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Terazol 7
Overview
What is Terazol 7?
TERAZOL 7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, -1-[-[[2-(2,4-Dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
TERAZOL 3 (terconazole) Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, -1-[-[[2-(2,4-Dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
TERAZOL 3 (terconazole) Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, -1-[-[[2-(2,4-Dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.
The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.
What does Terazol 7 look like?
What are the available doses of Terazol 7?
Sorry No records found.
What should I talk to my health care provider before I take Terazol 7?
Sorry No records found
How should I use Terazol 7?
TERAZOL 7 (terconazole) Vaginal Cream 0.4%, TERAZOL 3 (terconazole) Vaginal Cream 0.8% and TERAZOL 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
One full applicator (5 g) of TERAZOL 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
What interacts with Terazol 7?
Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.
What are the warnings of Terazol 7?
Usage in Meningitis - Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
What are the precautions of Terazol 7?
General
For vulvovaginal use only. TERAZOL 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 lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) 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
Carcinogenesis
Studies to determine the carcinogenic potential of terconazole have not been performed.
Mutagenicity
Terconazole was not mutagenic when tested for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or 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
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 TERAZOL 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.
What are the side effects of Terazol 7?
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.
TERAZOL 7 (terconazole) Vaginal Cream 0.4%
During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching.
TERAZOL 3 (terconazole) Vaginal Cream 0.8%
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
TERAZOL 3 (terconazole) Vaginal Suppositories 80 mg
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 (295 patients), 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).
Post-marketing Experience
The following adverse drug reactions have been first identified during post-marketing experience with TERAZOL. 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
Nervous: Dizziness
Respiratory: Bronchospasm
Skin: Rash, Toxic Epidermal Necrolysis, Urticaria
What should I look out for while using Terazol 7?
Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.
Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. TERAZOL therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
What might happen if I take too much Terazol 7?
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 or cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
How should I store and handle Terazol 7?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in: Bottles of 100 (NDC 0527-1381-01). Bottles of 200 (NDC 0527-1381-04). Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in: Bottles of 100 (NDC 0527-1382-01). Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: Bottles of 16 (NDC 0527-1383-02). Bottles of 100 (NDC 0527-1383-01). Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in: Bottles of 100 (NDC 0527-1381-01). Bottles of 200 (NDC 0527-1381-04). Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in: Bottles of 100 (NDC 0527-1382-01). Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: Bottles of 16 (NDC 0527-1383-02). Bottles of 100 (NDC 0527-1383-01). Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in: Bottles of 100 (NDC 0527-1381-01). Bottles of 200 (NDC 0527-1381-04). Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in: Bottles of 100 (NDC 0527-1382-01). Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: Bottles of 16 (NDC 0527-1383-02). Bottles of 100 (NDC 0527-1383-01). Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in: Bottles of 100 (NDC 0527-1381-01). Bottles of 200 (NDC 0527-1381-04). Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in: Bottles of 100 (NDC 0527-1382-01). Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: Bottles of 16 (NDC 0527-1383-02). Bottles of 100 (NDC 0527-1383-01). Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in: Bottles of 100 (NDC 0527-1381-01). Bottles of 200 (NDC 0527-1381-04). Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in: Bottles of 100 (NDC 0527-1382-01). Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: Bottles of 16 (NDC 0527-1383-02). Bottles of 100 (NDC 0527-1383-01). Dispense in a tight container with a child-resistant closure.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following a single intravaginal application of a suppository containing 240 mg C-terconazole to healthy women, approximately 70% (range: 64–76%) of terconazole remains in the vaginal area during the suppository retention period (16 hours); approximately 10% (range: 5–16%) of the administered radioactivity was absorbed systemically over 7 days. Maximum plasma concentrations of terconazole occur 5 to 10 hours after intravaginal application of the cream or suppository. Systemic exposure to terconazole is approximately proportional to the applied dose, whether as the cream or suppository. The rate and extent of absorption of terconazole are similar in patients with vulvovaginal candidiasis (pregnant or non-pregnant) and healthy subjects.
Non-Clinical Toxicology
Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. TERAZOL therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
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.
For vulvovaginal use only. TERAZOL 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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