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Ritodrine | CAS No: 26652-09-5 | GMP-certified suppliers
A medication that acts as a tocolytic agent for the treatment and prevention of premature labor by relaxing uterine smooth muscle to delay preterm birth.
Therapeutic categories
Primary indications
- For the treatment and prophylaxis of premature labour
Product Snapshot
- Ritodrine is available as injectable solutions for parenteral administration and oral tablets
- It is primarily used for the treatment and prophylaxis of premature labor
- Ritodrine holds approved and investigational status in the Canadian pharmaceutical market
Clinical Overview
Pharmacologically, ritodrine targets beta-2 adrenergic receptors located on the smooth muscle cells of the uterus. Upon binding, it activates adenylate cyclase via the beta-2 receptor, which leads to an increase in intracellular cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP results in reduced intracellular calcium concentrations, thereby inducing relaxation of uterine smooth muscle and suppression of premature contractions.
Key pharmacokinetic properties include absorption characteristics and metabolic pathways typical of beta-2 adrenergic agonists, though specific ADME data for ritodrine are variable and should be confirmed via regulatory dossiers or pharmacopoeial standards. It is important to consider that ritodrine’s systemic adrenergic effects may extend beyond the uterus, potentially affecting cardiovascular parameters such as heart rate and blood pressure.
Safety considerations include the risk of tachycardia, hypertension, and other adrenergic-mediated adverse effects. Monitoring cardiovascular status during treatment is advisable. Contraindications and usage restrictions must align with regulatory guidance as ritodrine has a narrow therapeutic index and variable approval status worldwide.
Ritodrine is classified within multiple groups including adrenergic agents, beta-2 adrenergic agonists, sympathomimetics, tocolytic agents, and reproductive control agents. It has been incorporated into clinical protocols for managing preterm labor under diverse brand names and formulations in regions where it remains approved or investigational.
For pharmaceutical development and API procurement, sourcing ritodrine requires rigorous attention to purity, assay, and impurity profile consistent with international pharmacopeias or regulatory pharmacological monographs. Quality control should ensure compliance with global regulatory frameworks to support safe formulation and therapeutic use.
Identification & chemistry
| Generic name | Ritodrine |
|---|---|
| Molecule type | Small molecule |
| CAS | 26652-09-5 |
| UNII | I0Q6O6740J |
| DrugBank ID | DB00867 |
Pharmacology
| Summary | Ritodrine is a beta-2 adrenergic receptor agonist that increases intracellular cAMP levels, leading to decreased calcium concentrations in uterine smooth muscle cells. This reduction in calcium inhibits myosin light chain kinase activity, resulting in relaxation of the uterine muscle and suppression of premature contractions. The compound primarily targets beta-2 adrenergic receptors and associated ion channels involved in smooth muscle contractility. |
|---|---|
| Mechanism of action | Ritodrine is beta-2 adrenergic agonist. It binds to beta-2 adrenergic receptors on outer membrane of myometrial cell, activates adenyl cyclase to increase the level of cAMP which decreases intracellular calcium and leads to a decrease of uterine contractions. |
| Pharmacodynamics | Beta-2 adrenergic receptors are located at sympathetic neuroeffector junctions of many organs, including uterus. Ritodrine is beta-2 adrenergic agonist. It stimulates beta-2 adrenergic receptor, increases cAMP level and decreases intracellular calcium concentration. The decrease of calcium concentration leads to a relaxation of uterine smooth muscle and, therefore, a decrease in premature uterine contractions. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-2 adrenergic receptor | Humans | agonist |
| Beta adrenergic receptor | Humans | agonist, downregulator |
| ATP-sensitive potassium channel | Humans | activator |
ADME / PK
| Half-life | 1.7-2.6 hours |
|---|---|
| Protein binding | ~56% |
| Metabolism | Hepatic, by both the mother and fetus |
Formulation & handling
- Ritodrine is a small molecule API available for both oral and parenteral (intramuscular, intravenous) administration, enabling flexible route selection.
- Low water solubility (0.179 g/L) requires solubilization strategies in injectable formulations to ensure bioavailability and stability.
- Solid state handling must consider potential sensitivity to moisture, given its peptide-like dosing forms, although no specific stability issues were noted.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in Canada, with patent protection having expired, allowing for the availability of generic versions and indicating a mature market phase. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Ritodrine is manufactured by several originator companies including Abraxis Pharmaceutical Products, Hospira Inc, and AstraZeneca LP, with packaging handled by Solvay Pharmaceuticals. Its branded products, such as Yutopar, are primarily marketed in Canada. Patent expiration status is not indicated, but the presence of multiple manufacturers suggests potential availability of generic alternatives. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=64mg/kg (mice, IV); LD<sub>50</sub>=540 mg/kg (mice, oral); LD<sub>50</sub>=85 mg/kg (rat, IV) |
|---|
- Handle with appropriate personal protective equipment due to low intravenous LD50 indicating high acute toxicity
- Avoid inhalation and ingestion
- Ensure adequate ventilation during processing to minimize exposure risk
Ritodrine is a type of Uterotonics
Uterotonics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the field of obstetrics and gynecology. These drugs are primarily employed to induce or enhance uterine contractions, thereby promoting labor and preventing postpartum hemorrhage.
Uterotonics exert their pharmacological effects by targeting specific receptors in the smooth muscle of the uterus. One of the most commonly used uterotonics is oxytocin, a hormone naturally produced by the body during childbirth. Synthetic forms of oxytocin, known as oxytocin analogs, are also utilized in medical settings to initiate or augment labor.
In addition to oxytocin, other uterotonics include ergot alkaloids, such as methylergonovine, and prostaglandin analogs, such as misoprostol. These drugs act through different mechanisms to stimulate uterine contractions.
The administration of uterotonics requires careful monitoring and precise dosing to avoid complications. While they are generally safe and effective, uterotonics can cause side effects, including nausea, vomiting, and uterine hyperstimulation. Therefore, medical professionals closely monitor patients receiving uterotonics to ensure optimal outcomes.
Overall, uterotonics play a vital role in obstetric care, facilitating safe and efficient labor and preventing excessive bleeding after childbirth. These pharmaceutical APIs have significantly contributed to improving maternal and neonatal health worldwide, making them indispensable tools in the field of obstetrics and gynecology.
Ritodrine (Uterotonics), classified under Genitourinary Agents
Genitourinary agents are a category of pharmaceutical active ingredients (APIs) that are specifically designed to target and treat disorders related to the genitourinary system. The genitourinary system encompasses the organs and structures involved in the production, storage, and elimination of urine, as well as the reproductive organs.
These APIs play a crucial role in the treatment of various genitourinary conditions, including urinary tract infections (UTIs), erectile dysfunction, urinary incontinence, benign prostatic hyperplasia (BPH), and other related disorders. They exert their therapeutic effects by interacting with specific receptors or enzymes in the genitourinary system, regulating physiological processes, and restoring normal function.
Some commonly used genitourinary agents include alpha-blockers, which relax the smooth muscles in the prostate and bladder neck, improving urine flow in patients with BPH. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are widely prescribed for erectile dysfunction, as they enhance blood flow to the penile tissues, facilitating erection.
These APIs are typically formulated into various dosage forms, such as tablets, capsules, creams, gels, or injections, allowing for convenient administration to patients. The development and production of genitourinary agents involve stringent quality control measures and compliance with regulatory guidelines to ensure safety, efficacy, and consistent product performance.
In summary, genitourinary agents form a crucial category of pharmaceutical APIs used to treat a range of disorders affecting the genitourinary system. Their targeted mechanisms of action and diverse dosage forms make them valuable tools in improving genitourinary health and enhancing patients' quality of life.
Ritodrine API manufacturers & distributors
Compare qualified Ritodrine API suppliers worldwide. We currently have 3 companies offering Ritodrine API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Lundbeck Pharma | Producer | Italy | Italy | CoA, JDMF | 15 products |
| Lusochimica | Producer | Italy | Italy | CoA, JDMF | 23 products |
| Suzhou Lixin Pharmaceutic... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 34 products |
When sending a request, specify which Ritodrine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Ritodrine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
