Dekalin VT10 mg

Bacterial Vaginosis (Vaginal Tablets)

Dekalin VT 10 mg vaginal tablets are an established, guideline-recognized treatment for bacterial vaginosis in adult women, supported by clinical trial evidence of activity against Gardnerella vaginalis, Atopobium vaginae, and other anaerobic organisms associated with bacterial vaginosis.

Minor Infections of the Mouth and Throat (Lozenges)

Dekalin VT lozenges are an established local antiseptic treatment for minor infections and inflammation of the mouth and throat, such as gingivitis, minor oral ulceration, and pharyngitis, based on the local antibacterial and antifungal action of Dekalin VT.

General Antiseptic Use

Dekalin VT is also used as a topical antiseptic in solutions, creams, and other formulations for disinfection of skin and mucous membranes, as an adjunct to standard skin and wound care rather than as a primary treatment for deep or systemic infection.

Not Indicated For

Dekalin VT is not a treatment for sexually transmitted infections other than the bacterial vaginosis-associated organisms it targets; Dekalin VT does not treat trichomoniasis, chlamydia, gonorrhea, or other STIs, and appropriate testing and treatment for those infections should be pursued separately when clinically indicated.

Vaginal tablets: each tablet contains Dequalinium Chloride 10 mg. Lozenges: each lozenge typically contains Dequalinium Chloride 0.25 mg. The exact strength and formulation of Dequalinium Chloride vary by manufacturer and marketed product.

Dekalin VT is a quaternary ammonium compound with broad local antiseptic activity against bacteria and fungi. Dekalin VT is most widely used as a vaginal tablet for the treatment of bacterial vaginosis, and is also formulated as an antiseptic lozenge for minor infections of the mouth and throat, and in topical solutions for general antiseptic use. Dekalin VT acts locally at the site of application with minimal systemic absorption, and Dekalin VT should be used exactly as directed by a qualified healthcare professional or according to the product labeling.

Antiseptic and Disinfectant (Quaternary Ammonium Compound); Vaginal Anti-infective / Local Oral Antiseptic

Dequalinium Chloride is a quaternary ammonium antiseptic that acts by increasing the permeability of the bacterial and fungal cell membrane, causing leakage of essential intracellular components and loss of enzyme activity, which results in cell death. Dequalinium Chloride exerts bactericidal effects within approximately 30 to 60 minutes of application and is active against a broad range of gram-positive and gram-negative bacteria, anaerobes (including Gardnerella vaginalis and Atopobium vaginae), and fungi such as Candida albicans. After a vaginal tablet of Dequalinium Chloride dissolves in vaginal fluid, local concentrations of Dequalinium Chloride reach very high levels (in the range of 2,000 to 4,000 mg/L) at the site of action, while systemic absorption of Dequalinium Chloride is negligible, limiting the potential for systemic side effects or drug interactions.

• For vaginal tablets, insert Dekalin VT deep into the vagina, preferably while lying down, at bedtime.
• If the vaginal tissue is very dry, the Dekalin VT tablet may be moistened briefly with water before insertion to aid dissolution.
• Continue using Dekalin VT for the complete prescribed course even if symptoms improve within the first 1 to 3 days, to reduce the risk of relapse.
• Avoid sexual intercourse and the use of other vaginal products (including tampons, douches, and spermicides) during treatment with Dekalin VT, as advised on the specific product labeling.
• For lozenges, allow Dekalin VT to dissolve slowly in the mouth; do not chew or swallow the lozenge whole.
• Do not exceed the recommended dose or duration of Dekalin VT, since prolonged or excessive use of vaginal tablets can increase the risk of local irritation or ulceration.

• Anionic (soap-based) products, spermicides, and vaginal detergents: concurrent vaginal use of soap, detergent-based cleansers, or spermicidal products can reduce the antimicrobial activity of Dekalin VT and should be avoided during treatment.
• Non-latex condoms and diaphragms: Dekalin VT may affect the integrity of certain non-latex barrier contraceptive devices; use of these devices should be avoided during and for a period after treatment with Dekalin VT, per product labeling (latex condoms are generally unaffected).
• Systemic drug interactions: because absorption of Dekalin VT into the bloodstream is negligible when used as directed, clinically significant systemic drug-drug interactions with Dekalin VT are not established.

Common Side Effects (Vaginal Tablets)

• Vaginal discharge
• Vulvovaginal itching (pruritus)
• Vulvovaginal burning sensation
• Vaginal candidiasis (fungal overgrowth)

Uncommon Side Effects

• Vaginal bleeding or spotting
• Vaginal pain
• Headache
• Nausea
• Bacterial vaginitis or vulvitis

Rare / Not Known Frequency

• Ulceration or maceration of the vaginal epithelium, usually associated with exceeding the recommended dose or duration of Dekalin VT
• Uterine bleeding, vaginal dryness
• Allergic reactions (rash, localized swelling) and fever

Lozenge Formulations

Mild oral or throat irritation, altered taste, or a local burning sensation can occasionally occur with lozenges containing Dekalin VT; discontinue and seek medical advice if symptoms worsen or a hypersensitivity reaction develops.

Pregnancy

Data from clinical studies of vaginal Dekalin VT tablets used in pregnant women have not shown an increased risk of adverse fetal outcomes; however, as with any medicine, Dekalin VT should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus, and only under the guidance of a qualified healthcare professional. As a precaution, use of vaginal Dekalin VT tablets should be avoided in the 12 hours immediately before expected delivery, to minimize direct exposure of the newborn.

Breastfeeding

Because systemic absorption of Dekalin VT after vaginal use is negligible, exposure of a breastfeeding infant to Dekalin VT through breast milk is expected to be minimal. Dekalin VT may be used during breastfeeding when clinically necessary, but a healthcare professional should be consulted before use.

• Complete the full course: patients should complete the full recommended course of Dekalin VT even if symptoms of bacterial vaginosis improve within the first 1 to 3 days, to reduce the risk of recurrence.
• Avoid interference with efficacy: avoid vaginal use of soap, detergent-based cleansers, or spermicidal products while using Dekalin VT, and avoid sexual intercourse or use of other vaginal products during treatment, per specific product labeling.
• Menstruation: vaginal use of Dekalin VT is generally not recommended during active menstruation, as this may reduce efficacy and alter the local vaginal environment; treatment can typically be resumed once bleeding has stopped, per product labeling.
• Risk of local irritation with excess use: exceeding the recommended dose or duration of vaginal Dekalin VT tablets increases the risk of vaginal irritation, ulceration, or maceration; use Dekalin VT only as directed.
• Lozenge use: allow lozenges containing Dekalin VT to dissolve slowly; do not chew or swallow whole, due to choking risk, and do not use lozenge formulations of Dekalin VT in children below the minimum age stated on the product labeling.
• Not a treatment for other STIs: Dekalin VT does not treat sexually transmitted infections other than the specific bacterial vaginosis-associated organisms it targets; appropriate testing and treatment for other STIs should be pursued separately if clinically indicated.
• Seek medical advice if no improvement: discontinue Dekalin VT and seek medical evaluation if symptoms worsen or fail to improve after completing the labeled treatment duration.
• Limited data in certain age groups: safety and efficacy data for vaginal Dekalin VT tablets are limited in women younger than 18 years or older than 55 years; use with additional caution in these groups.

Because systemic absorption of Dekalin VT is negligible when used as directed, systemic toxicity from overdose is not expected under normal conditions of use. Exceeding the recommended dose or duration of vaginal Dekalin VT tablets increases the risk of local vaginal irritation, ulceration, or maceration rather than systemic toxicity. If accidental ingestion of a large quantity of Dekalin VT tablets or lozenges occurs, or if any other overdose is suspected, seek immediate medical attention or contact a poison control center or emergency services; do not attempt unsupervised home treatment.

Store Dekalin VT at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric Population

Dekalin VT vaginal tablets are not intended for use in premenarchal (sexually immature) girls. Lozenge formulations of Dekalin VT are not recommended in children below the minimum age stated on the product labeling (commonly around 4 to 6 years, depending on the product), because of choking risk with lozenges and because safety and efficacy have not been established in younger children.

Elderly

Safety and efficacy data for vaginal Dekalin VT tablets are limited in women older than 55 years; Dekalin VT should be used with additional caution and medical supervision in this age group.

Renal and Hepatic Impairment

Because systemic absorption of Dekalin VT is negligible after topical, vaginal, or lozenge use, no specific dose adjustment of Dekalin VT is established for patients with renal or hepatic impairment.

Pregnant and Breastfeeding Women

See the Pregnancy and Lactation section above for detailed guidance on the use of Dekalin VT in this population.

The standard course of Dekalin VT vaginal tablets for bacterial vaginosis is 6 consecutive days, used once daily. Lozenge formulations of Dekalin VT for minor mouth and throat infections are typically used for no more than 4 to 5 days; if symptoms have not improved by the end of the labeled treatment duration, a healthcare professional should be consulted rather than continuing Dekalin VT beyond the recommended course.

Antiseptics and Disinfectants; Quaternary Ammonium Compounds; Local Anti-infectives

Dequalinium Chloride is a quaternary ammonium compound that acts as a local antiseptic by increasing the permeability of microbial cell membranes. This disrupts the integrity of the bacterial or fungal cell wall and membrane, causing leakage of essential cytoplasmic components and inactivation of key enzyme systems, which together lead to cell death. Dequalinium Chloride is bactericidal and fungicidal, generally acting within 30 to 60 minutes of application, and is effective against a broad range of gram-positive and gram-negative bacteria as well as Candida species.

Dekalin VT vaginal tablets are not indicated for premenarchal (sexually immature) girls, since the product is intended for use in sexually mature women. For lozenge formulations of Dekalin VT used for minor mouth and throat infections, safety and efficacy have not been established in children below the minimum age stated on the specific product's labeling (commonly around 4 to 6 years), and lozenges carry a choking risk in young children who may not be able to safely dissolve them without chewing or swallowing whole. Any use of Dekalin VT in a child or adolescent should be guided by a pediatrician or qualified healthcare professional and should follow the specific product's approved age range.