DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Terconazole Vaginal Suppositories, 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Patients known to be hypersensitive to Terconazole or to any of the components of the suppositories.
Anaphylaxis and toxic epidermal necrolysis have been reported during Terconazole therapy. Terconazole Vaginal Suppositories, 80 mg therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
For vulvovaginal use only. Terconazole Vaginal Suppositories, 80 mg is not for ophthalmic or oral use. Discontinue use and do not retreat with Terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.
The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms or latex condoms; therefore concurrent use is not recommended.
Laboratory Tests -
If there is a lack of response to Terconazole, appropriate microbiologic studies should be repeated to confirm the diagnosis and rule out other pathogens.
Drug Interactions -
The therapeutic effect of Terconazole is not affected by oral contraceptive usage.
The levels of estradiol and progesterone did not differ significantly when 0.8% Terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies to determine the carcinogenic potential of Terconazole have not been performed.
Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations, or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.
Impairment of Fertility -
No impairment of fertility occurred when female rats were administered Terconazole orally up to 40 mg/kg/day for a three month period.
Pregnancy: Teratogenic Effects: Pregnancy Category C -
There was no evidence of teratogenicity when Terconazole was administered orally up to 40 mg/kg/day in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of Terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of Terconazole 80 mg vaginal suppository. This safety assessment does not account for possible exposure of the fetus through direct transfer to Terconazole from the irritated vagina by diffusion across amniotic membranes. Since Terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
Terconazole may be used during the second and third trimester if the potential benefit outweighs the possible risks to the fetus.
Nursing Mothers -
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from Terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use -
Safety and efficacy in children have not been established.
Geriatric Use -
Clinical studies of Terconazole vaginal suppositories 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.
Adverse Reactions from Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with Terconazole 80 mg vaginal suppositories. Based on comparative analyses with placebo, the adverse experiences considered adverse reactions most likely related to Terconazole 80 mg vaginal suppositories were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that have also been reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The adverse drug experience on Terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
The following adverse drug reactions have been first identified during post-marketing experience with Terconazole Vaginal Suppositories, 80 mg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise
Immune: Hypersensitivity, Anaphylaxis, Face Edema
Skin: Rash, Toxic Epidermal Necrolysis, Urticaria
In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively.
In the event of oral ingestion of suppository, supportive and symptomatic measures should be carried out.
DOSAGE AND ADMINISTRATION
One Terconazole Vaginal Suppository, 80 mg should be administered intravaginally once daily at bedtime for three consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Terconazole vaginal suppositories is not affected by menstruation.
Terconazole Vaginal Suppositories, 80 mg are available as follows:
Carton containing 3 suppositories (NDC 45802-717-08)
Store at 20-25°C (68-77°F).
Manufactured By Perrigo
Bronx, NY 10457
Allegan, MI 49010 - www.perrigo.com
:2X300 RC J6
Consumer Information Leaflet
Terconazole VAGINAL SUPPOSITORIES, 80 mg
Three oval suppositories, for use inside the vagina only.
Designed to be inserted into the vagina.
HOW TO USE:
Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor.
The Terconazole vaginal suppository is self-lubricating and may be inserted with or without the applicator.
A. Insertion with the applicator
1. Filling the applicator
2. Using the applicator
3. Cleaning the applicator
After each use, you should thoroughly clean the applicator by following the procedure below:
B. Insertion without the applicator
Store at 20-25°C (68-77°F).
A WORD ABOUT YEAST INFECTIONS
Why do yeast infections occur?
Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimesthe natural balance of the vagina becomes upset. This maylead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.
Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.
How can I prevent yeast infections?
Certain factors may increase your chance of developing a yeast infection. These factors don’t actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.
Controlling these factors can help eliminate yeast infections and may prevent them from coming back.
Some other helpful tips:
Manufactured By Perrigo
Bronx, NY 10457
Allegan, MI 49010 - www.perrigo.com
:2X300 RC J6
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Terconazole Vaginal Suppositories, 80 mg
3 SUPPOSITORIES with vaginal applicator
Terconazole 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.
Terconazole 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.
Terconazole 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.
Terconazole 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.
Terconazole 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Terconazole?
Depending on the reaction of the Terconazole after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Terconazole 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 Terconazole 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.
Reviewsdrugs.com conducted a study on Terconazole, 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 Terconazole 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 reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology