Urocedulamin

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Urocedulamin uses


DESCRIPTION:

Urocedulamin, USP, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Urocedulamin, USP is available for oral use as film-coated tablets.

Active Ingredients:

Urocedulamin: 500 mg or 0.5 gm.

Urocedulamin: 1000 mg or 1.0 gm.

Other Ingredients: Dicalcium Phosphate, FD and C Blue #1 Lake, FD and C Red #40 Lake, FD and C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Silica, Sodium Starch Glycolate and Titanium Dioxide.

CLINICAL PHARMACOLOGY

Urocedulamin, USP is readily absorbed but remains essentially inactive until it is excreted by the kidney and concentrated in the urine. An acid urine is essential for antibacterial action, with maximum efficacy occurring at pH 5.5 or less. In an acid urine, mandelic acid exerts its antibacterial action and also contributes to the acidification of the urine. Mandelic acid is excreted both by glomerular filtration and tubular excretion. The methenamine component, in an acid urine, is hydrolyzed to ammonia and to the bactericidal agent formaldehyde. There is equally effective antibacterial activity against both gram-positive and gram-negative organisms, since the antibacterial action of mandelic acid and formaldehyde is nonspecific. There are reports that Urocedulamin, USP is ineffective in some infections with Proteus vulgaris and urea-splitting strains of Pseudomonas aeruginosa and A aerogenes. Since urea-splitting strains may raise the pH of the urine, particular attention to supplementary acidification is required. However, results in any single case will depend to a large extent on the underlying pathology and the overall management.

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INDICATIONS AND USAGE

Urocedulamin, USP is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also for infected residual urine sometimes accompanying neurologic diseases. When used as recommended, Urocedulamin, USP is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop. Pathogens resistant to other antibacterial agents may respond to Urocedulamin, USP because of the nonspecific effect of formaldehyde formed in an acid urine.

Prophylactic Use Rationale: Urine is a good culture medium for many urinary pathogens. Inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. Thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. There is a growing body of evidence that long-term administration of Urocedulamin, USP can prevent the recurrence of bacteriuria in patients with chronic pyelonephritis.

Therapeutic Use Rationale: Urocedulamin, USP helps to sterilize the urine, and in some situations in which underlying pathologic conditions prevent sterilization by any means, it can help to suppress the bacteriuria. Urocedulamin, USP should not be used alone for acute infections with parenchymal involvement causing systemic symptoms such as chills and fever. A thorough diagnostic investigation as a part of the overall management of the urinary tract infection should accompany the use of Urocedulamin, USP.

CONTRAINDICATIONS

Contraindicated in renal insufficiency.

Urocedulamin, USP should not be used in patients who have previously exhibited hypersensitivity to it.

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PRECAUTIONS

General: Dysuria may occur (usually at higher than recommended dosage). This can be controlled by reducing the dosage and the acidification. When urine acidification is contraindicated or unattainable (as with some urea-splitting bacteria), the drug is not recommended.

Drug Interactions: Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, Urocedulamin, USP should not be administered concurrently with sulfamethizole.

Drug/Laboratory Test Interactions: Formaldehyde interferes with fluorometric procedures for determination of urinary catecholamines and vanillylmandelic acid (VMA), causing erroneously high results. Formaldehyde also causes falsely decreased urine estriol levels by reacting with estriol when acid hydrolysis techniques are used; estriol determinations which use enzymatic hydrolysis are unaffected by formaldehyde. Formaldehyde causes falsely elevated 17-hydroxycorticosteroid levels when the Porter-Silber method is used and falsely decreased 5-hydroxyindoleacetic acid (5HIAA) levels by inhibiting color development when nitrosonaphthol methods are used.

Pregnancy Category C: Animal reproduction studies have not been conducted with Urocedulamin, USP. It is also not known whether Urocedulamin, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocedulamin, USP should be given to a pregnant woman only if clearly needed. Since introduction, published reports on the use of Urocedulamin, USP in pregnant women have not shown an increased risk of fetal abnormalities from use during pregnancy.

ADVERSE REACTIONS

An occasional patient may experience gastrointestinal disturbance or a generalized skin rash. Microscopic and rarely gross hematuria have been described.

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DOSAGE AND ADMINISTRATION

The average adult dose is 4 grams daily given as 1 gram after each meal and at bedtime. Children 6 to 12 should receive half the adult dose, and children under 6 years of age should receive 250 mg per 30 lb body weight, four times daily. Since an acid urine is essential for antibacterial activity, with maximum efficacy occurring at pH 5.5 or below, restriction of alkalinizing foods and medication is thus desirable. If testing of urine pH reveals the need, supplemental acidification should be given.

Dosage Adults

Pediatric

Patients


Tablets

Tablets

1000mg

1 tablet qid

-

500mg

2 tablets qid

(Ages 6-12)

1 tablet qid

HOW SUPPLIED

Urocedulamin Tablets, USP 500 mg are supplied as:

NDC 42799-105-01 Bottles of 100

Each tablet is blue, film coated, and bears the product code “105”.

Urocedulamin Tablets, USP 1000 mg are supplied as:

NDC 42799-106-01 Bottles of 100

Each tablet is pink, film coated, and bears the product code “106”.

Store at controlled room temperature between 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured for:

Edenbridge Pharmaceuticals, LLC

Parsippany, NJ 07054

877-381-3336

July 2011

[Bottle Label]

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Urocedulamin 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.


Urocedulamin 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.


Urocedulamin 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.


Urocedulamin 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.


Urocedulamin 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."METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Urocedulamin?

Depending on the reaction of the Urocedulamin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Urocedulamin 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 Urocedulamin 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 Urocedulamin, 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 Urocedulamin 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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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