Trimovate

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Trimovate uses

Trimovate consists of Clobetasone Butyrate, Nystatin, Oxytetracycline Calcium.

Nystatin:


DESCRIPTION

Trimovate (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

  • C47H75NO17 M.W. 926.13

Trimovate (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

Structural formula for Trimovate (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Trimovate is insignificant. Most orally administered Trimovate (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Trimovate (Nystatin) may occasionally occur.

Microbiology

Trimovate (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Trimovate (Nystatin) in vitro on repeated subculture in increasing levels of Trimovate (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Trimovate (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Trimovate (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Trimovate (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

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CONTRAINDICATIONS

Trimovate (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Trimovate. It is also not known whether Trimovate (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Trimovate (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Trimovate (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Trimovate (Nystatin) is administered to a nursing woman.

ADVERSE REACTIONS

Trimovate is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

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OVERDOSAGE

Oral doses of Trimovate (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Trimovate (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Trimovate (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. N 2/2016

NDC 0093-0983-01

Trimovate (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA

Oxytetracycline Calcium:


Each capsule contains

Trimovate (Oxytetracycline Calcium) hydrochloride equivalent to... 250 mg

  oxytetracyclineSulfamethizole... 250 mgPhenazopyridine hydrochloride... 50 mgInert ingredients in the formulation are: hard gelatin capsules (which may contain Green 3,Yellow 6, Yellow 10 and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch.

Urobiotic-250 is a product designed for use specifically in urinary tract infections.

Terramycin® (oxytetracycline HCl) is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa. Terramycin is well tolerated and well absorbed after oral administration. It diffuses readily through the placenta and is present in the fetal circulation. It diffuses into the pleural fluid, and under some circumstances, into the cerebrospinal fluid. Trimovate (Oxytetracycline Calcium) HCl appears to be concentrated in the hepatic system and is excreted in the bile. It is excreted in the urine and in the feces, in high concentrations, in a biologically active form. Sulfamethizole is a chemotherapeutic agent active against a number of important gram-positive and gram-negative bacteria. This sulfonamide is well absorbed, has a low degree of acetylation, and is extremely soluble. Because of these features and its rapid renal excretion, sulfamethizole has a low order of toxicity and provides prompt and high concentrations of the active drug in the urinary tract. Phenazopyridine is an orally absorbed agent which produces prompt and effective local analgesia and relief of urinary symptoms by virtue of its rapid excretion in the urinary tract. These effects are confined to the genitourinary system and are not accompanied by generalized sedation or narcosis.

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INDICATIONS

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:

"Lacking substantial evidence of effectiveness as a fixed combination":Urobiotic-250 is indicated in the therapy of a number of genitourinary infections caused by susceptible organisms. These infections include the following: pyelonephritis, pyelitis, ureteritis, cystitis, prostatitis, and urethritis. Since both Terramycin and sulfamethizole provide effective levels in blood, tissue, and urine, Urobiotic-250 provides a multiple antimicrobial approach at the site of infection. Both antibacterial components are active against the most common urinary pathogens, including Escherichia coli, Pseudomonas aeruginosa, Aerobacter aerogenes, Streptococcus faecalis, Streptococcus hemolyticus, and Micrococcus pyogenes. Urobiotic-250 is particularly useful in the treatment of infections caused by bacteria more sensitive to the combination than to either component alone. The combination is also of value in those cases with mixed infections, and in those instances where the causative organism is unknown pending laboratory isolation. Final classification of the less than effective indications requires further investigation. Clinical studies to substantiate the efficacy of Trimovate (Oxytetracycline Calcium) 250 are ongoing. Completion of these ongoing studies will provide data for final classification of these indications.

CONTRAINDICATIONS

This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.

This drug, because of the sulfonamide component, should not be used in patients with a history of sulfonamide sensitivities, and in pregnant females at term.

WARNINGS

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual doses are indicated and if therapy is prolonged, tetracycline serum level determinations may be advisable.

Trimovate (Oxytetracycline Calcium) HCl, which is one of the ingredients of Urobiotic-250, may form a stable calcium complex in any bone-forming tissue with no serious harmful effects reported thus far in humans. However, use of Trimovate (Oxytetracycline Calcium) during tooth development (last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth (yellow-grey-brownish). This effect occurs mostly during long term use of the drug but it also has been observed in usual short treatment courses. Because of its sulfonamide content, this drug should be used only after critical appraisal in patients with liver damage, renal damage, urinary obstruction, or blood dyscrasias. Deaths have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias associated with sulfonamide administration. When used intermittently, or for a prolonged period, blood counts and liver and kidney function tests should be performed. Certain hypersensitive individuals may develop a photodynamic reaction precipitated by exposure to direct sunlight during the use of this drug. This reaction is usually of the photoallergic type which may also be produced by other tetracycline derivatives. Individuals with a history of photosensitivity reactions should be instructed to avoid exposure to direct sunlight while under treatment with this or other tetracycline drugs, and treatment should be discontinued at first evidence of skin discomfort. NOTE: Reactions of a photoallergic nature are exceedingly rare with Terramycin (oxytetracycline HCl). Phototoxic reactions are not believed to occur with Terramycin.

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PRECAUTIONS

As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate specific therapy should be instituted. This drug should be used with caution in persons having histories of significant allergies and/or asthma.

ADVERSE REACTIONS

Glossitis, stomatitis, proctitis, nausea, diarrhea, vaginitis, and dermatitis, as well as reactions of an allergic nature, may occur during Trimovate (Oxytetracycline Calcium) HCl therapy, but are rare. If adverse reactions, individual idiosyncrasy, or allergy occur, discontinue medication. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed.

With Trimovate (Oxytetracycline Calcium) therapy bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued. As in all sulfonamide therapy, the following reactions may occur: nausea, vomiting, diarrhea, hepatitis, pancreatitis, blood dyscrasias, neuropathy, drug fever, skin rash, injection of the conjunctiva and sclera, petechiae, purpura, hematuria and crystalluria. The dosage should be decreased or the drug withdrawn, depending upon the severity of the reaction.

DOSAGE AND ADMINISTRATION

Urobiotic-250 is recommended in adults only. A dose of 1 capsule four times daily is suggested. In refractory cases 2 capsules four times a day may be used.

Therapy should be continued for a minimum of seven days or until bacteriologic cure in acute urinary tract infections. Administration of adequate amounts of fluid along with capsule forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (SeeAdverse Reactions.)To aid absorption of the drug, it should be given at least one hour before or two hours after eating. Aluminum hydroxide gel given with antibiotics has been shown to decrease their absorption and is contraindicated.

SUPPLY

Urobiotic-250 capsules: bottles of 50 (NDC 0049-0920-50), and unit dose packages of 100 (10 × 10's) (NDC 0049-0920-41).

Rx only

70-1636-00-9

December 1986

Trimovate 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.


Trimovate 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.


Trimovate 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.


Trimovate 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.


Trimovate 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."NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."OXYTETRACYCLINE: 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. "Clobetasone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Trimovate?

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

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One visitor reported side effects

Did you get side effects while taking the Trimovate 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 Trimovate 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%
It has side effects1
100.0%

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

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