Fumaderm

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Fumaderm uses

Fumaderm consists of Calcium Monoethyl Fumarate, Dimethyl Fumarate, Magnesium Monoethyl Fumarate, Zinc Monoethyl Fumarate.

Dimethyl Fumarate:


INDICATIONS AND USAGE

Fumaderm (Dimethyl Fumarate)® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. Fumaderm (Dimethyl Fumarate)® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of Fumaderm (Dimethyl Fumarate) sulfoxide in the treatment of bacterial infections of the urinary tract.

CONTRAINDICATIONS

None known.

WARNINGS

Fumaderm (Dimethyl Fumarate) sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of Fumaderm (Dimethyl Fumarate) sulfoxide. This hypersensitivity has been reported in one patients receiving intravesical Fumaderm (Dimethyl Fumarate)®. The physician should be cognizant of this possibility in prescribing Fumaderm (Dimethyl Fumarate)®. If anaphylactoid symptoms develop, appropriate therapy should be instituted.

PRECAUTIONS

Changes in the refractive index and lens opacities have been seen in monkeys, dogs and rabbits given high doses of Fumaderm sulfoxide chronically. Since lens changes were noted in animals, full eye evaluations, including slit lamp examinations, are recommended prior to and periodically during treatment.

Approximately every six months patients receiving Fumaderm (Dimethyl Fumarate) sulfoxide should have a biochemical screening, particularly liver and renal function tests, and complete blood count.

Intravesical instillation of Fumaderm (Dimethyl Fumarate)® may be harmful to patients with urinary tract malignancy because of Fumaderm (Dimethyl Fumarate) sulfoxide-induced vasodilation.

Some data indicate that Fumaderm (Dimethyl Fumarate) sulfoxide potentiates other concomitantly administered medications.

Pregnancy Category C

Fumaderm (Dimethyl Fumarate) sulfoxide caused teratogenic responses in hamsters, rats and mice when administered intraperitoneally at high doses (2.5 to 12 gm/kg). Oral or topical doses of Fumaderm (Dimethyl Fumarate) sulfoxide did not cause problems of reproduction in rats, mice and hamsters. Topical doses (5 gm/kg first two days, then 2.5 gm/kg - last eight days) produced terata in rabbits, but in another study, topical doses of 1.1 gm/kg days 3 through 16 of gestation failed to produce any abnormalities. There are no adequate and well controlled studies in pregnant women. Fumaderm (Dimethyl Fumarate) sulfoxide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

INFORMATION FOR PATIENTS

Fumaderm (Dimethyl Fumarate)® is a sterile solution of 50% Fumaderm (Dimethyl Fumarate) sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis.

Fumaderm (Dimethyl Fumarate)® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.

Some data indicate that Fumaderm (Dimethyl Fumarate) sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a Fumaderm (Dimethyl Fumarate)® instillation.

A garlic-like taste may be noted by the patient within a few minutes after instillation of Fumaderm (Dimethyl Fumarate)® (dimethyl sulfoxide). This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours.

Some patients may experience discomfort on administration of the drug. Usually this becomes less prominent with repeated administration.

If you are pregnant or nursing, ask your physician about the advisability of using Fumaderm (Dimethyl Fumarate)®.

Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods. Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fumaderm (Dimethyl Fumarate) sulfoxide is administered to a nursing woman.

Safety and effectiveness in children have not been established.

Information available to be given to the patient is reprinted at the end of this text.

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ADVERSE REACTIONS

A garlic-like taste may be noted by the patient within a few minutes after instillation of Fumaderm (Dimethyl Fumarate)® (dimethyl sulfoxide). This taste may last several hours and because of the presence of metabolites, an odor on the breath and skin may remain for 72 hours.

Transient chemical cystitis has been noted following instillation of Fumaderm (Dimethyl Fumarate) sulfoxide.

The patient may experience moderately severe discomfort on administration. Usually this becomes less prominent with repeated administration.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

The oral LD50 of Fumaderm (Dimethyl Fumarate) sulfoxide in the dog is greater than 10 gm/kg. It is improbable that this dosage level could be obtained with intravesical instillation of Fumaderm (Dimethyl Fumarate)® in the patient.

In case of accidental oral ingestion, specific measures should be taken to induce emesis. Additional measures which may be considered are gastric lavage, activated charcoal and force diuresis.

DOSAGE AND ADMINISTRATION

Instillation of 50 mL of Fumaderm (Dimethyl Fumarate)® (dimethyl sulfoxide) directly into the bladder may be accomplished by catheter or asepto syringe and allow to remain for 15 minutes. Application of an analgesic lubricant gel such as lidocaine jelly to the urethra is suggested prior to insertion of the catheter to avoid spasm. The medication is expelled by spontaneous voiding. It is recommended that the treatment be repeated every two weeks until maximum symptomatic relief is obtained. Thereafter, time intervals between therapy may be increased appropriately.

Administration of oral analgesic medication or suppositories containing belladonna and opium prior to the instillation of Fumaderm (Dimethyl Fumarate)® can reduce bladder spasm.

In patients with severe interstitial cystitis with very sensitive bladders, the initial treatment, and possibly the second and third (depending on patient response) should be done under anesthesia. (Saddle block has been suggested).

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HOW SUPPLIED

Vials contain 50 mL of sterile and non-pyrogenic Fumaderm (Dimethyl Fumarate)® (50% w/w Fumaderm (Dimethyl Fumarate) sulfoxide aqueous solution).

Fumaderm (Dimethyl Fumarate) sulfoxide is clear and colorless.

NDC 67457-177-50

carton containing a 50 mL vial

Store at 20° to 25°C (68° to 77°F).

Protect from strong light.

For additional information concerning RIMSO-50®, contact Mylan Institutional LLC,

Rockford, IL 61103.

Manufactured for:

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

INFORMATION FOR PATIENTS

Fumaderm (Dimethyl Fumarate)® is a sterile solution of 50% Fumaderm (Dimethyl Fumarate) sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis.

Fumaderm (Dimethyl Fumarate)® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.

Some data indicate that Fumaderm (Dimethyl Fumarate) sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a Fumaderm (Dimethyl Fumarate)® instillation.

A garlic-like taste may be noted by the patient within a few minutes after instillation of Fumaderm (Dimethyl Fumarate)® (dimethyl sulfoxide). This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours.

Some patients may experience discomfort on administration of the drug. Usually this becomes less prominent with repeated administration.

If you are pregnant or nursing, ask your physician about the advisability of using Fumaderm (Dimethyl Fumarate)®.

Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods. Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment.

RIMSO-50®

(dimethyl sulfoxide) irrigation, USP 0582L103

Mylan Institutional LLC REVISED JULY 2012

Rockford, IL 61103 U.S.A. MI:RIMSIG:R2

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Fumaderm pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Fumaderm available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Fumaderm destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Fumaderm Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Fumaderm pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DIMETHYL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Dimethyl fumarate". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Fumaderm?

Depending on the reaction of the Fumaderm after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fumaderm not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Fumaderm addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Fumaderm, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Fumaderm consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Two visitors reported side effects

Did you get side effects while taking the Fumaderm drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Fumaderm medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects2
100.0%

Visitor reported price estimates

No survey data has been collected yet

Three visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Fumaderm drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Fumaderm is mentioned below.
Visitors%
Once in a day2
66.7%
Twice in a day1
33.3%

One visitor reported doses

What is the dose of Fumaderm drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 6-10mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
6-10mg1
100.0%

Three visitors reported time for results

What is the time duration Fumaderm drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed > 3 month to notice the result from using Fumaderm drug. The time needed to show improvement in health condition after using the medicine Fumaderm need not be same for all the users. It varies based on other factors.
Visitors%
> 3 month1
33.3%
1 week1
33.3%
5 days1
33.3%

One visitor reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Fumaderm drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
Empty stomach1
100.0%

Three visitors reported age

Visitors%
30-452
66.7%
16-291
33.3%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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