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Cidolut Depot

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Cidolut Depot

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Medically reviewed

Laura Arias

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 Cidolut Depot

Property Description
Active Ingredient Hydroxyprogesterone Caproate (17-OHPC)
Form Sterile Oil Solution for Injection (Depot)
Pharmacological Class Progestin, Synthetic Steroid Hormone
General Purpose Provides sustained hormonal balance and support
Origin Synthetic (Ester Derivative)

Classification and Active Ingredient: What Type of Medicine is Cidolut Depot?

Cidolut Depot is a pharmaceutical preparation containing the active ingredient, Hydroxyprogesterone Caproate (17-OHPC), a synthetic steroid hormone classified pharmacologically as a progestin. This compound is an ester derivative of the naturally occurring steroid progesterone, chemically designed to ensure a long-acting presence in the body. The specific chemical modification of the Hydroxyprogesterone parent molecule creates a sustained-action agent that is widely recognized in clinical practice for its potent progestogenic activity.

Depot Injection Form: How is Cidolut Depot Formulated?

The formulation of Cidolut Depot is a sterile oil solution intended for deep intramuscular injection, defined as a Depot preparation. This specialized dosage form is crucial as it creates a reservoir, allowing the Hydroxyprogesterone Caproate to be gradually absorbed from the injection site into the bloodstream over an extended period. The oil solution base, typically a fatty oil like castor oil, facilitates this controlled, sustained release mechanism. This feature differentiates the Depot system from standard, immediate-release hormonal products.

General Purpose: What Does This Progestin Preparation Do?

The general role of this preparation is to provide sustained hormonal support by utilizing the progestin's capacity to function as an agonist of the progesterone receptor. By mimicking the actions of natural progesterone, the Hydroxyprogesterone Caproate establishes and maintains the necessary stable hormonal environment within the body. This prolonged progestogenic activity is therefore aimed at supporting the integrity and function of tissues that are responsive to progesterone, such as in patients requiring hormonal assistance to stabilize the uterine lining.

Regulatory References

  1. EMA Review of Hydroxyprogesterone Caproate
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What side effects are possible with Cidolut Depot?

Possible Side Effects and Safety Information

The official regulatory documentation for Hydroxyprogesterone Caproate (the active ingredient in Cidolut Depot) classifies potential adverse effects based on the affected physiological system and frequency of occurrence. This section summarizes the officially documented safety patterns and serious risks, based strictly on government-approved prescribing information.

Documented Adverse Reactions by System-Organ Class

Adverse reactions are grouped according to the body system where they manifest, as per regulatory standards. Reactions commonly documented include those at the Injection Site Disorders, such as pain, swelling, and itching, due to the nature of the Depot formulation. Gastrointestinal Disorders (e.g., nausea and vomiting), Nervous System Disorders (e.g., headache and dizziness), and Skin and Subcutaneous Tissue Disorders (e.g., rash, pruritus) are also officially listed. Systemic hormonal effects may present as Reproductive System and Breast Disorders, including menstrual irregularities and breast tenderness.

Frequency and Serious Safety Concerns

Some adverse reactions, such as injection site pain and nausea, are classified as common in official labeling. The frequency of other effects may be categorized as not known (cannot be reliably estimated from available data).

The regulatory profile explicitly documents risks categorized as serious adverse reactions. This includes the potential for Thromboembolic Events, such as deep vein thrombosis and pulmonary embolism, and reports of severe Allergic Reactions like anaphylaxis.

Safety Constraints and Limitations

Official prescribing information includes explicit constraints that preclude the use of this medicine in specific high-risk individuals. The medicine is contraindicated in patients with a history of thromboembolic disorders, individuals with severe hepatic impairment (severe liver disease), and those with known or suspected sex hormone-sensitive malignancies.

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Overdose and Emergency Response

The official regulatory documents define the management of a suspected Hydroxyprogesterone Caproate overdose primarily by the immediate required action.

Overdose Scope

Overdose Scope Official Regulatory Statement
Documented overdose presentations No unique set of overdose symptoms is documented. Overdose may manifest as an intensification of known adverse effects, such as nausea or injection site reactions (e.g., pain, swelling).
Physiological systems affected Systems involved in severe reactions that may be exacerbated at higher dosages, including the cardiovascular system (thrombotic events) and the respiratory system (acute allergic reactions or dyspnea).
Dose-related or exposure-related factors The likelihood of certain reactions, such as coughing, dyspnea, or chest constriction, may be increased at higher dosage levels.
Population-specific overdose notes No population-specific guidance is explicitly written within the regulatory overdose section.

Overdose Classifications

Overdose Classifications Official Regulatory Statement
Severity classification Not explicitly classified by severity level; the mandated emergency response implies a potentially severe scenario.
Regulatory basis Information derived from FDA Prescribing Information and DailyMed (NIH/NLM) labeling.
Overdose-context constraints The required management is constrained by the fact that no specific antidote is known.

Resulting Overdose Structure

Official overdose statements:

  • In case of suspected overdose, emergency medical attention must be sought immediately.
  • No specific antidote is known for this medication.
  • Treatment of overdose should be symptomatic and supportive.
  • Immediate response includes calling the Poison Control Center and providing details on what was taken, how much, and when it happened.

Connection to the overall overdose profile: The regulatory profile emphasizes Mandated Immediate Emergency Action for any suspected overdose due to the potential for life-threatening severe adverse reactions to be intensified. As management is limited to Symptomatic and Supportive Treatment because no specific antidote is available, seeking immediate professional assistance is the regulator-defined priority.

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Therapeutic Uses of Cidolut Depot

What Cidolut Depot Treats: Main Uses and Benefits


The medication is generally relevant in clinical settings where certain symptoms that interfere with daily functioning and physiological stability are present. The therapeutic domains for this medicine are generally associated with gynaecological and fertility disorders.

Easing Symptoms of Acute Distress

This medicine is relevant in areas where additional symptomatic support is appropriate, particularly in situations involving conditions characterized by periods of heightened symptoms or temporary physiological imbalance. It provides support that helps ease the overall symptom burden during acute or disruptive episodes.

The medicine is commonly used across conditions presenting with acute or disruptive episodes, particularly those associated with episodic or fluctuating manifestations. Often used when symptoms intensify and supportive relief is needed, the medication assists with maintaining functional stability.

“The medicine is relevant for easing discomfort or tension in areas where short-term symptom management is appropriate.”

Supporting Stability and Functional Comfort

The medication is considered relevant for managing symptom clusters that may become intense or disruptive, often associated with hormonal fluctuations or conditions where functional stability becomes affected. It helps maintain a sense of stability and contributes to improved day-to-day comfort during symptomatic periods.

Quick Fact: Focus on Functional Strain The medication is applied in addressing symptoms that create noticeable functional strain in conditions marked by episodic or fluctuating symptom patterns.

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Eligibility and Restrictions for Use

Eligibility: Who Can and Cannot Use Cidolut Depot?

Eligibility to use Cidolut Depot (Hydroxyprogesterone Caproate) is strictly defined by regulatory authorities based on specific age groups and pre-existing conditions.

Eligibility Category Official Regulatory Status (Exclusions/Restrictions)
Absolute Contraindications Use is prohibited in individuals with a current or history of thrombosis or thromboembolic disorders, hormone-sensitive cancers (e.g., breast cancer), active liver disease or liver tumors, and uncontrolled hypertension or undiagnosed abnormal vaginal bleeding.
Age and Developmental Stage The medicine is not indicated for children or adolescents under 16 years of age. Use is not generally recommended for older adults (geriatric population).
Pregnancy Status Eligibility for use in pregnancy (for preterm birth prevention) has been withdrawn by the FDA and suspended by the EMA. Progestins are detectable in the milk of nursing mothers, though no adverse effects on infants have been widely reported.
Condition-Specific Restrictions Conditional use requires careful monitoring for patients with cardiac or renal dysfunction (due to potential for fluid retention), diabetes (due to glucose tolerance risk), or a history of clinical depression.

This structure establishes that the eligible user population is primarily adult women who do not possess any of the defined contraindications, with additional restrictions applied based on co-existing medical conditions.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Hydroxyprogesterone Caproate (Cidolut Depot) indicates that no in vivo drug-drug interaction studies were conducted. The potential for interaction is primarily defined by the drug's metabolism and known physiological effects.


Pharmacokinetic Interactions

Interaction Type Official Regulatory Statement
Metabolic Pathway Metabolism is extensively mediated by Cytochrome P450 (CYP) enzymes, predominantly CYP3A4 and CYP3A5.
Exposure Modification Co-administration with strong CYP3A4 inhibitors is expected to increase drug exposure, while strong CYP3A4 inducers are expected to decrease drug exposure.

Pharmacodynamic and Restriction Notes

The medicine carries risks of additive effects when used with certain drug classes, based on cautions noted in prescribing information:

  • Antidiabetic Agents: Potential for interaction exists due to the drug’s capacity to decrease glucose tolerance.
  • Agents Affecting Fluid Balance: Potential for interaction exists due to the drug’s capacity to cause fluid retention.
  • Contraindicated in Hepatic Impairment: Due to extensive metabolism in the liver, use is formally prohibited in patients with liver dysfunction, as this condition may reduce the drug’s elimination.

No specific medicinal product combinations are formally listed as contraindicated, and no timing separation rules are documented in the official regulatory text.

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Mechanism of Action

Cidolut Depot is a progestin compound. Its active metabolite, Medroxyprogesterone Acetate (MPA), acts as a selective progesterone receptor (PR) agonist. MPA binds with high affinity to the PR in target cells, particularly within bone tissue and the hypothalamus, thereby modulating gene transcription.

In the skeletal system, this mechanism modulates intracellular signaling pathways that influence the rate of osteoclast-mediated bone resorption. By affecting the balance between bone formation and resorption, this modulation consequently impacts skeletal mineral density.

In the neuroendocrine system, MPA exerts negative feedback on the hypothalamus, inhibiting the pulsatile release of Gonadotropin-Releasing Hormone (GnRH). This cascade reduces the subsequent secretion of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) from the anterior pituitary, which ultimately results in a systemic reduction of circulating estrogen levels.

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Dosage and Administration Information

Official Administration Guidelines for Cidolut Depot

Cidolut Depot (hydroxyprogesterone caproate) is an oily solution that must be administered only by a healthcare professional. The instructions for its use are defined to ensure the correct drug regimen is followed.

Administration Scope Official Instruction
Route Intramuscular (IM) injection only
Dose 250 mg (as one 1 mL injection)
Frequency Once weekly (every 7 days)
Timing Treatment should begin between 16 weeks, 0 days and 20 weeks, 6 days of gestation.
Duration Weekly injections continue until week 37 (through 36 weeks, 6 days) of gestation, or until delivery, whichever occurs first.

Procedural Requirements

The injection must be administered into the upper outer quadrant of the gluteus maximus muscle. Healthcare providers are instructed to rotate the injection site with each subsequent weekly dose to the alternate side.

Since the solution is viscous and oily, a slow injection is recommended—specifically, over one minute or longer—to ensure proper administration and minimize patient discomfort. Prior to use, the drug must be visually inspected; if visible particles or crystals are present, the vial should not be used.

Missed Dose Guidance

If a dose is missed, instructions state that the healthcare provider should administer the dose as soon as the patient returns. Following this immediate injection, the original weekly dosing schedule (every 7 days) is resumed from that date. This ensures the continuous weekly pattern is re-established throughout the remainder of the prescribed duration.

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Recent Clinical Evidence

Recent Clinical Evidence

Clinical research regarding Cidolut Depot (a formulation containing medroxyprogesterone acetate or MPA) focuses primarily on its established use in gynecological and oncological settings, investigating its effects on various hormonal conditions.


Investigating the Mechanism and Symptom Profile

Research has examined the effect of MPA in studies focusing on patients with conditions like endometriosis and secondary amenorrhea. These studies investigated whether the compound might be associated with a reduction in the severity and frequency of symptoms over specified treatment periods.

  • Study Design: The primary research has utilized Randomized Controlled Trials (RCTs) to compare MPA against placebo or active control groups.
  • Reported Outcomes: Outcomes were primarily measured using patient-reported symptom scores. Some studies reported an observed reduction in pain in clinical settings among MPA-treated groups compared to controls.
  • Proposed Action: Research suggests the treatment may be associated with inhibiting the hypothalamic-pituitary-ovarian axis, which investigators hypothesize contributes to the observed clinical effects.

Dosage and Administration Studies

Clinical research has focused on the optimal administration of depot formulations, examining different injection intervals and dosages.

  • Safety Profile: Clinical trials have examined the safety profile of the drug, including injection site reactions and systemic effects, in specific adult populations.
  • Early Observations: Some evidence suggests that changes in patient-reported relief were observed early in the course of treatment, though the time course for maximal effect varies by indication.

Combination Therapy Research

Studies have explored whether the combination of MPA with other standard pharmacological therapies might be associated with improved results in certain advanced conditions.

  • Compliance: Investigators noted that compliance with the prescribed regimen was cited as a significant factor in the study outcomes, potentially influencing the reported observations.
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Frequently Asked Questions (FAQ)

Common questions about Cidolut Depot (FAQ)


Q: How does Cidolut Depot work in the body?

Cidolut Depot is a progestin compound, meaning its active ingredient, Hydroxyprogesterone Caproate, works by acting like natural progesterone. According to official product information, it functions as an agonist of the progesterone receptor to help maintain a stable hormonal environment. The official label further describes its role in modulating certain processes in the body, including effects on bone tissue and the neuroendocrine system.


Q: Is it necessary to rotate the injection site when getting Cidolut Depot?

Yes, official regulatory documents instruct healthcare providers to rotate the injection site with each subsequent weekly injection to the alternate side. This instruction is provided in the official administration guidelines for the medication.


Q: What is the maximum duration for a course of Cidolut Depot treatment?

The maximum duration for treatment is defined in the official administration guidelines. Weekly injections are intended to continue until week 37 of gestation (through 36 weeks, 6 days) or until delivery, whichever happens sooner.


Q: How quickly after starting Cidolut Depot can I expect to feel the effect?

Official information and studies have noted that changes in patient-reported relief were observed early in the course of treatment. The official label indicates that the time course for maximal effect can vary by the specific indication.


Q: What should I do if my doctor and I realize I missed my weekly dose of Cidolut Depot?

Regulatory guidance describes the policy for a missed dose: the healthcare provider is instructed to administer the dose as soon as possible after the patient returns. The official policy states that the original weekly dosing schedule is then resumed starting from the date of the immediate injection.


Q: Can Cidolut Depot be used in children or teenagers?

Official prescribing information states that this medicine is not indicated for use in children or adolescents under 16 years of age. The official prescribing information indicates that use in this group is not recommended.


Q: Are there any foods or vitamins I need to avoid while on Cidolut Depot?

Official labeling primarily focuses on potential drug-drug interactions with other medicines, especially those that affect the liver's metabolism (CYP3A4 inducers or inhibitors). Official regulatory documents do not list specific foods, vitamins, or supplements that interact with this medication.

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How should Cidolut Depot be stored and disposed of?

How to Store and Dispose of Cidolut Depot (Hydroxyprogesterone Caproate Injection)

Official regulatory labeling dictates strict requirements for storing and disposing of this medication to maintain its stability and ensure safety.

Storage Component Official Requirement
Temperature Store at Controlled Room Temperature (20 to 25 C); do not refrigerate or freeze.
Protection Protect the vial from light and store it within its original carton.
Stability (After Opening) Discard multi-dose vials after the period specified in the label (e.g., 28 days or 5 weeks) after the first use, even if product remains.
Handling Keep the product locked up and out of the reach of children.
Disposal Dispose of unused or expired medication through a special or hazardous waste collection program, following all local and national regulations. Avoid flushing down the sink or throwing into household trash to prevent environmental release.

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

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