Predalon

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Predalon

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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.

Overview of Predalon

Property Description
Active ingredient Chorionic Gonadotropin (hCG)
Form Sterile, lyophilized powder for solution for injection
Pharmacological class Gonadotropin; Pituitary and hypothalamic hormone analogue
General purpose Provides the critical hormonal signal for reproductive function
Origin Human-derived (biological origin)

What Type of Hormone is Predalon?

Predalon is a highly purified therapeutic product whose active ingredient is Chorionic Gonadotropin (hCG), a substance with a structural and functional resemblance to Luteinizing Hormone (LH). It belongs to the pharmacological class of gonadotropins, which are Pituitary and hypothalamic hormones and analogues used to regulate reproductive and sexual development processes. This classification means Predalon is a hormone therapy that functions by delivering a precise signaling molecule to the body, essentially supplementing or replacing the natural chemical messages sent by the pituitary gland.

The drug is supplied as a single component, biological product because its hCG is human-derived, often extracted and highly purified from the urine of pregnant women. This ensures the glycoprotein hormone is structurally identical to the endogenous hormone produced naturally in the human body, a key distinguishing feature from laboratory-synthesized recombinant analogues.

Composition, Form, and Origin of Chorionic Gonadotropin

The medication's active component, hCG, is a complex glycoprotein hormone composed of specific alpha and beta subunit structures. Predalon is physically supplied as a sterile, lyophilized powder for solution for injection, a stable solid form designed to maintain chemical stability. This preparation necessitates reconstitution with an aqueous solvent immediately before use, after which it is administered via parenteral administration (injection).

Predalon's General Purpose: An LH Analog

The general purpose of Predalon is to serve as a Luteinizing Hormone (LH) analog, providing the critical hormonal signal necessary for reproductive function. The hCG molecule structurally mimics the actions of LH by binding to the same receptors. This binding action is essential for the hormone's biological activity, which includes inducing the final maturation and release of an egg (ovulation) and stimulating the production of steroid hormones like testosterone, a process known as steroidogenesis. A typical use scenario involves providing the signal necessary for the final phase of egg development in individuals undergoing fertility protocols.

What side effects are possible with Predalon?

Possible Side Effects and Safety Information

The safety profile of Chorionic Gonadotropin (hCG), the active ingredient in Predalon, is officially documented by regulatory authorities (such as the FDA and EMA) and is primarily shaped by its role as a potent gonadotropin hormone analog.

Frequency-Classified Adverse Reactions

Side effects are categorized by frequency based on clinical trials and regulatory assessment. Very Common adverse reactions, those occurring in 1 out of 10 people or more, often include headache, nausea, abdominal pain/cramps, and local reactions at the injection site (pain, bruising, inflammation). Common reactions, occurring in 1 to 10 out of every 100 people, may involve vomiting, emotional disturbance, rash, and irritability.

Systemic and Serious Adverse Reactions

The most significant safety focus in regulatory documents is on the Reproductive System and Vascular Disorders. Serious adverse reactions explicitly documented include Ovarian Hyperstimulation Syndrome (OHSS), a condition of rapid ovarian enlargement that can lead to fluid accumulation and electrolyte imbalance, and Thromboembolic Events (blood clots), which include conditions like deep venous thrombosis and pulmonary embolism.

Other adverse effects are classified across systems, including the Nervous System (headache, depression) and Gastrointestinal System (nausea, diarrhea).

Population-Specific Safety Considerations

Specific safety statements are documented for certain populations. In males/children, the treatment may induce precocious puberty or gynecomastia, requiring close safety assessment. For women undergoing fertility treatment, the risks of multi-fetal gestation and ectopic pregnancy are explicitly noted. Furthermore, regulatory labels advise caution in patients with pre-existing conditions sensitive to fluid retention, such as certain cardiac or renal diseases, due to the hormone's potential for androgen-induced fluid effects.

Overdose and Emergency Response

The primary documented manifestation of overexposure to Chorionic Gonadotropin (hCG) is the development of Ovarian Hyperstimulation Syndrome (OHSS), a condition classified as potentially life-threatening. The most critical risk factor is administration during controlled ovarian stimulation protocols, where the risk and duration of the syndrome are increased if pregnancy occurs.

Documented Overdose Presentations

The official labeling describes OHSS symptoms including severe pelvic pain and abdominal distension, rapid weight gain, nausea, and vomiting. Physiological changes documented in regulatory sources include oliguria, hemoconcentration, and significant electrolyte imbalances. Severe outcomes include documented risks of arterial and venous thromboembolism, acute pulmonary distress syndrome, and ovarian cyst rupture. In pediatric male patients, overexposure may result in signs of precocious puberty.

Required Emergency Response

The labeling specifies that patients must seek immediate medical attention and the medication must be discontinued immediately if signs of severe OHSS or a life-threatening complication are observed. Hospitalization may be required for the management of the severe form of OHSS. As no specific antidote is known, management is limited to symptomatic and supportive treatment, typically involving bed rest and careful fluid and electrolyte management.

Therapeutic Uses of Predalon

Quick Facts

  • Supportive use in: Certain allergic states and severe inflammatory conditions.
  • Key therapeutic areas: Rheumatic, dermatologic, respiratory, and gastrointestinal diseases.
  • Purpose: To assist in the management of specific immune and inflammatory responses.

Predalon is a prescription medication utilized in supportive management across various therapeutic domains. Its primary role is to assist the body's processes in reducing manifestations associated with specific severe inflammatory and autoimmune conditions.

This agent may be administered to help control severe, self-limiting exacerbations in conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is also an option for use during acute episodes of certain gastrointestinal disorders, including regional enteritis (Crohn's disease) and ulcerative colitis.

In dermatologic care, Predalon may contribute to the temporary management of conditions like pemphigus, severe psoriasis, and bullous dermatitis herpetiformis. Furthermore, it is indicated to support the control of severe or incapacitating allergic conditions that have not adequately responded to typical treatments.

The medication may also be employed in the palliative management of select hematologic and neoplastic conditions, as well as to assist in the remission of proteinuria linked to certain types of nephrotic syndrome.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Eligibility Overview

Official regulatory information defines clear restrictions for the use of Predalon (prednisolone). Most adults and children for whom the medicine is indicated are eligible; however, specific populations are strictly excluded or require special clinical consideration.

Classification Population/Condition
Contraindicated Patients with systemic fungal infections.
Patients with known hypersensitivity to the drug or any component.
Special Caution/Restriction History of tuberculosis, herpes infection of the eyes, stomach ulcers, osteoporosis, high blood pressure, diabetes, liver cirrhosis, or kidney dysfunction.
Patients receiving immunosuppressive doses must not receive live or live attenuated vaccines.

Age and Physiological Restrictions

  • Pediatric Use: Use in children must be carefully monitored for potential growth and development suppression with long-term therapy.
  • Pregnancy: The medicine carries a documented risk of embryo-fetal toxicity, and fetal harm can occur with use, particularly during the first trimester.
  • Lactation: The drug passes into breast milk, requiring a clinical decision to weigh the potential benefit against possible hazards to the nursing infant.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Predalon (Chorionic Gonadotropin) is defined by a high degree of specificity, with government documents noting a lack of traditional drug-drug interactions (DDI) but emphasizing critical consequences stemming from its inherent hormonal activity.


Interaction Scope

  • Medicinal product categories with documented interactions: None formally documented in pharmacokinetic interaction categories.
  • Specific interacting medicines (if explicitly listed): None explicitly listed.
  • Mechanistic basis of interactions (only if stated in label): The drug’s action stimulates androgen secretion, which can lead to fluid retention.
  • Timing-based interaction rules (if applicable): None documented.
  • Population-specific interaction notes (if applicable): Use requires special caution in patients with cardiac disease, renal disease, epilepsy, migraine, or asthma due to the officially documented fluid retention.
  • Interaction-related restrictions: The substance may interfere with radioimmunoassay for gonadotropins, particularly Luteinizing Hormone.

Interaction Classifications (High-Level)

  • Interaction severity classification (as defined in official documents): Not applicable to formal DDI. The note is a regulatory Use With Caution constraint.
  • Regulatory basis (EMA / FDA / etc.): U.S. Food and Drug Administration (FDA) Prescribing Information.
  • Interaction-context constraints (as defined in official documents): Population-specific caution; Procedural constraint due to interference with diagnostic tests.

Resulting Interaction Structure

Official interaction statements:

  • No known traditional drug-drug interactions are documented in the regulatory prescribing information.
  • The substance can officially cause androgen-induced fluid retention (edema) as a result of its pharmacodynamic effect.
  • The medicine may interfere with laboratory tests that measure the concentration of other hormones.
  • Use requires special caution in patients with cardiac disease, renal disease, epilepsy, migraine, or asthma due to the risk of exacerbation linked to the fluid retention.

Connection to the overall interaction profile (2–4 sentences): Regulatory documents define this product’s interaction structure primarily by the absence of official pharmacokinetic interactions and the presence of a pharmacodynamic-based consequence (fluid retention) that necessitates specific population-dependent restrictions. The official profile is further limited to a procedural constraint concerning drug-test interference that may affect the accurate measurement of endogenous hormone levels.

Mechanism of Action

How Predalon Works: Mechanism of Action

Predalon, containing Chorionic Gonadotropin (hCG), operates through a precise mechanism that functionally mimics the body's natural signaling molecule, Luteinizing Hormone (LH). This action is dependent on stimulating receptors and pathways located on target reproductive organs.

The mechanism initiates when the hCG molecule binds as a full agonist to the Luteinizing Hormone Receptor (LHR), a G-protein coupled receptor found on specific gonadal cells (ovarian follicular and Leydig cells). Unlike endogenous LH, hCG's structure ensures sustained receptor occupancy, resulting in a prolonged activation of the intracellular signaling cascade required to complete cellular events.

This sustained LHR activation triggers a downstream increase in the second messenger cAMP, which rapidly upregulates the required steroidogenic enzymes within the target cells. This molecular sequence drives the final step in hormone production, resulting in the synthesis and secretion of Progesterone (in the corpus luteum) or Testosterone (in Leydig cells).

The combined effect of prolonged LHR signaling and the subsequent local surge in steroid hormones facilitates necessary cellular transformations. This ensures the completion of oocyte maturation and triggers luteinization, the differentiation process that converts the ruptured follicle into the functional corpus luteum. This action facilitates the physiological consequence of the LH signal.

Dosage and Administration Information

How to Use Predalon (Chorionic Gonadotropin)

The administration of Predalon follows a framework that defines the preparation, route, and dosing schedule. This section outlines the procedural parameters for its use.

Route and Preparation

Predalon is supplied as a sterile, lyophilized powder for solution for injection. The required administration route is parenteral, typically through Intramuscular (IM) injection. The powder must be reconstituted immediately before use with the provided diluent. The preparation process involves gently agitating the vial until the powder is dissolved, and it is specified not to shake the solution.

Dosing Regimens

Dosing is not standardized but depends on the condition being addressed, requiring adherence to the specified regimen:

Indication Standard Regimen (Frequency) Duration Pattern
Ovulation Induction 5,000 to 10,000 USP Units (Single dose) Timed for one day after last dose of an FSH preparation.
Hypogonadism (Male) 4,000 to 5,000 USP Units (3 times weekly) Typically 6 to 9 months, followed by an optional lower-dose phase.
Cryptorchidism 4,000 USP Units (3 times weekly) Short course, typically 2 to 3 weeks.

Administration Requirements

This medication requires close medical supervision by a physician experienced in fertility issues, and its administration is structured into timed or cyclic courses. Human Chorionic Gonadotropin has not been demonstrated to be effective for weight reduction and must not be used for that purpose.

Recent Clinical Evidence

Research evidence / Overview of studies for Predalon


Evidence for Supportive Use in Severe Inflammatory and Autoimmune Conditions

The research base for Predalon's use as a supportive agent in conditions such as rheumatoid arthritis, severe psoriasis, and ulcerative colitis is characterized by its focus on understanding the underlying biological processes. Research explored the role of the medicine's active ingredient, Chorionic Gonadotropin (hCG), in immune system function. The work completed so far contributes to the broader evidence landscape but does not yet include large-scale clinical trials evaluating clinical effects in human patients for these specific chronic diseases.

Types of Studies and Outcomes Examined

Most of the evidence in this area stems from pre-clinical mechanistic studies. These include laboratory work using cell cultures (in vitro) and animal models of inflammatory disease. Researchers examined outcomes related to immunological markers. Studies monitored key immunological markers, such as the proportion of specific immune cells (e.g., regulatory T cells, or Tregs) and the measured levels of pro-inflammatory substances (e.g., cytokines like TNF-alpha and IL-6). These studies explored changes measured during the study period and often reported that the active ingredient was associated with measurable shifts in immune cell activity. These findings provide context regarding observed biological changes, but research does not determine whether an individual will respond similarly.


Long-Term Studies and Follow-up Data

Research exploring short-term symptom changes monitored responses over defined time intervals that are typically brief. Studies focusing on this supportive use have generally employed short observation periods. This means there is limited information for long-term outcomes, and the data do not determine how any changes observed during the study period may be maintained over a sustained duration. The research provides context but not individual predictions regarding the sustainability of observed patterns. Long-term effects are not fully established.


What Is Still Uncertain About Predalon's Research Base

A significant limitation in the research base is the lack of comparative evidence and large-scale, controlled studies in human patients. While the medicine was studied for its potential to influence immune responses, certainty remains low regarding its clinical impact on conditions characterized by fluctuating or episodic manifestations. The evidence is limited to pre-clinical and mechanistic findings, and data are still emerging.

Key Studies & References Label: CHORIONIC GONADOTROPIN kit - DailyMed (National Library of Medicine)

Frequently Asked Questions (FAQ)

Common questions about Predalon (FAQ)

Q: Can I take Predalon with common supplements like Vitamin D?

Official product information generally focuses on prescription drug interactions and notes that no traditional drug-drug interactions are documented for Predalon. The regulatory labeling does not list specific warnings or contraindications related to common dietary supplements or vitamins like Vitamin D.

Q: Is Predalon considered a high-risk medication by regulators?

Regulatory documents indicate that the use of Predalon requires careful consideration due to the potential for serious side effects. Official labeling includes warnings about potentially life-threatening risks, such as Ovarian Hyperstimulation Syndrome (OHSS) and the formation of Thromboembolic Events (blood clots).

Q: Does Predalon require specific laboratory monitoring?

Official product information indicates that the medical procedure often includes regular monitoring of the patient's ovarian response. This monitoring is typically done through diagnostic tests, such as checking serum estradiol levels and performing transvaginal ultrasounds.

Q: Can Predalon be taken alongside medications for chronic conditions like diabetes?

While the official label notes a lack of traditional drug-drug interactions, special caution is advised for patients with certain chronic conditions. This is because the drug can cause fluid retention, which may worsen pre-existing conditions like cardiac disease, kidney dysfunction, or diabetes.

Q: Is weight gain or loss a known effect of Predalon?

According to regulatory warnings, sudden weight gain can be an early and important sign of a serious side effect called Ovarian Hyperstimulation Syndrome (OHSS). Official labeling also explicitly states that this drug has not been demonstrated to be effective for weight reduction.

Q: What is the shelf life of Predalon?

Official product information provides stability details for both forms of the medicine. The unreconstituted powder is labeled for storage at controlled room temperature until its expiration date. The reconstituted solution is labeled as requiring refrigeration and should be discarded if not used within 60 days.

Q: What are the differences between the various strengths or forms of Predalon?

The drug is supplied in different unit strengths, such as 5,000 USP Units or 10,000 USP Units, as a lyophilized powder. The specific strength prescribed is based entirely on the medical condition being treated and the official dosing regimen.

Q: How quickly should I expect to see effects from Predalon?

Studies summarized in the official labeling describe the drug's action over time. Following an intramuscular injection, the active ingredient begins to increase in the bloodstream within two hours and generally reaches its peak concentration within six hours.

Q: Are there any major diet restrictions when using Predalon?

Official regulatory labeling does not list any specific diet or food restrictions that are noted in the product information.

Q: How long does Predalon typically stay in your system?

Pharmacokinetic studies show that the active substance is eliminated from the body in a two-phase process. The substance is typically detectable in the bloodstream for up to 72 hours after administration, with the final phase of elimination being the longest.

Q: Where can I find the official clinical trial results for Predalon?

Official prescribing information, including summaries of clinical trial data, is made publicly available by government bodies. You can typically find these authoritative documents on websites such as the U.S. Food and Drug Administration (FDA) and the DailyMed database.

Q: Are there any known interactions between Predalon and alcohol?

Regulatory documents regarding drug-drug interactions for Predalon do not specify any interaction with alcohol.

Q: Is Predalon available as a generic drug?

The active ingredient, Chorionic Gonadotropin (hCG), is described in official records as being available under multiple brand names and generic names. The availability of generic alternatives is listed in government databases such as the FDA's Approved Drug Products.

Q: Why do people sometimes discuss Predalon for conditions other than its main purpose?

This drug is often discussed by users in relation to weight reduction, but regulatory labeling strictly prohibits this use. The official documents explicitly state that the drug has not been demonstrated to be effective for weight loss.

Q: Is Predalon considered suitable for use in older patients?

According to the official regulatory documents, studies to date have not demonstrated geriatric-specific problems that would limit the usefulness of the active ingredient in older patients.

Q: What information is given in the official Patient Information Leaflet (PIL) for Predalon?

The Patient Information Leaflet is a required document that contains essential information written for patients. It typically outlines the drug's use, instructions for preparation, a list of potential side effects, and important warnings, such as Ovarian Hyperstimulation Syndrome (OHSS).

Q: How soon after stopping Predalon do the effects wear off?

The therapeutic effects of the drug generally diminish as the substance is eliminated from the body. Since the substance remains in the body for several days, the effects typically wear off gradually over the course of several days after the last injection.

Q: Who regulates the safety of Predalon?

The safety and efficacy of the drug are overseen by national governmental regulatory bodies. In the United States, for example, this responsibility falls to the U.S. Food and Drug Administration (FDA).

Q: Does Predalon carry a Black Box Warning?

The official U.S. regulatory labeling for the active ingredient, Chorionic Gonadotropin, does not contain a Black Box Warning. A Black Box Warning is the FDA's strictest warning required for certain serious risks.

Q: Can Predalon be used if someone has a history of cancer?

Regulatory documents list specific contraindications related to cancer history. Use is officially contraindicated in patients with tumors of the hypothalamus, pituitary gland, ovary, breast, uterus, or prostate, especially those that are androgen-dependent.

Q: Is it necessary to limit physical activity while taking Predalon?

Official regulatory warnings advise that if a serious side effect like Ovarian Hyperstimulation Syndrome (OHSS) occurs, limiting physical activity and avoiding strenuous exercise is noted as a necessary precaution. This is due to the potential risk of ovarian rupture associated with the condition.

How should Predalon be stored and disposed of?

How to Store and Dispose of Predalon?

Predalon is supplied as a lyophilized powder, requiring specific storage conditions that change after the medication is prepared for injection (reconstituted).


Storage Requirements

  • Unreconstituted Powder: Store at controlled room temperature, between 20 C to 25 C (68 F to 77 F), in the original container. The powder must be protected from light and excessive moisture.
  • Reconstituted Solution: The solution requires refrigeration, stored between 2 C to 8 C (36 F to 46 F). Do not freeze the reconstituted solution.

Stability and Child Safety

The reconstituted solution must be used completely within 60 days; any remaining product must be discarded after this period or the expiration date. All forms of the medicine and associated injection supplies must be kept out of the reach of children.

Disposal Instructions

Used needles and syringes must be placed immediately into a puncture-proof sharps disposal container. Disposal of the sharps container and any leftover or expired medicine must follow state or local laws and regulations.

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

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