Dolostat

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Medically reviewed

Marina Burgos

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 Dolostat

Quick Facts

Property Description
Active ingredient Ketoprofen
Form Oral (capsule, tablet), Topical (gel, cream), Injectable solution, Suppository
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Pain, inflammation, and fever management
Origin Synthetic compound (Propionic acid derivative)

What Type of Medicine is Dolostat?

Dolostat is the medicinal preparation containing the active ingredient Ketoprofen, a substance widely recognized in clinical pharmacology as belonging to the Nonsteroidal Anti-inflammatory Drug (NSAID) pharmacological class. This compound is a synthetic compound derived from the propionic acid class, a category distinguished by its established efficacy in mitigating inflammatory responses and addressing musculoskeletal discomfort. The classification of Ketoprofen as a potent agent in this group is noted, particularly regarding its role in general pain and inflammation management. The fundamental classification as an NSAID defines its therapeutic profile, distinguishing it from non-anti-inflammatory analgesics by its dual capacity to provide both symptomatic relief and reduce the underlying inflammation.

Composition, Forms, and General Therapeutic Role

The efficacy of Dolostat relies on Ketoprofen as a single-ingredient product, which functions by inhibiting the Cyclooxygenase (COX) enzymes to reduce the synthesis of prostaglandins, key chemical mediators of inflammation and pain. The preparation is manufactured in several specialized dosage forms to facilitate varied routes of administration, including oral preparations (such as tablets and capsules), a sterile solution for injection for systemic use, and localized topical forms (such as a gel or cream). This extensive range of forms is a differentiating factor, providing flexibility in clinical management, whether targeting acute localized swelling or systemic pain states. The collective goal of these different forms is to provide a comprehensive anti-rheumatic agent that delivers an analgesic effect, an anti-inflammatory effect, and an antipyretic effect.

Regulatory References

  1. Ketoprofen: MedlinePlus Drug Information

What side effects are possible with Dolostat?

Possible Side Effects and Safety Information

The official safety documentation for Dolostat (Ketoprofen) classifies potential adverse effects based on the physiological system affected and their reported frequency.

Adverse Reaction Scope

Classification System-Organ Class (SOC) Examples
Common Effects on the Gastrointestinal system (dyspepsia, nausea, abdominal pain, diarrhea, constipation), Nervous system (headache, dizziness, drowsiness), and general effects (tinnitus, nervousness).
Rare Severe hepatic (liver) reactions, acute renal (kidney) failure, and photosensitivity reactions.

Serious Adverse Reactions

Regulatory documents emphasize two primary serious, class-specific constraints which can occur without warning and may be fatal:

  • Serious Gastrointestinal Events: An increased risk of bleeding, ulceration, and perforation of the stomach or intestines.
  • Serious Cardiovascular Thrombotic Events: An increased risk of myocardial infarction (MI) and stroke. The risk may begin early in treatment and is associated with longer duration of use and higher dose levels.

Population-Specific Safety Constraints

Official labels define specific considerations for certain patient groups:

  • Older Adults: At documented greater risk for serious gastrointestinal events.
  • Pregnancy: Use at or after 20 weeks of pregnancy is restricted due to the potential risk of fetal renal dysfunction. Use around or after 30 weeks is constrained by the risk of fetal cardiopulmonary toxicity.
  • Surgical Restriction: The medication is contraindicated for the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Dolostat (Ketoprofen) overdose describes documented clinical manifestations primarily affecting the Gastrointestinal (GI) and Central Nervous System (CNS). Reported presentations include nausea, vomiting (which may contain blood), stomach pain, diarrhea, drowsiness (lethargy), dizziness, headache, confusion, and ringing in the ears (Tinnitus). The physiological systems potentially affected also include the Renal/Metabolic and Cardiovascular systems.

Severity and Emergency Response

A large overdose or massive exposure is associated with the risk of severe, life-threatening systemic outcomes, including seizures, coma, acute renal failure, and serious GI bleeding or perforation. Regulatory guidance mandates that immediate medical help must be sought when an overdose is suspected or has occurred. Emergency response statements explicitly require calling the local emergency number or the national toll-free Poison Help hotline (1-800-222-1222).

Management and Monitoring

Management of this condition is based on symptomatic and supportive care, as regulatory documentation confirms that no specific antidote is known for Ketoprofen overdose. Procedural interventions may include gastrointestinal decontamination with gastric lavage or oral activated charcoal. Monitoring requirements include observation of vital signs, ECG, blood/urine tests, and other diagnostic procedures. A large overdose can cause serious damage to both children and adults.

Therapeutic Uses of Dolostat

What Dolostat Treats: Main Uses and Benefits

Dolostat (Ketoprofen) is commonly used across therapeutic domains where additional symptomatic support is needed, including in situations involving pain, inflammation, and fever.

The medication is generally applied in addressing symptoms related to inflammatory or irritative states that may become more noticeable or create functional strain. It is relevant in conditions characterized by periods of heightened symptoms, specifically those linked to chronic joint conditions like rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute gout flares. This application helps address symptom clusters that may become more noticeable, such as those involving stiffness, swelling, or tenderness.

The medication is also relevant for easing symptoms associated with acute or episodic changes, such as the cramping and discomfort of primary dysmenorrhea (menstrual pain), pain following minor surgical procedures, and the symptoms of systemic fever. Applied during phases when symptoms become more noticeable, it provides support that helps ease the overall symptom burden. It may assist with maintaining functional stability.


Quick Fact: Symptomatic Support for Inflammation
Commonly used for: Chronic joint conditions, acute trauma, and episodic pain.
Primary benefit: Contributes to easing the overall symptom load, which includes pain and swelling.
Scenarios: Soft tissue injuries, post-dental procedure discomfort, and menstrual cramps.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Dolostat's eligibility is strictly defined by regulatory documents, distinguishing between populations permitted, restricted, or prohibited from using the medicine. Adults 18 years are the primary population for prescription forms, while safety and efficacy are not established for the general pediatric population. Geriatric patients (age 65 years) are eligible but require use with caution and close supervision.

Use of Dolostat is contraindicated (absolutely prohibited) for several populations, including patients with known hypersensitivity to Ketoprofen, aspirin, or any other NSAID. It is also contraindicated for those with active peptic ulcer disease or gastrointestinal bleeding, and for women in the third trimester of pregnancy.

Eligibility is further constrained by specific health conditions. Patients with advanced renal disease, severe heart failure, or impaired hepatic function are typically required to avoid use or proceed with extreme caution under conditional limits. Furthermore, use is not recommended for women who are breastfeeding. This framework ensures eligibility aligns with established regulatory safety profiles.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dolostat (Ketoprofen) exhibits specific drug interactions officially documented in regulatory information, classified primarily as absolute prohibitions and pharmacodynamic risk intensifications.

Absolute Regulatory Prohibitions

The use of Dolostat is contraindicated for treating pain related to Coronary Artery Bypass Graft (CABG) surgery. It is also prohibited in patients with a history of allergic reactions, such as asthma or hives, following exposure to Aspirin or other NSAIDs. Co-administration with other NSAIDs (including COX-2 inhibitors) is not generally recommended by regulators.


Pharmacodynamic Risk Intensification

The official profile notes a documented synergistic effect with oral anticoagulants (e.g., Warfarin), which increases the risk of serious gastrointestinal bleeding. The risk of GI ulceration is also increased when co-administered with oral corticosteroids, antiplatelet agents, or SSRIs. Furthermore, Ketoprofen can officially diminish the therapeutic effects of ACE-inhibitors, ARBs, and Diuretics and cause an elevation of plasma lithium levels by reducing renal clearance.


Exposure Modification

Co-administration with Probenecid officially reduces Ketoprofen’s plasma clearance, resulting in higher systemic drug exposure. Ingestion with food is documented to reduce the maximum plasma concentration (Cmax) by approximately 50%. Patients with chronic liver disease are noted to have altered pharmacokinetics, potentially leading to high blood levels, a population-specific consideration. Consumption of alcohol increases the labeled risk of gastrointestinal mucosal bleeding.

Mechanism of Action

Central Mechanism: Targeting the Cyclooxygenase Enzymes

The action of Dolostat (Ketoprofen) is fundamentally based on its role as a reversible inhibitor of the Cyclooxygenase (COX) enzymes, specifically targeting the COX-1 and COX-2 isoforms. This molecular interaction directly affects the body's Arachidonic Acid Metabolism pathway, a biological system involved in creating lipid mediators. By suppressing the activity of these enzymes, the drug modifies early molecular steps that determine systemic physiological outcomes.


Physiological Cascade: Pain and Inflammation Modulation

By limiting the conversion of arachidonic acid into prostaglandins and thromboxanes, the drug engages mechanisms that influence mediator activity at the site of tissue damage. The resulting reduction in prostaglandin E2 ( PGE2) modifies the activity profile of the mediator system, preventing the sensitization of peripheral nociceptors and modulating activity within inflammatory pathways. This alters the resulting physiological response profile, which defines the drug’s observable effect.


Hypothalamic Set Point Adjustment

The central presence of Ketoprofen influences specific regulatory systems within the brain. The drug suppresses PGE2 synthesis in the hypothalamus, the body's thermoregulatory center. This action allows the hypothalamic set point to reset, resulting in physiological adjustments that modulate an elevated body temperature.

Dosage and Administration Information

Official Administration Guidelines

Dolostat (Ketoprofen) is available in several forms, including oral (immediate-release and extended-release capsules/tablets), topical (gel), and parenteral (injectable solution), with the specific route chosen according to official guidance.

The standard approach to use is governed by the mandated lowest effective dose for the shortest duration necessary to achieve symptomatic relief. For chronic conditions, immediate-release oral forms are typically administered in divided doses, such as 50 mg four times daily or 75 mg three times daily, with a maximum daily limit of 300 mg. Extended-release capsules are dosed at 200 mg once daily.

Procedural instructions specify that oral forms may be consumed with food, milk, or antacids; this procedural step is intended to minimize gastrointestinal discomfort and slows the absorption rate without altering the drug's total bioavailability. It is a mandatory administration step that extended-release capsules must be swallowed whole and should not be crushed or chewed.

Furthermore, official labels mandate population-specific adjustments. A lower initial dose should be initiated for older adults, and a reduction in the maximum daily dose is required for patients with severe renal or hepatic impairment. The concomitant use of immediate-release and extended-release products is not recommended due to the risk of exceeding the total daily dose limit.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dolostat

Dolostat was studied in research exploring how symptoms change over time across various conditions characterized by fluctuating manifestations. Evidence is rooted in Controlled Trials (RCTs) and systematic reviews, focusing on short-term symptom changes and patient-reported outcomes.


Evidence for Use in Chronic Joint Conditions

Research has explored both oral and topical preparations for conditions such as osteoarthritis and rheumatoid arthritis in adults and the elderly. Study outcomes was evaluated in trials assessing functional status (mobility scores) and pain intensity. The collected data show patterns related to measured differences in global condition assessment over time. However, long-term effects are not fully established, and this evidence is often based on older studies.


Evidence for Use in Acute Pain and Inflammation

This section outlines trials that was studied for acute situations, including soft tissue injuries, postoperative pain, and episodic visceral pain.

Acute Localized Injuries and Inflammation

Research examined the use of both topical and oral formulations in addressing acute musculoskeletal discomfort. Studies monitored changes in spontaneous pain intensity and required usage of additional pain relief medication over short follow-up periods (typically 7 to 21 days).

Acute Pain Following Procedures

Evidence is derived from systematic reviews of single-dose Randomized Controlled Trials (RCTs). These studies was evaluated in research exploring immediate short-term symptom changes following surgery, focusing on the proportion of participants who reached a pre-defined threshold of pain relief over the initial 4 to 6 hours.


Long-Term Studies and Follow-up Durations

Available evidence, especially for the topical forms, has been studied for periods of only a few weeks to a few months. Therefore, there is limited information for long-term outcomes regarding the durability of response or patterns of symptom management spanning many years.


Evidence in Specific Patient Groups

Research was evaluated in specific patient groups to explore outcomes related to physical discomfort. Older adults with chronic joint conditions were studied for functional outcomes. For episodic visceral pain (primary dysmenorrhea), research focused on women of reproductive age. However, sample sizes were modest in some foundational studies.


Research Gaps and Areas of Uncertainty

The follow-up durations were limited in many trials, meaning long-term effects are not fully established. Furthermore, evidence quality varies across studies, and comparative data against the full range of alternative treatments is lacking in certain areas. Subgroup findings are uncertain when specific demographic groups are separated from the main trial populations.

Key Studies & References

  1. Ketoprofen: MedlinePlus Drug Information (NIH/NLM authoritative drug information)

Frequently Asked Questions (FAQ)

Common questions about Dolostat (FAQ)

Q: How quickly do the effects of Dolostat usually begin?

According to the official product information, when taking the extended-release forms, the medicine begins to show up in the bloodstream about 2 to 3 hours after administration. The concentration that indicates its peak level is typically reached 6 to 7 hours after the dose is taken. This indicates the time frame for maximum absorption into the body.

Q: If I miss a dose of Dolostat, what usually happens?

Patient information leaflets for medicines in this class generally recommend that if a dose is forgotten, it is taken as soon as it is remembered. However, if it is already close to the time for the next scheduled dose, general guidance suggests skipping the missed one and returning to the regular schedule. Taking a double dose to compensate for the missed one is generally not advised in official guidance.

Q: What happens if I suddenly stop using Dolostat?

Abrupt discontinuation of this type of medicine is generally not associated with defined withdrawal symptoms. However, if the medicine is used for a condition where it was replacing a corticosteroid, abruptly stopping the steroid could potentially lead to a worsening of the underlying condition. Any decision regarding the discontinuation of therapy should involve consultation with a healthcare provider.

Q: Is the active ingredient in Dolostat available under different names?

Yes, the active ingredient in Dolostat is Ketoprofen. Official records indicate that this substance is or has been available under various brand names, such as Orudis or Oruvail, depending on the region and the specific formulation. It is also commonly available as a generic medicine.

Q: How long does Dolostat stay in the system after the last intake?

Based on the clinical pharmacology data, the time it takes for half of the drug to be eliminated from the bloodstream, known as the elimination half-life, is reported to be approximately 2 hours. This is a measure of how the body processes the medicine over time.

Q: Can Dolostat cause weight changes, according to regulatory data?

The official product label does not specifically list general weight change as a common or serious side effect. However, regulatory warnings are issued for fluid retention and edema (swelling). This fluid build-up can sometimes be reported as unexplained weight gain, and this symptom is generally advised to be brought to the attention of a healthcare provider.

Q: Does Dolostat require any special monitoring by a healthcare provider?

Official warnings indicate that because this medicine can potentially affect the kidneys and liver, and influence blood pressure, certain at-risk patients may require close attention. Healthcare providers may consider monitoring these conditions (such as blood pressure, kidney function, or liver function) through routine checks, particularly for high-risk individuals.

Q: Does Dolostat have a known risk of dependence or withdrawal symptoms?

Regulatory agencies, such as the FDA, have not classified Dolostat (Ketoprofen) as a controlled substance. As a result, official drug information does not document a risk of dependence or significant withdrawal symptoms associated with its use.

Q: Is there a generic version of Dolostat available?

Yes. According to drug regulatory listings, lower-cost generic versions of the active ingredient, Ketoprofen, are generally available by prescription. Generic medicines contain the same active ingredient and are regulated to meet the same standards.

Q: Has Dolostat been studied in people with diabetes?

The official product label does not include dedicated studies focused on people with diabetes. However, it does note a potential interaction if this medicine is used alongside metformin, a common diabetes medication. Due to the drug’s potential effect on the kidneys, in this scenario, close monitoring of kidney function by a healthcare provider may be deemed necessary.

Q: Does the time of day matter when taking Dolostat?

The official dosing instructions specify taking the immediate-release form in divided doses throughout the day or the extended-release form once daily. While a consistent schedule is required to maintain the medication's level in the body, the label does not mandate a specific time of day (such as morning or night) for administration.

How should Dolostat be stored and disposed of?

Dolostat must be stored at Controlled Room Temperature, which is officially defined as 20 to 25 C (68 to 77 F), with temperature excursions permitted up to 30 C (86 F) [1.1], [1.6]. The medication must be kept from freezing and protected from excessive heat above 40 C (104 F) [1.6], [2.4].

For containment, the product must be dispensed in a tight container with a child-resistant closure and must be kept out of the reach of children [1.1], [2.4]. The container must be kept tightly closed to minimize exposure to moisture, and certain formulations require protection from light [2.10], [2.5].

Disposal must be conducted safely; regulators advise against flushing the product or discarding it in household trash, instead recommending the use of authorized take-back programs or consultation with a pharmacist [2.9], [2.10].

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

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