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DRUGS & SUPPLEMENTS
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What are the side effects you encounter while taking this medicine? |
Condyline is the brand name of Condyline, an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Condyline 0.5% Solution is formulated for topical administration. Each milliliter of solution contains 5 mg of Condyline, in a vehicle containing lactic acid and sodium lactate in alcohol 95%, USP.
Condyline has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is 5,8,8a,9-Tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7] naphtho[2,3,d]-1, 3-dioxol-6(5aH)-one. Condyline has the following structural formula:
Treatment of genital warts with Condyline results in necrosis of visible wart tissue. The exact mechanism of action is unknown.
In systemic absorption studies in 52 patients, topical application of 0.05 mL of 0.5% Condyline solution to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1 to 4.5 hours. The drug was not found to accumulate after multiple treatments.
In clinical studies with Condyline Solution, the test product and its vehicle were applied in a double-blind fashion to comparable patient groups. Patients were treated for 2 to 4 weeks, and reevaluated at a 2-week follow-up examination. Although the number of patients and warts evaluated at each time period varied, the results among investigators were relatively consistent.
The following table represents the responses noted in terms of frequency of response by lesions treated and the overall response by patients. Data are presented for the 2-week follow-up only for those patients evaluated at that time point.
Responses in Treated Patients
Initially | Recurred after | Cleared | |
Cleared* | Clearing* | at 2-Week Follow-up* | |
% Warts | 79% | 35% | 60% |
(n=524) | (412/524) | (146/412) | (269/449) |
% Patients | 50% | 60% | 25% |
(n=70) | (35/70) | (21/35) | (14/57) |
* Cleared and clearing mean no visible wart tissue remained at the treated sites
Condyline 0.5% Solution is indicated for the topical treatment of external genital warts. This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS ).
Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Condyline 0.5% Solution.
Condyline 0.5% Solution is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.
Correct diagnosis of the lesions to be treated is essential. See the "Diagnosis" subsection of the INDICATIONS AND USAGE statement.
Condyline 0.5% Solution is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patients should immediately flush the eye with copious quantities of water and seek medical advice.
Data are not available on the safe and effective use of this product for treatment of warts occurring in the perianal area or on mucous membranes of the genital area. The recommended method of application, frequency of application, and duration of usage should not be exceeded (see DOSAGE AND ADMINISTRATION ).
The patient should be provided with a Patient Information leaflet when a Condyline prescription is filled.
Reports of lifetime carcinogenicity studies in mice are not available. Published animal studies, in general, have not shown the drug substance, Condyline, to be carcinogenic.1,2,3,4,5 There are published reports that, in mouse studies, crude podophyllin resin applied topically to the cervix produced changes resembling carcinoma in situ. 6 These changes were reversible at 5 weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin7 (the drug was applied twice weekly over a 15-month period).
Condyline was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to Condyline at concentrations up to 0.008 μg/mL without metabolic activation and 12 μg/mL Condyline with metabolic activation. Results from the mouse micronucleus in vivo assay using Condyline 0.5% solution in concentrations up to 25 mg/kg, indicate that Condyline should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).
Daily topical application of Condyline 0.5% Solution at doses up to the equivalent of 0.2 mg/kg (5 times the recommended maximum human dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.
Pregnancy Category C: Condyline was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (5 times the maximum human dose) once daily for 13 days. The scientific literature contains references that Condyline is embryotoxic in rats when administered systemically in a dose approximately 250 times the recommended maximum human dose.8,9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Condyline should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Condyline, 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.
Safety and effectiveness in pediatric patients have not been established.
In clinical trials, the following local adverse reactions were reported at some point during treatment.
Adverse Experience | Males | Females |
Burning | 64% | 78% |
Pain | 50% | 72% |
Inflammation | 71% | 63% |
Erosion | 67% | 67% |
Itching | 50% | 65% |
Reports of burning and pain were more frequent and of greater severity in women than in men.
Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.
Topically applied Condyline may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of Condyline in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure, and seizures. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated, the technique for initial application of the medication should be demonstrated by the prescriber.
Apply twice daily morning and evening (every 12 hours), for 3 consecutive days, then withhold use for 4 consecutive days. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. If there is incomplete response after four treatment weeks, alternative treatment should be considered. Safety and effectiveness of more than four treatment weeks have not been established.
Condyline 0.5% Solution is applied to the warts with a cotton-tipped applicator supplied with the drug. The drug-dampened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Treatment should be limited to less than 10 cm 2 of wart tissue and to no more than 0.5 mL of the solution per day. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.
Care should be taken to allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, the used applicator should be carefully disposed of and the patient should wash his or her hands.
3.5 mL of Condyline 0.5% Solution is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. NDC 52544-046-13. Store at 20-25°C (68-77°F). Avoid excessive heat. Do not freeze.
Keep out of reach of children.
Rx only
For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525
Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Manufactured By:
DPT Laboratories, Ltd.
San Antonio, TX 78215 USA
Content Updated: August 2014
140350
Depending on the reaction of the Condyline after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Condyline 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 Condyline 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.
Visitors | % | ||
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Twice in a day | 1 | 100.0% |
Visitors | % | ||
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501mg-1g | 1 | 50.0% | |
1-5mg | 1 | 50.0% |
Visitors | % | ||
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> 3 month | 1 | 100.0% |
Visitors | % | ||
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16-29 | 1 | 100.0% |
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The information was verified by Dr. Rachana Salvi, MD Pharmacology