Drug Name Search
Generic Name: coal tar (Topical route)
kole tar
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Keratolytic
Coal tar is used to treat eczema, psoriasis, seborrheic dermatitis, and other skin disorders.
Some of these preparations are available only with your doctor's prescription.
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.
Coal tar products should not be used on infants, unless otherwise directed by your doctor. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.
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 comparing use of this medicine in the elderly with use in other age groups.
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.
This section provides information on the proper use of a number of products that contain coal tar. It may not be specific to Spectro Tar Skin Wash. Please read with care.
Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
After applying coal tar, protect the treated area from direct sunlight and do not use a sunlamp for 72 hours, unless otherwise directed by your doctor, since a severe reaction may occur. Also, make sure you have removed all the coal tar medicine from your skin before you go back into direct sunlight or use a sunlamp.
Do not apply this medicine to infected, blistered, raw, or oozing areas of the skin.
Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once.
To use the cream or ointment form of this medicine:
To use the gel form of this medicine:
To use the shampoo form of this medicine:
To use the nonshampoo liquid form of this medicine:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If this medicine is used on the scalp, it may temporarily discolor blond, bleached, or tinted hair.
Coal tar may stain the skin or clothing. Avoid getting it on your clothing. The stain on the skin will wear off after you stop using the medicine.
In animal studies, coal tar has been shown to increase the chance of skin cancer.
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 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:
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: Spectro Tar Skin Topical side effects (in more detail)
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