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Dalacin Ovulos

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Dalacin Ovulos

Quick Facts

Property Description
Active ingredient Clindamycin Phosphate
Form Vaginal Ovule (Vaginal Suppository)
Pharmacological class Lincosamide Antibiotic
Common use Local anti-infective treatment
Origin Synthetic Compound

Dalacin Ovulos: A Lincosamide Antibiotic and Its Classification

Dalacin Ovulos is a specialized pharmaceutical preparation classified as an anti-infective agent containing the active substance, Clindamycin Phosphate. This compound belongs to the distinct Lincosamide antibiotic class, which acts against specific types of susceptible bacteria. The use of Clindamycin in this form is clinically recognized for its efficacy against a specific profile of anaerobic pathogens. Clindamycin is a synthetic compound derived from lincomycin, and its chemical identity is that of a lincosamide derivative. This classification is central to understanding the preparation's function, defining its specific spectrum of activity as an antimicrobial agent primarily administered via prescription.

Composition and the Vaginal Ovule Dosage Form

This medication is presented as the vaginal ovule (or ovulo), a semi-solid formulation specifically designed for topical vaginal application within the genitourinary tract. The active component is the Clindamycin Phosphate, delivered as a single product integrated into a semi-solid, lipophilic base or vehicle. This ovule form is a significant differentiating factor, providing a localized method of delivery specifically suited for adult female patients. This formulation design ensures a sustained and localized release of the antibiotic for optimal delivery in the vaginal environment.

General Therapeutic Purpose of the Anti-Infective Agent

The primary therapeutic purpose of Dalacin Ovulos is to achieve the suppression of bacterial growth in localized areas by virtue of its antimicrobial agent status. The inherent activity of Clindamycin is rooted in its ability to inhibit protein creation within susceptible bacterial cells, thereby preventing them from replicating and thriving. This specific bacteriostatic effect provides a method for managing conditions caused by problematic bacterial pathogens. The ultimate benefit of this treatment is localized control over the microbial imbalance, utilizing the active compound's targeted action to stop the proliferation of the organisms causing the underlying issue.

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What side effects are possible with Dalacin Ovulos?

Possible Side Effects and Safety Information

The safety profile of Dalacin Ovulos, which contains Clindamycin, is defined by both common localized reactions and the potential for systemic effects due to confirmed drug absorption. Official regulatory documents categorize adverse reactions based on their frequency.


Documented Adverse Reactions

Classification System-Organ Classes Involved Examples of Reactions
Common Infections and infestations, Nervous system disorders, Gastrointestinal disorders, General disorders Vulvovaginal candidiasis (yeast infection), headache, abdominal pain, diarrhea, nausea, vaginal irritation, back pain
Uncommon Renal and urinary disorders Urinary tract infection

Serious Adverse Reactions

The official labeling for clindamycin products, including the vaginal ovule, highlights the potential for Pseudomembranous colitis and Clostridium difficile-associated diarrhea (CDAD). This is a rare but serious systemic risk associated with antibacterial agents, confirmed as possible due to the absorption of clindamycin from the vagina. Serious hypersensitivity reactions (e.g., angioedema) have also been reported in post-marketing surveillance.

Population-Specific Safety Constraints

Safety data is subject to constraints for specific groups. Use during pregnancy requires careful consideration due to limited human data. Clindamycin is excreted in breast milk, necessitating caution during lactation. Safety and effectiveness have not been established in premenarchal pediatric patients.

Safety Restrictions

Clindamycin use is restricted in patients with a history of certain pre-existing gastrointestinal conditions, such as regional enteritis or ulcerative colitis. Furthermore, regulatory notes document that clindamycin possesses properties that may enhance the action of neuromuscular blocking agents.

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Overdose and Emergency Response

Overdose and When to Seek Help

Overdose Scope

Official prescribing information addresses the potential for overdose due to systemic absorption of clindamycin, the active ingredient in Dalacin Ovulos (clindamycin phosphate vaginal suppositories). While the product is used locally, approximately 30% of the dose is absorbed into the bloodstream. Systemic exposure to clindamycin from the vaginal suppository is substantially lower than that from therapeutic oral doses.

Classification Detail (As per regulatory documents)
Documented Presentations No specific overdose symptom cluster is explicitly documented.
Systemic Effects Vaginally applied clindamycin phosphate could be absorbed in sufficient amounts to produce systemic effects, related to therapeutic levels of oral clindamycin.
Overdose Treatment Treatment, in the event of overdosage, should be symptomatic and supportive.

Required Emergency Actions

Immediate medical attention is required if there is suspicion of having taken too much of the medication, or in the case of accidental ingestion, even if no symptoms are present.

  • Emergency Contact: If you think you have taken too much of this medicine, contact a poison control center or hospital emergency room immediately.
  • Ingestion Risk: The medication may be harmful if swallowed. Accidental ingestion may lead to effects associated with high levels of clindamycin, such as severe diarrhea, abdominal pain, and fever, which require prompt medical evaluation.
  • Symptom Awareness: Severe, persistent diarrhea or watery/bloody stools occurring during or up to several months after treatment may be a sign of a serious intestinal condition associated with antibiotics (pseudomembranous colitis) and necessitates immediate medical care.
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Therapeutic Uses of Dalacin Ovulos

What Dalacin Ovulos Treats: Main Uses and Benefits

Dalacin Ovulos is commonly used for the localized management of Bacterial Vaginosis (BV), a condition arising from the overgrowth of susceptible bacteria that disrupts the natural vaginal microflora. This intervention is applied during acute or recurrent episodes and is relevant for easing symptomatic manifestations in adult female patients. The medication provides support that helps ease the overall symptom burden by addressing the hallmark manifestations of BV, specifically the abnormal, thin vaginal discharge and the accompanying unpleasant, persistent odor.

The core benefit plays a role in managing the bacterial infection, which supports the overall goal of contributing to the return of the vaginal microflora balance. It is relevant for managing symptoms that interfere with daily comfort, and the therapeutic goal encompasses the specific indications of addressing the symptoms related to conditions involving inflammatory or irritative processes and supporting the patient during difficult episodes by easing distress. This process assists with maintaining functional stability when symptoms are more noticeable, supporting general well-being during symptomatic phases.

“The primary goal of this therapy may assist with the elimination of the specific symptoms that cause daily discomfort and helps stabilize the localized environment.”

Quick Fact: Relief for Symptomatic BV
Primary Condition Conditions characterized by periods of heightened symptoms (Bacterial Vaginosis)
Symptom Focus Symptoms that create noticeable physiological strain (Abnormal discharge and characteristic odor)
Therapeutic Benefit Supports restoration of local microbial balance
Clinical Context Applied in clinical settings that involve acute or unstable symptom patterns
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Eligibility and Restrictions for Use

Dalacin Ovulos is an anti-infective treatment officially designated for use in adult female patients. Regulatory labeling strictly defines populations who must not use the medicine and those for whom use is restricted or not established.

Absolute Non-Eligibility

The medicine is strictly contraindicated and must not be used by individuals with certain medical histories:

  • A documented hypersensitivity or allergy to clindamycin, lincomycin, or any antibiotic in the lincosamide class.
  • A history of severe gastrointestinal disease, including antibiotic-associated colitis, ulcerative colitis, or regional enteritis.

Restricted Populations

Official documents define explicit limitations for other groups:

  • Age: Safety and efficacy are not established in the pediatric population under 16 years of age, and use is consequently not recommended. Furthermore, use in patients 65 years and older is not established due to limited clinical data.
  • Pregnancy: Use is not generally recommended during the first trimester.
  • Organ Function: Regulatory experience is not available regarding the use of the ovules in patients with impaired renal or hepatic function.
  • Lactation: For breastfeeding women, official guidance requires a decision to discontinue nursing or discontinue the drug, as clindamycin is known to be excreted in human breast milk.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for clindamycin vaginal ovules documents interactions across two primary categories: pharmacodynamic effects with other medications and physical/timing restrictions involving other substances and products. No explicit pharmacokinetic (metabolic or transporter-based) interactions resulting in altered drug exposure are specified for this low-systemic-absorption formulation.

Interaction with Medicinal Products

Classification Interacting Agents Official Statement
Pharmacodynamic Interaction Neuromuscular Blocking Agents Clindamycin has documented neuromuscular blocking properties that may enhance the action of other agents in this class, requiring cautious use where applicable.

Interaction with Products and Substances

Regulatory documentation establishes constraints based on the physical properties of the ovule's oleaginous base and the duration of the treatment period.

Restriction Type Substance/Product Regulatory Constraint
Material Integrity / Timing Latex or Rubber Products (e.g., condoms, diaphragms) The ovule base may weaken these materials. Their use is officially restricted for 72 hours following the conclusion of treatment.
Administration Restriction Other Vaginal Products (e.g., douches, tampons) Use is restricted during the course of treatment as stated in the product labeling.
Administration Restriction Vaginal Intercourse Restricted during the course of treatment as stated in the product labeling.

The overall interaction profile focuses on potential additive effects with specific pharmacological classes and strict procedural restrictions with barrier products, reflecting both the drug's inherent properties and its specific localized dosage form.

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Mechanism of Action

Molecular Mechanism: Ribosomal Inhibition

The active component, Clindamycin, exerts its action by selectively targeting the machinery of susceptible bacterial cells. Its primary biological target is the 50S ribosomal subunit, specifically binding to the 23S ribosomal RNA (rRNA) component within the peptidyl transferase center. This interaction is a direct form of inhibition that physically blocks enzyme function and interferes with the bacterial process of translation (protein synthesis).

Mechanistic Cascade and Physiological Effect

Binding to the 50S subunit prevents the necessary translocation of transfer RNA (tRNA) and halts the elongation of the polypeptide chain. The resulting inability of the bacteria to synthesize vital functional proteins leads directly to the arrest of cell growth and replication, a physiological consequence known as bacteriostasis. This mechanism results in the localized reduction of the functional bacterial population. The efficacy is constrained by target modification resistance, where bacterial methylase enzymes chemically alter the 23S rRNA binding site, substantially weakening the inhibitory mechanism.

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Dosage and Administration Information

How to Use Dalacin Ovulos

Dalacin Ovulos is a specific pharmaceutical preparation for intravaginal use only, and it must never be taken orally. The instructions for its administration follow a standard regimen.

The course of treatment requires the administration of one ovule per day, for three consecutive days. Each ovule is a 2.5 g suppository containing Clindamycin Phosphate equivalent to 100 mg clindamycin. The regimen focuses on daily administration, which is preferably performed at bedtime to support sustained delivery of the antibiotic.

Dosing and Administration Constraints

Feature Standard Instruction
Dose One ovule (100 mg clindamycin)
Frequency Once daily
Duration 3 consecutive days

The ovule's oleaginous base may weaken products made of latex or rubber, such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such products is not recommended during treatment or within 72 hours following the completion of the three-day course. Additionally, usage guidelines do not provide specific dose adjustments for older adults (over 65 years) or patients with renal impairment, as specific studies have not been conducted in these populations.

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Recent Clinical Evidence

Evidence for use in Bacterial Vaginosis (BV)

The research base for this medication includes clinical research, primarily focused on conditions characterized by fluctuating manifestations like Bacterial Vaginosis. These studies included key Randomized Controlled Trials (RCTs) that examined the ovule formulation. Research explored short-term symptom changes, tracking changes in the clinical status (such as abnormal discharge and characteristic odor) and the microbiologic status (assessing bacterial patterns) of the observed populations. Research highlights changes measured during the study period for non-pregnant adult women participating in these trials.

Trial Designs and Comparative Research

To understand the observed patterns, the ovule was studied in comparative trials against different active study arms, including the clindamycin vaginal cream formulation and oral metronidazole. These trial designs allowed researchers to track short-term changes and functional outcomes, such as how the measured criteria evolved under different study arms. The data show patterns related to the clinical measurements and was used to assess the short-term findings of the study.

Evidence in Special Populations

Evidence related to certain patient groups remains insufficient. The majority of the study findings apply only to symptomatic non-pregnant adult women. The ovule formulation itself has not been the subject of adequate or well-controlled studies in pregnant or lactating women. Furthermore, there is limited information for older adults; the use of this medication in patients over 65 years of age or those with kidney or liver issues has not been studied in the clinical trials.

What is Still Uncertain About the Research for Dalacin Ovulos

Research exploring sustained responses over long periods is limited. Long-term effects are not fully established, and there is limited information for long-term outcomes following the initial short-term changes measured in the primary trials. Given the nature of Bacterial Vaginosis, research acknowledges that recurrence is a notable pattern in the broader body of literature. Data for certain groups remain insufficient; research on outcomes in pre-menarchal females is not fully established.

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Frequently Asked Questions (FAQ)

Common questions about Dalacin Ovulos (FAQ)


Q: Can I have sex while I am using Dalacin Ovulos?

Official product information indicates that vaginal intercourse is generally not recommended during the course of treatment. The ovule base may also weaken latex or rubber products, such as condoms or diaphragms. The product information advises against the use of these latex or rubber products for 72 hours following the completion of the treatment.


Q: How should I properly dispose of unused ovules?

According to regulatory disposal guidance, unused or expired medication must not be disposed of in household trash or poured down drains or wastewater. To help ensure proper pharmaceutical waste disposal, the official instructions recommend returning the product to a pharmacy or designated collection point.


Q: What do I do if I forget to use an ovule at bedtime?

Specific regulatory patient information for related clindamycin vaginal products advises against taking extra doses to compensate for a missed one. Instead, it often suggests continuing with the next scheduled dose at the usual time. For the most accurate advice regarding a missed dose, consultation with a healthcare professional is recommended.


Q: What is the difference between Dalacin Ovulos and the Dalacin vaginal cream?

These are two different dosage forms of the same active ingredient. The ovule is a solid suppository formulation typically used for a shorter treatment period. In contrast, the vaginal cream is a 2% formulation that is generally prescribed for a longer course of treatment.


Q: Can I get Dalacin Ovulos without a doctor's prescription?

This medication is approved under a New Drug Application and is classified as a prescription-only drug. It is not available for purchase without a valid doctor's prescription.


Q: What happens if I accidentally swallow one of the ovules?

This product is strictly intended only for intravaginal application and must not be taken by mouth. The product labeling advises that if an ovule is accidentally swallowed, a poison control center or medical assistance should be contacted immediately.

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How should Dalacin Ovulos be stored and disposed of?

Storage and Disposal Information

Dalacin Ovulos must be stored at or below 25 C (77 F) to maintain the stability of the vaginal ovule.

  • Temperature and Protection: The medication requires protection from heat exceeding 30 C (86 F) and must also be protected from high humidity. Freezing should be avoided, as extreme temperatures may compromise the physical form of the ovule.
  • Packaging Rules: The product must remain in its original, sealed aluminum laminated pouch and carton until the time of use. Do not use the ovule if the individual pouch is torn, open, or damaged.
  • Child Safety: This medicine must be kept strictly out of the sight and reach of children.
  • Expiration and Disposal: Do not use the product after the expiration date printed on the package. Unused or expired medication must not be disposed of in household trash or poured down drains or into wastewater. The product must be returned to a pharmacy or designated collection point for proper pharmaceutical waste disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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