Dalacin Vc 20 mg Vaginal cream
PDF Leaflet Revision Date: 12 December 2024
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of symptomatic bacterial vaginosis in non-pregnant women.
Dosage (summary)
1 applicator full (5 grams) intravaginally once daily for 3 to 7 days.
Special Populations
- Geriatric use not established
- Children
Pregnancy & Breastfeeding
Not safe in pregnancy; avoid breastfeeding during treatment.
Key Drug Interactions
- Caution with neuromuscular blocking agents
Contraindications
- Hypersensitivity to clindamycin or lincomycin
- History of antibiotic-associated colitis
- Pregnancy and lactation
Common side effects
- Fungal infections
- Headache
- Abdominal pain
- Vulvovaginal candidiasis
Counselling Points
- Avoid vaginal intercourse and other vaginal products during treatment
- May weaken latex products for 72 hours post-treatment
Serious warnings
- Risk of pseudomembranous colitis
- May cause overgrowth of non-susceptible organisms
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
DALACIN VC is indicated in the treatment of symptomatic bacterial vaginosis in non-pregnant women. Other pathogens commonly associated with vulvovaginitis e.g. Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus should be ruled out by appropriate methods.
4.2 Posology and method of administration
The recommended dose is one applicator full (approximately 5 grams, which contains approximately 100 mg of clindamycin phosphate) of cream intravaginally, preferably at bedtime, for 3 to 7 consecutive days. Concomitant use with other intravaginal products is not recommended.
Directions for use:
- Plastic disposable applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.
- Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube.
- Rolling tube from the bottom, squeeze gently and force the medication into the applicator. The applicator is filled when the plunger reaches its pre-determined stopping point.
- Unscrew the applicator from the tube and replace the cap.
- While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort.
- Slowly push the plunger until it stops.
- Carefully withdraw applicator from the vagina, and discard applicator.
4.3 Contraindications
DALACIN VC is contraindicated:
- in patients with a history of hypersensitivity to clindamycin, lincomycin or any of the components of these products.
- in individuals with a history of antibiotic-associated colitis, ulcerative colitis, or regional colitis (Crohnu2019s disease).
- Pregnancy and lactation (see HUMAN REPRODUCTION)
4.4 Special warnings and precautions for use
The use of DALACIN VC may result in the overgrowth of non-susceptible organisms particularly yeasts (like Candida albicans). Clindamycin has been associated with diarrhoea and in some cases pseudomembranous colitis. Minimal absorption (approximately 4 %) occurs following the use of DALACIN VC intravaginally; however, if significant or prolonged diarrhoea occurs DALACIN VC should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.
The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with DALACIN VC. DALACIN VC contains mineral oil that may weaken latex or rubber products, such as condoms or vaginal contraceptive diaphragms. The use of such products within 72 hours following treatment with DALACIN VC is not recommended.
Use in children; Safety and efficacy in paediatric patients have not been established.
4.5 Interactions with other medicines
Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of neuromuscular blocking medicines. Therefore, neuromuscular blocking medicines should be used with caution in patients on treatment with DALACIN VC.
4.6 Fertility, pregnancy and lactation
Pregnancy: Safety in pregnancy has not been established (see CONTRAINDICATIONS). DALACIN VC should not be used during pregnancy.
Lactation: It is not known if DALACIN VC is excreted in breast milk following the use of vaginally administered DALACIN VC. Orally and parenterally administered DALACIN VC has been reported to appear in breast milk. Therefore, mothers on treatment with DALACIN VC should not breastfeed their infants.
4.7 Effects on ability to drive and use machines
The effect of DALACIN VC on the ability to drive or operate machinery has not been evaluated.
4.8 Undesirable effects
The safety of DALACIN VC was evaluated in both non-pregnant patients and patients during their second and third trimesters of pregnancy. Side effects are categorised as follows: Very common (u2265 1/10); common (u2265 1/100, < 1/10); uncommon (u2265 1/1 000, < 1/100); rare (u2265 1/10 000, < 1/1 000); very rare (< 1/10 000), including isolated reports.
| System organ class | Frequency | Side effect |
|---|---|---|
| Infections and infestations | Common | Fungal infections, candida infections |
| Uncommon | Bacterial infection | |
| Not known | Skin candida | |
| Immune system disorders | Uncommon | Hypersensitivity |
| Endocrine disorders | Not known | Hyperthyroidism |
| Nervous system disorders | Common | Headache, dizziness, dysgeusia |
| Ear and labyrinth disorders | Uncommon | Vertigo |
| Respiratory, thoracic and mediastinal disorders | Common | Upper respiratory infection |
| Uncommon | Epistaxis | |
| Gastrointestinal disorders | Common | Abdominal pain, constipation, diarrhoea, nausea, vomiting |
| Uncommon | Abdominal distension, flatulence, breath odour | |
| Not known | Gastrointestinal disorder, dyspepsia | |
| Skin and subcutaneous tissue disorders | Common | Pruritus (non-applicable site), rash |
| Uncommon | Urticaria, erythema | |
| Not known | Maculopapular rash | |
| Musculoskeletal and connective tissue disorders | Common | Back pain |
| Renal and urinary disorders | Common | Urinary tract infection, glycosuria, proteinuria |
| Uncommon | Dysuria | |
| Pregnancy, puerperium and perinatal conditions | Common | Abnormal labour |
| Reproductive system and breast disorders | Very common | Vulvovaginal candidiasis |
| Common | Vulvovaginitis, vulvovaginal disorder, menstrual disorder, vulvovaginal pain, metorrhagia, vaginal discharge | |
| Uncommon | Trichomonal vulvovaginitis, vaginal infection, pelvic pain | |
| Not known | Endometriosis | |
| General disorders and administration site conditions | Not known | Inflammation, pain |
| Investigations | Uncommon | Microbiology test abnormal. Abnormal microbiologic test findings on examination of body fluids, substances and/or tissues which typically mean positive culture findings in specimens from organs, systems and/or tissues |
Post-marketing: The following post-marketing adverse event has been reported with DALACIN VC: Gastrointestinal disorders: Pseudomembranous colitis
4.9 Overdose
Vaginally applied clindamycin phosphate contained in DALACIN VC can be absorbed in sufficient amounts to produce systemic effects. Accidental ingestion of the product could be accompanied by effects related to therapeutic levels of oral clindamycin. In the event of overdosage treatment should be symptomatic and supportive.
